Toward Better Reporting Standards of Patients' Characteristics in Rehabilitation Trials: Applying a New Conceptual Framework to Current Standards

Background and Aim The reporting of clinical studies in rehabilitation has been criticized in several aspects, including the reporting of patient characteristics. This article aims to contribute to the improvement of the reporting of patient characteristics in rehabilitation trials. Specifically, we want to determine the type of information that should be reported in rehabilitation trials that is specific to rehabilitation patients and how this information is captured by current reporting standards. Methods In the first step, we made a conceptual analysis of characteristics of rehabilitation patients by addressing the specifics of the field of medical rehabilitation, including the definition of rehabilitation and a description of its beneficiaries. In the second step, we compared this reference framework to the current reporting standards, especially the Consolidated Standards of Reporting Trials (CONSORT) statement and its extensions, as well as standards for the reporting of clinical guidelines (agree, right). Results Patients included in rehabilitation interventions should be distinguished by specific information. From a clinical perspective, patients dealt with in rehabilitation comprise broader diagnostic groups compared with other clinical settings. Information on comorbidities should be added in the description of the patients. In addition, a description of baseline characteristics of patients should always include functioning characteristics of the patients, including information on relevant context factors, ie, environmental and personal factors. The CONSORT statement aims to provide patient characteristic to enable transferability of results to users. It is represented in terms of selection (inclusion/exclusion) criteria and the description of the resulting samples. Extensions of the CONSORT statement specified that information on socioeconomic variables should be added, and the selection of patient characteristics to be reported at baseline should be based on the selection of outcome variables. In addition, all relevant prognostic variables should be reported. Only one CONSORT extension asks explicitly to include comorbid conditions. The reporting standards on guidelines demand a more comprehensive characterization of patients, specific to the rehabilitation area. Conclusions Present reporting standards can only partly address relevant issues pertinent to medical rehabilitation. The present analysis provides a conceptual and empirical framework for the development of reporting standards on patient characteristics in rehabilitation trials.