Cochrane Rehabilitation recognises strengthening the methodology relevant to evidence-based clinical practice as one of its main goals.
The need to improve the quality of conduct and reporting in rehabilitation research has been highlighted by several research activities. Issues such as the low replicability of randomised controlled trials and desired items relevant to reporting have been underlined in a scoping review, a research study and two reviews.
To answer these needs, Cochrane Rehabilitation has launched the Randomized Controlled Trial Rehabilitation Checklists (RCTRACK) project aimed at producing a specific reporting guideline in rehabilitation.
The RCTRaCk project aims to provide a checklist that reports unified recommendations, including all the items needed for the production and reporting of randomised studies in rehabilitation, emphasising functions.
This checklist can be used as an addition to the original CONSORT 2010 checklist.
According to the methodology adopted from the CONSORT Group and adapted to the EQUATOR Network suggestions, the project followed five phases.
A group of experts discussed the methodological problems in rehabilitation research during a meeting held in Paris, France, in July 2018 (the 1st Cochrane Rehabilitation Methodological Meeting).
After a scoping review of the literature, during the 2nd Cochrane Rehabilitation Methodological Meeting held in Kobe, Japan, in June 2019, the RCTRACK project was launched to create a reporting guideline to complement CONSORT aiming at interventions in rehabilitation.
Eight Technical Working Groups were created, and further literature reviews were carried out to build the first list of items on a checklist.
The checklist draft was discussed at the main RCTRACK Consensus Conference in Orlando, United States, in March 2020 during the 3rd Cochrane Rehabilitation Methodological Meeting.
Delphi rounds for refinement of the preliminary items were carried out afterwards. Participants in the Delphi were (a) authors of articles on methodological issues in rehabilitation research, (b) members of editorial boards of rehabilitation journals, (c) members of groups dealing with evidence, methodology and checklists in rehabilitation, (d)members of Cochrane methods groups, (e) authors of Cochrane Reviews relevant to rehabilitation, (f) authors of RCTs published in rehabilitation journals, and (h) members of patients groups and organisations.
They were asked to express their judgment about adding 16 new items to the original CONSORT and 13 additional explanations to existing CONSORT items that added further information or contextualised the item to the rehabilitation field.
Authors of RCTs on rehabilitative intervention can use the RCTRaCk together with GUIDE- Rehab (https://rehabilitation.cochrane.org/special-projects/ongoing-special-projects/guide-rehab), a checklist developed within the same project and aimed at providing detailed information on how to report the rehabilitative interventions in randomised and non-randomised studies.
The reporting guideline will be published in 2025, as an open-access document.
Link to EQUATOR:
References:
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