A Mixed Methods and Triangulation Model for Increasing the Accuracy of Adherence and Sexual Behaviour Data: The Microbicides Development Programme
A Mixed Methods and Triangulation Model for Increasing the Accuracy of Adherence and Sexual Behaviour Data: The Microbicides Development Programme
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DOI：
10.1371/journal.pone.0011600
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发表时间：
2010-07-21
期刊：
影响因子：
3.7
通讯作者：
McCormack, Sheena
中科院分区：
文献类型：
--
作者：
Pool, Robert;Montgomery, Catherine M.;McCormack, Sheena
背景：收集关于依从性和性行为的准确数据在杀微生物剂（和其他艾滋病毒相关）研究中至关重要。在缺乏“黄金标准”的情况下，此类数据的收集主要依赖于参与者的自我报告。在回顾了现有的方法后，本文描述了一种混合方法/三角模型，用于在多中心阴道杀微生物剂临床试验中产生更准确的依从性和性行为数据。在另一篇论文中，给出了该模型的一些结果。方法/主要发现：数据收集自随机抽样的725名女性（占试验人口的7.7%），采用结构化访谈、性交日记、深度访谈、计数返回的凝胶涂抹器、焦点小组讨论和人种学。该模式的核心是定制的、半结构化的深度访谈。三角测量有两个层次：首先，确定问卷、日记、深度访谈和申请人反馈数据之间的差异，与参与者讨论并在很大程度上解决；其次，个人参与者的结果与焦点小组讨论和民族志中出现的更一般的数据有关。临床试验人员和定性社会科学家之间民主和公平的合作促进了该模型的成功，正如试验前的准备研究一样。这一过程揭示了“临床试验文化”中的一些潜在假设和常规做法，这些假设和做法可能不利于准确数据的收集，以及大型定性研究的一些缺点，并指出了一些潜在的解决方案。结论/意义：在临床试验中整合定性社会科学、使用混合方法和三角测量是可行的，可以揭示（并解决）依从性和敏感行为数据的不准确性，以及阐明可能影响数据准确性的“试验文化”方面。
Background: The collection of accurate data on adherence and sexual behaviour is crucial in microbicide (and other HIV-related) research. In the absence of a "gold standard'' the collection of such data relies largely on participant self-reporting. After reviewing available methods, this paper describes a mixed method/triangulation model for generating more accurate data on adherence and sexual behaviour in a multi-centre vaginal microbicide clinical trial. In a companion paper some of the results from this model are presented [1].Methodology/Principal Findings: Data were collected from a random subsample of 725 women (7.7% of the trial population) using structured interviews, coital diaries, in-depth interviews, counting returned gel applicators, focus group discussions, and ethnography. The core of the model was a customised, semi-structured in-depth interview. There were two levels of triangulation: first, discrepancies between data from the questionnaires, diaries, in-depth interviews and applicator returns were identified, discussed with participants and, to a large extent, resolved; second, results from individual participants were related to more general data emerging from the focus group discussions and ethnography. A democratic and equitable collaboration between clinical trialists and qualitative social scientists facilitated the success of the model, as did the preparatory studies preceding the trial. The process revealed some of the underlying assumptions and routinised practices in "clinical trial culture'' that are potentially detrimental to the collection of accurate data, as well as some of the shortcomings of large qualitative studies, and pointed to some potential solutions.Conclusions/Significance: The integration of qualitative social science and the use of mixed methods and triangulation in clinical trials are feasible, and can reveal (and resolve) inaccuracies in data on adherence and sensitive behaviours, as well as illuminating aspects of "trial culture'' that may also affect data accuracy.