心理健康试验中多种结果的分析和报告:一个方法论的系统审查
Dominic Stringer1, Mollie Payne2, Ben Carter2
1Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, Kings College London, London, UK. Dominic.stringer@kcl.ac.uk.
BMC medical research methodology
|December 21, 2024
概括
大多数心理健康随机对照试验 (RCT) 遵循单个主要结果的指导方针. 然而,很少有人在使用多个主要结果时解决多重性问题,这与监管指导相矛盾.
科学领域:
- 精神病学是一个精神病学.
- 临床试验方法论 临床试验方法论
背景情况:
- 在随机试验中选择单一的初级结果具有挑战性,特别是在心理健康研究中,干预通常会影响多个领域.
- 本系统性审查评估了与当前CONSORT和监管标准相比,在心理健康RCT中报告和分析多种结果.
研究的目的:
- 评估心理健康随机对照试验 (RCT) 中多种结果分析和报告的质量.
- 将心理健康RCT的现行实践与CONSORT声明和关于结果报告的监管准则进行比较.
主要方法:
- 在2019年1月至2020年12月期间发表在九个主要期刊上的晚期心理健康RCT的系统审查.
- 排除了试点,可行性,非随机化和早期阶段试验.
- 记录了初级,二级和其他结果的数量,以及在初级分析中处理多个初级结果的任何策略.
主要成果:
- 包括147个心理健康RCT. 大多数 (101/147) 通过指定单个主要结果,坚持CONSORT.
- 少数人 (33/147) 使用多个主要结果,大多数人 (26/33) 没有纠正多重性,违反了监管指导.
- 报告的临床结果的中位数为8个 (IQR 5-11).
结论:
- 虽然大多数试验在单个初级结果上遵循CONSORT,但在使用多个初级结果时,对多重性和结果相关性的关注不足.
- 指定多个主要结果的试验必须实施多重性校正或替代策略.
- 在心理健康RCT中,先进的初级分析策略 (如多变量建模) 尚未得到充分利用,需要进一步研究以提高效率和解释.
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