Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data

摘要: Randomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, many have limited real-world generalizability. Designs for RCTs conducted using cohorts routinely collected health data, including registries, electronic records, administrative databases, been proposed address these challenges being rapidly adopted. These designs, however, relatively recent innovations, published RCT reports do not describe important aspects of their methodology in a standardized way. Our objective is extend the Consolidated Standards Reporting Trials (CONSORT) statement with consensus-driven reporting guideline data. The development this CONSORT extension will consist five phases. Phase 1 (completed) consisted project launch, fundraising, establishment research team, conceptual framework. In phase 2, systematic review performed identify publications (1) that methods or considerations data (2) protocols report results from such RCTs. An initial “long list” possible modifications checklist items new generated based on Strengthening Observational Studies Epidemiology (STROBE) REporting studies Conducted Routinely-collected Data (RECORD) statements. Additional identified review. 3 three-round Delphi exercise content experts evaluate generate “short key items. 4, serve as basis an in-person consensus meeting finalize core set included checklist. 5 involve drafting elaboration-explanation documents, dissemination implementation guideline. Development contribute more transparent