Chen Hongrui, Yu Qinqi, Huang Zening, Sun Bin, Hua Chen, Lin Xiaoxi
Department of Plastic & Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Ninth People's Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
School of Stomatology, Fujian Medical University, Fuzhou, China.
J Oral Rehabil. 2025 Feb;52(2):190-198. doi: 10.1111/joor.13889. Epub 2024 Nov 1.
A notable obstacle in applying the findings of hyaluronic acid (HA)-related randomised controlled trials (RCTs) to real-world patient treatment is trial waste (TW). To date, the extent of TW in RCTs for HA is not clear.
To analyse the extents of TW within HA-RCTs and identify protective factors against TW.
In July 2024, we searched the ClinicalTrials database using the 'hyaluronic acid' as keyword. We documented the data available and then explored PubMed and Scopus for the publication status. Reporting adequacy was evaluated using the CONSORT checklist. Design limitations were analysed based on bias risk and whether the article referenced a relevant systematic review. Subsequently, we evaluated extent of TW (unpublished studies, insufficient reporting and design flaws).
One hundred and eighty-four RCTs met the inclusion criteria. The analysis of TW excluded 53 RCTs completed after June 2020 that remained unpublished. Among the remaining 131 RCTs, 72 were published, 47 had adequate reporting and 19 had design limitations. Taken together, 96 RCTs (73.3%) exhibited at least one characteristic of TW. Characteristics of these RCTs included early registration (p < 0.001) and the absence of a multi-blind approach (p = 0.007). Registration prior to 2014 (p < 0.001) and the open-label or single-blinding design (p = 0.003) emerged as independent risk factor for TW.
We delineated the features of 184 HA-related RCTs. 73.3% of the RCTs included in TW analysis exhibited TW. The diverse traits of the different TW indicators identified could serve as valuable insights for conducting future HA-RCTs more rationally and efficiently.
将透明质酸（HA）相关随机对照试验（RCT）的结果应用于实际患者治疗的一个显著障碍是试验浪费（TW）。迄今为止，HA的RCT中TW的程度尚不清楚。
分析HA-RCT中的TW程度，并确定预防TW的保护因素。
2024年7月，我们以“透明质酸”为关键词搜索了临床试验数据库。我们记录了可用数据，然后在PubMed和Scopus上搜索其发表状态。使用CONSORT清单评估报告的充分性。根据偏倚风险以及文章是否引用了相关的系统评价来分析设计局限性。随后，我们评估了TW的程度（未发表的研究、报告不足和设计缺陷）。
184项RCT符合纳入标准。对TW的分析排除了2020年6月后完成但仍未发表的53项RCT。在其余131项RCT中，72项已发表，47项报告充分，19项存在设计局限性。综合来看，96项RCT（73.3%）表现出至少一种TW特征。这些RCT的特征包括早期注册（p<0.001）和缺乏多盲方法（p=0.007）。2014年前注册（p<0.001）以及开放标签或单盲设计（p=0.003）成为TW的独立危险因素。
我们描述了184项HA相关RCT的特征。纳入TW分析的RCT中有73.3%表现出TW。所确定的不同TW指标的多样特征可为更合理、高效地开展未来的HA-RCT提供有价值的见解。
