The Randomized Controlled Trials Rehabilitation Checklist: Methodology of Development of a Reporting Guideline Specific to Rehabilitation

Abstract

Background: One of the goals of Cochrane Rehabilitation is to strengthen methodology relevant to evidence-based clinical practice. Toward this goal, several research activities have been performed in rehabilitation literature: a scoping review listed the methodological issues in research, a study showed the low clinical replicability of randomized controlled trials, two systematic reviews showed the relevant items in reporting guidelines, and a series of articles discussed main methodological issues as a result of the first Cochrane Rehabilitation Methodological Meeting (Paris 2018). The need to improve the quality of conduct and reporting of research studies in rehabilitation emerged as a relevant task. The aim of this article is to present the Randomized Controlled Trial Rehabilitation Checklists (RCTRACK) project to produce a specific reporting guideline in rehabilitation.

Methods: The project followed a combination of the CONsolidated Standards of Reporting Trials and EQUATOR Network methodologies. The project includes five phases. The first is kick-off, first consensus meeting and executive and advisory committee identification. The second is literature search and synthesis, where eight working groups will produce knowledge synthesis products (systematic or scoping reviews) to compile items relevant to reporting of randomized controlled trials in rehabilitation. The topics will be as follows: patient selection; blinding; treatment group; control group and co-interventions; attrition, follow-up, and protocol deviation; outcomes; statistical analysis and appropriate randomization; and research questions. The third is guidelines development, which means drafting of a document with the guidelines through a consensus meeting. The fourth is Delphi process consensus, a Delphi study involving all the rehabilitation research and methodological community. The fifth is final consensus meeting and publication.

Conclusions: The RCTRACK will be an important contribution to the rehabilitation field and will impact several groups of rehabilitation stakeholders worldwide. The main goal is to improve the quality of the evidence produced in rehabilitation research. The RCTRACK also wants to improve the recognition and understanding of rehabilitation within Cochrane and the scientific and medical community at large.