To assess the degree of core outcome set alignment and identify issues with alignment to the 2019 COS among clinical trial registrations focused on knee and/or hip osteoarthritis (OA). Our search was performed on registered knee and hip OA randomized controlled trials (RCTs) available on ClinicalTrials.gov and WHO International Clinical Trials Registry Platform. The screening process considered trials registered between 8/2014 and 6/2023. We extracted data on general trial characteristics and the five trial endpoints detailed in the COS (pain, physical function, quality of life, patient global assessment, and adverse events), in a masked and duplicate manner. The frequencies of COS alignment were assessed over time prior to and after COS publication. Of the 10,718 RCTs screened, 481 met inclusion criteria. Most were phase 3 (368/481, 76.51%) and heavily university-funded (184/481, 38.25%). Despite the 2019 COS, no marked enhancement in overall alignment was noted. The outcome 'Pain' exhibited the highest degree of COS alignment (455/481, 94.59%), whereas 'adverse events' lagged behind (89/481, 18.50%). Additionally, trial factors such as 'Continent', ‘Funding Type’, and ‘Recruitment Status’ displayed no significant influence on COS alignment. Despite the acknowledged advantages of using COS in RCTs and the availability of an updated COS, the alignment to these outcomes remains notably low. Significant efforts are needed to encourage broader adoption in future studies on knee and hip OA, with the aim of improving research quality and patient care.

中文翻译：

---

评估随机对照试验与膝关节和髋关节骨关节炎核心结果的一致性程度：横断面分析


评估核心结果集的一致性程度，并确定针对膝关节和/或髋关节骨关节炎 (OA) 的临床试验注册中与 2019 年 COS 一致性的问题。我们的检索是在 ClinicalTrials.gov 和 WHO 国际临床试验注册平台上提供的注册膝关节和髋关节 OA 随机对照试验 (RCT) 中进行的。筛选过程考虑了 8/2014 至 6/2023 之间注册的试验。我们以隐藏和重复的方式提取了一般试验特征和 COS 中详细说明的五个试验终点的数据（疼痛、身体功能、生活质量、患者整体评估和不良事件）。在 COS 发布之前和之后，随着时间的推移，对 COS 对齐的频率进行了评估。在筛选的 10,718 项随机对照试验中，481 项符合纳入标准。大多数是第三阶段（368/481，76.51％）并且由大学大量资助（184/481，38.25％）。尽管推出了 2019 年 COS，但整体一致性并未显着增强。结果“疼痛”表现出最高程度的 COS 一致性（455/481，94.59%），而“不良事件”则落后（89/481，18.50%）。此外，“大陆”、“资金类型”和“招募状态”等试验因素对 COS 一致性没有显着影响。尽管在随机对照试验中使用 COS 具有公认的优势并且可以使用更新的 COS，但与这些结果的一致性仍然很低。需要做出巨大努力来鼓励未来膝关节和髋关节 OA 研究的更广泛采用，以提高研究质量和患者护理。