Characterization changes and research waste in randomized controlled trials of global gastroesophageal reflux disease and hiatus hernia over the past 20 years

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BACKGROUND: The results of many large randomized clinical trials (RCTs) have transformed clinical practice in gastroesophageal reflux disease (GERD) and esophageal hiatal hernia (HH). However, research waste (i.e., unpublished data, inadequate reporting, or avoidable design limitations) remains a major challenge to evidence-based medicine. METHOD: A cross-sectional analysis was conducted to comprehensively review and evaluate RCTs related to GERD and esophageal HH, registered in the ClinicalTrials.gov database between 2003 and 2023. A sample of eligible RCTs was identified by excluding early-stage trials, pediatric studies, and duplicate studies. Publication status was tracked using PubMed and Scopus databases, reporting adequacy was assessed according to the CONSORT guidelines, and design flaws were checked with the help of Cochrane tools. Shortcomings of RCT studies in different regions and intervention types were identified by quantifying RCT conduct, recruitment, reporting adequacy, risk of bias, and guideline citations. RESULTS: From 2003 to 2023, a total of 182 RCTs were included in the analysis, of which 69.8% (127 trials) were drug-related, and 71.4% of the principal investigators were located in North America and Asia (65 trials [35.7%] in both). Among them, the country with the most RCTs is the United States. RCTs in Asia were under-conducted in "procedure" and "other" types and fewer RCTs were conducted in Europe in "drug" type. RCTs in Oceania and South America were relatively under-conducted in the device and "other." The study revealed that more than 86.7% of RCTs were characterized by at least one type of research waste. Research waste was associated with the size of the RCT, blinded design, and regional healthcare access and quality index. CONCLUSIONS: This study describes for the first time the characteristics of RCTs for GERD and esophageal HH over the past 20 years and the conduct of various types of RCTs at the continental level. It identifies the burden of research waste and shortcomings in the conduct of RCT programs on each continent, which may provide evidence for the development of rational RCTs and the reduction of waste in the future.

Warrants cautious interpretation of GERD/hiatal hernia RCT evidence in practice; leaves open targeted strategies to curb research waste.