Proposed categories for reporting of service organization in rehabilitation in clinical trials: a discussion paper.

Background: The lack of standardized reporting for crucial organizational factors in rehabilitation poses a significant barrier to understanding their impact on patient outcomes in clinical trials and meta-analyses.

Aim: Based on the categories in the International Classification of Service Organization in Rehabilitation (ICSO-R 2.0), we aimed to develop reporting standards specifically for organizational factors in clinical trials.

Methods: A comprehensive two-step process was conducted. In Step 1, important categories were identified. The identification was based on previous results from a Delphi survey with international stakeholder participation, two systematic literature reviews and results from focus groups with users in Germany, Indonesia and Norway. Step 2 involved the necessary reduction of categories and the proposal of reporting specifications, achieved through two voting rounds among key researchers, stakeholders and users.

Results: The suggested minimum reporting set comprises Context and Setting as well as Quality assurance and management. The Context and Setting is proposed to include whether the intervention is delivered by Hospital, Community or Other service providers. The Mode of delivery is proposed to be specified as Inpatient, Outpatient, In-home, or Tele-rehabilitation. Furthermore, the Level of specialization (Primary/Secondary) and the Phase of service delivery Acute, Subacute or Long-term rehabilitation services should be reported. The Quality assurance and management should be reported as Yes or No, with the option Yes requiring description of the quality assurance applied in the methods section.

Conclusions: This study proposed a compulsory and standardized reporting of organizational factors in clinical trials to facilitate the generation of scientific evidence regarding effective service provision and delivery in rehabilitation medicine. Authors are encouraged to consider the proposed reporting set to testing, criticism, and modification to enhance its applicability and robustness.