Department of Women's and Children's Health, Karolinska Intitutet, Stockholm, Sweden.
College of Health Professions, Department of Health Sciences, Northeastern University, Boston, Massachusetts, USA.
Phys Ther. 2021 Oct 1;101(10). doi: 10.1093/ptj/pzab161.
The Consolidated Standards of Reporting Trials (CONSORT) recommends reporting adverse events (AEs) and dropouts (DOs) with their definitions. The purpose of this study was to identify how AEs and DOs were reported in randomized controlled trials of therapeutic exercise for knee osteoarthritis (OA).
Data sources were the Cochrane Library, Embase, PubMed, and CINAHL. Databases were searched to identify randomized controlled trials of therapeutic exercise for knee OA published from January 1, 1980, through July 23, 2020. Researchers independently extracted participant and intervention characteristics and determined whether a clear statement of and reasons for AEs and DOs existed. The primary outcome was exercise-related harm. Physiotherapy Evidence Database (PEDro) scoring described study quality and risk of bias. Descriptive and inferential statistics characterized results. Meta-analysis was not performed due to data heterogeneity.
One hundred and thirteen studies (152 arms) from 25 countries were included, with 5909 participants exercising. PEDro scores ranged from 4 to 9. Exercise intensity was not specified in 57.9% of exercise arms. Fifty studies (44.2%) included an AE statement and 24 (21.2%) reported AEs, yielding 297 patients. One hundred and three studies (91.2%) had a DO statement. Sixteen studies (15.5%) provided reasons for DOs that could be classified as AEs among 39 patients, yielding a 13.1% increase in AEs. Thus, 336 patients (6.0%) experienced exercise-related harm among studies with a clear statement of AEs and DOs. A significant difference existed in misclassification of DOs pre- and post-CONSORT-2010 (12.2% vs 3.1%; $\chi^{2}_{1} = 21.2$).
In some studies, the reason for DOs could be considered AEs, leading to potential underreporting of harm. Improvements in reporting of harm were found pre- and post-CONSORT-2010. Greater clarity regarding AE and DO definitions and therapeutic exercise intensity are needed to determine safe dosing and mode of therapeutic exercise for knee OA.
More adherence to the CONSORT statement is needed regarding reporting of and defining of AEs, DOs, and therapeutic exercise intensity; however, despite this, therapeutic exercise seems to be associated with minimal risk of harm.
《临床试验报告统一标准》（CONSORT）建议报告不良事件（AE）和脱落（DO）并对其进行定义。本研究旨在确定在治疗膝骨关节炎（OA）的治疗性运动的随机对照试验中，AE 和 DO 的报告情况。
资料来源为 Cochrane 图书馆、Embase、PubMed 和 CINAHL。检索数据库以确定 1980 年 1 月 1 日至 2020 年 7 月 23 日发表的治疗性运动治疗膝 OA 的随机对照试验。研究人员独立提取参与者和干预措施的特征，并确定是否存在明确的 AE 和 DO 声明以及原因。主要结局是与运动相关的伤害。物理治疗证据数据库（PEDro）评分描述了研究质量和偏倚风险。描述性和推断性统计分析了结果。由于数据异质性，未进行荟萃分析。
来自 25 个国家的 113 项研究（152 个臂）纳入了 5909 名参与者进行运动。PEDro 评分范围为 4 至 9。57.9%的运动臂未指定运动强度。50 项研究（44.2%）包含 AE 声明，24 项（21.2%）报告了 AE，导致 297 名患者。103 项研究（91.2%）有 DO 声明。16 项研究（15.5%）提供了 DO 的原因，其中 39 名患者可归类为 AE，导致 AE 增加 13.1%。因此，在明确 AE 和 DO 声明的研究中，有 336 名患者（6.0%）经历了与运动相关的伤害。与 CONSORT-2010 之前相比，DO 的分类错误存在显著差异（12.2%比 3.1%；$\chi^{2}_{1} = 21.2$）。
在一些研究中，DO 的原因可被视为 AE，从而导致潜在的伤害报告不足。在 CONSORT-2010 前后，伤害报告得到了改善。需要更明确 AE 和 DO 定义以及治疗性运动强度，以确定膝 OA 的安全剂量和治疗运动模式。
需要更严格地遵守 CONSORT 声明，报告 AE、DO 和治疗性运动强度，并对其进行定义；然而，尽管如此，治疗性运动似乎与极小的伤害风险相关。
