Objectives Randomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.Methods The development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist.Results 27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report.Conclusion Uptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data.All data relevant to the study are included in the article or uploaded as supplemental information.
Funding The development of CONSORT-ROUTINE was supported by the Canadian Institutes of Health Research (CIHR; PJT156172; PCS-161863), and the UK National Institute of Health Research (NIHR) Clinical Trials Unit Support Funding – Supporting efficient/innovative delivery of NIHR research (Principal Investigator (PI): EJ, co-PI: CG). DBR was supported by a Vanier CIHR Graduate Scholarship; SML was supported by a Wellcome Senior Clinical Fellowship in Science (205039/Z/16/Z); EIB was supported by a New Investigator Award from CIHR, the Canadian Association of Gastroenterology and Crohn’s and Colitis Canada, and the Career Enhancement Program of the Canadian Child Health Clinician Scientist Program; RU was supported by the Canada Research Chairs Program (Award #231397); CG was supported by the UK Medical Research Council through a Clinician Scientist Fellowship; and BDT was supported by a Tier 1 Canada Research Chair, all outside of the present work.