Bias due to MEasurement Reactions In Trials to improve health (MERIT): protocol for research to develop MRC guidance.

Bias due to MEasurement Reactions In Trials to improve health (MERIT): protocol for research to develop MRC guidance.
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DOI:
10.1186/s13063-018-3017-5
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发表时间:
2018-11-26
期刊:
影响因子:
2.5
通讯作者:
French DP
French DP
中科院分区:
医学4区
文献类型:
--
作者:
Miles LM;Elbourne D;Farmer A;Gulliford M;Locock L;McCambridge J;Sutton S;French DP

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现在有明确的系统评价证据表明,测量可以影响被测量的人;这些证据大多集中在要求人们完成一份问卷是如何导致行为改变的。由于这种反应性而导致的测量行为和其他结果的变化可能会在本来进行良好的随机对照试验(rct)中引入偏差,从而产生对干预效果的错误估计。尽管如此,测量反应性目前还没有充分考虑到偏差框架的风险。目前的研究旨在就如何在改善健康的干预措施研究中最好地避免或尽量减少由于测量反应性而产生的偏差提出一套指导性声明,并特别关注随机对照试验中的偏差。MERIT研究包括一系列系统和快速审查,德尔菲研究和专家研讨会,以制定关于如何尽量减少由于测量反应性而导致的试验偏倚的指导。将更新现有的关于问题行为对健康相关行为影响的系统审查,并将进行三次新的快速审查,以确定(1)关于测量反应性的现有指导;(2)对量化测量对健康和非健康环境中与行为和情感结果相关的结果的影响的研究进行系统评价;(3)调查行为的客观测量对并发或后续行为本身的影响的试验。将采用德尔菲程序将专家的意见结合起来,以期就指导说明的范围达成协议。最后,将于2018年秋季举行一次研讨会,目的是编制一套指导声明,这些指导声明将构成MRC关于如何在改善健康的干预措施研究中最好地避免由于测量反应性而产生偏差的新指导的核心部分。我们的目标是为试验中的测量反应提供MRC指南,供未来的试验研究人员使用,从而导致不太可能存在偏倚风险的试验的发展。本文的在线版本(10.1186/s13063-018-3017-5)包含补充内容,仅供授权用户使用。
There is now clear systematic review evidence that measurement can affect the people being measured; much of this evidence focusses on how asking people to complete a questionnaire can result in changes in behaviour. Changes in measured behaviour and other outcomes due to this reactivity may introduce bias in otherwise well-conducted randomised controlled trials (RCTs), yielding incorrect estimates of intervention effects. Despite this, measurement reactivity is not currently adequately considered in risk of bias frameworks. The present research aims to produce a set of guidance statements on how best to avoid or minimise bias due to measurement reactivity in studies of interventions to improve health, with a particular focus on bias in RCTs. The MERIT study consists of a series of systematic and rapid reviews, a Delphi study and an expert workshop to develop guidance on how to minimise bias in trials due to measurement reactivity. An existing systematic review on question-behaviour effects on health-related behaviours will be updated and three new rapid reviews will be conducted to identify (1) existing guidance on measurement reactivity; (2) systematic reviews of studies that have quantified the effects of measurement on outcomes relating to behaviour and affective outcomes in health and non-health contexts and (3) trials that have investigated the effects of objective measurements of behaviour on concurrent or subsequent behaviour itself. A Delphi procedure will be used to combine the views of experts with a view to reaching agreement on the scope of the guidance statements. Finally, a workshop will be held in autumn 2018, with the aim of producing a set of guidance statements that will form the central part of new MRC guidance on how best to avoid bias due to measurement reactivity in studies of interventions to improve health. Our ambition is to produce MRC guidance on measurement reactions in trials which will be used by future trial researchers, leading to the development of trials that are less likely to be at risk of bias. The online version of this article (10.1186/s13063-018-3017-5) contains supplementary material, which is available to authorized users.
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