Quality, Safety and Informatics Research Group, Population Health Sciences, Medical Research Institute, University of Dundee, Mackenzie Building, Dundee DD2 4BF, UK.
Trials. 2013 Jan 12;14:15. doi: 10.1186/1745-6215-14-15.
Process evaluations are recommended to open the 'black box' of complex interventions evaluated in trials, but there is limited guidance to help researchers design process evaluations. Much current literature on process evaluations of complex interventions focuses on qualitative methods, with less attention paid to quantitative methods. This discrepancy led us to develop our own framework for designing process evaluations of cluster-randomised controlled trials.
We reviewed recent theoretical and methodological literature and selected published process evaluations; these publications identified a need for structure to help design process evaluations. We drew upon this literature to develop a framework through iterative exchanges, and tested this against published evaluations.
The developed framework presents a range of candidate approaches to understanding trial delivery, intervention implementation and the responses of targeted participants. We believe this framework will be useful to others designing process evaluations of complex intervention trials. We also propose key information that process evaluations could report to facilitate their identification and enhance their usefulness.
There is no single best way to design and carry out a process evaluation. Researchers will be faced with choices about what questions to focus on and which methods to use. The most appropriate design depends on the purpose of the process evaluation; the framework aims to help researchers make explicit their choices of research questions and methods.
Clinicaltrials.gov NCT01425502.
过程评估被推荐用于打开试验中评估的复杂干预措施的“黑箱”，但目前针对如何设计过程评估的指导有限。目前关于复杂干预措施过程评估的文献大多侧重于定性方法，对定量方法的关注较少。这种差异促使我们为设计群组随机对照试验的过程评估开发了自己的框架。
我们回顾了最近的理论和方法文献，并选择了已发表的过程评估；这些出版物确定需要有结构来帮助设计过程评估。我们从这些文献中汲取灵感，通过迭代交流来开发框架，并将其与已发表的评估进行对照测试。
所开发的框架提出了一系列候选方法，用于了解试验实施、干预措施的实施以及目标参与者的反应。我们相信这个框架将对其他设计复杂干预试验过程评估的人有用。我们还提出了过程评估可以报告的关键信息，以促进其识别并增强其有用性。
没有一种设计和实施过程评估的最佳方法。研究人员将面临关注哪些问题以及使用哪些方法的选择。最合适的设计取决于过程评估的目的；该框架旨在帮助研究人员明确研究问题和方法的选择。
Clinicaltrials.gov NCT01425502。
