Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions
Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions
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DOI：
10.1371/journal.pone.0153220
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发表时间：
2016-04-08
期刊：
影响因子：
3.7
通讯作者：
Thombs, Brett D.
中科院分区：
文献类型：
--
作者：
Coronado-Montoya, Stephanie;Levis, Alexander W.;Thombs, Brett D.
背景很大一部分基于正念的治疗试验报告了具有统计学意义的结果，即使在统计能力非常低的情况下也是如此。本研究的目的是描述正念治疗随机对照试验中报道的“阳性”结果。我们还评估了基于正念的治疗试验注册，以寻找可能的报告偏差的迹象，并回顾了最近的系统综述和荟萃分析，以确定是否发现了报告偏差。方法搜索CINAHL、Cochrane Central、EMBASE、ISI、MEDLINE、SqucINFO和Scope us数据库，寻找基于正念的治疗的随机对照试验。描述了阳性试验的数量，并将其与基于正念的治疗与个体治疗抑郁症类似有效的预期数量进行了比较。在试验登记中搜索基于正念的治疗登记。检索CINAHL、Cochrane Central、EMBASE、ISI、MEDLINE、SqucINFO和SCOPUS，对正念治疗进行系统综述和荟萃分析。结果在124篇已发表的试验中，108篇(87%)报道了摘要中的1个阳性结果，109篇(88%)得出结论，正念治疗有效，是基于效应大小d=0.55的预期阳性试验数量的1.6倍(预期阳性试验=65.7)。在21项试验登记中，13项(62%)在试验结束30个月后仍未公布。没有一项试验登记充分规定了评估时间的单一主要结果衡量标准。在36项系统综述和荟萃分析中，没有一项结论是由于报告的偏差而高估了疗效估计。结论具有统计学意义的基于意识的治疗试验的比例可能夸大了实际发生的情况。
BackgroundA large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified.MethodsCINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses.Results108 (87%) of 124 published trials reported >= 1 positive outcome in the abstract, and 109 (88%) concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7). Of 21 trial registrations, 13 (62%) remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases.ConclusionsThe proportion of mindfulnessbased therapy trials with statistically significant results may overstate what would occur in practice.