Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE)

Abstract

ObjectivesRandomised 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.MethodsThe 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.Results27 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.ConclusionUptake 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.

CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration

“…The extension was developed after a consensus driven process25 and included: confirmation of the need for a reporting guideline; a scoping review to assess reporting quality and identify reporting considerations to include in a preliminary checklist version26; a three round Delphi process to collect input on the checklist items from stakeholders, including reporting guideline developers, funders, journal editors, patient representatives, trial methodologists, epidemiologists, meta-research authors, ethicists, biostatisticians, and clinical trialists who were identified by members of the project team; a consensus meeting to advise on items to include and the checklist structure; and publication, dissemination, and implementation of the final checklist. Details on methods and results from each stage of the process are described elsewhere 27. In brief, 27 items for consideration were initially developed by members of the CONSORT Extension Project Team based on review of items included in the CONSORT 2010 statement,89 the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE)28 statement, and the REporting of studies Conducted using Observational Routinely collected Data (RECORD)29 statement, and also discussions with steering committee members.…”

Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE

“…Our methodology will be guided by: the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network’s recommended steps for developing a health research reporting guideline, 34 and methodological considerations used to develop other recent or ongoing SPIRIT/CONSORT extensions (e.g., ACE (Adaptive designs CONSORT Extension), 35 CONSORT-ROUTINE 36 and dose-finding CONSORT extension 37 )…”

“…Secondary objectives will be to identify additional items not included in the initial list and allow for modifications in the wording of important items. 36 …”

“… 33 40 In round 1 of the Delphi, 33 56 participants will have the opportunity (through a free-text box) to add any proposed modification of items wording and suggestion of additional items. 36 We will consider new items in the second round if proposed by at least two Delphi participants. 59 Participants can also use the free-text box to explain any of their ratings.…”

Did an introduction of CONSORT for abstracts guidelines improve reporting quality of randomised controlled trials’ abstracts onHelicobacter pyloriinfection? Observational study

“… 11 12 It offers a way for authors to organise reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical analysis and interpretation. 13 An addition to the CONSORT statement was developed and it gives a list of essential elements that authors should include when describing the main outcomes of a randomised trial in a journal or conference abstract—CONSORT-A. 14 Those elements include recognising study as an RCT to allow indexing in databases, as well as description of the trials design, with contact details of a corresponding author to ask for additional information or clarification.…”