Clinical trial participants' experiences of completing questionnaires: a qualitative study.
Clinical trial participants' experiences of completing questionnaires: a qualitative study.
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DOI：
10.1136/bmjopen-2013-004363
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发表时间：
2014-03-24
期刊：
影响因子：
2.9
通讯作者：
Witt CM
中科院分区：
文献类型：
--
作者：
Holmberg C;Karner JJ;Rappenecker J;Witt CM
为了改善老年人群的临床研究发展，我们的目标是了解他们如何将他们的经验转化为有效的、标准化的自我完成的研究测量工具。我们分析了参与随机对照试验（RCT）的女性（平均78±8岁）如何使用认知研究工具来评估干预的结果。访谈研究嵌套在一项关于慢性颈部疼痛的随机对照试验中，使用了位于德国柏林的一个老年人社区的常见测量仪器，该社区由独立和辅助生活选择单元组成。从RCT样本（n=117, 95%为女性，平均年龄76 （SD±8）岁）中选取样本（n=20名女性）。访谈对象是根据随机对照试验结果选择的有目的的抽样清单。我们询问了参与者完成RCT问卷的经历。对访谈进行主题分析，然后与问卷进行比较。受访者在将复杂的经验转化为单一的价值量表和理解问卷与研究目标的关系方面存在困难。受访者认为试验组织者了解他们的实际经历对试验很重要。这些信息不能通过问卷的方式转移。为了纠正这些困难，受访者使用了诸如添加注释、添加回答类别或跳过一个项目等策略。老年访谈参与者了解完成问卷对试验成功的重要性。这导致了填写问卷的策略导致“缺失”或模糊的数据。为了改善老年人口的数据收集，应该开发和测试解决差异逻辑的教育材料。在这些人群中，使用认知访谈的试点测试验证工具可能特别重要。最后，当干预的目标是主观体验时，创造一种参与者可以传达他们个人体验的方法似乎很重要。这些可以是嵌套的定性研究。ISRCTN77108101807。
To improve clinical study developments for elderly populations, we aim to understand how they transfer their experiences into validated, standardised self-completed study measurement instruments. We analysed how women (mean 78±8 years of age) participating in a randomised controlled trial (RCT) cognised study instruments used to evaluate outcomes of the intervention. The interview study was nested in an RCT on chronic neck pain using common measurement instruments situated in an elderly community in Berlin, Germany, which comprised of units for independent and assisted-living options. The sample (n=20 women) was selected from the RCT sample (n=117, 95% women, mean age 76 (SD±8) years). Interview participants were selected using a purposive sampling list based on the RCT outcomes. We asked participants about their experiences completing the RCT questionnaires. Interviews were analysed thematically, then compared with the questionnaires. Interviewees had difficulties in translating complex experiences into a single value on a scale and understanding the relationship of the questionnaires to study aims. Interviewees considered important for the trial that their actual experiences were understood by trial organisers. This information was not transferrable by means of the questionnaires. To rectify these difficulties, interviewees used strategies such as adding notes, adding response categories or skipping an item. Elderly interview participants understood the importance of completing questionnaires for trial success. This led to strategies of completing the questionnaires that resulted in ‘missing’ or ambiguous data. To improve data collection in elderly populations, educational materials addressing the differential logics should be developed and tested. Pilot testing validated instruments using cognitive interviews may be particularly important in such populations. Finally, when the target of an intervention is a subjective experience, it seems important to create a method by which participants can convey their personal experiences. These could be nested qualitative studies. ISRCTN77108101807.
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