Can research assessments themselves cause bias in behaviour change trials? A systematic review of evidence from solomon 4-group studies.
Can research assessments themselves cause bias in behaviour change trials? A systematic review of evidence from solomon 4-group studies.
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DOI：
10.1371/journal.pone.0025223
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发表时间：
2011
期刊：
影响因子：
3.7
通讯作者：
Elbourne D
中科院分区：
文献类型：
--
作者：
McCambridge J;Butor-Bhavsar K;Witton J;Elbourne D
研究评估对参与者行为的可能影响引起了研究兴趣，特别是在行为干预和/或结果的研究中。在随机对照试验中，评估可能通过改变实验组对干预的接受程度和对对照组行为的不同影响而引入偏倚。在所罗门四组设计中，参与者被随机分配到四组中的一组：(1)评估实验组；(2)未评估实验组(3)评估对照组；(4)未评估对照组。本设计通过控制基线评估的效果，并评估干预与基线评估之间的相互作用，对传统两组试验中获得的效应量的内部效度进行了检验。本系统综述的目的是评估所罗门4组研究的证据，这些研究的行为结果表明，基线研究评估本身可能会给试验带来偏倚。检索电子数据库，辅以引文检索。如果研究在同行评议的期刊上报告了适当分析的结果，并在非实验室环境中使用所罗门4组设计，采用行为结果测量，每组样本量为20或更多，则研究符合条件。包括来自一系列应用领域的10项研究。评估主要效果的证据不一致，与行为干预相互作用的证据较少，并且缺乏与本综述研究问题相关的令人信服的数据。高质量的已完成研究太少，无法最终推断基线研究评估是否存在偏倚。因此，有必要进行新的严格的所罗门4组研究，有目的地评估研究评估在行为改变试验中引起偏倚的可能性。
The possible effects of research assessments on participant behaviour have attracted research interest, especially in studies with behavioural interventions and/or outcomes. Assessments may introduce bias in randomised controlled trials by altering receptivity to intervention in experimental groups and differentially impacting on the behaviour of control groups. In a Solomon 4-group design, participants are randomly allocated to one of four arms: (1) assessed experimental group; (2) unassessed experimental group (3) assessed control group; or (4) unassessed control group. This design provides a test of the internal validity of effect sizes obtained in conventional two-group trials by controlling for the effects of baseline assessment, and assessing interactions between the intervention and baseline assessment. The aim of this systematic review is to evaluate evidence from Solomon 4-group studies with behavioural outcomes that baseline research assessments themselves can introduce bias into trials. Electronic databases were searched, supplemented by citation searching. Studies were eligible if they reported appropriately analysed results in peer-reviewed journals and used Solomon 4-group designs in non-laboratory settings with behavioural outcome measures and sample sizes of 20 per group or greater. Ten studies from a range of applied areas were included. There was inconsistent evidence of main effects of assessment, sparse evidence of interactions with behavioural interventions, and a lack of convincing data in relation to the research question for this review. There were too few high quality completed studies to infer conclusively that biases stemming from baseline research assessments do or do not exist. There is, therefore a need for new rigorous Solomon 4-group studies that are purposively designed to evaluate the potential for research assessments to cause bias in behaviour change trials.
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影响因子：
4.1
作者：
Clemes, Stacy A.;Parker, Richard A. A.
通讯作者：
Parker, Richard A. A.
影响因子：
168.9
作者：
Lopez, Alan D.;Mathers, Colin D.;Murray, Christopher J. L.
通讯作者：
Murray, Christopher J. L.
DOI：
10.1177/109019818901600112
发表时间：
1989-03-01
期刊：
HEALTH EDUCATION QUARTERLY
影响因子：
--
作者：
CAMPANELLI, PC;DIELMAN, TE;RENNER, DS
通讯作者：
RENNER, DS
DOI：
10.1093/jnci/88.22.1670
发表时间：
1996-11-20
期刊：
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子：
--
作者：
Dignan, M;Michielutte, R;McQuellon, RP
通讯作者：
McQuellon, RP
影响因子：
15.8
作者：
Kirsch, Irving;Deacon, Brett J.;Huedo-Medina, Tania B.;Scoboria, Alan;Moore, Thomas J.;Johnson, Blair T.
通讯作者：
Johnson, Blair T.