在第三类随机临床试验中,患者报告的结果报告得有多好? 一个关于遵守CONSORT-PRO扩展的元流行病学评估
Eduardo Frederico Eduardo Maferano1, Paulo Ricardo Martins-Filho2, Paulo Goberlânio de Barros Silva3
1Department of Dentistry, Faculty of Health Sciences, Zambeze University, Tete City, Mozambique; Postgraduate Program in Dentistry, Faculty of Dentistry, Federal University of Ceará, Ceará, Fortaleza, Brazil.
概括
在第三手术的随机对照试验 (RCT) 中,遵守CONSORT-PRO指南的程度较低,特别是当患者报告的结果 (PRO) 是次要的时. 提高报告质量需要更好地遵守这些基本报告标准.
科学领域:
- 口腔和牙面部外科手术
- 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:
- 随机对照试验 (RCT) 对于评估第三手术干预措施至关重要.
- 患者报告的结果 (PROs) 提供了对治疗有效性和患者体验的宝贵见解.
- "CONSORT-PRO"扩展提供了在RCT中报告PRO的指导方针.
研究的目的:
- 评估第三手术的RCT是否符合CONSORT-PRO扩展指南.
- 评估这些RCT中的偏差风险.
- 确定影响遵守PRO报告标准的因素.
主要方法:
- 采用了一种超流行病学,横截面的研究设计.
- 在多个数据库 (Medline,EMBASE,Cochrane图书馆等) 中进行了系统的文献搜索. ) 的情况.
- 包括23个RCT报告的PRO,并对CONSORT-PRO项目和偏差风险进行了评估.
主要成果:
- 总体而言,对CONSORT-PRO的坚持是不理想的,平均为45.6%.
- 当PRO是主要结果时 (50.5%) 与二次结果 (43.5%) 相比,遵守率更高.
- 大约43.5%的试验表现出一些关于偏差风险的担忧.
结论:
- 在第三手术RCT中遵守CONSORT-PRO报告标准是不够的.
- 提高PRO数据的质量和透明度需要更严格地遵守CONSORT-PRO指南.
- 加强方法论的严谨性和指导方针的整合对于该领域的可重复性研究至关重要.
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