大规模系统性审查中的许多随机试验未被注册,并且有选择性结果报告的证据:一项超流行病学研究
Samuel Silva1, Sareen Singh2, Shazia Kashif3
1Department of Community Health and Epidemiology, Dalhousie University, Halifax, Canada; Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Brazil.
慢性腰部疼痛 (CLBP) 研究中的潜在试验注册率较低,但注册试验显示偏差风险降低,报告质量提高. 需要制定政策,以提高预期的注册和可靠研究结果的一致性.
科学领域:
- 临床试验 临床试验
- 疼痛管理 疼痛管理
- 研究诚信研究诚信
背景情况:
- 预期试验的注册对于研究透明度和减少选择性报告至关重要.
- 在慢性腰部疼痛 (CLBP) 领域观察到有限的潜在注册.
- 了解注册对试验质量的影响对于基于证据的实践至关重要.
研究的目的:
- 描述CLBP研究中的试验注册实践.
- 评估试验注册状态与偏差风险之间的关联,报告质量和影响估计.
- 检查注册与最终报告的一致性及其对研究质量的影响.
主要方法:
- 一个361个试验的元流行病学研究,来自Cochrane关于CLBP运动的评论.
- 评估试验注册状态 (前性与后性) 和偏差风险,使用Cochrane风险偏差1工具.
- 描述性分析,物流回归和子组元分析以评估关联.
主要成果:
- 只有23.3%的CLBP试验被前性地注册;许多显示注册不一致.
- 已注册的试验比未注册的试验具有较低的偏差风险 (OR 0.6) 和更高的报告质量 (OR 1.6).
- 预期注册与较低的报告偏差 (OR 2.7) 和更好的报告质量 (OR 1.3) 有关;没有发现与影响估计的关联.
结论:
- 很大一部分CLBP试验缺乏潜在的注册和一致性.
- 注册试验通常显示出更高的质量和更低的偏差.
- 在CLBP研究领域,需要改进未来的注册政策和遵守.
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