Research Unit Rehabilitation Sciences, Health Services Research in Rehabilitation, School of Public Health, Bielefeld University, Bielefeld, Germany -
Research Unit Rehabilitation Sciences, Health Services Research in Rehabilitation, School of Public Health, Bielefeld University, Bielefeld, Germany.
Eur J Phys Rehabil Med. 2020 Dec;56(6):829-835. doi: 10.23736/S1973-9087.20.06710-6. Epub 2020 Nov 20.
The reporting of patients' characteristics in randomized-controlled trials (RCTs) is one important dimension to improve the clinical replicability or transferability of study results into clinical practice.
Based on a previously developed framework for reporting on patient characteristics, the aim of this study was to determine whether and how patients' characteristics are presented in RCTs of major rehabilitation journals.
A literature search in eight high-impact medical rehabilitation journals was conducted.
Any setting.
A rehabilitation patient group.
Papers were included if they presented results on a RCT on rehabilitation patients. We excluded pilot or feasibility studies. We extracted information related to the description of personal, clinical and diagnosis-specific characteristics, comorbidities, and functioning according to the ICF (body functions and structures, activities and participation and context personal/environmental factors).
From a total of 129 papers initially identified we finally included 100 papers. Patient groups were almost exclusively defined by clinical diagnostic groups. Age and gender were the most prominent persons' characteristics (100% / 99% reported), followed by marital (22%), educational (15%) and occupational status (14%). Clinical characteristics usually relate to the respective diagnosis; general characteristics were reported on the duration of illness or symptoms (62%), to a lesser degree on BMI (45%) and/or weight (32%) and height (27%). One out of five papers report on comorbidities of the patients (20%). Information of body functions were present in almost every paper (98%), and nearly two third reported at least some aspect of activities and participation at baseline (63%).
The present analysis shows that there is a need to further the development of appropriate standards for the reporting of patient characteristics in rehabilitation trials.
In future it should help rehabilitation practitioners to decide whether the patients in a study and their own patients share features similar enough to allow for transferability of results.
报告随机对照试验（RCT）中患者的特征是提高研究结果在临床实践中可复制或可转移的重要维度之一。
基于之前为报告患者特征而开发的框架，本研究旨在确定主要康复期刊的 RCT 中是否以及如何呈现患者的特征。
在 8 种高影响力的医学康复期刊中进行文献检索。
任何环境。
康复患者群体。
如果论文报告了康复患者 RCT 的结果，则将其纳入研究。我们排除了试点或可行性研究。我们根据国际功能、残疾和健康分类（身体功能和结构、活动和参与以及个人/环境因素背景）提取与描述个人、临床和诊断特异性特征、合并症以及功能相关的信息。
从最初确定的 129 篇论文中，我们最终纳入了 100 篇论文。患者群体几乎完全由临床诊断组定义。年龄和性别是最突出的个人特征（100%/99%报告），其次是婚姻状况（22%）、教育程度（15%）和职业状况（14%）。临床特征通常与相应的诊断有关；一般特征报告了疾病或症状的持续时间（62%），较少程度上报告了 BMI（45%）和/或体重（32%）和身高（27%）。五分之一的论文报告了患者的合并症（20%）。几乎每篇论文都有身体功能的信息（98%），近三分之二的论文在基线时至少报告了一些活动和参与的方面（63%）。
本分析表明，需要进一步制定康复试验中报告患者特征的适当标准。
未来，它应该有助于康复从业者决定研究中的患者及其自身患者是否具有足够相似的特征，以允许结果的可转移性。
