MacNeill Virginia, Foley Marian, Quirk Alan, McCambridge Jim
Faculty of Public Health & Policy, London School of Hygiene & Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
Faculty Health, Psychology and Social Care Manchester Metropolitan University, 799 Wilmslow Road, Manchester, M20 2RR, UK.
BMC Public Health. 2016 Jan 29;16:91. doi: 10.1186/s12889-016-2741-6.
The sequence of events in a behaviour change trial involves interactions between research participants and the trial process. Taking part in such a study has the potential to influence the behaviour of the participant, and if it does, this can engender bias in trial outcomes. Since participants' experience has received scant attention, the aim of this study is thus to generate hypotheses about which aspects of the conduct of behaviour change trials might matter most to participants, and thus have potential to alter subsequent behaviours and bias trial outcomes
Twenty participants were opportunistically screened for a health compromising behaviour (unhealthy diet, lack of exercise, smoking or alcohol consumption) and recruited if eligible. Semi structured face to face interviews were conducted, after going through the usual processes involved in trial recruitment, baseline assessment and randomisation. Participants were given information on the contents of an intervention or control condition in a behaviour change trial, which was not actually implemented. Three months later they returned to reflect on these experiences and whether they had any effect on their behaviour during the intervening period. Data from the latter interview were analysed thematically using a modified grounded theory approach.
The early processes of trial participation raised awareness of unhealthy behaviours, although most reported having had only fleeting intentions to change their behaviour as a result of taking part in this study, in the absence of interventions. However, careful examination of the accounts revealed evidence of subtle research participation effects, which varied according to the health behaviour, and its perceived social acceptability. Participants' relationships with the research study were viewed as somewhat important in stimulating thinking about whether and how to make lifestyle changes.
These participants described no dramatic impacts attributable to taking part in this study. This study demonstrates the likely value of well conducted qualitative studies of subtle research participation effects, which may be particularly important to explore for alcohol. Separating unintended influences in trial participation from the effects of behaviour change interventions being evaluated therein is necessary for valid estimates of intervention effects.
行为改变试验中的一系列事件涉及研究参与者与试验过程之间的相互作用。参与此类研究有可能影响参与者的行为，如果确实如此，这可能会导致试验结果出现偏差。由于参与者的体验很少受到关注，因此本研究的目的是提出假设，即行为改变试验的哪些方面可能对参与者最为重要，从而有可能改变后续行为并使试验结果产生偏差。
对20名参与者进行机会性筛查，以确定其是否存在危害健康的行为（不健康饮食、缺乏运动、吸烟或饮酒），符合条件者予以招募。在经历了试验招募、基线评估和随机分组的常规流程后，进行了半结构化面对面访谈。向参与者提供了行为改变试验中干预或对照条件的内容信息，但该试验并未实际实施。三个月后，他们回来反思这些经历以及在此期间这些经历是否对他们的行为产生了影响。使用改良的扎根理论方法对后一次访谈的数据进行了主题分析。
试验参与的早期过程提高了对不健康行为的认识，尽管大多数人报告称，在没有干预措施的情况下，由于参与本研究，他们只有短暂的改变行为的意图。然而，对这些叙述的仔细审查发现了微妙的研究参与效应的证据，这些效应因健康行为及其感知的社会可接受性而异。参与者与研究的关系在激发关于是否以及如何进行生活方式改变的思考方面被认为具有一定重要性。
这些参与者表示参与本研究没有产生显著影响。本研究证明了对微妙的研究参与效应进行良好定性研究的潜在价值，这对于酒精研究可能尤为重要。为了有效估计干预效果，有必要将试验参与中的意外影响与其中所评估的行为改变干预的效果区分开来。
