Criteria to Evaluate the Quality of Outcome Reporting in Randomized Controlled Trials of Rehabilitation Interventions.

ABSTRACT: No standardized guideline for the reporting of outcomes measures in randomized controlled trials 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 randomized controlled trials. First, we surveyed the author instructions for rehabilitation journals to determine how journals require authors to report outcomes. Second, we reviewed all consolidated standards of reporting trials extensions to determine how other speciality groups require reporting of outcomes in randomized controlled trials. Third, we conducted a focused scoping review to examine the nature and variations of criteria used to evaluate the quality of outcome measures in randomized controlled trials. Finally, we synthesized the information from phases 1-3 and propose four criteria specific to the reporting of outcomes in randomized controlled trials of rehabilitation interventions: (1) clearly describe the construct to be measured as outcome(s); (2) justify the selection of outcome measures by mapping to World Health Organization International Classification of Function, Disability, and Health (International Classification of Functioning) 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.