Major discrepancies between what clinical trial registries record and paediatric randomised controlled trials publish

Background: Whether information from clinical trial registries (CTRs) and published randomised controlled trial (RCTs) differs remains unknown. Knowing more about discrepancies should alert those who rely on RCTs for medical decision-making to possible dissemination or reporting bias. To provide help in critically appraising research relevant for clinical practice we sought possible discrepancies between what CTRs record and paediatric RCTs actually publish. For this purpose, after identifying six reporting domains including funding, design, and outcomes, we collected data from 20 consecutive RCTs published in a widely read peer-reviewed paediatric journal and cross-checked reported features with those in the corresponding CTRs. Methods: We collected data for 20 unselected, consecutive paediatric RCTs published in a widely read peer-reviewed journal from July to November 2013. To assess discrepancies, two reviewers identified and scored six reporting domains: funding and conflict of interests; sample size, inclusion and exclusion criteria or crossover; primary and secondary outcomes, early study completion, and main outcome reporting. After applying the Critical Appraisal Skills Programme (CASP) checklist, five reviewer pairs cross-checked CTRs and matching RCTs, then mapped and coded the reporting domains and scored combined discrepancy as low, medium and high. Results: The 20 RCTs were registered in five different CTRs. Even though the 20 RCTs fulfilled the CASP general criteria for assessing internal validity, 19 clinical trials had medium or high combined discrepancy scores for what the 20 RCTs reported and the matched five CTRs stated. All 20 RCTs selectively reported or failed to report main outcomes, 9 had discrepancies in declaring sponsorship, 8 discrepancies in the sample size, 9 failed to respect inclusion or exclusion criteria, 11 downgraded or modified primary outcome or upgraded secondary outcomes, and 13 completed early without justification. The CTRs for seven trials failed to index automatically the URL address or the RCT reference, and for 12 recorded RCT details, but the authors failed to report the results. Conclusions: Major discrepancies between what CTRs record and paediatric RCTs publish raise concern about what clinical trials conclude. Our findings should make clinicians, who rely on RCT results for medical decision-making, aware of dissemination or reporting bias. Trialists need to bring CTR data and reported protocols into line with published data

Endoscopic retrograde cholangiopancreatography in children with pediatric congenital biliary dilatation associated with pancreatobiliary maljunction: experience from a tertiary center

BackgroundCongenital biliary dilatation (CBD) is a congenital malformation of the main biliary tract usually associated with the pancreatobiliary maljunction (PBM), determining stone formation, cholangitis, pancreatitis, and cholangiocarcinoma. The role of endoscopic retrograde cholangiopancreatography (ERCP) in treatment and diagnosis has not been established yet. Therefore, the aim of our study is to define the actual role of ERCP in children with CBD.MethodsA retrospective review of consecutive patients with congenital biliary dilatation undergoing preoperative ERCP and subsequent surgical treatment at our pediatric tertiary referral center (Endoscopy and Digestive Surgery, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy) was performed between 2012 and 2023.ResultsA total of 31 patients were included in the present study. Preoperative ERCP detected a PBM in 28 patients (90%). According to Todani's classification, 2 patients (6.5%) had choledochal cyst (CC) type IV, and 29 patients (93.5%) were diagnosed with CC type I. In 18 (58%) patients, ERCP was performed for treating acute pancreatitis. Sphincterotomy could be performed in 23 of 31 (74%) patients. Patients who did not undergo sphincterotomy had a higher number of acute episodes while awaiting surgery.ConclusionsThe present study is supportive of an essential role of ERCP in the diagnostic and preoperative management of children with CBD with acute presentation or inconclusive magnetic resonance cholangiopancreatography findings

Risk scores for choledocholithiasis perform poorly in patients with hemolytic diseases: a PEDI database report

Patients with hemolytic diseases are at increased risk for gallstone-related complications. Modified scoring systems have been developed to assess which pediatric patients would benefit from endoscopic retrograde cholangiopancreatography (ERCP) to treat choledocholithiasis. This study aimed to evaluate the ability of the available criteria to determine which pediatric patients with hemolytic diseases are likely to benefit from ERCP. A secondary analysis was performed using the Pediatric ERCP Database Initiative database, which contains prospectively collected data from 1,124 ERCPs at tertiary-care institutions. We compared patients with a hemolytic disease to those without. Data was analyzed by two-tailed Fisher’s exact test and paired student t-test. Of the 47 (17.0%) patients who had a hemolytic disease, 34 (72.3%) had one or more common bile duct (CBD) stones at the time of ERCP. Among patients with hemolytic diseases, there were no differences in pre-ERCP imaging or laboratory findings between those with a CBD stone removed at ERCP and those without. Patients with hemolytic diseases did not fit the current choledocholithiasis selection criteria well: 80% in the no-stone at ERCP group met the American Society of Gastrointestinal Endoscopy high-risk criteria, and 90% met the 2016 modified Baylor pediatric criteria. Although not statistically significant, there was an increased number of adverse events in patients with hemolytic diseases. Existing ERCP criteria perform poorly in patients with hemolytic diseases, overestimating their risk of choledocholithiasis. Peri-procedure evaluations such as endoscopic ultrasound, magnetic resonance cholangiopancreatography, and intraoperative cholangiography appear underutilized and may be essential modalities in this population

Global disparities in surgeons’ workloads, academic engagement and rest periods: the on-calL shIft fOr geNEral SurgeonS (LIONESS) study

: The workload of general surgeons is multifaceted, encompassing not only surgical procedures but also a myriad of other responsibilities. From April to May 2023, we conducted a CHERRIES-compliant internet-based survey analyzing clinical practice, academic engagement, and post-on-call rest. The questionnaire featured six sections with 35 questions. Statistical analysis used Chi-square tests, ANOVA, and logistic regression (SPSS® v. 28). The survey received a total of 1.046 responses (65.4%). Over 78.0% of responders came from Europe, 65.1% came from a general surgery unit; 92.8% of European and 87.5% of North American respondents were involved in research, compared to 71.7% in Africa. Europe led in publishing research studies (6.6 ± 8.6 yearly). Teaching involvement was high in North America (100%) and Africa (91.7%). Surgeons reported an average of 6.7 ± 4.9 on-call shifts per month, with European and North American surgeons experiencing 6.5 ± 4.9 and 7.8 ± 4.1 on-calls monthly, respectively. African surgeons had the highest on-call frequency (8.7 ± 6.1). Post-on-call, only 35.1% of respondents received a day off. Europeans were most likely (40%) to have a day off, while African surgeons were least likely (6.7%). On the adjusted multivariable analysis HDI (Human Development Index) (aOR 1.993) hospital capacity > 400 beds (aOR 2.423), working in a specialty surgery unit (aOR 2.087), and making the on-call in-house (aOR 5.446), significantly predicted the likelihood of having a day off after an on-call shift. Our study revealed critical insights into the disparities in workload, access to research, and professional opportunities for surgeons across different continents, underscored by the HDI