在注册的随机对照试验中,关节疾病的研究浪费:一项超流行病学研究
Ruopeng Zhao1,2, Zheng Ye2, Yiwei Liu2,3
1State Key Laboratory of Oral Diseases & National Center for Stomatology & National Clinical Research Center for Oral Diseases, West China Hospital of Stomatology, Sichuan University, Chengdu, Sichuan, China.
Journal of oral rehabilitation
|June 18, 2025
概括
在关疾病 (TMDs) 试验中的研究浪费很高. 提高次诊断准确性和试验可行性可以提高TMD随机对照试验 (RCT) 的质量.
科学领域:
- 口腔和牙面部外科手术
- 牙科研究 牙科研究
- 临床试验方法论 临床试验方法论
背景情况:
- 部疾病 (TMD) 带来了复杂的临床挑战,阻碍了标准化治疗.
- 方法上的不一致和研究浪费阻碍了证据整合到TMD研究中.
- 随机对照试验 (RCT) 正在增加,但面临重大障碍.
研究的目的:
- 系统地分析103个TMD相关的RCT (2005-2025) 来自clinicaltrials.gov.gov.
- 确定导致TMD临床试验中研究浪费的因素.
- 提出减轻研究浪费和提高RCT质量的战略.
主要方法:
- 对试验特征,出版状况,CONSORT遵守情况和Cochrane偏差风险的分析.
- 使用千平方/费舍尔精确测试和后勤回归的统计分析.
- 对103个注册的TMDsRCT进行系统审查.
主要成果:
- 观察到RCT注册和TMD出版的趋势越来越大.
- 大多数试验集中在与疼痛相关的TMD (85.52%) 和非侵入性干预 (85.44%).
- 缺乏次诊断 (31.07%),药理干预,大样本大小,多臂和开放标签设计与研究浪费有关.
结论:
- 未来的TMD研究需要加强临床医师在亚诊断方面的培训.
- 采用可行性驱动的试验设计,包括招募和干预评估,至关重要.
- 通过解决这些因素,可以优化RCT质量和减少研究浪费.
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