April 2021
Detection of Human Papillomavirus using polymerase chain reaction methods in transitional urothelial bladder cancer
Mehmet Yıldızhan 1 , İzzet Koçak 2, Sevin Kırdar 3, Nil Çulhacı 4
1 Department of Urology, Ankara City Hospital, Ankara 2 Department of Urology, Adnan Menderes University, Medicine Faculty, Aydin 3 Department of Microbiology, Adnan Menderes University, Medicine Faculty, Aydin 4 Department of Pathology, Adnan Menderes University, Medicine Faculty, Aydin, Turkey
DOI: 10.4328/ACAM.20284 Received: 2020-07-20 Accepted: 2020-08-17 Published Online: 2020-09-07 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):353-357
Corresponding Author: Mehmet Yıldızhan, Ankara City Hospital, Department of Urology, 06600-Bilkent, Ankara, Turkey. E-mail: dr.mehmetyildizhan@gmail.com GSM: +90 5335499373 P: +90 3125526000 / 621549 Corresponding Author ORCID ID: https://orcid.org/0000-0001-8592-0874
Aim: In this study, we aimed to evaluate the role of low- and high-risk human papillomavirus (HPV) types in the etiology of different stages of transitional urothelial bladder carcinoma (TUBC).
Materials and Methods: The medical records of 212 patients operated between 2009 and 2014 were analyzed retrospectively. One hundred thirteen patients with TUBC who underwent transurethral resection and partial/total cystectomy with a diagnosis of bladder cancer were reviewed and compared with 99 control patients with non-neoplastic disorders. Formalin-fixed and paraffin-embedded archival tissue samples were used for deoxyribonucleic acid (DNA) ex- traction. Specimens were analyzed using polymerase chain reaction (PCR) with HPV-specific general primers set for the detection of viral DNA. PCR-positive samples were also tested using HPV type-specific primers with the same method. The presence of HPV was evaluated using MolecuTech REBA HPV-ID. Results: The median ages of the patients in the cancer and control groups were 68.5 (24-89) and 63.5 (28-83), respectively. None of the control patients exhibited HPV-DNA positivity. However, HPV-DNA positivity was observed in four patients (3.5%) in the cancer group. HPV types 6 and 84 are regarded as low risk, and 53 and 66 as high risk. There was no correlation between HPV infection and tumor development (χ2 df(1)=3.572, p=0.125). No statistically significant relationship was observed between HPV-DNA positivity and tumor grade. However, a statistically significant association was determined between smoking and the development of bladder cancer (p<0.001).
Discussion: Our study findings indicate a low prevalence of HPV infection in FFPE bladder cancers, and suggest that HPV infections are unlikely to play a major role in the development of TUBC.
Keywords: Bladder cancer; Human papillomavirus; PCR; Transitional cancers
Introduction
Bladder cancer is the seventh most common cancer among men worldwide, and the 11th most common cancer in both genders [1]. The incidence of bladder cancer and mortality rates vary from country to country due to differences in risk factors, detection and diagnostic practices, and the availability of treatments [2]. Several potential risk factors have been identified, including tobacco smoking, occupational exposure to aromatic amines, polycyclic aromatic hydrocarbons and chlorinated hydrocarbons, exposure to ionizing radiation, bladder schistosomiasis, chronic urinary tract infection, urinary calculi, and chronic irritation or inflammation of the urothelium [2]. The World Health Organization estimates that approximately 12% of cancer cases worldwide are caused by viral infections [5]. Various bacterial or viral agents in the bladder have been shown to cause dysplastic changes in the bladder epithelium and ultimately to lead to cancer [4].
Human papillomavirus is the principal agent of sexually transmitted diseases, and can cause cancers in different anatomical regions at differing prevalences [5]. The potential role of high-risk human papillomavirus (hrHPV) in the development of cancer of the cervix, penis, vulva, anus and oropharynx is already well established in a publication of the International Agency for Research on Cancer in 2007. The presence of hrHPV is the main initiator factor for dysplasia, and eventually cancer [6]. Since the urinary bladder is in direct connection with the genital area through the urethra, HPV may also play a causative role in bladder cancer. HPV is associated with the development of a variety of proliferative lesions, including papilloma, intraepithelial neoplasia, and invasive cancer. Since HPV is the leading infectious cause of human cancers, this makes bladder HPV infection of particular medical importance. Advances in HPV diagnosis may have immediate implications for the fight against cancer [6].
Material and Methods
The research was performed as a retrospective, cross- sectional, descriptive study. The medical records and bladder tissue specimens of the 212 patients operated in our clinic between 2009 and 2014 were analyzed retrospectively. The cancer group consisted of 113 patients who underwent transurethral resection and partial/total cystectomy with a diagnosis of bladder cancer, the pathology being confirmed as TUBC. The control group consisted of 99 patients with benign bladder pathologies. Patients without TUBC pathology were excluded from the study. The control group consisted of patients who underwent transurethral resection for suspected mucosal appearance and/or luminal mass with no history of bladder cancer, and whose pathology was reported as benign [inflammation, inverted papilloma, papilloma, and cystitis). Clinical information such as pathology reports, and data for age, education, smoking status, sexuality, age of sexual debut, marital status, and present history of sexually transmitted infections were collected from the hospital database and patient charts. Patients were categorized as smokers (currently active smokers or with a history of smoking) or non-smokers
(never smoked) for a common definition.
Formalin-fixed and paraffin-embedded (FFPE) archival tissue samples were used for deoxyribonucleic acid (DNA) extraction. Tissue samples 4 micrometers (μm) in thickness obtained from paraffin blocks after fixation with 10% neutral buffered formalin solution and hematoxylin-eosin (HE) staining were reviewed again. Specimens were analyzed using polymerase chain reaction (PCR) with HPV-specific general primer set for the detection of viral DNA. PCR-positive samples were also tested with HPV type-specific primers using the same method. Presence of HPV was analyzed using MolecuTech REBA HPV-ID. Written informed consent was obtained from the patients who participated in this study. All procedures performed in studies involving human participants were in accordance with the ethical standards of the Adnan Menderes University research with ADU-BAP-TPF 2014/55 permit number and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards, with ‘’Regulations on Pharmaceutical Research”, enforced by the Ministry of Health of Turkey published in the 27089 numbered Official Journal dated 23 December 2008 and also with other regulations published at a later date.
MolecuTech REBA HPV-ID test
This test can identify 18 high-risk HPV types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69 and 73) together with the possible high-risk type 34, and 13 low-risk group HPV types (6,11, 32, 40, 42,43, 44, 54, 70, 72,81, 84, and 87). The target of the test is the L1 gene, which is expressed in the late stages of infection. The test includes nested PCR and reverse hybridization steps. A commercial NucleoSpin Tissue mini-column (Macherey-Nagel, Duren, Germany) isolation kit was used for paraffin removal and deoxyribonucleic acid (DNA) isolation from the tissue. DNA isolation was performed according to the manufacturer’s instructions. PCR amplification of HPV-DNA was performed following the manufacturer’s instructions.
Evaluation
The strips were glued to the evaluation table, and the control line and the expected bands were matched. In the evaluation of each band
• The marker line indicates the top line of the membrane (Figure),
• The hybridization control (HC) line will appear if the chromogenic reaction is correctly prepared (Figure),
• The HPV universal probe band will form if no genotype of HPV is found (Figure) and,
• Each HPV type was assessed by observing the presence of band lines at the location (Figure).
Statistical Analyses
SPSS 22.0 for Windows software (IBM, Illinois, USA) was used for statistical analyses. Descriptive statistics were employed for assessing normality of distribution. Descriptive data were expressed as median values (min-max). The Chi-square and Fisher’s exact tests were used to evaluate consistency between categorical variables. The statistical threshold value was set at p <0.05.
Results
The median ages of the patients in the cancer and control groups were 68.5 (min: 24, max: 89) and 63.5 (min: 28, max: 83) years, respectively. Ninety-two (81.4%) of the patients in the cancer group were men, compared to 73 (73.7%) in the control group. Smoking rates were statistically significantly higher in the cancer group compared to the control group (p<0.001).
In terms of pathological cancer stages, 15 (13.3%) patients had papillary urothelial neoplasm of low malignant potential (PUNLMP), 65 (57.5%) had Ta urothelial carcinoma, 17 (15%) had T1 urothelial carcinoma, and 16 (14.2%) had T2 urothelial carcinoma. One patient with pT1 had comorbid carcinoma in situ, and two patients with pT2 exhibited squamous differentiation (Table 1). Low grade differentiation was seen in 64.6% (73) of the cancer group, and high grade differentiation in 35.4% (40). Pathological results of the patients in the control group were inflammation (acute and / or chronic) in 74 patients, polypoid cystitis in 14, inverted papilloma in two, papilloma in two, and cystitis cystica or von Brunn’s islands in eight.
Genital warts or sexually transmitted diseases were positive in nine (9.1%) and 12 (10.6%) patients in the cancer and control groups, respectively. The difference was not significant (p=0.710). HPV positivity (type 53) was detected in only one of the 21 patients with a positive history.
HPV positivity was detected in four patients (3.5%) using the multiplex PCR method. The HPV types involved were 6, 53, 66 and 84. HPV types 6 and 84 are in the low-risk group, and types 53 and 66 are in the high-risk group. The cancer was in the pathological T1 stage in all HPV-positive patients. HPV types 6, 53 and 66 cause high-grade urothelial cancer, while HPV type 84 causes low-grade cancer (Table 2).
All the HPV-positive patients were men, and smokers. None of the four patients had a history of sexually transmitted disease or treatment. No condyloma-like lesions were observed in the genital or perineal regions. HPV positivity was not detected in any of the women in the cancer group. There was no correlation between HPV infection and tumor development (χ2 df(1)=3.572, p=0.125). However, a statistically significant association was observed between smoking and the development of bladder cancer (p<0,001).
Discussion
According to U.S. data, bladder cancer is more than 2.5 times more common in men than in women [1]. In the present study, bladder cancer was four times more common in men. Bladder cancer is largely a disease of the elderly. The median age of our patients was 68.5 (min: 24, max: 89) in the cancer group and 63.5 (min: 28, max: 83) in the control group. Our findings confirm that bladder cancer is more common in the elderly population.
The relationship between HPV and TUBC is thought to be caused by the tendency of the virus to involve the epithelium and the anatomical proximity of the urethra to the bladder. This suggests that the male urethra may have a reservoir function and thus be implicated in at least the initial stage of bladder cancer. A carcinogenic role of hrHPV has been demonstrated in many previous studies [7-9]. And, also it was seen higher in male population according to our results.
The first study examining the relationship between HPV and bladder cancer was performed using the immunohistochemical (IHC) method with biopsy specimens in 1988 [9]. In 1992 Anwar and Phil showed that PCR was highly sensitive compared to IHC methods [10]. Several studies have investigated the relationship between bladder cancer and HPV using deparaffinized tissues with PCR methods [11-13]. The frequency of HPV as an etiological agent in studies evaluating the etiological role of HPV in TUBC pathogenesis varies between 0% and 80% [12-14]. This wide discrepancy in HPV detection rates between studies is due to problems in tissue fixation and DNA preparation and amplification, as well as problems that arise during sampling, contamination, the sensitivity of the scanning systems involved, and geographical differences [15,16].
There is still no consensus concerning the best molecular method for obtaining HPV-DNA in FFPE tissues. However, PCR with type-specific primers maintains remains the gold standard method by ensuring an overall HPV-DNA detection rate of 33.2% positivity in bladder cancer [17]. The commercial kit used in the present study can detect a total of 65 HPV types in the low-, medium-, and high-risk groups. However, technical failures in the methods employed to obtain DNA from deparaffinized tissue may explain the low rate of positivity. The principal difficulty in using FFPE tissues in genomic studies lies in the low quantity and quality of nucleic acid obtained from the blocks. The purpose of the FFPE method is to ensure that cellular proteins are preserved for future IHC-based studies, rather than providing good protection of nucleic acids. Fragmentation and degradation of nucleic acids due to chemical modification, and cross-linking to proteins and nucleic acids via amino groups (methylene bridges) can be caused by the formalin fixation process [18-21]. The extent of the potential damage to DNA resulting from the formalin fixation process is not entirely clear, although several different DNA damage mechanisms have been proposed. Formalin oxidized to formic acid causes breaks in nucleic acid in FFPE tissue. In order to obtain high-quality DNA, the tissue must be fixed with 10% buffered formalin for one day. The DNA quality of tissues treated for two days is 50% lower than that of one-day treatment. Keeping FFPE blocks in unsuitable environments, such as hot and humid conditions, and a long storage time can accelerate this process. At the same time, small and thin tissue to be fixed with formalin exhibited greater penetration by formalin and showed that DNA damage may increase. For all these reasons, the use of the DNA sample obtained for genomic analysis entails a number of limitations [22]. Studies have previously reported different success rates in processing FFPE samples for DNA sequencing [23,24]. This wide variability in sample viability will be affected by the age of the tissue block, the quality of DNA input, and the DNA sequencing methodology.
We used FFPE blocks obtained from the pathology archive for patients operated over a five-year period. A prolonged waiting period may cause tissue damage in FPFE blocks. Technical difficulties in block storage and deparaffinization may have caused our low HPV-DNA recovery rates. The number of samples in the control group was lower than that in the cancer group. This once again suggests the presence of formalin-induced DNA damage in low-volume samples. Although HPV has also been
detected in benign bladder pathologies, it was not observed in our control group. Re-examination of the pathology reports of four patients in the cancer group were re-examined and revealed that at least 5 cc of tissue sample had been removed in all four cases and sent to the pathology lab.
Common virus types, such as HPV types 16 and 18, which have been found to be associated with malignancy in previous studies [15] were not observed in the present research. Detection of types 6 and 84 in the low-risk group with low potential for cancer, and of types 53 and 66 in the high-risk group, does not support the view that hrHPV causes cancer at a higher rate. This is because two types of viruses implicated in the etiology of benign lesions such as genital warts were found to be associated with bladder cancer in the present study. Low-grade cancer was detected in three out of four patients with HPV positivity, while high-grade cancer was detected in only one patient. The presence of HPV type 84, from the low-risk group, in a patient with high-grade cancer does not support the idea that HPV causes higher risk cancers. The presence of a history of smoking in all four patients with HPV positivity suggests a more significant etiological relationship with smoking. The present study observed a statistically significant difference between smoking and cancer detection compared to the control group (p <0.001).
HPV-DNA positivity being observed in four patients suggested that HPV should not be implicated as an etiological agent in the development of transitional bladder cancer. HPV types 16 and 18, which were the most common types in other studies, were not detected in any of our patients. The relationship between the stage and grade of the tumor and the presence of HPV could not be evaluated due to the lack of sufficient HPV positivity. However, a statistically significant relationship between smoking and bladder cancer was shown in our research, in agreement with other studies.
In Li et al.’s study performed with fresh samples, the HPV-DNA prevalence was higher than in FFPE samples. Those authors stated that no DNA damage occurred, and that the possibility of HPV-DNA detection might therefore be higher without the formalin fixation steps [16]. Sarıer et al. also used fresh tissues, and observed significantly higher HPV-DNA positivity in the patient group [24]. However, in another study by Llewellyn et al. using the combined assay for HPV16/HPV18 sequences to analyze the DNA extracted from fresh frozen tissue specimens, the authors obtained a positive result for HPV in one out of the 689 UBCs tested (0.1%) whereas the internal control was positive in all cases [25]. Different results can thus be obtained with fresh tissues. In the light of these different findings, there is still no generally accepted method that provides a high rate of nucleic acid in fresh or FFPE tissues.
In conclusion, the role of HPV infection in the etiology of bladder cancer is still unclear, and the impact on bladder cancer development continues to be controversial. However, the majority of studies have reported a relationship between bladder cancer and HPV. However, the rate of detection of HPV, which plays an active role in the etiology of cervical cancer, in bladder cancer was 3.3% in this study. The differences in detection rates may be related to HPV prevalence in the populations in which studies are conducted. Further studies involving large and different populations are needed to confirm the association of bladder cancer with HPV reported in previous studies. In addition, the importance of carefully monitoring patients diagnosed with HPV type 16 and 18 infections and informing patients in terms of risks is self-evident.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: This study was supported by research funding from Aydin Adnan Menderes University with ADU-BAP-TPF-12014 fund number.
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Mehmet Yıldızhan , İzzet Koçak, Sevin Kırdar, Nil Çulhacı. Detection of Human Papillomavirus using polymerase chain reaction methods in transitional urothelial bladder cancer. Ann Clin Anal Med 2021;12(4):353-357
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The application of artificial intelligence for the detection of chorionic villi in the biopsy specimens
Syed Usama Khalid Bukhari 1, Syed Khuzaima Arsalan Bokhari 2, Ubeer Mehtab 3, Asmara Syed 4, Syed Sajid Hussain Shah 4
1 Department of Computer Science, University of Lahore Islamabad Campus, Pakistan, 2 Department of Pediatric Medicine, Doctors Hospital, Lahore, Pakistan, 3 Bahawal Victoria Hospital, Quaid e Azam Medical college, Bahawalpur, Pakistan, 4 Department of Pathology, Faculty of Medicine, Northern Border University, Arar, Kingdom of Saudi Arabia
DOI: 10.4328/ACAM.20287 Received: 2020-07-22 Accepted: 2020-08-22 Published Online: 2020-09-04 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):358-361
Corresponding Author: Syed Usama Khalid Bukhari, Department of Computer Science, The University of Lahore, Islamabad, Pakistan. E-mail: usama.khalid@cs.uol.edu.pk P: 00923491050449 Corresponding Author ORCID ID: https://orcid.org/0000-0003-1581-8609
Aim: In this study, we aimed to find out the usefulness of artificial intelligence for the histological diagnosis of products of conception by identifying the cho- rionic villi in the tissue specimens.
Materials and Methods: A total of 400 anonymized digital images were acquired, which were divided into two groups. Group 1 included 200 images containing chorionic villi while Group 2 was comprised of 200 images of decidual tissue. Two variants of two deep learning computer vision algorithms VGG-16, VGG-19, and Resnet -18, Resnet -34 had been applied for the evaluation and analysis of the digital pathology image.
Results: The application of deep learning computer vision algorithms, VGG-16, VGG-19, Resnet-18, and Resnet-34 revealed the diagnostic accuracy of 95.3%, 99.4%, 98.1 %, 98.2% and F1-Score of 0.989, 0.989, 0.984 and 0.989 on test data respectively.
Discussion: The specimens of products of conception are quite frequently received for histopathological evaluation by the pathology laboratory. A careful his- tological examination is required for the identification of chorionic villi in the submitted specimens. The present study revealed that the application of artificial intelligence could be valuable assistance to the histopathologists for the microscopic examination of biopsy specimens. The diagnostic accuracy achieved in the present study is quite close to the reported figures for the diagnosis of lung and prostatic cancer with the help of deep learning in other series. The present study revealed that computer vision-based system may be an effective adjunct tool for the histopathological detection of chorionic villi.
Keywords: Chorionic villi; Deep learning; Computer vision; Resnet; VGG
Introduction
One of the important causes of vaginal bleeding in females of the reproductive age group is retained products of conception (RPOCs) after the childbirth or miscarriage. Different modalities are used for the diagnosis of retained products of conception (RPOCs) which include assessment of clinical features, ultrasound, and histopathology. The clinical signs and symptoms of retained products of conception include bleeding per vagina, fever, and pain in the lower abdomen. Ultrasound is usually done to detect retained products of conception, which usually shows hyperechoic material and increased thickness of the endometrium [1, 2]. Histopathological evaluation for the diagnosis of retained products of conception is considered to be the gold standard of all. The histopathological examination is also required for the differentiation between the trophoblastic and non- trophoblastic tissue which cannot be done on the basis of clinical, sonographic, and intraprocedural criteria [3]. The retained products of conception are managed either medically or surgically [4, 5]. Medical management is usually given to women with no signs of infection, heavy bleeding or fever. While surgical management is usually performed in patients who show signs and symptoms of infection like fever, heavy bleeding, severe abdominal pain or suspected gestation trophoblastic disease. The majority of females who were admitted to the hospital due to miscarriage were in the gestational week of five to thirteen [6]. Surgical management includes traditional Evacuation and Curettage or hysteroscopic removal (morcellation or loop resection) [7]. After the uterine evacuation, the tissue should be examined histologically to rule out the possibility of any neoplasm or gestational trophoblastic disease [8]. The thorough microscopic evaluation of retained products of conception is quite time-consuming task as sometimes the tissue is abundant in amount. The mounting stress on histopathologists due to histological examination of a large number of glass slides maybe relieved to some extent by the application of artificial intelligence.
This study is aimed to find out the effectiveness of artificial intelligence for the histological diagnosis of products of conception by identifying the chorionic villi in the tissue specimens.
Material and Methods
Four hundred (400) anonymized digital images have been acquired from the anonymized glass slides stained with hematoxylin and eosin stain. The state-of-the- art two deep learning computer vision algorithms with two variations, VGG- 16, VGG-19, Resnet-18 and Resnet -34 have been applied for the evaluation and analysis of digital pathology images. Due to the data limitation, transfer learning approach was applied; weights trained on ImageNet data set were downloaded and given as initial weights to the algorithms using FastAI library [9]. The 400 anonymized digital images have been split into two categories. There were 200 images of chorionic villi and this category was labeled as chorionic villi. The other category had 200 images of decidual tissues. These images have been reviewed by two histopathologists.
A random approach of FastAI API was used to load the data into train and test sets, to avoid the chances of selecting images
of the same class been selected for mini-batch input, which could harm the performance of model validation in the training phase.
The entire dataset have been split into two sets. Eighty (80) % of the images were included in the training set. The testing set contained 20% of the total images. To increase the accuracy and F1-Score image, augmentation was done using default parameters of FastAI library. A 5-fold cross-validation was used to train the algorithms.
Results
A total of four hundred (400) anonymized digital images were collected. One group was composed of two hundred images (200), which contain chorionic villi and this group was labeled as chorionic villi. The other group had two hundred (200) images of decidual tissues only without any chorionic villi and this group was labeled as decidual tissue. Three hundred and twenty (320) images were chosen randomly from both groups (chorionic villi and decidual tissue) that is 80% of the total data set and employed for training data set. Whereas eighty (80) images were randomly chosen from both groups (chorionic villi and decidual tissue), which is 20% of the total data set employed in the test data set. Two deep learning computer vision algorithms with two variations, VGG-16, VGG- 19, Resnet-18, and Resnet-34 were used that revealed the accuracy of 95.3%, 99.4 %, 98.1 %, 98.2% and F1-Score of 0.989, 0.989, 0.984, and 0.989 respectively on test data set. The results are shown in Tables 1 and 2.
Discussion
The results of the present study are very encouraging regarding the application of artificial intelligence for the histological diagnosis of products of conception. The retained products of conception may occur due to miscarriage or abortions. The miscarriage/abortions are associated with morbidity and mortality in women [10]. Miscarriages are also a risk factor of anemia in females [11].
The tissue specimens of miscarriage/abortion/products of conception are quite frequently received by the pathology laboratory for histopathological examination. A thorough microscopic assessment of slides is required for the identification of chorionic villi. Artificial intelligence may be applied to provide assistance to the histopathologists for the histological assessment of glass slides.
Artificial intelligence is making a significant contribution to the digital revolution. The artificial intelligence is trying to enhance the capabilities of computers so that the computer-based system can better do what humans are currently doing. The application of artificial intelligence will provide the capability to the system to learn and improve automatically from the experience and available data. The development of deep learning technology (a subset of artificial intelligence) has yielded markedly improvement in image analysis and recognition. The subset of deep learning is a convolutional neural network which has remarkably improved the image processing [12]. Makimoto H et al. published a study in which the performance of the convolutional neural network was better than clinicians for the accuracy in the diagnosis of myocardial infarction by analyzing the images of electrocardiogram [13]. In the present study, two deep learning computer vision algorithms with two variations VGG-16, VGG-19, Resnet-18, and Resnet-34 have been applied on the test data, which revealed the accuracy of 95.3%, 99.4%, 98.1 %, 98.2% respectively. The diagnostic accuracy of convolutional neural network architecture for the diagnosis of products of conception in the present study is quite close to the reported figures for the diagnosis of lung and prostatic cancer with deep learning [14,15]. The microscopic examination of glass slides by the anatomic pathologist for the histopathological diagnosis of malignant tumors is a labor- intensive and time- consuming process. Missing or non- visualization of a small area on the slide may lead to a lethal mistake in the diagnosis. Over the past century, this process has been practiced with minor modifications. This laborious job increases the chance of fatigability which raises the risk of human errors. There are possibilities of errors in the pathology laboratories which may have severe devastating effects in patient care [16]. The development of artificial intelligence applications for the assessment of biopsies will be a great help to the histopathologists in the current scenario of the rising trend in workload in the diagnostic laboratories. The limitation of the present study includes the limited availability of digital pathology images. Further studies on large data set are recommended.
Conclusion
The application of deep learning technology in the field of pathology for the histological diagnosis of chorionic villi in biopsy specimens is a very helpful tool.
Acknowledgment
The authors are grateful to Faran Mazhar and Syed Umar Armaghan for their assistance.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
References
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2. Iqbal H, Khan MS, Muneeb A, Mirza WA. Diagnostic Accuracy of Ultrasound in Detecting Retained Products of Conception: A Study from a Tertiary Care Hospital in Karachi, Pakistan. Cureus. 2018;10(11):e3564. DOI:10.7759/cureus.3564.
3. Ganer Herman H, Kogan Z, Dabas A, Kerner R, Feit H, Ginath S, et al. Clinical and Sonographic Findings in Suspected Retained Trophoblast: Correlation with Histological Findings. Isr Med Assoc J. 2018;20(12):761-4.
4. Butt TA, Iqbal A, Saeed M, Yousuf I, Murtaza A. Outcomes of Manual Vacuum Aspiration Versus Dilatation and Curettage in First Trimester Miscarriages. Pakistan Journal of Medical and Health Sciences. 2018;12(2):611-13.
5. Zaman N, Zahoor S, Zulfiqar S, Afzal R, Younus S, Zahoor A. Comparison of Misoprostol with Manual Vacuum Aspiration for The Management of Incomplete Miscarriage. Pakistan Journal of Medical and Health Sciences. 2019;13(2):637-9. 6. Campillo ISL, Meaney S, O’Donoghue K, Corcoran P. Miscarriage hospitalisations: a national population-based study of incidence and outcomes, 2005–2016. Reprod Health. 2019;16(1). DOI:10.1186/s12978-019-0720-y.
7. van Wessel S, Coryn N, van Vliet H, Schoot B, Weyers S, Hamerlynck T. Reproductive and Obstetric Outcomes After Hysteroscopic Removal of Retained Products of Conception. J Minim Invasive Gynecol. 2020;27(4):840-6. DOI:10.1016/j.jmig.2019.07.016.
8. Kordić S, Matijević R. Does Routine Pathology Evaluation of Uterine Content Following Evacuation for Abnormal Early Pregnancy Influence Further Management? Acta Med Croatica. 2016;70(2):97-101.
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10. Reardon DC, Thorp JM. Pregnancy associated death in record linkage studies relative to delivery, termination of pregnancy, and natural losses: A systematic review with a narrative synthesis and meta-analysis. SAGE Open Med. 2017; 5:205031211774049. DOI:10.1177/2050312117740490.
11. Khalid R, Irshad J, Saleem A, Ashraf S. Risk factors for Anemia in Pregnant Women in a rural area of Bahawalnagar Pakistan – a Descriptive Cross-Sectional Study. Pakistan Journal of Medical and Health Sciences. 2017;11(4):1238-80. 12. LeCun Y, Bengio Y, Hinton G. Deep learning. Nature. 2015;521 (7553):436–44. DOI: 10.1038/nature14539.
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14. Campanella G, Hanna MG, Geneslaw L, Miraflor A, Silva VW, Busam KJ, et al. Clinical-grade computational pathology using weakly supervised deep learning on whole slide images. Nat Med. 2019;25(8):1301-9. DOI:10.1038/s41591-019- 0508-1.
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Download attachments: 10.4328_ACAM.20287
Syed Usama Khalid Bukhari, Syed Khuzaima Arsalan Bokhari, Ubeer Mehtab, Asmara Syed, Syed Sajid Hussain Shah. The application of artificial intelligence for the detection of chorionic villi in the biopsy specimens. Ann Clin Anal Med 2021;12(4):358-361
Citations in Google Scholar: Google Scholar
Glomerular filtration rate in type 1 diabetic adolescent by using single plasma sample and gamma camera methods
Feray Aras, Elvan Sayit Bilgin
Department of Nuclear Medicine, Celal Bayar University, School of Medicine, Manisa, Turkey
DOI: 10.4328/ACAM.20288 Received: 2020-07-23 Accepted: 2020-08-22 Published Online: 2020-09-08 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):362-366
Corresponding Author: Feray Aras, Celal Bayar University, School of Medicine, Department of Nuclear Medicine, Manisa, Turkey. E-mail: feray.aras@cbu.edu.tr P: +90 532 420 69 63 Corresponding Author ORCID ID: https://orcid.org/0000-0001-5867-5367
Aim: Type-1 diabetes mellitus (DM) has indicated that glomerular hyperfiltration (GFR) is a risk factor for nephropathy. Renal pathological changes develop before features of clinical renal disease including proteinuria and declining GFR are evident. We investigated changes in GFR in children and adolescents with type 1 DM by means of single plasma sample (SPS) and gamma camera Gate’s methods using Tc-99m DTPA. Additionally, we determined the specificity, sen- sitivity, and consistency of the two methods.
Material and Methods: Thirty-six patients (mean age: 15.01±4.03 years) with Type-1 DM (19 males, 17 females) were studied. Impairment of renal function was not detected in any of the patients with routine biochemical tests. Standard Tc-99m DTPA renal images were obtained for 40 minutes and GFR is calcu- lated by Gate’s method and values>130/1.73m2 b.s. were considered hyperfiltration. SPS was obtained at 120 min-post injection and the Cristensen-Groth equation (CG) was used. The patients were divided into two groups according to the duration of diabetes as less than 5 years (Group A) and longer than 5 years (Group B).
Results: In Group A, hyperfiltration was detected in 11 of 14 patients with SPS, whereas in 7 of 14 patients with Gate’s method. In Group B, hyperfiltration was detected in 17 of 22 patients with SPS, whereas in 13 of 22 patients with Gate’s method. Sensitivity of Gate’s method was 67.9 % in all patients for diagnosis (Sensitivity: 67.9%, Specificity: 87.5 %, positive predictive value (PPV): 95 %, negative predictive value (NPV): 43.8%). The consistency of these two methods was found as 72.6% (p=0.005).
Discussion: Gate’s method is useful for clinical practice due to ease of use and high consistency with SPS, especially in the children. SPS remains the first-line method of GFR measurement in suspected diabetic nephropathy patients.
Keywords: Type-1 diabetes; Glomerular filtration; Gamma camera; Tc-99m DTPA; Single plasma
Introduction
Diabetes is a complete or partial deficiency of insulin secretion or carbohydrate, protein, and fat metabolism disorder caused by a different degree of insulin resistance. Prognosis in diabetic patients is closely related to degenerative complications. Microvascular (retinopathy, nephropathy, neuropathy) and macrovascular (atherosclerosis) complications occur 10 to 15 years after the onset of diabetes [1]. Diabetic nephropathy is rare in the child age group. It is proteinuria as the first symptom, usually 10 years after the onset of diabetes. Proteinuria, which does not show any clinical symptoms initially, is accompanied by edema, hypertension, and progressive impairment in kidney function. Nodular glomerular sclerosis and diffuse intracapillary glomerular sclerosis are detected in histopathology of the kidney. There is a thickening of the basement membrane in electron microscopy [2]. Diabetic nephropathy is the cause of death in 50% of patients with juvenile diabetes. Diabetic nephropathy encompasses a variety of kidney lesions such as diabetic glomerulosclerosis, arteriolosclerosis, increased sensitivity to pyelonephritis, and papilla necrosis [3].
Type 1 diabetes mellitus (DM) have indicated that glomerular hyperfiltration is a risk factor for diabetic nephropathy. In the early stages of DM, the renal plasma flow and the glomerular filtration rate (GFR) have often been found higher than normal. Hyperfiltration occurs in the early stages of DM and has been implicated development of microalbuminuria. In diabetic rats increased GFR, in association with elevated intraglomerular pressure was positively related to subsequent glomerulosclerosis [4, 5].
Renal dynamic imaging with 99mTc-diethylene triamine pentaacetic acid (99mTc-DTPA) is a commonly used method to determine renal blood flow and unilateral kidney function. The timed uptake curves of the two kidneys, especially the comparison, give notable information such as quantitative unilateral renal function and pathophysiological changes in the kidney in renovascular hypertension, hydronephrosis, and renal transplant [6, 7]. Since it is exhaustive and difficult to perform in routine clinical practice, single plasma sample (SPS) method and double plasma sample method of GFR estimation were derived from the multi-sample technique. Multi, double, and single-sample techniques were observed to have a significant correlation [8]. Apart from the plasma sample technique, few computer-based methods have also been developed among which the gamma camera (GC)-based method became highly popular as it can provide an immediate calculation of individual kidney function as well as of global renal function. The most popular calculation method nowadays is the modified Gate’s method, which is commercially available. To measure glomerular filtration rate (GFR) using this kind of gamma camera method, no blood and urine collection is needed, and measurement takes approximately only 20 min. Because of its convenience, it is usually used as a surrogate of GFR in some clinical trials [9]. Renal pathological changes develop before features of clinical renal disease including proteinuria and declining GFR, become evident. We investigated changes in glomerular filtration rate in children and adolescents with type 1 DM by means of single plasma sample (SPS) and gamma camera methods using Tc99m-DTPA.
Material and Methods
The research study was approved by the Celal Bayar University Health Sciences Ethics Committee. Written informed consent was obtained from all participants of the study. Thirty-six patients (mean age: 15.01 ± 4.03 years) with type 1 DM (19 males, 17 females) with the duration of diabetes between 3 months to 18 years (mean: 6.48 ± 3.8 years) were studied. Impairment of renal function was not detected in any of the patients with routine biochemical tests. The patients were divided into two groups according to the duration of diabetes as less than 5 years (Group A) and longer than 5 years (Group B). All subjects were hydrated with 500 ml of fluid 30 minutes prior to the test. The patients were asked to void before Tc99m DTPA injection. The patient lay down on a bed in the supine position. Following immediately intravenous injection of Tc99m-DTPA (AmerscanTM Pentetate II Agent) about 200μCi/kg through an indwelling butterfly needle in an antecubital vein, acquisition with gamma camera (General Electric, 600 XR/T, Rectangular) which was attached to a low energy general-purpose parallel hole collimator started and renal images were obtained for 40 minutes. Frames of 64 x 64 matrix were recorded with an online-computer, initially at one second for one minute and then at 60 seconds for 39 minutes. The percent renal uptake at 2-3 min after tracer arrival in the kidney was determined with background subtraction. The GFRGates was automatically estimated by a commercially available computer (Entegra, GE) according to the Gates’ algorithm. A standard solution (diluted) was prepared. The blood samples were taken 120 minutes after injection of radiotracer and plasma samples were obtained from that blood samples. After both 1 ml standard solution and 1 ml plasma sample were counted in the well counter (Biodex Medical System; Atomlab 950). The GFRsps was determined from a single-plasma concentration at 120 minute-post- injection using Christensen-Groth’s equation. Christensen and Groth introduced another one-compartment method by estimating extracellular volume from the body surface area. The GFR (ml/min) obtained by the two methods was normalized for a body surface area of 1.73 m2 according to Haycock’s equation and values>130 were considered hyperfiltration. Statistical analysis
The data were analyzed using SPSS 25.0 statistics program. The paired Mann-Whitney-U test, Fisher’s exact test, Pearson correlation, and Kappa consistency analysis were used for statistical analysis. Values smaller than p <0.05 were considered statistically significant.
Results
The anthropometric properties and clinically obtained metabolic data of the research population are shown in Table 1. The average age of the patients was 15.01 ± 4.03 years, BSA mean 1.46 ± 0.31, DM diagnosis time 6.48 ± 3.8 years, insulin dose (U / kg) mean 45.19 ± 14.91 and HbA1c mean (%) was 11.0 ± 0.03 (Table 1).
GFR values of the research population obtained by scintigraphically single plasma sampling and gamma camera methods are shown in Table 2. The normalized GFR mean measured by Gate’s gamma camera method was 148.27 ± 51.84, whereas GFR mean measured by the Single plasma sampling method was 177.53 ± 38.00 (Table 2).
GFR value of 130 ml/dk/ m2 cut point is taken and the comparison of GFRs calculated by single plasma sampling and normalized gamma camera method is shown in Table 3. Assuming a hyperfiltration limit of 130 ml/min/ m2 and above, glomerular hyperfiltration was detected in 28 (78%) of 36 patients with GFRs calculated by a single plasma sampling method. Considering the normalized GFR values in Gate’s gamma camera method, glomerular hyperfiltration was detected in 20 (56%) of 36 patients (Table 3).
In comparison of GFR values and Type 1 DM diagnosis time distributions of the two groups, the number of patients with Type 1 DM for less than 5 years was 14 (39%), the number of patients with Type 1 DM for more than 5 years was 22 (61%). GFRsps values (196.9 ± 92.6) are statistically significant higher than GFRgate’s values (139.6 ±57.9) in the Type 1 DM for less than 5 years group (p=0.017). In comparison of GFR values measured according to diabetes duration, in Group A, hyperfiltration was detected in 11 of 14 patients with SPS, whereas in 7 of 14 patients with Gate’s method. In Group B, hyperfiltration was detected in 17 of 22 patients with SPS, and in 13 of 22 patients with Gate’s method. Sensitivity of Gate’s method was 67.9 % in all patients for diagnosis (Sensitivity: 67.9 %, Specificity: 87.5 %, positive predictive value (PPV): 95 %, negative predictive value (NPV): 43.8%). The consistency of these two methods was 72.6 % (p= 0.005). In comparison of Pearson’s correlation between insulin doses and BSAGFR and NORMGFR, there was a statistically significant negative correlation between insulin doses and BSAGFR and NORMGFR (r: -0.543 **, p = 0.001 and r: -0.461 **, p = 0.005, respectively). The relationship of GFR values normalized to the body surface area obtained from two separate plasma samples prepared from the patients’ plasma at the same time is shown in Figure 1. To evaluate their accuracy, two plasma samples of 1 ml were obtained from each patient. As a result, the correlation coefficient between GFR amounts calculated from both single plasma samples, corrected for body surface area, was found to be r: 0.833 and p = 0.001, and a linear curve was obtained (Figure 1A).
When compared to the single plasma sampling method and the gamma camera method (Gate’s), which showed the distribution volume at the 2nd hour in 36 patients included in the study and whose Type 1 DM diagnosis period ranged from 3 months to 18 years, the consistency between the two methods was 66.7% (kappa: 0.314 and p: 0.034) (Figure 1B).
The comparison of body surface area (BSA) and normalized GFR values calculated with Gate’s method is shown in Figure 3. As the body surface area of the patient increases, the normalized GFR value decreases as calculated by the Gate’s method. Since the surface area increases, the attenuation factor also increases and the GFR value is calculated below the predicted (Rho = – 0.733, p = 0.001) (Figure 1C).
In addition to the gamma camera method, there was also information we obtained which allowed us to have information about kidney function individually. Although the blood urea and creatinine levels of the patients participating in the study were within normal limits, seven of the patients had normal kidneys while the other had nonobstructive dilatation. We found renal dysfunction in four of them, nonobstructive dilatation in both kidneys and in one patient, obstructive in one kidney, and in nonobstructive dilatation patterns in the other.
Discussion
In our study, it was found that compared to normalized GFR measurement calculated by Gate’s method, BSAGFR measurement obtained with a single plasma sampling method and corrected by body surface area correction showed kidney function more accurately in patients with Type 1 diabetes mellitus. However, there was a statistically significant negative correlation between the insulin doses and BSAGFR and NORMGFR (r: -0.543**, p=0.001 ve r: -0.461**, p=0.005, respectively). It was found that BSAGFR value correlated better with insulin doses compared to NORMGFR.
Failure to detect individual kidney GFR rapidly or evaluating the correct GFR in varying situations are seriously limiting the use of creatinine clearance. Radionuclide techniques have evolved to overcome these limitations and meet the needs of evaluating renal functions in clinical trials. In general, after meeting ERPF-based renography in clinical studies, radionuclide techniques used to measure GFR have been developed [10]. The chemical properties of inulin do not allow for easy binding with radioactive isotopes, however C-14, I-125, I-131 and Cr- 51 have been used for GFR measurement, although the degree of success varies [11]. After the development of the gamma camera and the use of Tc-99m bound kidney screening agents, new horizons have been opened clinically for radionuclide renography. Technetium-99m-pertechnetate was used with a gamma camera in the dynamic renal scintigraphy study to evaluate the vascularity of kidney lesions [12]. The DTPA technique associated with Technetium-99m is still an excellent radiopharmaceutical that can calculate the GFR measurement while performing a radionuclide renogram [13]. Tc-99m-DTPA allows imaging of the kidneys using a gamma camera. The distribution of function between the kidneys on both sides depends on the amount reaching the kidneys in a short time following radiopharmaceutical application [13]. Tc-99m-DTPA has ground-corrected relative renal uptake. This fractional distribution of activity is determined by image analysis and is then used to calculate the percentage distribution of each kidney with total GFR. The last value of the two (total GFR) can be determined using either single or multiple blood sampling or gamma camera techniques. The relative distribution of activity between the kidneys occurs within 2 to 3 minutes following the arrival of the radiopharmaceutical. It is stated that the best time for determining the relative distribution of the function between the kidneys is 2-3 minutes when Tc-99m-DTPA is used, whiletheothersareusedfor1-3minutes[14].Inourstudy, Normalized GFR measured by Gate’s gamma camera method using by Tc-99m-DTPA was 148.27 ± 51.84.
In 1975, Fisher and Veall predicted GFR with a modified single blood sampling technique [15]. Bibbo et al. reported a very good correlation between the two methods in the study comparing single injection, single plasma sample diatrizoate and Inulin clearance in detecting GFR [16]. Nautiyal et al. reported that Gates method of GFR estimation using a Gamma camera shows a significant correlation with plasma sample technique in people with normal BMI. In people with BMI outside the normal range, it significantly underestimates GFR [17]. In the GFR estimation, Ham and Piepsz showed that there was a linear equation suitable for children of all ages by linear regression equation converting the 2nd hour distribution volume data [18]. However, they recommended the use of a single sampling technique for GFR measurement in Children. In our study, we have seen that the plasma sampling method gives more accurate results about GFR than the gamma camera method as stated in the literature. However, considering the difficulty of taking blood from young patients and the depth of the kidney is less, we can estimate GFR with the gamma camera method. Glomerular hyperfiltration has also been reported as a risk factor for type 1 DM in diabetic nephropathy [19, 20]. Gao F and Zhang C have found glomerular filtration in diabetics for less than 5 years in diabetic mellitus (NIDDM) in patients with diabetes mellitus (NIDDM) in their studies evaluating radionuclide renal dynamic imaging in the diagnosis of diabetic nephropathy. In diabetics, this situation has deteriorated for more than 5 years [21]. However, they found it particularly supportive in the early diagnosis of glomerular hyperfiltration, especially diabetic nephropathy, without nucleic renal dynamic imaging β2-microglobulinuria and microalbuminuria [21]. Itoh reported that the single sampling method was more accurate than the gamma camera method and the gamma camera method was more accurate than the 24-hour creatinine clearance in predicting studies with the single sampling and gamma camera methods for detecting GFR with Tc-99m DTPA.
It should be kept in mind that the only sampling method is more accurate in detecting GFR and DTPA in a patient with moderate and moderate renal dysfunction [22]. Itoh et al reported that the only sampling method was the first choice in a routine application due to its technical simplicity and accuracy in the study where they investigated the accuracy of the single sampling method for detecting GFR with Tc-99m DTPA [23]. In our study, when over 130 ml / min / m2 was considered as hyperfiltration, hyperfiltration was detected in 78% of patients in the single plasma sampling method (body surface area correction) taken at 120 min, and 56% in the gamma camera method (Gate’s). At this stage, patients are recommended to reduce the amount of protein in the diet.
Conclusion
Our study shows that reliable estimation of absolute GFR is possible from the routine dynamic renal scinti-scanning procedure using the gamma camera computer systems, and hence might prove applicable in clinical practice. Although the Gate’s method requires neither blood sampling nor additional imaging, the plasma sampling method could be used as a first choice in detecting GFR in patients suspected of diabetic nephropathy, as we want to calculate the GFR more accurately.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Download attachments: 10.4328_ACAM.20288
Feray Aras, Elvan Sayit Bilgin. Glomerular filtration rate in type 1 diabetic adolescent by using single plasma sample and gamma camera methods. Ann Clin Anal Med 2021;12(4):362-366
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Markers for creatinine height after percutaneous coronary intervention in patients with normal renal function
Serkan Karahan, Fahrettin Katkat, Ertugrul Okuyan
Department of Cardiology, Bağcılar Training and Research Hospital, İstanbul, Turkey
DOI: 10.4328/ACAM.20289 Received: 2020-07-23 Accepted: 2020-08-25 Published Online: 2020-09-08 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):367-371
Corresponding Author: Serkan Karahan, Department of Cardiology, Health Sciences University, Bağcılar Training and Research Hospital, İstanbul, Turkey. E-mail: drserkankarahan@gmail.com P: +90 5321594401 Corresponding Author ORCID ID: https://orcid.org/0000-0002-1203-7615
Aim: We aimed to research the risk indicators of high-level creatinine in patients with normal renal functions, following percutaneous coronary intervention (PCI).
Material and Methods: Two hundred thirty-eight patients who were subjected to PCI were enrolled in our study. The present single-centered observation study was carried out retrospectively. Pre-intervention serum creatinine values were below 1,2 mg/dl, and information about patients who underwent percutaneous coronary intervention (PCI) was obtained. The patients included in the study were divided into two groups according to creatinine values at 24 hours after intervention (Group 1: patients with creatinine (CRE) <1,2 mg/dl after PCI; Group 2: patients with CRE≥1,2 mg/dl after PCI). These two groups were also ex- amined separately according to risk factors. The patients were given 100-300 ml low osmolar nonionic monomer iopromide (Ultravist vial, 370-200 ml vial) during intravenous PCI.
Results: The size of Group 1 was 18,5% (n = 44) and the size of Group 2 was 81,5% (n = 194). When these groups were compared in terms of risk factors, heart failure (25% n=11) and male gender (77,3%, n=34) were found to be independent risk factors in the development of contrast media nephropathy (p<0,035 and p<0,006, respectively). In addition, in the correlation analysis, it was found that the patients whose CRE levels were very high in their follow-ups also increased significantly in the same correlation in the same degree of heart failure.
Discussion: Contrast-induced nephropathy (CIN) should consider the risk factors in all interventions using contrast media, and special care should be exercised in high-risk patients with male gender and/or heart failure.
Keywords: Percutaneous coronary intervention (PCI); Heart failure; Contrast-induced nephropathy (CIN)
Introduction
Contrast-induced nephropathy (CIN) is an often reversible form of acute renal failure (ABY) that occurs after intravascular radiocontrast administration [1]. Contrast media-associated ABY has been increasing in recent years in both inpatient and outpatient patients [2]. Even a small increase in creatinine level in patients with CIN has been associated with an increase in morbidity and mortality [3]. In patients using CIN intravascular radiographic contrast media, it is defined as the development of acute renal failure (ABY) within 48 hours after the procedure, regardless of the need for any clinical symptoms or hemodialysis [4, 5]. For patients without any risk factors, the risk of CIN is low even after intraarterial injection and is around 2% [3, 6]. Angiography and percutaneous coronary intervention are the most important causes leading to CIN and the risk of CMN after these procedures; while it is around 2% in patients with normal kidney function, it is up to 20-30% in patients with basal creatinine level above 2 mg/dl [7, 8]. It has been shown that 13% of all ABY cases are secondary to the use of contrast media, while the third most common cause of ABY occurring within the hospital is CIN [9]. A different definition of CIN is 25% or 44 μmol / L (0.5mg / dl) increase in serum creatinine level within three days after the administration of contrast media, without any other etiological reason [10, 11]. Development of CIN is clinically associated with long- and short-term survival, and hemodialysis needs are linked to increased hospitalization, increased cost, increased mortality and morbidity [12, 13]. Various risk factors have been identified for the development of CIN. Age, hypertension (HT), diabetes (DM), pre-existing kidney failure, type and amount of contrast media, place of administration (IV, IA) and frequency of administration, New York Heart Association (NYHA) Stage III-IV congestive heart failure and left low ventricular ejection fraction, decreased intravascular volume, dehydration, cardiogenic shock and hypotension are defined as risk factors [14].
The increased use of contrast media in diagnostic and interventional cardiac catheterization procedures has made contrast media nephropathy a common problem in clinical cardiology practice. This important clinical problem, which may be associated with high mortality and morbidity, is still not adequately identified by physicians. Chronic kidney failure is the main predisposing factor for CIN [15]. The exact mechanism of CIN is not known in detail. It is accepted that alteration of kidney hemodynamics and direct tubular toxic effect of contrast media are the main cause of CIN [15].
Various studies have been carried out to prevent CIN, and the accepted application is hydration (increasing extracellular volume), and the type and amount of contrast media are adjusted [16, 17].
The aim of this study was to determine the possible risk factors of CIN that may develop after percutaneous coronary intervention in adults with normal renal function and coronary artery disease, and to investigate the correlation between these risk factors and CIN.
Material and Methods
Patients
The research study was approved by the Yeditepe University Health Sciences Ethics Committee. Written informed consent was obtained from all participants of the study. For this study, 238 patients with normal renal function who underwent PCI between 2009 and 2010 at the Cardiology Clinic of Yeditepe University Medical School were included in the study. Patients with known chronic renal failure, pre-procedure creatinine (CRE) value above 1,2 mg/dl and known to be allergic to contrast media were excluded from the study.
Study Design
This single-center observation study was carried out retrospectively. Before the procedure, serum creatinine values were below 1,2 mg/dl and percutaneous coronary intervention was performed, and the information of the patients who met the inclusion criteria was obtained. Patients’ age, gender, concomitant diseases, the nephrotoxic drugs they used and the history of contrast media use in the last month were recorded. Before the intervention, serum sodium (NA), potassium (K), blood urea nitrogen (BUN), creatinine (CRE) and complete blood count measurements were made. Blood pressure of the patients measured manually was recorded before the procedure. In addition, the left ventricular ejection fraction (EF) values were recorded from echocardiographs performed within 1 week before the intervention. Heart failure was defined as EF <50%. BUN and CRE levels of all patients were examined for the first 24 hours after the intervention. In cases with increased CRE levels, 48th and 72nd hour BUN and CRE levels were examined. The patients included in the study were divided into two groups according to CRE values at 24 hours after the procedure (Group 1: patients with CRE <1,2 mg/dl after PCI; Group 2: patients with CRE≥1,2 mg/dl after PCI). These two groups were also examined separately according to risk factors.
Hydration protocol
A total of 500ml 0.9% NACL liquid (100-120 ml / h) was administered to all patients via a peripheral intravenous (IV) before PCI. All patients were taken to PCI procedure between the second and third hours after starting the infusion. After the intervention, a total of 1000ml 0.9% NACL liquid (100-120 ml / hour) was administered via a peripheral intravenous (IV) route. In contrast, patients with EF below 50% received intravenous (IV) intravenous (IV) fluid after the procedure at 100-120 ml/ hour. All patients were given 100-300ml low osmolar nonionic monomer iopromide (Ultravist vial, 370-200ml vial) during intravenous percutaneous coronary intervention (PCI). Statistical analysis
SPSS 13 computer program was used for statistical analysis of the study. Quantitative data were defined as X + SD (mean ± standard deviation). One-way ANOVA significance test was performed to compare the analyzed data between the groups by normality. The Scheffe procedure was used to determine which group was different. The comparison between basal values and other times was made using the Repeated Variance Analysis materiality test. The Bonferroni test was used to determine which time was different. The distribution in qualitative data was expressed as a percentage. The chi-square (x2) test was used to determine statistical significance between the appropriate data. The comparison of contrast media nephropathy between the two groups was made using the Hosmer Lemoshow test. Regression analysis Wald test was used to determine dependent and independent risk factors (markers) causing contrast substance nephropathy. Pearson Correlation Coefficient was calculated to determine the relationship between two quantitative variables. The significance level was accepted as <0,05.
Results
Records of 238 patients with normal renal function that met the inclusion criteria were examined. The ages of the cases ranged between 32 and 90 years, with an average of 63,2 ± 17,9 years; 36,5% of the patients (87) were women; 63,45% (151) of them were male cases. According to the CRE value after PCI, 194 patients were included in Group 1 and 44 patients were included in Group 2. Group 1 and Group 2 were compared in Table 1 in terms of demographic characteristics and possible CIN risk factors. Group 1 included 117 males (60,3%) and 77 females (39,7%), Group 2 included 34 males (77,3%) and 10 females (22,7%). There was a statistically significant difference between the gender distributions of the groups (p<0,05). Group 1 included 49 patients (25,3%) over 70 years old and 145 patients (74,7%) under 70 years old, Group 2 included 15 patients (34,1%) over 70 years old and , 29 patients under 70 years old (65,9%). There was no statistically significant difference in the age distribution between the groups (p>0,05). The number of diabetic patients in Group 1 was 67 (34,5%) and the number of diabetic patients in Group 2 was 12 (27,3%). There were 141 patients (72,7%) in Group 1 and 34 patients (77,3%) in Group 2. Coronary artery disease (CAD) was observed in 115 patients (59,3%) in Group 1and 28 patients (63,6%) in Group 2. The number of Atrial fibrillation (AF) was 12 (6,2%) in Group 1 and 5 (11,4%) in Group 2. There was no statistically significant difference between the groups in terms of diabetes, hypertension, CAD and AF distributions (p>0,05). The frequency of heart failure (HF) was evaluated in two groups. In Group 1, 19 patients (9,8%) and in Group 2, 11 patients (36,7%) had HF. There was a statistically significant difference in the distribution of HF in these patients (p<0,05). Also, the correlation with CRE was investigated in patients whose EF was below 50% and CIN developed. In the correlation analysis, it was found that the size of the CRE height that occurred during the follow-ups showed a significant negative relationship with the degree of HF (shown as the EF value) (r=-0,255, p<0,05) (Figure 1). This analysis was tested with the Hosmer-Lemeshow test and it was determined that the regression equation is a suitable model (p>0,05). Contrast media use history was examined in the last 1 month in both groups. Thirty-seven patients (19,2%) in Group 1 and 5 patients (11,4%) in Group 2 had a history of contrast media (CM) use within the past month. No statistically significant difference was found between the distributions of these patients according to their history of using CM (p>0,05). The potassium and sodium values of the patients examined before the procedure were within normal values.
Independent variables in CIN are shown in Table 2. In our study, male gender and HF were found as independent variables for CRE height to develop after PCI. For the male gender, variables were as follows: p=0,038, OR: 2,27 and 95% CI: 1,048 – 4,932. Accordingly, the risk of CRE≥1.2 mg / dl after PCI increased 2,27 times compared to women. For heart failure (HF), p=0,008, OR: 3,151 and 95% CI: 1,354 – 7,336. Accordingly, in those with HF, the risk of CRE≥1,2 mg/dl after PCI increased by 3,151 times compared to those without HF (Table 2).
Discussion
CIN is a frequently encountered problem in clinical practice. With the increase in the use of contrast media in diagnoses and interventions over the past three decades, CIN has become the third common cause of ESI acquired in the hospital [1]. The development of CIN depends on the physical and chemical properties of the media used, along with the patient’s existing characteristics.
The negative effect of contrast-mediated nephropathy on
the clinical results of patients undergoing diagnostic and interventional procedures is well known [1, 6, 8, 15]. Today, there is no cure to reverse or correct contrast media nephropathy once it occurs, but prophylaxis is possible. However, most of these methods were found to be useless in well-designed, prospective, randomized double-blind studies [10]. This group of treatments includes diuretics, mannitol, dopamine, atrial natriuretic peptide, endothelin receptor antagonists and phenoldopam [18, 19].
Hydration is the primary intervention in the prevention of contrast nephropathy [20]. The mechanism of hydration reduces the activity of the renin-angiotensin system, decreases the levels of other vasoconstrictor hormones such as endothelin, increases sodium diuresis, decreases the tubuloglomerular feedback cycle, prevents tubular obstruction, protects against reactive oxygen species and ensures that the contrast media is diluted at the tubular level, is to reduce any direct nephrotoxic effect [21]. Hydration with saline infusion is useful for preventing contrast-induced nephropathy. Intravenous hydration has become a standard method for the prevention of contrast-induced nephropathy [22].
Our study was planned primarily to evaluate the markers of patients with normal renal function in our clinic that may cause contrast media nephropathy after PCI. In our study, it was found that heart failure and male gender are independent risk factors for the development of contrast media nephropathy in patients with normal renal function. There are different data in the literature regarding male gender and CIN risk. Mehran et al. have shown that gender has a strong relationship with other CIN risk factors and men are 3.2 times at the risk of CIN than females [23]. Similarly, in our study, male gender was found statistically significant in terms of CIN development. However, another study on 8628 people showed that women are more risky in terms of CIN development [24]. The general approach is that men are at higher risk.
In patients with heart failure, especially if the EF value is below 50%, the patients’ cardiac performance is impaired and their renal perfusion also deteriorates, and when these patients are
exposed to radiocontrast, CIN development rates are higher than in normal individuals [25]. Similarly, in our study, the risk of developing contrast media nephropathy was significantly increased in patients with HF (p<0,05). There are studies in the literature supporting the findings of our study. In a study, if the EF value of patients undergoing coronary angiography is not below 30%, it was shown that the EF values of these patients did not have a significant effect on the development of contrast media nephropathy [25]. In addition to these findings, we found a significant negative correlation between EF and post-PCI CRE values in our study. This shows that as the EF value decreases, CRE values after PCI increase.
Limitations
Although it was not statistically significant in terms of other risk factors in our study, in some studies, history of coronary artery disease in the last month, age, diabetes mellitus and history of contrast agent use were shown as risk factors for CIN. In our study, due to the low number of patients developing CIN, these parameters may not have reached statistical significance, which will be risk factors.
Conclusion
CIN is an important, preventable and reversible condition due to hospital cost and its effects on patient morbidity and mortality. Today, there is a resistance to the prevention of contrast media nephropathy. There are two reasons for this: the first is that a good preventive intervention cannot be done before the procedure, and the second is that the physicians performing the intervention cannot predict the risk of patients before the procedure. Awareness should be at the forefront in order to prevent CIN development. Therefore, CIN should consider the risk factors in all interventions using contrast media. Particular attention should be paid to pre-hydration, appropriate pharmacological support, the use of contrast substances with low toxic potential, and the absence of concomitant nephrotoxic medias, when high-risk patients such as male gender and heart failure are required to be given contrast media.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Knowledge levels and behavior of women related to breast milk and breastfeeding
Humeyra Yaka 1, Ruhusen Kutlu 2, Fatma Goksin Cihan 2
1 Department of Family Medicine, Health Sciences University, Konya Training and Research Hospital, 2 Department of Family Medicine, Meram Medical Faculty, Necmettin Erbakan University, Konya, Turkey
DOI: 10.4328/ACAM.20291 Received: 2020-07-25 Accepted: 2020-09-04 Published Online: 2020-11-05 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):372-376
Corresponding Author: Humeyra Yaka, Department of Family Medicine, Health Sciences University, Konya Training and Research Hospital, Konya, Turkey. E-mail: humeyracobanoglu@hotmail.com P: +90 5055950962 Corresponding Author ORCID ID: https://orcid.org/0000-0002-8502-0232
Aim: Breast milk should be given alone for the first six months and after six months with supplementary food for at least two years. In this study, we aimed to evaluate the level of knowledge and behavior of women related to breast milk and breastfeeding of 0-24 months old babies.
Materials and Methods: This cross-sectional analytical study was conducted on 401 women. Sociodemographic characteristics of mothers were questioned, a questionnaire including questions about breast milk and breast-feeding knowledge levels and behaviors was applied.
Results: Infants born normally were introduced earlier to breast milk after delivery compared to infants born by cesarean section (p<0.001). Premature infants have started to take breast milk later than the infants born mature (p<0.001), and the rates of taking only breast milk in the first six months were low (p<0.001). The breastfeeding rate of working mothers was lower than housewives (p=0.036). While the normal spontaneous delivery rate was high in non-working moth- ers, the rate of cesarean section was higher in working mothers (p=0.021). The frequency of exclusive breastfeeding in the first six months, when babies aged between 6-24 months (n=339) were evaluated, 71.1% (n=241) took only breast milk during the first six months. Fathers with higher levels of education were more positive and supportive of breastfeeding than the fathers with lower education levels (p=0.028).
Discussion: In conclusion, starting breastfeeding educations from pregnancy, reducing the incidence of cesarean sections without indications, encouraging normal spontaneous delivery, and motivating and raising awareness of mothers with premature infants will positively affect breastfeeding.
Keywords: Breastfeeding; Mother; Infant; Breast milk; Knowledge level
Introduction
Nutrition is very important in the first years of life, especially in the first months. Breast milk is uniquely suited to the human infant, both in its nutritional composition and in the non- nutritive bioactive factors that promote survival and healthy development and should be given alone for the first six months and after six months with supplementary foods for at least two years [1]. Available help from the mother, via the transfer of immunity through breastfeeding assists the infant’s immune system during this susceptible time [2-5]. Breastfeeding provides protection against childhood diseases including asthma, gastroenteritis, and sudden infant death syndrome [6]. The early benefits of breastfeeding extend throughout the life course to further protect the health of a mother and her infant by reducing the longer-term risk of certain cancers and other chronic diseases [7, 8]. The disadvantages of not breastfeeding have both short- and long-term consequences, including an increased risk of infection, immunological diseases, allergies, sudden infant death syndrome, obesity, leukemia/lymphoma, and diabetes [9, 10]. Many children in the world die every year because of preventable diseases. Most of these deaths occur within the first year [11]. Promoting and supporting breastfeeding is an important public health intervention, with multiple health benefits for infants and mothers which results in prescriptive recommendations for breastfeeding based on nutritional considerations, combined with recent evidence of health effects of infant feeding practices. The World Health Organisation (WHO) recommends mothers to exclusively breastfeed their infant for 6months, followed by continued breastfeeding alongside complementary feeding for 2years [8,11,12]. Exclusively breastfeeding decreased from 42% in Turkey Demographic and Health Survey (TDHS)-2008 to 30% in TDHS-2013. Therefore, although breastfeeding is common in Turkey, only exclusive breastfeeding remains well below the desired rate. Artificial nutrition with formula milk and early onset of other fluids have been frequently encountered. In addition, bottle nursing is widely preferred in our country. These findings showed that trainings on breast milk and infant nutrition should be continued continuously and effectively [13]. In this study, we aimed to evaluate the knowledge levels and behaviors related to breast milk and breastfeeding in women with 0-24-months old baby. In addition, we planned to increase the awareness of mothers about breastfeeding and breast milk during the research and to evaluate what can be done on this subject.
Material and Methods
Type, place and universe of the research
This research is an analytical cross-sectional study and was applied to mothers who came to the breastfeeding room while waiting for the examination order between 07.01.2016- 07.01.2017 in the training and research hospital. Participants were selected among mothers with infants 24 months old or younger. Mothers under the age of 18 and who did not want to participate in the study were excluded from the study. The study was completed with a total of 401 mothers.
Research Sample
In previous studies, the incidence of taking only breast milk for the first 6 months in our country has been found as 37% [14]. In our study, since the number of individuals in the universe is unknown, the number of subjects required to be included in the study was calculated as 358 using the “n = t2.p.q/d2” formula. In line with this calculation, it was planned to include in our study at least 358 individuals aged 18 and over. It was planned to include at least 404 people, adding a 10% share due to the possibility of incomplete filling out the questionnaire and refusal to participate in the study. However, the planned date was abided and the data collection process of the study was completed with 401 individuals who applied in this period.
The Objective of the Study
The first two years of age are of a critical period for breastfeeding. The knowledge of mothers about infant feeding is the behavior influenced by their perceptions and beliefs. In this study, we aimed to understand this critical process affecting mothers’ decision-making, to evaluate the knowledge level and attitudes of mothers with 24-months and younger infants about breastfeeding, in order to emphasize the importance of breastfeeding and increase the awareness of mothers about this subject.
Ethical Approval of the Study
The study was approved prior to the initiation by the decision of the Ethics Committee of the Meram Medical Faculty of Necmettin Erbakan University with the decision dated 06/26/2015 and numbered 2015/291. The participants were informed about the study and their written and verbal consent was obtained according to the principles of the Helsinki Declaration.
Inclusion Criteria
Mothers who agreed to participate in the study, aged over 18 years of age, whose babies were 24 months or younger at the time of performing the questionnaire were included.
Exclusion Criteria
Mothers who refused to participate in the study, aged under 18 years of age, malignancy, psychiatric disease, disability to answer questions, having babies older than 24 months were excluded from the study.
Data Collection Tools
Before starting to collect the data, 15 mothers who met the inclusion criteria were pre-tested using the questionnaire. Then the necessary corrections and arrangements were made and the questionnaire was applied. Participants were informed about the study at the beginning, informed consent form was taken and questionnaires were filled with face to face interview technique. Each survey was completed in an average of 15-20 minutes.
Questionnaire Application
In our study, the questionnaire test technique was used as a data collection method. Mothers were asked about their sociodemographic characteristics (age, educational status, occupation, place of residence, educational status and occupation of their spouses, etc.), birth week, birth type and weight of the infant. When assessing the approach to breastfeeding the infant, it was asked about the time of starting breastfeeding, the first food taken after the birth, about the baby’s intake of only breast milk for the first six months, the total duration of breastfeeding, and when and with what foods they switched to additional food. In order to examine the factors affecting breastfeeding, they were asked whether they had received breastfeeding education, the sources of knowledge if they had received education, the presence of grandmother at home, the use of pacifiers and bottles, and they were asked one figured question to evaluate the correct breastfeeding technique. On the last page of the questionnaire, 17 questions were asked about breast milk as true (T) or false (F).
Statistical Analysis
Data were analyzed using SPSS 22.0 package program. After the error control of the data was performed through the same program, statistical analysis was performed. Frequency, mean, standard deviation, median, minimum and maximum values were calculated. In the comparison of categorical data, a chi-square test was used. Results were evaluated at a 95% confidence interval and statistical significance was evaluated at a level of p<0.05.
Results
The mean age of 401 mothers included in the study was 28.1±5.7 years. When education levels were examined, 61.8% (n = 248) were educated in secondary school and above, 38.2% (n=153) were educated in primary school and below, and 90.3% (n=362) were housewives (Table 1). The delivery place was the hospital with the help of health personnel with a rate of 97.5% (n=391). The mean age of the babies of the mothers in the study was 13.4±6.7 months, 52.6% (n=211) were girls, 47.4% (n=190) were boys, 79% (n=317) were born after the 37th week, 21% (n = 84) were born at 37th week or earlier. Among the babies, 78.6% (n=315) had normal birth weight, 18.5% (n=74) had low birth weight, 3% (n=12) had excessive birth weight, 52.1% (n=209) were born by normal spontaneous and 47.9% (n=192) were born by caesarean section.
When calculating the frequency of taking only breast milk during the first six months, when babies aged 6 to 24 months (n=339) were evaluated, 71.1% (n=241) took only breast milk during the first six months, while 28.9% (n = 98) took foods other than breast milk. While 77.8% (n=312) of the mothers gave breast milk only through breast-feeding, 22% (n=89) were using the milking method for giving breast milk as well as breast-feeding. In addition to breastfeeding, working mothers used milking as a method of giving breast milk more frequently than housewives (p=0.049). The breastfeeding rate was higher in mothers who were non-working (housewives) than working mothers (p=0.036). The frequency of delivery by cesarean section in working mothers was higher than mothers who were housewives (p=0.021).
The frequency of taking only breast milk in the first 3 days after delivery in infants born by normal spontaneous was found to be higher than infants born by cesarean section (p<0.001). The rate of taking only breast milk in the first 3 days after delivery in infants born mature was found to be higher than infants born premature (p=0.004). The breastfeeding rate was higher in mothers who did not use a bottle (p<0.001). The infants born by normal spontaneous way were found to be taking breast milk earlier than those born by caesarean section (p<0.001). The infants born mature received breast milk earlier than those born by cesarean section (p<0.001). As the education level of fathers increased, the rates of support for breast-feeding increased (p = 0.028) (Table 1). The problems encountered by mothers while breast-feeding and their knowledge about breast milk were shown in Table 2. Nipple problems were the most common problems encountered while breast-feeding with a frequency of 29.6%. The frequency of knowing the correct breastfeeding method was 87.8% (n=352). Unfortunately, 19.5% (n=78) of the mothers reported that they did not receive education on breastfeeding. The relationship of giving food other than breast milk in the first three days/first six months with some parameters was shown in Table 3.
Discussion
Breast milk is a primary nutrition for the optimal growth and development of the infant. UNICEF and WHO recommend that breast milk should be given to the infants starting within the first half hour after delivery, and only breast milk should be given for the first six months [11]. The support of mothers’ knowledge and attitudes during the breastfeeding period will help implement these recommendations. According to recent data, the rate of breastfeeding of infants during the first months after birth is high in Turkey; however, the total duration of breastfeeding is not at the desired level. While the rate of giving only breast milk in the first six months was 42% in 2008 in Turkey, it has dropped to 30% in 2013. This rate is 71% in our study and is significantly higher than Turkey’s general population. According to the TDHS-2013, the median duration of total breastfeeding countrywide was 16.7 months, it was found to be 12.1 months in the present study [13]. In a study conducted by Guo et al in 2010 in China on the effects of breastfeeding on child and population health, the median duration of breastfeeding was 15 months. The reason for this may be related to the average age of 13 months of the babies of the mothers we included in the study [15].
In our study, 61.6% of mothers breastfeed their babies in the first half hour after birth. In the study conducted by Koç et al, examining mothers’ views on breastfeeding coaching, the frequency of breastfeeding of the mothers in the first half hour was lower (52%) [16]. In a study of Kutlu et al on the
breastfeeding behaviors of the mothers, 66.1% of the mothers who received breast milk education breastfeed their baby in the first half hour, while this rate was 56.2% for those who did not receive education [14]. In our study, there were both mothers who received and did not receive breast milk education. In a study by Mbada et al in Nigerian breastfeeding mothers, the frequency of breastfeeding in the first hour after birth was 78.3% [17].
In this study, mothers who delivered with normal spontaneous way started to contact and breast-feed their infants earlier after the delivery compared to those who delivered by caesarean section. The first three days after birth are critical for the infant in terms of taking colostrum rich in protective antibodies.
In our study, while breastfeeding rate was 48.7% in working mothers for the first six months, this rate was 61.3% in housewives. There was no relationship between working status and the frequency of exclusively breastfeeding for the first six months. These results were similar to our study in the study of Mbada et al [17].
In a study by Dagher et al, it was found that mothers who returned to work within the first six months were more likely to breastfeed than those who did not start working. The frequency of breastfeeding would not decrease with the milk permit and the support of employers during the day [18]. There are also studies showing that there is a positive relationship between using milk permit after birth and breastfeeding period [19, 20]. In our study, while cesarean rate was high in working mothers (66.7%), normal spontaneous delivery rate was higher in housewife mothers (54.1%). In our study, it was observed that the incidence of taking colostrum of the infants of the mothers who delivered in the normal way was higher than those whose mothers have delivered by cesarean section. Infants born at early gestational week were later introduced to breast milk after delivery and had lower breastfeeding rates for the first six months. Prematurity was decreasing the frequency of giving only breast milk in the first three days and in the first six months and was increasing the frequency of giving supplementary food. Suction and swallowing reflex in the infants develop after the 32th-34th gestational week. Therefore, since premature infants less than 32 weeks of age do not develop the suction reflex, breast milk should be given by milking until the infant is able to receive oral intake [21]. In our study, the frequency of normal spontaneous birth in housewife was higher and the frequency of cesarean section in working mothers was higher. Normal spontaneous delivery should be the first choice unless there is a risky condition for the mother and/or the infant. Today, modern and working women think that the pain and difficulty during labor will be dangerous. The fact that the mothers have a preference for cesarean section may have increased the frequency of cesarean in working mothers [22, 23]. It is known that mothers with spouses who have a high education level and who have an active role in baby care are more prominent in breastfeeding [24, 25]. In our study, 79.6% of the fathers supported breastfeeding. Fathers with high educational level have higher breastfeeding awareness and supported mothers more.
In the first six months, mothers who had more than one child had higher breastfeeding frequency than mothers with only one child, but it was not statistically significant in our study. In a study conducted by Yanıkkerem et al, it was observed that primipar pregnants had a fear that their milk would be cut prematurely compared to multiparous pregnant women and needed more support in postnatal breastfeeding [26]. In a study conducted with primipar and multipar mothers, it is reported that the doctor, spouse and grandmother are very effective in the attitude and behavior of the mother regarding baby feeding [27].
Conclusion
The breastfeeding rate in working mothers was lower than housewives. While the normal birth rate was high in housewives, cesarean section rate was higher in working mothers. Working mothers have used the breast milking method. The positive and supportive attitudes to breastfeeding of the fathers with high education level were higher than those with low education level. Infants born by normal spontaneous were receiving more colostrum than those born by cesarean section. Premature infants were receiving less colostrum than infants born mature. There are numerous proven medical data on the benefits and necessity of breast milk. In the Convention on the Rights of the Children, it has been stated that breastfeeding is the right of children and parents should be educated before and after delivery. The mother has the right to breastfeed the infant as much as the child has the right to be breastfed. It is important to determine the type and trends of breastfeeding and to determine the factors that affect it. Therefore, breastfeeding trainings should be started from pregnancy, cesarean section should be decreased and indication of normal births should be supported. Mothers with premature babies should be constantly motivated and informed about breastfeeding. Breastfeeding trainings should start at the gestation period and fathers should be informed as well as mothers and awareness should be raised.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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The relationship between hope in healthcare employees and social support and coping ability during the outbreak process
Aslı Kazgan 1, Sevler Yıldız 2, Osman Kurt 3
1 Department of Psychiatry, Siverek State Hospital, Şanlıurfa, 2 Department of Psychiatry, Tunceli State Hospital, Tunceli, 3 Department of Publich Health, Fırat University, Medical Faculty, Elazığ, Turkey
DOI: 10.4328/ACAM.20292 Received: 2020-07-28 Accepted: 2020-09-04 Published Online: 2020-09-28 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):377-383
Corresponding Author: Aslı Kazgan, Siverek State Hospital, 63000 Şanlıurfa, Turkey. E-mail: dr.kazgan@hotmail.com P: +90 505 740 33 68 Corresponding Author ORCID ID: https://orcid.org/0000-0002-0312-0476
Aim: In this study, it was aimed to examine the relationship between the concept of hope that is present in healthcare professionals during the COVID-19 pandemic process and the possible relationship between perceived social support and coping ability.
Material and Method: Sociodemographic and Clinical Data Form, State-Trait Anxiety Inventory (STAI), Trait Hope Scale (THS), Multi-Dimensional Perceived Social Support Scale (MDPSSS), Coping with Stress Scale (CSS) were applied to 170 healthcare professionals working in the pandemic hospital and meeting the study criteria.
Results: The THS score was found to be the lowest in those working in both the service and emergency service/polyclinic, and a statistically significant dif- ference was found between this group and those working in the service and those working in the emergency/outpatient clinic (p <0.001). The MDPSSS score of the group working in both departments was the lowest and this decrease was statistically significant (p=0.002). THS scores of the doctors were lower than nurses, and this lowness was statistically significant (p=0.001). A positive significant correlation was found between the total score of THS and CSS and MDPSSS scores (r=0.226, p=0.003) (r=0.194, p=0.023).
Discussion: Perceived social support and hope levels decrease as the number of working units of health personnel increases during the Covid-19 pandemic process. Levels of hope differ according to the professions. The level of hope is positively associated with the coping ability and perceived multi-dimensional social support. This study has revealed that functional coping attitudes and perceived social support in healthcare professionals during pandemic periods are associated with high levels of hope.
Keywords: Social support; Coping ability; COVID-19; Healthcare workers; Hope concept
Introduction
Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS- CoV-2) spread rapidly to many countries in the world with its high contamination property and was declared as a pandemic by the World Health Organization on January 31, 2020.
In all recent outbreaks such as SARS, Ebola, MERS – CoV infections and COVID-19 that we are currently experiencing, which have had fatal consequences, healthcare professionals have been the most affected and at risk of harm [1-4]. In 2003, psychiatric symptoms were reported in 27% of healthcare professionals during the SARS-CoV epidemic in Singapore [5]. In the COVID-19 epidemic, stress, anxiety, hopelessness, insomnia, and anger have been seen in health workers in Wuhan due to mental health problems such as the high risk of infection they have been exposed to, overwork, and isolation [6].
Hope is defined as a cognitive process that expresses the capacity of individuals to produce paths for their goals and to act in accordance with the path they produce. Individuals with high levels of hope exhibit motivating attitudes when faced with worrying problems. Therefore, the concept of hope and anxiety are interrelated structures [7]. We believe that the most important motivation for healthcare professionals who work devotedly in times of pandemic is hope, and social support is important for individuals to avoid despair.
Perceived social support is the person’s belief that she/he has strong connections with other people and his/her cognitive perception that she/he will be supported when necessary. Individuals with a high level of social support adapt to stress more easily [8]. We think that perceived social support, which we think is one of the most important requirements during the pandemic periods, can be effective for individuals to control their anxiety.
State anxiety is associated with subjective and momentary anxiety and is temporary anxiety caused by environmental stress. Trait anxiety is that a stressful situation is perceived as dangerous, and a person shows anxiety symptoms even in the absence of danger [9]. For healthcare professionals, the risk of decaying and death is very important stress factors [10]. Although the time spent by the healthcare professionals in the hospital increases even more during the COVID-19 epidemic period, it may have increased the workload, but it may have been a source of stress outside the working hours. In these cases, methods of coping with the stress are important for a person. Coping, on the other hand, is cognitive and behavioral efforts that individuals make to learn to reduce or tolerate negative or stressful life events and is associated with psychological well- being [11].
Stress and anxiety of physicians, nurses, and other personnel who are in direct contact with patients can play an active role in pandemic management. In our study, it is among the determined goals to discuss the effects of factors affecting anxiety in epidemic periods that reveal anxiety and we aimed to examine the relationship between the concept of hope that is present in healthcare workers with the social support perceived by the healthcare worker and the coping ability created by the healthcare worker.
Material and Methods
Ethics committee approval was obtained for our cross- sectional study from XXXX University Hospital. This ethics committee approval was also reported to the Ministry of Health and the study was carried out in accordance with the Helsinki Declaration. The study included 170 healthcare professionals working in the pandemic hospital between March 2020 and April 2020, which has recorded the highest number of COVID-19 pandemic cases in Turkey. While the volunteering condition was required for the participants, the fact that they had physical and mental illnesses that could prevent them from responding to questionnaires and scales, and that they were illiterate was accepted as exclusion criteria. Sociodemographic and Clinical Data Form, State-Trait Anxiety Inventory (STAI), Trait Hope Scale (THS), Multi-Dimensional Perceived Social Support Scale (MDPSSS), Coping with Stress Scale (CSS) were applied to all of the participants.
1. Sociodemographic and Clinical Data Form
This is a form prepared by us considering the objectives of the study, which includes socio-demographic information such as age, gender, marital status, educational status, profession, place of residence, economic status, family structure in individuals included in the study.
2. Trait Hope Scale (THS)
It was developed by Snyder et al. (1991) to determine the constant level of hope of individuals aged 15 and over. The scale, which consists of twelve items, includes four items regarding the alternative ways of thinking of hope and acting thought dimensions. The lowest score that can be obtained from the scale is 4, and the highest score is 32. The high score obtained indicates that the level of hope is high [12].
3. Multi-Dimensional Perceived Social Support Scale (MDPSSS)
The form of the scale developed in 1988 by Zimmet et al. was revised in 2001. The scale, which is Likert type, consists of 12 questions in total. Each question was created with seven grades (1-7 points) ranging from “absolutely no” to “absolutely yes”. As a result, the high score obtained shows that perceived social support is high [13].
4. Coping with Stress Scale (CSS)
This scale is a 5-point Likert-type scale (5=totally suitable- 1=not suitable at all). A total score of 23-115 is obtained from 23 items in the CSS. It was developed by Folkman and Lazarus. The scale consists of 30 items and is a 4-Likert (0=not suitable at all, 1=not suitable, 2=suitable, 3=completely suitable) type [14].
5. State-Trait Anxiety Inventory (STAI)
It was developed by Spielberger et al. in 1970. The State Anxiety Inventory of the scale, which consists of 40 items in total, measures a person’s anxiety at a certain time, and the Trait Anxiety Form measures the person’s susceptibility to anxiety experience in a fixed personality structure. It consists of 4-Likert type and twenty items. The total score value obtained from both scales varies between 20 and 80, and the score between 26 and 42 is accepted as average. A high score indicates a high level of anxiety and a small score indicates a low level of anxiety [15].
Statistical Analysis
Analyzes were evaluated in SPSS (Statistical Package for Social Sciences; SPSS Inc., Chicago, IL) 22 package program. In the study, descriptive data were shown with n, % values in categorical data and average values ± standard deviation, median, interquartile range (25-75 percentile values) in continuous data. The Chi-square analysis (Pearson Chi-square) was used to compare intergroup categorical variables. The compliance of continuous variables to normal distribution was evaluated with the Kolmogorov-Smirnov Test. Independent Samples t-test was used for comparison of variables that comply with a normal distribution, One Way ANOVA test was used when more than two groups were compared, the Mann- Whitney U Test was used for comparison of variables that do not comply with normal distribution, and the Kruskal-Wallis test was used when more than two groups were compared. Pearson or Spearman Correlation analyses were used to compare the measurement data. The statistical significance level was accepted as p <0.05 in the analysis.
Results
A total of 170 healthcare workers, 94 (55.3%) males and 76 (44.7%) females, with the mean age of 33.36 ± 7.85 years were included in the study. It was observed that 113 (66.5%) of the healthcare professionals were married, 131 (77.1%) were university graduates, 138 (81.2%) lived in the city and 134 (78.8%) had moderate economic status. Forty (23.5%) of the participants were doctors, 80 (47.1%) were nurses and 50 (29.4%) were other healthcare professionals (health officers, laboratory and x-ray technicians, medical secretaries, servants). Other socio-demographic characteristics of healthcare professionals are shown in Table 1.
When the state and trait anxiety scores were evaluated in the whole group, the mean state anxiety scale (WHO) score was 41.5 ± 9.2, and the mean trait anxiety scale (SDI) score was 41.4 ± 8.9. The total mean score of the State-Trait Anxiety Inventory (STAI) was 82.5 ± 16.7. While the mean trait hope scale (SRS) total score was 54.4 ± 14.5, the scale’s acting thoughts sub- dimension mean score was 26.8 ± 7.2 and the alternative thoughts sub-dimension mean score was 27.4 ± 8.03. The total score average of the coping stress scale (CSS) of the whole group was found as 60.8 ± 18.1, and the total score average of the multi-dimensional perceived social support scale (MDPSSS) was found as 73.1 ± 22.2.
Health personnel were divided into 3 as both emergency/ outpatient and service workers (Group 1), emergency/outpatient (Group 2) and only service workers (Group 3) according to COVID-19 workplaces. According to the COVID-19 workplace, a statistically significant difference was found between the scores in terms of STAI total (p <0.001). It was observed that this difference was due to the difference between all groups. The total STAI mean score of those who were separated from their family was found to be significantly higher than those living with their family during the COVID-19 pandemic process (p=0.034). According to the profession group, a significant difference was found in terms of total score in the THS (p=0.001). It was found that this difference is only between doctors and nurses (Figure 1). Again, according to the COVID-19 workplace, a statistically significant difference was found between the scores in terms of THS total (p <0.001). It was observed that this difference arises between the group working in the service and those working in both the service and emergency/polyclinics. The total THS mean score of those who were separated from their family was found to be significantly higher than those living with their family during the COVID-19 pandemic process (p=0.009) (Table 2).
1) According to the COVID-19 working unit, a significant difference was found in terms of STAI state anxiety (p <0.001). It was observed that this difference originated from all three places (p=0.02 for emergency service/polyclinic, p <0.001 for both emergency service/polyclinic-both, p=0.015 for both services) (Table 2).
2) According to the COVID-19 study unit, a significant difference was found in terms of trait anxiety (p=0.004). It was observed that this difference was only due to the difference between those working in the emergency/outpatient clinic and those working in both places (p=0.091 for emergency/polyclinic- service, p=0.007 for emergency/polyclinic-both, p=0.068 for service-both) (Table 2).
3) The STAI trait anxiety scores of those who separated from their families during the COVID-19 pandemic process were significantly higher than those who did not separate (p=0.009) (Table 2).
4) A significant difference was found between the professional group in terms of the THS acting sub-dimension (p=0.002). This difference was statistically significant only between doctors and nurses (p=0.001 for doctor-nurse, p=0.212 for doctor-other health personnel, p=0.265 for nurse-other health personnel) (Table 2).
5) A significant difference was found between the professional group in terms of the THS alternative sub-dimension (p=0.001). This difference was significant between doctors and nurses and between doctors and other healthcare professionals (p=0.001 for doctor-nurse, p=0.043 for doctor-other health personnel, p=0.961 for nurse-other health personnel) (Table 2).
6) According to COVID-19 workplace status, a significant difference was found in terms of THS acting (p <0.001). This difference arises from the difference between COVID-19 emergency or outpatient employees and the group working in the service, and those working in both places and those working in the service (p=0.049 for emergency/polyclinic-clinic, p=1,000 for emergency/polyclinic-both, p <0.001 for service-both) (Table 2).
7) According to the COVID-19 workplace status, a significant difference was found in terms of THS alternative (p <0.001). This difference was found to be related only to the difference between those working in the service and the group working in both (p=0.611 for emergency/outpatient-clinic, p=1,000 for emergency/outpatient-clinic-both, p <0.001 for service-both) (Table 2).
8) The staff who lived separately from their families during the COVID-19 pandemic had significantly higher scores on both the THS acting thought and the THS alternative thoughts (p=0.021), (p=0.029) (Table 2).
9) Alternative THS scores of men were found to be significantly higher than that of women (p=0.029) (Table 2).
The CSS score of the high school and lower group was significantly higher than that of the university graduate (p=0.049). A significant difference was observed between the professional groups in terms of the CSS score (p <0.001). It was observed that this difference resulted from the difference between doctor and nurse and doctor and other healthcare personnel (Figure 1).
A significant difference was found between COVID-19 work units in terms of MDPSSS (p=0.002). This difference seemed to be related to the difference between those who worked in both places and those who worked in the emergency/outpatient clinic, and those who worked in both places and those who worked in the service (Table 3).
A positive significant correlation was found between STAI total
score and the CSS (r=0.267, p <0.001). A negative significant relationship was found between STAI total score and MDPSSS score (r=-0.400, p <0.001). A positive correlation was found between the total score of THS and CSS (r=0.222, p=0.003). It was observed that there was a positive and significant relationship between the THS total score and MDPSSS (r=0,174, p=0,023) (Figure2).
Discussion
According to the results obtained from this research, no significant difference was found between the scale scores (STAI, THS, CSS, MDPSSS) of the employees according to age, gender, marital status, education, income level, profession durations, whether there was additional disease and whether they lived with a risky individual at home. These sociodemographic features do not predict the level of anxiety, hope levels, perceived social support, and coping with the stress of the personnel. This may be related to the development of different life situations due to the personal characteristics of the participants. In terms of age and professional durations, the fact that employees can be more conscious in coping with problems and stress can increase their anxiety level during difficult times such as pandemic. In the study, it was determined that the STAI mean scores differed according to COVID-19 workplaces and whether the healthcare professionals spent this process separately from their families. Personnel were divided into 3 according to COVID-19 workplaces as follows: working in both emergency service/polyclinic and working in service (Group 1), and working in emergency service/polyclinic (Group 2) and working in service (Group 3). The STAI average score of Group 1 was found to be the highest. With an increase in the number of units in which medical personnel work, state and trait anxiety levels have also increased. During the Ebola outbreaks in Sierra Leone in 2014 and in the Democratic Republic of the Congo in 2018, a high level of concern has been reported among healthcare professionals in direct contact with infected patients [2]. COVID-19 services are places where the time spent with the patient and the virus exposure are intense during the pandemic process. Due to this virus with a high transmission rate, considering that healthcare workers in COVID-19 services are at higher risk of infection, we attribute that service workers have higher levels of anxiety than working in emergency service/polyclinic due to this condition.
STAI and trait anxiety scores of the personnel who were separated from their families were significantly higher than those who lived with their families during the COVID-19 pandemic. In the case of trait anxiety, the person shows anxiety symptoms even in the absence of danger and becomes constantly uneasy and nervous. This situation can be explained by the fact that the personnel are deprived of the social support they receive from their families in this process and their social relations decrease.
Alternative ways from the components of hope, defined as the expectation of a positive future, are defined as the person’s ability to formulate possible goals, and the acting thought is defined as thoughts about actions shown to achieve the goal [16]. These thoughts can provide a person to motivate oneself [16]. A significant difference was found between the doctors and nurses by profession in terms of THS score in the study. The fact that doctors have the lowest THS scores may be due to the fact that they are the first occupational group that meets possible and precise cases during the COVID-19 process, and also have primary responsibility for the follow-up and treatment of these patients. According to the COVID-19 study unit, there was a statistically significant difference between Group1 and Group 3 in terms of THS scores. THS acting thought was statistically different between Group 2 and Group 3, between Group 1 and Group 3, and THS alternative thoughts were statistically different between Group 3 and Group 1. Besides, the staff that lived separately from their families during the COVID-19 pandemic had significantly higher scores on both the THS acting thought and the THS alternative thoughts. If the person is prevented, she/he should be able to predict alternative ways in order to continue thinking hopefully. It was observed that individuals with high levels of hope produced more alternative ways. People with high levels of hope have more life goals and can produce more strategies to achieve these goals [16]. Staff that lives separately from their families may have more motivation than those who live with their families.
In our study, the alternative thought scores of the men were significantly higher than those of women. The change in the level of hope varies according to gender. For example, there are studies indicating that men have higher levels of hope compared to women, even though they are not examined according to subgroups [17].
Coping with stress is cognitive and behavioral efforts that individuals make to learn to reduce or tolerate negative or stressful life events [11]. Individuals develop various methods to deal with the stressful life events they encounter in their lives. A positive significant correlation was found between the CSS and STAI scores in the study. This shows us that as individuals’ anxiety levels increase, they try harder to cope with stress.
In the study, the ability of groups to cope with stress varies according to their educational level, and the CSS scores of the people with high school and under-graduate degrees were found to be significantly higher than university graduates. Among the professional groups, the CSS scores of the nurses and other health personnel were found to be significantly higher than the doctors. This may be due to the fact that the staff with lower education level uses negative methods to deal with stress more, and the influence of variable factors such as problem-solving skills and personality traits.
There are studies supporting our study data showing that people with poor health can find effective ways to cope if their hope level is high [18]. In another study conducted with patients with breast cancer, it was determined that patients with high hope levels used their coping strategies more [19]. A positive significant correlation was found between the CSS and THS scores of the whole group in our study. As people try to cope with stress, they may tend to increase their hope levels. With these data, our study revealed that coping attitudes, which are effective in reducing the symptoms of anxiety triggered by stress, are associated with high levels of hope.
Perceived social support is the support that the individual perceives individually as she/he thinks that she/he is loved by others and that other people will help him/her in difficult times [20]. This material and moral support that the person feels protects the individual’s mental and physical health in stressful situations. Since social support is provided through social relations, social isolation applied in cases of epidemic disease will make it difficult for the individual to establish and maintain relationships with people. According to the data obtained in the study, As perceived support scores increased, THS scores also increased. Arslantaş et al. have studies supporting our study, which reveals that perceived social support is negatively correlated to hopelessness [21]. In the negative correlation between MDPSSS and STAI scores, anxiety levels decreased as the social support perceived by the staff increased. Kaya et al. (2012) mentioned that social support is a concept that acts as a buffer for the negative effects of stress in the workplace and plays an effective role in reducing the stress level as a result of the work done on unit officers in the health institution [22]. Our study shows that increasing the social support that individuals receive from their friends, their environment, and work environment reduces their anxiety levels.
It is clear that all pandemics primarily endanger the physical and psychosocial health of healthcare professionals working in the outbreak. In this study, it has been revealed that functional coping attitudes and perceived social support, which are effective in reducing the symptoms of anxiety triggered by stress in healthcare professionals during the pandemic period, are associated with high levels of hope. The level of hope, attitudes to cope with perceived stress, perceived support, and anxiety levels differ according to demographic characteristics. The level of hope is positively associated with the coping strategies and perceived multi-dimensional social support. Trait and state anxiety predicts coping with stress positively and multi-dimensional perceived support negatively. As the anxiety levels of the staff increase, their coping attitudes increase and their perceived social support decreases. It can be thought that socio-demographic features that do not predict hope levels in the study are due to research conducted on different samples and different study groups.
The limitations of our study are that the sample consists of healthcare professionals working in two hospitals in total during the pandemic, and the data collected are obtained with self-report-based scales. Evaluations based on self-report may cause individuals to respond biased or the pattern other than awareness cannot be evaluated. In conclusion, although both group comparisons and correlational analyzes are included in this study, the cross-sectional design of the research limits the interpretation of the cause and effect relation. Although the relationship between hope and coping with stress, trait, and state anxiety, perceived support has been addressed in the current study, the lack of consideration of the predictive role of these variables makes it difficult to comment on this issue.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with
the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Aslı Kazgan, Sevler Yıldız, Osman Kurt. The relationship between hope in healthcare employees and social support and coping ability during the outbreak process. Ann Clin Anal Med 2021;12(4):377-383
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Surgically treated fractures of the acetabulum; clinical and radiological results of eighty-three patients
Ahmet Mert 1, Burçin Karslı 2
1 Deparment of Orthopedics and Traumatology, 25 Aralık State Hospital, 2Deparment of Orthopedic Surgery, Gaziantep University Hospital, Gaziantep, Turkey
DOI: 10.4328/ACAM.20293 Received: 2020-07-27 Accepted: 2020-08-25 Published Online: 2020-09-10 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):384-387
Corresponding Author: Ahmet Mert, Değirmiçem Mahallesi, Maraşal Fevzi Çakmak Blv. No:38, 27090 Şehitkamil, Gaziantep, Turkey. E-mail: rparldar@yahoo.com P: +90 5079914462 Corresponding Author ORCID ID: https://orcid.org/0000-0001-5111-2051
Aim: The aim of our study was to examine the clinical outcomes and radiological results of acetabular fractures that were followed up and treated in our clinic. Materials and Methods: The age, gender, accompanying injuries, fracture mechanisms, Judet-Letournel fracture classification, surgical incision and complica- tions of patients admitted to our clinic with acetabular fracture were recorded. Patients with open fractures of the acetabulum, those who were not operated with an ilioinguinal approach, and those who were followed up conservatively were excluded from the study. All patients were evaluated according to the Matta scoring system and Modified Merle d’Aubigné Criteria.
Results: The study included 83 patients who were followed up and treated for acetabular fracture and who were operated with ilioinguinal incision, posterior approach (Kocher-Langenbeck) and combined surgical approaches. The reduction was anatomical in 67 (80.7%) patients, fair in 12 (14.4%) and poor in 4 (4.8%) patients according to the Matta Reduction Criteria. According to the Modified Merle d’Aubigné Criteria, 46 (55.4%) patients had an excellent clinical outcome, 26 (31.3%) patients had a good clinical outcome, 7 (8.4%) patients had a fair clinical outcome, and 4 (4.8%) patients had a poor clinical outcome. There was a significant correlation between the obtained radiological results and clinical outcomes (p<0.001). In the analysis performed by age, it was found that the clinical outcomes of the patients over 45 years of age were statistically worse than those of the patients under 45 years of age (p=0.05). It was found that there was a significant correlation between reduction quality assessment performed on the postoperative radiographs of the patients and the clinical outcome (p<0.001).
Discussion: Acetabular fractures are difficult to treat; ensuring anatomical reduction should be the primary goal, and this may be reflected in clinical outcomes and radiological results of patients.
Keywords: Acetabulum fracture; Pelvis; Multitrauma; Ilioinguinal
Introduction
Acetabular fractures are difficult to deal with compared to other orthopedic traumas. Anatomical restoration and reconstruction of the joint line is one of the cornerstones of treatment. It has been reported that fractures, where anatomical reduction can be achieved well during operation, have much better clinical outcomes [1]. The ilioinguinal approach, an anterior surgical approach, described by Judet and Letournel has been the main approach in surgeries involving the anterior part of acetabular fractures for years [2-3]. In the literature, anatomical reduction rates have been shown to be 45-74% in patients undergoing surgeryaftertheilioinguinalapproach[4-5].Atthesametime, acetabular fractures involve not only the anterior part, but can also present to the emergency department as fractures requiring posterior approaches. Kocher-Langenbeck (K-L) approach is recommended for the reduction and internal fixation of fractures of both anterior and posterior columns in treating transverse with or without posterior wall fractures of the acetabulum [6]. In some cases, acetabular fractures cannot be adequately treated with the use of anterior or posterior approaches alone, and in such a case, combined procedures are preferred. In addition, acetabular fractures are caused by high-energy injuries and may be accompanied by other organ and system injuries. In the literature, it is seen that acetabular fractures are accompanied by lower extremity fractures in approximately 36% of cases [7].
The aim of our study was to demonstrate the clinical and functional outcomes of acetabulum fractures in patients who were admitted to our clinic with different injury mechanisms and treated with the ilioinguinal, Kocher-Langenbeck approach, and combined approaches.
Material and Methods
The study was approved by Gaziantep University Institutional reviewer board. Informed consent form was received from the patients. The study included 83 patients who were followed-up and treated in our clinic for acetabular fracture between 2009- 2015. This study was a single-center study. The age, gender, accompanying injuries, fracture mechanisms, Judet-Letournel fracture classification, surgical incision, and complications of patients were recorded. Patients with open fractures of the acetabulum, those who were not operated with an ilioinguinal approach, and those who were followed up conservatively were excluded from the study.
The patients were evaluated with X-ray and pelvic CT at their first admission to the emergency department. Skeletal traction was applied to all patients on the side of acetabular fracture. The patients’ follow-up was performed with standard anterior- posterior pelvic radiographs and Judet radiographs (Judet view). The ilioinguinal surgical incision was used in all patients as an anterior intrapelvic approach. The Kocher-Langenbeck approach was used for fixation of fractures involving the posterior acetabulum in patients with an additional injury. The quality of the reduction was checked by taking intraoperative fluoroscopy images of all patients. All operations were performed by the same surgeon. In the follow-up of the patients, the additional surgery requirement for acetabular fracture was recorded.
The patients started passive in-bed exercise to the extent that they could tolerate on the first postoperative day. All patients were mobilized using crutches without stepping on their feet for early mobilization after surgery. They were forbidden to load their fractured side for two months. Low-molecular-weight heparin treatment was administered for deep vein thrombosis prophylaxis so as to be completed to one month postoperatively. The clinical evaluations of the patients were performed according to the Modified Merle d’Aubigné Criteria, while radiological evaluations were performed using the Matta’s radiological staging system [8].
Statistical Analysis
The categorical data were expressed as numbers and percentages, while the numerical data were expressed as mean and standard deviation. The Shapiro-Wilk test was used for testing the normality of numerical data. The relationship between categorical variables was analyzed with the Chi- square test. The SPSS 22.0 software package was used for the analyses. For all analyses, a p-value of <0.05 was considered statistically significant.
Results
The study included 83 patients who were followed-up and treated for acetabular fracture and who were operated with ilioinguinal incision, posterior approach (Kocher-Langenbeck), and combined surgical approaches. Sixty-seven patients were female, and 16 were male. The mean age was 34.6 (15-86 years) years, and the mean follow-up period was 33.3 months (8-85 months). The mean time to surgery was 5.6 days (1-26 days). Thirty-eight of the patients had one or more fractures accompanying acetabular fracture (45.7%) (Figure 1). When the mechanism of fractures the patients was analyzed, it was found that 33 patients had fractures due to a non-vehicle traffic accident (39.8%), 29 had fractures due to falls from height (34.9%), 16 had fractures due to an in-vehicle traffic accident (19.3%), 4 had fractures as a result of a heavy object falling (4.8%), and 1 had a fracture as a result of an assault (1.2%). When the fracture configurations were analyzed according to the Judet-Letournal classification, the most common fracture type was found to be anterior column fracture with 16 (19.2%) patients. Anterior column fracture was followed by posterior wall fracture with 15 (18%) patients, and double column acetabular fracture with 12 (14.4%) patients, T-type fracture with 11 (13.7%) patients, transverse+posterior wall fracture with 10 (12.5%) patients, anterior wall fractures with 6 (7%) patients, transverse fracture with 5 (6%) patients, anterior column + posterior hemitransverse fracture with 4 (5%) patients, and posterior column fracture with 3 (3.7%) patients. The least common fracture type was the combined fracture of the posterior wall and posterior column, in addition to anterior fractures. There were no bilateral acetabulum fractures.
When the surgical intervention of the patients was analyzed, 38 (45.7%) of 83 patients were operated with an anterior ilioinguinal approach alone, while the Kocher Langenbeck surgical approach alone was preferred for 27 (32.5%) patients. The surgery of 18 patients with complex fractures (21.6%) was performed by combining the ilioinguinal approach with the Kocher-Langenbeck approach. Reduction was anatomical in 67 (80.7%) patients, fair in 12 (14.4%) and poor in 4 (4.8%) patients according to the Matta Reduction Criteria.
An evaluation was performed on the pelvic x-rays taken at the last follow-up of the patients based on the Matta’s Radiological Staging System. According to the Matta’s Radiological Staging System, 59 (71%) patients had an excellent outcome, 11 (13.2%) patients had a good outcome, 5 (6%) patients had a fair outcome, and 8 (9.6%) patients had a poor outcome. According to the Modified Merle d’Aubigné Criteria, 46 (55.4%) patients had an excellent clinical outcome, 26 (31.3%) patients had a good clinical outcome, 7 (8.4%) patients had a fair clinical outcome, and 4 (4.8%) patients had a poor clinical outcome. After statistical analysis, it was found that there was a significant correlation between reduction quality assessment on the postoperative x-rays of the patients and clinical outcomes (p<0.001). No patient underwent total hip arthroplasty during the follow-up period.
All patients were classified according to the Matta Radiological Scoring System based on the radiographic findings obtained in their last follow-ups. There was a significant correlation between the obtained radiological results and clinical outcomes (p<0.001). In the analysis performed by age, it was found that the clinical outcomes of patients aged over 45 years were statistically worse than those of patients under 45 years of age (p<0.05).
Union was achieved in all 83 patients analyzed. Postoperative peroneal nerve injury was observed in 5 patients who underwent posterior intervention. All of these improved during follow-ups. In 1 patient who underwent anterior ilioinguinal surgery, wound infection was observed by the 5th postoperative day. The patient healed with debridement and antibiotherapy.
Discussion
In our study, we analyzed the results of fracture analyses, radiological results and clinical outcomes, as well as additional injuries of 83 patients presented to our clinic with acetabular fractures. In our study, we achieved an anatomical reduction in 80.7% of the patients and excellent clinical outcomes in 55.4% of the patients.
There are many negative predictive factors that affect the results of acetabular fractures. These can be defined as such factors as non-anatomical reduction, femoral cartilage lesion, marginal impaction, delayed reconstruction, and keeping the dislocated hip for more than 6 hours [1-9, 10,11]. Almost all types of acetabular fractures were included in our study. Furthermore, the results were evaluated based on Matta’s radiological scoring system.
If a good restoration of the hip joint is not achieved after acetabular fractures, patients may require hip arthroplasty in the future. In the literature, it is reported that the requirement for total hip replacement increases by 25 times after acetabular fractures [12]. No patient underwent total hip arthroplasty during the follow-up period in our study. However, as the follow- up duration prolongs, we think that the patients with poor outcomes may require arthroplasty.
In our study, an ilioinguinal approach was preferred for acetabular fractures requiring anterior fixation. The clinical outcomes of the patients were reported to be good as a result of the fixation of the anterior wall, column, and even both columns with the ilioinguinal approach [13-14]. We used the ilioinguinal approach for anterior acetabular fracture fixation in 45 of 83 patients who participated in our study.
Acetabular fractures are also a problem for elderly patients. There are some authors recommending arthroplasty for elderly patients whose anatomical reduction cannot be achieved [15]. It has also been reported that acetabular fractures have poor outcomes in elderly patients [16]. Although the mean age of our patients in the study was low, we statistically determined that the outcomes of our patients over 45 years of age were worse than those of the patients under 45 years of age. And this shows that the outcomes of acetabular fractures are not very satisfactory with increasing age.
Patients with additional injuries were also included in our study. The complication rates, prolonged length of stay and re-admissions increase in patients with additional injuries accompanying acetabular fracture [17]. We did not compare the results of both groups, and we think that this may be the subject of another study. Also, patients with open fractures were not included in our study. Additional injuries were not classified, for example, whether the additional tibial fracture lengthened the hospital stay or increased complications, we do not know. In the literature, it is indicated if there is an additional fibula fracture with a tibial fracture that could affect the healing time [18], but in our study, we only investigated whether the patients had additional injuries or not.
Also, fractures around the pelvis like femur proximal fractures were not evaluated if these fractures affect the results. A study that comparing of two implants that can be used for proximal femoral fractures shows that proximal femoral fractures have problems in the healing process [19]. Thus, if these problems ocur, the results can be changed.
Our study had some limitations. Firstly, our patients were heterogeneous. Thus, we did not evaluate a single fracture group. Our study included all types of acetabular fractures. Secondly, our study contained retrospective data. Although having a large number of patients was an advantage, patients could be grouped separately. Patients with additional injuries were included in the study; and, it is not clear how they affected the outcomes. Thirdly, the results of both the anterior and posterior approaches, as well as combined approach results were evaluated together. All of them could be evaluated separately, and their results could be compared among themselves. Acetabular fractures are difficult to treat and are accompanied by additional injuries; however, when anatomical reduction can be achieved, these fractures have satisfactory results. We believe that our study will contribute to the literature by demonstrating the outcomes of acetabular fractures thanks to a broad patient profile.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Diet restriction is not mandatory with sodium picosulphate/magnesium citrate based bowel preparation
Süleyman Kargın 1, Nisa Çetin Kargın 2
1 Department of General Surgery, Karatay University, Medical Faculty, 2 Department of Family Medicine, Konya Numune Hospital, Konya, Turkey
DOI: 10.4328/ACAM.20294 Received: 2020-07-27 Accepted: 2020-09-04 Published Online: 2020-09-10 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):388-391
Corresponding Author: Süleyman Kargın, KTO Karatay University, Medicana Konya Medical Faculty, Department of General Surgery, Feritpasa Street, Konya, Turkey. E-mail: drs.kargin@hotmail.com P: +90 332 2218080/ 2067 Corresponding Author ORCID ID: https://orcid.org/0000-0003-4597-8654
Aim: This study aimed to investigate whether a 3-day diet restriction before colonoscopy is necessary as part of a bowel preparation regimen.
Material and Methods: This retrospective trial was conducted as a single-blinded study at a tertiary hospital. Overall, 60 adult patients who used sodium pico- sulphate with magnesium citrate regimen for bowel preparation were divided into two groups (Group 1: diet restriction = 29; Group 2: no diet restriction = 31) based on whether they used a 2-day diet restriction before the colonoscopy. The colonoscopy video records were evaluated by a clinician who was blinded to the type of bowel preparation. The Ottawa Bowel Preparation Quality Score was used to evaluate the quality of bowel cleansing.
Results: No significant intergroup differences were observed regarding the bowel cleansing quality, both overall and all segments of the colon. The overall ad- equate colon cleansing was 93.1% in Group 1 and 77.4% in Group 2. The percentage of patients with a score of 0 on the Ottawa scale based on the cleansing was higher in Group 2 than Group 1 (6.9% vs. 22.6%)
Discussion: This study observed that sodium picosulphate with magnesium citrate regimen without diet restriction delivered similar bowel preparation and successful colonoscopy results like those achieved with diet restriction. Sodium picosulphate with magnesium citrate, which requires less fluid volume and has a better taste, can be chosen without diet restriction for bowel preparation to ensure adequate patient compliance.
Keywords Bowel preparation; Diet restriction; Sodium picosulphate; Colonoscopy
Introduction
Adequate bowel cleansing is crucial for evaluating the colon mucosa and performing colonoscopic interventions safely. Despite the various combinations of bowel preparation regimens and agents, the rates of inadequate bowel preparation are reported to be between 20% and 30% [1].
Currently, all bowel preparation protocols for colonoscopy are performed using a combination of laxative agents and a clear or less fibre diet [2]. In Europe, three bowel preparation agents are commonly used, namely high-volume osmotically balanced polyethylene glycol (PEG); low-volume hyperosmotic sodium phosphate; and sodium picosulphate with magnesium citrate (SPMC), a low-volume osmotic laxative and its combination [2]. Nevertheless, there are contradictions regarding the PEG solutions owing to their taste and high-volume, as well as the NaP solutions because of concerns regarding their safety [3,4]. Sodium picosulphate with magnesium citrate is effective because of its small volume, besides being easy to administer and a well-tolerated bowel preparation agent [5]. Notably, the primary purpose of an ideal bowel cleansing is not only to empty the bowel completely but also to ensure that the agents used are suitable and tolerable by the patient. Various additional products have been used in conjunction with conventional regimens to provide more effective bowel cleansing and improve patient compliance. One of these methods is to combine the bowel preparation agents with pineapple juice, which has been reported to be successful [6-8].
Several studies have focused on the comparison between a low residue diet and a clear liquid diet in bowel preparation [9-11]. However, studies that explored bowel preparation regimens without diet restriction are scarce [12, 13]. Diet restriction during bowel preparations is often considered a normal protocol. Therefore, the effect of diet restriction is unknown because of the lack of studies on bowel preparation protocols without diet restriction. In fact, one of the reasons for patient noncompliance and dissatisfaction in bowel cleansing regimens is dietary restrictions [14].
In this study, we evaluated the effect of no diet restriction on bowel preparation before colonoscopy.
Material and Methods
Patients and study design
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Informed approval was obtained from every participant in the study. Our study was a retrospective single-blind study that examined the data of patients who underwent elective colonoscopy at KTO Karatay University, Hospital of Medical Faculty between January 2018 and January 2019. This study was approved by the local ethics committee of the KTO Karatay University, Hospital of Medical Faculty. Exclusion criteria included pregnancy, age under 18 years, chronic constipation, major psychiatric illness and serious medical conditions, such as severe cardiac, renal, liver or metabolic disease, stroke or dementia. We included patients of two experienced endoscopy teams who applied SPMC with a
two-day liquid diet protocol (Group 1 = 29) and SPMC without diet restriction (Group 2 = 31). The patients were divided into two groups based on the type of bowel preparation protocol. Bowel preparation procedure
Patients in Group 1 were instructed to avoid foods that contain a lot of fibre, such as vegetables, seaweeds, mushrooms and fruits for 2 days before the scheduled colonoscopy. No dietary restriction was recommended to patients in Group 2. SPMC (PICOPREP, Ferring Arzneimittel Ges.m.b.H, Vienna, Austria) was used as the bowel cleansing agent. Patients were instructed to mix two sachets of PICOPREP powder (10 mg of sodium picosulphate, 3.5 g light magnesium oxide and 12 g anhydrous citric acid per sachet), each separately, with 150 mL of water. The first 150 mL was ingested at 18:00 the day before the colonoscopy, followed by at least 2 L of clear liquids. The remaining 150 mL was ingested the next morning at least 4 hours before colonoscopy, followed by at least 2 L of clear liquids. All patients underwent rectal enema (BT enema 210 mL, Yenişehir lab, Çankaya, Ankara) at 23:00 and 6 am before colonoscopy.
Colonoscopy evaluation and bowel cleansing assessment
The colonoscopy video records of patients were reassessed by the endoscopist, who was blinded to the patient’s regimen, and bowel cleansing was evaluated. Bowel cleansing adequacy was assessed using the Ottawa Bowel Preparation Scale, with scores ranging 0–4 (Table 1) [15]. The score comprised a subscore of 0–4 for each colon segment, namely right, transverse, left, rectosigmoid, as well as the entire colon. Ottawa scores of 3 and 4 were considered inadequate bowel cleansing. Moreover, it was recorded whether ileum intubation could be performed. Statistical analysis
Statistical analyses were performed using SPSS version 21.0 computer-based software (SPSS Inc, Chicago, IL, USA). Statistical significance was accepted as <0.05. The chi-square test and Mann-Whitney U test were employed to analyse the categorical and continuous variables, respectively.
Results
Overall, 60 patients were enrolled in this study. The demographic features of the patients are presented in Table 2. No intergroup differences were observed regarding demographic features. The mean age of the patients was 45.7 years (range 20–85 years), and 60% of them were men.
Rates of bowel preparation adequacy were similar for both groups regarding each colonic segment, as well as the entire colon (Table 3). Similarly, the ileum intubation rates were similar for both groups. However, favourable results were observed in Group 1 compared with Group 2. The overall colon cleansing adequacy was 93.1% in Group 1 and 77.4% in Group 2.
The mean bowel cleansing scores per the Ottawa Scoring System were similar for Group 1 vs Group 2, regarding right, transverse, left and rectosigmoid region of colonic segment and overall colon evaluation (respectively, p= 0.983, p= 0.569, p= 0.367, p= 0.509, p= 0.277). The mean score of the overall colon was 1.13 in Group 1 and 1.45 in Group 2. Notably, the percentage of patients with a score of 0 on the Ottawa Score according to the cleansing in the overall, transverse and left segment of the colon was higher in Group 2 than Group 1 (35.5%, 32.3%, 51.6% vs. 27.6%, 20.7%, 41.4%, respectively; p > 0.05). However, the percentage of inadequate cleansing of the overall, transverse and left segment of the colon was lower in Group 1 than Group 2 (6.9%, 13.8%, 6.9% vs. 22.6%, 22.6%, 25.8%; p > 0.05).
Discussion
Even though PEG solutions are considered the gold standard in bowel preparation regimens for a colonoscopy, there is still no consensus regarding the ideal bowel preparation protocol. The primary aim of intestinal cleansing is not only achieving a well-cleansed colon lumen but also ensuring maximum patient compliance and tolerance. Currently, the most common problems in bowel preparation regimens are the necessity for high-volume fluid intake, difficulty in drinking the preparation owing to bad taste and side effects after the regimen, such as nausea, vomiting and excessive bowel sensitivity. However, SPMC protocols have gained popularity because of its small volume and good taste, as well as for being easy to administer and well tolerated by patients [2]. Several studies have reported that SPMC solutions have similar effects on the bowel preparation for colonoscopy procedures compared with PEG solutions [16-19].
One of the major reasons that affect a patient’s compliance with bowel preparation protocols is the liquid or less fibre diet that lasts 2-3 days. Notably, diet restriction is a crucial component for adequate bowel preparation, and the current guidelines recommend a low residue or full liquid diet on the day before colonoscopy [19]. Previous studies have demonstrated that reduced dietary restriction does not affect bowel cleansing quality [20, 21]. On the other hand, few studies have reported only regarding the effect of diet in colon preparation [20-23]. In the first study on this subject, Sayed et al. [24] reported excellent patient compliance and colon cleansing results (66% vs. 75%, p < 0.05) in patients with a less restricted diet compared with the liquid diet. Aoun et al [22] used PEG solutions for bowel preparation and reported similar results with a liquid diet and no dietary restrictions. Nevertheless, to our knowledge, this is the only study that addressed the use of an unrestricted diet for colonoscopy preparation with SPMC solutions in adults.
Our study compared the results of the SPMC regimen with a 2-day liquid diet and SPMC regimen without any dietary restriction. Based on our results, we observed that dietary restriction with the SPMC regimen did not provide superiority in colonoscopy results. Adequate bowel preparation and ileum intubation rates of both colon segments and overall colon evaluation were similar between the two groups (Tables 3). Notably, the perfect cleansing rate of the overall, transverse and left segment of the colon was higher in the unrestricted diet group. In addition, inadequate cleansing rates in both bowel preparation groups were consistent with previous studies (6.9% vs. 22.6%) [25].
Nonetheless, this study had some limitations. First, we could not conduct patient compliance and patient satisfaction survey because it was a retrospective study. Second, we could not exclude some factors that may affect colon cleansing, such as BMI, chronic constipation. Moreover, we could not distribute patients to random groups because of the retrospective nature of this study.
Nevertheless, based on the study results, it can be suggested that excellent colon cleansing results can be obtained using SPMC solutions without any dietary restrictions, thereby facilitating patient compliance during bowel preparation in clinical practice. Furthermore, this technique allows colonoscopy to be performed a day after the examination because no dietary restriction is required.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Comparison of smartphone addiction and food addiction in patients admitted for weight loss
Selma Pekgör, Mehmet Ali Eryılmaz
Department of Family Medicine, University of Health Science, Konya Training and Research Hospital, Konya, Turkey
DOI: 10.4328/ACAM.20298 Received: 2020-07-29 Accepted: 2020-08-27 Published Online: 2020-09-14 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):392-397
Corresponding Author: Selma Pekgör, Ayanbey Neighborhood, Yeni Meram Street, University of Health Science, Konya Training and Research Hospital, Department of Family Medicine, 42030, Konya, Turkey. E-mail: selmapekgor@outlook.com P: +90 3322210000/1803 F: +90 3322210000 Corresponding Author ORCID ID: https://orcid.org/0000-0001-9907-1842
Aim: This study aims to compare smartphone addiction and food addiction in patients admitted for weight loss.
Materials and Methods: The study was conducted with the participation of 113 volunteers who were admitted to the obesity outpatient clinic of our hospital between January 2017 and January 2018. The participants of the study were given a sociodemographic characteristics form, the Yale food addiction question- naire, and the smartphone addiction scale. The physical examination and anthropometric measurements (age, gender, height, weight, waist circumference, hip circumference, blood pressure) of all patients were performed by the researcher. SPSS 22 package program was used for the statistical analysis of the data. A p-value of <0.05 was considered significant.
Results: The median age of the participants, 95 of whom were female and 18 were male, was 34,5 (45,0-31,0) years. Among the participants, 17.7% had smartphone addiction and 33.6% had food addiction. The rate of food addiction was 50.0% in the group with smartphone addiction, while it was 30.1% in the group without smartphone addiction (p> 0.05), and there was a positive correlation between the smartphone addiction score and the food addiction score (r; 0.207 p = 0.033). While the mean age of the group with smartphone addiction was lower (28.5 years vs. 34.0 years) (p = 0.013), the height, weight, BMI, waist circumference, hip circumference, systolic and diastolic blood pressure parameters were similar to those without smartphone addiction (p> 0.05) (Table 2). The age, height, weight, BMI, waist circumference, hip circumference, systolic and diastolic blood pressure parameters of the groups with and without food addiction were similar (p> 0.05).
Discussion: Overweight and obese people with smartphone addiction exhibited negative eating behaviors. Effective nutrition education programs and a na- tional support policy are required to correct the unhealthy eating behaviors of obese people caused by smartphone use.
Keywords: Smartphone addiction; Food addiction; Obesity
Introduction
Obesity is a chronic disease characterized by increased body fat mass in proportion to the fat-free body mass [1]. Social, cultural, emotional and diet-related factors as well as genetic predisposition play a role in the development of obesity. Neurobiological research reveals that there are similarities in reward systems involved in obesity and substance addiction. Therefore, the probability that food addiction may also have a role in obesity has become the main topic of conversation. While some researchers recommend including obesity in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) as a mental disorder other than a food addiction, [2] others suggest that obesity should be defined as a hereditary neurobehavioral disorder [3]. It has been stated that the behaviors arising in food addiction are not sufficient to explain the entire obesity, but that it is an important finding that many neurobiological changes arising in food addiction are also detected in obese people [4].
Eating habits, lifestyle, physical inactivity, stress and irregular sleep are some of the important risk factors for the development of obesity. In addition to personality traits, occupation, educational background, and spiritual characteristics, the use of the internet and smartphones, which are increasingly used nowadays, can also be a factor for physical inactivity. In the last decade, smartphones have become an indispensable instrument of daily life. As per the data published in April 2020, the rate of smartphone use in the world increased to 79% in women and 74% in men. The rate of smartphone use in Turkey was determined to be 77%. Smartphones provide many satisfactory elements, such as constant internet access, access to social networks, games, entertainment, finding information, effective use of time, in addition to its fundamental functions of being a communication device [5,6]. Since individuals almost always keep their smartphones with them and can use their smartphones many times during the day, the use of smartphones can become an automated behavior requiring little thought [7]. It is stated that the use of high-frequency smartphones can become a behavioral addiction in individuals. Individuals with signs of smartphone addiction tend to bring their phones with them wherever they are and to think about their phones even if they cannot use them, which affects their daily activities. The criteria recommended to determine whether an individual suffers from smartphone addiction include a compulsive use of phones, tolerance resulting from a longer and more intensive use, withdrawal symptoms and disruption in daily life activities [8]. However, smartphone addiction is not identified as a disorder in the DSM-5 [9]. Overuse of smartphone, although it is not yet officially defined as a disorder, has been associated with sleeping disorders, [10] in addition to physical and mental problems, such as visual impairment, musculoskeletal problems, depression, and anxiety [11,12] Nevertheless, no study investigating the association of smartphone addiction with other health problems, such as problematic eating behaviors, food addiction, and fattening, were found except for two studies conducted on adolescents and elementary school students [13,14]. Many studies that take into account smartphone use and health risks analyze the total time spent on smartphones rather than the smartphone
addiction itself. Considering the high rates of smartphone use and the concerns about phone addiction, it is important to clarify whether smartphone addiction can contribute to problematic eating behaviors and fattening.
In order to address the limitations of previous studies and to form a basis for prospective clinical studies, our study aims to investigate: (1) the differences in smartphone addiction and food addiction by age, gender, profession, educational level, income level, exercise level; (2) the relationship between food addiction and obesity in individuals with smartphone addiction; (3) the characteristics of smartphone use of individuals with food addiction; (4) whether the combination of smartphone addiction and food addiction triggers each other.
Material and Methods
Approval was obtained from the local ethics committee before starting the study. Among 1247 patients, who were admitted to the Family Medicine Polyclinic between January 2017 and January 2018 for weight loss, 350 who met our criteria were informed about the study in accordance with the Helsinki Declaration, and 160 patients voluntarily wanted to participate in the study. The participants of the study were provided with a sociodemographic characteristics form, the Yale Eating Addiction questionnaire, and the smartphone addiction scale. They were ensured to fill in the forms on their own. They were assisted by the researcher in cases where they did not understand. Forty-seven patients were excluded from the study because they incompletely filled in the questionnaires. The study was completed with 113 patients. Those who were illiterate, pregnant and breastfeeding, those under the age of 18 years and over the age of 65 years, those with malignancy, endocrine disorder, diagnosed psychiatric disorder, those who do not use a smartphone, and those who do not want to fill in the questionnaire were excluded from the study. Sociodemographic characteristics form:
Gender, marital status, profession, monthly income, educational background, exercise habits, any previous dieting experiences, smoking, alcohol consumption, and chronic diseases were questioned using this form prepared by the researcher. Anthropometric measurements:
The physical examination and anthropometric measurements of all patients (age, gender, height, weight, waist circumference, hip circumference, blood pressure) were performed by the researcher and recorded on the patient cards. Height (m) and weight (kg) were measured with the upper clothes taken off. Waist circumference was measured at the umbilical level between the iliac crest and lateral costa (cm). Hip circumference was measured at the level of the trochanter major (cm). Body mass index (BMI) was calculated using the weight (kg)/ height (m)2 formula. Those with a BMI of 25-29.9 kg/m2 were classified as overweight, those with a BMI of 30-34.9 kg/m2 as grade 1 obese, those with a BMI of 35-39.9 kg/m2 as grade 2 obese, and those with a BMI of 40.0 kg/m2 and above as grade 3 obese [15].
Yale Food Addiction Scale:
In order to make the diagnosis and measurement of food addiction in a unified and feasible order, the researchers at the Yale University created a scale that evaluates the habits of consuming foods containing high sugar and high-fat content and that is adapted by transforming the substance addiction criteria in the DSM-IV-TR. [16]. The Yale Food Addiction Scale measures 2 different values. The scale contains 27 questions used to detect addictive-like eating behaviors in the last year. Three questions measure excessive and long-term consumption of food; four items measure the willingness to quit and failed attempts; three questions measure the level of time and activity spent on access to and use of the substance; four questions measure the decreasing or abandoned social life, work-life and leisure activities; one question measure the continuous use despite knowing of adverse effects and results; two questions measure tolerance; three questions measure the withdrawal symptoms and the continuous use for the purpose of diminishing the withdrawal symptoms, and two questions measure disorders from a clinical aspect. The number of symptoms ranges from 0 to 7. In order to diagnose food addiction, the score for clinical sensitivity should be equal to 1 and the number of symptoms should be at least 3 in a similar manner to substance addiction. The Cronbach’s alpha value of the scale was found to be 0.93 in the reliability analysis made for the Food Addiction Scale [17]. In studies conducted with this scale, it has been found to have good internal consistency and high cross-validity with scales evaluating other eating disorders. It is stated that this questionnaire can evaluate the addictive potential of those with eating disorders, as well as functioning as an appropriate assessment tool in other eating- related disorders [16]. Its Turkish validity and reliability study was performed by Bayraktar et al [17].
Smartphone Addiction Scale:
Kwon et al. initially prepared a 33-question scale to assess smartphone addiction. Subsequently, due to the fact that this scale was long and did not yield consistent results and failed to reveal the cut-off scores, they developed a shorter form of the same scale, which can be filled in in a shorter time and more easily by selecting 10 questions out of the 33 questions and has a diagnostic value with cut-off points [18]. Noyan et al. showed its validity and reliability by adapting the Smartphone Addiction Scale Short Form to Turkish [19]. The scale consisting of 10 items was evaluated with a six-point Likert scale. The scale is evaluated with a minimum of 10 and a maximum of 60 points. As the score increases, the risk of addiction increases. The cut- off score was considered as 33 for females and 31 for males [18]. Cronbach’s alpha internal consistency coefficient and concurrent validity of the original form are 0.91. The Cronbach’s alpha coefficient of the scale was found to be 0.86 in Turkey [19].
Statistical method:
Statistical analysis of the data obtained in the study was carried out with the SPSS 22 software package at a significance level of α = 0.05. Categorical variables were presented as frequency and percentage, and numerical variables as mean, standard error, median, interquartile values. Descriptive statistics were used in single groups, while the chi-square test was used to compare categorical data. The Kolmogorov-Smirnov and Shapiro-Wilk analyses, the normality distribution tests for continuous data, were used. Since all data were non-parametric, the Mann Whitney-U test, one of the non-parametric tests, was used for the comparison of two groups, while the Spearman correlation analyses were used to measure the correlation levels.
Results
The study was completed with 113 patients who were admitted for weight loss. The median age of the participants (95 females and 18 males) was 34,5 (45,0-31,0) years. The majority of the participants (70.8%) were unemployed, 36.7% had an income level of the minimum wage (1300 TL) and below, 41.3% had an income between 1300-3000 TL. Among the participants, 42% were elementary school graduates, 25% were high school graduates, and 27.5% were university graduates, and 52.5% had attempted to follow a diet at least once before. Among the applicants, 73.5% stated that they rarely or have never exercised, 18.6% were smokers, and 40.7% had a history of chronic disease. Diabetes, hypertension, chronic ischemic heart disease, asthma, chronic obstructive pulmonary disease were the most common chronic diseases. Among the participants, 17.7% had smartphone addiction and 33.6% had food addiction (Table 1).
While the mean age of the group with smartphone addiction was lower (28.5 years vs. 34.0 years) (p = 0.013), the height, weight, BMI, waist circumference, hip circumference, systolic and diastolic blood pressure parameters were similar to those without smartphone addiction (p> 0.05) (Table 2). The age, height, weight, BMI, waist circumference, hip circumference, systolic, and diastolic blood pressure parameters of the groups with and without food addiction were similar (p> 0.05).
While the rate of food addiction was 50.0% in the group with smartphone addiction, the rate of food addiction was 30.1% in the group without smartphone addiction. The difference was not significant (p> 0.05), yet there was a positive correlation between the smartphone addiction score and the food addiction score (r; 0.207, p = 0.033). The rate of smartphone addiction was 17.9% in females and 12.5% in men (p> 0.05), 15% in married individuals, 25% in singles (p> 0.05), 20.3% in unemployees, and 11.3% in employees (p> 0.05). While the rate of addiction is 15.4% in those with elementary and lower education levels, the rate of smartphone addiction was 20% in those with education levels of high school and above (p> 0.05). The rate of smartphone addiction was 20% in those who earned a minimum wage and below and 16.2% in those earning more than minimum wage (p> 0.05). While a lower level of addiction was detected in those who exercised at least once a week compared to those who did not exercise at all or rarely exercise, a higher rate of smartphone addiction was found in non-smokers, although it was not significant (p> 0.05). While the rate of smartphone addiction was 23.3% in those who previously followed a diet, it was 11.3% in those who have never followed a diet (p> 0.05).
While the rate of food addiction was 32.6% in females, this rate was found to be 43.8% in males (p> 0.05). The rate of food addiction was 35% in those who were married, 28.1% (p>0.05) in singles, 40% in those with a low-income level, and 30% in those with a high-income level (p>0.05). While it was 41.2% in smokers, it was 32.3% in non-smokers (p> 0.05). While the rate of food addiction was 39.1% in those with a chronic disease, it was 29.9% in those without comorbidity (p> 0.05). Of the overweight individuals, 27.8% had food addiction, while this rate was 36.4 in obese individuals (p> 0.05).
The responses given by the group with food addiction for smartphone addiction were addressed one by one. In those with food addiction, the rate of disrupting the planned works was found to be higher due to the use of smartphones compared to those without food addiction (p = 0.041). Those with food addiction were found to be more likely to say, “I cannot tolerate the absence of my smartphone” (p = 0.035) (Table 3). The total score of smartphone addiction was found to be similar in the groups with and without food addiction (p> 0.05), but the food addiction score was found to increase with increasing smartphone addiction score (r; 0.207 p = 0.033). There was a negative correlation between smartphone addiction and age (r; -0,361 p <0.001), smartphone addiction decreased as age increased. However, no correlation was found between smartphone addiction and weight, BMI, waist circumference, hip circumference, systolic, and diastolic blood pressure. There was a strong positive correlation between weight and waist circumference, hip circumference, BMI, systolic, and diastolic blood pressure.
Discussion
The primary aim of this study is to evaluate the smartphone addiction, which is one of the types of screen addiction thought to be effective in the emergence of obesity and to understand whether it correlates with body composition (weight, BMI, waist circumference, hip circumference) and eating behavior. The rate of food addiction was found to be higher in the group with smartphone addiction. As the degree of smartphone addiction increased, the food addiction scores increased. However, we found that weight, BMI, waist and hip circumferences did not increase in those with smartphone addiction. The group with smartphone addiction was of a younger age. It was found to be higher in women, singles, unemployees, those with a low- income level, those with a high educational level, those who did not exercise, although the difference was not significant. We believe that this is caused by the limited number of patients. Food addiction was found to be higher in males, married individuals, employees, those with low education and income levels, smokers, those with a chronic disease, and obese individuals. However, the difference was not significant.
In studies conducted in the literature, the rate of smartphone addiction has been found to be higher in women [13,20]. The reason for this may be the fact that women attach more importance to peer relationships and use social media and messaging more. In our study, the rate of smartphone addiction was higher in females, but it did not reach a significant level; we believe that the reason for this is the limited number of patients and 70% of the participants were housewives, had advanced age, and use smartphones less frequently. The mean age of the group with smartphone addiction was lower than that of the non-addicted group. The results we obtained are expected, as the rates of following innovations, internet, social media, smartphone use, and playing games are higher among young people than middle-aged and elderly people. Studies in the literature have been mostly conducted on adolescents and university students [12-14, 20-23]. Our study was conducted on adults aged 18-65 years who were admitted for weight loss.
In our study, the weight, BMI, waist circumference, hip circumference, systolic, and diastolic blood pressure parameters of those with smartphone addiction were found to be similar to those without smartphone addiction. There are few studies on this subject in the literature. In a study conducted on university students, it was found that the rate of smartphone addiction was higher in overweight and obese individuals, that the rate of smartphone addiction increased the risk of obesity two-fold, and that obese people used smartphones more commonly [24]. In a study conducted on adolescents, it was found that smartphone addiction was correlated with body fat percentage, although no correlation could be found between it and BMI [13]. In our study, smartphone addiction was not found to be correlated with BMI, waist circumference, hip circumference, and blood pressure. This may be caused by the low mean age of our patients with smartphone addiction or by the fact that obesity is less prevalent in young people in our country compared to the middle-aged and elderly individuals. Furthermore, we examined weight, BMI,
waist circumference, hip circumference but did not measure the fat ratio. Since these parameters cannot distinguish between muscle and adipose tissue, they do not fully reflect the ratio of adipose tissue in the body. In order to understand the fattening in the body, the methods of measuring body fat ratio might yield more accurate results.
Eating disorder was found to be correlated with smartphone addiction. In the literature, the term “multiple addictions” is recommended. It is stated that addictions trigger each other and that a susceptible personality increases the risk of addiction [13,25]. Similarly, in a study conducted on adolescents, smartphone addiction, and food addiction were found to be correlated [13,14]. In quite a similar way to support this study, food addiction increased as smartphone addiction increased in our study. This is caused by the fact that a person using a smartphone as a means of relaxation and to avoid mental distress will also tend to eat more. Similarly, eating can also be increased by distancing oneself from social communication and loneliness associated with smartphone addiction.
Our study has several limitations. Our study is a cross- sectional study, which was conducted only on overweight and obese individuals who were admitted for weight loss. It does not reflect the general population. The smartphone addiction and food addiction scales used are self-report scales and can be manipulated. No clinical interviews were made with the patients in the study; it is not possible to make a definitive diagnosis with the scale. Equalizing the ages of those with and without smartphone addiction would be more accurate in terms of comparing weight, BMI, waist circumference and hip circumference. However, we could not do this due to our limited number of patients.
Conclusion
In conclusion, overweight and obese individuals with smartphone addiction exhibited negative eating behaviors. Effective nutrition education programs and a national support policy are required to correct the unhealthy eating behaviors of obese people caused by smartphone use.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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8. Lin Y-H, Chiang C-L, Lin P-H, Chang L-R, Ko C-H, Lee Y-H, et al. Proposed diagnostic criteria for smartphone addiction. PLoS One. 2016;11(11):e0163010. DOI: 10.1371/journal.pone.0163010.
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18. Kwon M, Kim D-J, Cho H, Yang S. The smartphone addiction scale: development and validation of a short version for adolescents. PLoS One. 2013;8(12):e83558. 19. Noyan CO, Enez-Darçin A, Nurmedov S, Yilmaz O, Dilbaz N. Akıllı Telefon Bağımlılığı Ölçeğinin Kısa Formunun üniversite öğrencilerindeTürkçe geçerlilik ve güvenilirlik çalışması (Validity and reliability of the Turkish version of the Smartphone Addiction Scale-Short Version among university students). Anatolian Journal of Psychiatry. 2015; 16(Suppl. 1): 73-81.
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Cardiac panel evaluation of usak state hospital stat laboratory
Arzu Akagac Etem 1, Abdurrahman Yılmaz 2
1 Department of Clinical Biochemistry, Usak Training and Research Hospital 2 Department of Emergency Medicine, Usak Training and Research Hospital, Usak, Turkey
DOI: 10.4328/ACAM.20300 Received: 2020-08-04 Accepted: 2020-09-04 Published Online: 2020-09-20 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):398-401
Corresponding Author: Arzu Akagac Etem, Usak Training And Research Hospital, Fevzi Çakmak Mahallesi, Denizli Caddesi, No:4, Usak, Turkey. E-mail: arzuetem@yahoo.com P: +90 5052283578 Corresponding Author ORCID ID: https://orcid.org/0000-0002-5849-0642
Aim: In this study, we aimed to determine clinical usefulness and advantages of ordering tests that include total creatine kinase (CK), creatine kinase myocar- dial band (CK-MB, enzymatic), troponin I, myoglobin, and CK-MB (mass) in stat laboratory of our hospital with an assessment according to patients diagnoses in Usak region.
Materials and Methods: Four hundred thirty-eight patients presenting to Usak State Hospital Stat Laboratory between March 2010 and April 2010 were included in this study. CK, CK-MB (enzymatic), troponin I, myoglobin, and CK-MB (mass) levels, diagnosis, and hospitalization were evaluated.
Results: Among the total of 107 patients, 41 (9,3%) were hospitalized to coronary intensive care unit, 13 (2,9%) to cardiology service, 13 (2,9%) to chest disease service, 10 (2,2%) to internal medicine service, 10 (2,2%) to neurology service, 5 (1,1%) to chest disease intensive care unit, and 15 (3,4%) to other services (24,4%). The preliminary diagnosis and second diagnosis after hospitalization were found same (89.9 %).
Seventy-eight (17,8%) patients had troponin level over the upper reference limit of 0,06ng/mL (mean±SD;5,130±11,682 (0,06-50) ng/mL); 108 (24,6%) pa- tients had myoglobin level over the upper reference limit of 110ng/mL. Sixteen (%3,65) patients were diagnosed with AMI.
Discussion: In our study, we found that nearly half of the patients ordering cardiac marker tests in the stat clinical biochemistry laboratory were hospitalized associated with cardiovascular system services. The preliminary diagnosis and second diagnosis after hospitalization were found the same (89.9 %) and this value was evaluated as good in terms of clinical practice. Early diagnosis of acute coronary syndrome (ACS), hospitalization to an appropriate service, and treatment or timely invasive procedures are provided to shorten hospital stay and improve disease prognosis.
Keywords: Stat laboratory; Cardiac panel; Troponin
Introduction
A significant proportion of patients admitted to the Emergency Room (ER) with chest pain are diagnosed with Acute Coronary Syndrome (ACS) [1]. All of the clinical pictures associated with acute myocardial ischemia are defined as ACS [2]. In the USA, 500.000 people die every year due to Coronary Artery Disease (CAD) [1]. The early diagnosis of these patients is very important in terms of guiding their treatment [3].
Mortality and morbidity are positively affected by early diagnosis of the disease and especially by timely administration of thrombolytic therapy and interventional applications, and it is easier to control the complications that may arise during follow-up of the disease [3].
The incidence of Acute Myocardial Infarction (AMI), severity, social and economic cost, responsibility for medical intervention are very important health problems in terms of community and health policies [4,5]. According to the World Health Organization, the diagnosis of AMI is based on the presence of at least two of three criteria: clinical presentation, electrocardiography change, and an increase in creatine kinase-myocardial band (CK-MB) [6]. Identification of serum cardiac markers plays a key role in the diagnosis of AMI. In recent years, myoglobin, CK- MB mass and troponins have been used more widely in clinical practice [7]. Studies have shown that 4-6% of patients with ACS admitted to the ER are accidentally discharged from the ER as a result of misdiagnosis [8].
Cardiac markers are frequently used for differential diagnosis in patients who do not have chest pain with nonspecific symptoms such as headache, dyspepsia, myalgia, anxiety and nausea.
In this study, we aimed to examine the hospitalization rate of patients who applied to our hospital ER and who were requested for cardiac markers, what services they were admitted to and in what proportions, what initial diagnosis is requested for cardiac markers and the correct use of cardiac markers.
Material and Methods
Our retrospective study included 438 patients who applied the Stat Laboratory of Usak State Hospital ER with cardiac panel tests request between March 2010-April 2010. The study was approved by Usak State Hospital Ethical Committee.
The total creatine kinase (CK) activity was determined by measuring the NADPH formation rate at 340 nm while reducing the NADP to NADPH with a series of reactions using the hexokinase and glucose 6 phosphate dehydrogenase enzymes with CK NAC method in the Abbott Architect c 8000 analyzer. CK-MB (enzymatic) immunoinhibition activity measurement of a series of reactions using hexokinase and glucose 6 phosphate dehydrogenase enzymes measured the result of inhibition of creatinine kinase muscle band (CK-MM) activity of mouse antibodies in Abbott Architect c 8000. Troponin I, Myoglobin and CK-MB (mass) measurements were made by using direct chemiluminometric technology with sandwich immunometer using fixed amounts of various antibodies in Advia Centaur CP device.
Statistical analyzes were made with SPSS 11.5 package program. Cardiac marker parameters of the patients were given as mean ± SD.
Results
One hundred and seven (%24,4) of 438 patients were hospitalized, of whom 41 (%9,3) were hospitalized to the coronary intensive care unit, 13 (%2,9) to the cardiology service, 13 (%2,9) to the pulmonary diseases service, 10 (%2,2) to the internal medicine service, 10 (%2,2) to the neurology service, 5 (%1,1) to the pulmonary diseases intensive care unit, 3 to the (%0,6) internal medicine intensive care unit, 3 to the (%0,6) nephrology service, 3 to the (%0,6) general surgery service, 2 (%0,4) to the surgical intensive care unit, 2 (%0,4) to the neurology intensive care unit, 1 (%0,2) to the psychiatric service and 1 (%0,2) to the enfectious diseases service. The preliminary diagnosis and second diagnosis after hospitalization were found the same (89.9 %).
The number of patients and percentages are given in Table 1 according to the preliminary diagnosis related with system.
There were 81 (18,4%) patients with total CK in the reference range (male 30-200 U/L; female 29-168 U/L) and CK-MB (activity) above the upper reference limit (>24U/L), without clinical AMI. The relationship between CK-MB (activity) and CK-MB (mass) values was evaluated by Pearson Correlation analysis and r-value was found to be low (r = 0,094) (Table 2) in this group of patients. There were 4 (0,9%) patients in this group with CK-MB (mass) values above the upper reference limit of 5ng/mL. The diagnoses of these patients were chronic kidney failure, CAD, CAD + heart failure and CAD + acute kidney failure.
There were 64 patients without clinical AMI with excess of the upper reference limit of the total CK. CK-MB (activity) value in 44 (68,7%) of these patients was above the upper reference limit.
There were 16 (3,65%) patients diagnosed with AMI. The relationship between CK-MB (activity) and CK-MB (mass) values was found to be high using Pearson Correlation analysis in AMI patients group (r =0,908 ).
The troponin value of 78 (17,8%) patients was above the upper refrence limit of 0,06 ng/mL, the mean ± SD was 5,130±11,682 (0,06-50) ng/mL. The myoglobin value of 108 (24,6%) patients was above the upper reference limit of 110ng/mL.
Discussion
Millions of patients apply to the ER every year with possible AMI symptoms; however the vast majority do not have AMI. Delays in AMI diagnosis may also affect the assessment of other underlying diseases. Rapid evaluation of these patients helps to prevent congestion in the ER and to eliminate medical and economic problems [9].
In our study, it was found that approximately half of the patients (48,6%) (Table 1) who were asked for cardiac markers from the stat clinical biochemistry laboratory were admitted to the services related to the cardiovascular system. It was later found that the patients whose cardiac requests were made, and who were hospitalized, most frequently were admitted to the related services due to problems related to psychiatry, gastrointestinal system, and respiratory system, respectively.
The preliminary diagnosis and second diagnosis after hospitalization were found same as 89.9 % and this value was evaluated as good in terms of clinical practice. In our study, as shown in Table 1, almost half (n=213) of the patients who had requests for cardiac markers received preliminary diagnosis related to the cardiovascular system at a rate of 48,6 %. The frequency of requests was followed as a preliminary diagnosis related to psychiatric (n=58, 13.2%) and respiratory system (n=49, 11.1%), respectively. It was thought that various cardiac problems including AMI in ER can be most frequently confused with psychiatric disorders and in second place, with respiratory system disorders. Keeping this information in mind by emergency physicians may be beneficial in terms of emergency practice.
Correlations coefficients between CK-MB activity and mass measurements of the two groups consisting of high total CK (n=64) group and total CK in the reference range and CK-MB activity measured high (n=81) group were better in high total CK group. However, correlation was not good for both groups between CK-MB activity and mass measurements (Table 2). This was in line with the results of a previous study in which we found no correlation between the results, of CK-MB activity and mass values with linear regression and correlation of two healthy groups [10]. Especially in the group where the total CK is in the reference range and the level of CK-MB activity is high, we thought that in emergency conditions, sampling may be related to the possibility of hemolysis more often due to taking the vascular access instead of the vacutainer. However, in our retrospective study, we were unable to obtain data on hemolysis. This situation can be accepted as the limitation of our study. Prospective studies can be conducted on this subject. Using Person Correlation analysis, the r value was found to be high in AMI patients group (r=0,908, Table 2) between CK-MB activity and CK-MB mass measurements. There was a positive correlation between CK-MB activity and CK-MB mass value. These results show that CK-MB mass test is more reliable in the differential diagnosis in AMI patients.
There were 4 (0,9%) patients with a total CK in the reference range and CK-MB (activity) group above the upper reference limit whose CK-MB (mass) values were above the upper reference limit of 5ng/mL. The diagnoses of these patients were chronic kidney failure, CAD, CAD+heart failure and CAD+acute kidney failure. The follow up of these patients with serial measurements may be recommended. In addition, the total CK was below the lower reference limit and the CK-MB (activity) was above the upper reference limit in 5 patients, and in these patients, CK-MB (mass) values were within the normal limits. In such patients, the presence of hemolysis should be considered. The troponin value of 78 (17,8%) patients was above the upper reference limit and 16 of these patients were diagnosed with AMI. The remaining 62 patients had troponin elevations due to other existing diagnoses. These diagnosis were CAD, heart failure, chronic obstructive pulmonary disease, diabetes mellitus, pulmonary edema, acute bronchitis, hemiplegia, cerebrovascular diseases, acute myocarditis, and atrial fibrillation. It will be beneficial to consider these diseases in differential diagnosis at the height of troponin.
In our study, it was found that approximately half of the patients who were asked for cardiac markers from the stat clinical biochemistry laboratory were hospitalized in the services related to the cardiovascular system. With the early diagnosis of ACS, hospitalization in the appropriate service, and timely treatment or interventional procedures, patients hospital stay decreases and the prognosis of the disease improves.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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10. Etem AA, Etem EÖ, Yıldırmak ST, Ulutaş GŞ, Ünal S. CK-MB Kütle ve Aktivite Ölçüm Yöntemlerinin Akut Miyokard Enfarktüslü ve Sağlıklı Gruplarda Karşılaşltırılması (Comparison of CK-MB Mass and Activity Measurement Methods in Acute Myocardial Infarction and Healthy Groups). Türk Klinik Biyokimya Derg/ Turkish Journal of Clinical Biochemistry. 2011; 9(2): 53-9.
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Prognostic value of platelet mass index in pulmonary emboli in the emergency department
Hüseyin Uzunosmanoğlu, Şeref Kerem Çorbacıoğlu, Tuba Şafak, Seda Dağar, Emine Emektar, Yunsur Çevik
Department of Emergency Medicine, Kecioren Training and Research Hospital, Ankara, Turkey
DOI: 10.4328/ACAM.20305 Received: 2020-08-11 Accepted: 2020-09-30 Published Online: 2020-10-13 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):402-406
Corresponding Author: Hüseyin Uzunosmanoğlu, Emergency Medicine Specialist, Kecioren Training and Research Hospital, Department of Emergency Medicine, Ankara, Turkey. E-mail: huzunosmanoglu@gmail.com GSM: +90 5058908090 P: +90 312 356 90 00 F: +90 312 3569002 Corresponding Author ORCID ID: https://orcid.org/0000-0002-4370-1283
Aim: Pulmonary embolism is one of the common causes of pulmonary emergencies that are encountered frequently in the emergency department, the diagno- sis of which can be extended or skipped. It is approximately one-third of the causes of death in the emergency room. A missed diagnosis increases mortality rates fivefold. Many scoring systems can be used in diagnosis but it may lead to prolonged stay in the emergency room and increase cost and mortality rate. This study primarily aims to evaluate PMI (Platelet mass index) in early diagnosis and mortality relationship in clinically compatible cases.
Materials and Methods: This retrospective study was conducted with patients diagnosed with pulmonary embolism in the emergency room between 01.01.2018 and 01.03.2020. From accessed data of all patients, vital signs, additional diseases, laboratory parameters, PESI scores, and one-month mortality rates were recorded with given thrombolytic treatments.
Results: One hundred forty patients, with available data were included in the analysis. Patients were classified according to mortality. In the mortal group, PMI value was 1.55 & 1.2 and lower, respectively, than the non-mortal group (p: 0.031). In addition, when compared with the non-mortal group, in the mortal group, lactate, troponin, D-Dimer and PESI score increase were statistically significant (p <0.001).
Discussion: PMI value decreased in the mortal patient group. PMI can be useful in predicting the course of the disease and the risk of mortality in patients diagnosed with pulmonary embolism.
Keywords: Pulmonary embolism; Platelet mass index; PESI score
Introduction
Pulmonary thromboembolism (PE) remains the third leading cause of death with a high mortality rate in populations admitted to ED, despite advanced therapeutic options. If this disease is properly diagnosed and high-risk patients are determined in early stage, the high mortality rate can be decreased [1]. Therefore, risk stratification in the early-stage period gains importance in decreasing mortality rate. Although several clinical scores including pulmonary embolism severity index (PESI) have been developed to predict short-term prognosis [2-4], the majority of these scores are complicated and time-consuming tools. Therefore, in recent years, there has been a growing interest among physicians in simple blood markers that can be helpful in risk stratification [5,6].
Platelet mass index (PMI) is a member of the platelet indices and it is obtained by multiplication of platelet count (PC) with mean platelet volume (MPV) value (PMI= PC x MPV). Since PMI includes PC and MPV values, PMI is considered to provide more comprehensive data on total platelet mass [7]. Several previous studies showed that increased total platelet mass and PMI related several diseases with thrombotic processes in its pathogenesis such as; ischemic stroke, myocardial infarcts, carotid artery stenosis, recurrent abortus, etc. [8-11]. Similarly, increased platelet indices were reported in PE patients in several studies [12-14]. However, the results of current studies on PMI in patients with PE are uncertain and controversial. Therefore, this study aimed to assess the prognostic utility of PMI values in predicting the 30-day-mortality in adult patients who presented to the ED and were diagnosed with PE.
Material and Methods
Study design
This retrospective prognostic study was conducted with PE patients in the Emergency Department of a training and research hospital between January 2018 and March 2020 after receiving approval from a local hospital ethics committee (No: KEAH-43278876-929- E1267).
Study population and data collection
This study screened electronic data and file records of all patients over 18 years of age who admitted to ED and were diagnosed with PTE by pulmonary computed tomography (CT) angiography. Patients who had acute exacerbations of chronic obstructive pulmonary disease, chronic inflammatory disease, hematological disease or pregnancy were excluded from this study because it is shown that platelet indices increase in these diseases [15-18].
The demographical and clinical characteristics of the patients, results of complete blood count (CBC) including PMI, D-Dimer values, length of hospitalization, PESI scores, and disposition types including mortality were extracted from the hospital electronic data system and patient file records by two independent researchers.
Measurement of platelet indices
For PMI measurement, 2 cc venous blood samples taken from all patients routinely at admission were used. Samples were collected in EDTA tubes and were processed at the laboratory of the emergency department within 2 hours by a Mindray BC 6800 hematology analyzer. The normal range of platelet indices at our laboratory was as follows: platelet count (PC), 156– 373×103/μL; mean platelet volume (MPV), 6.9–10.8 fL, platelet distribution width (PDW), 12-25; plateletcrit (PCT) 0-10%. Statistical analysis
Statistical analyses were performed using SPSS 15.0 (Chicago, IL, USA). The categorical values of the patients were expressed as a number and a percentage and were analyzed with a chi-square test. The normality of the data distribution was determined with the Shapiro-Wilk test, histogram, and Q-Q plots. Continued values were presented as a mean standard deviation (SD) or median values and an interquartile range (IQR) of 25%–75%. The non-parametric values were analyzed using the Mann–Whitney U, and the parametric values were analyzed with the Student t-test. To assess the prognostic utility of PMI levels at varying cut-off values for the distinction between the survivor and non-survivor groups, a receiver-operating characteristic (ROC) curve was generated, and the area under the curve (AUC) was calculated. The 95% confidence intervals (95% CIs) were also calculated when appropriate, and a p-value of less than 0.05 was considered statistically significant.
Results
In the study period, 140 patients with diagnosed PE were included in the analyses. Among them, 52.1% (73) were males. The median age of the patients was 63.5 [IQR25%–75%; 54 to 87.9] years. The median value of the PESI score was 104 [IQR25-75%: 91.5 to 121]. The mortality rate was %18.6 (26 patients). All other demographics and the laboratory results of all patients are presented in Table 1.
When comparing survivor and non-survivor patients, PMI was found as 1.55 [IQR25-75%: 1.20 to 2.20] in the survivor group and 1.2 [IQR25-75%: 0.85 to 2] in the non-survivor group. Similarly, the median value of D-Dimer was found as 1310 [IQR25-75%: 840 to 2100] in survivor group and 4625 [IQR25- 75%: 3000 to 5650] in the non-survivor group (p<0.001). And finally, median values of the PESI score were found as 98 [IQR25-75%: 88 to 111] in the survivor group and 150.5 [IQR25- 75%: 144 to 164] in the non-survivor group. These differences were statistically significant (p<0.03, p<0.001, and <0.001, respectively). All other data are presented in Table 2.
ROC analysis was performed, and AUCs were calculated to discover the cut-off level for PMI, MPV, D-Dimer, and PESI score for distinguishing between the survivor and non-survivor groups. Accordingly, the AUC values were found to be 0.636 (95%CI; 0.503 to 0.768), 0.646 (95%CI; 0.532 to 0.760), 0.856 (95%CI; 0.772 to 0.940), and 0.989 (95%CI; 0.973 to 1.000) (Figure 1). In addition, when the correlation between the PMI and both variables (PESI score and D-Dimer) was evaluated, no statistically significant correlation was found (p=0.058 and p=0.6, respectively).
Discussion
The present study, which evaluated the prognostic value of PMI in detecting the mortality in patients who presented to ED and were diagnosed PE, revealed that PMI values are lower in non-survivor patients with PE diagnosis than survivor patients. However, when considered the low AUC value of PMI (0.636), it is difficult to say that this is a useful marker for predicting mortality in patients diagnosed with PE. In the current literature, several studies evaluated the relationship between platelet indices and venous thromboembolism, the number of studies that evaluated the relationship between PMI and venous thromboembolism is limited.
In particular,, the relationship between MPV and venous thromboembolism has been well-studied in previous studies. The main findings of these studies suggest that high MPV values are related to venous thromboembolism and its severity, and may be thrombus size. In a study that researched the relationship between MPV and venous thromboembolism, Icli et al have reported that MPV values were higher in all deep vein thrombosis (DVT) cases than healthy control subjects. In addition, they reported that MPV values were higher in cases with DVT accompanied by PE than in patients without PE [19]. When they performed ROC analysis to predict whether all DVT patients would have PE for MPV values, they found that the AUC value for MPV as 0.93. In another study, conducted with patients with PE, Yardan et al evaluated whether MPV values predict right ventricle (RV) dysfunction or not. They reported that MPV values were higher in PE patients with RV dysfunction than without RV dysfunction. In ROC analysis, to predict RV dysfunction for MPV, they reported that the AUC value of MPV was 0.671 (95% CI: 0.584 to 0.758) [6]. Other studies focused on the diagnosis of VTE in the literature have clearly reported that MPV values were related to VTE (DVT or PE) patients. However, at the same time, these studies’ results suggest that MPV has no additional diagnostic contribution to D-Dimer for VTE diagnosis [12, 20- 24]. Similar to previous studies, we found that increased MPV values were related to PE diagnosis and prognosis. However, considering low AUC values, we believe that the clinical use of MPV values in daily practice for prediction mortality is limited. In more recent years, as a member of the platelet indices, PMI is considered to provide more comprehensive data than MPV alone on total platelet mass. Therefore, recent studies have focused on PMI. However, there are several studies on different diseases such as ischemic stroke, myocardial infarcts, carotid artery stenosis, and recurrent abortus [8- 11]; to the best of our knowledge, the number of studies that focused on the relationship between PMI and VTE is limited. In a study conducted with PE patients, Moharamzadeh et al studied PMI values and have reported that no statistically significant differences were found between PE patients and healthy control subjects [14]. In our study, we did not study the diagnostic performance of PMI. Therefore, we did not have control subjects. At the beginning of the study, given that PMI values with CBC examining are performed routinely, we planned to evaluate the prognostic performance of PMI values. Finally, we found that PMI values were lower in non-survivor patients than survivor patients. However, considering low AUC value of PMI for prediction mortality, we believe that clinical use of PMI is limited to distinction survivor and non-survivor patients. Limitations
This study has some limitations. First, this study was conducted in a single center and it was retrospectively planned. In addition, the study population was relatively small. Therefore, the main findings of this study cannot be generalized to the general population.
Conclusion
In conclusion, this study showed that the PMI levels decreased in the non-survivor group of PE patients; it might be helpful to distinguish between the survivor and non-survivor. However, considering the low AUC value of PMI and no correlation between PMI and PESI score, we believe that additional prognostic contribution is limited.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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8. Mohamed AB, Elnady HM, Alhewaig HK, Moslem Hefny H, Khodery A. The mean platelet volume and plateletcrit as predictors of short-term outcome of acute ischemic stroke. Egypt J Neurol Psychiatr Neurosurg. 2019;55(1):4. DOI: 10.1186/ s41983-018-0035-x.
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Hüseyin Uzunosmanoğlu, Şeref Kerem Çorbacıoğlu, Tuba Şafak, Seda Dağar, Emine Emektar, Yunsur Çevik. Prognostic value of platelet mass index in pulmonary emboli in the emergency department. Ann Clin Anal Med 2021;12(4):402-406
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Effect of using autotransfusion system on cost in open-heart surgery
Sonay Oğuz
Department of Cardiovascular Surgery, Faculty of Medicine, Canakkale Onsekiz Mart University, Canakkale, Turkey
DOI: 10.4328/ACAM.20342 Received: 2020-09-11 Accepted: 2020-10-12 Published Online: 2020-10-26 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):407-410
Corresponding Author: Sonay Oğuz, Department of Cardiovascular Surgery, Faculty of Medicine, Canakkale Onsekiz Mart University, Barbaros Street Terzioglu Campus B Block No. 4, 17100, Canakkale, Turkey. E-mail: soguz@comu.edu.tr P: +90 5434733928 F: +90 2862180535 Corresponding Author ORCID ID: https://orcid.org/0000-0002-4274-3828
Aim: The high cost of autotransfusion systems can limit its usage. In our study, we aimed to compare the cost of open-heart surgery cases with and without the use of an autotransfusion system in our hospital.
Material and Method: Of the isolated coronary artery bypass grafting (CABG) cases performed, 22 cases (Group 1), in which the autotransfusion system was used and 22 cases (Group 2), in which the autotransfusion system was not used, were retrospectively determined. In particular, the use of blood and blood prod- ucts that will affect costs, the amount of drainage for the first 24 hours, mechanical ventilator, intensive care-hospitalization periods, preoperative hematocrit and postoperative hemotocrit values and demographic data were obtained. Costs between groups were calculated and compared taking into consideration the current prices.
Results: In Group 1, the use of erythrocyte suspension (median: 2.0 – 3.0; p = 0.003) and intensive care periods (mean: 1.77 – 2.55; p = 0.046) were found to be significantly lower than Group 2. There were no significant differences between the groups in terms of other variables. When calculating, it was determined that in Group 1, the cost for each case was more than 1050 TL.
Discussion: The autotransfusion system is expensive and can provide a reduction in total cost with the benefits it provides. However, it is seen that this does not reduce the total cost enough to save its own costs when considering the current expenses. Compared to the short-and long-term benefits they provide, meeting this cost seems to be tolerable with case selection.
Keywords: Autotransfusion; Open heart surgery; Cost analysis
Introduction
The process of giving the patient’s blood collected during the surgery back to the patient was first reported by Blundell in 1818 [1]. Even though the focus was on autotransfusion, due to the fact that blood banks were not developed at the time and homologous blood transfusion was not widely available, the issue was avoided with the increased number of blood centers. However, autotransfusion has again become the center of attention with the discovery of the harms of homologous blood transfusions [2]. Thus, it has been recommended to reduce the use of homologous blood as much as possible by showing these harmful effects in open-heart surgery in various studies [3,4,5]. The negative effects of homologous blood transfusion include hemolytic reactions (high antibody titer, intra- or extravascular hemolysis), febrile reactions, bacterial reactions, the risk of infectious disease (viral hepatitis, cytomegalovirus, Epstein- Barr virus, syphilis, herpes group, malaria AIDS, etc.) [6].
The methods used to reduce the need for blood transfusion can be listed as follows: (a) the patient’s own blood is collected in the preoperative period and stored after certain procedures, (b) phlebotomy and volume replacement during early surgery, (c) giving the patient’s blood back to him/her using autotransfusion (Cell Saver) during surgery [7].
Today, the most frequently used methods of autologous blood transfusion during surgery are simple aspiration system (Solcotrans), semi-automatic system (Haemonetics, Cell Saver) and continuous autotransfusion system (CATS) [8]. The most important advantage of the autotransfusion system is that it creates a fast and high level of hematocrit and provides a high rate of fat and particle removal by washing the blood collected from the patient [9]. This is of great benefit in patients with high bleeding rates to reuse the lost blood.
Furthermore, the known advantages of autotransfusion include the elimination of the possibility of blood incompatibility, and the absence of the risks of alloimmunization, immunosuppression and infection [10,11]. The autotransfusion method can be used in vascular, orthopedic, hepatic, gastrointestinal, and some other surgical branches in addition to cardiac surgery [12-14]. Open-heart surgery is a surgery with a high risk of bleeding. Therefore, autotransfusion systems gain particular importance because blood can remain out of use in the heart-lung machine lines and reservoirs at the end of the surgery. On the other hand, the high cost of autotransfusion systems narrows and limits their areas of use.
Autotransfusion reduces the need for blood and blood products [4,5]. Although costs are limiting its usage, it may have a positive effect on the total hospital cost by reducing the use of blood and blood products. Based on this basic principle, in this study, we aimed to compare the total hospital costs of the cases by analyzing them according to the use of the autotransfusion system.
Material and Methods
Between July 2017 and December 2018, patients who were diagnosed with coronary artery disease and decided to have coronary artery bypass grafting (CABG) in our Cardiovascular Surgery Department were retrospectively identified. Twenty- two patients (Group 1) for whom the autotransfusion system
(Xtra, LivaNova, London, UK) was used, and 22 patients (Group 2) for whom the autotransfusion system was not used, were included in the study. Redo cases, cases that needed to be taken urgently and were given antiplatelet loading therapy or using it routinely, patients with known platelet and coagulation disorders were excluded from the study. Cases in which cardiac chambers were opened, aortotomy was performed, and cases reoperated due to surgical bleeding, and cases not using left internal mammary artery were not included in the study.
The study was approved by the local ethical Committee of Canakkale Onsekiz Mart University (COMU) (The chairperson of the ethics committee; Prof.Dr. Coşkun Sılan. File registry/ decision/no: KAEK-27/2020-E.200009218).
The variables such as age and gender of the patients, number of bypass surgeries undergone, postoperative 24-hour drainage amount, mechanical ventilation (MV) duration, duration of intensive care stay, total hospital stay, preoperative Hct and postoperative Hct values, number of blood and blood products used (erythrocyte suspension (ES), complete blood, fresh frozen plasma (FFP), platelet suspension) were identified. The difference in cost arisen according to the values of the variables that differed significantly between the groups was calculated according to the current Social Security Institution (SSI) prices. Statistical analysis
The data of the study were analyzed with the statistics package program SPSS, IBM, Chicago, USA 20.0 version. The data were presented using number, percentage, mean, standard deviation, median, minimum and maximum values. The Mann-Whitney U test was used as a nonparametric test according to the results of the normal distribution test. P < 0.05 was considered statistically significant.
Results
There was no difference in age and gender of the patients in both groups (Table 1). The average number of bypasses was determined as 3 (range: 2-5) in the groups. There was no significant difference between the groups in terms of the whole blood, (fresh frozen plasma) FFP, MV duration, drainage, preoperative Hct, postoperative Hct values, and hospitalization times. Intensive care period (p = 0.046), ES (p = 0.003) values were found to be significantly lower in Group 1. The blood volume given back to the patient from the Group 1 autotransfusion system was determined to be an average of 640cc (min: 200, max: 1400).
The unit price list of blood and blood products according to the SSI current price list (June 2020) is shown in Table 2. Autotransfusion Set (XTRA, LivaNova) unit price (June 2020): 1.200 TL + VAT (8%) = 1296 TL
1-unit ES SSI unit price (June 2020): 239.45 TL + 1 blood transfer set: 6 TL = 245.45
Group 1 cost difference = – 1296 + 245.45 = – 1050.55 TL
Discussion
Blood preservation techniques are one of the subjects that are known to be important and have been tried to be applied in open-heart surgery. Inconvenient situations related to the use of blood products are tried to be avoided in cardiac surgery cases as in all other surgeries. Autotransfusion systems are systems developed to provide benefits in this regard by making the patient’s blood reusable. However, they are costly devices due to their many mechanisms, and this cost can limit their usage.
Reducing the use of blood products is expected to have a positive effect on both the adverse conditions that may develop in the patient and the total cost. Considering the major costs of blood products, this reduction could create a significant change in the total cost. In our study, which we planned on this basic forecast, we aimed to find the total cost analysis computationally. This is a calculation that shows the early cost, and the calculations on the long-term cost may be much different (for example, the long-term treatment cost of an infection transmitted by blood products transfusion).
While making this determination, all patients’ files were examined one by one, as the blood product may be registered in the system even if the blood product was not used for the patient after the blood product was checked out from the blood bank, and this may be misleading. Therefore, the blood products used were determined precisely by examining the epicrisis notes, intensive care follow-up treatment charts, service follow- up forms and blood product transfusion forms.
In the package pricing, the factors such as intensive care, hospital admission, mechanical ventilator durations that could indirectly affect the costs were determined to be a source for other studies.
While determining the patients, all surgical differences that may affect bleeding, and especially patients who were given medication that would increase bleeding, were excluded from the study. Only patients who underwent bypass surgery were included in the study, as this may alter bleeding and therefore the need for blood products. The differences between groups that could affect the use of blood products were determined by identifying the preoperative and postoperative Hct values. There was no difference in age and gender of the patients in both groups (Table 1). The average number of bypass surgeries was 3 (range: 2-5).
There was no significant difference between the groups in terms of age, gender, number of bypass surgeries, whole blood, FFP, MV duration, drainage, preoperative Hct, postoperative Hct values, and hospitalization times. ES (p = 0.003) intensive care period (p = 0.046) was found to be significantly lower in Group 1. When this difference in the ES value was compared with the median values (2.0 – 3.0), it was seen that 1 less erythrocyte suspension was used for each patient in Group 1. Although there is a significant difference between the groups in terms of the intensive care hospitalization period, it does not appear to have a direct effect on the cost due to the package price application. However, it is known that the psychological effects of staying in the intensive care unit for a long time increase the material cost and the workload of the staff. In addition, thrombocyte suspension was never used in both groups. We think that this situation is related to the exclusion criteria.
According to the data obtained, the cost difference between Group 1 and Group 2 = – 1296 + 245.45 = – 1050.55 TL.
The result obtained is a computational result. There was no cost difference according to statistically significant parameters. According to this calculation, the difference of 1296/245.45 = 5.28 ES should be achieved in order for the autotransfusion set to meet its own cost in Turkey. In the meta-analysis study by Carless et al., it was shown that the use of autotransfusion reduces the need for ES up to 0.68 units per patient [15].
Xie Z showed that the cost can be different depending on the difference in the unit price in different countries [16]. For example, the cost of 1-unit ES in China is $22.8, while it is $219 in England and $201 in Italy, respectively. In Turkey, 1-unit ES is $33 ($1 = 7.25 TL; July/2020). In the same study, although there was an overuse of 4.09 units of ES per patient with autotransfusion in China, the cost analysis was negative (-150.6 $). In addition, the price of 1-unit red blood cell (RBC) in Italy is $201, and a profitability of $134 was seen in the cost analysis with 1.95 unit more RBC usage per patient (Figure 1) [16].
It is seen that the cost analysis can give different results based on the unit prices in the countries. In our study, we aimed to find the cost effectiveness of the use of autotransfusion system in our country. As a result, it was seen that autotransfusion systems provide a partial reduction of costs at an early stage with 1-unit reduction in RBC use, but cannot generate profitability. However, this is just a computational analysis of the initial cost. Long-term results may be completely different, especially considering the cost of diseases that can only be transmitted through blood.
Should autotransfusion systems be used in all cases when the cost is ignored? Alexander B et al. [5] argued that autotransfusion systems should be used in all open-heart surgery cases; on the contrary, there are studies showing that the routine use of these systems is ineffective and causes an additional cost burden [17]. Seyfried T. et al, on the other hand, pointed out that the risk of bleeding may occur with arrhythmia, decrease in the number of platelets and dilution coagulopathy that can result from decreased potassium levels with washing, and emphasized the importance of case selection [18]. In another study, it was shown that such complications do not occur, and that cost effectiveness is achieved with a bleeding volume of 600-1000 ml [19]. There are also some other studies stating that clots can develop in the autotransfusion system [20]. All of these show the possible drawbacks of autotransfusion systems and the importance of suitable case selection apart from cost. Conclusion
The importance and benefits of blood preservation in open heart surgery have been shown in many studies. Although the autotransfusion system is expensive, it can provide a reduction in total cost due to the benefits it provides. Given the current prices in Turkey, it was seen that these systems cannot provide a reduction in the total cost enough to meet their own costs. Compared to the short- and long-term benefits they provide, meeting this cost seems to be tolerable with case selection.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Evaluation of patients admitted to the emergency department with headache and undergoing neuroimaging
Canan Akman 1, Bülent Erbil 2, Mehmet Akif Topçuoğlu 3, Mehmet Ali Karaca 2, Erhan Akpınar 4, Mehmet Mahir Özmen 5
1 Department of Emergency Medicine, Canakkale Onsekiz Mart University Faculty of Medicine, Canakkale, 2 Department of Emergency Medicine, Hacettepe University Faculty of Medicine, Ankara, 3 Department of Neurology, Hacettepe University Faculty of Medicine, Ankara, 4 Department of Radiology, Hacettepe Universty of Medicine, Ankara, 5 Department of General Surgery, Hacettepe University Faculty of Medicine, Ankara, Turkey
DOI: 10.4328/ACAM.20347 Received: 2020-09-16 Accepted: 2020-10-21 Published Online: 2020-11-04 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):411-417
Corresponding Author: Canan Akman, ÇanakkaleOnsekiz Mart University, Department of Emergency Medicine, Çanakkale, Turkey. E-mail: drcananakman@gmail.com P: +90 5037654360 Corresponding Author ORCID ID: https://orcid.org/0000-0002-3427-5649
Aim: It is of great importance to differentiate the primary or secondary causes of headaches in the intensity of emergency services. The underlying causes of secondary headaches can be caused by neurological causes and may have a mortal course. In this study, it was aimed to determine red flags in neuroimaging for life-threatening secondary causes of patients who applied to the emergency department with headache complaints and underwent brain imaging. Material and Methods: Our study was planned retrospectively and descriptively. Patients who presented to the 3rd step emergency department with headache within 10 years were included. Demographic characteristics, disease history and information, imaging information and results of the patients were recorded. Results: In this study, the mean age of 704 patients was 48.9 (17-92) years, 62.8% of whom were female, and 99.6% of the patients presented to the de- partment within the first 24 hours after headache. Their cranial CT scans identified intracranial pathologies in 19.2% (n=139) of the patients. Intracranial pathologies were detected in 27.5% who experienced the most severe headache in their life, in 31.7% who had a sudden headache, in 52.9% who had focal neurological deficits, in 23.8% who were older than 50 years old, and in other headache reasons.
Discussion: In the study on the elimination of secondary headaches in the emergency room, we concluded that having the most severe headache ever, sudden onset, neurological deficit, and being over 50 years of age are warning criteria. Although brain CT scans are generally used in clinically suspicious situations, MRI should also be used for mortality and morbidity in these patients.
Keywords: Headache, Neuroimaging, Emergency, CT
Introduction
Headache is one of the most common complaints in the society and the emergency department [1]. According to the Headache Classification Committee of the International Headache Society (IHS), headaches are divided into two categories as primary and secondary. Most of the headaches are primary headaches [2]. Patients are admitted to the emergency department largely due to primary headaches. Migraine or stress-type headaches are the most frequently observed primary headaches. It may be often challenging to distinguish between primary and secondary headaches [3]. It is of great importance to distinguish between life-threatening secondary headaches and benign primary headaches (migraine, cluster, tension-type headaches) in a hospital emergency department full of patients. Since the underlying causes of secondary headaches can be fatal and lead to neurological deficits, a thorough medical history and detailed physical examination are the keys to evaluation. While patients admitted to the emergency department with primary headache are often conservatively treated, secondary headaches may be due to underlying structural, infectious or vascular causes. They are life-threatening in the absence of fast diagnosis [4].
The patients presenting with acute headache to the emergency department in the American College of Emergency Physician (ACEP) in 2009 were categorized under four specific groups based on whether they required neuroimaging. These groups included patients with new sudden-onset severe headache, with focal neurological deficit and altered mental status, HIV- positive patients and patients with other immunodeficiency, and patients older than 50 years with a new type of headache, but with a normal neurological examination [5]. Sudden and severe headache, different from other headaches, recent seizures or altered mental status, headache in age above 50, history of immunosuppressive therapy may be risk factors; abnormalities in physical examination and neurological examination, toxic complications and papilledema are signs of secondary headaches [6]. The decision for neuroimaging should be made to exclude the causes of secondary headaches, and appropriate imaging techniques are important for the confirmation of diagnosis and organizing the treatment plan [3]. The most commonly used imaging methods are computed tomography (CT) and magnetic resonance imaging (MRI) scans [7]. This study seeks to evaluate the patients who presented to the emergency department with headache and underwent neuroimaging and to determine the red flags which may be the neuroimaging indicators of life-threatening secondary headaches.
Material and Methods
Following the approval of the ethics committee, the records of the patients with headache (age ≥ 16 years) and those of the patients who underwent neuroimaging were evaluated in Hacettepe University archives retrospectively for 10 years (2001-2011). Data were obtained from the hospital records and the automation system. The demographic characteristics of the patients and neuroimaging indications (most severe headache that one has ever had, one’s first headache, sudden onset, focal neurologic findings, change in character of pain, increased severity of pain, resistance to analgesia, patient’s age ≥ 50 years) were recorded. After consultation and follow-up in the emergency department, hospitalization ratios in the ward or intensive care unit, neuroimaging reports were analyzed. Patients who had cranial CT at external centers and had trauma were excluded from of the study.
Statistical analysis
In the analyses, descriptive statistics of mean and standard deviation, minimum and maximum were used for numerical data, while number and percentage were given for qualitative data. The two-way significance test (t-test), chi-square analysis, Fisher’s chi-square analysis and the McNemar test were used in the correlations between categorical data.
In all statistical tests, p<0.05 was accepted as significantly different and data were analyzed using the SPSS 20.0 program.
Results
A total of 1007 patients were admitted to the emergency department during the study period. After excluding the patients who had a cranial CT at an external center and had trauma, statistical analysis was performed with the remaining 704 patients. The mean age of the patients was 48.9 (17-92) years; 62.8% (n=442) of whom were female and 37.2% (n=262) were male. The average age was 48.08 (±15.674) years in male patients and 49.37 (±16.065) years in female patients, and there was no difference. In the vital evaluations of the cases applied to the emergency service, mean systolic blood pressure was 135.80 ± 29.46 (70-260) mmHg, mean diastolic blood pressure was 84.34 ± 17.39 (40-170) mmHg, mean pulse was 79.25 ± 14.35 (40-164) beats / min, mean respiratory rate was 18.61 ± 2.28 / min, mean temperature measured was 36.46 ± 0.63 (34.6-39.7) °C and mean saturation was 98.48 ± 1.87 (87 -100). It was found that the patients who were admitted to the emergency department with headache and underwent neuroimaging suffered from a headache for an average of 4.12 (±4.995) hours until they first presented to the emergency department, and 99.6% of the patients presented to the emergency department within the first 24 hours after the onset of headache (Figure 1).
The most common symptoms accompanying headaches were nausea (46.30%) and vomiting (33.20%) (Figure 2).
After studying the medical histories of the patients, it was revealed that 37.1% (n=261) of the patients had hypertension, 11.4% (n=80) of them underwent previous intracranial surgery, 10.9% (n=77) suffered from diabetes mellitus. The patients were examined for a history of previous intracranial surgery; 11.4% (n=80) of them had a history of surgery. Among those with a history of surgery, intracranial masses were the most common cause, accounting for 6.3% (n=44). When the patients were asked about a history of headache, 29% (n=209) had a previous history of headache. Headache in 6.4% of them was triggered by primary causes, whereas in 23.7% of cases, headache was led by secondary causes. At the same time, 69.9% of the patients had not been diagnosed with headache before. When we look at headache in two different groups as primary and secondary headache, the most common cause of primary headache was migraine, accounting for 5.8% (n=41), and for secondary headache, it was intracranial mass, accounting for 9.5% (n=67) (Table 1).
When the patients were asked whether they used any medication for headache, 80.8% (n=569) of them responded that they did not use any medication, while 19.3% (n=135) reported that they used medication, and nonsteroidal anti- inflammatory drugs were the most commonly used medication (Table 2).
The most common presenting complaints to the emergency department were nausea (46.3%, n=326), vomiting (33.2%, n=234), vertigo (11.3%, n=79), photophobia (2.6%, n=18), sonophobia (1.4%, n=10), phonophobia (1.1%, n=8), neck pain (4.1%, n=29). The complaints of the patients who admitted to the emergency department with headache and underwent neuroimaging (nausea, vomiting, vertigo, neck pain, photophobia, sonophobia, phonophobia) were compared considering primary and secondary causes, and no significant difference was found. The assessment of the neurological symptoms revealed that 101 out of 704 patients (14.3%) had focal neurological symptoms. Table 2 shows the distribution of neurological examination results of the patients who underwent neuroimaging by number and percentage.
The results of the cranial CT reports in the cases who underwent neuroimaging show that 19.7% (n=139) of the patients had pathology. Table 2 presents the cases with pathologies and outcomes of the patients.
CT results were examined in terms of the relationship with pathology, with the most severe headache (SCPA). There was a significant correlation between SCBA and CT pathology results (p=0.007). While the CT pathology negative number of patients without SCBA complaints was 457, the number of CT pathology negative patients who reported SCBA complaints was 108. Although the calculated Odds ratio is 1.770, the 95% lower confidence interval did not fall below 1.
In this case, not reporting a complaint to SCPA increases being pathology negative, reporting a complaint to SCPA increases being pathology negative 1.7 times. The effect size of the chi- square analysis calculated for this relationship was determined as 0.10. According to Cohen’s [8] classification, this effect size is small. In this case, it can be interpreted that CT imaging should not be requested in the first place for patients who do not report the most severe headache complaint.
The CT result of the first headache (IBA) and the emergency department admission was examined in terms of the relationship with pathology. This relationship was examined with the chi-square Pearson Exact value. Since the expected frequency in one of the pores has fallen below 5%, there is no significant relationship between IBA and CT pathology results (p>0.05, p=0.477).
The CT results on admission to the emergency service with sudden headache (ABA) were examined in terms of the relationship with pathology. There was a significant relationship between ABA and CT pathology results (p <.05, p = 0.015). While the number of CT pathology negative patients without ABA complaint was 524, the number of CT pathology negative patients reporting ABA complaint was 41. Although the calculated Odds ratio is 2.024, the 95% lower confidence interval did not fall below 1. In this case, not reporting ABA complaints increases being pathology negative, and reporting ABA complaints increases being pathology negative 2 times. The effect size of the chi-square analysis calculated for this relationship was determined as 0.10. This effect size is of small effect size. In this case, it can be interpreted that CT imaging should not be requested in the first place for patients who do not report sudden headache complaints.
Focal neurological findings (FNF) and CT results on admission to the emergency department were examined in terms of the relationship with pathology. There was a significant relationship between FNF and CT pathology results (p=0.0001). While the number of CT pathology negative patients without FNF complaint was 533, the number of CT pathology negative patients reporting FNF complaint was 32. Although the calculated Odds ratio was 5.822, the 95% lower confidence interval did not fall below 1. In this case, not reporting FNF complaints increases being pathology negative, reporting FNF complaints increases pathology negative 5 times. The effect size of the chi-square analysis calculated for this relationship was determined as 0.27. This effect size is medium effect size. In this case, it can be interpreted that CT imaging should not be requested in the first place for patients who do not report focal neurological findings.
The change in the character of pain (CCP) and the CT results at the emergency department were examined in terms of the relationship with pathology. There was no significant relationship between CCP and CT pathology results (p>0.05, p = 0.614).
The CT results were examined in terms of the relationship with pathology with increased pain severity (IPS). There was no significant relationship between IPS and CT pathology results (p>0.05, p=0.199).
Resistance to analgesia (RA) was examined in terms of the relationship with pathology on CT in the emergency department.
There was no significant relationship between the name and CT pathology results (p>0.05, p=0.402).
Being under the age of 50 or over was examined in terms of the relationship with pathology on the CT result. There was a significant correlation between being under or over 50 years of age and CT pathology results (p=0.015). While the number of CT pathology negative patients under 50 years of age was 321, the number of patients over 50 years of age was 244. Although the calculated Odds ratio was 1.587, the 95% lower confidence interval did not fall below 1. In this case, pathology under 50 years of age increases being negative, and above 50 years of age increases being negative 1.5 times. The effect size of the chi-square analysis calculated for this relationship was determined as 0.09. This effect size is of small effect size. In this case, it can be interpreted that CT imaging should not be requested for patients under 50 years of age (Table 3).
Discussion
In 98% of the headache cases, presented to the ED, headaches were caused by primary causes. Secondary causes, on the other hand, lead to serious consequences [9]. To rule out secondary headache, the international classification for headache by the International Headache Society (IHS) suggests looking at the causes of primary headaches [10]. In this study, migraine is the most common cause of primary headaches accounting for 5.8% (n=41), which is consistent with the literature [11]. Headaches in this study were led by secondary causes in 23.7% of cases and mostly caused by intracranial mass in 9.5% (n=67). The results of this study were consistent with the literature. In the study conducted by Rizos et al., the rate of admission to the emergency department in the first 24 hours after the onset of headache was 52.7% [12]. Similarly, in this study, 99.6% of the patients admitted to the emergency department after the onset of headache. The highest rate of visits to the ED was between 16.00 – 24.00. This may be due to the fact that visits to the ED are high usually in the evening. The most common complaints accompanying headache were nausea and vomiting. A study by Langeetal.statedthatthesesymptomswereassociatedwith migraine [13]. Though nausea and vomiting may be associated with migraine, they can be present in secondary headaches. The most common diseases in the medical histories of the patients were hypertension, previous intracranial surgery and diabetes mellitus. A study by Vinson et al. showed that hypertension was the most common disorder in patients’ histories [14]. To distinguish between primary and secondary headache, it is paramount to perform physical examination focusing on anamnesis and neurological examination. This makes it possible to identify clinical warning signs. Among these signs are sudden onset headache, increased severity of pain, patients aged 50 and over, which is ten times more risky than patients 75+ (11%), who also have more serious pathologies than patients younger than 50. It is important to question the use of anticoagulants or sedative drugs, which support the presence of lightning bolt headaches and focal neurological deficits (arterial dissection, cancer) and systemic diseases (hypertension and diabetes mellitus) [15]. This study reveals that the detection of pathological findings on CT scans of the brain of patients with the most severe headache they have ever had, sudden onset headache, focal neurological deficits and older than 50 years through neuroimaging, is statistically different. The existing body of research shows that sudden onset headache, headache in patients 50+, the presence of abnormalities in the neurological examination are the cases of suspected secondary headache, and brain CT is recommended for these cases [16- 19]. Change in headache pattern constitutes a risk factor for secondary headaches. Besides, abnormal neurological examination or focal neurological findings require a CT scan [20]. In this study, neuroimaging was performed considering these clinical warning signs. Sudden and severe onset headache is particularly important to diagnose subarachnoid hemorrhage, which is associated with significant morbidity and mortality [21]. The most severe, acute onset headache and headache with increasing severity of pain indicated subarachnoid hemorrhage in this study. These situations serve as clinical warning signs requiring neuroimaging. The American College of Emergency Physicians (ACEP) recommends the use of clinical warning signs to exclude secondary causes in deciding which patient groups should undergo neuroimaging. These clinical warning signs are focal neurologic deficit with headache, new-sudden onset severe headache, and new-onset headache in those aged over 50 years even if they have normal neurologic examination. In our study, findings such as sudden onset headache accompanied by focal neurological findings, and whether it was the most severe headache ever experienced, were shown to be important clinical early warning findings. A study by Jordan et al. recommended emergency neuroimaging in the presence of “sudden-severe headache” and “abnormal finding in neurologic examination” [22]. Aygun et al. reported that using clinical warning signs in the evaluation of headaches is important in the detection of significant pathologic findings with cranial CT [23].
Due to its cost and accessibility, the first option in the emergency department would be often a brain CT scan. Clinical warning signs serve as screening tools in determining which patients with headache in the ED should undergo neuroimaging; these signs are also useful in increasing effectiveness in clinics with a high patient density in their emergency departments. The most accurate approach in the diagnostic algorithm to distinguish between primary and secondary headaches is to follow the appropriate steps by benefiting from clinical warning signs. Limitations
This study did not include any trauma patients or patients under the age of sixteen. Also, the patients with headache who had undergone neuroimaging before their admission to the ED were excluded from this study.
Conclusion
Clinical warning signs in patients admitted to the emergency departments with headache are useful in making a rapid and accurate diagnosis, excluding the causes of secondary headache, ensuring appropriate follow-up and treatment, and also preventing the need for unnecessary neuroimaging tests, consequently, avoiding high costs. In this study, when the patients admitted to the emergency department with headache, they were questioned about the clinical warning signs such as the most severe headache ever, sudden onset of headache, presence of focal neurologic findings, and being aged 50 or higher. Their answers to these questions appear to have significance for neuroimaging indications. The use of clinical warning signs will make it easier for physicians and health staff serving in emergency departments to identify life-threatening situations in advance and will also provide convenience for patients admitted to emergency services with headaches.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Canan Akman, Bülent Erbil, Mehmet Akif Topçuoğlu, Mehmet Ali Karaca, Erhan Akpınar, Mehmet Mahir Özmen. Evaluation of patients admitted to the emergency department with headache and undergoing neuroimaging. Ann Clin Anal Med 2021;12(4):411-417
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Prevalence of atopy in children with celiac disease
Ayse Senay Sasihuseyinoglu 1, Mehmet Agın 2, Zeliha Haytoglu 3, Aylin Ozhan 1, Gokhan Tumgor 2, Mahir Serbes 1, Dilek Dogruel 1, Derya Ufuk Altıntaş 1
1 Department of Pediatric Allergy and Immunology, 2 Department of Pediatric Gastroenterology, Hepatology and Nutrition, 3 Department of Pediatri, Faculty of Medicine, Cukurova University, Adana, Turkey
DOI: 10.4328/ACAM.20375 Received: 2020-10-16 Accepted: 2020-12-07 Published Online: 2020-12-19 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):418-421
Corresponding Author: Ayse Senay Sasihuseyinoglu, Cukurova University, School of Medicine, Balcalı Hospital, Department of Pediatric Allergy and Immunology, 01330, Sarıcam, Adana, Turkey. E-mail: ssashuseyinoglu@yahoo.com.tr P: +90 5066083040 F: +90 322 338 69 00 Corresponding Author ORCID ID: https://orcid.org/0000-0003-4085-0256
Aim: Celiac disease (CD) is an autoimmune disorder caused by dietary gluten. There are only a few studies reporting on the prevalence of atopy in CD and the results are conflicting. The aim of this study was to examine the prevalence of atopy in CD patients.
Material and Methods: A total of 97 children with confirmed CD and a control group of 95 age- and gender-matched healthy controls were included in the study. The immunoglobulin (Ig) A-G-E-M levels, complete blood count, Phadiatop and milk-egg-rice-wheat specific (sp) IgE were assessed and skin prick tests (SPTs) were applied.
Results: The CD patients comprised 51 (52.6%) girls and 46 (47.4%) boys with a mean age of 10.3 ± 4.8 (range, 1-16) years. The median level of IgE, total eosinophil count, Phadiatop, food sp IgE, and SPT positivity were significantly higher in CD patients compared to healthy controls (p=0.001, p=0.001, p=0.001, p=0.001, p=0.013, respectively). No positive reaction was detected in any of the participants in the oral food challenge test. The prevalence of atopy in the CD patients was higher than that of control group (29.9% vs. 11.0%). Moreover, six patients with CD were diagnosed with allergic diseases.
Discussion: The incidence of atopy was found to be higher in CD patients than in healthy children.
Keywords: Atopy; Celiac disease; Child; Wheat
Introduction
Celiac disease (CD) affects 0.6% to 1% of the world population [1]. In a study which included 20190 students aged 6-17 years screened in various regions of Turkey, the prevalence of CD diagnosed by biopsy with antibody positivity was found to be 0.47% [2]. CD is caused by dietary gluten which is found in wheat in genetically predisposed individuals carrying the human leukocyte antigen (HLA) DQ2 or DQ8 [1]. Consumption of gluten proteins (gliadins and glutenins) induces a T-cell mediated inflammation of the small intestine in CD [3]. Although the relationship between CD and allergy remains unclear, some reports suggest that patients with CD have an increased frequency of allergic manifestations compared with the general population [4,5]. Moreover, CD and allergy might share a similar predisposing background [6]. The aim of this study was to evaluate the prevalence of atopy in CD.
Material and Methods
Study population
All children followed up with a diagnosis of Celiac disease in the pediatric gastroenterology clinic, and the healthy children who applied to the social pediatrics clinic for the group were referred to the pediatric allergy clinic during the study. CD was diagnosed based on the accepted guideline [7]. Atopy was defined as a personal tendency to produce immunoglobulin (Ig) E antibodies in response to exposure to common allergens, with an increased risk of developing typical diseases such as asthma, allergic rhinitis, atopic dermatitis, or food allergy (FA). The presence of serum allergen-specific (sp) IgE antibodies and/or positive skin prick test (SPT) was accepted as an indicator of atopy [8]. The diagnosis of asthma was made according to the Global Initiative for Asthma (GINA) guidelines. Asthma was diagnosed in the presence of asthma symptoms (respiratory distress, wheezing, wheezing or shortness of breath after exercise) within the last one year, in the detection of a 12% increase in forced expiratory volume in 1 second (FEV1) after bronchodilator inhalation, and in children with a history of regular medication for asthma within the last one year. Allergic rhinitis was defined as the presence of immunologically mediated hypersensitivity symptoms of the nose such as itching, sneezing, increased secretion, and blockage [9]. Throughout the study, no medication was used by any patient. All the participants completed a questionnaire that included items probing their demographic characteristics. The IgE, IgA, IgM, and IgG levels, complete blood count, phadiatop® and milk-egg- rice-wheat sp IgE were measured in all participants. SPT was performed using the same antigens for all participants. Food challenge tests were performed in children with suspected FA. Laboratory analysis
The IgE, IgA, IgM, and IgG levels were measured using nephelometric immunoassay. Eosinophil count measurements were performed using a Coulter Hmx Haematology Analyzer (Beckman Coulter, Inc., CA, USA). Eosinophilia was diagnosed in the detection of >0.45×109 eosinophils/L and an eosinophil ratio of >4% in peripheral blood. Serum concentrations of IgE against cow’s milk, hen’s egg, wheat, rice allergens were analyzed using an ImmunoCAP ® kit (InVitroSight, Phadia AB, Uppsala, Sweden).
Serum concentrations of IgE against common inhaled allergens including fungi, pollens, insects and dust mites were analyzed using Phadiatop®. The detection of sp IgE antibodies exceeding 0.35 kUA/L indicated a positive result.
Skin prick test
Participants were considered eligible for SPT if they had not received antihistamines for at least one week. SPT was performed using a commercial extract and was applied epicutaneously for Dermatophagoides pteronyssinus, Dermatophagoides farinae, tree pollens (Alnus glutinosa, Betula verrucosa, Coryllus avellena, Populus alba, Quercus robur, Olea europa, Fagus silvatica), grass pollens (Lolium perenne, Cynodon dactylon, Phleum pratense, Poa pratensis, Festuca pratensis, Alopecurus pratensis, Secale sereale, Triticum sativum), moulds (alternaria, penicilliumi mucor, candida, aspergillus, cladosporium), milk, egg, rice, and wheat (Allergopharma, Rheinbek, Germany). Histamine was accepted as a positive control and saline was accepted as a negative control. SPT was considered as positive if the mean wheal diameter was ≥3 mm compared with the negative control after 20 min.
Food challenge test
Food allergy (FA) was suspected in children with a serum sp IgE ≥0.35 kUA/l and in children with a positive SPT by food [9]. The double-blind placebo-controlled food challenge (DBPCFC) test was performed in children with suspected FA and was not performed in CD patients with suspected wheat allergy. Both the active food and the placebo food were given on two separate days. Prior to testing, children were given an elimination diet free of the considered allergenic foods for 15 days. The suspected food was administered starting at a minimum amount, and then incremental doses were given at 20-min intervals until the total challenge dose was tolerated or an adverse reaction occurred. The starting dose of the food was determined according to the history of reaction intensity or the results of sp IgE or SPT. The total dose administered was the age-adjusted normal daily intake of the food. The infants were observed for at least 2 hours after the last dose before going home. Parents of all children were contacted by telephone 72 hours and one week after test completion in order to determine the findings suggestive of FA that could be defined as positive when urticaria, angioedema, vomiting, diarrhea, eczema or respiratory and cardiovascular symptoms developed during the challenge procedure.
Statistical Analysis
Data were analyzed using SPSS 15 for Windows (SPSS Inc. Chicago, IL, USA). Descriptive values were expressed as mean ± standard deviation (SD) and median (minimum-maximum) for continuous variables and as frequencies (n) and percentages (%) for categorical variables. Categorical variables were compared using the Chi-square test. The groups’ serum IgE and food sp IgE concentrations were compared using the Mann-Whitney U test. A p-value of <0.05 was considered significant.
Ethical approval
This study was approved by the local Research Commission and Ethics Committee (Date: May 13, 2016; No: 6/53). The study protocol was conducted in accordance with the Declaration of Helsinki [10]. Informed parental consent was obtained from all the participants before inclusion.
Results
A total of 97 children with confirmed CD and a control group of 95 age-and gender-matched healthy controls were included in this study. The CD patients comprised 51 (52.6%) girls and 46 (47.4%) boys with a mean age of 10.3 ± 4.8 (range, 1-16) years. All patients with CD were in clinical remission and were on a gluten-free diet. Atopy was detected in 29.9% and 11% of the CD patients and control subjects, respectively, and this difference was statistically significant (p=0.02). In the CD group, six patients were diagnosed with an atopic disorder (both allergic asthma and allergic rhinitis in 2, allergic asthma in 2, and allergic rhinitis in 2 patients). Accordingly, the prevalence of atopic disorder was significantly higher in the CD group compared to the control group (p=0.029).
Demographic Features
Table 1 demonstrates the demographic, clinical, and laboratory characteristics of both groups. The mean follow-up period for CD patients was 23.6±27.67 (range, 4-144) months. A family history of allergic disorders was detected in 11 (11.4%) patients with CD reported, while no family history of allergic disorders was reported in the control group.
Laboratory Results
The median level of IgE was significantly higher in children with CD than in control subjects (59 vs. 25.5 IU/l; p=0.001). However, the mean levels of Ig A-G-M were similar and within normal ranges in both groups. The percentage and total counts of eosinophils were significantly higher in children with CD compared to control subjects (p=0.001). The percentages of Phadiatop and food sp IgE positivity were higher in children with CD than in controls (p=0.001 for both). Thirteen patients with CD had multiple food sensitivity.
Skin prick test
The percentage of SPT positivity was higher in children with CD than in controls (p=0.013). House dust mites were the most common allergens in both groups (11.3% and 4.2%, respectively). There was no reaction to food in SPT except for one patient with CD who showed a positive reaction to eggs. The results of skin test are shown in Table 1.
Food provocation test
In total, 14 DBPCFC tests were performed in 10 patients with positive SPTs and/or positive food-sp IgE. DBPCFC with wheat was not perfumed in patients with CD since they were on a gluten-free diet. Moreover, DBPCFC was not performed in four patients since they did not consent to undertake the test. No patient tested positive for DBPCFC.
Discussion
The results indicated that the prevalence of atopy in our CD patients was higher than in the control group (29.9% vs. 11.0%). A recent study on 2297 adult CD patients showed a possible association between CD and IgE sensitization to some food and inhalant allergens [11]. Moreover, CD patients had a higher prevalence of atopic disease such as asthma, allergic rhinitis, and were more sensitized against aeroallergens and food allergens, while no patient had FA. To our knowledge, there are several studies reporting on allergic disorders in CD patients. Our result is higher than in some studies and in line with some studies [5,12-15]. Cooper et al. investigated the prevalence of asthma, allergic rhinitis, and atopic dermatitis in children with CD and detected atopic disease (asthma and eczema) in 7% of the patients [14]. In a similar study, Yavuzyilmaz et al. reported that the frequency of atopic dermatitis was higher in CD patients than in control subjects [13]. Hodgson et al. found atopic asthma and eczema in 6 (17%) out of 35 patients with CD as opposed to 3% of control subjects with peptic ulcer [14]. Another study suggested that the impaired intestinal mucosal permeability of untreated CD patients might result in an increased flow of dietary antigens through the intestinal mucosa, stimulating food-dependent hypersensitivity or reversing the impaired intestinal permeability, which has been observed in some allergic patients, could break the tolerance to gluten, promoting the CD among the genetically predisposed subjects [15]. The prevalence of FA in children ranges between 3-7%, with the majority of allergies caused by cow’s milk, hen egg, soya bean, wheat, peanut, tree nuts, fish, and shellfish [16]. Gastrointestinal manifestations of FA include emesis, nausea, diarrhea, abdominal pain, dysphagia, food impaction, protein-losing enteropathy, and failure to thrive [17]. Similarly, classic symptoms of CD include gastrointestinal problems such as chronic diarrhea, abdominal distention, abdominal pain, malabsorption, loss of appetite, vomiting, and failure to thrive [18]. Gluten is the main structural protein of wheat, composed of two main fractions depending on their solubility in aqueous alcohols: the monomeric soluble gliadins and the poorly soluble glutenins [19]. Gliadins are supposed to be the active fractions of gluten, while they actually contain the immunogenic peptides [20]. A recent study by Pillon et al. suggested that the risk of CD increases among patients with severe FA [18]. In our study, although food sp IgE positivity rate was higher in the CD patients than in the control subjects, no food allergy was detected by DBPCFC.Wheat allergy (WA) is a common gluten-related disorder, which was classified in 2012 [21]. The mechanism in WA may be mediated by sp IgE or cellular immunoreaction [22]. WA is often associated with other allergic manifestations, such as asthma (48-67%) or allergic rhinitis (34-62%) [23]. Symptoms last from a few minutes to two hours following wheat consumption. In young children, gastroenterological manifestations such as vomiting, diarrhea, or abdominal pain are more common [24]. SPTs and sIgE in vitro assays are the first-level diagnostic tests for WA [24]. Moreover, oral food challenge is the gold standard for diagnosis of WA [25]. In food allergies, the elimination of allergen food from the diet may cause tolerance over time. In our study, no reaction was detected in SPT with wheat, while seven patients with CD had positive wheat sp IgE, which could be attributed to the ongoing gluten-free diet of the patients. Nevertheless, DBPCFC with wheat could be not be performed in these patients due to their ongoing gluten-free diet, which is a part of CD treatment. Accordingly, the exact prevalence of WA in CD patients could not be determined. Our study was limited due to several reasons. First, our study population was relatively small. Second, patients with CD were in clinical remission, and all of them were on a gluten-free diet until the diagnosis of CD, and thus DBPCFC with wheat could not be performed in these patients. In conclusion, the prevalence of allergic sensitization was higher in CD patients than in healthy controls. In CD patients presenting with the signs of allergic disorders (eczema, rhinitis, asthma), concomitant allergy tests may be helpful at the time of diagnosis. Given that patients with confirmed CD are more sensitized against wheat proteins, we suggest that wheat allergy tests could be interesting in diagnosing CD and then repeated regularly over time to determine if the patient is at risk of allergic manifestations in case of an accidental exposure. Further studies are needed to evaluate the relationship between atopy and CD.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Ayse Senay Sasihuseyinoglu, Mehmet Agın, Zeliha Haytoglu, Aylin Ozhan, Gokhan Tumgor, Mahir Serbes, Dilek Dogruel, Derya Ufuk Altıntaş. Prevalence of atopy in children with celiac disease. Ann Clin Anal Med 2021;12(4):418-421
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Comparison of single versus double-row techniques in arthroscopic rotator cuff repair of full-thickness tears
Fatih Doğar 1, Erdal Uzun 2
1 Department of Orthopaedics and Traumatology, Kahramanmaras Sutcu Imam University, Faculty of Medicine, Kahramanmaras, 2 Department of Orthopaedics and Traumatology, Erciyes University, Faculty of Medicine, Kayseri, Turkey
DOI: 10.4328/ACAM.20459 Received: 2020-12-30 Accepted: 2021-02-01 Published Online: 2021-02-13 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):422-427
Corresponding Author: Fatih Doğar, Kahramanmaras Sutcu Imam University, Faculty of Medicine, Department of Orthopaedics and Traumatology, 46050, Kahramanmaras, Turkey. E-mail: drfatihdogar@hotmail.com P: +90 530 404 54 89 F: +90 344 300 36 69 Corresponding Author ORCID ID: https://orcid.org/0000-0003-3848-1017
Aim: This study aimed to evaluate the effect of suture techniques on clinical outcomes and re-tear rate following arthroscopic rotator cuff repair (aRCR) in full-thickness rotator cuff tears.
Material and Methods: The study included 115 consecutive aRCRs with a minimum 1-year follow-up. Patients were divided into two groups according to the repair technique used (Group 1: single-row technique; Group 2: double-row technique). Pre- and postoperative clinical and functional outcomes were measured using the Visual Analog Scale (VAS), the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), the Constant-Murley Score (CMS) and range of motion (ROM) (abduction degrees). Magnetic Resonance Imaging (MRI) was used for radiological evaluation pre- and postoperatively. Patte’ classification was used to determine the retraction amount of the tear. Failure was determined by MRI imaging together with clinical and functional evaluation. A comparative analysis of clinical and functional outcomes and failure rates were performed between groups.
Results: The mean follow-up period was 25.3 ± 9.7 months. The mean age at the time of surgery was 58.6 ± 8.3 years. While no statistical difference was observed between preoperative patient and tear characteristics, the number of anchors used in Group 2 was significantly higher than the Group 1, p=0.001). A significant improvement was found in clinical and functional scores in both groups (p < 0.001 for both). However, pre- and postoperative clinical and functional outcomes and failure rates did not differ between groups (p>0.05). Eight patients (7%) had a re-tear at the last follow-up (4 in Group 1; 4 in Group 2, p=0.571). Patients with no re-tear could return to their preoperative activities at the last follow-up.
Discussion: Satisfactory results can be obtained in the early postoperative period, regardless of the suture technique in aRCR of full-thickness rotator cuff tears. We suggest that the single-row method is at least as effective as the double-row and cost-effective procedure in aRCR.
Keywords: Rotator cuff; Repair technique; Arthroscopic; Single row; Double row
Introduction
Rotator cuff tear (RCT)s are among the most common shoulder pathologies, the incidence of which increases with age and requires surgical intervention [1]. Arthroscopic rotator cuff repair a(RCR) procedures have gradually improved with the use of suture anchors with several advantages over open surgery [2]. Fixation methods based on the use of anchors have become popular with their convenient use, better biomechanics of the repair structure, and the ease of creating a variety of suture configurations [3]. Single-row (SR) and double-row (DR) fixation techniques are the most commonly used techniques with good clinical short-and long-term results [4-6]. However, early repair failures are still common, and re-tear rates ranging from 9% to 29% have been reported [5]. Although various studies report that the DR repair technique has several biomechanical advantages (footprint re-creation [7], wider contact area [8], superior resistance to gap formation under static loading [9], fixation strength [10], resistance to cyclic displacement [11] ) over SR, studies comparing functional outcomes and healing rates after SR and DR of RCTs published in the last decade have reported conflicting results [6]. Furthermore, in several meta- analyzes, variable conflicting clinical outcomes and re-tear rates have been reported in terms of suture repairing technique (SR vs DR) in partial and full-thickness RCT subgroups [12–14]. Therefore, the present study aimed to evaluate the effect of surgical technique on clinical and functional outcomes and retear rate in the repair of full-thickness RCTs. We hypothesized that a double-row aRCR would provide a better clinical and functional outcome and also lower re-tear rate in full-thickness RCTs.
Material and Methods
Between 2015 and 2019, we performed 186 aRCRs, of which, we retrospectively reviewed 115 aRCRs with a minimum 1-year follow-up. We included patients with total aRCRs who did not respond to conservative treatment and attended regular follow- ups. The exclusion criteria were as follows: non-attendance of regular follow-ups (25 patients), history of previous surgery on the affected shoulder (subacromial pathologies: 18 patients; trauma: 2 patients; glenohumeral pathologies: 8 patients), isolated subscapularis tendon tear (2 patients), or non-attendance of the postoperative rehabilitation program regularly (16 patients).
All surgical procedures were performed in the beach-chair position. For aRCRs, the SR (Figure 1 a-d) or DR (Figure 2 a-d) repair techniques were used. Repairs were performed using a suture anchor (Twinfix® or Footprint PK®, Smith & Nephew, London, UK). Subacromial decompression and release of the anterior aspect of the coracoacromial ligament were performed following aRCR.
Postoperative in-hospital analgesics included 50 mg of tramadol and 500 mg of acetaminophen three times a day. After discharge, the same drugs were prescribed with the order of one or two pills a day. An immobilizer was used postoperatively for six weeks. Pendulum exercises were started immediately at day 1 postoperatively. Pendulum exercises with active elbow, wrist, and hand exercises were allowed for the first six weeks. Passive range of motion (ROM) was allowed in weeks 6-8, active-assisted ROM between weeks 8 and 10, and active ROM between weeks 10 and 12. A strengthening program was started on the 12th week.
Patient characteristics and demographic data were recorded. Operative reports were evaluated and pre- and postoperative clinical and preoperative radiological examinations were performed. While preoperative magnetic resonance imaging (MRI) was used routinely, postoperative MRI was evaluated only in patients with ongoing or new-onset symptoms. Pre- and postoperative clinical and functional outcome scores were measured preoperatively and at the last follow-up visit using the Visual Analog Scale (VAS; ranging from 0 to 10; 0 = no pain, 10 = worst pain ever), the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) [15], the Constant-Murley-Score (CMS) [16] and range of motion (ROM) (abduction degrees). Patte classification was used to determine the retraction amount of the tear [17] . Postoperative rotator cuff re-tear was evaluated by physical examination (persistent pain, loss of strength) correlating with MRI (assessing the structural integrity of the repaired rotator cuff) [18]. Informed consent was obtained from all participants and the study was approved by the Local Ethics Committee.
Statistical Analysis
Mean, standard deviation, median, lowest, and highest values, and frequency ratio were used in descriptive statistics of the data. The Kolmogorov-Smirnov test was used to measure the distribution of the variables. For the analysis of independent quantitative data, the independent sample t-test and the Mann- Whitney U tests were used. The Wilcoxon test was used for the analysis of dependent quantitative data. The Chi-square test was used to analyze independent qualitative data, and Fischer’s exact test was used when the chi-square test requirements were not met. A p-value of < 0.05 was considered significant. All statistical analyses were performed using SPSS v22.0 for Windows (SPSS Inc., IL, USA).
Results
The mean age of the 115 patients was 58.6 ± 8.3 years. There were 83 right-sided and 32 left-sided tears. The mean follow- up duration was 25.3 ± 9.7 months (range: 12 to 52 months). No statistical difference was observed between pre- and postoperative patient characteristics and demographics of patients of the groups. Patient characteristics and demographic data of all patients and two groups are summarized in Table 1. The tear pattern, torn tendon, tear size (cm) and retraction amount were similar between groups, however, the number of anchors used in Group 2 was significantly higher than the Group 1 (p=0.001). Tear and surgical characteristics of all patients and two groups are summarized in Table 2.
Good to excellent outcomes with significant improvements in clinical and functional scores were obtained at the last follow- up. Pre- and postoperative VAS, ASES, CMS, and abduction degrees of ROM were significantly improved compared to the baseline (p < 0.001 for all). However, no statistical difference was observed in terms of clinical and functional outcomes between the groups (p>0.05 for all). In addition, there was no significant difference in failure rates between groups. The pre- and postoperative clinical outcome scores and failure rates of all patients and two groups are summarized in Table 3. Eight patients had re-tear and underwent revision surgery during the follow-up period. The mean re-tear time was 12.7 ± 5.1 months (range: 8 to 24 months; 12.0 ± 2.9 for group 1 vs 13.5 ± 5.7 for group 2, p=0.713). In the re-tear group, all the patients underwent revision aRCR. No patients developed a superficial or deep infection. No major complications were observed perioperatively or at the last follow-up.
Discussion
The most important finding of this study was that good and satisfactory outcomes can be obtained in aRCR of full thickness RCTs in the early postoperative period, regardless of the suture technique. Moreover, the repair technique (SR or DR) did not affect re-tear development in the early period after aRCR.
The most appropriate technique for aRCR is controversial. An ideal surgical technique involved in the repair of rotator cuff tears should have the potential to withstand physiological loads and at the same time provide healing and prevent re-rupture [19]. There are several surgical techniques described for the repair of RCTs including SR and DR suture anchor techniques, knotless anchors, transosseous tunnels [19]. These techniques, especially SR and DR repairs and their effectiveness were evaluated in various studies [3–11,18,19]. Different results have been reported with the efficiency of SR or DR repairs in aRCR repair, and even between partial and full thickness tears these methods have been reported to produce different results [12-14]. This difference in existing studies was thought to be due to the comparison of SR and DR repair techniques with different configurations in more heterogeneous patient groups [19]. There is also a recent study that suggests comparing the methods in which both are the most robust to show which method is the most effective, and that the current literature does not respond to this [20]. The present study evaluated the effectiveness of these two methods in a relatively homogeneous patient group in full-thickness RCT, and whether there was a difference between the techniques.
Several studies reported that the DR repair technique has several biomechanical advantages (footprint re-creation [7], wider contact area [8], superior resistance to gap formation under static loading [9], fixation strength [10], resistance to cyclic displacement [11] ) over SR. Zhang et al. [13] in their meta-analysis performing a subgroup analysis of RCT size, revealed that the DR technique increased postoperative cuff integrity and improved the clinical outcomes for full-thickness RCTs (>3cm). In line with this study, Xu et al. [21] reported significantly better clinical outcomes (ASES, UCLA scores) with the DR technique than SR for full-thickness tears (>3 cm). Although biomechanical advantages of DR repair techniques in favor of biological healing have been shown, a comparative study by Gerhardt et al. [22] reported similar results between the fixation methods 2 years after surgery. In concordance with this study, Perser et al. [23] revealed that the DR repair technique did not show a statistically significant improvement in clinical outcomes in the short-term. A long-term comparative study by Plachel et al. [5] stated that there was no difference in clinical outcomes between DR and SR repair. Findings in our study were in line with the latter studies with no significant difference between groups.
An important outcome measure that evaluates success after RCR is the re-tear rate. The relationship between clinical results and retears is controversial [6]. Overall, although there was a significant increase in retear rates with imaging after SR repair, this difference did not always correlate with lower outcome scores. Plachel et al. [5] stated that more re-tears occurred in the SR repair group (33% vs 55%). They observed that re-tear rates increased over time (27% occurred at a mean 2-year, while 45% occurred at a mean 12-year follow-up) and revealed that rotator cuff integrity deteriorated over time. In contrast, Heuberer et al. [24] reported that the majority of retears occurred in the short-term period. In contrast to the findings of Plachel et al.’s study, we found similar re-tear rates as eight patients (7%) (4 in Group 1; 4 in Group 2). The short follow-up time may be the reason for the similar and relatively low re-tear rates in both groups in our study.
There are several limitations to be mentioned. First, this study was retrospective in nature, although we used prospectively collected patients’ data without loss of follow-up to reach more accurate results. Secondly, a mean follow-up time of 2 years may not be sufficient to evaluate re-tear rates, long-term outcomes may differ, and more accurate results may be obtained. Thirdly, our study population was relatively small in number. Finally, since we did not have a postoperative MRG in all patients, asymptomatic re-tears may have been overlooked. Despite these limitations, conducting the study in a homogeneous patient population with similar patient characteristics and full-thickness tears was the strength of the present study. The results of the current study might be useful for showing that a SR technique can be as effective as DR technique on clinical results in the short term in full-thickness RCTs. Moreover, SR technique can also reduce the cost by reducing the number of anchors used and possible morbidity rates shortening the surgical time.
Conclusions
As a result, good and satisfactory clinical outcomes can be obtained using arthroscopic DR or SR repair techniques for full-thickness RCTs in the short -term. The present study suggests that the SR technique is at least as effective as the DR and cost-effective procedure in arthroscopic repair of full-thickness RCTs.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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4. McElvany MD, McGoldrick E, Gee AO, Neradilek MB, Matsen FA 3rd. Rotator cuff repair: published evidence on factors associated with repair integrity and clinical outcome. Am J Sports Med. 2015;43(2):491–500.
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6. Rossi LA, Rodeo SA, Chahla J, Ranalletta M. Current Concepts in Rotator Cuff Repair Techniques: Biomechanical, Functional, and Structural Outcomes. Orthop J Sport Med. 2019;7(9):2325967119868674.
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Fatih Doğar, Erdal Uzun. Comparison of single versus double-row techniques in arthroscopic rotator cuff repair of full-thickness tears. Ann Clin Anal Med 2021;12(4):422-427
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Comparison of intraocular pressure change in patients under sedation- assisted and sedation-free upper gastrointestinal endoscopy
Mehmet Kağan Katar 1, Murat Serkan Songur 2
1 Deparment of General Surgery, Yozgat Bozok University Faculty of Medicine, 2 Deparment of Ophthalmology, Yozgat Bozok University Faculty of Medicine, Yozgat, Turkey
DOI: 10.4328/ACAM.20476 Received: 2021-01-09 Accepted: 2021-02-08 Published Online: 2021-02-19 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):428-432
Corresponding Author: Mehmet Kağan Katar, Department of General Surgery, Yozgat Bozok University, Faculty of Medicine, Çapanoğlu Neighborhood, Cemil Çiçek Street, Yozgat, 66100, Turkey. E-mail: drkagankatar@gmail.com P: +90 532 383 68 03 F: +90 354 217 10 72 Corresponding Author ORCID ID: https://orcid.org/0000-0002-1599-5456
Aim: The study aimed to compare the intraocular pressure (IOP) in patients with upper gastrointestinal endoscopy (UGE) under sedation and without sedation. Material and Methods: This study was performed prospectively. Among patients with indications for upper gastrointestinal endoscopy, we included in the study fifty subjects who wanted the procedure to be performed without sedation and fifty subjects who wanted the procedure to be performed with sedation. All participants were aged between 18-60 years, with a body mass index (BMI) of less than 30 kg/m2 and did not have any systemic and ocular disease. Demo- graphic data of all patients were recorded. Systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were recorded before and during the procedure. IOP was measured 5 times in all patients.
Results: There was no significant difference between the two groups in terms of age, BMI, gender, IOP values prior to the procedure, IOP values 60 minutes after the procedure (p=0.066, p=0.057, p=0.230, p=0.593, p=0.749, respectively). It was found that the IOP values were significantly lower in the sedated group during, at 15 and 30 minutes after the procedure(p<0.001). While there was no statistically significant difference between the two groups in terms of SBP, DBP and HR values before the procedure (p=0.688, p=0.538, p=0.494, respectively), these values measured during the procedure were significantly higher in the non-sedated group (p<0.001).
Discussion: The increase of IOP can be prevented during the procedure by performing UGE with sedation. Complications related to acute IOP increase may be prevented by performing sedation-assisted UGE, especially in patients with glaucoma and those undergoing ocular surgery due to glaucoma and eye perfora- tion.
Keywords: Endoscopy; Glaucoma; Intraocular pressure; Propofol; Sedation
Introduction
Upper gastrointestinal endoscopy (UGE) is a powerful diagnostic tool because it provides direct mucosal imaging and is widely used in the treatment of many gastrointestinal diseases [1]. During UGE, full-time imaging of the oropharynx, pharynx, esophagus, stomach and proximal duodenum is provided with an esophagogastroduodenoscope (EGD). During the oropharynx and pharynx transition at the beginning of the procedure, the gag reflex, which is one of the normal reflexes, is produced by contraction of the pharyngeal muscles as a result of stimulation of the pharynx and velar region [2]. Although local lidocaine was administered to prevent this reflex during UGE, it was shown that the gag reflex occurred during the procedure [3]. Also, intraabdominal pressure increases abruptly with retching caused by the gag reflex [4]. In this case, the Valsalva reflex, which is defined as forced exhalation when the glottis is closed, may occur due to a sudden increase in intrathoracic and/or intraabdominal pressure [5]. The Valsalva reflex has been shown to cause an increase in intraocular pressure (IOP) [6].
On the other hand, previous studies have shown that laryngopharynx or epilarynx contact during direct laryngoscopy before endotracheal intubation leads to sympatho-adrenergic discharge [7,8]. As with laryngoscopy, the sympathetic discharge may occur due to the pressure of the EGD on the laryngopharynx area during UGE. Therefore, many hemodynamic changes may occur, including hypertension, tachycardia, and cardiac arrhythmia [9]. Moreover, the sympathetic-adrenergic discharge has been reported to cause a sudden increase in IOP, independent of hemodynamic changes [8].
An acute IOP increase may have negative effects in some patient groups and may cause various complications in healthy adults. For example, acute IOP elevation in adults without a history of the ocular disease has been reported to cause permanent visual field defects due to optic nerve damage [10,11]. Besides, orbital hematoma that occurs during UGE, and is thought to be caused by Valsalva reflex, has been reported as a complication of UGE [12]. Also, an acute IOP increase, especially in patients with a history of glaucoma and ocular surgery due to glaucoma, may have some negative results. For example, in a study performed by Tun et al., especially in open-angle glaucoma, it was shown that visual field loss occurred due to an acute elevation of IOP [13].
We anticipate that with sedation-assisted UGE, the pressure on the laryngopharynx area will be reduced and adrenergic discharge will be relatively low in these patients, with a reduction in the gag reflex and minimal retching, and consequently, there will be no increase in IOP.
Therefore, this study aimed to compare the IOP in patients with UGE under sedation and the IOP in patients without sedation.
Material and Methods
Ethics committee approval was obtained from the local Clinical Research Ethics Committee (approval no: 2017-KAEK- 189_2019.05.29_03). The study was conducted prospectively in accordance with the Declaration of Helsinki. Signed informed consent forms were obtained from all patients.
Before starting the study, the sample size was determined using power analysis.
Between June 2019 and September 2019, patients admitted to the general surgery outpatient clinic with various complaints and indicated for UGE, aged between 18 and 60 years, and whose body mass index (BMI) was below 30 kg/m2 , were included in the study. Patients with any systemic disease were excluded from the study. Then all patients underwent an ophthalmologic examination by an ophthalmologist. Patients with any ocular disease (such as glaucoma, vernal conjunctivitis, valve deformity) and any history of ocular surgery for any reason were excluded from the study. Then 50 people who wanted to perform UGE with sedation were included in the study as the sedated group, and 50 people who did not want to take sedation were included as the non-sedated group.
The sociodemographic characteristics of all patients were recorded.
Anesthesia Protocol
Sedation was performed without an anesthesiologist (accompanied by a physician experienced in intensive care and resuscitation and a trained nurse) to achieve an adequate level of sedation and ensure the continuity of sedation. Propofol (1 mg/kg) (propofol-lipuro %1 Braun, Istanbul, Turkey) was administered just before the procedure. Subsequently, if necessary, sedation was maintained with repeated doses of propofol (10–20 mg). During sedation, oxygen was given through a nasal cannula at 2 L/min.
UGE Protocol
All patients were taken to the endoscopy room and their heart rate (HR), blood pressure, oxygen saturation, and respiration rate were monitored. First, systolic blood pressure (SBP), diastolic blood pressure (DBP) and HR were recorded. In all patients, topical anesthesia was applied with 3 puffs of lidocaine (Xylocaine pump spray 10 %, AstraZeneca Inc., Turkey). Then all patients underwent the standard UGE procedure by the same physician with the same fiber optic EGD (Fujinon Fujifilm Corporation, Tokyo, Japan). In addition, blood pressure and HR were recorded during gastric mucosa examination of all patients during the procedure.
IOP Evaluation
The IOP measurement was performed by the same ophthalmologist with the I-Care Pro tonometer (Tiolat Oy, Helsinki, Finland), which works on the principle of rebound tonometry. The measurement was performed in the right eye of all patients and, a total of 5 times. The mean value was recorded from three consecutive measurements during each evaluation. The first measurement was taken 2 minutes before the initiation of UGE in the non-sedated group and before the propofol administration in the sedated group (T1). The second measurement was taken when examining the gastric mucosa, as it was filled with air (T2). The third measurement was taken 15 minutes after the end of the UGE process (T3). The fourth measurement was taken 30 minutes after the end of UGE (T4). The final, fifth, measurement was taken 60 minutes after the end of UGE (T5).
Statistical Analysis
SPSS 22.0 (Statistical Package for Social Sciences, IBM Inc., Chicago, IL, USA) was used for statistical analysis of the data. The Kolmogorov–Smirnov test was used to test the distribution of normality. The chi-square test was used to compare categorical variables. The Student’s t-test was used for the comparison of two groups for parametric data, and the Mann-Whitney U test was applied for nonparametric data. Comparisons of the changes in variables in the same group were performed using the Wilcoxon test for nonparametric data. The Pearson correlation test was used for correlation analysis of normally distributed data, and the Spearman correlation test was used for non-normally distributed data. A P-value of less than 0.05 was considered statistically significant.
Results
In our study, while the mean age in the non-sedated group was 41.10 ± 9.44 years, the mean age in the sedated group was 44.72 ± 10.02 years. There was no statistical difference between the groups in terms of average age (p = 0.066). Similarly, no significant difference was found between the groups in terms of BMI (p = 0.057). In addition, 21 (42%) patients in the non-sedated group were women, while 27 (54%) patients in the sedated group were women. However, this situation did not create a statistical difference (p = 0.230). The sociodemographic characteristics of the patients are shown in Table 1.
The mean propofol dose used in the sedation group was 82.40±13.78 mg.
There was no statistically significant difference between the IOP values at T1 and T5 in both groups. However, T2, T3, and T4 IOP values were significantly higher in the non-sedated group. The IOP measurement values are shown in Table 2. In addition, the mean values of the IOP measurements are shown in Figure 1. On the other hand, when T1 and T2, T3, and T4 values were compared in the non-sedated group, T2, T3, and T4 values were found to be significantly higher than T1 (p<0.001). However, there was no statistically significant difference between T1 and T5 values in the non-sedated group (p=0.151). In the sedation group, T2, T3, and T4 values were statistically significantly lower than T1 values (p<0.001). No statistically significant difference was found between T1 and T5 values in the sedated group (p=0.118).
Furthermore, no statistically significant difference was found between the two groups in terms of SBP, DBP and HR values recorded before the procedure. However, SBP, DBP and HR values measured during the procedure in the non-sedated group were found to be significantly higher than those measured in the sedated group. Data for SBP, DBP, and HR are shown in Table 2.
Additionally, SBP, DBP and HR values measured during the procedure in the non-sedated group were significantly higher than those measured before the procedure (p<0.001). However, in the sedated group, there was no significant difference between SBP, DBP and HR values measured during the procedure and pre-procedural values (p=0.069, p=0.139, p=0.092, respectively).
Also, our correlation analysis did not reveal any correlation between age and BMI and any of the measured values. Correlation data are shown in Table 3.
Discussion
In our study, it was found that the IOP was significantly increased during the procedure as compared to the pre- procedure in patients, who underwent UGE without sedation. Moreover, IOP was high even 30 minutes after the procedure, but regressed to pre-procedural levels by 60 minutes after the procedure. We think that one of the reasons for this increase in IOP during the procedure may be the retching that occurs during the pharynx transition. Intra-abdominal pressure may increase suddenly and the Valsalva reflex may occur [5]. In the literature, it has been shown that the Valsalva reflex causes an increase in IOP [14,15]. Additionally, it has been reported that an increase in intraabdominal pressure caused either by the gag reflex or intragastric air insufflation, independent of the Valsalva reflex, may lead to an increase in intracranial pressure [16,17]. A positive correlation has been shown between increased intracranial pressure and increased intraocular pressure [18]. We also believe that another reason for the high IOP in non- sedated UGE patients was that retching was intense due to the procedure being performed without sedation, and consequently, intensive pressure of the EGD on the laryngopharynx region. In the literature, it has been shown that sympatho- adrenergic discharge occurs as a result of compression to the laryngopharynx region [19]. Furthermore, sympatho-adrenergic discharge has been reported to cause a sudden increase in IOP [8]. The following situation in our study supports this information: in patients who underwent UGE without sedation, SBP, DBP, and HR were significantly higher during the procedure than before the procedure, and in the same group of patients, the IOP during the procedure was higher than before the procedure.
Regardless of the mechanism underlying the IOP increase during UGE, this increase may cause complications in some special patient groups (such as glaucoma) and may result in significant complications in adults without any ocular disease. For example, in a study conducted in a healthy adult, Valsalva retinopathy, which is thought to result from multiple and continuous retching during UGE, has been reported [5]. However, in the literature, we have not come across a study of acute glaucoma attack due to increased IOP after UGE. In order to elucidate this issue, we plan to investigate this issue in our next study. On the other hand, it has been shown in the literature that retinal and vitreous hemorrhage occurs as a result of strong and continuous retching for various reasons [20]. Also, transient IOP elevation after ocular surgery has been shown to cause glaucoma progression, particularly in patients with advanced glaucoma [21,22]. On the other hand, Ghai et al. reported that a sudden IOP increase in patients with a history of eye perforation may have negative consequences [23].
In our study, it was found that the IOP during, at15 and 30 minutes after the procedure was significantly lower in patients with UGE under sedation compared to those without sedation. In fact, in patients with UGE performed with sedation, the IOP during, at 15 and 30 minutes after the procedure was significantly lower than the IOP measured before the procedure. Moreover, although the IOP increased gradually after the procedure, it remained low compared to the pre-procedure, even after 15 and 30 minutes; however, it was found to reach the level before UGE by 60 minutes after the procedure. We propose that one of the causes of this condition is the use of propofol for sedation, because topical anesthesia using lidocaine combined with propofol sedation has been shown to reduce the retching reflex in UGE [24]. Thus, the intraabdominal pressure does not increase abruptly due to the absence of, or reduced, retching and, therefore, the Valsalva reflex does not occur. Consequently, there was no increase in the IOP during the process. In addition, propofol has been reported to reduce IOP regardless of changes in HR, SBP, and DBP [25]. In our study, in patients with UGE performed under sedation, it was observed that the IOP was low during and after the procedure compared to the pre-procedure, supporting findings presented in the literature. Also, in our study, it was found that there was no significant difference between pre-procedure and during the procedure values of SBP, DBP, and HR in patients with UGE under sedation. This is due to the fact that the retching reflex is lower when performing the procedure with sedation; therefore, we think that the EGD is relatively less compressive to the laryngopharynx region, and thus less sympatho-adrenergic discharge occurs. However, we would like to emphasize the need for further studies on sympatho-adrenergic discharge during UGE due to the limited number of studies in the literature. Furthermore, the fact that our study was conducted in a single center and with a relatively small number of patients can be considered a limiting factor. In addition, the fact that our study was not a randomized study is another limiting factor. However, according to our literature research, we have not come across a study that measured IOP during the UGE and, therefore, the work that we have carried out fills this gap in the literature. We also believe that our work will provide a basis for future work on this subject.
Conclusions
In conclusion, it should be noted that a sudden increase in IOP during UGE without sedation may lead to several complications in glaucoma patients, people with a history of eye perforation and ocular surgery due to glaucoma, as well as in healthy individuals. In these patients, the increase in IOP can be prevented by performing UGE accompanied by sedation using propofol. Therefore, we suggest that UGE should be performed with sedation using propofol in patients with a history of glaucoma, eye perforation and ocular surgery due to glaucoma.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Mehmet Kağan Katar, Murat Serkan Songur. Comparison of intraocular pressure change in patients under sedation-assisted and sedation-free upper gastrointestinal endoscopy. Ann Clin Anal Med 2021;12(4):428-432
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Key issues in tracheal injuries and complications
Mustafa Calik 1, Saniye Goknil Calik 2
1 Department of Thoracic Surgery, Health Sciences University, Konya Training and Research Hospital, 2 Emergency and First Aid Program, Vocational School of Health Services KTO Karatay University, Konya, Turkey
DOI: 10.4328/ACAM.20492 Received: 2021-01-18 Accepted: 2021-02-21 Published Online: 2021-02-23 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):433-437
Corresponding Author: Mustafa Calik, Department of Thoracic Surgery, Health Sciences University, Konya Training, and Research Hospital, Center Campus, Yeniyol street No:97, 42090, Meram, Konya, Turkey. E-mail: drmcalik@hotmail.com P: +90 332 323 67 09 / 1837 F: +90 332 323 67 23 Corresponding Author ORCID ID: https://orcid.org/0000-0001-9963-5724
Aim: In this study, we aimed to investigate the histopathological changes in tracheal epithelia after conventional tracheostomy in a rabbit model.
Material and Methods: Thirty-nine male New Zealand White rabbits were used for this study. They were randomly divided into five groups. Classic tracheostomy was carried out in 29 subjects. Group 1, which was created after any surgical procedure, served as a control group. After tracheostomy, we applied sterile saline in Group 2, Mitomycin-C (MMC) (0.8 mg/ml) in Group 3, MMC (0.4 mg/ml) in Group 4 and 5-Fluorouracil (5-FU) (10 mg/ml) in Group 5 around tracheotomy for 5 minutes.
Results: At three weeks after surgery, tracheas were evaluated by morphometric and histopathological examination, including tracheal lumen diameter, the number of capillary vessels, subepithelial tissue thickness, fibroblasts, and inflammatory cells. There were statistically significant differences between trache- ostomy and control group for tracheal lumen diameter (P=0.35), number of capillary vessels (P=0.06), subepithelial tissue thickness, fibroblasts and number of lymphocyte (p < 0.001). Histopathological analysis showed decreased fibrosis in both of the groups treated with MMC and 5-FU.
Discussion We believed that wound healing modulation may prevent scar formation, but requires further treatment. Herein, as we have shown in our study, fibroblasts are critical cells, but not one. MMC and 5-FU are medications that have been used for antiproliferative activity on fibroblasts.
Keywords: Tracheal epithelia; Mitomycin-C; 5-Fluorouracil
Introduction
However, tracheostomy is associated with a considerable morbidity, with reported complication rates of 8–45% [1,2]. Its complications range from intraoperative that can be rapidly life-threatening, to late or chronic postoperative, which may become apparent much later, such as tracheal stenosis (TS) and granulation [3]. Benign tracheal stenosis usually depends on prolonged endotracheal intubation (ETI) and tracheostomy. Clinically significant stenosis after prolonged intubation is very rare and occurs in approximately 1% of patients. They arise due to local ischemic necrosis of the tracheal wall due to defects in the new scar formation [4].
Mitomycin-C (MMC) is an antitumor antibiotic derived from Streptomyces caespitosus. It has an antineoplastic effect that causes breakage in the cross-linking of DNA like alkylating agents, at higher concentrations; it inhibits the protein and RNA synthesis. Similarly, 5-Fluorouracil (5-FU) is a pyrimidine analogue with antimetabolic activity due to blocking the enzyme thymidylate synthase, which converts ribonucleotides deoxyribonucleotides, thus inhibiting DNA synthesis. MMC and 5-FU are medications that have been used for antiproliferative activity on the fibroblasts [5].
We aimed to investigate the histopathological changes in tracheal epithelia caused by the application of topical MMC and 5-FU after the conventional tracheostomy in a rabbit model.
Material and Methods
Thirty-nine male New Zealand White rabbits, 24 weeks of age were used for this study. They were randomly divided into five groups. All animals received humane care and were used in compliance with the standards established by the European Convention for Animal Care and Use of Laboratory Animals. The rabbits were fed a standard pelleted diet, and tap water was provided ad libitum as drinking water. Animals were housed in conventional individual cages on a 12-hour light/dark cycle at room temperature in a humidity-controlled environment. This experiment was approved by the local animal care and the local ethics committee for animal experiments.
Groups
The subjects were divided into five groups: control containing ten and tracheostomy eight rabbits. Group 1, which was created after any surgical procedure, served as a control for tracheal measurements. After tracheostomy, we applied sterile saline in Group 2, MMC (0.8 mg/ml) (Mitomycin- C Kyowa 10 mg /flk, Kyowa Hakko Kogyo Ltd. Tokyo, Japan) in Group 3, MMC (0.4 mg/ml) in Group 4 and 5-FU (10 mg/ml) (5-fluorouracil 1000 mg/20 ml flk, Sandoz Pharmaceutical Company, Istanbul, Turkey) in Group 5 around tracheotomy for 5 minutes. Anesthesia
Ketamine HCl induced general anesthesia (Ketanest, Pfizer Pharma GmbH, Karlsruhe, Germany) 15-20 mg/kg i.v. or 20-25 mg/kg i.m. in addition was maintained by Xylazine (Alfazyne 2%; Alfasan International. BV, Woerden, Holland) 0.5-1 mg/ kg i.v. or 1-2 mg/kg i.m. Previous doses were repeated with a reflex response to Ketamine HCl and Xylazine for the depth of anesthesia as needed.
Operation technique
Under general anesthesia, all subjects were placed in a supine position on the operating table with spontaneously breathing. Traditional tracheostomy was performed in 32 subjects. Group 1, which any surgical procedure was made, served as a control for tracheal measurements. After tracheostomy, all subjects immediately received the research medication applications with cottoned pledget topically to the tracheotomy site around the tube. We applied sterile saline in Group 2, MMC (0.8 mg/ml) in Group 3, MMC (0.4 mg/ml) in Group 4 and 5-FU (10 mg/ml) in Group 5 around tracheotomy for 5 minutes.
Postoperative Care and Follow-Up
Tradomol HCl (Contramal, 100 mg 2 ml, Abdi Ibrahim Ltd., Istanbul, Turkey) 2 mg/kg/day i.m. from the first to the fifth day was used for pain control. The animals were followed-up for about three weeks after surgery. All animals were euthanized with a lethal IV dose of non-barbiturate anesthetic (Ketamine/ Xylazine) painlessly according to the existing instructions established by the latest AVMA Panel report on Euthanasia [6]. Pathological Evaluation
All materials were fixed in 10% of buffered paraformaldehyde for 48 hours. Tissue specimens were prepared in an automatic tissue processor (Leica ASP300 S-Tissue Processing), embedded in paraffin and sectioned with a microtome (Leica RM 2025 microtome). The sections (5μm) were stained in an automated slide processing system (VENTANA BenchMark XT Automated Slide Processing System) with Hematoxylin and Eosin and Masson’s trichrome. A Nikon Eclipse E400 light microscope (Nikon Corporation. Minatoku, Tokyo Japan) investigated the stained specimens at the 20-fold magnified area in tissue samples. For each sample, the same area was photographed after staining with a Nikon Coolpix 5000 camera (Nikon Corporation. Minatoku, Tokyo Japan) attached to a microscope. In the pathological evaluation, depending on the magnification used, the photograph of Nikon micrometer microscope slide (MBM11100, Nikon Corporation. Minatoku, Tokyo Japan) was also taken for calibration. All images were then transferred into a PC environment and analyzed using the Clemex Vision Lite 3.5 Image Analysis program. The length was calibrated by comparing the specimen’s photograph with a Nikon micrometre’s photo microscope slide, which was taken under the same magnification. Areas of 0,25 square millimeters were designated using Clemex Vision Lite 3.5 (Clemex Technologies inc. Longueuil, Quebec Canada) Image Analysis program. Fibroblasts, capillary vessel, and lymphocytes were labelled and counted with the same Image Analysis program in an area of 0,25 square millimeters. The damaged cells were excluded from the study. Marked cells were counted with the same computerized Image Analysis Program without human intervention. Tracheal lumen diameter (Figure 1A) and subepithelial tissue thickness (Figure 1B) were also measured with the same Image Analysis program. The pathologist evaluated the sample blindly to its origin.
Statistical analysis
Results were analyzed using the SPSS 18.0 portable for Windows (SPSS Inc, Chicago, Illinois, USA). Data noted in the third week were expressed as median and interquartile range (25%-75% quartiles). The Kruskal-Wallis test analyzed the comparison between groups. The Mann– Whitney U-test was used to compare the significance between the control and
MMC / 5-FU groups. A p-value <0.05 was used to indicate a significant difference.
Results
Only three animals were excluded from the study due to necrosis. Regardless of the cause of death, dead animals are replaced with new ones. Thirty-nine subjects were included in our experiment also lived up to the end of three weeks. There was no skin reaction, wound infection, or bleeding around the surgical site in the perioperative period. No local complications were encountered connected with MMC or 5-FU.
A statistically significant difference (p<0.035) was found between groups of Tracheal Lumen Diameter (TLD). In the control group, Group 1, TLD was 3198.8 (3027.3-3926.9), the maximum TLD loss of 2530.3 (1415.3-2897.5) was detected in Group 2 with a sterile saline group, 2616.4 (2338.1-2832.5) in Group 4 underwent 0.4 mg/ml MMC, the closest values to Group 2 were obtained. In 0.8 mg/ml MMC Group 3 and 10 mg/ ml 5-FU group 5, 3243.3 (2148.6-3771.9) and 3190.9 (2216.7- 3767.7) were found, respectively (Figure 2A). High-doses of MMC and 5-FU were close to each other, but the best result was in Group 5.
There was a statistically significant difference (p<0.006) in subepithelial tissue thickness (STT) between the groups. In the control group, STT was 168.3 (94.3-281.1). The highest increase in STT was in Group 2: 516.1 (327.3-741.1) followed by Group 4: 433.8 (381.3-493.4), Group 5: 428.7 (243.2-635) and Group 3: 298.9 (243.9366), respectively. According to the control group, Group2, 3, 4, and five increased threefold by1.7 times, 2.57 times, and 2.54 times, respectively (Figure 2B).
A statistically significant difference (p<0.001) was found in inflammatory cells (IC) between groups. Ten (6.5-16) ICs were detected in the control group. The highest increase in IC was in Group 2, 229.5 (48.5-454), followed by Group 4, 54.5 (35.5- 73.5), Group 3, 34 (30.5-39) and Group 5, 22 (18-32) cells (Figure 3A). According to the control group, in groups 2, 3, 4, and 5, it increased 23-fold, 3.4-fold, 5.4-fold, and 2.2-fold, respectively. A statistically significant difference (p<0.001) was found in Capillary Vessels (CV) between the groups. In the control group, 4 (2-6) CVs were detected. The highest increase in CV was in Group 2, 19 (15-29.5), followed by Group 4, 15.5 (9-37.5), Group 3, 8 (6-9) and Group 5, 6 (4-10) capillary vessels (Figure 3B). According to the control group, groups 2, 3, 4, and 5, it increased five times, twice, 3.9 times and 1.5 times, respectively.
A statistically significant difference (p<0.001) was found in fibroblasts between the groups. In the control group, 5 (3,5-8) fibroblasts were detected. The highest increase in fibroblasts was in Group 2, 30.5 (21-36), followed by Group 4, 19 (13.5- 28.2), Group 5, 12 (12-16) and Group 3, 10 (8.5-14) fibroblasts (Figure 3C). According to the control group, groups 2, 3, 4, and 5, it increased six-fold, two-fold, 3.8- fold, and 2.4- fold, respectively.
5-FU is more effective than MMC in TLD, IC, and CV. MMC was only 0.84 fold more evident on STT and 0.4 times less effective on Fibroblasts.
Discussion
TS is a significant decrease in the tracheal lumen that can be potentially life-threatening and avoided at large. A cascade of pathological events started with pressure and/or excessive irritation ulceration and subsequent healing, starting with granulation, progressing to cicatrization and scar contraction [6]. They ordinarily occur at the tracheostomy or ETI tube cuff site and less commonly at the end of the cannula.
Although ETI has serious complications, it has been ignored because of its life-saving feature. In the literature, these complications are considered in studies with less than one hand fingers. Unfortunately, tissue damage and granulation can occur even within hours. Esteller et al. showed laryngotracheal injury in 11%, and Vallés et al. in 8.1% of the patients who underwent ETI [7]. In the same study by Esteller et al., severe TS was found as 3.1%, and when lower TSs were added, it was perceived as 4.6%. In another study, it was reported that TS was about 6-21%. With increasing intubation, tracheostomy, indications and possibilities of mechanical ventilation, prolonged survival and the increased number of days spent in ICUs led to an increase in TS incidence. In the United Kingdom, 30.000 patients undergo mechanical ventilation, and 500.000 in the United States annually. This means 1.380 new patients in the UK and 23.000 in the USA [8]. The incidence may even differ between countries and even between regions in the same country.
Thankfully, clinically significant TS develops in about 1% of patients after tracheostomy or ETI [9]. Several treatments have been used for its treatment; current modalities tend to fail due to the new scar formation and restenosis through either the persistence of the chronic inflammatory process that caused the initial stenosis or the surgical intervention [5]. In the literature, because of the effect of topical MMC and 5-FU on fibroblast proliferation in TS, many in vitro and in vivo studies are available. However, Wang et al. have not recommended for use, since they increase anastomosis complications after 263-disease current severe resection [10]. In another study, Gangar et al. have been using it for 16 years for the same purpose, but it has not proven useful. As a result, the utility remains hypothetical, and its future role is unclear [11].
Wang et al. evaluated 263 patients with idiopathic subglottic stenosis (ISS) and found that 47% of antinuclear antibodies were positive. Tracheal and endoscopic procedures have been applied to 92% of cases before. In 97% of the cases, tracheal membranous wall flap resection and tailored cricoplasty were performed. In 23 patients (8.7%), 14 of whom were mild and nine were persistent, recurrences requiring dilatation were detected. Steroids, mitomycin C use, and previous tracheostomy, stents and vocal cord involvement have been found as anastomotic complications and risk factors for recurrence. In the study published in 1993, the first phase of which lasted for 42 years, the average diagnosis was 36 months, and the duration until surgical treatment was 24 months; 42% of the patients were treated with asthma misdiagnosis. After 1998, there has been an increase together with decreases in some periods. MMC was administered to 27 patients (11.4%) in the form of endobronchial injection without specifying the dose and duration of administration, and the steroid was administrated to 12 patients (5%). The results that we extracted from this study are that surgery is the best treatment method for the selected patients at the right time and that MMC has been administered to only 27 patients in 40 years, and that they can lead to anastomotic complications with steroids parallel to the literature [10].
Gangar et al. studied pediatric airway diseases, and in a randomized, double-blind, placebo-controlled study, they applied 0.4 mg/ml MMC for 2 minutes to 24 patients with grade 3 or 4 stenosis and underwent laryngotracheal reconstruction or cricotracheal resection. It was terminated upon its invalidity [12]. In a similar study, 0.5 mg/ml topical MMC was administered to 26 patients single and twice; the twice application was found to be more beneficial. However, this benefit was only 3.8 years for dual applications and 2.4 years for unique applications, not five years. Also, Hseu et al. reported that 66 of 92 adults showed no benefit in using MMC, and indeed, MMC receivers showed a second procedural requirement. However, the authors attribute this to their use in more severe and difficult situations [12, 13]. As previously demonstrated in our current study [5], when MMC was used at low doses such as 2 minutes and 0.4- 0.5 mg/ml, no benefit could be detected. In Group 4, where 0.4 mg/ml MMC was used, only fibroblast and IC were reduced compared to Group 1, which underwent tracheostomy; despite a relative decrease in TLD, STT and CV, similar values were obtained. There is a statistically significant difference with the control group.
There is no consensus on the treatment dose of MMC. The majority of human studies use a topical dose of 2-10 mg/ ml due to ophthalmological experience, and 0.1-0.4 mg/ml in animal studies. However, we agree that humans can safely use and heal in a wider field on less sensitive tissues, repeated doses at higher concentrations [12]. In vitro proliferation of MMC in human fibroblasts at 1.6 mg/ml and increased level showed inhibition. This effect of MMC increases with dose, and in an animal model, in vivo cultures and airway, it is limited to 3 weeks and four weeks in the skin [14].
To prevent the formation of scar tissue, MMC and 5-FU were used in our experiment. According to the literature, there were statistically significant differences between tracheostomy and control group for TLD (P=0.35), CV (P=0.06), STT, fibroblasts, and lymphocyte count (p < 0.001).
In conclusıon, they are currently successfully used as adjunctive therapeutic agents to prevent excessive scarring in various surgical fields, including ophthalmology, otorhinolaryngology, and urology. The works showing the usefulness are presented in retrospective and case presentations. A low-dose and a small number of patients have been used in very few prospective studies. Therefore, their effects have not been shown. We think it is too optimistic to believe that it will be prevented with a single medication dose. We still believe that wound healing modulation may prevent scar formation and need further treatment. Herein, as we have shown in our study, fibroblasts are critical cells, but not one. MMC and 5-FU are medications that have been used for antiproliferative activity on the fibroblasts.
Acknowledgment
We are grateful to the pathologist, Prof. Mustafa Cihat Avunduk M.D. from the Department of Pathology, for her contribution and assistance in evaluating statistical and pathological analysis.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
References
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Management of COVID-19 in 55 hemodialysis patients: Experience from Eastern Turkey
Can Sevinc 1, Ozge Timur 2, Mustafa Utlu 2, Erdem Cankaya 1
1 Department of Nephrology, Ataturk University Faculty of Medicine, 2 Department of Internal Medicine, Regional Training and Research Hospital, Erzurum, Turkey
DOI: 10.4328/ACAM.20508 Received: 2021-01-28 Accepted: 2021-02-26 Published Online: 2021-03-01 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):438-442
Corresponding Author: Can Sevinc, Ataturk University Faculty of Medicine, Department of Nephrology, Yakutiye, Erzurum, Turkey. E-mail: can.sevinc@atauni.edu.tr P: +90 442 344 6666 F: +90 442 236 1014 Corresponding Author ORCID ID: https://orcid.org/0000-0002-4069-9181
Aim: The novel coronavirus causes acute severe respiratory syndrome (SARS COV 2), and the disease is named COVID-19. The virus spreads easily, and CO- VID-19 may be asymptomatic or cause severe pneumonia and ARDS. Hemodialysis patients are affected by COVID-19 because of the immunosuppression caused by uremia, comorbid diseases and the risk of cross-contamination during dialysis. In this study, we aimed to examine the clinical features and outcomes of 55 hemodialysis patients diagnosed with COVID-19.
Material and Methods: Fifty-five hemodialysis patients who met the COVID-19 probable case definition were included in the study. Clinical and laboratory features were recorded from patient files and electronic data retrospectively.
Results: The study included 55 patients, the average age was 59.6 ± 13.2 years, 49% (n = 27) were female. Hypertension, Diabetes Mellitus, coronary heart diseases were the most common comorbid diseases. Comparing survivors and non-survivors, it was seen that the non-survivors were older (p=0.010). Logistic regression analyses revealed that age, SO2, lactate, WBC, neutrophil count, CRP, LDH, CK, ALT, AST, albumin, total protein, ferritin and D-Dimer were associ- ated with the risk of mortality
Discussion: Myalgia, cough, and shortness of breath are the most common symptoms of COVID-19 infection in HD patients, with no apparent fever. Age, SO2, WBC count, neutrophil count, CRP, LDH, CK, ALT, AST, albumin, total protein, ferritin and D-Dimer were found to be associated with mortality. Close monitoring of these parameters during the follow-up and treatment of patients may provide additional benefits in terms of survival.
Keywords: COVID 19; Hemodialysis; Mortality
Introduction
A new type of coronavirus that emerged in Wuhan, People’s Republic of China in December 2019 causes acute severe respiratory syndrome (SARS COV 2), and the disease is named COVID-19 (Corona Virus Disease 19) [1]. The virus spread all over the world in a short time and was declared a pandemic by the World Health Organization on March 11, 2020. The first case of the disease in our country was reported on March 10, 2020. The pandemic has put a heavy burden on health systems and country economies, as there is no effective treatment and vaccine available yet.
The virus is transmitted from person to person by airborne droplets and by direct contact, and the incubation period varies between 2-14 days (average 5 days). Respiratory symptoms such as fever, cough and shortness of breath are common symptoms of the disease COVID-19 may be asymptomatic or cause severe pneumonia and acute respiratory distress syndrome (ARDS). Although some comorbid conditions have been identified, such as old age and chronic disease, the course of the disease and what clinical symptoms may occur in which patient is not yet known.
Immune dysfunction caused by chronic uremia is present in patients with end-stage renal disease (ESRD) who are on hemodialysis (HD); therefore, these patients are more likely to have infections. In addition, comorbid conditions such as diabetes, cardiovascular disease and hypertension are more common in hemodialysis patients. These patients who are generally older, regularly visit the hospital or dialysis center and stay in the same indoor environment with other patients and staff for 3-4 hours each session, which increases cross- contamination [2]. There are studies examining the course of the disease, the response to available treatments, and mortality in hemodialysis patients, but the disease is still full of uncertainties [3, 4]. Therefore, in this study, we aimed to examine the clinical features and outcomes of 55 hemodialysis patients diagnosed with COVID-19.
Material and Methods
Fifty-five hemodialysis patients who met the COVID-19 probable case definition were included in the study. All patients were treated at the pandemic hospital in our region between March 22 and September 1, 2020.
Our study was designed as a retrospective cross-sectional study. The demographic characteristics (such as age, gender) of the patients included in the study, chronic diseases, complaints during hospitalization, pH, oxygen saturation (SO2), lactate, bicarbonate (HCO3), white blood cell count (WBC), neutrophil count, lymphocyte count, platelet count (109/L), hemoglobin (g/dL), alanine aminotransferase (ALT) (U / L), aspartate aminotransferase (AST) (U/L), Total Bilirubin (mg / dL), Lactate Dehirohenesis (LDH) (U / L), Creatinine Kinase CK (U / L), Blood Urea Nitrogen (BUN) (mg / dL), Creatinine (mg / dL), Albumin (mg / dL), D-dimer (ng / mL), Biomarker values such as ferritin (ng / mL), C-reactive protein (CRP) (mg / L) and Procalcitonin (PCT (ng/mL), whether there was admission to the ICU during follow-up, the treatments given, survival were recorded from patient files and electronic data retrospectively. CT images and reports of the patients were accessed from the hospital’s information system. The study was conducted with the necessary permissions from the Erzurum Regional Training and Research Hospital Ethics Committee and the Turkish Ministry of Health.
Statistical analysis
All procedures were performed using IBM SPSS Statistics 22.0 software. The results are presented as mean ± standard deviation (SD). Pearson’s chi-square and Fisher’s exact test were used for categorical variables where appropriate. After checking the normality distribution of scale variables using the Shapiro–Wilk test, independent samples were compared with appropriate significance tests (e.g., the Mann–Whitney U test, Kruskal–Wallis H test). When comparing more than two independent variables, the Bonferroni correction was applied post-hoc (Mann–Whitney U test and z-test) after the Kruskal- Wallis H test and Pearson’s chi-square test. We also performed a univariate logistic regression for mortality (dependent), establishing predicting factors such as age, various laboratory parameters (independent variables), and their odds ratios (OR). Two-sided p-values of < 0.05 were considered statistically significant.
Results
Fifty-five hemodialysis patients diagnosed with COVID-19 were included in our study. The average age of the patients was 59.6 ± 13.2 (min: 31, max: 87) years, 49% (n = 27) were females, 51% (n = 28) were males, and dialysis duration was 59.9 ± 41.1 (2-237) months. The most common complaint of the patients was myalgia with 70.9%. This was followed by cough with 67.3%, shortness of breath with 58.2% and fever with 40%. The most common comorbid diseases in patients were hypertension (96.4%), diabetes mellitus (74.5%), coronary artery disease (47.3%) and heart failure (20%). While findings of COVID- 19 were detected on CT in 44 patients, CT was normal in 7 patients. CT could not be performed in 4 patients due to technical reasons; 87.2% of the patients received favipravir, 32.7% hydroxychloroquine, 76.4% low molecular weight heparin (LMWH), and 52.7% corticosteroid treatment. Immune plasma was given to 2 patients and tocilizumab treatment was administered to 2 patients. While 14 (25.5%) patients needed intensive care during follow-up, 12 (21.8%) patients died. Comparing patients with and without intensive care need, it was observed that the mean age of the patients followed up in the intensive care unit was higher, all patients developed covid pneumonia on tomography, and the mortality rate was higher (p = 0.001, p = 0.032, p = 0.000, respectively). In addition, while the oxygen saturation and serum albumin levels of the patients followed up in the intensive care unit were statistically significantly lower, WBC, neutrophil, CRP, procalcitonin, LDH, AST, ferritin, D-Dimer, INR values were higher (p = 0.006, p = 0.010, p = 0.000 p = 0.000, p = 0.001, p = 0.009, p = 0.004 p = 0.029, p = 0.021, p = 0.023, p = 0.003, respectively.), shortness of breath and myalgia symptoms were found to be more frequent. (p = 0.002, p = 0.022). The data are shown in Table 1. Comparing survivors and non-survivors, it was seen that the non-survivors were older (p = 0.010). Coronary heart disease was the most common chronic disease among non-survivors (p = 0.025). The symptom that was statistically significant in the non-survivor group was shortness of breath (p = 0.001). The lactate, WBC, neutrophil, MPV, CRP, procalcitonin, LDH, CK, ALT, AST, ferritin, D-Dimer, INR values of the non-survivors were found to be statistically significantly higher (p = 0.00, p <0.001, p <0.001, p = 0.002, p = 0.007, p = 0.001, p = 0.001, p = 0.008, p = 0.029, p <0.001, p = 0.016, p = 0.003, p = 0.041, respectively). Oxygen saturation and albumin levels of these patients were found to be statistically significantly lower (p <0.001, p = 0.007). These data are given in Table 2.
Logistic regression analyses were performed to identify the association of various factors with p-values < 0.05, such as age, SO2, lactate, WBC, neutrophil count, CRP, LDH, CK, ALT, AST, albumin, total protein, ferritin and D-Dimer with the risk of mortality. The odds ratios and significance levels of univariate analyses are shown in Table 3.
Discussion
Infection risk is increased in chronic kidney disease (CKD), and infections are the second leading cause of death after cardiovascular disease. The increased risk of infection is more marked, especially in hemodialysis patients. COVID-19 infection, which started in China in December 2019 and turned into a pandemic in a short time, affects older individuals with serious chronic diseases (such as cardiovascular disease, diabetes, chronic kidney disease, chronic lung diseases, chronic liver disease, cancer) more [5]. Hemodialysis patients have a high risk of COVID-19 infection due to both CKD itself and their existing comorbidities [6]. Therefore, studies are needed to demonstrate the clinical characteristics and outcomes of COVID-19 infection in HD patients. Our study, which examined 55 HD patients with COVID- 19 infection , is one of the studies with the largest number of patients in the literature.
The average age of 55 patients included in the study was 59.6 ± 13.2 (min: 31, max: 87) years, 49% (n = 27) were females, 51% (n = 28) were males. The fact that the number of female and male patients is similar differs from the fact that the number of male and female patients is more dominant in the general population [7]. The reason why COVID-19 infection is less common in women is thought to be a positive effect of the X chromosome and sex hormones on the natural and acquired immune system [8]. However, changes in sex hormones in women with end-stage renal disease may cause significant differences compared with the general population [9]. We think that the lack of gender difference in our patient group is due to the negative effect of chronic uremia on the immune system in HD patients.
The most common symptoms in COVID-19 infection are fever, myalgia, cough and shortness of breath [10, 11]. While gastrointestinal symptoms were common in a study of HD patients, a small number of patients in our group had gastrointestinal symptoms such as diarrhea, nausea and vomiting [12]. In our study, the most common symptoms were myalgia, cough, and shortness of breath. Unlike studie conducted in the general population, fever is not a common symptom in our patient group. In our study, the most common comorbid diseases in HD patients are HT, CHD and DM. This finding is consistent with studies in HD patients and the general population [13, 14].
PCR was found to be positive in 48 of 55 patients included in the study and COVID pneumonia was observed in 86% of 51 patients who underwent CT. There was no clinically significant difference in the comparison of PCR positive and negative patients. INR value and the need for ICU were significantly higher in patients with lung involvement. Pulmonary involvement was observed more frequently in patients with 3 or more comorbid diseases. Both PCR and CT positivity did not make a significant difference in terms of mortality. Among the patients, 21.8% were followed at home, and 25.5% needed an ICU. It was found that the mean age and mortality rates of the patients who needed ICU were significantly higher, and all patients had pulmonary involvement. The albumin levels and oxygen saturations of the patients who needed ICU were lower. WBC, CRP, procalcitonin, LDH, AST, ferritin, D-Dimer and INR levels were found to be significantly higher. Studies have also found that age and D-Dimer levels are higher in patients who need ICU [15, 16].
Since HD patients have comorbid diseases and are more susceptible to infection, mortality from COVID-19 infection is considerably higher than in the general population [17]. Similarly, in our study, 21.9% of our patients died due to COVID- 19 infection and related complications. Those with severe COVID-19 infection have been shown to have lower leukocyte, platelet, lymphocyte count and higher D-dimer, total bilirubin, troponin, LDH, AST, creatinine, PCT, ferritin and CRP levels than those without COVID-19 [18, 19]. In studies conducted with HD patients, the situation is a little more complicated. In the studies performed, generally, no significant relationship was found between leukocyte, neutrophil and lymphocyte counts and mortality [3, 4]. In our study, it was found that the WBC and neutrophil counts at the time of admission were significantly higher in non-survivors. In the regression analysis, both WBC and neutrophil count were found to be associated with mortality. Inflammation and inflammatory storm during viral infections cause systemic inflammatory damage. Some markers such as CRP, PCT, D-Dimer, ferritin and INR are frequently used in clinical practice as indicators of this inflammation. Although CRP is widely used in HD patients, the use of PCT is still controversial. Studies have emphasized that the PCT level is associated with the CKD stage and that the serum range for PCT should be a little wider in HD patients [20, 21]. In our study, CRP, PCT, INR, ferritin and D-Dimer levels were found to be significantly higher in both patients who died and those who needed ICU follow-up. Another remarkable point of our study is that this increase in CRP, ferritin and D-dimer levels was associated with mortality. In our patient group, whose albumin value, which is used in daily practice as a negative acute phase reactant, was found to be significantly lower, it was found to be associated with mortality. Muscle damage and myalgia, which often occur with viral infection, are directly related to the damage of muscle fibers by direct virus effect and, more likely, by myotoxic cytokines that occur in virus infections, especially tumor necrosis factor (TNF). This situation causes an increase in the serum levels of intracellular enzymes such as CK and AST. High CK levels has been associated with a poor prognosis in some viral infections [22-24]. While there was no significant difference in CK, AST, LDH and ALT in COVID-19 studies conducted in HD patients, in our study, these four parameters were found to be significantly higher among non-survivors [3, 17]. In addition, these four parameters were associated with mortality.
As a result, while myalgia, cough and shortness of breath are the most common symptoms of COVID-19 infection in HD patients, the presence of fever is not evident. Age, SO2, WBC count, neutrophil count, CRP, LDH, CK, ALT, AST, albumin, total protein, ferritin and D-Dimer were found to be associated with mortality. Close monitoring of these parameters during the follow-up and treatment of patients may provide additional benefits in terms of survival. Our study enriches what we know about COVID-19 infection in HD patients by supporting the literature and with different points from the literature.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
References
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2. Ikizler TA. COVID-19 and dialysis units: what do we know now and what should we do? Am J Kidney Dis. 2020; 76(1):1-3.
3. Zou R, Chen F, Chen D, Xu CL, Xiong F. Clinical characteristics and outcome of hemodialysis patients with COVID-19: a large cohort study in a single Chinese center. Ren Fail. 2020; 42(1):950-7.
4. Zhang J, Cao F, Wu SK, Xiang-Heng L, Li W, Li GS, Wang J. Clinical characteristics of 31 hemodialysis patients with 2019 novel coronavirus: a retrospective study. Ren Fail. 2020; 42(1):726-32.
5. Zheng Z, Peng F, Xu B, Zhao J, Liu H, Peng J, et al. Risk factors of critical & mortal COVID-19 cases: A systematic literature review and meta-analysis. J Infect. 2020; 81(2):e16-e25.
6. Henry BM, Lippi G. Chronic kidney disease is associated with severe coronavirus disease 2019 (COVID-19) infection. Int Urol Nephrol. 2020; 52(6):1193-4.
7. Zhang G, Hu C, Luo L, Fang F, Chen Y, Li J, et al. Clinical features and short- term outcomes of 221 patients with COVID-19 in Wuhan, China. J Clin Virol. 2020; 127:104364.
8. Channappanavar R, Fett C, Mack M, Ten Eyck PP, Meyerholz DK, Perlman S. Sex-Based Differences in Susceptibility to Severe Acute Respiratory Syndrome Coronavirus Infection. J Immunol. 2017; 198(10):4046-53.
9. Ahmed SB, Ramesh S. Sex hormones in women with kidney disease. Nephrol Dial Transplant. 2016; 31(11):1787-95.
10. Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, et al. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020; 382(18):1708-20. 11. Wei Y, Lu Y, Xia L, Yuan X, Li G, Li X, et al. Analysis of 2019 novel coronavirus infection and clinical characteristics of outpatients: An epidemiological study from a fever clinic in Wuhan, China. J Med Virol. 2020;92(11): 2758-67.
12. Ferrey AJ, Choi G, Hanna RM, Chang Y, Tantisattamo E, Ivaturi K, et al., A Case of Novel Coronavirus Disease 19 in a Chronic Hemodialysis Patient Presenting with Gastroenteritis and Developing Severe Pulmonary Disease. Am J Nephrol. 2020; 51(5):337-42.
13. Zuin M, Rigatelli G, Zuliani G, Rigatelli A, Mazza A, Roncon L, et al. Arterial hypertension and risk of death in patients with COVID-19 infection: Systematic review and meta-analysis. J Infect. 2020; 81(1):e84-e6.
14. Trujillo H, Caravaca-Fontán F, Sevillano Á, Gutiérrez E, Caro J, Gutiérrez E, et al. SARS-CoV-2 infection in hospitalized patients with kidney disease. Kidney Int Rep. 2020; 5(6):905-9.
15. Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, et al. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020; 323(11):1061-9.
16. Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020; 395(10229):1054-62.
17. Pio-Abreu A, do Nascimento MM, Vieira MA, de Menezes Neves PDM, Lugon JR, Sesso R. High mortality of CKD patients on hemodialysis with Covid-19 in Brazil. Journal of Nephrology. 2020; 33(5):875-7.
18. Xie J, Tong Z, Guan X, Du B, Qiu H. Clinical characteristics of patients who died of coronavirus disease 2019 in China. JAMA Netw Open. 2020; 3(4). DOI:10.1001/ jamanetworkopen.2020.5619
19. Lippi G, Plebani M, Henry BM. Thrombocytopenia is associated with severe coronavirus disease 2019 (COVID-19) infections: A meta-analysis. Clin Chim Acta. 2020; 506:145-8.
20. Sun Y, Jiang L, Shao X. Predictive value of procalcitonin for diagnosis of infections in patients with chronic kidney disease: a comparison with traditional inflammatory markers C-reactive protein, white blood cell count, and neutrophil percentage. Int Urol Nephrol. 2017; 49(12):2205-16.
21. Wu SC, Liang CX, Zhang YL, Hu WP. Elevated serum procalcitonin level in patients with chronic kidney disease without infection: A case-control study. J Clin Lab Anal. 2020; 34(2). DOI: 10.1002/jcla.23065
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24. Borgatta B, Pérez M, Rello J, Vidaur L, Lorente L, Socías L, et al. Elevation of creatine kinase is associated with worse outcomes in 2009 pH1N1 influenza A infection. Intensive Care Med. 2012; 38(7):1152-61.
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Can Sevinc, Ozge Timur, Mustafa Utlu, Erdem Cankaya. Management of COVID-19 in 55 hemodialysis patients: Experience from Eastern Turkey. Ann Clin Anal Med 2021;12(4):438-442
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Effects of orthopedic instruments breakage during surgery: A minimum five-year follow-up
Bahtiyar Haberal 1, Salih Beyaz 2
1 Department of Orthopaedic and Traumatology, Faculty of Medicine, Baskent University, Ankara, 2 Department of Orthopaedic and Traumatology, Faculty of Medicine, Baskent University, Adana, Turkey
DOI: 10.4328/ACAM.20531 Received: 2021-02-08 Accepted: 2021-03-12 Published Online: 2021-03-16 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):443-446
Corresponding Author: Bahtiyar Haberal, Baskent University, Faculty of Medicine, Department of Orthopaedics and Traumatology, Mareşal Fevzi Çakmak street, No:45 06490, Bahçelievler, Çankaya, Ankara, Turkey. E-mail: bahtiyarhaberal@hotmail.com P: +90 530 870 19 07 F: +90 312 223 73 33 Corresponding Author ORCID ID: https://orcid.org/0000-0002-1668-6997
Aim: The present study aims to investigate the the long-term effect of metallic orthopedic instruments that were broken and not removed during surgery on the health status of patients.
Material and Methods: Radiographs of 12,601 patients (5765 females and 6836 males; mean age: 48.9 years; range: 0-105) who underwent orthopedic surgery in our clinic between January 2009 and January 2015 were screened. Thirty-six patients (13 females and 23 males; mean age: 45.3 years; range: 12-82) with metallic instruments, broken and not removed during surgery, were included in the study and minimum five-year follow-up radiographs of the patients were examined.
Results: The rate of orthopedic instrument breakage during surgery was 0.28%. This was 0.64% in trauma cases and 0.08% in elective surgery cases. The broken instrument was a Kirschner wire (K-wire) in 16 (44.4%) cases, a screw in 14 (38.9%), and a drill bit in 6 (16.6%). The rate of instrument breakage was 7.44 times higher in trauma cases than in elective surgery cases, which was statistically significant (p = 0.001). Only 1 patient required reoperation for the broken instrument 7 years later. No surgical notes regarding broken implants were identified in patient files.
Discussion: Instruments that are broken and not removed during surgery do not cause any complication if they are entirely within the bone. Nevertheless, any instance of instrument breakage should be documented, and the patient should be informed about the condition and followed closely.
Keywords: Drill Bit; Kirschner Wire; Broken Sew; Malpractice; Complication
Introduction
There is an unwritten bond of trust between physicians and patients, and this forms the basis of medicine. Physicians are required to consider the benefit of the patient to the greatest extent possible in every procedure they perform and adhere to the principle of primum non nocere. This should serve as a guideline, especially in decisions involving unexpected complications that may arise during surgeries. The most common material broken during surgical operations is the drill bit with 40%, followed by hand tools with 26%, needle tip with 18%, guidewire with 7%. It has been reported that failure to remove the broken metallic implant does not cause serious complications in the patient [1]. However, FDA USA reported that nearly 1000 cases were reported annually, and implants that were not removed in these cases could cause complications, including infection, local reaction and even death [1].
In the literature, the rate of instrument breakage during orthopaedic procedures has been reported to be between 0.18% and 0.35%. [2, 3] In general, the broken instrument must be removed if it is (i) embedded in soft tissue, (ii) adjacent to or in contact with the joint, (iii) adjacent to neurovascular structures, or (iv) intersecting both cortices of the bone [2]. If it is estimated that the surgical time for the removal of the instrument fragment may adversely affect the patient’s health and entail further complications, the surgeon may opt not to remove the substance. There are case reports indicating that instruments broken during or after surgery can cause serious complications and even death [4, 5].
The recent increase in malpractice lawsuits in Turkey and worldwide has led to a reconsideration of decisions taken during surgeries, especially concerning patient health. The present study aims to investigate the effects of orthopedic instruments that were broken and not removed during surgery on the health status of patients over a five-year period.
Material and Methods
Initially, 18,578 patients who were operated in the Orthopaedics and Traumatology Department of the Faculty of Medicine between January 2009 and January 2015 were included in the study. Outpatient surgeries (closed reduction, soft tissue tumor removal, carpal tunnel syndrome treatment, etc.) were then excluded. Postoperative radiographs of the remaining 12,601 patients (5765 females and 6836 males; mean age: 48.9 years; range: 0-105) were examined. Location and number of fragments of metallic instruments that were not planned to remain in the patient’s body before the operation, the type of surgery performed for the removal of the fragments, and the seniority of the surgeon performing the operation were recorded on these radiographs taken in the operating room. Six patients with a follow-up less than five years and 4 patients who had died within five years after surgery were excluded from the study. Any changes in the location of fragments observed in the follow-up radiographs that were present in our hospital archives were recorded, as well as any additional surgical procedures undergone due to the fragments. The patients who were not followed up in our hospital were tracked through the Turkish national personal health record system.
The study was conducted in accordance with the Declaration of
Helsinki. Approval was obtained from the University Research and Ethics Committee (Project Number: KA19/346).
Statistical Analysis
Binary logistic regression was conducted to estimate the odds ratio (OR) and 95% confidence interval (CI). Statistical analysis was performed with SPSS Statistics for Windows, Version 24.0. A p- value < 0.05 was considered statistically significant.
Results
Breakage of an orthopedic instrument occurred in 36 (0.28%) of 12,601 cases (8095 elective surgery cases, n = 13, 0.08%; 4506 trauma cases, n = 23, 0.64%). The mean follow-up time for these cases was 7.4 years (range: 6-13 years). The rate of instrument breakage was 7.44 times higher in trauma cases than in elective surgery cases (p = 0.001).
The broken instrument was a K-wire in 16 (44.4%) cases, a screw in 14 (38.9%), and a drill bit in 6 (16.6%). In 1 patient, a second surgery was required due to a broken drill bit. In 4 patients who underwent revision surgery for screws with broken heads, it was decided during the procedure that the removal of the broken instrument was not necessary. However, no remarks were found in the medical records to indicate that the patients were informed about the broken instruments. In 12 of 16 cases with broken K-wire, the breakage was in the drill guide pin used for the cannulated screw (Figure 1). All cases with a broken drill bit had undergone minimally invasive trauma surgery. A comparison of the patients with instruments broken during surgery and the control group is given in Table 1. Among the cases with a broken drill bit, fragments were detected in the proximal humerus in 3, in the pelvis in 1, in the tibia in 1, and in the femur in 1. In all 3 cases, in the proximal humerus, the drill bit fragments were located at points fit for the calcar screw (Figure 2). Among the 14 cases with broken screws, 8 were elective surgery and 6 were trauma. The rate of orthopedic instrument breakage in male patients was twice that of female patients, but no statistically significant difference was observed compared with the control group (p = 0.34). Also, there was no relationship between the age of the patients and the seniority of the surgeon performing the operation. The distribution of broken implants with respect to bones was as follows: 13 in the femur, 8 in the humerus, 8 in the tibia, 4 in the pelvis, 2 in the calcaneus and 1 in the metacarpal. In other words, 27 (75%) of the broken implants were in the lower extremities and 9 (25%) in the upper extremities.
Discussion
The patient filed lawsuits considering the failure to remove orthopedic implants broken during surgery as part of malpractice. In these cases, patients demand serious compensation because the implants broken during surgery seriously affect their lives.
Our study, which was conducted to clarify these claims, showed that the implant broken in the bone does not adversely affect the patient’s health in the long-term.
In the present study, orthopedic instrument breakages occurring during surgery were mostly in trauma cases and in the lower extremities and long bones, which was in line with the literature [2, 3]. Although there are numerous case reports elaborating on life-threatening complications due to implants broken during surgery, we did not come upon such conditions in our case series.
Price et al reported a 0.18% rate of instrument breakage in their study [3]. The rate was 0.03% in elective cases and 0.79% in trauma cases. Among the 14 broken instruments, 11 were drill bits, and 8 of the surgical cases were performed by residents. In 7 cases, the fragment was removed during surgery, but patients in most cases were not informed about the situation.
In a multicenter study by Pichler et al, the rate of implant breakage was 0.35% [2]. The fragment was removed in 5 cases and left in situ in 7. No complications were encountered in the cases without removal. However, only in 3 out of the 7 cases, the situation was recorded in the operation note. The investigators of the study underlined the necessity of documenting implant breakages.
The present study determined a rate of instrument breakage similar to both studies above. One major reason for the breakages may be that drill bits and guide wires, which should normally be single-use, are sterilized and reused in general orthopedic practice. As mentioned above, implant breakages were more common in trauma cases, and this is apparently related to the frequent use of drill bits and K-wires in surgery. The investigators also realized that the instruments that were broken and not removed during surgery were left undocumented, possibly meaning that patients were not informed either. This may entail a high risk of legal problems in the future.
K-wires without fixation to the bone must be removed due to their tendency to migrate into soft tissue. There are publications reporting cases of unremoved K-wires in soft tissue that are later extracted from the esophagus, abdominal cavity, spinal cord and brachiocephalic artery [6-9]. In the present study, there was migration of a broken drill bit in 1 case, and the fragment was removed without causing neurovascular complications. Examination of postoperative radiographs of the patient revealed that the fragment was not entirely within the bone cortex and had soft tissue penetration.
It seems likely that limited surgical approaches due to the increasing popularity of minimally invasive intervention in the last 20 years have played part in breakages of drill bits and K-wires. In the present study, in 3 cases with broken drill bits located in the proximal humerus, the fragments corresponded to the alignment of the calcar screw. This suggests that the screw may have been inserted at a tight angle with a minimal incision so as not to damage the axillary nerve adjacent to the insertion point. Similarly, the fragments of drill bits broken in the posterior acetabular surgery and tibia plateau posterior approach were found aligned with the distal holes of the plates. In the cases with broken K-wire, the breakage was in the guide pin used for cannulated screw placement. A major reason for guide pin breakage is repeated use, which causes deformation, resulting in reduced flexibility and diminished torsion strength [10]. The guide pin direction may be distorted while passing through bones of differing densities or during transition through a joint, in which movement of the joint during fixation, or pin deflection crossing the joint space, creates a slight change in direction. The deformation of direction may impede smooth passage of the drill bit over the guide pin and can erode the pin, creating a stress that results in breakage. Roy et al. have described a minimally invasive technique for the retrieval of broken guide pins using a cannulated drill [11]. However, it is risky to use this technique in regions such as hip and pelvis, where the neurovascular structures are concentrated. In the case report by Afshar et al., a cannulated screw placed adjacent to the joint for the fixation of femoral neck fracture caused breakage of the K-wire and its ensuing advance into the pelvis. Through the ilioinguinal approach, a wire fragment was retrieved from the pelvic surface of the acetabulum [4].
Screw head breakage, especially when removing locking screws, is not an uncommon complication. Special sets and techniques have been developed to remove a screw with a broken head [12]. The working principle of these sets is based on drilling a hole around the remaining shaft larger than its diameter and clenching the shaft with another instrument. However, the hole drilled during this process may indeed weaken the cortical bone. In addition, the removal of each broken screw increases the operating time.
Broken metallic instruments should be routinely removed if the remaining fragment is within the bone, not in contact with the joint space, and not adjacent to neurovascular structures. The surgeon should properly assess the type of operation, the time and effort required to remove the fragment, and any complications that may arise during and after the procedure Our investigation did not substantiate that broken implants not removed during surgery necessarily lead to complications and second surgeries. In our series, there was only 1 case with a broken drill bit, which required revision surgery. It is probable that the perioperative assessment was not duly performed in this particular case.
Drill bits used during the surgery are single-use. If the torque on the drill is too large, the drill may tend to jam or even to break in the bone [12, 13]. Reuse of drills bits may result in metal fatigue and, in turn, breakages. Higher rate of drill bit breakage in our case series compared to the literature may be associated with this phenomenon.
According to the results of our investigation, screw fragments in the bone due to head breakage did not cause complications in the long haul. However, broken screws are encountered in patients with implant failure due to various reasons after plate osteosynthesis technique applied with screws in long bone fractures. In a long bone fracture that failed to heal, it is necessary to remove all screw fragments in the canal with an intramedullary nail (IM nail) prior to the revision procedure. Study Limitations
A major limitation of the present study is the uncertainty regarding the exact number of cases where instruments are broken and not removed during surgery. Another limitation is that it is not clear how many times the drill bits and K-wires had been used prior to breakage. Availability of this particular data would enable more accurate results in investigation. Another limitation of our study is that it is not known whether metallic implants that have not been removed cause a problem in patients’ magnetic resonance imaging. There is no data on whether this situation is a problem for patients or not. Conclusion
In conclusion, the rate of orthopedic instrument breakage in the present study was in line with the literature. Although remaining fragments in the patient’s body did not cause severe complications, according to our case series, perioperative assessment should be duly performed, the situation should be properly documented and the patient should be informed within the framework of a sound physician-patient relationship. In addition, these patients should be followed closely in order to ensure early diagnosis of possible complications.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
References
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2. Pichler W, Mazzurana P, Clement H, Grechenig S, Mauschitz R, Grechenig W. Frequency of instrument breakage during orthopaedic procedures and its effects on patients. J Bone Joint Surg Am. 2008;90(12):2652-4.
3. Price MV, Molloy S, Solan MC, Sutton A, Ricketts DM. The rate of instrument breakage during orthopaedic procedures. Int Orthop. 2002;26(3):185-7.
4. Afshar A. Intrapelvic protrusion of a broken guide wire fragment during fixation of a femoral neck fracture. Arch Bone Jt Surg. 2017;5(1):63-5.
5. Duransoy YK, Mete M, Zengel B, Selcuki M. Missing screw as a rare complication of anterior cervical instrumentation. Case Rep Orthop. 2013;2013:593905. DOI: 10.1155/2013/593905.
6. Fransen P, Bourgeois S, Rommens J. Kirschner wire migration causing spinal cord injury one year after internal fixation of a clavicle fracture. Acta Orthop Belg. 2007;73(3):390-2.
7. Freund E, Nachman R, Gips H, Hiss J. Migration of a kirschner wire used in the fixation of a subcapital humeral fracture, causing cardiac tamponade: Case report and review of literature. Am J Forensic Med Pathol. 2007;28(2):155-6.
8. Minic L, Lepic M, Novakovic N, Mandic-Rajcevic S. Symptomatic migration of a kirschner wire into the spinal canal without spinal cord injury: Case report. J Neurosurg Spine. 2016;24:291-4.
9. Mishra P, Gautam VK. Broken guide wire with intrapelvic protrusion: A technique for removal. Injury. 2004;35(12):1324-6.
10. Sharma H, Chauhan M, Maini L. A technique to remove a broken guide wire transfixing the hip joint. Acta Orthop Belg. 2008;74(5):683-5.
11. Roy SP, Lim CT, Tan KJ. A useful surgical technique for retrieval of a broken guide pin in the midfoot. J Foot Ankle Surg. 2014;53(1):120-3.
12. Hak DJ, McElvany M. Removal of broken hardware. J Am Acad Orthop Surg. 2008;16(2):113-20.
13. Sui J, Sugita N, Ishii K, Harada K, Mitsuishi M. Mechanistic modeling of bone- drilling process with experimental validation. Journal of Materials Processing Technology. 2014;214:1018-26.
Download attachments: 10.4328_ACAM.20531
Bahtiyar Haberal, Salih Beyaz. Effects of orthopedic instruments breakage during surgery: A minimum five-year follow-up. Ann Clin Anal Med 2021;12(4):443-446
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Evaluation of factors affecting social media addiction in adolescents during the COVID-19 pandemic
Şenay Kılınçel 1, Gürkan Muratdağı 2
1 Department of Child Development, Istanbul Gelişim University, Istanbul, 2 Department of Family Medicine, Sakarya University Medical Faculty, Sakarya, Turkey
DOI: 10.4328/ACAM.20541 Received: 2021-02-14 Accepted: 2021-02-28 Published Online: 2021-03-03 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):447-451
Corresponding Author: Şenay Kılınçel, Istanbul Gelişim University, Department of Child Development, Istanbul, Turkey. E-mail: senaykilincel@gmail.com P: +90 505 825 74 05 Corresponding Author ORCID ID: https://orcid.org/0000-0001-5298-0264
Aim: Daily internet use, particularly the use of social media, is preferred as a method for coping with stress and anxiety caused by the current outbreak of coronavirus disease 2019 (COVID-19) or for reducing depressive mood. This study aimed to investigate the relationship of changes in social media use among children aged 12 to 18 years who were at risk for excessive use of social media during the pandemic period with anxiety and a sense of loneliness.
Material and Methods: The study population consisted of children aged 12 to 18 years and living in Turkey. Participants completed the COVID-19 information form, the Social Media Disorder Scale, the Loneliness Scale, and the State-Trait Anxiety Inventory (STAI).
Results: This study evaluated the data of 1,142 patients. The mean age of the participants was 15.6 years, and 63.2% were females. Among the participants, 63.8% stated that they knew someone diagnosed with COVID-19 in their family or close environment, and 7.1% stated that they were diagnosed with CO- VID-19. Furthermore, 46.4% stated that what they learned from the media increased their anxiety, and 60.4% stated that their academic success decreased during the pandemic period. In the model, STAI (B: 0.166 p: 0.001), age (B: 0.397, p: 0.001), and UCLA loneliness (B: 0.150, p: 0.001) were observed to predict social media addiction.
Discussion: The present study has revealed factors predicting an increase in social media addiction in this period, during which the use of social media by adolescents in the high-risk group for social media addiction has increased. Taking the necessary measures to reduce the risks and increase the protective factors is the most important way to protect adolescents’ mental health in times of difficult life conditions.
Keywords: Adolescent; Anxiety; Loneliness; Social media
Introduction
The coronavirus disease 2019 (COVID-19) starting with the reporting of a new virus from China at the end of 2019 was declared as a global epidemic (pandemic) by the World Health Organization (WHO) on March 11, 2020. Upon the identification of the first COVID-19-positive case in Turkey, various measures have been taken to prevent the spread of the epidemic. Within the framework of these measures, face-to-face classes at school were suspended as of March 16, 2020, and distance education was started on March 23, 2020 through Education Information Network (EBA) channels (available at: https://www.meb.gov.tr/ bakan-selcuk-23-martta-baslayacak-uzaktan-egitime-iliskin- detaylari-anlatti/haber/20554/tr2020). Although there have been several attempts to reopen schools gradually from time to time, the increase in the number of cases has caused the re-introduction of restrictions. The suspension of face-to-face education continues and school classes are provided through distance education. The measures taken were not only limited to the closure of schools; the lockdown has been imposed on certain age groups. According to the latest decisions, as of 20 November 2020, individuals under the age of 20 are allowed to go out between 13:00 and 16:00 during the day (available at: http://www.istanbul.gov.tr/kurumlar/istanbul.gov. tr/PDF/il_Hifzissihha_Meclis_Karari_No_104.pdf ). Epidemics have various effects on human behavior and mental health. Psychological problems, such as anxiety, depression, insomnia, and anger, are known to be more common in individuals diagnosed with COVID-19 or suspected of being positive for COVID-19, and in those who have close contact with infected patients. Social isolation, quarantine, and restrictions have increased the time people spend at home, deteriorated their daily routines, and caused them to experience social and economic problems [1]. As a result of all these factors, individuals may suffer from psychiatric problems, including increased stress, loneliness, depressive mood, anger and adjustment disorders, trauma-related problems, and behavioral addictions [2].
During epidemic periods, communication tools as television, telephone, and the internet make it easier to deliver and share accurate information about the disease to the majority of the population. Furthermore, daily internet use, particularly the use of social media and online games, is the preferred as a coping method to alleviate stress and anxiety caused by the outbreak or to reduce depressive mood. According to an international study investigating the use of media at home during the COVID-19 pandemic, 67% of individuals watch more news, 45% spend more time on messaging, whereas 44% spend more time on social media, and 36% are engaged in computer/ video games more (A W. Consuming media at home due to the coronavirus worldwide 2020, by generation: Statista. Available at: https://www.statista.com/statistics/1106563/home-media- consumption-coronavirus-worldwide-by-generation/). In particular, there has been an increase of 75% in online games and game-related use of the internet (P S. Gaming Usage Up 75 Percent Amid Coronavirus Outbreak, Verizon Reports Hollywood Reporter2020. Available at: https://www.hollywoodreporter. com/news/gaming-usage-up-75-percent-coronavirus- outbreak-verizon-reports-1285140). Online games are thought to be less harmful than many methods used to cope with stress, such as alcohol and drug use or overeating [3]. However, being less harmful does not mean it does not harm. Uncontrolled gaming may turn into a habit that can negatively affect the lives of vulnerable and high-risk groups [3]. In this period, requiring social isolation and children and adolescents to stay at home, unhealthy gaming to cope with stress, disruption of sleep patterns, and increased sedentary lifestyle turn into an insidious vicious circle with excessive gaming [3].
Considering that the restrictions introduced mostly cover individuals under the age of 20, social isolation has mostly affected adolescents and young adults. Lockdown, social isolation, concerns about the future, mental problems, economic problems, and excessive free time lead to an increase in addictions [3].
This study aimed to investigate the relationship of changes in social media use among children aged 12 to 18 years, who were at risk for excessive use of social media, during the pandemic period with anxiety and a sense of loneliness.
Material and Methods
This was an online cross-sectional self-reported survey. The study population consisted of children aged 12 to 18 years and living in Turkey. Data were collected through an online survey created using Google Forms (Google, California, USA), which was sent to smartphones of families in the databases of 12 different schools and their children, using the snowball sampling method. A total of 1,234 individuals participated in the survey and 1,142 of them were found to meet the age criteria and answered all questions.
Sociodemographic Data Form: This form was developed by the researchers. It includes questions about the participants’ age, gender, chronic illness, and whether they have applied to a psychiatric clinic before.
COVID-19 Data Form: This form was developed by the researchers to question participants’ status of getting information about the disease during the COVID-19 pandemic, whether a person was infected or knew someone who was infected, the level of anxiety about the disease, and change in school success.
Social Media Disorder (SMD) scale: This scale, which was developed by van den Eijnden et al. [4] is a Likert-type scale consisting of nine items and one dimension. It was adapted to Turkish by Savcı, Ercengiz and Aysan [5]. The reliability of the SMD was assessed by the test-retest method and Cronbach’s alpha internal consistency reliability coefficient in three different samples. The Cronbach’s alpha coefficient of the SMD was found to be 0.83, 0.86, and 0.86, and the three-week test- retest correlation was 0.805. There is no reverse-scored item on the scale. High scores indicate an increased risk of social media disorder/addiction.
State-Trait Anxiety Inventory (STAI): The scale was developed by Spielberger et al. [6]. It has two subscales, each consisting of 20 items. State Anxiety Scale (STAI-S): It determines how a person feels at a particular time and under a particular condition. Trait Anxiety Scale (STAI-T): It determines how a person feels regardless of the time and situation he/she is in. Feelings or behaviors expressed in the STAI-S and STAI-T are answered as “almost never”, “sometimes”, “often”, and “almost always” depending on the intensity of the relevant experience. The total score of reverse expressions is subtracted from the total score obtained for direct expressions. A predetermined constant value is added to the number obtained. The total value obtained shows the anxiety score of the individual. The total score from each scale ranges from 20 to 80. It was adapted to Turkish by Oner and Le Compte, and the authors reported its Cronbach’s alpha internal consistency coefficient as 0.83- 0.87, test-retest reliability as 0.71-0.86, and item reliability as 0.34-0.72 (Oner N, LeCompte WA. State-trait anxiety inventory handbook. 1985).
UCLA Loneliness Scale: The scale was developed by Russel et al. [7]. It is a four-point Likert-type self-assessment questionnaire aimed at determining the general loneliness of anindividual. The scale consists of 20 items: 10 positively scored (expressions not containing loneliness) and 10 negatively scored (expressions containing loneliness). Demir conducted the Turkish reliability and validity study of the scale and reported its Cronbach’s alpha internal consistency coefficient as 0.96 and the test-retest reliability coefficient as 0.94 [8].
Statistical Analysis: Statistical processing and analysis of the data were performed using the Statistical Package for Social Sciences (SPSS) statistics program for Windows version 15.0 (SPSS Inc., Chicago, IL, USA). Descriptive statistics were expressed as mean (±) standard deviation, median (minimum- maximum), frequency distribution, and percentage. Visual (histogram and probability graphs) and analytical (Kolmogorov- Smirnov, Shapiro-Wilk tests) methods were used to determine whether the variables followed a normal distribution. Pearson’s correlation coefficient was used for correlation analysis.
Ethics Statement: Approval for the study was granted by the Sakarya University Ethical Committee with Approval no:71522473/050.01.04/648, dated December 28, 2020. All patients signed informed consent for participation in this study, and their anonymity is preserved.
Results
This study evaluated the data of 1,142 patients. The mean age of the participants was 15.6 years and 63.2% were females; 84.7% of the participants were attending high school, 94.5% had access to distance education, and 6.0% reported that they had applied to a psychiatry clinic before. Sociodemographic characteristics are presented in Table 1.
Among the participants, 63.8% stated that they knew someone diagnosed with COVID-19 in their family or close environment, and 7.1% stated that they were diagnosed with COVID-19. Information about the disease was observed to be most frequently obtained from social media (40.3%). Furthermore, 46.4% stated that what they learned from the media increased their anxietyб and 60.4% stated that their academic success decreased during the pandemic period. Data related to the COVID-19 pandemic are presented in Table 2.
When the relationship between scale scores was examined, SMD was observed to have a statistically significant positive correlation with STAI Total (r: 0.417), STAI-T (r: 0.367), STAI-S (r: 0.380), and UCLA Loneliness Scale (r: 0.093) (Table 3).
In multiple linear regression analysis performed with retrospective elimination to predict social media addiction, the following variables were analyzed: STAI, UCLA loneliness, age, school success, presence of COVID-19 diagnosis in the person himself/herself, his/her family or relatives, gender, and presence of mental illness prior to the pandemic. At the fourth step, the model was found to be significant (F(4.1133, p <0.001), and the R2 value was calculated to be 0.30. In the model, STAI (B: 0.166 p: 0.001), age (B: 0.397, p: 0.001), and UCLA loneliness (B: 0.150, p: 0.001) were observed to predict social media addiction.
Discussion
The present study included a total of 1,142 children aged 12–18 years. The mean age of the participants was 15.6 years, and most of them had access to distance education. Social media was found to be the most commonly used tool by the participants to obtain information. Almost half of the participants reported that the information they learned from the media increased their anxiety levels, while very few reported that their anxiety decreased. The literature review has shown that anxiety symptoms during the pandemic period include the presence of peer communication, physical exercise, following news about the epidemic less, and access to psychological support resources are the most important factors that protect adolescents against depression [9]. Infectious diseases have a complex relationship with mass media (e.g. television, internet, and radio) [10]. In situations influencing the whole world (e.g. a pandemic), communication tools such as social media become very important for informing people about emergencies and for timely communicating the frequently changing decisions [11]. Studies emphasize that media is a highly effective tool to protect and maintain public health if it is used logically, consciously, and correctly [10]. On the other hand, besides being used for providing accurate information, it also contains too much misleading information. Publication of various conspiracy theories on public networking sites and the spread of unfounded rumors are frequently encountered situations at the present time. In a study investigating the relationship between the increase in the spread of the disease and the use of the social media site Facebook as an information source following the Zika virus in the United States, the authors found that the misleading posts were far more popular than the posts dispersing accurate information about the disease and aroused more curiosity in the society [12]. In another study, misinformation on social media was reported to increase people’s perception of risk of disease, negatively affect their stress levels, and lead to an anxiety-dominated environment [13]. Therefore, it is necessary to develop effective preventive methods and strategies to combat the spread of false, unfounded, and misleading news in pandemic periods, particularly for the vulnerable population [14].
The majority of the participants were observed to have a decrease in their academic success and were concerned about their future school life. In a study reported from Turkey, the opinions of eighth- and 12th-grade students on exam anxiety were evaluated, and the results showed that students had more exam anxiety during the pandemic period. Furthermore, in the same study, the majority of the students stated that passing the exam under pandemic conditions would adversely affect their success [15]. The most common problems experienced by adolescents during the pandemic period are reported to be the absence of routines established by the school, having a monotonous life at home, disruption in normal sleep patterns, inability to cope with negative emotions (e.g. anxiety), inappropriate eating behaviors, attention and concentration problems, and decrease in academic success due to decreased motivation [16]. Studies have further shown that evaluating this period as an opportunity for personal development, understanding the value of important moments and people in life, adopting positive thoughts such as setting future goals, maintaining daily routines, and organizing regular meetings with peers and family members help to cope more easily with the uncertainty and anxiety caused by the pandemic and increase psychological resilience [13].
The risk of social media addiction was observed to increase as the level of anxiety and loneliness increased. In a study conducted at the beginning of the pandemic in China, the effects of repeated exposure to media on mental health were investigated, and high levels of daily media exposure were found to increase negative mood and severity of depression [17]. In a study on parental reports conducted in Italy and Spain, 85.7% of the parents reported that their children experienced changes in their emotional state and behaviors, such as difficulty in concentrating, boredom, irritability, restlessness, nervousness, feelings of loneliness, uneasiness, and worries, during the pandemic period. They further reported that their children started to spend more time in front of screens [18]. In the study reported from Turkey, the views of eighth- and 12th-grade students on their mental state were evaluated and it was reported that about 70% of the students were negatively affected by the pandemic, 65% felt lonely at home, and the majority of the students, particularly those attending 12th grade, felt depressed [15]. In a study involving Chinese adolescents aged 13-17 years, the use of negative coping methods, such as denial, avoidance, and substance use, was reported to cause an increase in depression, anxiety, and stress reactions, whereas the use of positive coping methods, such as problem-solving, planning, and cognitive restructuring and high psychological resilience scores, which were expressed as the ability to maintain mental well-being in the face of difficult living conditions, were shown to be protective against depression and anxiety [19]. The results of the present study suggest that social media, which has been used significantly during the pandemic period, is used by adolescents mostly as a strategy for coping with negative emotions.
Furthermore, age, anxiety level, and feeling of loneliness have been observed as factors predicting social media addiction. Similar to the present study, older age and higher stress score parameters have been shown to be associated with internet addiction risk among adolescents in the study involving Chinese children and adolescents aged six to 18 years. In the same study, internet addiction risk has been further shown to be associated with male gender and depression symptoms [20].
Conclusion
The present study has revealed factors predicting an increase in social media addiction during this period, when the use of social media by adolescents in the high-risk group for social media addiction has increased. Taking the necessary measures to reduce the risks and increase the protective factors is the most important way to protect adolescents’ mental health in times of difficult life conditions. This study has shown that the use of correct methods to cope with loneliness and stress has a positive effect on the mental health of adolescents.
Acknowledgment
The authors would like to thank Dr. Miraç Barış Usta for Statistical Analysis.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Download attachments: 10.4328_ACAM.20541
Şenay Kılınçel, Gürkan Muratdağı. Evaluation of factors affecting social media addiction in adolescents during the COVID-19 pandemic. Ann Clin Anal Med 2021;12(4):447-451
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People’ responsibilities and adaptation in the struggle against the COVID-19 pandemic
Mustafa Demirkıran 1, Mehmet Yorulmaz 2, Burhanettin Uysal 3
1 Deprtment of Health Institutions Management, Isparta University of Applied Sciences, Isparta Vocatinal School, Isparta, 2 Department of Healthcare Management, Selçuk University, Faculty of Health Sciences, Konya, 3 Department of Healthcare Management, Bilecik Seyh Edebali University, Faculty of Health Sciences, Bilecik, Turkey
DOI: 10.4328/ACAM.20548 Received: 2021-02-22 Accepted: 2021-03-13 Published Online: 2021-03-16 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):452-456
Corresponding Author: Burhanettin Uysal, Department of Healthcare Management, Bilecik Seyh Edebali University, Faculty of Health Sciences, Bilecik, Turkey. E-mail: burhanettin.uysal@bilecik.edu.tr P: +90 5052963993 Corresponding Author ORCID ID: https://orcid.org/0000-0003-2801-9726
Aim: In this study, it was aimed to determine the individual responsibilities that the public should fulfill in the struggle against the COVID-19 pandemic and develop a scale in this regard; to identify the extent to which Turkish society complies with this responsibility.
Material and Methods: First, the briefings of the members of the COVID-19 Science Board, formed by the Ministry of Health of the Republic of Turkey were scanned on the web, and a ‘COVID-19 Individual Responsibilities Scale’ comprising 45 statements was established, which includes personal precautions. As a result, 6,770 surveys were taken into consideration. The appropriate number of people was reached from seven regions of Turkey, most of them from the Central Anatolia region (n=3,068).
Results: As a result of the analyses, 13 statements were removed from the scale, and the remaining 32 phrases were collected under seven factors. Of the seven dimensions identified, the most acceptable to the public is the use of mask. This one is followed by application to health institutions and hand hygiene. The least adaptable dimensions of the people are healthy lifestyle and home hygiene.
Discussion: Perhaps the most effective weapon against the spread of the virus, the physical distance protection dimension, was ranked fifth. The study findings reveal that the ‘COVID-19 Individual Responsibilities Scale’ can be used for similar studies.
Keywords: COVID-19; Pandemic; Responsibilities; Adaptation
Introduction
During a pandemic, the necessary precautions should be taken in a timely way to reduce the rate of cases in the community and the maximum number of cases, prevent excessive agglomerate in hospitals, and keep the total case number and its effects on health to a minimum level [1]. Regarding the precautions to be taken in the struggle against COVID-19, persons and organizations, especially the advisory organizations (such as WHO), states, and the public, have essential responsibilities. To this end, WHO has identified COVID-19 representatives to advise countries on February 21; Most of the meetings were held by Italy (February 24), China (February 25), and Iran (March 2) [2]. Some states have put in place implementations such as the emergency declaration, determination of pandemic hospitals, construction of new hospitals, improving the diagnostic requirements of health institutions, increasing the number of tests, determination of appropriate medical treatment, particular treatment practices, remote access to health professionals, monitoring the pandemic process, Q.R. code, ‘stay at home’ policies, increasing physical distances, banning mass meetings, closing educational institutions, and public spaces, e-learning in education, closure of religious facilities, closure of businesses, cinema, restaurants and bars, work/telework from home, postponement of sporting events, restriction of flights, curfews, city quarantines, strict control of entry into the country (available at: https://www.ecdc.europa. eu/en/current-risk-assessment-novel-coronavirus-situation) [2- 6].
One of the primary conditions for the fight against the pandemic is that the public is aware of individual responsibilities and adapts to these responsibilities. The fact that states put into operation various practices that are counted above and require high budgets, guiding the public, does not mean that the fight against the pandemic will be entirely successful. Moreover, a significant part of government precautions is not permanent, and if implemented for a long time, will inevitably lead to economic, social, and psychological consequences.
Regarding the responsibilities that ordinary people should take in the fight against COVID-19 pandemic, individuals and organizations such as various organizations, government officials, scientists, and individuals and organizations make statements and publish guides. The World Health Organization recommends regular washing of hands with soap and water, using an alcohol-based hand sanitizer when it is not possible to reach soap and water, avoiding going to crowded places, being at least one meter away from people, and wearing masks on the way out, staying at home until you recover, avoiding touching the eyes, nose, and mouth, closing your mouth and nose with twisted elbows or handkerchiefs when you cough/ sneeze (available at: https://www.who.int/emergencies/ diseases/novel-coronavirus-2019/advice-for-public). The stated recommendations were implemented and found to be useful in countries such as China and South Korea. For this reason, it is frequently applied in other countries around the world [7]. Individual responsibilities to be fulfilled by the public should be determined by authorized persons and institutions and disclosed to the people with a scientific perspective. Afterward, measuring the compliance of people is essential to develop new policies. Accordingly, the current study was carried out to determine the individual responsibilities in the fight against the COVID-19 pandemic and determine the extent to which Turkey’s people edict.
Material and Methods
A two-stage data collection method was used to accomplish the purpose of the study. The first stage aims to identify the individual responsibilities that people must fulfill in the fight against the COVID-19 pandemic and develop a scale in this regard. For this purpose, since the beginning of the COVID-19 pandemic, information about the pandemic of the Ministry of Health of the Republic of Turkey and the Science Board of the Ministry of Health was scanned web via the Google search and subjected to content analysis. As a result of the analysis, the ‘COVID-19 Individual Responsibilities Scale’ consisting of 45 items was established. The second phase aims to determine the extent to which the people of Turkey are obeyed the individual responsibilities specified.
The survey was conducted between 20.05.2020-30.06.2020, and it was targeted to provide participation in the study from all regions of Turkey. As a result of the study, 6,932 people were surveyed. Before starting the data analysis, it was checked whether there was incorrect data in the prepared dataset, and the incorrectly entered data were corrected. The dataset was subsequently controlled for missing data. At the same time, the dataset was checked for an outlier. These forms were removed from the dataset because outlier was detected in the data of 162 participants. For this reason, 6,770 surveys were analyzed.
Results
6,770 surveys were received, including 6,932 people from all seven regions of Turkey and 3,068 people from the Central Anatolia region, 966 from the Mediterranean Region, 914 from the Marmara Region, 717 from the Aegean Region, 475 from the Black Sea Region, 339 from the Eastern Anatolia region, and 291 from the Southeast Anatolia region (Figure 1).
About a third of respondents (32.4%) were between the ages of 21 and 25. The largest number of participants (n= 2,191) was in this age group. The proportion of male participants (59.2%) was higher than that of female participants (40.8%). The proportion of unmarried participants (64.6%) was close to twice the proportion of married people (35.4%).
For testing the validity of COVID-19 Individual Responsibilities Scale, exploratory factor analysis was applied to the data on 45 statements on the scale. The main factors related to the targeting were tried to be identified. In this process, basic components were analyzed, and factor loads were examined. If each item’s factor load value on the scale was more significant than 0.3, it was considered moderate. If it was more significant than 0.6, it was rated high [8]. The 13 statements with the item load below 0.35 were removed from the scale, and the remaining 32 statements and analyses were repeated. According to the analysis, the scale’s KMO value was greater than 0.50, and the data were suitable for factor analysis [9]. The calculated KMO value was 0.930, which can be considered excellent. At the same time, since p=0.000<0.05, the Bartlett test result was significant
The scatter diagram is a test used to find the number of factors in scale [10]. As a result of the analysis, it was determined that the scale plateaued after the seventh point, according to eigenvalue values, and the cutting point was defined as seven (Figure 2).
Principal Axis Factoring was applied as an extraction method, and the Equamax with Kaiser Normalization was used, which is one of the orthogonal ways as a rotation method. This method is a mix of the Varimax and Quartimax methods [10]. Dimensions were based on the total scores.
The items that constitute the factors and factor load values of the items are shown below:
Factor 1
1. When I come home from the outside, if my clothes cannot be washed, I air them on the balcony (.695).
2. When I bring home what I bought from outside, I leave it behind the door/on the balcony for 2-2.5 hours (.630).
3. I am cleaning my phone when I get home from the outside (.622).
4. When I come home from the outside, I wash my washable clothes (.598).
5. I wash and dry the packaged goods I buy at the grocery store with soap and water if possible and put them back. (.578).
6. When I come home from the outside, I change my clothes (.481).
7. We clean surfaces that we frequently use at home, such as door handles, fixtures, sinks, every day (.368).
Factor 2
8. I am not hugging anyone anymore (.825).
9. I do not get hands-on with anyone anymore (.786).
10. I do not kiss the elders’ hand anymore (.651).
11. We do not accept guests at home, and I do not go to the guest house (.385).
Factor 3
12. I wear a mask when I shop (.732).
13. If I am going to a health care institution, I wear a mask (.699).
14. I wear a mask when I get on public transport (.628).
15. I wear a mask when I go out (.511).
16. My mask is special to me; I do not share it with others (.411). Factor 4
17. I wash my hands often (.648).
18. I wash my hands with soap and water (.630).
19. I wash my hands for at least twenty seconds (.559).
20. I provide hand hygiene when I touch mobile phones, computer keys, elevator keys, etc. (.392).
21. I use hand sanitizer when there is no soap or water (.385). 22. I do not come into contact with my mouth, nose, eyes, etc. without washing my hands (.377).
Factor 5
23. When I go outside, I keep at least three steps distance from people (.523).
24. I keep a social distance (2 meters) when shopping (.488). 25. I am not in crowded environments (.457).
26. I kindly warn people who do not follow the advice around me (.377).
Factor 6
27. I go on a balanced diet (.749).
28. I sleep regularly (.667).
29. I sport regularly (.538).
30. I consume plenty of fluids (.481).
Factor 7
31. I try to avoid going to family health centers as much as possible (.754).
32. I try to avoid going to hospitals as much as possible (.742). As a result of the analysis, 13 items were removed from the scale, and the remaining 32 statements were collected under seven factors. The first factor is ‘home hygiene’ (1-7); the second is ‘communication routines’ (8-11), the third is ‘use of mask’ (12-16), the fourth is ‘hand hygiene’ (17-22), the fifth is ‘physical distance’ (23-26), the sixth ‘healthy lifestyle’ (27-30), and the seventh is called ‘application to health care organizations’ (31-32).
As a result of the exploratory factor analysis, confirmatory factor analysis (CFA) was applied to the dimensions obtained. The values generally considered in the CFA are χ2 / df, GFI, CFI, and RMSEA. The path diagram provides a schematic version of the model. In the study, the relationship between the variables (dimensions) examined was made schematically, assuming that it is compatible [11].
Looking at the general fit index (χ2 / sd) of the model (Table 1), which is 1.27, and the RMSEA index, which is 0.05, it can be said that it is a good fit. The NFI value (.96) can be said to be a good fit. The CFI value (.96) can be said that it is acceptable. As the SRMR value approaches zero (to 0), it is assumed that the model’s fit increases. In the study, it can be said that the scale has a good fit with a 0.049 fit index value. In light of the above information, it can be said that the fit indexes of the scale used in the study are good and acceptable. The GFI fit index value (.93) appears to be acceptable. The AGFI fit index (.93) seems to be a good fit [12].
Table 2 provides descriptive statistics for reliability, normality test, and scale sub-dimensions. Cronbach alpha (α) coefficient of the scale size was found to be 0.884. In the sub-dimensions, the highest reliability coefficient is home hygiene (α = .795), and the lowest is physical distance (α = .670).
Shapiro-Wilk test results were examined to determine the test techniques to be used in the analyses, and non-parametric test techniques were used because the distribution did not show normal distribution (p<.05).
Among dimensions, the one with the highest average is use of musk (x- max=25; x- =24.44=98%), and the one with the lowest is healthy lifestyle (x-max =20; x-=14.66=73%). These results show that individuals give more weight to use of musk within the framework of their responsibilities.
When looking at correlation analysis results, positive, statistically significant relationships were found between all dimensions (p<.01). When looking at the relationship analysis between sub-dimensions, the highest relationship was between home hygiene and hand hygiene (r= .578). The second highest relationship was between hand hygiene and physical distance (r=.520).
Discussion
This study was carried out to determine the individual responsibilities that people must fulfill in the fight against the COVID-19 pandemic and develop a scale in this regard, and determine the extent to which the people of Turkey edict these responsibilities. Among the seven dimensions determined as a result of this study, the most adapted dimension to the public is use of musk. The application to health organizations follows this with statements about not going to health organizations during the pandemic process and the hand hygiene dimension containing substances that prevent the virus from being infected through hands. The least adaptable dimensions of the public are healthy lifestyle and home hygiene.
When the literature was examined, there was no study of the scale development of individual responsibilities in the fight against the COVID-19 pandemic. There are a limited number of studies regarding the harmony of the people. One of these studies was carried out in China with 4,826 people. As a result, participants were found to largely follow the rules issued by the Chinese Government (such as avoiding travel to areas affected by the COVID-19 pandemic, wearing the mask, changing the mask regularly, and washing hands regularly) [4]. On the other hand, in another study conducted to clarify the situation of applying personal protective measures (hand hygiene, social distancing measures, avoiding touching eyes, nose and mouth, respiratory etiquette, self-isolation) by the Japanese people during the COVID-19 pandemic process and including 2,400 people, it was found that personal protective precautions were applied insufficiently and therefore public awareness activities were needed [13].
Public awareness of personal protective measures will reduce the spread of the COVID-19 pandemic and provide significant advantages in combating diseases such as tuberculosis, influenza, and community-acquired pneumonia [7]. It should also be noted that the use of personal protective precautions in combination with connected methods, such as antiviral prototype, vaccination, and appropriate treatment, will produce more effective results [14-16].
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Mustafa Demirkıran, Mehmet Yorulmaz, Burhanettin Uysal. People’ responsibilities and adaptation in the struggle against the COVID-19 pandemic. Ann Clin Anal Med 2021;12(4):452-456
Citations in Google Scholar: Google Scholar
Diagnostic accuracy of angiopoietin-like protein 2 and atherosclerotic variables in psoriasis vulgaris using ROC analysis
Ebru Celik 1, Yusuf Celik 2, Gulen Burakgazi 3, Gokhan Cakirca 4, Gokhan Ucgul 1
1 Department of Dermatology, Faculty of Medicine, Hatay Mustafa Kemal University, Hatay, 2 Department of Biostatistic, Faculty of Medicine, Biruni University, Istanbul, 3 Department of Radiology, Faculty of Medicine, Hatay Mustafa Kemal University, Hatay, 4 Department of Biochemistry, Faculty of Medicine, Hatay Mustafa Kemal University, Hatay/ Department of Biochemistry, Sanliurfa Mehmet Akif Inan Training and Research Hospital, Sanliurfa, Turkey
DOI: 10.4328/ACAM.20551 Received: 2021-02-25 Accepted: 2021-03-12 Published Online: 2021-03-18 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):457-461
Corresponding Author: Ebru Celik, Department of Dermatology, Faculty of Medicine, Hatay Mustafa Kemal University, Tayfur Sokmen Campus, Serinyol, Antakya, Hatay, Turkey. E-mail: ebruecelik@yahoo.com P: +90 326 2291000 GSM: +90 505 8835483 F: +90 326 2455305 Corresponding Author ORCID ID: https://orcid.org/0000-0003-0985-7396
Aim: Psoriasis vulgaris is a chronic inflammatory skin disease associated with various comorbidities such as metabolic syndrome and cardiovascular disease. The disease is affected by many variables. Angiopoietin-like protein 2 (ANGPTL2) is a proinflammatory cytokine, and increased serum levels are associated with inflammation, obesity, dyslipidemia, metabolic syndrome, and atherosclerosis. The aim of this study was to determine the diagnostic accuracy of the new variable ANGPTL2 and other atherosclerotic variables for psoriasis, using Receiver Operating Characteristic (ROC) analysis.
Material and Methods: The study included 41 psoriasis patients and 43 healthy volunteers. Ultrasound examination of the carotids and carotid intima-media thickness (CIMT) measurements were performed in all participants. Serum ANGPTL2 levels, lipid levels/ratios and anthropometric measurements were re- corded. A ROC curve of multivariate statistical methods was used for statistical evaluation.
Results: According to the results of the ROC curves, seven diagnostic variables (ANGPTL2, BMI, weight, systolic blood pressure, waist circumference for fe- males, uric acid and LDL-cholesterol) were found to be significant. The highest Area Under the Curve (AUC) value was found for ANGPTL2; AUC=0.721, 95% CI: 0.595-0.847, p=0.002. There was no significant difference in the lipid ratios and CIMT measurements between psoriasis patients and healthy controls. Discussion: This study revealed that increased ANGPTL2 levels in psoriasis patients are evidence of the strong relationship between the disease and ath- erosclerosis. Therefore, the measurement of serum ANGPTL2 level may be a new marker that can be used to determine the risk of early atherosclerosis and metabolic complications in psoriasis patients.
Keywords: ANGPTL2; Psoriasis vulgaris; Atherosclerosis; ROC analysis
Introduction
Psoriasis vulgaris is an inflammatory skin disease, in the etiopathogenesis of which genetic, autoimmune, and immunological factors act. It has been reported to be more frequent in patients with metabolic syndrome, cardiovascular disease (CVD), obesity, type 2 diabetes mellitus, and hypertension, and is related to many comorbidities [1, 2]. Various pro-inflammatory, prothrombotic markers increase in psoriasis disease. Atherosclerosis is considered an inflammatory disease like psoriasis. Proinflammatory cytokine production in the formation of atherosclerotic lesions is similar to that of psoriasis. All biologically active cytokines, chemokines, adipokines, and adhesion molecules have been determined to be related to the pathogenesis of both psoriasis and atherosclerosis [3, 4].
Angiopoietin-like protein (ANGPTL) is a protein with structural resemblance to angiopoietin, which is responsible for angiogenesis. Eight types of ANGPTL protein with different structures and functions have been detected. The recently identified ANGPTL2 is a proinflammatory cytokine secreted primarily from adipose tissue. ANGPTL2 has autocrine, paracrine, proinflammatory, and pro-oxidative characteristics. It is secreted from various cells such as adipocytes, macrophages, endothelial cells, cardiomyocytes, cancer cells, kidney, liver, and skeletal muscle cells, triggered by genetic susceptibility, environmental stress and risk factors, increasing the ANGPTL2 level in circulation. It has been reported that an increased serum ANGPTL2 level may be positively correlated with inflammation, atherosclerosis, insulin resistance, obesity, dyslipidemia, metabolic syndrome and cancer progression [5-7].
Carotid intima-media thickness (CIMT) measurement is a non-invasive ultrasonographic parameter, which provides information about subclinical atherosclerosis [8]. The total cholesterol/HDL (TC/HDL) ratio, low-density lipoprotein/high- density lipoprotein (LDL/HDL) ratio, and triglyceride/HDL (TG/ HDL) ratio are also accepted as parameters showing the risk of CVD progression risk [9]. Body mass index (BMI), waist circumference, and waist-to-hip ratio (WHR) are body fat distribution and accumulation parameters, which are known to be related to coronary artery disease, cardiovascular mortality, and metabolic complication risk (Waist Circumference and Waist-Hip Ratio: Report of a WHO Expert Consultation, Geneva, 8-11 December 2008) [10].
When the results of current studies are examined, it can be seen that the data have generally been analyzed using a univariate method. However, multivariate statistical methods consider variations in all of the variables as a whole and therefore provide more sensitive and powerful results than univariate statistical methods. When the univariate analysis is used for multivariate data, the validity and reliability of the results decrease because of the shortcomings of the test and loss of information. This can be prevented by using multivariate statistical methods [11]. The aim of this study was to determine the Area Under Curve (AUC) diagnostic value of the new biomarker serum ANGPTL2, newly studied in psoriasis vulgaris, and other atherosclerotic variables that were included using Receiver Operating Characteristic (ROC) analysis. With the determination of asymptomatic atherosclerosis burden, the power of these diagnostic markers can be revealed.
Material and Methods
This study was conducted in the Department of Dermatology, Faculty of Medicine, Hatay Mustafa Kemal University between September 2017 and June 2019. The study included 41 patients with psoriasis vulgaris who presented at the Dermatology Outpatient Clinic and 43 age and gender-matched healthy volunteers as the control group. Adult patients with plaque type psoriasis who had not received any systemic treatment recently were included in the study. Patients with psoriatic arthritis and patients receiving immunosuppressive therapy were excluded from the study, considering that it might affect inflammation. Pregnant women, disabled individuals, aged <18 years, other dermatological diseases and those with chronic diseases such as hypertension, CVD, diabetes mellitus were excluded from the study. Informed consent was obtained from all study participants. The disease severity score in the patient group was evaluated with the psoriasis area severity index (PASI). BMI, waist circumference, WHR values, current smoking, alcohol consumption, regular daily activity, disease duration, and demographic data were recorded. The serum ANGPTL2 level measurement was made using a Human (ANGPT2) Elisa Kit (Sunredbio-Shanghai). Blood lipid levels were measured spectrophotometrically using an autoanalyzer (Abbot Architect C-8000) in a biochemistry laboratory. Lipid ratios (TC/HDL, LDL/HDL and TG/HDL) were calculated. The bilateral intima- media thickness of the common carotid arteries (carotid intima-media thickness, CIMT) measurement and the presence of carotid plaque lesion were recorded ultrasonographically via a superficial transducer (5-13 MHz).
Ethical approval was obtained for the study from the Hatay Mustafa Kemal University, Faculty of Medicine (06.16.2016/164). All procedures were applied in compliance with the Helsinki Declaration. Patient confidentiality was ensured.
Statistical analysis
The current study was planned from the outset with the aim of increasing validity and reliability. It was planned to use multivariate statistical methods instead of univariate statistical methods to increase the internal validity and accuracy of the analysis in the evaluation of the data. Mean and standard deviation (SD) values were calculated for continuous variables. The conformity of the variables to normal distribution was analyzed using the Kolmogorov-Smirnov test. Student’s t-test was used to compare the mean values between the two groups. The Chi-Square test was used to analyze the interaction between categorical variables. The Mann Whitney U-test was applied to determine the relationship between ANGPTL2 and PASI.
ROC curve analysis was applied to calculate the diagnostic accuracy, as defined by the AUC, with a 95% Confidence Interval (CI). The advantage of ROC analysis for quantitative diagnostic variables is to determine the optimal cut-off points in ROC space. Therefore, optimal cut-off points were also determined. Sample size: Based on literature information [12], the rate of psoriasis is given as 0.013. Taking the expected rate as 0.055, it was calculated with the R program that at least 57 participants should be included in the study to provide 80% power.
Two-sided p-values were considered statistically significant at p≤0.05. All statistical analyses were made using R software (version 3.6.2 (2019-12-12) – CRAN).
Results
The demographic, clinical and laboratory findings of the patients and control group were calculated as mean ± standard deviation values and analyzed with the Student’s t- test. The results are presented in Table 1. ANGPTL2, BMI, weight, systolic pressure, waist circumference for females, uric acid and LDL-cholesterol were determined to be statistically significantly higher in the patient group compared to the control group (p <0.05). The demographic characteristics, symptoms, and comorbidity findings were analyzed with the Chi-Square test and the results are presented in Table 2. No statistically significant difference was determined between the groups in respect of all the categorical variables presented in Table 2 when analyzed with the Fisher Exact Test (p>0.05). The mean disease duration was 12.17±7.20 years. The mean PASI
score was 8.39±5.78 (range 2 to 20). Serum ANGPTL2 level was compared with the PASI value in psoriasis patients, and no statistically significant difference was found (p> 0.05).
The ROC curve and the AUC were calculated to define the diagnostic effect of ANGPTL2, systolic blood pressure, LDL, uric acid as shown in Figure 1. ROC curves for the diagnostic accuracy of the anthropometric variables of BMI, weight and waist circumference for females are shown in Figure 2.
The AUC, Standard Error (SE) of AUC values, 95% CI, cut-off values of the diagnostic variables that were considered and the sensitivity and specificity values of the cutoff values obtained from the ROC curve analysis are shown in Table 3.
The AUC values of seven variables in the ROC analysis were found to be statistically significant (p<0.05) as follows: ANGPTL2 (AUC=0.721 at a cut-off value of ≥9.522 ng/ml), BMI (AUC=0.689 at a cut-off value of ≥ 25.75 kg/m2), weight (AUC=0.667 at a cut-off value of ≥71.50 kg), systolic blood pressure(AUC=0.665atacut-offvalueof≥112.5mmHg),waist circumference for females (AUC=0.659 at a cut-off value of ≥ 85.50 cm), uric acid (AUC=0.650 at a cut-off value of ≥4.545 mg/dL) and LDL-cholesterol (AUC=0.342 at a cut-off value of ≥131.7 mg/dL).
Discussion
The results of this study demonstrated the highest statistically significant AUC value (0.721, p=0.002) for the serum ANGPTL2 level, therefore this could be accepted as a strong diagnostic variable in psoriasis. BMI, weight, systolic blood pressure, waist circumference for females, uric acid and LDL-cholesterol levels were also found to be significant diagnostic markers for the disease.Theincreaseofthesemarkersinpatientswithpsoriasis may be a significant indicator of inflammation associated with CVD risk and atherosclerosis. This study demonstrates the diagnostic power of these biomarkers.
In the literature, there is only one study, which has evaluated the ANGPTL2 level in psoriasis vulgaris and the relationship with metabolic syndrome. Kenawy et al. reported that serum ANGPTL2 levels were statistically significantly increased in patients with psoriasis compared to the healthy control group, and the serum ANGPTL2 level correlated with PASI [13]. In the current study, no statistically significant difference was found between the increase in serum ANGPTL2 levels and PASI values in the psoriasis patient group.
Hata et al. suggested that high serum ANGPTL2 levels are also a new risk factor for CVD progression in the general population and that this marker is partially mediated for metabolic disorders and inflammation [14]. Wang et al. reported that high serum ANGPTL2 levels are a new biomarker for determining acute coronary syndrome risk [15]. In another study, high serum ANGPTL2 levels were seen to be related to an increased risk of CVD in patients with type-2 diabetes [16]. In patients with coronary artery disease and in males with post-acute coronary syndrome, ANGPTL2 levels have been found to decrease with exercise [17, 18]. These data affirm the relationship between ANGPLT2 and CVD. In another study, it was suggested that high ANGPTL2 levels in circulation were clinical markers of systemic inflammation [7]. Current research suggests high serum ANGPTL2 level in psoriasis patients may be associated with an increased risk of inflammation, CVD and atherosclerosis.
BMI, waist circumference, and WHR are parameters of the distribution and accumulation of body fat, which have been shown to be associated with coronary artery disease, cardiovascular mortality, and metabolic complication risk [10]. The risk of metabolic complications has been shown to be increased in patients with waist circumference >94 cm in males, and >80 cm in females, and significantly increased when waist circumference is >102 cm in males and >88 cm in females (Waist Circumference and Waist-Hip Ratio: Report of a WHO Expert Consultation, Geneva, 8-11 December 2008). Tabata et al. reported that high serum ANGPTL2 levels indicated chronic adipose tissue inflammation and obesity related to systemic insulin resistance [19]. Park et al. reported that through diet modifications, the ANGPTL2 levels in circulation could be decreased in overweight and obese males and arterial stiffness was also seen to decrease [20]. Kenawy et al. evaluated anthropometric measurements, lipid profile, fasting blood glucose, and ANGPTL2 levels in patients with psoriasis and a control group. In addition to elevated serum ANGPTL2 levels in the psoriatic patients, fasting blood glucose, body mass index, waist circumference and mean blood pressure were also determined to be higher than in the control group [13]. Similarly, in the current study, BMI, weight, systolic blood pressure, waist circumference for females, uric acid and LDL-cholesterol levels were found to be higher in patients with psoriasis compared to healthy individuals.
TC/HDL, LDL/HDL, and TG/HDL ratios and the CIMT measurement are accepted as parameters showing CVD progression risk [8, 9]. Warnecke et al. reported that the LDL/ HDL ratio was a pro-atherogenic cholesterol profile that has been seen to be increased in patients with psoriasis. It was also reported that smoking, obesity, diabetes, insulin resistance, and myocardial infarction prevalence increased significantly and cardioprotective adiponectin decreased significantly in patients with psoriasis [21]. Pietrzak et al. demonstrated that lipid metabolism anomalies and oxidative imbalance may be related to chronic inflammation in patients with psoriasis and psoriatic arthritis. The results of that study showed that HDL concentrations were higher in healthy individuals, and
TC/HDL and LDL/HDL ratios were increased in patients with psoriatic arthritis [22]. Ciccone et al. reported that central fat accumulation can accelerate the development of clinically silent early atherosclerosis and that the prevalence of CVD is higher in patients with abdominal obesity. The CIMT value was also seen to be higher in obese patients than in non-obese patients [23]. In the study conducted in patients with psoriasis, CIMT values, which are known early atherosclerosis markers, have been shown to be higher in the patient group than in the control group [24]. In the current study, no significant difference was found between the groups in terms of CIMT measurement and lipid ratios. However, it was determined that the LDL- cholesterol level was statistically significantly higher in the patient group. The increase in ANGPTL2 is thought to occur at an earlier stage than the early CVD marker of CIMT and the increase in blood lipid ratios.
The greater the AUC, the greater the diagnostic power of the variable for psoriasis vulgaris. Therefore, ANGPTL2, BMI, weight, systolic blood pressure, waist circumference for females, uric acid and LDL-cholesterol were proven to be the most powerful diagnostic variables, with high AUC values obtained in ROC analysis, as a modern multivariate statistical analysis. The evidence-based optimal cut-off points obtained in the ROC curves and their sensitivity-specificity values will provide important insights for the clinician in clinical practice. The strengths of this study were the statistical comparison of many variables including serum ANGPTL2, which determines the risk of atherosclerosis and CVD, in patients with psoriasis and healthy individuals, and the use of ROC curve analysis with higher sensitivity and specificity as a multivariate statistical method for statistical evaluation. However, as this study was cross-sectional in design, a limitation of the study was the lack of a cohort for long-term follow-up of patients with psoriasis. Conclusion
In conclusion, the AUC values of the variables, including ANGPTL2, defined in this study provide a new approach to the clinical diagnosis of psoriasis vulgaris. The variables of ANGPTL2, BMI, weight, systolic blood pressure, waist circumference for females, uric acid and LDL-cholesterol were determined to be significant for psoriasis vulgaris, and also constituted a risk for atherosclerosis and CVD. The data obtained in this study revealed that increased ANGPTL2 levels in patients with psoriasis are evidence of the strong relationship between the disease and atherosclerosis. Therefore, the measurement of serum ANGPTL2 level may be a new marker that can be used to determine the risk of early atherosclerosis and metabolic complications in psoriasis patients.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Ebru Celik, Yusuf Celik, Gulen Burakgazi, Gokhan Cakirca, Gokhan Ucgul. Diagnostic accuracy of angiopoietin-like protein 2 and atherosclerotic variables in psoriasis vulgaris using ROC analysis. Ann Clin Anal Med 2021;12(4):457-461
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Bakri balloon in the treatment of postpartum hemorrhage
Işık Kaban, Besim Haluk Bacanakgil
Department of Obstetrics and Gynecology, Istanbul Training and Research Hospital, Istanbul, Turkey
DOI: 10.4328/ACAM.20552 Received: 2021-02-25 Accepted: 2021-03-16 Published Online: 2021-03-21 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):462-465
Corresponding Author: Işık Kaban, Department of Obstetrics and Gynecology, Istanbul Training and Research Hospital, Istanbul, Turkey. E-mail: drisikkaban81@gmail.com P: +90 5057946228 Corresponding Author ORCID ID: https://orcid.org/0000-0001-5134-0513
Aim: Bakri Balloon is used in the treatment of postpartum hemorrhage (PPH) for conservative management of uterine bleeding.The aim of this study is to evaluate the results of using Bakri balloon in the treatment of PPH in a 5-year period in a tertiary hospital.
Material and Methods: Patients who underwent Bakri balloon for PPH treatment from October 2015 to December 2020 were retrospectively screened.
Results: The total number of deliveries were 17117, including 9595 vaginal (56%) and 7522 cesarean sections (44%). The Bakri balloon was applied to a total of 60 patients with a median age of 29 years; 20% of these patients were nullipara, 25% primiparous and 55% multiparous. The delivery method of 83.3% of the patients was cesarean section and vaginal delivery in 16.7% of the patients. A previous cesarean section history was present in 60% of the patients. While 47 patients were above the 34th gestational week, 13 patients were below the 34th gestational week.While 40 newborns were healthy, 2 newborns died and 18 were hospitalized in intensive care units. The cause of uterine hemorrhage was placenta previa in 29 patients and uterine atony in 28 patients. Bakri balloon treatment was sufficient in 91.7% of the patients, and no additional method was required. The Bakri balloon application failed in 5 patients (8.3%) and these patients underwent surgery.
Discussion:According to this study, the most common Bakri balloon indications were bleeding due to placenta previa and uterine atony. In these patients, treat- ment with Bakri Balloon was successful. In the treatment of PPH caused by placenta previa or uterine atony after both vaginal delivery or cesarean delivery, obstetricians can benefit from the cushioning effect of the Bakri balloon on the endometrial space to reduce or stop bleeding.
Keywords: Uterine hemorragia; Uterine atony; Pregnancy complications
Introduction
Postpartum hemorrhage (PPH) is defined as a blood loss of 1,000 mL or more or signs and symptoms of hypovolemia within the first 24 hours after delivery and up to 12 weeks postpartum, regardless of method of delivery (vaginal or cesarean) [1]. Early or primary PPH, the most common type occurs within the first 24 hours of delivery. PPH is the cause of approximately 35% of all maternal deaths. In the developing world, about 1.2% of deliveries are associated with PPH, and when PPH occurred, about 3% of women died [2]. Most research on PPH has focused on the PPH prevention. Although controversy continues regarding the optimal protocol for PPH prevention, the use of oxytocin is currently preferred. Misoprostol may be a reasonable option when parenteral administration of uterotonics is not possible [3]. There is little evidence to guide treatment decisions when PPH occurs [4]. Pharmacological, mechanical, and surgical methods to treat PPH are mentioned in many publications [5]. Many reports recommend uterine massage and bladder emptying to induce uterine contractions as first-line therapy. [6] Surgical options are usually laparotomy to apply compression sutures, bilateral uterine and/or hypogastric artery ligation, hysterectomy (total or subtotal) or Pelvic tamponade (abdominal packing) [6-8].
In recent years, many studies have referred to intrauterine balloon tamponade as a second-line therapy, before resorting to emergency peripartum hysterectomy in cases with PPH and uterotonic treatment failure [9-12]. The Bakri balloon is the first specifically designed for the uterus cavity [13].
In this study, the 5-year Bakri balloon experience in a maternity hospital was reviewed. General characteristics of the patients who underwent Bacri balloon, indication, whether the procedure was successful, and the condition of the newborn were analyzed.
Material and Methods
Local ethics committee approval was obtained for this study (Date: February 5, 2021 Number: 2709). In this study, patients with Bakri balloon records for the last 5 years (from October 1, 2015, to December 30, 2020) were scanned from the hospital pharmacy. Since the Bakri balloon is a high-cost device, the insurance system requires an official report, which is recorded in the hospital pharmacy. Patients were found from these records, and then the files of these patients were collected from the hospital archive. The age, gravida, parity, delivery method, gestational week of these patients were found in the patient file. The cause of postpartum bleeding, the condition of the newborn, and whether the Bakri balloon application was successful or not, were recorded in excel format.
Patient selection
As a clinical approach, in the maternity ward, patients are taken to the follow-up room after birth (cesarean or vaginal delivery) where blood pressure, pulse, vaginal bleeding and hemogram are closely monitored. According to this monitoring by the service nurse, the delivery team is informed when PPH is detected. Patients diagnosed with PPH are applied uterine massage and medical treatment (oxitocin and misoprostol) as first-line therapy. Among the patients who did not respond to this treatment, Bakri Balon implanted patients were included in the study. The entire study group consists of patients who failed this first- line treatment. The Bakri balloon was inserted during cesarean section in cases of bleeding during cesarean section (especially in patients with placenta previa) and continuing bleeding despite sufficient suturing in the uterine bed. The Bakri balloon was inflated to an average of 300 to 500 cc. Patients who underwent laparotomy directly for hysterectomy or uterine artery ligation without applying Bakri balloon were excluded from the study.
Results
The total number of deliveries was 17117, including 9595 vaginal (56%) and 7522 cesarean sections (44%). The Bakri balloon was applied in a total of 60 patients with a median age of 29 (14-42) years (Table 1); 20% (n=12) of these patients were nullipara, 25% (n=15) primiparous and 55% (n=33) multiparous. In terms of delivery method, 83.3% (n = 50) of the patients had a cesarean section and 16.7% (n = 10) had a vaginal delivery. 60% (n = 36) of the patients had a previous cesarean section history. While 47 patients (78.3%) were above the 34th gestational week, 13 patients (21.7%) were below the 34th gestational week. While 40 newborns (66.7%) were healthy, 2 newborns died and 18 received intensive care treatment. In the study group, 2 patients had twin pregnancy and the rest had single pregnancy. The cause of uterine hemorrhage was placenta previa in 29 patients (48.4%) and uterine atony in 28 patients (46.7%). Two patients (3.4%) were diagnosed with placenta accreta and one patient (1.7%) was diagnosed with ablatio placenta and Bakri balloons were applied.
Bakri balloon treatment was sufficient in 91.7% of the patients, and no additional method was required. The Bakri balloon application failed in 5 patients (8.3%), and these patients underwent surgery. Postpartum hysterectomy was applied to three of these patients, hypogastric artery ligation to one and hypogastric artery ligation plus recurrent Bacri balloon to one.
Discussion
In this study, the results of patients who were unresponsive to first-line treatment (oxitocin, misoprostol and uterine massage) for PPH and who were applied Bakri balloon were reviewed. The purpose of Bakri balloon application is to treat uterine bleeding, provided that laparotomy and possible hysterectomy are avoided. The success of the Bakri balloon can be mentioned in patients who have achieved PPH treatment without the need for surgical approach. In our study consisting of 60 patients, we saw that the Bakri balloon was successful in 55 patients (91.7%). According to the results of this study, Bakri balloon seems to be quite effective. We think that patient selection has a critical role in this. We saw that the number of patients with insertion anomalies such as placenta accreta, increta or percreata was low in the study population (2 patients). This approach may be effective in the emergence of this high rate. The predominant group (95.1%) of the study were patients with uterine atony or placenta previa.
Postpartum hemorrhage continues to be a gross cause of maternal deaths [2]. Timely and appropriate approach plays a critical role in preventing maternal death. There are many publications in the literature on the place of the Bakri balloon at PPH, and a consensus seems to have been occurred for the Bakri balloon with meta-analyses and systematic reviews in recent years [14-16].
Application of Bakri balloon instead of uterine-sparing surgical approaches (uterine/hypogastric artery ligation, B-lynch suture) is more advantageous to prevent the morbidity of the surgery. In this topic, Ramler et al. in their study, compared uterine artery embolization and uterine balloon tamponade in 100 patients with postpartum hemorrhage and stated that no difference in the risk of peripartum hysterectomy and/or maternal death was observed between women who had intrauterine balloon tamponade and women who underwent uterine artery embolization as initial management for persistent postpartum hemorrhage [9]. In another study, Kaya et al. found that the Bakri balloon and B-Lynch suture had similar success rates in uterine atony during cesarean section [11].
Grange et al. found 74.1% Bakri balloon success for persistent PPH in their study and stated that Bakri balloon is an effective second-line treatment for persistent primary PPH. In their study, they found that pre-pregnancy obesity was a risk factor for Bakri balloon failure [17]. Cho et al. used a Bakri balloon during cesarean section due to postpartum bleeding from the lower uterine segment and they found that Bakri balloon was successful in 75% of the patients and stated that Bakri balloon is an adequate adjunct management for postpartum hemorrhage following cesarean section for placenta previa to preserve the uterus [18]
This study has limitations such as being retrospective, partially a small number of patients, and lack of some data. If it was recorded how many cc of Bakri balloon was inflated for each patient, more useful results could be obtained.
In conclusion, intrauterine tamponade with a Bakri balloon can be considered as an option before the surgical approach, especially in patients with PPH due to uterine atony or placenta previa who do not respond to first-line therapy such as uterine massage, oxytocin and misoprostol. Identifying the group with the high probability of failure of the Bakri balloon also plays a critical role.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
References
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9. Ramler PI, Henriquez DDCA, van den Akker T Comparison of outcome between intrauterine balloon tamponade and uterine artery embolization in the management of persistent postpartum hemorrhage: A propensity score-matched cohort study. Acta Obstet Gynecol Scand. 2019;98(11):1473-82.
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11. Kaya B, Guralp O, Tuten A, Unal O, Celik MO, Dogan A. Which uterine sparing technique should be used for uterine atony during cesarean section? The Bakri balloon or the B-Lynch suture? Arch Gynecol Obstet. 2016;294(3):511-7.
12. Nagai S, Kobayashi H, Nagata T, Hiwatashi S, Kawamura T, Yokomine D, et al. Clinical Usefulness of Bakri Balloon Tamponade in the Treatment of Massive Postpartum Uterine Hemorrhage. Kurume Med J. 2016;62(1-2):17-21.
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18. Cho HY, Park YW, Kim YH, Jung I, Kwon JY. Efficacy of Intrauterine Bakri Balloon Tamponade in Cesarean Section for Placenta Previa Patients. PLoS One. 2015;10(8).
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Işık Kaban, Besim Haluk Bacanakgil. Bakri balloon in the treatment of postpartum hemorrhage. Ann Clin Anal Med 2021;12(4):462-465
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Frequency of antibiotic use in the end-of-life cancer patients
Semiha Urvay 1, Hatice Karagöz 2
1 Department of Radiotherapy, Acibadem University Vocational School of Health Services, İstanbul, 1 Department of Medical Oncology, Acibadem Kayseri Hospital, Kayseri, 2 Department of Internal Medicine, Acıbadem Kayseri Hospital, Kayseri, Turkey
DOI: 10.4328/ACAM.20567 Received: 2021-03-04 Accepted: 2021-03-19 Published Online: 2021-03-24 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):466-469
Corresponding Author: Semiha Urvay, Acibadem University Vocational School of Health Services, Radiotherapy, İstanbul/ Acibadem Kayseri Hospital, Medical Oncology, Mustafa Kemal Paşa street, No:1, 38030, Melikgazi, Kayseri, Turkey. E-mail: s.elmaci@yahoo.com.tr P: +905541817500, +90 352 2073 915 Corresponding Author ORCID ID: https://orcid.org/0000-0002-0181-3842
Aim: Making decisions about how to maintain general medical care and manage complications for patients in the last stage of advanced cancer is difficult. The benefits and necessity of antibiotic use in the last period of life are controversial. In this study, we aimed to investigate the frequency of antibiotic use in terminal stage cancer patients followed up with palliative care and died during their hospitalization.
Material and Methods: One hundred twenty-one patients from January 2015 to June 2020 were included.
Results: Among the 121 patients, 104 (86%) received antibiotics. Eighty-five (81.7%) patients received antibiotics until death. The mean duration of antibiotic treatment was 8.9 days. Antibiotic treatment was started 1 week before death in 88 (84.6%) of 104 patients who used antibiotics. The number of patients whose antibiotic treatment was discontinued was 3 (15.7%) in hospital wards and 16 (84.2%) in the intensive care unit.
Discussion: This is the first study on the frequency of antibiotic use in the end-of-life cancer patients in our country, and we found that the antibiotic prescrip- tion rate is high in dying cancer patients. It is questionable whether such care has positive effects on survival or quality of life. Guidelines on antibiotic use and discontinuation in patients with end-stage cancer should be developed.
Keywords: Palliative care; Cancer; Death; Dying; Infectious disease; Antibiotics
Introduction
Making decisions about how to maintain general medical care and manage complications for patients in the last stage of advanced cancer is extremely difficult for clinicians. The goal of palliative care is to help people die with dignity, but there may come a time when treatment can do more harm than good to patients.
Infections are one of the most common causes of morbidity and mortality in cancer patients [1]. However, the clinical evidence for using or not using antibiotics in the end- of-life period is scarce, and the results are divergent [2-4]. Studies have shown that the frequency of antibiotic use in dying cancer patients varies greatly [5-7]. The use of antibiotics in dying cancer patients was found to be higher in hospitals than in hospice or palliative care centers [8-10].
Due to the lack of hospice care and the newly established palliative care centers, most of the terminal stage cancer patients still die in hospitals in our country. The aim of this study is to investigate the frequency of antibiotic use in patients with cancer in their last period of life.
Material and Methods
One hundred twenty-one terminal stage cancer patients who were followed up with palliative care and died in hospital from January 2015 to June 2020 were included. The term of terminal stage was used for patients who could not receive chemotherapy, radiotherapy or surgery due to reasons such as poor performance status or disease progression, and these patients received palliative care only for symptom control. Patient’s data were retrieved from medical records. Demographic data, including age, sex, primary cancer site and characteristics of infective episodes, including the site of infection, bacteriological results, use of second-line antibiotics, number of days of antibiotic use and stopping or not stopping antibiotics before death were recorded. The study was approved by the Acibadem University Ethics Committee.
Statistical Analyses
Data were analyzed using the statistical program Statistical Package for the Social Sciences (SPSS), version 20. We reported continuous variables as mean ± standard deviation. Categorical variables were defined as numbers (n) and percentages (%).
Results
There were 68 men and 53 women, and the mean patient age was 64.3±11.1 (29-87 years). Patient characteristics are shown in Table 1.
Among the 121 patients, 104 (86 %) received antibiotics. The mean duration from admission to death for all patients was 9.7±7.8 (1-30) days, and the mean duration of antibiotic use was 8.93±7.5 (1-30) days. Antibiotic treatment was started 1 week before death in 88 (84.6%) of 104 patients who used antibiotics. It was found that 80 (76.9%) of these patients lived less than 14 days. Eighty-five (81.7%) patients received antibiotics until death, only 19 (18.3%) had their antibiotic treatment discontinued before death. The mean duration of antibiotic withdrawal before death was 7.3 days. The number of patients whose antibiotic treatment was discontinued was 3 (15.7%) in the hospital wards and 16 (84.2%) in the intensive care unit. Sixty-four (52.8 %) patients died in the hospital wards, while 57 (47.1%) patients died in the intensive care unit. Culture was performed in 81 (77.8%) patients who received antibiotics. The culture was positive in 39 (48.1%) of these patients. In 18 (46.2%) patients, microorganisms were detected in blood culture, in 10 (25.6%) in urine, in 4 (10.3%) in sputum and respiratory secretions, and in 5 (12.8%) in pus. The infection episodes are shown in Table 2.
Discussion
The use of antibiotics in near-death cancer patients poses a dilemma. Patients with advanced cancer are more susceptible to infection [11-13]. It is not possible to predict whether antibiotics will cure or whether withholding them will result in death [8]. Currently, there is no consensus regarding the use of antibiotics for patients in palliative care, and there is still uncertainty regarding ethical and legal issues such as stopping or interrupting antibiotic treatment [11-19]. Antibiotics for terminally ill patients may have some benefits, and although limited, they also have the potential to prolong life [10,11,16]. However, even if the risks of antibiotic use are low, they can be significant for frail patients. Antibiotics can also harm patients by prolonging the dying process [20-22].
Most data on antibiotic use in end-of-life patients comes from hospices and palliative care centers, hospitals data are limited. The frequency of prescribing antibiotics varies significantly between centers, but data show that antibiotic use in hospitals is higher than hospice and palliative care centers [3,7,9]. Oneschuk et al., showed that this rate was 58% in acute care hospitals, 52% in tertiary palliative care units, and 22% in hospice [9]. However, in the teaching hospitals, 83% of individuals with cancer in their terminal hospitalization were treated with antibiotics in a review including eight studies [11]. In another study examining cancer patients who died in hospital, 86.9% of patients used antibiotics, and 35.4% of these patients continued to receive antibiotics after a transition to comfort care [7]. In this study, we found that 86% of the patients who were followed up in the hospital for palliative care used antibiotics. While this rate is higher than in hospice or palliative care units, it is similar to hospital data, in accordance with the literature.
Differences in the ‘end-of-life’ decisions of physicians, family members, and patients, and differences in the organization of health systems may cause differences in antibiotic use across societies towards the end of life. While it was shown that 14% of the patients who were followed up in hospice with a primary diagnosis of cancer received antibiotic treatment in the last week of life in the USA [23], this rate was found to be 85.7% in a similar study from China [5]. While some doctors are concerned that the decision to discontinue antibiotics may risk shortening the life of the patient, others worry that this therapy may prolong the death process. We determined the antibiotic withdrawal rate before death as 18.2%. This rate is lower than antibiotic withdrawal rates in hospices in Western countries. Interestingly, this ratio was 15,7% in the hospital wards and 84,2% in the intensive care unit. Explanations for the difference in antibiotics withdrawal rates in the intensive care unit are unknown.
Study Limitations
There are several limitations to our study. First, our study was a single-centered study in a private hospital and may not reflect public hospitals practices. There are no large databases, and end-of-life care remarkably varies from hospital to hospital. Another limitation is the lack of data on decisions about using antibiotics in patients or whether they benefit from treatment. However, the main purpose of this study was not the reasons or benefit of using antibiotics.
Conclusion
To the best of our knowledge, this is the first study on the frequency of antibiotic use in the end-of-life cancer patients in our country.
Our study found that the antibiotic prescription rate is high in dying cancer patients. The main reasons for these high rates may be follow-up of the patients in the hospital instead of the hospice, the reluctance to stop the treatment initiated, cultural differences and the lack of guidelines on the use of antibiotics.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Semiha Urvay, Hatice Karagöz. Frequency of antibiotic use in the end-of-life cancer patients. Ann Clin Anal Med 2021;12(4):466-469
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Comparison of ultrasound-guided single vs bi-level erector spinae plane block for postoperative pain in benign thoracotomy operations
Ersagun Tuğcugil 1, Ahmet Beşir 1, Ahmet Şen 2
1 Department of Anesthesiology, KTU Farabi Hospital, Medical School of Karadeniz Technical University, 2 Department of Anesthesiology, Kanuni Education and Research Hospital, University of Healthy Sciences, Trabzon, Turkey
DOI: 10.4328/ACAM.20570 Received: 2021-03-05 Accepted: 2021-03-22 Published Online: 2021-03-25 Printed: 2021-04-01 Ann Clin Anal Med 2021;12(4):470-473
Corresponding Author: Ersagun Tuğcugil, Department of Anesthesiology, KTU Farabi Hospital, Medical School of Karadeniz Technical University, 61080 Trabzon, Turkey. E-mail: erstug@gmail.com P: +90 (462) 377 5398 F: + 90 (462) 325 59 09 Corresponding Author ORCID ID: https://orcid.org/0000-0002-1963-2206
Aim: Chronic postoperative pain may develop in more than half of patients after thoracotomy. Studies have shown that the Erector Spinae Plane Block is both an effective and safe analgesia method for thoracotomy. This study aims to investigate the effect of 10 ml 0.5% bupivacaine on postoperative pain in two doses divided from T4-T6 level with a single dose of 20 ml 0.5% bupivacaine from T5 level.
Material and Method: Sixty-three patients aged 20-55 years who underwent thoracotomy were included in the study. The patients were divided into two groups as single-level (Group S, n: 32) and bi-level (Group B, n: 31). Pain scores, intraoperative remifentanil, and postoperative 24-hour morphine consumption were recorded at postoperative hours 1, 6, 12, and 24.
Results: Postoperative visual analog pain scores were significantly lower (p<0.001) at 1, 6, and 12 hours in single-level block patients. There was a significant decrease in intraoperative remifentanil consumption and postoperative 24-hour morphine consumption in the single-level block group (p<0.001).
Discussion: It was concluded that 20 ml 0.5% bupivacaine with a single injection provided lower pain scores and decreased the need for additional morphine during the postoperative 24 hours.
Keywords: Nerve block; Thoracotomy; Postoperative pain; Opioid
Introduction
Chronic postoperative pain may develop in 25-60% of patients after thoracotomy [1]. Thoracic epidural analgesia and paravertebral block are commonly used to relieve post- thoracotomy pain after thoracic surgery [2,3]. However, the failure and complication rates are high since these techniques are difficult to perform [4,5]. Erector spinae plane block (ESPB) is preferred because it is easy to apply in patients undergoing thoracic surgery and provides safe and effective analgesia [6- 8]. Clearer visualization of anatomical structures has increased the popularity of ESPB with advances in ultrasound technology in recent years. Single and multiple injection techniques have been used in ESPB applications in the literature [9,10]. In this current study, we thought that the patient comfort would increase, and the complication rate would decrease with single- level injection, and local anesthetic distribution would be more reliable in bi-level injections. Thus, this study aims to compare the effect of two different injection techniques on postoperative analgesia.
Material and Methods
The study was conducted in the thoracic surgery operating room of KTU Farabi Hospital after obtaining approval from the local ethics committee (2017-588) for our randomized controlled, observer-blind study. Our study was conducted between December 2017 and January 2020 in 63 patients aged 20-55 years who were scheduled for posterolateral thoracotomy (lobectomy, but without chest wall resection and pneumonectomy) at the level of T5-T6. Exclusion criteria for patients were: age ≤20 or ≥55 years, body mass index (BMI) >30 or ≤18 kg/m2, skin infection at the ESPB site, any known allergies, pre-existing pain syndromes, patients with pregnancy, malignancy, severe liver disorders, kidney disorders (serum creatinine greater than 2 mg/dL, oliguria, anuria or hemodialysis), or cardiovascular disorders.
During the preoperative visit, patients were informed about the postoperative visual analog scale (VAS) used to assess pain scores and the use of the patient-controlled analgesia (PCA) device. The patients were divided into two groups as single- level of ESPB (Group S) or bi-level of ESPB (Group B) with computer-generated randomization. The study design is shown as a consort diagram in Figure 1.
In the regional block application room, patients were noninvasively monitored with a pulse oximeter, continuous arterial blood pressure, and an electrocardiogram. ESPB was performed in the sitting position. The same ultrasound device (Mindray Diagnostic Ultrasound System, DC-T6, Shenzhen, China) and 10 MHz ultrasound probe, and 21 G, 100 mm block needle (Stimuplex® A, B.Braun, Melsungen AG, Germany) were used in all blocks. Single-level block applications were performed with 20 ml 0.5% bupivacaine at the T5 level, and bi-level applications were performed at the levels of T4 and T6, 10 ml 0.5% bupivacaine each.
The probe was moved downwards to detect the T5 spinous process, and the probe was positioned 2 cm laterally to the spinous process after the detection of the C7 spinous protrusion by palpation in Group S. The trapezius muscle, rhomboideus major muscle, and erector spinae muscles were visualized from the outside to the inside. The needle was advanced in the craniocaudal direction towards the midpoint of the T5 transverse process using the in-plane technique after providing a clear ultrasound image of the pleura and T5 transverse process. After 0-5-1 ml saline injection, the local anesthetic mixture was injected into the target point to confirm the needle position. The same procedures were performed separately by dividing the local anesthetic dose from both T4 and T6 levels in Group B. The sensory block was performed with unilateral cold application in the 6th intercostal area in the midaxillary line. Patients without a sensory block at the end of 30 minutes were excluded from the study.
All patients received 1.5-2.0 mg/kg of intravenous propofol, and 1 μg/kg fentanyl to induce general anesthesia. Neuromuscular block was obtained with 0.6 mg/kg of intravenous rocuronium. The placement of the double-lumen endotracheal tube was confirmed with a fiberoptic bronchoscope. All patients were monitored with the bispectral index to ensure a level of 40- 60. Anesthesia was maintained with sevoflurane and 0.05– 0.5 μg/kg/min of intravenous remifentanil infusion. A 25 μg remifentanil bolus dose was administered, and the infusion dose was increased in case of a 20% increase in blood pressure compared to baseline and a 20% difference in heart rate despite appropriate fluid resuscitation. All patients underwent a 15-20 cm long incision and excision of the serratus anterior, latissimus dorsi, and intercostal muscles. All patients underwent chest tube insertion through the T8 intercostal space. Patients received intravenous doses of 1 g paracetamol and 100 mg tramadol for postoperative analgesia approximately 30 minutes before the end of surgery.
At the end of the surgery, all patients were extubated and transferred to the ICU. Patient-controlled analgesia was applied to all patients in the intensive care unit with a PCA device containing morphine with the following settings: 1 mg bolus for 8 minutes, and 0.5 mg/ml continuous infusion, a limit of 6 mg per hour. PCA was terminated when side effects such as SPO2 <95%, respiratory rate <10/min, development of sedation (Ramsay sedation scale >2), allergy, itching, vomiting, and a decrease in systolic blood pressure of more than 20% occurred. Tramadol was administered intravenously for rescue pain if VAS > 3 despite PCA.
Demographic data, duration of operation and anesthesia, intraoperative remifentanil consumption were recorded. Patients were asked to score pain their levels at the 1st, 6th, 12th, and 24th hours using the VAS after surgery. The total demand times of PCA were read from PCA memory and the 24-hour morphine consumption, morphine-related side effects (nausea, vomiting, itching, and respiratory depression) and the amount of tramadol were recorded.
Statistical Analysis:
The total number of samples was calculated as 52 (Type 1 error=0.05, type 2 error=0.20, and effect size=0.7) based on the study conducted by Gürkan Y. et al. [11]. It was decided to include approximately 63 patients in the study, considering possible data losses (20%). Descriptive statistics were given as mean±standard deviation and number(frequency%). For intergroup comparisons, the Mann-Whitney U test and the Chi-square tests were used. A p- value <0.05 was considered significant.
Results
The study involved a total of 66 patients in Group B (n=34) and Group S (n=32). One patient in Group B and 2 patients in Group S were excluded from the study because the sensory block did not reach the T5 level. Demographic data are shown in Figure 1. Intraoperative remifentanil consumption was significantly lower (p< 0.001) in Group S (515±63.8 μg) compared to Group B (588±64 μg). Postoperative VAS scores were significantly lower (p<0.01) at 1st, 6th, and 12th hours in Group S (Table 3). In addition, 24-hour morphine consumption in Group S (5.84±1.24 mg) was significantly lower (p<0.001) compared with Group B (8.66 ±1.35 mg). Nausea-vomiting occurred in 9 patients (28.1%) in Group S and 13 patients (40.6%) in Group B and was significantly different (p=0.03). The amount of rescue analgesic tramadol was similar between groups (p>0.05, Table 2).
Discussion
Erector spinae plane block is a new regional analgesia technique that has recently begun to be applied. The erector spinae plane is located between the erector spinae muscle and the transverse process. Local anesthetic, injected into this plane, spreads to the paravertebral area, intervertebral area, dorsal and ventral rami of thoracic spinal nerves [12]. Thus, it affects the retrolaminar and paravertebral block areas in this way [13]. The likelihood of damage to the neuraxial structures, pleura, and major vascular structures is very low since transverse processes can be seen on USG and anatomical signs are prominent. ESPB using USG has been reported to be a safer alternative to thoracic epidural and paravertebral block [6, 14].
This current study showed that patients with single-level ESPB had better pain scores after thoracotomy surgery. In addition, morphine consumption during the postoperative 24-hour period was less when a single-level block was performed.
ESPB is important in providing adequate analgesia of the nerve block, the dose of the local anesthetic, the region where it is applied and its spread, as with all interfascial plane blocks. There are conflicting results regarding the optimal dose of local anesthetic and the mechanism of action of ESPB. It was stated that ESPB may provide visceral analgesia through spreading to the anterior direction along the paravertebral area and by passing to the ventral and dorsal rami [14-16]. Examination of cadavers showed that injection of 20 ml of normal saline and methylene blue to the erector spinae plane at the T5 level spread 5 levels in the craniocaudal direction, but the spread to neural foraminal and epidural spaces was limited to 2-3 levels [16]. Another cadaver study using 10 ml of distilled water, latex and green ink at the same injection site reported no spread to the paravertebral area and only 2 levels of craniocaudal spread [17]. In contrast, a case report showed spread of local anesthetic to the paravertebral area and epidural space following ESPB using 20 ml of local anesthetic at the T5 level, resulting in sensory block at level of T4-T7 and sufficient visceral analgesia [18]. Another case report showed T2-T7 level dermatomal analgesia and paravertebral and neural foraminal spread on computerized tomography with 25 ml of local anesthetic applied at the T5 level with ESPB [19]. In accordance with the clinical and cadaver studies mentioned above, we thought that pain scores were good and opioid consumption was low, since both paravertebral and craniocaudal spread of 20 ml of local anesthetic was sufficient in our study. Consistent with the study by Choi et al, the higher pain scores and morphine consumption in our study may be due to inadequate spread with 10 ml of local anesthetic [17].
Tulgar et al. [9] compared the effect of two-dose ESPB at bi- level on pain scores, intraoperative, and postoperative opioid consumption of single-dose ESPB at single level in thoracotomy cases in a study similar to our study. They found better pain scores and less opioid consumption with bi-level injections. However, they used a higher volume (30 ml) of local anesthetic compared with our study. Sufficient spread may have occurred with bi-level application since a high volume of local anesthetic is used. In contrast to the study by Tulgar et al., we used a lower volume with a higher concentration.
Patients who underwent thoracotomy surgery for non-cancer etiologies were included in our study, unlike the studies conducted in the literature using ESPB in thoracotomy surgery. Thus, it was ensured that the existing cancer-related pain did not affect postoperative pain scores and other frequency of side effects.
Conclusion
We have concluded that the use of 20 ml 0.5% bupivacaine with a single level injection provides better postoperative analgesia compared with bi-level block.
Limitation:
There were several limitations in our study. First, it is known that the rate of local anesthetic injection affects the spread in the neuraxial area and the number of dermatomes it forms the block. However, we did not include this parameter in our study. Secondly, we could not support the spread of the local anesthetic dose administered with two different methods using imaging techniques.
Scientific Responsibility Statement
The authors declare that they are responsible for the article’s scientific content including study design, data collection, analysis and interpretation, writing, some of the main line, or all of the preparation and scientific review of the contents and approval of the final version of the article.
Animal and human rights statement
All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No animal or human studies were carried out by the authors for this article.
Funding: None
Conflict of interest
None of the authors received any type of financial support that could be considered potential conflict of interest regarding the manuscript or its submission.
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Ersagun Tuğcugil, Ahmet Beşir, Ahmet Şen. Comparison of ultrasound-guided single vs bi-level erector spinae plane block for postoperative pain in benign thoracotomy operations. Ann Clin Anal Med 2021;12(4):470-473
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