The National Endoscopy Database (NED) Automated Performance Reports to Improve Quality Outcomes Trial (APRIQOT) randomized controlled trial design

国家内镜数据库 (NED) 自动化绩效报告以提高质量结果试验 (APRIQOT) 随机对照试验设计

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Abstract

Background and study aims  Colonoscopists with low polyp detection have higher post colonoscopy colorectal cancer incidence and mortality rates. The United Kingdom's National Endoscopy Database (NED) automatically captures patient level data in real time and provides endoscopy key performance indicators (KPI) at a national, endoscopy center, and individual level. Using an electronic behavior change intervention, the primary objective of this study is to assess if automated feedback of endoscopist and endoscopy center-level optimal procedure-adjusted detection KPI (opadKPI) improves polyp detection performance. Methods  This multicenter, prospective, cluster-randomized controlled trial is randomizing NHS endoscopy centres to either intervention or control. The intervention is targeted at independent colonoscopists and each center's endoscopy lead. The intervention reports are evidence-based from endoscopist qualitative interviews and informed by psychological theories of behavior. NED automatically creates monthly reports providing an opadKPI, using mean number of polyps, and an action plan. The primary outcome is opadKPI comparing endoscopists in intervention and control centers at 9 months. Secondary outcomes include other KPI and proximal detection measures at 9 and 12 months. A nested histological validation study will correlate opadKPI to adenoma detection rate at the center level. A cost-effectiveness and budget impact analysis will be undertaken. Conclusion  If the intervention is efficacious and cost-effective, we will showcase the potential of this learning health system, which can be implemented at local and national levels to improve colonoscopy quality, and demonstrate that an automated system that collects, analyses, and disseminates real-time clinical data can deliver evidence- and theory-informed feedback.

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