University of Applied Sciences, Faculty of Business and Social Sciences, Osnabrück, Germany; Faculties of Rehabilitation Medicine and Medicine and Dentistry Edmonton, Alberta, Canada; Don Carlo Gnocchi Foundation (IRCCS), Milan, Italy.
Don Carlo Gnocchi Foundation (IRCCS), Milan, Italy.
Arch Phys Med Rehabil. 2021 Aug;102(8):1606-1613. doi: 10.1016/j.apmr.2021.04.007. Epub 2021 May 11.
(1) To determine whether new tools and items have been developed to evaluate the risk of bias (RoB) and reporting of randomized controlled trials (RCTs) in rehabilitation; (2) to determine which items are included in the existing reporting guidelines, and to create a matrix of items to report and conduct trials in rehabilitation as the first step for a starting a rigorous validation process.
Searches were conducted in MEDLINE, EMBASE, and Cumulative Index to Nursing and Allied Health databases.
Studies should describe a newly developed tool to evaluate the RoB or quality of reporting for RCTs in the area of rehabilitation.
(1) First, we extracted items from new tools identified by the electronic search strategies and then (2) we looked at the items provided by the Consolidated Standards of Reporting Trials statement and its relevant extensions. We determined whether these items were already included in our matrix of items. Items were classified based on methodological domains they accomplish, biases they were able to target, and whether they guide reporting or conduct.
Among the 1596 citations found, 23 articles were potentially relevant. From these, only 3 new scales (National Institute for Complementary Medicine Acupuncture Network, Quality of reports on spa and balneotherapy [SPAC], Assessment of Study Quality and Reporting in Exercise) were found. In addition, the newly updated Cochrane RoB tool (RoB 2.0) was included. Our matrix contained 122 unique items for any rehabilitation area, 46 items (37.7%) were related to conduct, and 58 (47.5%) were related to the reporting; 18 (14.8%) were related to both. Overall, 76 new items were added among all domains.
Many individual and diverse items have been used to guide the reporting and conduct of rehabilitation trials. This indicates a great variability in number of items and an apparent lack of consensus on a core set of items to be used in rehabilitation. Future research should look into developing a core set of items for the rehabilitation field.
（1）确定是否开发了新的工具和项目来评估康复领域随机对照试验（RCT）的偏倚（RoB）和报告风险；（2）确定现有的报告指南中包含哪些项目，并创建一个报告和进行康复试验的项目矩阵，作为开始严格验证过程的第一步。
在 MEDLINE、EMBASE 和 Cumulative Index to Nursing and Allied Health 数据库中进行了检索。
研究应描述一种新开发的工具，用于评估康复领域 RCT 的 RoB 或报告质量。
（1）首先，我们从电子搜索策略中确定的新工具中提取项目，然后（2）查看 CONSORT 声明及其相关扩展提供的项目。我们确定这些项目是否已经包含在我们的项目矩阵中。项目根据其完成的方法学领域、能够针对的偏差以及是否指导报告或进行进行分类。
在 1596 条引文的基础上，有 23 篇文章可能相关。从这些文章中，只发现了 3 种新的量表（国家补充医学研究所针灸网络、水疗和温泉疗法报告质量 [SPAC]、运动评估的质量和报告）。此外，还包括新更新的 Cochrane RoB 工具（RoB 2.0）。我们的矩阵包含了任何康复领域的 122 个独特项目，其中 46 个项目（37.7%）与行为相关，58 个项目（47.5%）与报告相关，18 个项目（14.8%）与两者都相关。总体而言，所有领域共增加了 76 个新项目。
许多单独的、不同的项目已被用于指导康复试验的报告和行为。这表明在康复领域，项目数量存在很大差异，而且在用于康复的核心项目集方面明显缺乏共识。未来的研究应该着眼于为康复领域开发一套核心项目。
