随机对照试验中治疗性运动治疗髋关节炎不良事件报告：系统评价。
Reporting of Adverse Events in Randomized Controlled Trials of Therapeutic Exercise for Hip Osteoarthritis: A Systematic Review.
机构信息
Department of Physical Therapy, Movement and Rehabilitation Sciences, Northeastern University, Boston, Massachusetts, USA.
Department of Women's and Children's Health, Karolinska Intitutet, Stockholm, Sweden.
出版信息
Phys Ther. 2021 Nov 1;101(11). doi: 10.1093/ptj/pzab195.
OBJECTIVE
The purpose of this study was to describe adverse events (AEs) and dropouts (DOs) in randomized controlled trials of therapeutic exercise for hip osteoarthritis (HOA) and to identify whether Consolidated Standards of Reporting Trials (CONSORT) guidelines were followed.
METHODS
The Cochrane Library, Embase, PubMed, and CINAHL databases were searched. Randomized controlled trials of therapeutic exercise for HOA published in English from January 1, 1980 to August 1, 2020 were included. Studies were excluded if other interventions were provided, if participants had previous hip arthroplasty, or if AEs and DOs for HOA participants were not reported separately. The internal validity of each study (Physiotherapy Evidence Database [PEDro] scoring) was assessed, participant and intervention characteristics were extracted, and the existence of a clear statement and reasons for AEs and DOs was reported. Descriptive statistics characterized results. Data heterogeneity prohibited the use of meta-analysis.
RESULTS
Fourteen studies (mean PEDro score = 7.4; range = 6-10) from 10 countries were included, with 707 participants exercising. Exercise intensity was unspecified in 72.2% of exercise arms. Six studies (42.9%) included a statement of AEs, and 32 AEs were reported. All studies had a DO statement, but 29.0% of DOs occurred for unknown reasons. Six studies (42.9%) gave reasons for DOs that could be classified as AEs in 9 participants; 41 participants (5.8%) experienced exercise-related AEs.
CONCLUSION
Reports of AEs were inconsistent, some DOs were potentially misclassified, and primary components of exercise interventions were frequently unreported. Despite these limitations, the overall low number of nonserious AEs suggests that the exercise-related risk of harm is minimal for individuals with HOA.
IMPACT
Understanding the risk of harm associated with exercise for HOA can better inform safe dosing of exercise, clinical implementation, and replicability. Informative, consistent reporting of AEs, DOs, and exercise is needed. Greater use of the CONSORT harms-reporting checklist is warranted.
目的
本研究旨在描述髋关节骨关节炎（HOA）治疗性运动的随机对照试验中的不良事件（AE）和脱落（DO），并确定是否遵循了 CONSORT 报告标准。
方法
检索了 Cochrane 图书馆、Embase、PubMed 和 CINAHL 数据库。纳入了 1980 年 1 月 1 日至 2020 年 8 月 1 日发表的英文治疗性运动治疗 HOA 的随机对照试验。如果提供了其他干预措施、如果参与者之前接受过髋关节置换术，或者如果未分别报告 HOA 参与者的 AE 和 DO，则排除这些研究。评估了每项研究的内部有效性（物理治疗证据数据库 [PEDro] 评分），提取了参与者和干预措施的特征，并报告了 AE 和 DO 的明确声明和原因。描述性统计数据描述了结果。由于数据异质性，无法进行荟萃分析。
结果
纳入了来自 10 个国家的 14 项研究（平均 PEDro 评分为 7.4；范围为 6-10），共有 707 名参与者进行了运动。72.2%的运动组未明确规定运动强度。6 项研究（42.9%）对 AE 进行了陈述，报告了 32 例 AE。所有研究都有 DO 陈述，但 29.0%的 DO 原因不明。6 项研究（42.9%）给出了 DO 的原因，其中 9 名参与者可归类为 AE；41 名参与者（5.8%）经历了与运动相关的 AE。
结论
AE 的报告不一致，一些 DO 可能被错误分类，运动干预的主要组成部分经常未报告。尽管存在这些局限性，但总体上 AE 数量较少表明，HOA 患者运动相关的伤害风险很小。
意义
了解与 HOA 运动相关的伤害风险可以更好地告知运动的安全剂量、临床实施和可复制性。需要对 AE、DO 和运动进行信息丰富且一致的报告。更有必要使用 CONSORT 伤害报告清单。
Zotero 插件