Department of Rheumatology, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, NSW, Australia.
Department of Rheumatology, Royal North Shore Hospital and Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, NSW, Australia.
Ann Phys Rehabil Med. 2022 Sep;65(5):101619. doi: 10.1016/j.rehab.2021.101619. Epub 2022 Feb 14.
In osteoarthritis (OA) clinical trials, reliable and responsive outcome measures to document physical and functional improvements are limited.
This study aimed to assess whether the use of an activity tracker in an OA clinical trial is a responsive measurement tool. Secondary objectives assessed feasibility and validity.
We recruited 65 participants in a prospective cohort study nested in a placebo-controlled clinical trial of platelet-rich plasma injection in knee OA. Participants wore an activity tracker (Fitbit Flex 2), and a smartphone was preloaded with a mobile application (OApp) designed to monitor load rates as a surrogate of knee loading. Participants used the systems for 7 days at baseline and for 7 days before the 2-month follow-up assessment. Effect size (ES) and standardised response mean (SRM) were calculated for change in step count and knee loading rate and regularly used knee OA outcome measures. Correlation coefficients (r) were calculated to examine the strength of the association between outcome measures.
. Step count showed a trivial ES and SRM and mean knee loading rate measurements a moderate ES and SRM. We found a weak but significant correlation between change in mean steps per day and global improvement overall (r= 0.28) and Western Ontario and McMaster Universities Osteoarthritis Index function (r = -0.28). Compliance was high with the activity trackers.
Despite good feasibility, this study did not show significant responsiveness or validity of the activity trackers as compared with currently recommended outcome measures in OA clinical trials. The main challenge is the lack of a gold standard outcome measure to validate against, and because of the complex interplay between pain and measured function, a lack of correlation does not necessarily represent a failed validation in this context.
ACTRN12617000853347. This trial is a substudy of the "Platelet-rich plasma as a symptom-and disease-modifying treatment for knee osteoarthritis - the RESTORE trial".
在骨关节炎（OA）临床试验中，用于记录身体和功能改善的可靠且敏感的结果测量方法有限。
本研究旨在评估在 OA 临床试验中使用活动追踪器是否是一种敏感的测量工具。次要目的评估了其可行性和有效性。
我们在一项前瞻性队列研究中招募了 65 名参与者，该研究嵌套在一项富血小板血浆注射治疗膝骨关节炎的安慰剂对照临床试验中。参与者佩戴活动追踪器（Fitbit Flex 2），智能手机预装有一个移动应用程序（OApp），用于监测负荷率作为膝关节负荷的替代指标。参与者在基线时使用该系统 7 天，在 2 个月随访评估前使用该系统 7 天。计算步计数和膝关节负荷率变化的效应量（ES）和标准化反应均值（SRM），以及常用的膝骨关节炎结局测量。计算相关系数（r）以检验结局测量之间的关联强度。
步计数的 ES 和 SRM 较小，平均膝关节负荷率测量的 ES 和 SRM 较大。我们发现，每日平均步数变化与整体改善（r=0.28）和西安大略和麦克马斯特大学骨关节炎指数功能（r=-0.28）之间存在微弱但显著的相关性。活动追踪器的依从性很高。
尽管可行性良好，但与 OA 临床试验中目前推荐的结局测量相比，本研究并未显示活动追踪器具有显著的敏感性或有效性。主要挑战是缺乏金标准结局测量来进行验证，而且由于疼痛和测量功能之间的复杂相互作用，在这种情况下，缺乏相关性并不一定代表验证失败。
ACTRN12617000853347。本试验是“富含血小板的血浆作为膝关节骨关节炎的症状和疾病改善治疗-RESTORE 试验”的子研究。
