Randomized Controlled Trial Rehabilitation Checklists

Cochrane Rehabilitation recognizes 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 low replicability of randomized controlled trials and desired items relevant in reporting have been underlined in a scoping review, a research study and two reviews.

To answer to these needs, Cochrane Rehabilitation has launched the Randomized Controlled Trial Rehabilitation Checklists (RCTRACK) project aimed at producing a specific reporting guideline in rehabilitation.

Following a methodology adopted from the CONSORT Group and adapted to the EQUATOR Network suggestions, the project will follow five phases.

  1. The first phase, the Kick-off, is concluded and led to the publication of an article.
  2. In the second phase each of the 8 RCTRACK Working Groups will prepare a systematic or scoping review on one of these 8 topics: (1) patient selection; (2) blinding; (3) treatment group; (4) control groups and co-interventions; (5) attrition, follow-up, and protocol deviation; (6) outcomes; (7) statistical analysis and appropriate randomization; and (8) research questions. This activity will produce a list of items to populate the RCTRACK checklist.
  3. The third will test the proposed checklist through a consensus meeting that will draft the guidelines
  4. The fourth phase will be a Delphi process involving all the rehabilitation research and methodological community
  5. The fifth and last phase is the final consensus meeting and publication.

References:

Arienti C, Armijo-Olivo S, Minozzi S, Lazzarini SG, Patrini M, Negrini S. Methodological issues in rehabilitation research: a scoping review. BMJ Evid-Based Med. 2019;24(Suppl 1):A35-A35. doi:10.1136/bmjebm-2019-EBMLive.68

Negrini S, Arienti C, Pollet J, et al. Clinical replicability of rehabilitation interventions in randomized controlled trials reported in main journals is inadequate. J Clin Epidemiol. 2019;114:108-117. doi:10.1016/j.jclinepi.2019.06.008

Negrini S, Armijo-Olivo S, Patrini M, et al. The Randomised Controlled Trials Rehabilitation Checklist (RCTRACK). Methodology of development of a reporting guideline specific to rehabilitation. Am J Phys Med Rehabil. December 2019. doi:10.1097/PHM.0000000000001370