Clinical Research Ethics Committee Research Articles

Non-hiatal diaphragmatic hernias: results of transabdominal and transthoracic surgical approaches at a fourth-level hospital.

The objective of this study is to elucidate the clinical and demographic profiles, as well as perioperative outcomes, of patients undergoing surgery for non-hiatal diaphragmatic hernias. Additionally, it aims to analyse these outcomes based on the surgical approach employed (transthoracic versus transabdominal). This retrospective, observational study was conducted at a single center and involved patients diagnosed with non-hiatal diaphragmatic hernia who underwent either emergency or elective surgery between July 2007 and March 2023. Clinical characteristics and perioperative outcomes of these patients were compared using appropriate statistical tests.The research protocol for this observational, retrospective, and comparative study followed the Declaration of Helsinki's ethical requirements. The need for Clinical Research Ethics Committee approval was waived according to our institutional law because the study was a retrospective cohort study based on anonymous data of patients. Informed consent was waived because this study involved the secondary analysis of patient medical records. Additionally, this study followed the STROBE guidelines for reporting observational studies. The analysis included 22 patients being 59.1% men, with median age of 61years. The predominant clinical presentation was restrictive lung disease (40.9%). The majority of cases (68%) had traumatic aetiology with a median defect size of 4cm (range of 3-8cm). Elective surgery was performed in 15 cases (68.1%) and transthoracic approach was employed in 13 patients (54.5%). Postoperative major morbidity reached 27.2% and mortality within 30days was 9.1%. Emergency surgeries accounted for 44.4% of transabdominal interventions, compared to 23% in the transthoracic subgroup (p = 0.376). There were no statistically significant differences between the transabdominal and trasnthoracic approaches in terms of global postoperative complications (88.8% vs. 84.6%, p = 1), major complications (44.4% vs 15.4%, p = 0.734), mortality (11.1% v 7.6%, p = 1) and recurrence (11.1% vs 7.6%, p = 1). Postoperative stay was significantly shorter in the transthoracic subgroup (6days vs. 14days, p = 0.011). Non-hiatal diaphragmatic hernias are characterized by significant postoperative major morbidity and mortality rates, standing at 27.2% and 9.1%, respectively, accompanied by a recurrence rate of 9.1%. Both transthoracic and transabdominal approaches demonstrate comparable short- and long-term outcomes.

Hospital Environmental Factors That Influence Peripheral Oxygen Saturation Measurements: A Cross-Sectional Study.

Pulse oximetry is a non-invasive, cost-effective, and generally reliable instrument measuring pulse rate and peripheral oxygen saturation (SpO2). However, these measurements can be affected by the patient's internal or external factors, including the type of pulse oximeter device (POD). (1) This study's objective was to identify potential environmental factors that may impact the measurements taken by three PODs. (2) Methods: A descriptive-analytical cross-sectional study was designed. The patients' SpO2 levels were measured using a standard monitor and two PODs owned by the professionals. The measurements were taken on the patients' fingers. Concurrently, we evaluated the surrounding environmental conditions, encompassing temperature, humidity, illuminance, and noise. (3) Results: This study involved 288 adult participants in the sample. For each 20-decibel increment in noise, there was a reduction in SpO2 by an average of 1%, whereas for every additional degree of ambient temperature, SpO2 decreased by an average of 2% (4) Conclusions: Significant correlations between SpO2 and age, as well as with noise and ambient temperature, were observed. No significant differences between oxygen saturation and lighting or humidity were observed. This study was prospectively registered with the Clinical Research Ethics Committee of Gran Canaria at the Dr. Negrín University Hospital, with protocol code 2019-247-1, and approved on 24 May 2019.

BREASTFEEDING ATTITUDES AND EXPERIENCES OF BREASTFEEDING WOMEN INFECTED WITH COVID-19: A MIXED METHODS STUDY

Aim: The aim of this study was to learn more about the attitudes and experiences of breastfeeding women infected with COVID-19. Method: A convergent parallel mixed methods design was used to conduct the study. The study included breastfeeding women who presented COVID-19 symptoms and tested positive for COVID-19, and who sought care at a community health center in a province located in the Black Sea region of Turkey. Quantitative and qualitative data for the study were collected online between July 2021 and February 2022. Data for the study were collected using the 'Socio-demographic Information Form', the 'Breastfeeding Attitude Scale' and the 'Semi-structured Interview Form'. Data were collected from 82 women for the quantitative part and seven women for the qualitative part. Before the research began, study approval was obtained from the TR Ministry of Health and ethical approval was granted by the Clinical Research Ethics Committee of Ondokuz Mayıs University (25 June 2021/ OMU KAEK2021/316). Results: The number of children, age of the baby, breastfeeding initiation and nutritional status of the baby were found to influence breastfeeding attitudes. The overall mean score of the breastfeeding attitude rating scale was 91.7710.63. Five themes were identified as a result of the content analysis: "Women's feelings during the disease," "How the disease affects the babies," "Woman-baby contact," "COVID -19 and breastfeeding," and "Status of support for women".Conclusions and Suggestions: It was found that women's attitudes towards breastfeeding during the disease process are moderate, that they experience considerable anxiety during this time, and that the support they receive affects both their psychological state and their attitudes towards breastfeeding. During this process, continuous online or phone support may improve women's attitudes towards breastfeeding.

The effect of ultrasound-guided rectus sheath block on postoperative analgesia in robot assisted prostatectomy: A randomized controlled trial.

Postoperative pain continues to represent an important problem even after minimally invasive robotic-assisted laparoscopic radical prostatectomy, which results in discomfort in the postoperative period and sometimes prolongs hospital stays. Regional anesthesia and analgesia techniques are used in addition to systemic analgesics with the multimodal approach in postoperative pain management. Ultrasound-guided fascial plane blocks are becoming increasingly important, especially in minimally invasive surgeries. Another important cause of discomfort is urinary catheter pain. The present randomized controlled study investigated the effect of rectus sheath block on postoperative pain and catheter-related bladder discomfort in robotic prostatectomy operations. This randomized controlled trial was conducted from March to August 2022. Written informed consent was obtained from all participants. Approval for the study was granted by the Clinical Research Ethics Committee. All individuals provided written informed consent, and adults with American Society of Anesthesiologists Physical Condition classification I to III planned for robotic prostatectomy operations under general anesthesia were enrolled. Following computer-assisted randomization, patients were divided into 2 groups, and general anesthesia was induced in all cases. Rectus sheath block was performed under general anesthesia and at the end of the surgery. No fascial plane block was applied to the patients in the non-rectus sheath block (RSB) group.Postoperative pain and urinary catheter pain were assessed using a numerical rating scale. Fentanyl was planned as rescue analgesia in the recovery room. In case of numerical rating scale scores of 4 or more, patients were given 50 µg fentanyl IV, repeated if necessary. The total fentanyl dose administered was recorded in the recovery room. IV morphine patient-controlled analgesia was planned for all patients. All patients' pain (postoperative pain at surgical site and urethral catheter discomfort) scores and total morphine consumption in the recovery unit and during follow-ups on the ward (3, 6, 12, and 24 hours) in the postoperative period were recorded. Sixty-one patients were evaluated. Total tramadol consumption during follow-up on the ward was significantly higher in the non-RSB group. Fentanyl consumption in the postanesthesia care unit was significantly higher in the non-RSB group. Total morphine consumption was significantly lower in the RSB group at 0 to 12 hours and 12 to 24 hours. Total opioid consumption was 8.81 mg in the RSB group and 19.87 mg in the non-RSB group. A statistically significant decrease in urethral catheter pain was noted in the RSB group at all time points. RSB exhibits effective analgesia by significantly reducing postoperative opioid consumption in robotic prostatectomy operations.

De-imFAR phase II project: a study protocol for a cluster randomised implementation trial to evaluate the effectiveness of de-implementation strategies to reduce low-value statin prescribing in the primary prevention of cardiovascular disease

IntroductionThis study aims to reduce potentially inappropriate prescribing (PIP) of statins and foster healthy lifestyle promotion in cardiovascular disease (CVD) primary prevention in low-risk patients. To this end, we will...

Aspirin versus metformin in pregnancies at high risk of preterm pre-eclampsia in China (AVERT): protocol for a multicentre, double-blind, 3-arm randomised controlled trial

IntroductionPre-eclampsia (PE) affects about 5% of Chinese pregnant women and is a major cause of maternal and perinatal morbidity and mortality. The first trimester screening model developed by the Fetal...

The Change in the Thoughts and Feelings after the Orientation Education of Nurses Starting Work during the COVID-19 Pandemic

Objective: The aim of this study was to determine the change in the thoughts and feelings after the orientation education of nurses who started work during the COVID-19 pandemic.
 Methods: This research was designed as a semi-experimental study with a single group applied with pre-test and post-test. The study was conducted with 358 nurses. The data were collected using the “Nurse Info Form”, “Pre-Orientation Evaluation Form” and “Post-Orientation Evaluation Form”. Approval for the study was granted by the Clinical Research Ethics Committee and permission was also received from the institution where the study was conducted. Data obtained in the study were analyzed statistically using Number Cruncher Statistical System Statistical Software (Utah, USA).
 Results: In the examination of the positive feelings, there was seen to be a statistically significant increase after the orientation education compared to before concerning feeling self-motivated, satisfied, and safe. In the examination of the negative feelings, there was seen to be a statistically significant decrease after the orientation education compared to before concerning feeling anxious. 
 Conclusions: The planning and application of orientation education taking the thoughts and feelings of nurses into account will facilitate adaptation to work.

Comparison of emergency medicine specialist, cardiologist, and chat-GPT in electrocardiography assessment

IntroductionChatGPT, developed by OpenAI, represents the cutting-edge in its field with its latest model, GPT-4. Extensive research is currently being conducted in various domains, including cardiovascular diseases, using ChatGPT. Nevertheless, there is a lack of studies addressing the proficiency of GPT-4 in diagnosing conditions based on Electrocardiography (ECG) data. The goal of this study is to evaluate the diagnostic accuracy of GPT-4 when provided with ECG data, and to compare its performance with that of emergency medicine specialists and cardiologists. MethodsThis study has received approval from the Clinical Research Ethics Committee of Hitit University Medical Faculty on August 21, 2023 (decision no: 2023–91). Drawing on cases from the “150 ECG Cases” book, a total of 40 ECG cases were crafted into multiple-choice questions (comprising 20 everyday and 20 more challenging ECG questions). The participant pool included 12 emergency medicine specialists and 12 cardiology specialists. GPT-4 was administered the questions in a total of 12 separate sessions. The responses from the cardiology physicians, emergency medicine physicians, and GPT-4 were evaluated separately for each of the three groups. ResultsIn the everyday ECG questions, GPT-4 demonstrated superior performance compared to both the emergency medicine specialists and the cardiology specialists (p < 0.001, p = 0.001). In the more challenging ECG questions, while Chat-GPT outperformed the emergency medicine specialists (p < 0.001), no significant statistical difference was found between Chat-GPT and the cardiology specialists (p = 0.190). Upon examining the accuracy of the total ECG questions, Chat-GPT was found to be more successful compared to both the Emergency Medicine Specialists and the cardiologists (p < 0.001, p = 0.001). ConclusionOur study has shown that GPT-4 is more successful than emergency medicine specialists in evaluating both everyday and more challenging ECG questions. It performed better compared to cardiologists on everyday questions, but its performance aligned closely with that of the cardiologists as the difficulty of the questions increased.

Multicentre randomised trial of screening with sFlt1/PlGF and planned delivery to prevent pre-eclampsia at term: protocol of the PE37 study

IntroductionPre-eclampsia affects ~5%–7% of pregnancies. Although improved obstetric care has significantly diminished its associated maternal mortality, it remains a leading cause of maternal morbidity and mortality in the world. Term...

Efficacy and safety of natural killer cells injection combined with XELOX chemotherapy in postoperative patients with stage III colorectal cancer in China: a prospective randomised controlled clinical trial study protocol

BackgroundColorectal cancer (CRC) is the second most frequently diagnosed cancer and the fifth leading cause of cancer-related death in China. However, resistance to multiple chemotherapeutics after surgery leads to failure...

Predictors and influence of postoperative moderate-to-severe pain of PACU in the patients with malignancy.

This study was identified the risk factors for and designed to investigate influence of postoperative moderate-to-severe pain of post anaesthesia care unit (PACU) in patients with malignancy. A retrospective study was performed on 22,600 cancer patients with malignancy who underwent elective radical surgery in the new hospital of First Affiliated Hospital of Wenzhou Medical University, between January 2016 and June 2021. All patients were transferred to the PACU after tracheal extubation. Patients were divided into two groups according to a visual analogue scale (VAS) score of > 3: the no-moderate-severe-pain group and moderate-to-severe-pain group. Data pertaining to demographic, surgical, anaesthetic, and other factors were recorded. Lasso and logistic regression analysis was performed to explore the risk factors, then a nomogram was constructed to predict the moderate-severe-pain in the PACU. Validation was performed by using another 662 cancer patients in old hospital. The ROC curves and calibration curve were used to evaluate the accuracy and predictive ability of the nomogram. The incidence of postoperative moderate-to-severe pain of PACU in patients with malignancy was 1.42%. Gender, type of surgery, postoperative use of PCA, intraoperative adjuvant opioid agonists, NSAIDS, epidural analgesia, duration of anaesthesia, intraoperative massive haemorrhage, PACU vomiting were independent predictors for postoperative moderate-to-severe pain of PACU in the patients with malignancy. The area under the ROC curve of the predictive models in the primary and validation groups were 0.817 and 0.786, respectively. Moderate-to-severe pain in the PACU correlated with hypertension, hyperglycaemia, agitation, and hypoxemia (P < 0.05). The prediction model for postoperative moderate-to-severe pain of PACU in patients with malignancy has good predictive ability and high accuracy, which is helpful for PACU medical staff to identify and prevent postoperative moderate-to-severe pain in advance. The study was approved by the Clinical Research Ethics Committee of the First Affiliated Hospital of Wenzhou Medical University (No.KY2021-097) and registered in the Chictr.org.cn registration system on 06/12/2021 (ChiCTR2100054013).

Superior mesenteric artery revisited using magnetic resonance angiography.

We aimed to examine the superior mesenteric artery in detail by magnetic resonance angiography to provide an alternative to other imaging methods, to reduce the exposure time of patients and physicians to X-rays and the time spent in catheter angiography, to determine the variations, positions, and locations of the celiac trunk, and to provide detailed information for surgeons and interventional radiologists using this method. The procedures were approved by the Kocaeli University Medical School Non-Interventional Clinical Research Ethics Committee (10.04.2023, approval number: 2021/51). MR angiography images of 185 patients with abdominal imaging in PACS (Picture Archiving Communication Systems) were retrospectively registered. The level of origin of the superior mesenteric artery according to the vertebral column, angle of origin, distance between the superior mesenteric artery and branches of the abdominal aorta, and branching pattern of the superior mesenteric artery were evaluated. Parameters were evaluated according to gender and age using SPSS version 25. The distance between superior mesenteric artery-inferior mesenteric artery and superior mesenteric artery-aortic bifurcation in males was higher than in females, and the difference was statistically significant. In females and the whole study group, a low, positive and significant relationship was found between age and superior mesenteric artery-sagittal angle. The most common origin site for the superior mesenteric artery, according to the vertebral column was found to be at L1 middle for males and L1 upper for females. The most common superior mesenteric artery branching pattern was classical type in both genders. Individual evaluation of the superior mesenteric artery could reduce the risks during surgical interventions, considering the relationship of the superior mesenteric artery, especially with distally located vessels, and the gender differences for the angle of origin. Furthermore, considering that interventional radiologists choose the catheter according to the angle of origin of the artery during catheter angiography procedures, individual evaluation of patients taking into account gender and age is of utmost importance.

Online platform for cardiopulmonary resuscitation and automated external defibrillator training in a rural area: a community clinical trial protocol

IntroductionSudden death resulting from cardiorespiratory arrest carries a high mortality rate and frequently occurs out of hospital. Immediate initiation of cardiopulmonary resuscitation (CPR) by witnesses, combined with automated external defibrillator...

Machine learning-based prediction of composite risk of cardiovascular events in patients with stable angina pectoris combined with coronary heart disease: development and validation of a clinical prediction model for Chinese patients.

Objective: To develop a risk score model for the occurrence of composite cardiovascular events (CVE) in patients with stable angina pectoris (SA) combined with coronary heart disease (CHD) by comparing the modeling effects of various machine learning (ML) algorithms. Methods: In this prospective study, 690 patients with SA combined with CHD attending the Department of Integrative Cardiology, China-Japan Friendship Hospital, from October 2020 to October 2021 were included. The data set was randomly divided into a training group and a testing group in a 7:3 ratio in the per-protocol set (PPS). Model variables were screened using the least absolute shrinkage selection operator (LASSO) regression, univariate analysis, and multifactor logistic regression. Then, nine ML algorithms are integrated to build the model and compare the model effects. Individualized risk assessment was performed using the SHapley Additive exPlanation (SHAP) and nomograms, respectively. The model discrimination was evaluated by receiver operating characteristic curve (ROC), the calibration ability of the model was evaluated by calibration plot, and the clinical applicability of the model was evaluated by decision curve analysis (DCA). This study was approved by the Clinical Research Ethics Committee of China-Japan Friendship Hospital (2020-114-K73). Results: 690 patients were eligible to finish the complete follow-up in the PPS. After LASSO screening and multifactorial logistic regression analysis, physical activity level, taking antiplatelets, Traditional Chinese medicine treatment, Gensini score, Seattle Angina Questionnaire (SAQ)-exercise capacity score, and SAQ-anginal stability score were found to be predictors of the occurrence of CVE. The above predictors are modeled, and a comprehensive comparison of the modeling effectiveness of multiple ML algorithms is performed. The results show that the Light Gradient Boosting Machine (LightGBM) model is the best model, with an area under the curve (AUC) of 0.95 (95% CI = 0.91-1.00) for the test set, Accuracy: 0.90, Sensitivity: 0.87, and Specificity: 0.96. Interpretation of the model using SHAP highlighted the Gensini score as the most important predictor. Based on the multifactorial logistic regression modeling, a nomogram, and online calculators have been developed for clinical applications. Conclusion: We developed the LightGBM optimization model and the multifactor logistic regression model, respectively. The model is interpreted using SHAP and nomogram. This provides an option for early prediction of CVE in patients with SA combined with CHD.

Effects of a multicomponent physical activity programme, Mobility-Fit, compared with a standard care lower limb strengthening programme, to promote safe mobility among older adults in care facilities: protocol for a cluster randomised controlled trial

IntroductionUpper limb and core strength training is essential for older adults to safely perform daily activities. However, existing exercise programmes mainly focus on lower limb strength and are not designed...

Efficacy and safety of the modified Zhiwang decoction combined with methotrexate in early rheumatoid arthritis: study protocol for a randomised controlled trial

IntroductionRheumatoid arthritis (RA) is a progressive inflammatory autoimmune disease characterised by chronic systemic inflammation, which can cause swelling, stiffening and destruction of articular cartilage and bone. Early diagnosis and treatment...

Farklı Ünvan ve Çalışma Merkezlerindeki Diş Hekimleri Tarafından Belirlenen Renk Seçim Kriterlerinin İncelenmesi

Aim: Color selection is an important factor in dentistry in terms of aesthetics and natural appearance. However, different dentists and practice centers may have different approaches to color selection processes. The aim of this study is to investigate how color selection criteria in prosthetic treatments are determined by dentists with different titles in different work centers.&#x0D; Material and Methods: The study obtained approval from the Clinical Research Ethics Committee of Dicle University Faculty of Dentistry (2019/44) and was conducted in September 2019 as a voluntary survey among academics and dentists nationwide. The study consisted of a total of 14 questions, two of which were demographic data and 12 were multiple-choice questions.&#x0D; Results: The study was completed with a total of 437 participants, including 213 males and 224 females. The participants had an average age of 30.6, and 50.6% of them worked in university hospitals. The remaining participants worked in oral and dental health centers, community health centers, state hospitals, private clinics owned by themselves, or private clinics owned by another dentist. In addition, 43.7% were general practitioners, 27.7% were dental students, 17.8% were research assistants, 7.8% were specialist dentists, and 3% were faculty members. The data were evaluated using SPSS 22 (statistical package for the sciences version 22.0) program. The chi-square test was used to evaluate categorical data. Statistical analysis was performed and interpreted for the study data (p

The Emotional State During Cesarean Section and Vaginal Delivery

Alterations in emotional, social, or psychological factors of a woman's life in postpartum could lead to impairing mood disturbances. Depressed mood in mothers in the first days after delivery is named maternity blues and accepted as a common phenomenon in the postpartum phase. The aim of the present study is to determine the mood of the women with pregnancy after delivery. After approval of Clinical Research Ethics Committee, this cross-sectional designed study was enrolled women in postpartum period who underwent vaginal delivery or cesarean section in Department of Obstetrics and Gynaecology, Medical Faculty, Gaziosmanpasa University, Tokat, Turkey. All subjects were invited to complete the questionnaires including Pain Catastrophizing Scale, Beck Depression Inventory, Beck Anxiety Inventory and Short Form-36 in the first 24th hour of postpartum period. The lumbopelvic pain intensity associated with cesarean section incision or episiotomy was evaluated using visual analog scale. The mean age of the participants was 28.43∓5.14. In catastrophizing group, the mean role limitations due to physical health problems, Beck Depression Inventory-C, Beck Depression Inventory-S, Beck Depression Inventory, Beck Anxiety Inventory and visual analog scale in women with cesarean section, and general mental health in women with vaginal delivery were significantly higher compared to each other (p=0.037, p=0.002, p=0.003, p=0.01, p=0.042, p&amp;lt;0.01, p=0.005, respectively). The present study revealed that the psychological condition and quality of life of women may impair after cesarean section, hence it might be beneficial to provide emotional support for patients after cesarean section.

Anatomical variations of the zygomaticofacial foramen and its related canal through the zygomatico-orbital and zygomaticotemporal foramina in dry human skulls.

The aim of this study is to reveal the location of the zygomaticofacial foramina, the variations of their numbers, and their connections between the zygomatico-orbital and zygomaticotemporal foramina. Ethics committee approval of our study was received by the Istanbul Medical Faculty Clinical Research Ethics Committee (date:30.07.2021, number:358356). 171 zygomatic bones of unknown gender from the Department of Anatomy, Istanbul University, were included in this study. The number of zygomaticofacial foramina and their connections with the zygomatico-orbital foramen and the zygomaticotemporal foramina were examined. Also, the morphometric distances between the zygomaticofacial foramen were calculated. Evaluation of the data was done with SPPS v.21. The number of zygomaticofacial foramina was found as 299. It was found single, double, three, four, five and six foramina, in 52 (30.4%), 52 (30.4%), 24 (14.03%), 10 (5.85%), 5 (2.93%), 1 (0.58%) zygomatic bone, respectively. Zygomaticofacial foramen was absent in 27 (15.8%) bones. Of these 299 foramina, 129 were found to be connected with zygomatico-orbital foramen and 23 with zygomaticotemporal foramen. It was noted that 147 zygomaticofacial foramina had no connection with any foramina. The distances between the zygomaticofacial foramen and the frontozygomatic suture, temporal process, maxillary process, the lowest point of the zygomatic bone, and orbital rim were found as 25.30 ± 2.81mm, 18.74 ± 3.56mm, 21.56 ± 4.16mm, 18.72 ± 2.57mm, 6.67 ± 3.27mm, respectively. Consequently, the location and variations of ZFF are of great importance for maxillofacial surgery and regional block anesthesia. Knowing its location and variations will help prevent complications during any surgical intervention in this region.

Establishment and validation of a prediction model for myocarditis in Chinese children below 14 years old: a protocol for a retrospective cohort study

IntroductionPaediatric myocarditis, a rare inflammatory disease, often presents without clear early symptoms. Although cardiac troponin I levels can aid in diagnosing myocarditis, they are not definitive indicators. Troponin I levels...