Search

Background: The ethics committee has the responsibility to comply with the rules and guidelines regarding oversight of all human research activities, particularly when the research study involves vulnerable people. It also has the role of educating researchers on ethical issues, scientific truthfulness, preventing misconduct and conflicts of interest. In our study we evaluate and benchmark the function of the local ethical committees across the country from the researchers point-of-view. Methods: We employed an online IRB-RAT survey to measure perspectives of investigators towards IRB functions dealing with fairness issues, services, bias, and competences and upholding the rights of the human participants. Two responses were recorded: first shows how important an IRB function is for the investigator in his work, second shows how researchers rate their IRBs in being descriptive in that specific function. The difference of these two scores represent the outcome. Results: We had 179 participants, 166(94%) researchers/research coordinators, and 13(7.2%) IRB members, 94 (53%) participants had been working in the research field for more than 11 years, and the majority 163(90%) revealed that they had IRB contact. The largest gap between actual rating and ideal was observed for the item "An IRB that requires that its chair be an experienced investigator" with a score difference of 1.53. In contrast, the smallest score difference was for the item "Considering the protection of human participants," which had a score of 0.51. Conclusion: According's to researchers point of view; IRBs respect researchers, view human protections as a primary role, do not allow personal bias, maintain accurate records and take timely action whenever misconduct is reported. Further collaborations are needed to enhance IRB performance and to engage researchers in more productive communication with their IRBs. [ABSTRACT FROM AUTHOR]

Background: Dentistry is essential for oral health, focusing on the diagnosis, prevention, and treatment of oral diseases. In recent decades, Saudi Arabia has expanded its dental education system, adding new dental schools and postgraduate programs to meet the growing demand for professionals. This study provided a detailed analysis of the trends and demographic characteristics of dental postgraduate programs in Saudi Arabia between 2013 and 2023. Methods: This retrospective study collected data on dental postgraduate programs from the Saudi Commission for Health Specialties (SCFHS) for the period from January 2013 to December 2023. Data were gathered on program types, gender, nationality, and geographic distribution. Descriptive statistics were used to analyze trends and distributions. Key variables included the number of postgraduate dental specialty programs, enrolled students, and training levels (board, fellowship). Institutional Review Board (IRB) approval was obtained, and the data was processed using Microsoft Excel 2016. Results: The study revealed a total of 1,520 dental postgraduates, with a near-equal gender distribution (51.4% males and 48.6% females). Saudi nationals represented 94.8% of board residency graduates, while 2.4% were non-Saudis. Riyadh had the highest concentration of postgraduates, followed by Makkah. A significant increase in postgraduate enrollment was observed, peaking at 398 in 2023. Conclusions: The findings indicate significant growth in Saudi dental postgraduate programs, with regional disparities and increasing numbers of graduates. However, this growth raises concerns about potential unemployment among dental postgraduates, as the number of available positions may not match the surge in graduates. Policymakers must evaluate the expanding programs and their potential impact on the Saudi dental workforce. [ABSTRACT FROM AUTHOR]

Abstarct: Background: The optimal positioned double-lumen endotracheal tubes (DLT) is crucial in thoracic surgery requiring lung isolation. This study aims to compare the accuracy and complication rates of DLT placement using videolaryngoscopy (VL) versus conventional direct laryngoscopy (DL). Methods: This retrospective single-center study included 89 patients who underwent thoracic surgery with DLT placement between July 2023 and May 2024. Patients were divided into two groups: VL (n = 45) and DL (n = 44). Patient characteristics, intubation times, malposition rates, and complications were recorded. DLT position was confirmed using fiberoptic bronchoscopy. Results: The incidence of DLT malposition was significantly lower in the VL group (13.3%) compared to the DL group (31.8%) (p = 0.037). The overall complication rate was also lower in the VL group (4.4%) compared to the DL group (11.4%) (p = 0.024). The mean time from anesthesia induction to the first incision was shorter in the VL group (25.2 ± 6.1 min) than in the DL group (28.3 ± 6.5 min) (p = 0.02). Conclusions: VL significantly reduces the incidence of DLT malposition and associated complications in thoracic surgery compared to DL. The improved visualization and multiple blade options of the C-MAC videolaryngoscopy set likely contribute to these findings. Further research is warranted to confirm these results in larger, multicenter studies. Trial registration: Institutional Review Board (Registration number: 80576354-050-99/437, 27.06.2024). [ABSTRACT FROM AUTHOR]

Background: This study evaluated the clinical characteristics of neuronal ceroid lipofuscinosis type 7 or CLN7 disease spectrum to characterize the clinical, electrophysiologic and neuroimaging phenotypes. Methods: We performed a single-center cross sectional data collection along with retrospective medical chart review in patients with a genetic diagnosis of CLN7. This study received ethical approval by the University of Texas Southwestern Medical Center Institutional Review Board. A total of 8 patients were included between the ages of 4 to 6 years. All patients had a genetic diagnosis of CLN7 with homozygous or compound heterozygous mutations in the MFSD8 gene. The information collected includes patient demographics, developmental history, neurological events including seizures and neurodevelopmental regression along with further evaluation of brain magnetic resonance imaging and electrophysiological findings. The clinical phenotype is described through cross sectional and retrospective data collection and standardized tools assessing quality of life and functional skills. Results: Our findings in this cohort of CLN7 patients indicated that development is initially normal with onset of clinical symptoms as early as two years of age. Language problems were noted prior to or at the onset of seizures in all cases. Gait problems were noted prior to seizure onset in 3 of 8 patients, and at or within 6 months after the onset of seizures in 5 of 8 patients. All patients followed a progressive course of language, motor, and neurocognitive deterioration. Congruent with the medical history, our patients had significantly low scores on adaptive abilities. Natural history data such as this can be used to support future clinical trial designs. Conclusions: This study provides a comprehensive description of CLN7 disease, highlighting clinical data alongside standardized neuropsychological assessments, neuroimaging, and electrophysiologic data. It emphasizes the value of importance of standardized tools for understanding disease phenotype and their potential use as endpoints in future clinical trials. The findings established can provide a baseline for developing future prospective natural history studies and potential therapeutic clinical trials. [ABSTRACT FROM AUTHOR]

Background: Pediatric Support Services (PSS) is a Patient Navigation Program designed to address barriers from referral-to-service connection from primary care to health system and community-based services and resources. This study aimed to evaluate PSS' implementation for mental health services along the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework and identify factors throughout implementation to inform sustainability and delivery. Methods: This study included descriptive analysis of all patients referred to PSS to assess reach, with a primary cohort analyses of a subset of patients referred specifically to mental health services. Data collection included triangulation of information extracted from electronic health records, direct contact with patients' caregivers, and follow-up surveys completed by patients' caregivers. Analyses were designed within each construct of the RE-AIM framework, and assessed for their tiered impact on the patient, provider, and system levels. Results: From October 2019 to June 2023, 13,109 total referrals for 11,214 unique patients were triaged by PSS. The patient population overrepresented younger, Hispanic, female patients compared to the clinical population included in this health system's service area. Of these patients, 3,929 were followed-up by trained navigators at two-weeks for mental health service connection, with 50.6% reported being connected to referred services and an additional 27.1% with pending appointments. There was a significant increase in referral connection rate as age increased and for Black patients, compared to other children. For patients considered connected to or pending services, a satisfaction survey found high satisfaction with PSS and the amount of navigator-patient contact (81.5 and 79.6%, respectively). Conclusion: These findings highlight potential program modifications to optimize quality of care and health for children and families, while enhancing capacity among providers, navigators, and clinics. Further adaptations, including electronic health record integration, patient/family feedback, and automated navigation processes, are suggested next steps for comprehensive navigation. Trial registration: This study was approved by the Institutional Review Board for Prisma Health, trial number 1,852,794, with the most recent approval for expanded evaluation received on June 15, 2022 (original application approved in 2016). [ABSTRACT FROM AUTHOR]

Background: Robot-assisted rehabilitation is considered beneficial for functional recovery in patients with stroke, but the therapeutic effect remains inconclusive. The present study investigated the therapeutic effects of gait training assisted by a user-initiated powered exoskeletal robot (UIPER) in patients in the early stage after stroke. We also characterized patients' improvement by analyzing chronological changes in clinical measurements together with gait parameters obtained from internal sensors in the exoskeletal robot. Methods: In this pilot case-controlled study, 17 and 81 patients with stroke onset durations of < 3 months were included in the robot-assisted combined with conventional treatment (RT + CT) group and conventional treatment only (CT) group, respectively. The UIPER, which provides knee flexion and extension support and has hip and knee sensors, was applied to guide gait performance in the RT + CT group. The patients in the RT + CT group received robot-assisted gait training for 40 min/ session, 1 session a day, and 2–3 sessions a week (6 sessions in total). The primary outcome was the proportion of patients reaching the minimum clinically important difference (MCID) in the 5-meter walking speed (5MWS) assessment, and the secondary outcomes were the MCID for the six-minute walking test, the Berg Balance Scale, the Barthel Index, the Fugl-Meyer assessment, and the timed up and go test before, during, and after the interventions. Gait parameters of the hip and knee were evaluated at baseline, midterm, and final sessions. Results: Gait function improved in both groups after the intervention (both P < 0.05). The primary outcome showed that a greater proportion of patients reached the MCID for the 5MWS in the RT + CT group than in the CT group (70.6 vs. 43.2%, P = 0.040; = 0.208). Similarly, in terms of the secondary outcomes, more patients in the RT + CT group reached the MCID for the Barthel index as compared with the CT group (41.2 vs. 17.3%, P = 0.047, = 0.220). Gait analysis revealed improvements in gait in the RT + CT group, as indicated by increases in the perimeter and area of the hip–knee cyclogram, as well as the range of motion in the hip joint. Conclusions: Gait training assisted by UIPER facilitates the recovery of walking speed and activities of daily living in patients with stroke, and these improvements may be related to improvements in gait parameters. Randomized controlled studies with larger sample sizes are needed to confirm these findings. Trial registration: This trial was approved by the Institutional Review Board of Chang Gung Medical Foundation (No. 202200822B0). [ABSTRACT FROM AUTHOR]

Background: The purpose of this study is to evaluate the retinal and choroidal microvascular state in children with congenital isolated growth hormone deficiency (IGHD) and determine the effect of recombinant human growth hormone treatment on these structures compared with healthy controls. Methods: The study included children with IGHD under recombinant human GH treatment as group one and another group of healthy controls. Both groups were examined using optical coherence tomography angiography (OCTA). Data concerning superficial capillary plexus (SCP), deep capillary plexus (DCP), choriocapillaris (CC), and retinal thickness were recorded. Results: The study included two equal groups of 30 individuals. Both groups had no statistically significant differences in age, gender, weight, or spherical equivalent. However, subjects of group II were taller than those of group I (p = 0.011). OCTA images of the SCP, DCP, and CC vessel density revealed statistically non-significant differences between the two groups. Conclusion: Children receiving recombinant growth hormone therapy showed no changes in the retinal and choroidal microvasculature or macular thickness. Trial registration number: 1094/03/2024 by Minia University Faculty of Medicine Institutional Review Board. Another registration number is UMIN000055654. [ABSTRACT FROM AUTHOR]

Background: An online mail order naloxone and harm reduction supply program was created by an interdisciplinary team at the University of Rhode Island College of Pharmacy and hosted on the university website (UNIV). The program was subsequently funded by the Rhode Island Department of Health (DOH) and added to the DOH website. This study compares demographic characteristics of the two populations submitting requests through the program's distinct access points, UNIV and DOH, to those of populations at-risk for overdose. Methods: This is a retrospective comparative analysis using voluntarily provided information from mail order request forms submitted through two websites from June 2020 through October 2023. The primary objective was to compare demographic characteristics of requesters through the two access points to those of individuals at-risk for experiencing or responding to an overdose. Descriptive statistics were used to characterize the two distinct populations. Chi-square tests were performed to determine if statistically significant differences in population demographics existed between access points. Odds ratios were estimated using a simple logistic regression model to assess the relationship between access point and demographic characteristic to determine if either access point had a greater likelihood of reaching individuals with at-risk demographics. Results: A total of 5,783 (UNIV = 1662; DOH = 4121) mail order request forms were included in the analysis. Participants who completed requests through UNIV were more likely to be 44 years old or younger and/or reside in rural areas. Participants who submitted requests through DOH were more likely to reside in non-rural and/or low-income areas, and/or identify as gender minorities. Additionally, UNIV respondents were more likely to be first-time naloxone requesters while DOH respondents were more likely to have obtained and used naloxone before. Conclusions: Results establish that different access points can reach different at-risk population subsets and support the use of multiple access points and advertising strategies to expand the reach of online mail order harm reduction programs. Study registration: The study was retrospectively approved by the University of Rhode Island Institutional Review Board (IRB reference #2124391-2). [ABSTRACT FROM AUTHOR]

Background: To identify and to summarize challenges related to the informed consent process for research completed during humanitarian emergencies. Methods: Using relevant search terms, a search of 5 databases was completed, without language, date, or study type restriction. Studies were screened for inclusion, with eligible studies being those that were relevant to the informed consent process for research studies completed in humanitarian emergencies. A Grounded Theory Analysis was completed to identify themes and subthemes. Results: Review identified 30 relevant studies. We identified 11 challenges (lack of trust, therapeutic misconception, reduced capacity, security and privacy concerns, harmful research, power differential, literacy, language/local and cultural context, researcher burden and re-evaluation of ongoing trials) and 7 strategies (engage local research communities, use alternative to standard written consent process, modify traditional process of research ethics board review, dynamic consent, training of research staff, mandating transparency of commercial interests, and mandating reporting of informed consent process in all publications) to confront the challenges. These challenges and strategies were unique to the informed consent process in research conducted during humanitarian emergencies. Conclusions: This scoping review identified an evidence-based guide for researchers and research ethics boards to perform ethical informed consent procedures in humanitarian emergencies. Trial Registration: This trial was not registered as scoping reviews can not be registered as per updated PROSPERO guidelines. [ABSTRACT FROM AUTHOR]

Background: The current study aimed to evaluate the bone union rate between infected vertebrae after minimally invasive posterior fixation without bone grafting in thoracolumbar pyogenic spondylitis. Methods: This retrospective multicenter cohort study evaluated 75 patients of posterior fixation for thoracolumbar pyogenic spondylitis that have been recorded at six relevant institutions from January 2016 to December 2022. Data on age, sex, location of infected vertebrae, number of infected disks, comorbidity, Pola classification, number of vertebrae fixed according to surgery, implant failure requiring revision surgery, and distance according to the type of infected vertebrae after surgery were evaluated. Further, their association with postoperative bone union was investigated > 12 months postoperatively. Results: Finally, 40 patients were included in the study. In total, 32 (80%) patients achieved bone union at the infected vertebrae after minimally invasive posterior fixation without bone grafting. The mean duration from surgery to union was 10.7 months. Twenty-six (65%) patients initially achieved bone union at the lateral and/or anterior bridging callus. Patients with multiple-level infected disks (33%, 2/6 patients) had a lower bone union rate than those with a single-level infected disk (88%, 30/34 patients) (p = 0.0095). Conclusions: In 80% of patients, bone union at the infected vertebrae was achieved after minimally invasive posterior fixation without bone grafting in thoracolumbar pyogenic spondylitis. A total of 65% of the patients achieved initial bone union at the lateral and/or anterior bridging callus. Moreover, patients with multiple-level infected disks had a low bone union rate. Hence, the treatment strategy should be cautiously considered. Trial registration: This study was registered retrospectively and all procedures used in this study including the review of patient records were approved by the institutional review board. [ABSTRACT FROM AUTHOR]

Background: Among the emerging treatments for erectile dysfunction (ED), platelet-rich plasma (PRP), known for its ability to enhance tissue repair and regeneration, stands out as a promising therapeutic approach. In this innovative study, we aimed to assess the efficacy of intracavernous injections of platelet lysate (PL), a derivative of PRP, in improving erectile function among ED patients. Methods: We enrolled twenty-six patients, aged between 35 and 70 years (mean age 51.6 ± 11.3 years), who had been experiencing ED for over six months and had an International Index of Erectile Function-5 (IIEF-5) score of 21 or less. Participants received autologous PL injections intracavernously every two weeks for a total of five administrations. We assessed Erection Hardness Score (EHS) and International Index of Erectile Function-5 (IIEF-5) bi-weekly for 16 weeks and conducted penile Doppler ultrasounds pre- and post-treatment to record peak systolic velocity (PSV) and resistance index (RI). Results: Before treatment, the mean EHS was 2.15 ± 0.88 and IIEF-5 was 10.92 ± 5.28. Remarkable improvements were observed post-treatment, with the EHS significantly increasing to 3.15 ± 0.83 (p < 0.05) and IIEF-5 to 17.23 ± 5.26 (p < 0.05). Penile Doppler ultrasound exhibited an increase in both PSV and RI post-treatment, with the rise in RI being statistically significant. Conclusions: Our findings indicate that intracavernous injections of PL substantially enhance erectile function, as evidenced by improvements in EHS, IIEF-5, and the RI of penile Doppler ultrasound, without hemorrhagic events or other adverse reactions apart from temporary pain at the injection site during the 16-week follow-up period. These encouraging results suggest that PL injections are a safe and effective treatment modality for patients with moderate ED, potentially providing a less invasive and more physiologically friendly alternative to current ED management strategies. Trial registration: The study received approval from the Institutional Review Board of National Taiwan University Hospital (IRB Number 202008061RIPC, date of registration 08/28/2020). [ABSTRACT FROM AUTHOR]

Background: Duodenal papillary adenoma, a potentially malignant benign tumor is primarily treated with endoscopic papillectomy. Despite its efficacy, endoscopic papillectomy has a high complication rate. This study investigates whether pancreatic duct and common bile duct stent placement can mitigate these complications. Methods: In a retrospective observational analysis, 79 patients with duodenal papillary adenoma, treated with endoscopic papillectomy at our center, were studied. The cohort included patients who underwent endoscopic papillectomy with no stents placement, common bile duct stent placement alone, pancreatic duct stent placement alone, or stents placement in both ducts. We assessed the outcomes of endoscopic papillectomy, including complete resection rate and recurrence rate as the primary and secondary outcomes respectively. In the meantime, the incidence of complications were also analysed as the safety outcomes. Results: Complete resection rates did not significantly differ between patients with or without stent placement (85.7% P group vs. 89.2% N-P group, P = 0.64). Early complication rates were similar across groups. However, significant reduction in common bile duct stenosis was observed in the stenting group (0% B group vs. 10.5% N-B group, P = 0.03). Furthermore, stent placement correlated with lower adenoma recurrence rates during follow-up (2.4% P group vs. 16.2% N-P group, P = 0.03; 2.4% B group vs. 15.8% N-B group, P = 0.04). Conclusions: Pancreatic duct and common bile duct stent placement in endoscopic papillectomy may decrease late complications, particularly common bile duct stenosis, and reduce the recurrence of duodenal papillary adenoma. Trial registration: This study received approval from the Institutional Review Board and Ethics Committee of Beijing Friendship Hospital (Approval No. BFHHZS20230203), and retrospectively registered in www.ClinicalTrials.gov (NCT06301048, Initial Release date: 02/18/2024, Last Public Release date: 03/03/2024). [ABSTRACT FROM AUTHOR]

Background: The University of California's Diabetes Prevention Program (UC DPP) Initiative was implemented systemwide to address diabetes and obesity risk on all 10 campuses. As little is known about implementing lifestyle change programs in university settings, we examined implementation partners' (i.e., UC DPP leaders and campus leads) perceptions of factors influencing program success on UC campuses. Methods: We conducted qualitative interviews with UC DPP leaders and campus leads to examine challenges and opportunities with university-based DPP delivery models. Interviews were recorded, professionally transcribed, and reviewed in detail by the research team. Transcripts were analyzed using rapid qualitative analysis (RQA). The study was approved by the UCLA Institutional Review Board. All implementation partners provided verbal informed consent. Results: Twenty-six implementation partners (8 UC DPP leaders and 18 campus leads) completed interviews in 2021. Seven themes were identified as critical for implementation, including (1) marketing and recruitment (i.e., market and recruit broadly through established channels as well as target at-risk populations); (2) enrollment (i.e., offer the program during convenient times and let participants know what to expect); (3) use an adaptable, evidence-based program; (4) secure funding for the program, participants, lifestyle coaches, and space; (5) hire experienced and dedicated staff and lifestyle coaches; (6) ensure leadership support; and (7) utilize campus linkages and resources. Perceptions of challenges faced with respect to these themes are also described. Conclusions: This is one of the first studies to examine the challenges and opportunities of delivering an intensive lifestyle change program across 10 university sites. Understanding factors that enhance success of university-based diabetes prevention programs can facilitate UC DPP efforts and help inform delivery strategies of health and wellness programs across other university settings more broadly. [ABSTRACT FROM AUTHOR]

Background: Patients undergo regular clinical follow-up after laminoplasty for cervical myelopathy. However, those whose symptoms significantly improve and remain stable do not need to conform to a regular follow-up schedule. Based on the 1-year postoperative outcomes, we aimed to use a machine-learning (ML) algorithm to predict 2-year postoperative outcomes. Methods: We enrolled 80 patients who underwent cervical laminoplasty for cervical myelopathy. The patients' Japanese Orthopedic Association (JOA) scores (range: 0–17) were analyzed at the 1-, 3-, 6-, and 12-month postoperative timepoints to evaluate their ability to predict the 2-year postoperative outcomes. The patient acceptable symptom state (PASS) was defined as a JOA score ≥ 14.25 at 24 months postoperatively and, based on clinical outcomes recorded up to the 1-year postoperative timepoint, eight ML algorithms were developed to predict PASS status at the 24-month postoperative timepoint. The performance of each of these algorithms was evaluated, and its generalizability was assessed using a prospective internal test set. Results: The long short-term memory (LSTM)-based algorithm demonstrated the best performance (area under the receiver operating characteristic curve, 0.90 ± 0.13). Conclusions: The LSTM-based algorithm accurately predicted which group was likely to achieve PASS at the 24-month postoperative timepoint. Although this study included a small number of patients with limited available clinical data, the concept of using past outcomes to predict further outcomes presented herein may provide insights for optimizing clinical schedules and efficient medical resource utilization. Trial registration: This study was registered as a clinical trial (Clinical Trial No. NCT02487901), and the study protocol was approved by the Seoul National University Hospital Institutional Review Board (IRB No. 1505-037-670). [ABSTRACT FROM AUTHOR]

Background: Tranexamic acid (TXA) effectively attenuates hyperfibrinolysis and preemptive administration has been employed to reduce bleeding and blood transfusions in various surgical settings. However, TXA administration could be associated with adverse effects, such as seizures and thromboembolic risks. While patients with fibrinolysis shutdown showed greater thromboembolic complications and mortality, TXA administration may aggravate the degree of shutdown in these patients. Selective TXA administration based on the results of rotational thromboelastometry (ROTEM) would be non-inferior to preemptive TXA administration in reducing postoperative bleeding and beneficial in reducing its risks in patients undergoing cardiovascular surgery. Methods: This non-inferiority, randomized, double-blind, placebo-controlled, multicenter trial will be performed in 3 tertiary university hospitals from August 2023 to March 2025. Seven hundred sixty-four patients undergoing cardiovascular surgery will be randomly allocated to get TXA as a preemptive (Group-P) or goal-directed strategy (Group-GDT) in each institution (with a 1:1 allocation ratio). After anesthesia induction, TXA (10 mg/kg and 2 mg/kg/h) and a placebo are administered after anesthesia induction in Group-P and Group-GDT, respectively. ROTEM tests are performed immediately before weaning from CPB and at the considerable bleeding post-CPB period. After getting the test results, a placebo is administered in Group-P (regardless of the test results). In Group-GDT, placebo or TXA is administered according to the results: placebo is administered if the amplitude at 10 min (A10-EXTEM) is ≥ 40 mm and lysis within 60 min (LI60-EXTEM) of EXTEM assay is ≥ 85%, or TXA (20 mg/kg) is administered if A10-EXTEM is < 40 mm or LI60-EXTEM is < 85%. The primary outcome is inter-group comparisons of postoperative bleeding (for 24 h). The secondary measures include comparisons of perioperative blood transfusion, coagulation profiles, reoperation, thromboembolic complications, seizures, in-hospital mortality, fibrinolysis phenotypes, and hospital costs. Discussion: The absence of inter-group differences in postoperative bleeding would support the selective strategy's non-inferiority in reducing postoperative bleeding in these patients. The possible reduction in thromboembolic risks, seizures, and fibrinolysis shutdown in Group-GDT would support its superiority in reducing TXA-induced adverse events and the cost of their management. Trial registration: This trial was registered at ClinicalTrials.gov with the registration number NCT05806346 on March 28, 2023. Trial status: recruiting. Issue date: 2023 March 28 (by Tae-Yop Kim, MD, PhD). The trial was registered in the clinical registration on March 28, 2023 (ClinicalTrials.gov, NCT05806346) and revised to the latest version of its protocol (version no. 8, August 26, 2024) approved by the institutional review boards (IRBs) of all 3 university hospitals (Konkuk University Medical Center, 2023–07-005–001, Asan Medical Center, 2023–0248, and Samsung Medical Center, SMC 2023–06-048–002). Its recruitment was started on August 1, 2023, and will be completed on December 31, 2024. Protocol amendment number: 08 (protocol version 08, August 26, 2024). Revision chronology: 2023 March 28:Original. 2023 April 10:Amendment No 01. The primary reason for the amendment is the modification of Arms (adding one arm for sub-group analyses) and Interventions, Outcome Measures, Study Design, Study Description, Study Status, Eligibility, and Study Identification. 2023 May 03:Amendment No 02. The primary reason for the amendment is to modify the Outcome Measures and update the study status. 2023 July 06:Amendment No 03. The primary reason for amendment is to update the chronological study status. 2023 July 07:Amendment No 04. The primary reason for the amendment is the modification of study information (the treatment category was changed to diagnostic, and Phase 4 was changed to not applicable) and a chronological update on the study status. 2023 September 12:Amendment No 06. The primary reason for the amendment is a chronological update in the study status and the inclusion of additional information regarding contacts/locations and oversight. 2023 December 29:Amendment No 07. The primary reason for the amendment is to modify the outcome measures (including detailed information on outcome measures, addition of extra secondary measures, and chronological updates in study status). 2024 August 26:Amendment No 08. The primary reason for the amendment is to add detailed descriptions regarding data handling and the names and roles of the participating institutions and to update the chronological process of the trial. [ABSTRACT FROM AUTHOR]

Background: Type A acute aortic dissection (TAAAD) is a deadly condition that demands immediate surgery, because it involves a critically. The mortality and morbidity associated with it are significant, and it is vital that the patient's conditions and treatment strategies are fully understood to ensure the appropriate management of TAAAD. This study aims to ascertain whether hemiarch repair (HAR) versus extended arch repair (EAR) with or without descending aortic intervention results in better perioperative and late outcomes for patients with TAAAD. Methods: Four leading centers of cardiac surgery from two European countries have joined forces to create a groundbreaking multicenter observational registry (AoArch). This study was approved by the institutional review board (IRB 202201173). We conducted a retrospective review (NCT 0591263) of our prospectively maintained database for patients who underwent operative repair of DeBakey type I or type II dissection from January 1, 2005 to March 2024 (NCT 05927090). We will analyze how patient co-morbidities, referral conditions, and surgical strategies involving hemi-arch repair (HAR) and extended arch repair (EAR) impact early and late adverse events. We have developed a procedure urgency algorithm based on the severity of preoperative hemodynamic conditions and malperfusion due to TAAAD, and we will use it to assess the primary clinical outcomes: in-hospital mortality, late mortality, and reoperations on the aorta. We will define secondary outcomes as permanent neurologic deficit, the need for new dialysis, respiratory failure, a composite of major adverse events (myocardial infarction, cerebrovascular accidents, the need for dialysis, or the need for tracheostomy), and a composite of major adverse pulmonary events (intubation over 48 h, pneumonia, reintubation, tracheostomy), and reoperation due to bleeding. Discussion: This multicenter registry will definitively determine the prognostic significance of critical preoperative conditions and the efficacy of extended arch interventions and hemiarch repair in reducing the risk of early adverse events after surgery for TAAAD. This registry will provide insights into the long-term durability of different strategies of surgical repair for TAAAD. [ABSTRACT FROM AUTHOR]

Background: Despite the well-known health benefits of exercise, women's participation in exercise is low worldwide. As women are at risk of developing various chronic diseases as they age, suggesting effective exercise methods that can maximize energy consumption is needed to prevent such conditions. Excess post-exercise oxygen consumption (EPOC) can maximize energy consumption. In this crossover, randomized controlled trial, we aimed to compare the EPOC for different exercise modalities including continuous exercise (CE), interval exercise (IE), and accumulated exercise (AE) that spent the homogenized energy expenditure during exercise in healthy women. Methods: Forty-four participants (age, 36.09 ± 11.73 years) were recruited and randomly allocated to three groups. The intensity of each modality was set as follows: CE was performed for 30 min at 60% peak oxygen uptake (VO2peak). IE was performed once for 2 min at 80% VO2peak, followed by 3 min at 80% VO2peak, and 1 min at 40% VO2peak, for a total of six times over 26 min. AE was performed for 10 min with a 60% VO2peak and was measured thrice a day. Results: During exercise, energy metabolism was higher for IE and CE than that for AE. However, this was reversed for AE during EPOC. Consequently, the greatest energy metabolism was shown for AE during total time (exercise and EPOC). Conclusions: By encouraging regular exercises, AE can help maintain and improve body composition by increasing compliance with exercise participation, given its short exercise times, and by efficiently increasing energy consumption through the accumulation of EPOC. Trial registration: Clinical number (KCT0007298), 18/05/2022, Institutional Review Board of Konkuk University (7001355-202201-E-160). [ABSTRACT FROM AUTHOR]

Background: S. pneumoniae (SPN) is the most common cause of pneumonia. The disease can be effectively prevented through immunisation. Since December 2020, the Malaysian Government has included the 10-valent pneumococcal conjugate vaccine (PCV10) for all infants born on or after 1 January 2020 as part of the National Immunisation Programme (NIP). However, the epidemiology of pneumonia remains poorly understood. To fill the knowledge gap, we established a multicentre surveillance study to understand the burden of pneumococcal pneumonia among young children in Peninsular Malaysia. Methods: MY-Pneumo is a multicentre prospective case–control study conducted in three sentinel sites located in three different states of Peninsular Malaysia – Kuala Lumpur, Pahang, and Kelantan. A cohort of at least 500 incident cases and 500 controls is enrolled beginning in October 2021 and matched for age. Cases are hospitalised children < 5 years with radiologically confirmed pneumonia, and the controls are children without any features suggestive of pneumonia. Clinical samples, including nasopharyngeal swabs (NPS) and urine, are collected according to the study protocol. Biological fluids such as blood, cerebrospinal fluid (CSF) and pleural fluid are obtained from invasive pneumonia disease (IPD) patients, if available. All children are tested for SPN using polymerase chain reaction (PCR) and pneumococcal urine antigen test (PUAT) using BinaxNow. Discussion: Surveillance data, including carriage rate, serotype variations and the phylogeny data structure of SPN among young children in Malaysia during PCV implementation, will be generated from this study. Trends and patterns of pneumococcal serotypes by different regions are important for targeted public health strategies. Our data will provide baseline information for estimating the impact of PCV10 implementation and will influence policymakers' decisions regarding the upgrade from PCV10 to a higher-valency conjugate vaccine in Malaysia. Trial registration: This project was registered at ClinicalTrials.gov (NCT04923035) on 2021, June 11. The study protocol was approved by the International Medical University Joint-Committee on Research & Ethics (4.15/JCM-216/2021) and the Institutional Review Board at sentinel sites (USM/JEPeM/21020190, IREC 2021–114, MREC ID No: 2021128–9769) and University of Southampton's Ethics and Research Governance (ERGo II 64844). [ABSTRACT FROM AUTHOR]

Background: Under the background of the increasing trend of population aging, the health and quality of life of older adults have become the focus of social concern. As an important part of older adults' daily life, the design and configuration of the built environment may positively or negatively affect older adults' health behaviors. Therefore, this study aims to explore the relationship between older adults' perceived built environments and health behaviors, which is the association between perceived built environments and older adults' physical activity (PA) and social interactions. This is important for optimizing the community built environment and improving the quality of life of older adults. Methods: In this study, a questionnaire was surveyed on 916 Chinese older adults aged 60 and above. The questionnaire was used to collect demographic information and social interaction from the participants, and the Physical Activity Neighborhood Environment Scale (PANES) and the Physical Activity Scale for the Elderly (PASE) were used to assess older adults' subjective perceptions of the built environment in their neighborhoods and their levels of PA, respectively. In data analysis, ANOVA and chi-square tests were used to compare the significance of differences between groups, and multiple linear regression model were used to estimate the association between older adults' perceived characteristics of the built environment and their PA and social interaction. Results: After controlling for confounders such as gender, age, BMI, and education level, the multiple linear regression model showed that perceived destination accessibility, neighborhood infrastructure, aesthetic qualities, and neighborhood environment indices were significantly correlated with PA (β = 0.083 ~ 0.095, P < 0.05) and social interaction (β = 0.087 ~ 0.144, P < 0.05) among older adults. In addition, neighborhood safety (β = -0.084, P < 0.05), social environment (β = 0.091, P < 0.01), and street connectivity (β = 0.112, P < 0.001) were also strongly associated with older adults' social interaction. Conclusions: Different perceived built environment attributes are correlated with the health behaviors of Chinese older adults to different degrees. This finding helps to guide community planning and construction, provides an empirical basis for improving health behaviors of older adults, and provides an important reference for building healthy communities for older adults and realizing comprehensive healthy development of older adults. Trial registration: There was no trial registration for this study, but the study was approved by the Institutional Review Board of Tsinghua University (No. THU0120230196). [ABSTRACT FROM AUTHOR]

Background: Calculating size-specific dose estimates (SSDEs) requires measurement of the patient's anteroposterior (AP) and lateral thickness based on computed tomography (CT) images. However, these measurements can be subject to variation due to inter-observer and intra-observer differences. This study aimed to investigate the impact of these variations on the accuracy of the calculated SSDE. Methods: Four radiographers with 1–10 years of experience were invited to measure the AP and lateral thickness on 30 chest, abdomen, and pelvic CT images. The images were sourced from an internet-based database and anonymized for analysis. The observers were trained to perform the measurements using MicroDicom software and asked to repeat the measurements 1 week later. The study was approved by the institutional review board at Taibah University, and written informed consent was obtained from the observers. Statistical analyses were performed using Python libraries Pingouin (version 0.5.3), Seaborn (version 0.12.2), and Matplotlib (version 3.7.1). Results: The study revealed excellent inter-observer agreement for the calculated effective diameter and AP thickness measurements, with Intraclass correlation coefficients (ICC) values of 0.95 and 0.96, respectively. The agreement for lateral thickness measurements was lower, with an ICC value of 0.89. The second round of measurements yielded nearly the same levels of inter-observer agreement, with ICC values of 0.97 for the effective diameter, 1.0 for AP thickness, and 0.88 for lateral thickness. When the consistency of the observer was examined, excellent consistency was found for the calculated effective diameter, with ICC values ranging from 0.91 to 1.0 for all observers. This was observed despite the lower consistency in the lateral thickness measurements, which had ICC values ranging from 0.78 to 1.0. Conclusions: The study's findings suggest that the measurements required for calculating SSDEs are robust to inter-observer and intra-observer differences. This is important for the clinical use of SSDEs to set diagnostic reference levels for CT scans. [ABSTRACT FROM AUTHOR]

Background: We investigated whether double-bundle (DB) anterior cruciate ligament (ACL) reconstruction (ACLR) combined with anterolateral ligament reconstruction (ALLR) improved clinical and radiological outcomes in patients at high risk of ACL failure. The primary outcome was graft failure, and secondary outcomes included knee stability and patient-reported outcome measures (PROMs). Patients and methods: Fifty-two patients who underwent DB ACLR combined with ALLR were included in this retrospective cohort study. Preoperative risk factors, including femorotibial angle (FTA), lateral tibial slope (LTS), medial tibial slope (MTS), and meniscal tears, were assessed using X-ray and magnetic resonance imaging (MRI). The grade of post-operative pivot shift, Lysholm score, and Tegner activity score were used to assess clinical outcomes. The minimum follow up duration was 2 years. Results: The cohort (mean age, 26.1 ± 9.4 years; 51.9% male) had a mean follow-up duration of 28.9 ± 3.4 months. Preoperatively, 57.8% had lateral meniscus (LM) tears, and 61.0% had a grade 2–3 pivot shift. Postoperatively, no graft failures or revision cases occurred during follow-up. Approximately 90.4% of the patients exhibited a negative pivot shift (p < 0.001), with Lysholm and Tegner activity scores of 92.5 ± 6.1 and 5.1 ± 2.0. The medial meniscus (MM) tear group had a significantly smaller FTA than the intact group (p = 0.043). No significant differences in PROMs were found between the LM tear and intact LM groups or between the high and low MTS or LTS groups (p = n.s.). Conclusion: DB ACLR combined with ALLR had satisfactory clinical outcomes in patients at high risk of ACL failure, with no graft failures observed during a mean follow-up duration of 2.4 years. The technique effectively reduced the postoperative pivot shift, regardless of preoperative risk factors. Study design: Level IV, retrospective therapeutic case-series. Trail registration: ethical approval number, 202300134B0; ethical committee, the Institutional Review Board of Chang Gung Medical Foundation. [ABSTRACT FROM AUTHOR]

Background: The current literature supports the effectiveness of exercise, education, and self-management interventions for the long-term management of persistent low back pain. However, there is significant uncertainty about the implementation of interventions related to barriers, facilitators, and patient's preferences. This study will evaluate the Back to Living Well program implementation from a participant and organizational perspective. More specifically we address the following objectives: 1) identify program barriers and facilitators from participants' perspectives, 2) identify factors related to program, personal and contextual factors that contribute to negative and positive outcomes, and outcome trajectories, 3) identify factors influencing participants' selection of an in-person or e-health program, and 4) evaluate program specific barriers and facilitators from the organization and care delivery perspectives. Methods: This study will utilize a mixed-method convergent design including a longitudinal cohort strand and a longitudinal qualitative interview strand. The RE-AIM framework will be used to assess program implementation. Participants (n = 90, 1:1: in person or virtual) who choose to register in the program as well as staff (n = 10 to 15) involved in the delivery of the program will be invited to participate. Participants will participate in a 12-week physical activity, education, and self-management program. Implementation outcomes will be measured at 3-, 6-, 12-months, and six months after the end of the follow-ups. Interview scripts and directed content analysis will be constructed based on the Theoretical Domains Framework and the Neuromatrix Model of Pain, Theoretical Domains Framework. Staff interviews will be constructed and analyzed using the Consolidated Framework for Implementation Research. Participants will also complete pain, disability, quality of life and psychological questionnaires, wear an activity tracker at all time points, and complete weekly pain and activity limitation questions using a mobile application. Discussion: The study results will provide evidence to inform potential future implementation of the program. An effective, appropriately targeted, and well implemented exercise program for the long-term management (i.e., tertiary prevention) of LBP could minimize the burden of the condition on patients, the health care system and society. Trial registration: ClinicalTrials.gov NCT05929846. This (Registration Date: July 3 2023) study has been approved by the Hamilton Integrated Research Ethics Board Project ID#15,354. [ABSTRACT FROM AUTHOR]

Background: It is extremely essential to accurately differentiate pheochromocytoma from Adrenal incidentalomas (AIs) before operation, especially biochemical tests were inconclusive. We aimed to evaluate the value of magnetic resonance imaging (MRI) features to differentiate pheochromocytomas among adrenal tumors, among which the consequences of biochemical screening tests of catecholamines and/or catecholamine metabolites are positive. Methods: With institutional review board approval, this study retrospectively compared 35 pheochromocytoma (PHEO) patients with 27 non-pheochromocytoma(non-PHEO) patients between January 2022 to September 2023, among which the consequences of biochemical screening tests of catecholamines and/or catecholamine metabolites are positive. T test was used for the independent continuous data and the chi-square test was used for categorical variables. Univariate and multivariate logistic regression were applied to find the independent variate of the features to differentiate PHEO from non-PHEO and ROC analysis was applied to evaluate the diagnostic value of the independent variate. Results: We found that the T2-weighted (T2W) signal intensity in patients with pheochromocytoma was higher than other adrenal tumors, with greatly significant (p < 0.001). T2W signal intensity ratio (T2W nodule-to-muscle SI ratio) was an independent risk factor for the differential diagnosis of adrenal PHEOs from non-PHEOs. This feature alone had 91.4% sensitivity and 81.5% specificity to rule out pheochromocytoma based on optimal threshold, with an area under the receiver operating characteristics curve (AUC‑ROC) of 0.910(95% C I: 0.833–0.987). Conclusion: Our study confirms that T2W signal intensity ratio can differentiate PHEO from non-PHEO, among which the consequences of biochemical screening tests of catecholamines and/or catecholamine metabolites are positive. [ABSTRACT FROM AUTHOR]

Background: The relationship between risk factors of common postoperative complications after pulmonary resection, such as air leakage, atelectasis, and arrhythmia, and patient characteristics, including nutritional status or perioperative factors, has not been sufficiently elucidated. Methods: One thousand one hundred thirty-nine non-small cell lung cancer patients who underwent pulmonary resection were retrospectively analyzed for risk factors of common postoperative complications. Results: In a multivariate analysis, male sex (P = 0.01), age ≥ 65 years (P < 0.01), coexistence of chronic obstructive pulmonary disease (COPD) (P < 0.01), upper lobe (P < 0.01), surgery time ≥ 155 min (P < 0.01), and presence of lymphatic invasion (P = 0.01) were significant factors for postoperative complication. Male sex (P < 0.01), age ≥ 65 years (P = 0.02), body mass index (BMI) < 21.68 (P < 0.01), coexistence of COPD (P = 0.02), and surgery time ≥ 155 min (P = 0.01) were significant factors for severe postoperative complication. Male sex (P = 0.01), BMI < 21.68 (P < 0.01), thoracoscopic surgery (P < 0.01), and surgery time ≥ 155 min (P < 0.01) were significant risk factors for postoperative air leakage. Coexistence of COPD (P = 0.01) and coexistence of asthma (P < 0.01) were significant risk factors for postoperative atelectasis. Prognostic nutrition index (PNI) < 45.52 (P < 0.01), lobectomy or extended resection more than lobectomy (P = 0.01), and surgery time ≥ 155 min (P < 0.01) were significant risk factors for postoperative arrhythmia. Conclusion: Low BMI, thoracoscopic surgery, and longer surgery time were significant risk factors for postoperative air leakage. Coexistence of COPD and coexistence of asthma were significant risk factors for postoperative atelectasis. PNI, surgery time, and surgical procedure were revealed as risk factors of postoperative arrhythmia. Patients with these factors should be monitored for postoperative complication. Trial registration: The Institutional Review Board of Kanazawa Medical University approved the protocol of this retrospective study (approval number: I392), and written informed consent was obtained from all patients. [ABSTRACT FROM AUTHOR]

Background: Temporary abdominal closure (TAC) techniques are essential in managing open abdomen cases, particularly in damage control surgery. Skin-only closure (SC) and Bogota bag closure (BBC) are commonly used methods for TAC, but their comparative effectiveness in achieving primary fascial closure (PFC) remains unclear. The objective of this study was to evaluate the rates of PFC between patients undergoing SC and BBC techniques for TAC in peritonitis or abdominal trauma cases at a tertiary care hospital. Methods: A retrospective cross-sectional study was conducted at the Surgical A Unit of Hayatabad Medical Complex, Peshawar, from January 2022 to July 2023. Approval was obtained from the institutional review board, and patient consent was secured for data use. Patients undergoing temporary abdominal closure using either skin-only or Bogota bag techniques were included. Exclusions comprised patients younger than 15 or older than 75 years, those with multiple abdominal wall incisions, and those with prior abdominal surgeries. Data analysis utilized SPSS version 25. The study aimed to assess outcomes following damage control surgery, focusing on primary fascial closure rates and associated factors. Closure techniques (skin-only and Bogota bag) were chosen based on institutional protocols and clinical context. Indications for damage control surgery (DCS) included traumatic and non-traumatic emergencies. Intra-abdominal pressure (IAP) was measured using standardized methods. Patients were divided into SC and BBC groups for comparison. Criteria for reoperation and primary fascial closure were established, with timing and technique determined based on clinical assessment and multidisciplinary team collaboration. The decision to leave patients open during the index operation followed damage control surgery principles. Results: A total of 193 patients were included in this study, with 59.0% undergoing skin-only closure (SC) and 41.0% receiving Bogota bag closure (BBC). Patients exhibited similar demographic characteristics across cohorts, with a majority being male (73.1%) and experiencing acute abdomen of non-traumatic origin (58.0%). Among the reasons for leaving the abdomen open, severe intra-abdominal sepsis affected 51.3% of patients, while 42.0% experienced hemodynamic instability. Patients who received SC had significantly higher rates of primary fascial closure (PFC) compared to BBC (85.1% vs. 65.8%, p = 0.04), with lower rates of fascial dehiscence (1.7% vs. 7.6%, p = 0.052) and wound infections (p = 0.010). Multivariate regression analysis showed SC was associated with a higher likelihood of achieving PFC compared to BBC (adjusted OR = 1.7, 95% CI: 1.3–3.8, p < 0.05). Conclusion: In patients with peritonitis or abdominal trauma, SC demonstrated higher rates of PFC compared to BBC for TAC in our study population. However, further studies are warranted to validate these results and explore the long-term outcomes associated with different TAC techniques. [ABSTRACT FROM AUTHOR]

Purpose: Symptom assessment is central to appropriate adenomyosis management. Using a WeChat mini-program-based portal, we aimed to establish a valid symptom assessment scale of adenomyosis (AM-SAS) to precisely and timely identify needs of symptom management and ultimately, to alert disease recurrence. Methods: A combination of intensive interviews of patients with adenomyosis and natural language processing on WeChat clinician-patient group communication was used to generate a pool of symptom items-related to adenomyosis. An expert panel shortened the list to form the provisional AM-SAS. The AM-SAS was built in a Wechat mini-programmer and sent to patients to exam the psychotically validity and clinical applicability through classic test theory and item response theory. Results: Total 338 patients with adenomyosis (29 for interview, 179 for development, and 130 for external validation) and 86 gynecologists were included. The over 90% compliance to the WeChat-based symptom evaluate. The AM-SAS demonstrated the uni-dimensionality through Rasch analysis, good internal consistency (all Cronbach's alphas above 0.8), and test-retest reliability (intraclass correlation coefficients ranging from 0.65 to 0.84). Differences symptom severity score between patients in the anemic and normal hemoglobin groups (3.04 ± 3.17 vs. 5.68 ± 3.41, P < 0.001). In external validation, AM-SAS successfully detected differences in symptom burden and physical status between those with or without relapse. Conclusion: Electronic PRO-based AM-SAS is a valuable instrument for monitoring AM-related symptoms. As an outcome measure of multiple symptoms in clinical trials, the AM-SAS may identify patients who need extensive care after discharge and capture significant beneficial changes of patients may have been overlooked. Trial registration: This trial was approved by the institutional review board of the Chongqing Medical University and three participating hospitals (Medical Ethics Committee of Nanchong Central Hospital, Medical Ethics Committee of Affiliated Hospital of Southwest Medical University, and Medical Ethics Committee of Haifu Hospital) and registered in the Chinese Clinical Trial Registry (registration number ChiCTR2000038590), date of registration was 26/10/2020. [ABSTRACT FROM AUTHOR]

Background: Q-CEP (Qualificação dos Comitês de Ética em Pesquisa que compõem o Sistema CEP/Conep) is a nationwide project resulting from a partnership between the Brazilian National Research Ethics Commission (Conep), the Ministry of Health and Hospital Moinhos de Vento (HMV). It was developed to consolidate policy for ethical review of research with human beings in all members of the CEP/Conep System, Brazil's national system of institutional review boards. The aim of this study was therefore to report on the experience and results of the Q-CEP project. Methods: An observational, retrospective study includes data from the Q-CEP, obtained from visits to all the institutional research ethics committees (RECs) in the country. The actions implemented by Q-CEP were part of a two-step process: (i) training visits to each REC; (ii) development of distance learning modules on strategic topics pertaining to research ethics evaluation. The data presented herein cover step one (training visits), defined by Q-CEP as the diagnostic stage of the project. For a country with social and economics inequalities such as Brazil, this is a particularly important stage; an accurate picture of reality is needed to inform planning of quality improvement strategies. Results: In 2019–2021, Q-CEP visited 832 RECs and trained 11,197 people. This sample covered almost all active RECs in the country; only 4 (0.5%) were not evaluated. Of the 94 items evaluated, 62% did not reach the target of at least 80% compliance and around 1/4 (26%) were below 50% compliance. The diagnostic stage of the process revealed inadequacies on the part of the RECs in their ethical reviews. The analysis of informed consent forms showed compliance in only 131 RECs (15.74%). The description of pending issues made by RECs in their reports was compliant in 19.33% (n = 161). Administrative and operational aspects were also considered inadequate by more than half of the RECs. Conclusions: Overall, Brazilian RECs showed poor compliance in several aspects of their operation, both in ethics evaluation and in other processes, which justifies additional training. The Q-CEP project is part of a quality improvement policy promoted by the Brazilian Ministry of Health. The data obtained in the diagnostic step of the project have contributed to the qualification and consolidation of one of the world's largest research ethics evaluation systems. [ABSTRACT FROM AUTHOR]

Background: Dental cone beam computed tomography (CBCT) is commonly used to evaluate cancellous bone density before dental implant surgery. However, to our knowledge, no measurement approach has been standardized yet. This study aimed to evaluate the relationship between three different regions of interest (ROI) methods on cancellous bone density at the dental implant site using dental CBCT images. Methods: Patients' dental CBCT images (n = 300) obtained before dental implant surgery were processed using Mimics (Materialise, Leuven, Belgium). At the potential implant sites, the rectangle, cylinder, and surrounding cylinder ROI methods were used to measure bone density. Repeated measures one-way analysis of variance was performed to compare the three ROI methods in terms of measurement results. Pearson correlation analysis was performed to identify the likely pair-wise correlations between the three ROI methods. Results: The density value obtained using the surrounding cylinder approach (grayscale value [GV],523.56 ± 228.03) was significantly higher than the values obtained using the rectangle (GV, 497.04 ± 236.69) and cylinder (GV,493 ± 231.19) ROI methods in terms of results. Furthermore, significant correlations were noted between the ROI methods (r > 0.965; p < 0.001). Conclusions: The density measured using the surrounding cylinder method was the highest. The choice of method may not influence the trends of measurement results. Trial registration: This study was approved by the Institutional Review Board of China Medical University Hospital, No. CMUH111-REC3-205. Informed consent was waived by the Institutional Review Board of China Medical University Hospital, CMUH111-REC3-205, owing to the retrospective nature of the study. [ABSTRACT FROM AUTHOR]

Background: We aimed to compare the changes in blood metabolomes and cardiac parameters following doxorubicin treatment in HER2-positive and HER2-negative breast cancer patients. Additionally, the potential roles of changes in blood metabolomes as severity and prognostic markers of doxorubicin-induced cardiotoxicity were determined. Methods: HER2-positive (n = 37) and HER2-negative (n = 37) breast cancer patients were enrolled. Cardiac function assessment and blood collection were performed at baseline and 2 weeks after completion of doxorubicin treatment in all patients, as well as at three months after completion of doxorubicin treatment in HER2-negative breast cancer patients. Blood obtained at all three-time points was processed for measuring cardiac injury biomarkers. Blood obtained at baseline and 2 weeks after completion of doxorubicin treatment were also processed for measuring systemic oxidative stress and 85 metabolome levels. Results: Cardiac injury and systolic dysfunction 2 weeks after completion of doxorubicin treatment were comparable between these two groups of patients. However, only HER2-negative breast cancer patients exhibited increased systemic oxidative stress and cardiac autonomic dysfunction at this time point. Moreover, 33 and 29 blood metabolomes were altered at 2 weeks after completion of doxorubicin treatment in HER2-positive and HER2-negative breast cancer patients, respectively. The changes in most of these metabolomes were correlated with the changes in cardiac parameters, both at 2 weeks and 3 months after completion of doxorubicin treatment. Conclusions: The changes in blood metabolomes following doxorubicin treatment were dependent on HER2 status, and these changes might serve as severity and prognostic markers of doxorubicin-induced cardiotoxicity. Trial registration: The study was conducted under ethical approval from the Institutional Review Board of the Faculty of Medicine, Chiang Mai University (Registration number: MED-2563-07001; Date: April 28, 2020). The study also complied with the Declaration of Helsinki. [ABSTRACT FROM AUTHOR]

Background: The process of obtaining prior informed consent for experimental treatment does not fit well into the clinical reality of acute and intensive care. The therapeutic window of interventions is often short, which may reduce the validity of the consent and the rate of enrolled participants, to delay trial completion and reduce the external validity of the results. Deferred consent and 'opt-out' are alternative consent methods. The SafeBoosC-III trial was a randomised clinical trial investigating the benefits and harms of cerebral oximetry monitoring in extremely preterm infants during the first 3 days after birth, starting within the first 6 h after birth. Prior, deferred and opt-out consent were all allowed by protocol. This study aimed to evaluate the use of different consent methods in the SafeBoosC-III trial, Furthermore, we aimed to describe and analyse concerns or complaints that arose during the first 6 months of trial conduct. Methods: All 70 principal investigators were invited to join this descriptive ancillary study. Each principal investigator received a questionnaire on the use of consent methods in their centre during the SafeBoosC-III trial, including the possibility to describe any concerns related to the consent methods used during the first 6 months of the trial, as raised by the parents or the clinical staff. Results: Data from 61 centres were available. In 43 centres, only prior informed consent was used: in seven, only deferred consent. No centres used the opt-out method only, but five centres used prior and deferred, five used prior, deferred and opt-out (all possibilities) and one used both deferred and opt-out. Six centres applied to use the opt-out method by their local research ethics committee but were denied using it. One centre applied to use deferred consent but was denied. There were only 23 registered concerns during the execution of the trial. Conclusions: Consent by opt-out was allowed by the protocol in this multinational trial but only a few investigators opted for it and some research ethics boards did not accept its use. It is likely to need promotion by the clinical research community to unfold its potential. [ABSTRACT FROM AUTHOR]

Introduction: Our group developed an Integrated Care Pathway to facilitate the delivery of evidence-based care for adolescents experiencing depression called CARIBOU-2 (Care for Adolescents who Receive Information 'Bout OUtcomes, 2nd iteration). The core pathway components are assessment, psychoeducation, psychotherapy options, medication options, caregiver support, measurement-based care team reviews and graduation. We aim to test the clinical and implementation effectiveness of the CARIBOU-2 pathway relative to treatment-as-usual (TAU) in community mental health settings. Methods and analysis: We will use a Type 1 Hybrid Effectiveness-Implementation, Non-randomized Cluster Controlled Trial Design. Primary participants will be adolescents (planned n = 300, aged 13–18 years) with depressive symptoms, presenting to one of six community mental health agencies. All sites will begin in the TAU condition and transition to the CARIBOU-2 intervention after enrolling 25 adolescents. The primary clinical outcome is the rate of change of depressive symptoms from baseline to the 24-week endpoint using the Childhood Depression Rating Scale—Revised (CDRS-R). Generalized mixed effects modelling will be conducted to compare this outcome between intervention types. Our primary hypothesis is that there will be a greater rate of reduction in depressive symptoms in the group receiving the CARIBOU-2 intervention relative to TAU over 24 weeks as per the CDRS-R. Implementation outcomes will also be examined, including clinician fidelity to the pathway and its components, and cost-effectiveness. Ethics and dissemination: Research ethics board approvals have been obtained. Should our results support our hypotheses, systematic implementation of the CARIBOU-2 intervention in other community mental health agencies would be indicated. [ABSTRACT FROM AUTHOR]

Background: The quality of life of patients is an important consideration when selecting treatments for localized prostate cancer (PCa). We retrospectively compared sexual function after robot-assisted radical prostatectomy (RARP) and carbon-ion radiotherapy (CIRT) using propensity score matching. Methods: In total, 127 Japanese PCa patients treated with RARP and 190 treated with CIRT monotherapy were evaluated. We evaluated the Expanded Prostate Cancer Index Composite (EPIC) score before treatment and 12 and 24 months after treatment. After propensity score matching, data from 101 patients from each group were analyzed. The study protocol was approved by the Institutional Review Board of Gunma University Hospital (no. IRB2020-050, 1839). Results: After propensity score matching, the mean EPIC sexual function summary scores in the RARP and CIRT groups were 46.4 and 48.2, respectively. At 12 and 24 months after treatment, these scores were 27.9 (39.9% decrease) and 28.2 (39.2% decrease) in the RARP group and 41.4 (14.1% decrease) and 41.6 (13.7% decrease) in the CIRT group, respectively. Both groups demonstrated significantly decreased scores after 12 and 24 months of treatment compared to before treatment (all p < 0.05). At 12 and 24 months, the sexual function summary score was significantly higher in the CIRT group than in the RARP group (p < 0.001). Conclusions: There was a smaller decrease in the EPIC sexual function score in the CIRT group than in the RARP group. These results provide useful information for treatment decision-making of Japanese PCa patients. [ABSTRACT FROM AUTHOR]

Background: Longitudinal integrated clerkships (LICs) and traditional block rotations (TBRs) employ different designs that provide various learning experiences for students. In this study, we explored students' clinical participation and interpersonal interactions in LICs and TBRs at 2 metropolitan hospitals in Taiwan. Methods: In April 2018, we enrolled 15 LIC and 29 TBR students. We conducted a cross-sectional survey which required the students to outline a typical daily schedule during their internal medicine rotations and draw an ecomap of the clinical team members. With the patient in the center as a reference, the size of each circle in an ecomap indicated the importance of the member; the distances and number of connecting lines between two circles represented the relationship and frequency of interaction, respectively, between the corresponding members. We analyzed the results and compared the responses of the LIC and TBR students. Results: The LIC students spent more time on direct patient care and in the outpatient clinic/operation room, whereas the TBR students participated more in educational activities and in observation behind their seniors. In the ecomap analysis, the LIC students had a closer relationship with attending physicians and had better interactions with patients and preceptors than did the TBR students. Conversely, the TBR students felt closer to and interacted more frequently with interns and residents. Conclusions: The LIC students had more opportunities to care for patients directly and engaged in interactions with patients and attending physicians more frequently than did the TBR students. Trial registration: Ethical approval for the study was obtained from the Institutional Review Board of Tri-Service General Hospital (TSGHIRB 2–106–05–018). [ABSTRACT FROM AUTHOR]

Background: NGAL and Cystatin C (CysC) as biomarkers for the early detection of AKI are subject to both pathophysiological, as well as patient related heterogeneity. The aim of this study was to investigate the timeline of plasma levels of NGAL and CysC during the first seven days of ICU admission in a mixed ICU population and to relate these to AKI severity during ICU stay. Via these means we aimed to bring clarity to the previously reported heterogeneity of these renal biomarkers. Methods: Prospective Observation Cohort. Consecutive patients admitted to adult ICU at an academic hospital in the Netherlands between 18-02-2014 and 31-03-2014 were included. Urine output, serum creatinine, plasma NGAL and CysC were recorded during the first seven days of ICU admission. Biomarker expression was analyzed based on KDIGO score and time of AKI diagnosis. Results: 335 patients were included, 110 met KDIGO criteria for AKI. NGAL and CysC plasma levels were higher in AKI patients compared to non-AKI, high variability in individual values resulted in 56% of AKI patients having a false negative, and 32% of non-AKI patients having a false positive. Individual biomarker levels were variable, and no pattern based on KDIGO score was observed. Conclusions: Plasma NGAL and CysC as biomarkers for the early AKI detection may be subject to pathophysiological, and patient related heterogeneity. Further understanding of individual biomarker profiles may help in their application amongst mixed ICU populations. Trial Registration: The need for informed consent was waived by the Institutional Ethical Review Board of the University Medical Center Groningen (METc 2013 − 174) by Prof. dr. W.A. Kamps on May 17th 2013. [ABSTRACT FROM AUTHOR]

Background: Current requirements for ethical research in Canada, specifically the standard of active or signed parental consent, can leave Indigenous children and youth with inequitable access to research opportunities or health screening. Our objective was to examine the literature to identify culturally safe research consent processes that respect the rights of Indigenous children, the rights and responsibilities of parents or caregivers, and community protocols. Methods: We followed PRISMA guidelines and Arksey and O'Malley's approach for charting and synthesizing evidence. We searched MEDLINE, PsycINFO, ERIC, CINAHL, Google Scholar, Web of Science, Informit Indigenous Collection, Bibliography of Native North Americans, and Sociological Abstracts. We included peer-reviewed primary and theoretical research articles written in English from January 1, 2000, to March 31, 2022, examining Indigenous approaches for obtaining informed consent from parents, families, children, or youth. Eligible records were uploaded to Covidence for title and abstract screening. We appraised the findings using a Two-Eyed Seeing approach. These findings were inductively coded using NVivo 12 and analyzed thematically. Results: We identified 2,984 records and 11 eligible studies were included after screening. Three key recommendations emerged: addressing tensions in the ethics of consent, embracing wise practices, and using relational approaches to consent. Tensions in consent concerned Research Ethics Board consent requirements that fall short of protecting Indigenous children and communities when culturally incongruent. Wise practices included allowing parents and children to consent together, land-based consenting, and involving communities in decision-making. Using relational approaches to consent embodied community engagement and relationship building while acknowledging consent for Indigenous children cannot be obtained in isolation from family and community. Conclusions: Very few studies discussed obtaining child consent in Indigenous communities. While Indigenous communities are not a monolith, the literature identified a need for community-driven, decolonized consent processes prioritizing Indigenous values and protocols. Further research is needed to examine nuances of Indigenized consent processes and determine how to operationalize them, enabling culturally appropriate, equitable access to research and services for all Indigenous children. [ABSTRACT FROM AUTHOR]

Background: Irritability, an increased proneness to anger, is a primary reason youth present for psychiatric care. While initial evidence supports the efficacy of exposure-based cognitive behavioral therapy (CBT) for youth with clinically impairing irritability, treatment mechanisms remain unclear. Here, we propose to measure peripheral psychophysiological indicators of arousal—heart rate (HR)/electrodermal activity (EDA)—and regulation—heart rate variability (HRV)—during exposures to anger-inducing stimuli as potential predictors of treatment efficacy. The objective of this study is to evaluate whether in-situ biosensing data provides peripheral physiological indicators of in-session response to exposures. Methods: Blood volume pulse (BVP; from which HR and HRV canl be derived) and EDA will be collected ambulatorily using the Empatica EmbracePlus from 40 youth (all genders; ages 8-17) undergoing six in-person exposure treatment sessions, as part of a multiple-baseline trial of exposure-based CBT for clinically impairing irritability. Clinical ratings of irritability will be conducted at baseline, weekly throughout treatment, and at 3-month and 6-month follow-ups via the Clinical Global Impressions Scale (CGI) and the Affective Reactivity Index (ARI; clinician-, parent-, and child-report). Multilevel modeling will be used to assess within- and between-person changes in physiological arousal and regulation throughout exposure-based CBT and to determine whether individual differences are predictive of treatment response. Discussion: This study protocol leverages a wearable biosensor (Empatica) to continuously record HR/HRV (derived from BVP) and EDA during in-person exposure sessions for youth with clinically impairing irritability. Here, the goal is to identify changes in physiological arousal (EDA, HR) and regulation (HRV) over the course of treatment in tandem with changes in clinical symptoms. Trial registration: The participants in this study come from an overarching clinical trial (trial registration numbers: NCT02531893 first registered on 8/25/2015; last updated on 8/25/2023). The research project and all related materials were submitted and approved by the appropriate Institutional Review Board of the National Institute of Mental Health (NIMH). [ABSTRACT FROM AUTHOR]

Objective: The risk of occupational exposure during endotracheal intubation has required the global Emergency Medicine (EM), Anesthesia, and Critical Care communities to institute new COVID- protected intubation guidelines, checklists, and protocols. This survey aimed to deepen the understanding of the changes in intubation practices across Canada by evaluating the pre-COVID-19, early-COVID-19, and present-day periods, elucidating facilitators and barriers to implementation, and understanding provider impressions of the effectiveness and safety of the changes made. Methods: We conducted an electronic, self-administered, cross-sectional survey of EM physician site leads within the Canadian COVID-19 Emergency Department Rapid Response Network (CCEDRRN) to characterize and compare airway management practices in the pre-COVID-19, early-COVID-19, and present-day periods. Ethics approval for this study was obtained from the University of Manitoba Health Research Ethics Board. The electronic platform SurveyMonkey (www.surveymonkey.com) was used to collect and store survey tool responses. Categorical item responses, including the primary outcome, are reported as numbers and proportions. Variations in intubation practices over time were evaluated through mixed-effects logistic regression models. Results: Invitations were sent to 33 emergency department (ED) physician site leads in the CCEDRRN. We collected 27 survey responses, 4 were excluded, and 23 analysed. Responses were collected in English (87%) and French (13%), from across Canada and included mainly physicians practicing in mainly Academic and tertiary sites (83%). All respondents reported that the intubation protocols used in their EDs changed in response to the COVID-19 pandemic (100%, n = 23, 95% CI 0.86-1.00). Conclusions: This study provides a novel summary of changes to airway management practices in response to the evolving COVID-19 pandemic in Canada. Information from this study could help inform a consensus on safe and effective emergent intubation of persons with communicable respiratory infections in the future. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to identify the predictors of neurologic outcomes and mortality in physically abused and unintentionally injured children admitted to intensive care units (ICUs). Methods: All maltreated children were admitted to pediatric, neurosurgical, and trauma ICUs between 2001 and 2019. Clinical factors, including age, sex, season of admission, identifying settings, injury severity score, etiologies, length of stay in the ICU, neurologic outcomes, and mortality, were analyzed and compared between the physically abused and unintentionally injured groups. Neurologic assessments were conducted using the Pediatric Cerebral Performance Category scale. The study was approved by the Institutional Review Board of Chang Gung Memorial Hospital and the Ethics Committee waived the requirement for informed consent because of the anonymized nature of the data. Results: A total of 2481 children were investigated; of them, there were 480 (19.3%) victims admitted to the ICUs, including 156 physically abused and 324 unintentionally injured. Age, history of prematurity, clinical outcomes, head injury, neurosurgical interventions, clinical manifestations, brain computed tomography findings, and laboratory findings significantly differed between them (all p < 0.05). Traumatic brain injury was the major etiology for admission to the ICU. The incidence of abusive head trauma was 87.1% among the physically abused group. Only 46 (29.4%) and 268 (82.7%) cases achieved favorable neurologic outcomes in the physically abused and unintentionally injured groups, respectively. Shock within 24 h, spontaneous hypothermia (body temperature, < 35 °C), and post-traumatic seizure were strongly associated with poor neurologic outcomes and mortality in both groups. Conclusions: Initial presentation with shock, spontaneous hypothermia at ICU admission, and post-traumatic seizure were associated with poor neurologic outcomes and mortality in physically abused and unintentionally injured children. [ABSTRACT FROM AUTHOR]

Background: Potassium regulation in the body is primarily done in the kidney. In addition to this, hyperkalemia, occurs in approximately 10% of individuals with chronic kidney disease (CKD) and is associated with elevated all-cause mortality. Individuals with CKD are often told to restrict dietary potassium (K), however, this recommendation is based on low quality evidence. Reduced quality of life, limited dietary choices and nutritional deficiencies are all potential negative outcomes that may occur when restricting dietary K in CKD patients. There is a need for randomized controlled trials investigating the impact of dietary K modification on serum K concentrations in people with CKD. Methods: A randomized 2-period crossover design comparing a liberalized K fruit and vegetable diet where participants will be required to consume ~ 3500 mg of dietary K daily, to a standard K restricted diet where participants will be required to consume < 2000 mg of dietary K daily. All participants will begin on a liberalized K run-in period for 2 weeks where they will receive fruit and vegetables home deliveries and for safety will have clinical chemistry, including serum potassium measurements taken after 1 week. Participants will then be randomized into either liberalized K or standard K diet for six weeks and then crossover to the other intervention for another 6 weeks after a 2-week washout period. Discussion: 30 male and female CKD outpatients, ≥ 18 years of age, who have an estimated glomerular filtration rate (eGFR) between 15 and 45 ml/min/1.73m2 and serum K between 4.5 and 5.5 mEq/L. This design would have greater than 80% power to detect a difference of 0.35 mEq/L serum K between groups. Anthropometric measurements, clinical chemistry, dietary recalls, physical function assessments, as well as a quality of life assessments will also be measured in this trial. These findings will provide high quality evidence for, or against, recommendations for dietary K restriction in individuals living with CKD. The removal of K restriction could provide individuals living with CKD more dietary choice leading to improved dietary status and quality of life. Trial Registration: This trial has received approval from the University of Manitoba Research Ethics board (HS25191 (B2021:104)). [ABSTRACT FROM AUTHOR]

Background: Major depressive disorder (MDD) is a prevalent mental health condition affecting millions worldwide, leading to disability and reduced quality of life. MDD poses a global health priority due to its early onset and association with other disabling conditions. Available treatments for MDD exhibit varying effectiveness, and a substantial portion of individuals remain resistant to treatment. Repetitive transcranial magnetic stimulation (rTMS), applied to the left and/or right dorsolateral prefrontal cortex (DLPFC), is an alternative treatment strategy for those experiencing treatment-resistant MDD. The objective of this study is to investigate whether this newer form of rTMS, namely theta burst stimulation (TBS), when performed unilaterally or bilaterally, is efficacious in treatment-resistant MDD. Methods: In this naturalistic, randomized double-blinded non-inferiority trial, participants with a major depressive episode will be randomized to receive either unilateral (i.e., continuous TBS [cTBS] to the right and sham TBS to the left DLPFC) or bilateral sequential TBS (i.e., cTBS to the right and intermittent TBS [iTBS] to the left DLPFC) delivered 5 days a week for 4–6 weeks. Responders will move onto a 6-month flexible maintenance phase where TBS treatment will be delivered at a decreasing frequency depending on degree of symptom mitigation. Several clinical assessments and neuroimaging and neurophysiological biomarkers will be collected to investigate treatment response and potential associated biomarkers. A non-inferiority analysis will investigate whether bilateral sequential TBS is non-inferior to unilateral TBS and regression analyses will investigate biomarkers of treatment response. We expect to recruit a maximal of 256 participants. This trial is approved by the Research Ethics Board of The Royal's Institute of Mental Health Research (REB# 2,019,071) and will follow the Declaration of Helsinki. Findings will be published in peer-reviewed journals. Discussion: Comprehensive assessment of symptoms and neurophysiological biomarkers will contribute to understanding the differential efficacy of the tested treatment protocols, identifying biomarkers for treatment response, and shedding light into underlying mechanisms of TBS. Our findings will inform future clinical trials and aid in personalizing treatment selection and scheduling for individuals with MDD. Trial registration: The trial is registered on https://clinicaltrials.gov/ct2/home (#NCT04142996). [ABSTRACT FROM AUTHOR]

Background: The safety and efficacy of 17-gauge needles used in CT-guided percutaneous cryoablation for lung nodules were explored in this study. The purpose of the study was to compare the findings with earlier research and multi-center clinical trials that used various needle sizes. Methods: Between 2016 and 2020, a retrospective study was conducted with approval from the institutional review board. A total of 41 patients were enrolled, and 71 lung nodules were treated in 63 cryoablation procedures using local anesthesia. Complication rates were recorded, and overall survival rates as well as tumor progression-free rates were calculated using the Kaplan-Meier method. Results: Self-limited hemoptysis was caused by 12.9% of the procedures, and drainage was required for pneumothoraces resulting from 11.3% of them. The overall survival rates at one, two, three, and four years were 97%, 94%, 82%, and 67%, respectively. The tumor progression-free rates at one, two, three, and four years were 86.2%, 77%, 74%, and 65%, respectively. Conclusion: Cryoablation for lung nodules using 17-Gauge needles can achieve similar rates of survival and tumor control rates, similar or even lower complication rates as compared with other studies and multi-center trials using mixed sized needles. [ABSTRACT FROM AUTHOR]

Background: Surveillance colonoscopy decreases colorectal cancer mortality; however, lesions are occasionally missed. Although an appropriate surveillance interval is indicated, variations may occur in the methods used, such as scope manipulation or observation. Therefore, individual endoscopists may miss certain areas. This study aimed to verify the effectiveness of performing repeat colonoscopies with a different endoscopist from the initial procedure. Methods: We retrospectively reviewed a database of 8093 consecutive colonoscopies performed in the Omori Red Cross Hospital from January 1st 2018 to June 30th 2021. Data from repeat total colonoscopies performed within three months were collected to assess missed lesions. The patients were divided into two groups according to whether the two examinations were performed by different endoscopists (group D) or the same endoscopist (group S). The primary outcome in both groups was the missed lesion detection rate (MLDR). Results: Overall, 205 eligible patients were analyzed. In total, 102 and 103 patients were enrolled in groups D and S, respectively. The MLDR was significantly higher in group D (61.8% vs. 31.1%, P < 0.0001). Multivariate logistic regression analysis for the detection of missed lesions identified performance by the different endoscopists (odds ratio, 3.38; 95% CI, 1.81–6.30), and sufficient withdrawal time (> 6 min) (odds ratio, 3.10; 95% CI, 1.12–8.61) as significant variables. Conclusions: Overall, our study showed a significant improvement in the detection of missed lesions when performed by different endoscopists. When performing repeat colonoscopy, it is desirable that a different endoscopist perform the second colonoscopy. Trial registration: This study was approved by the Institutional Review Board of the Omori Red Cross Hospital on November 28, 2022 (approval number:22–43). [ABSTRACT FROM AUTHOR]

Background: While genomic data sharing can facilitate important health research and discovery benefits, these must be balanced against potential privacy risks and harms to individuals. Understanding public attitudes and perspectives on data sharing is important given these potential risks and to inform genomic research and policy that aligns with public preferences and needs. Methods: A cross sectional online survey measured attitudes towards genomic data sharing among members of the general public in an Eastern Canadian province. Results: Results showed a moderate comfort level with sharing genomic data, usually into restricted scientific databases with controlled access. Much lower comfort levels were observed for sharing data into open or publicly accessible databases. While respondents largely approved of sharing genomic data for health research permitted by a research ethics board, many general public members were concerned with who would have access to their data, with higher rates of approval for access from clinical or academic actors, but much more limited approval of access from commercial entities or governments. Prior knowledge about sequencing and about research ethics boards were both related to data sharing attitudes. Conclusions: With evolving regulations and guidelines for genomics research and data sharing, it is important to consider the perspectives of participants most impacted by these changes. Participant information materials and informed consent documents must be explicit about the safeguards in place to protect genomic data and the policies governing the sharing of data. Increased public awareness of the role of research ethics boards and of the need for genomic data sharing more broadly is also needed. [ABSTRACT FROM AUTHOR]

Background: The criteria for metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUO) remain controversial. This research aimed to identify a potential biomarker to differentiate the subtypes of obesity. Methods: The study conducted a lipidomic evaluation of ceramide in the serum of 77 Chinese adults who had undergone hyperinsulinemic-euglycemic clamps. These adults were divided into three groups according to the clinical data: normal weight control group (N = 21), MHO (N = 20), and MUO (N = 36). Results: The serum Cer d18:1/24:1 level in the MHO group was lower than that in the MUO group. As the Cer d18:1/24:1 level increased, insulin sensitivity decreased, and the unfavorable parameters increased in parallel. Multivariate logistic regression analysis revealed that serum Cer d18:1/24:1 levels were independently correlated with MUO in obesity. Individuals with higher levels of Cer d18:1/24:1 also had an elevated risk of cardiovascular disease. Most ceramide subtype levels increased in obesity compared to normal-weight individuals, but the levels of serum Cer d18:0/18:0 and Cer d18:1/16:0 decreased in obesity. Conclusions: The relationships between ceramide subtypes and metabolic profiles might be heterogeneous in populations with different body weights. Cer d18:1/24:1 could be a biomarker that can be used to differentiate MUO from MHO, and to better predict who will develop unfavorable health outcomes among obese individuals. Trial registration: The First Affiliated Hospital of Nanjing Medical University's Institutional Review Board authorized this study protocol, and all participants provided written informed consent (2014-SR-003) prior to study entry. [ABSTRACT FROM AUTHOR]

Background: All learners at the Northern Ontario School of Medicine University complete a longitudinal integrated clerkship experience in their third year, which serves to improve learner experience with community and clinical acute and chronic health needs. Early in the program, Muskoka faculty (two of the 15 LIC sites of NOSM U) became aware that learners never had the occasion to complete a full history and physical exam on a real patient with complex needs. Recognizing this as a critical experience, a program was initiated to provide learners with this opportunity. This manuscript reports on the effectiveness and impact of this novel program and outlines the procedure developed to incorporate a similar program should communities see the relevance. Methods: Using a mixed method design, feedback was collected from learners and preceptors following the implementation of a novel learning opportunity for clinical clerks. Learners completed a full history and physical exam on volunteer complex patients, with supervision and immediate feedback. Using semi structured surveys, data was collected from each learner and preceptor to determine the program impact and optimize the program. Laurentian University research ethics board, certificate number 6021120. Results: Both learners and preceptors agreed this was a valuable experience for learners, a good use of their time and contributed to essential skills including, communication, time management and appropriate data collection. The use of real patients was reported to be very appropriate by learners and faculty and often highlighted gaps in the learner's knowledge that they were then able to address. Conclusion: Feedback collected in this study confirms that providing medical learners the opportunity to complete a full history and physical exam with supervision and feedback was significantly beneficial from both a clinical and a skills-based aspect. Requiring learners to complete this task within the established period forced them to manage their time, focus on clinical consideration and remain on task. Enhancing learning opportunities is associated with improved outcomes and understanding in medical learners. Positive community experience is also related to learner retention, which is paramount for attracting new physicians in a time with significantly limited human health resources. [ABSTRACT FROM AUTHOR]

Background: Institutional Review Boards (IRBs) play a vital role in safeguarding the rights and interests of both research participants and researchers. However, China initiated the establishment of its own IRB system relatively late in comparison to international standards. Despite commendable progress, there is a pressing need to strengthen the organizational capacity building of Chinese IRBs. Hence, this study aims to analyze the key factors driving the enhancement of organizational capacity within these committees. Method: The cross-sectional survey for this research was conducted from July 2020 to January 2022. Following the statistical grouping based on the "2020 China Health Statistical Yearbook", a systematic investigation of IRBs in various provinces of China was carried out. In-depth interviews and questionnaire surveys were conducted with the chairpersons and administrative executives (or secretaries) of highly cooperative IRBs. Subsequently, data were collected from 107 IRBs. Qualitative Comparative Analysis (QCA) was employed as the method to analyze the factors influencing the organizational capacity of medical ethics committees and explore the diverse combinations of these factors. Results: Through a singular necessary condition analysis, the variable "protection of rights and interests" emerges as a critical factor contributing to the robust construction of Institutional Review Boards Institutional Review Boards (IRBs). Conversely, the variables of "lack of member ability, absence of review process, and deficiency in the supervision mechanism" collectively constitute a sufficient condition leading to weaker IRB construction. The state analysis uncovers three interpretation modes: member ability-oriented (M1), system process-oriented mode (M2), and resource system-oriented mode (M3). Conclusions: The results of this study are effectively explicable using the "Triangular Force" model proposed for the hypothesis of IRBs' organizational capacity, which provides a solid foundation for the development of organizational capabilities in IRBs. To enhance the organizational capacity of IRBs in China, it is imperative to elevate the competence of committee members and strengthen team development. This can be achieved by establishing a comprehensive regulatory framework and refining procedural protocols. Moreover, clarifying the organizational structure and optimizing resource allocation are essential steps in bolstering the overall organizational capabilities of these committees. [ABSTRACT FROM AUTHOR]

Background: Pancreatic cancer is a devastating disease with less than 5% 5-year survival. Inoperable patients often present with pain. Randomized controlled trial have shown that endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) improves pain control. It is usually performed by injecting bupivacaine followed by absolute alcohol around the celiac axis. Study design: Single center, randomized, double blind controlled trial of EUS-CPN with and without bupivacaine in patients with inoperable malignancy (pancreatic or other) involving the celiac plexus. The study was approved by research ethics board with approval number of 2022-9969, 21.151 and registered on ClinicalTrials.gov (NCT04951804). Discussion: We hypothesize that bupivacaine is superfluous and may actually reduce pain control by diluting the neurolytic effect of alcohol. Bupivacaine is also potentially dangerous in that it may produce serious adverse events such as arrythmias and cardiac arrest if inadvertently injected intravascularly. Conclusion: This randomized trial is designed to assess whether bupivacaine is of any value during EUS-CPN. [ABSTRACT FROM AUTHOR]

Background: When reviewing a protocol, research ethics committees (RECs, equivalent to institutional review boards — IRBs) have the responsibility to consider whether the proposed research is justified. If research is not justified, it can waste participants' time, researchers' time and resources. As RECs are not constituted to cover all areas of scientific or academic expertise, it can be difficult for RECs to decide whether research is scientifically or methodologically justified especially in the absence of authoritative (often in the form of systematic) reviews. Where such reviews are absent, some have argued that RECs should insist on a new review of existing evidence as a condition of the REC favourable opinion. However, as RECs review a wide range of research, such requests must be proportionate to the type, and extent, of proposed projects. Risk is one factor that may influence the extent of evidence need for a REC to determine that the new project is justified, but not the only factor. The aim of the work described here was to determine whether REC members and researchers specifically link risk to the type of research methodology, and if so, whether this link could be used to help guide the need for systematic, or other, types of reviews. Method: We conducted a cross-sectional study, gathering data between November 2020 and January 2021, to examine whether proposed research methodologies impact how RECs perceive risk to participants. We presented 31 research methodologies to REC members and researchers in the form of an international survey. Results: We collected 283 responses that included both qualitative and quantitative data as to how research methodology impacts perceptions of risk to participants. We used the data to conclude that RECs did see a link between risk and type of research. We therefore constructed a hierarchy of risk with Phase 1 and 2 clinical trials, and clinical psychology/psychiatry intervention studies, at the top (i.e. viewed as most risky). Conclusions: We discuss whether this hierarchy is useful for guiding RECs as to the level of scientific justification that they should seek when reviewing proposed research protocols, and present a one-page guidance sheet to help RECs during their reviews. [ABSTRACT FROM AUTHOR]

Transcranial magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive method for controlling tremor and has recently been used in patients with X-linked dystonia-parkinsonism (XDP). This study aims to determine the improvement in dystonia and parkinsonism in patients with XDP after MRgFUS pallidothalamic tractotomy. This prospective study will be conducted at the Philippine General Hospital, University of the Philippines Manila. The primary outcome measure is the change in the pre- and post-treatment XDP-Movement Disorder Society of the Philippines Scale scores. In addition, demographic and clinical data will be collected, including the Burke-Fahn-Marsden Dystonia Rating Scale, Part III of the Movement Disorder Society-Unified Parkinson's disease Rating Scale score, XDP clinical and functional stage, the five-level EuroQol five-dimensional questionnaire, Montreal Cognitive Assessment scores, MRgFUS treatment parameters, and adverse events. Patients will be assessed within 24 hours of treatment, then at 2 weeks, 3 months, 6 months, 9 months, and 12 months post-treatment. This protocol was approved by the University of the Philippines Manila Research Ethics Board (UPMREB 2022-0271-01). Data collection began in January 2023. This protocol has been registered with ClinicalTrials.gov: Trial Registration number: NCT05592028. [ABSTRACT FROM AUTHOR]