Premier Orthopaedics and Sports Medicine, 300 Evergreen Drive, Suite 200, Glen Mills, PA, 19342, USA.
Zucker School of Medicine at Hofstra/Northwell, Northwell Phelps Hospital, Sleepy Hollow, NY, USA.
BMC Musculoskelet Disord. 2022 Feb 22;23(1):171. doi: 10.1186/s12891-022-05116-z.
The Osteoarthritis Research Society International (OARSI) updated their guideline for clinical trials on knee osteoarthritis (KOA) in 2015, which contains recommendations for the conduct, design, and reporting of clinical trials. The purpose of this study was to assess the quality of clinical trials published between 2010 and 2020 investigating intra-articular interventions in patients with KOA using the OARSI recommendations.
A targeted literature review was conducted to identify randomized controlled trials in patients with KOA receiving intra-articular interventions, published between 2010 and 2020. Included studies were assessed using the OARSI recommendations. For a comparison between the time periods before and after the introduction of the new OARSI recommendations, the year 2016 was selected as the cut-off.
One hundred forty-eight publications, representing 139 unique trials, were included in this review. Included studies adhered to between 9 and 24 recommendations (median: 19). The highest increase in adherence from studies published in 2016 or earlier compared to after 2016 was seen in the reporting and registration of trials and the use of structural outcome measures. Overall, adherence to the recommendations related to the collection of biochemical biomarkers and the use of structural outcome measures remained low.
An improvement can be made in the conduct, design, and reporting of clinical trials for intra-articular therapies in KOA. Despite proper guidelines, quality of clinical trials varies, and the methodological deficiencies found are preventable and can be corrected. The quality of research should be considered when making treatment decisions for patients with KOA in clinical practice.
国际骨关节炎研究协会（OARSI）于 2015 年更新了膝关节骨关节炎（KOA）临床试验指南，其中包含了对临床试验实施、设计和报告的建议。本研究旨在评估 2010 年至 2020 年间使用 OARSI 建议对接受关节内干预的 KOA 患者进行的关节内干预临床试验的质量。
进行了一项有针对性的文献综述，以确定 2010 年至 2020 年间接受关节内干预的 KOA 患者的随机对照试验。使用 OARSI 建议评估纳入的研究。为了比较新 OARSI 建议引入前后的时间段，选择 2016 年作为截止日期。
本综述共纳入 148 篇文献，代表 139 项独特的试验。纳入的研究符合 9 至 24 项建议（中位数：19 项）。与 2016 年之前发表的研究相比，2016 年或之后发表的研究在试验报告和注册以及结构结局测量的使用方面的依从性提高最高。总体而言，在收集生化生物标志物和使用结构结局测量方面，建议的依从性仍然较低。
可以改善 KOA 关节内治疗的临床试验的实施、设计和报告。尽管有适当的指南，但临床试验的质量存在差异，并且发现的方法学缺陷是可以预防和纠正的。在临床实践中为 KOA 患者做出治疗决策时，应考虑研究质量。
