In randomization we trust? There are overlooked problems in experimenting with people in behavioral intervention trials.
In randomization we trust? There are overlooked problems in experimenting with people in behavioral intervention trials.
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DOI：
10.1016/j.jclinepi.2013.09.004
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发表时间：
2014-03
影响因子：
7.2
通讯作者：
Elbourne, Diana
中科院分区：
文献类型：
--
作者：
McCambridge, Jim;Kypri, Kypros;Elbourne, Diana
行为干预试验可能容易受到因研究参与而产生的人们知之甚少的偏见。本文考虑了评估和其他随机化前的研究活动如何可能引入随机化无法完全防止的偏差。这是一篇假设生成的讨论文章。试验设计和分析中传统思维的可加性假设在行为干预试验中是有问题的。随机化后偏差的来源在临床流行病学和试验文献中更为人所知。忽视可能的研究参与效应意味着，由于研究过程的人为因素而产生的意外参与者行为变化可能会对行为干预效应的估计产生偏差。需要进行研究来评估如何引入研究参与效应，我们就如何推进这一领域的研究提出建议，包括如何在试验的设计和实施中解决这些问题。建议关注可能的研究参与效应可以改进评估行为和其他干预措施的试验设计，并为现有证据的解释提供信息。
Behavioral intervention trials may be susceptible to poorly understood forms of bias stemming from research participation. This article considers how assessment and other prerandomization research activities may introduce bias that is not fully prevented by randomization. This is a hypothesis-generating discussion article. An additivity assumption underlying conventional thinking in trial design and analysis is problematic in behavioral intervention trials. Postrandomization sources of bias are somewhat better known within the clinical epidemiological and trials literatures. Neglect of attention to possible research participation effects means that unintended participant behavior change stemming from artifacts of the research process has unknown potential to bias estimates of behavioral intervention effects. Studies are needed to evaluate how research participation effects are introduced, and we make suggestions for how research in this area may be taken forward, including how these issues may be addressed in the design and conduct of trials. It is proposed that attention to possible research participation effects can improve the design of trials evaluating behavioral and other interventions and inform the interpretation of existing evidence.
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影响因子：
3.3
作者：
Freedland KE;Mohr DC;Davidson KW;Schwartz JE
通讯作者：
Schwartz JE
影响因子：
7.2
作者：
Boutron, I;Tubach, F;Ravaud, P
通讯作者：
Ravaud, P
DOI：
10.1136/bmj.a1864
发表时间：
2008-10-31
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Preference Collaborative Review Group
通讯作者：
Preference Collaborative Review Group
影响因子：
--
作者：
BREWIN, CR;BRADLEY, C
通讯作者：
BRADLEY, C
影响因子：
4.2
作者：
Conner, Mark;Godin, Gaston;Sheeran, Paschal
通讯作者：
Sheeran, Paschal