Criteria to evaluate the quality of outcome reporting in RCTs of rehabilitation interventions.

No standardized guideline for the reporting of outcomes measures in RCTs of rehabilitation interventions is currently available. This study includes four phases to identify, synthesize, and make recommendations for potential attributes of reporting criteria of outcome measures in rehabilitation RCTs. First, we surveyed the author instructions for rehabilitation journals to determine how journals require authors to report outcomes. Second, we reviewed all CONSORT extensions to determine how other speciality groups require reporting of outcomes in RCTs. Third, we conducted a focussed scoping review to examine the nature and variations of criteria used to evaluate the quality of outcome measures in RCTs. Finally, we synthesized the information from phases 1-3 and propose four criteria specific to the reporting of outcomes in RCTs of rehabilitation interventions: 1) Clearly describe the construct to be measured as outcome(s); 2) Justify the selection of outcome measures by mapping to WHO International Classification of Function, Disability, and Health (ICF) framework; justify the psychometric properties (relevance, validity, reliability) of the selected measurement tool; 3) Clearly describe the timing of outcome measurement, with consideration of the health condition, the course of disease and hypothesized effect of intervention; and 4) Complete and unselective reporting of outcome data.