Barriers to and facilitators of paediatric medical device innovation: a scoping review protocol.

INTRODUCTION: The development of paediatric medical devices continues to lag adult medical devices and contributes to issues of inequity, safety, quality and patient outcomes. New legislation and funding mechanisms have been introduced over the past two decades, but the gap remains. Clinical trials have been identified as a pain point, but components of effective clinical research infrastructure are poorly understood. As part of a multimodal research strategy, the Pediatric Device Consortia (PDC) will conduct a scoping review to better understand infrastructural barriers to and facilitators of paediatric medical device clinical research identified in the health sciences literature. METHODS AND ANALYSIS: The following databases will be included for this review: Medline, Embase, Cochrane CENTRAL, Web of Science and IEEE Xplore. Additional grey literature will be sought out through Google Scholar and reviewing the citations of included studies. Included studies will discuss medical devices according to the U.S. Food and Drug Administration classification, focus on the paediatric population (ages 0-21 years) and involve human premarket or postmarket research. All study types that were published in 2007-present in English, Spanish, French or Italian will be included. Using Covidence web-based software, two independent reviewers will screen the resulting titles, abstracts and the full text of potential studies. Conflicts will be resolved by the primary investigator during both phases. REDCap will be used for quantitative and qualitative data charting, generating data tables and narrative synthesis. ETHICS AND DISSEMINATION: This research did not require research ethics board consideration as it does not involve human participants and all data will be collected from published literature. We will share our findings through peer-reviewed manuscripts, clinical and research conference presentations and professional networks available to the PDC. STUDY REGISTRATION: Open Science Framework (https://osf.io/k72bn).

Cost-effectiveness analysis of individual-level obesity treatment in paediatrics: A scoping review.

OBJECTIVES: This scoping review informs a health economics perspective on the treatment of paediatric obesity. The results detail recently published research findings on the cost-effectiveness of paediatric obesity treatments and identify key characteristics of cost-effective interventions. METHODS: A structured search was applied to six databases with no data restriction through March 2023: Medline, Embase, Cochrane CENTRAL, CINAHL, and PsycINFO. Studies that included a cost analysis of an individual level, weight management intervention (behavioural, pharmacotherapy, and surgical) in youth, with obesity, ages 2 to 21 years were eligible for inclusion. RESULTS: Of the 4371 records identified in the initial search, 353 underwent full-text review, 39 studies met the pre-specified inclusion criteria. The majority were published after 2010 (n = 36/39, 92%) and applied to high-income countries (n = 39/39, 100%). Thirty-five of the studies assessed the cost-effectiveness of lifestyle interventions (90%), and four studies assessed surgical outcomes (10%). No pharmacotherapy studies met eligibility criteria. Although the outcome measures differed across the studies, all four surgical interventions were reported to be cost-effective. Thirty of the 35 (85%) lifestyle modification studies were reported to be cost-effective compared to the study comparator examined. CONCLUSIONS: There is a small amount of evidence that individual-level paediatric obesity treatment interventions are cost-effective and, in some cases cost-saving, with most of this work conducted on behavioural interventions. The economic evaluation of paediatric obesity interventions poses various methodologic challenges, which should be addressed in future research to fully use the potential of economic evaluation as an aid to decision-making.

ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis

Each year choledocholithiasis results in biliary obstruction, cholangitis, and pancreatitis in a significant number of patients. The primary treatment, ERCP, is minimally invasive but associated with adverse events in 6% to 15%. This American Society for Gastrointestinal Endoscopy (ASGE) Standard of Practice (SOP) Guideline provides evidence-based recommendations for the endoscopic evaluation and treatment of choledocholithiasis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework was used to rigorously review and synthesize the contemporary literature regarding the following topics: EUS versus MRCP for diagnosis, the role of early ERCP in gallstone pancreatitis, endoscopic papillary dilation after sphincterotomy versus sphincterotomy alone for large bile duct stones, and impact of ERCP-guided intraductal therapy for large and difficult choledocholithiasis. Comprehensive systematic reviews were also performed to assess the following: same-admission cholecystectomy for gallstone pancreatitis, clinical predictors of choledocholithiasis, optimal timing of ERCP vis-à-vis cholecystectomy, management of Mirizzi syndrome and hepatolithiasis, and biliary stent therapy for choledocholithiasis. Core clinical questions were derived using an iterative process by the ASGE SOP Committee. This body developed all recommendations founded on the certainty of the evidence, balance of risks and harms, consideration of stakeholder preferences, resource utilization, and cost-effectiveness.