Ali Shabana Amanda, Kloseck Marita, Lee Karen, Walsh Kathleen Ellen, MacDermid Joy C, Fitzsimmons Deborah
Faculty of Health Sciences.
Faculty of Science, University of Western Ontario.
Rheumatology (Oxford). 2018 Jan 1;57(1):59-63. doi: 10.1093/rheumatology/kex050.
Among the challenges in health research is translating interventions from controlled experimental settings to clinical and community settings where chronic disease is managed daily. Pragmatic trials offer a method for testing interventions in real-world settings but are seldom used in OA research. The aim of this study was to evaluate the literature on pragmatic trials in OA research up to August 2016 in order to identify strengths and weaknesses in the design and reporting of these trials.
We used established guidelines to assess the degree to which 61 OA studies complied with pragmatic trial design and reporting. We assessed design according to the pragmatic-explanatory continuum indicator summary and reporting according to the pragmatic trials extension of the CONsolidated Standards of Reporting Trials guidelines.
None of the pragmatic trials met all 11 criteria evaluated and most of the trials met between 5 and 8 of the criteria. Criteria most often unmet pertained to practitioner expertise (by requiring specialists) and criteria most often met pertained to primary outcome analysis (by using intention-to-treat analysis).
Our results suggest a lack of highly pragmatic trials in OA research. We identify this as a point of opportunity to improve research translation, since optimizing the design and reporting of pragmatic trials can facilitate implementation of evidence-based interventions for OA care.
健康研究面临的挑战之一是将干预措施从对照实验环境转化到日常管理慢性病的临床和社区环境中。实用性试验提供了一种在现实环境中测试干预措施的方法,但在骨关节炎(OA)研究中很少使用。本研究的目的是评估截至2016年8月OA研究中实用性试验的文献,以确定这些试验在设计和报告方面的优势和不足。
我们使用既定指南来评估61项OA研究符合实用性试验设计和报告的程度。我们根据实用性-解释性连续体指标总结评估设计,并根据《报告试验的统一标准》实用性试验扩展版指南评估报告。
没有一项实用性试验符合所有11项评估标准,大多数试验符合5至8项标准。最常未满足的标准与从业者专业知识(要求专家)有关,最常满足的标准与主要结局分析(采用意向性分析)有关。
我们的结果表明OA研究中缺乏高度实用性试验。我们将此视为改善研究转化的一个机会点,因为优化实用性试验的设计和报告可以促进OA护理循证干预措施的实施。