遵守CONSORT-PRO扩展指导方针患者报告的结果随机对照试验集中在外围神经阻塞:一个元流行病学研究
Adam Khan1, Tiffany Nguyen2, Bryan Dunford3
1Office of Medical Student Research, Oklahoma State University Center for Health Sciences, 1111 W 17th St., Tulsa, OK, 74107, USA. Adam.khan@okstate.edu.
Pain and therapy
|August 6, 2025
概括
周围神经阻断试验显示,患者报告结果报告指南的遵守情况不佳. 提高报告质量需要采取多种措施,并一致应用CONSORT-PRO标准.
科学领域:
- 麻醉学 麻醉学
- 临床试验方法论 临床试验方法论
- 健康 结果 研究 研究 结果
背景情况:
- 患者报告的结果 (PROs) 对于评估患者在区域麻醉中的经验至关重要.
- CONSORT声明及其PRO扩展 (CONSORT-PRO) 为透明的PRO报告提供了指导方针.
- 在外围神经阻断 (PNB) 试验中对CONSORT-PRO的坚持尚不清楚.
研究的目的:
- 评估在PNB随机对照试验 (RCT) 中遵守CONSORT-PRO报告准则.
- 确定影响PNB研究中PRO报告质量的试验特征.
主要方法:
- 进行了一项超流行病学,横截面研究.
- 在CENTRAL,Embase和MEDLINE搜索了2006年至2020年间发表的PNB RCT,其中包括PROs.
- 包括具有PRO的RCT作为主要或次要结果;排除没有PRO的研究.
主要成果:
- 65个RCT符合纳入标准,平均CONSORT-PRO合规率为46.8%.
- 指定PRO作为主要终点的试验显示了较高的依从率 (49.3%),而不是那些具有二次PRO的试验 (38.6%).
- 长时间的随访 (≥6个月) 和联合PRO措施 (例如,VAS/NRS与其他) 与更好的坚持相关.
结论:
- 在PNB RCT中观察到大量的不遵守CONSORT-PRO指南.
- 报告不足的PRO,特别是次要的PRO,凸显了需要改进的情况.
- 提高报告质量需要多样化的措施,一致的CONSORT-PRO应用,以及针对研究人员和临床医生的有针对性的教育.
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