开放标签等待列表试验设计的可接受性：来自PROUD PrEP研究的经验
Acceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study.
作者信息
Gafos Mitzy, Brodnicki Elizabeth, Desai Monica, McCormack Sheena, Nutland Will, Wayal Sonali, White Ellen, Wood Gemma, Barber Tristan, Bell Gill, Clarke Amanda, Dolling David, Dunn David, Fox Julie, Haddow Lewis, Lacey Charles, Nardone Anthony, Quinn Killian, Rae Caroline, Reeves Iain, Rayment Michael, White David, Apea Vanessa, Ayap Wilbert, Dewsnap Claire, Collaco-Moraes Yolanda, Schembri Gabriel, Sowunmi Yinka, Horne Rob
机构信息
Medical Research Council Clinical Trials Unit, Institute of Clinical Trials & Methodology, University College London, London, United Kingdom.
HIV/STI Department, Public Health England, London, United Kingdom.
出版信息
PLoS One. 2017 Apr 20;12(4):e0175596. doi: 10.1371/journal.pone.0175596. eCollection 2017.
BACKGROUND
PROUD participants were randomly assigned to receive pre-exposure prophylaxis (PrEP) immediately or after a deferred period of one-year. We report on the acceptability of this open-label wait-listed trial design.
METHODS
Participants completed an acceptability questionnaire, which included categorical study acceptability data and free-text data on most and least liked aspects of the study. We also conducted in-depth interviews (IDI) with a purposely selected sub-sample of participants.
RESULTS
Acceptability questionnaires were completed by 76% (415/544) of participants. After controlling for age, immediate-group participants were almost twice as likely as deferred-group participants to complete the questionnaire (AOR:1.86;95%CI:1.24,2.81). In quantitative data, the majority of participants in both groups found the wait-listed design acceptable when measured by satisfaction of joining the study, intention to remain in the study, and interest in joining a subsequent study. However, three-quarters thought that the chance of being in the deferred-group might put other volunteers off joining the study. In free-text responses, data collection tools were the most frequently reported least liked aspect of the study. A fifth of deferred participants reported 'being deferred' as the thing they least liked about the study. However, more deferred participants disliked the data collection tools than the fact that they had to wait a year to access PrEP. Participants in the IDIs had a good understanding of the rationale for the open-label wait-listed study design. Most accepted the design but acknowledged they were, or would have been, disappointed to be randomised to the deferred group. Five of the 25 participants interviewed reported some objection to the wait-listed design.
CONCLUSION
The quantitative and qualitative findings suggest that in an environment where PrEP was not available, the rationale for the wait-listed trial design was well understood and generally acceptable to most participants in this study.
背景
“自豪”试验的参与者被随机分配立即接受暴露前预防（PrEP）或在延迟一年后接受。我们报告了这种开放标签的等待列表试验设计的可接受性。
方法
参与者完成了一份可接受性问卷，其中包括分类研究可接受性数据以及关于该研究最喜欢和最不喜欢方面的自由文本数据。我们还对特意挑选的部分参与者子样本进行了深入访谈（IDI）。
结果
76%（415/544）的参与者完成了可接受性问卷。在控制年龄后，立即组参与者完成问卷的可能性几乎是延迟组参与者的两倍（调整后比值比：1.86；95%置信区间：1.24，2.81）。在定量数据中，两组中的大多数参与者从加入研究的满意度、留在研究中的意愿以及加入后续研究的兴趣来看，都认为等待列表设计是可以接受的。然而，四分之三的人认为被分到延迟组的可能性可能会使其他志愿者不愿加入该研究。在自由文本回答中，数据收集工具是最常被报告的该研究最不喜欢的方面。五分之一的延迟参与者报告“被延迟”是他们最不喜欢该研究的事情。然而，比起必须等待一年才能获得PrEP，更多延迟参与者不喜欢数据收集工具。深入访谈中的参与者对开放标签等待列表研究设计的基本原理有很好的理解。大多数人接受该设计，但承认如果被随机分到延迟组，他们当时会或将会感到失望。接受访谈的25名参与者中有5人对等待列表设计表示了一些反对意见。
结论
定量和定性研究结果表明，在无法获得PrEP的环境中，本研究中的大多数参与者很好地理解了等待列表试验设计的基本原理，并且总体上可以接受。
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