Department of Social & Environmental Health, Faculty of Public Health and Policy, London School of Hygiene & Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, UK.
Centre for Clinical Epidemiology and Biostatistics, School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.
J Clin Epidemiol. 2014 Mar;67(3):247-53. doi: 10.1016/j.jclinepi.2013.09.004. Epub 2013 Dec 4.
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.
行为干预试验可能容易受到源于研究参与的各种尚未被充分理解的偏倚影响。本文探讨了评估和其他随机化前研究活动如何可能引入随机化无法完全预防的偏倚。
这是一篇假说生成性讨论文章。
在试验设计和分析中，传统思维所基于的加性假设在行为干预试验中存在问题。随机化后偏倚的来源在临床流行病学和试验文献中较为为人所知。忽视对可能的研究参与效应的关注意味着，源自研究过程中的人为因素的无意识的参与者行为变化可能对行为干预效果的估计产生未知的偏倚影响。
需要开展研究来评估研究参与效应是如何引入的，我们提出了如何推进该领域研究的建议，包括如何在试验的设计和实施中解决这些问题。有人建议，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。
