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心理治疗随机对照试验中试验注册和选择性结果报告的系统评价。

A systematic review of trial registration and selective outcome reporting in psychotherapy randomized controlled trials.

作者信息

Bradley H A, Rucklidge J J, Mulder R T

机构信息

Department of Psychology, University of Canterbury, Christchurch, New Zealand.

Department of Psychological Medicine, University of Otago, Otago, New Zealand.

出版信息

Acta Psychiatr Scand. 2017 Jan;135(1):65-77. doi: 10.1111/acps.12647. Epub 2016 Sep 30.

Abstract

OBJECTIVE

Selective outcome reporting poses serious implications on our evidence base for best practice. The extent to which selective outcome reporting and trial registration occurs in the wider psychotherapy literature needs to be investigated.

METHOD

Randomized controlled psychotherapy trials published between 2010 and 2014 were selected from the five highest impact factor journals in clinical psychology that publish clinical trials. Data on primary and secondary outcomes, funding, and participant numbers were extracted from the article and registry and compared.

RESULTS

From 112 trials, 67 (59.8%) were registered, 27 (24.1%) were prospectively registered, and only 13 (11.6%) were correctly registered and reported. Seven of these 13 trials showed evidence of selective outcome reporting, of which four had discrepancies favoring significant outcomes. One of the remaining six trials changed their primary outcomes during participant enrollment. Overall, only five (4.5%) trials were free from selective outcome reporting. Three of these five trials had more than a 10% change between planned and achieved sample size. Funding was not associated with correct registration or reporting.

CONCLUSIONS

The proportion of psychotherapy randomized controlled trials correctly registered and transparently reported is poor. Psychologists should consider the impact these results have on public confidence in reported outcomes.

摘要

目的

选择性结果报告对我们最佳实践的证据基础造成了严重影响。需要调查在更广泛的心理治疗文献中选择性结果报告和试验注册的程度。

方法

从临床心理学领域影响因子最高的五本发表临床试验的期刊中选取2010年至2014年发表的随机对照心理治疗试验。从文章和注册信息中提取关于主要和次要结果、资金以及参与者数量的数据并进行比较。

结果

在112项试验中,67项(59.8%)进行了注册,27项(24.1%)进行了前瞻性注册,只有13项(11.6%)进行了正确注册和报告。这13项试验中有7项显示出选择性结果报告的迹象,其中4项存在有利于显著结果的差异。其余6项试验中有1项在招募参与者期间改变了主要结果。总体而言,只有5项(4.5%)试验没有选择性结果报告。这5项试验中有3项计划样本量与实际样本量之间的变化超过了10%。资金与正确注册或报告无关。

结论

正确注册并透明报告的心理治疗随机对照试验的比例很低。心理学家应考虑这些结果对公众对报告结果的信心的影响。

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