From the School of Public Health, Bielefeld University, Bielefeld, Germany (TM); Swiss Paraplegic Research, Nottwil, Switzerland (MS, GS); Katholieke Universiteit Leuven, Leuven, Belgium (CK); Universitaire Ziekenhuizen Leuven, Leuven, Belgium (CK); Department of Rheumatology, Physical Medicine and Rehabilitation in the Centre Sestre Milosrdnice, Zagreb, Croatia (FG); University Hospital Centre Sestre Milosrdnice, Zagreb, Croatia (FG); IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy (CA); Department of Health Sciences and Health Policy, University of Lucerne, Lucerne, Switzerland (GS); and Physical and Rehabilitation Medicine, University of Brescia, Brescia, Italy (SN).
Am J Phys Med Rehabil. 2020 Mar;99(3):216-223. doi: 10.1097/PHM.0000000000001375.
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.
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).
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.
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.
康复领域的临床研究报告在多个方面受到了批评，包括对患者特征的报告。本文旨在提高康复试验中患者特征的报告质量。具体而言，我们希望确定应在康复试验中报告哪些特定于康复患者的信息，以及当前报告标准如何捕捉这些信息。
在第一步中，我们通过解决医学康复领域的具体问题，包括康复的定义和对其受益人的描述，对康复患者的特征进行了概念分析。在第二步中，我们将这个参考框架与当前的报告标准进行了比较，特别是 CONSORT 声明及其扩展，以及临床指南报告的标准（同意，正确）。
纳入康复干预的患者应通过特定信息加以区分。从临床角度来看，与其他临床环境相比，康复中处理的患者包含更广泛的诊断组。应在患者描述中添加合并症信息。此外，患者基线特征的描述应始终包括患者的功能特征，包括有关背景因素的信息，即环境和个人因素。CONSORT 声明旨在提供患者特征，以实现结果对使用者的可转移性。它以选择（纳入/排除）标准和结果样本的描述来表示。CONSORT 声明的扩展规定，应添加社会经济变量的信息，并应根据选择的结果变量来选择要在基线报告的患者特征。此外，应报告所有相关预后变量。只有一个 CONSORT 扩展明确要求包括合并症。指南的报告标准要求更全面地描述康复领域特定的患者特征。
目前的报告标准只能部分解决与医学康复相关的问题。本分析为康复试验中患者特征报告标准的制定提供了概念和实证框架。
