在试验方案和结果出版物中对患者报告的结果进行的元研究表明,结果报告有很大的偏差
Ala Taji Heravi1, Dmitry Gryaznov2, Jason W Busse3
1CLEAR-Methods Center, Division of Clinical Epidemiology, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
在临床试验中,患者报告的结果 (PRO) 往往是不一致的. 只有不到一半的计划PRO被报告为指定的,影响基于证据的决策.
科学领域:
- 临床试验 临床试验
- 健康 结果 研究 研究 结果
- 科学出版科学出版
背景情况:
- 患者报告的结果 (PROs) 对于评估医疗干预措施至关重要.
- 之前的研究表明,在特定的医疗领域,PRO的使用和报告不频繁且不完整.
- 这项研究调查了PRO在随机临床试验 (RCT) 协议中的使用情况.
研究的目的:
- 检查不同医学领域的RCT协议中PRO的流行率和特征.
- 评估试验出版物中PRO报告的质量.
- 评估协议中规定的PRO与出版物中报道的PRO之间的一致性.
主要方法:
- 分析了2012年和2016年在瑞士,德国和加拿大批准的488个RCT协议.
- 系统地搜索相应的出版物和试验注册结果.
- 独立的数据提取和质量评估使用CONSORT-PRO扩展用于PROs.
主要成果:
- 在70%的协议中指定了PRO,其患病率因医疗领域而异 (100%的风湿病学/精神病学到33%的心脏病学/麻醉学).
- 在批准后8-10年内,有77%的协议可获得结果.
- 只有44%的发表试验报告了所有指定的PROs;21%报告没有,36%报告了不同的PROs. 报告质量往往是不够的.
结论:
- 在RCT中,计划和报告的PRO之间存在重大差异,这表明结果报告有偏见.
- 缺陷的PRO报告质量阻碍了患者提供者的知情决策和指导方针的制定.
- 在临床试验中对PRO的标准化报告对于可靠的证据合成至关重要.
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