Towards standardized reporting of service organization in rehabilitation for clinical trials.

Meta-analysis of clinical trials in rehabilitation is often inconclusive, even when similar interventions are investigated. A possible reason for this is the influence of the settings in which rehabilitation services are delivered. Examples show that factors related to service organization in rehabilitation can influence study outcomes. This, in particular, is relevant, as contextual factors in rehabilitation are known to influence the participation and functioning of persons with disability. The Consolidated Statement of Reporting Trials (CONSORT) group and other initiatives published standards for reporting relevant factors for clinical trials. However, description of the rehabilitation setting of factors related to rehabilitation service provision is under-represented. Systematic reviews show that, on the one hand, these factors are scarcely reported, and only a few studies systematically evaluated the influence of factors related to service organization on rehabilitation outcomes. The International Classification of Service Organization in Rehabilitation (ICSO-R) provides a framework to systematically describe rehabilitation services. It contains 40 categories and sub-categories for the domains "provider" and "service delivery". Therefore, it is important and relevant to develop a minimum reporting set for factors relevant to service organization for rehabilitation trials. This paper sets out a methodological approach for this purpose, including literature reviews, Delphi survey focus group discussion, and consensus conference.