Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, 58 Turner Street, London, E1 2AB, UK.
Usher Institute, The University of Edinburgh, Doorway 3, Medical School, Teviot Place, Edinburgh, EH8 9AG, UK.
Trials. 2020 Nov 9;21(1):916. doi: 10.1186/s13063-020-04762-9.
BACKGROUND: Process evaluations are increasingly conducted within pragmatic randomised controlled trials (RCTs) of health services interventions and provide vital information to enhance understanding of RCT findings. However, issues pertaining to process evaluation in this specific context have been little discussed. We aimed to describe the frequency, characteristics, labelling, value, practical conduct issues, and accessibility of published process evaluations within pragmatic RCTs in health services research. METHODS: We used a 2-phase systematic search process to (1) identify an index sample of journal articles reporting primary outcome results of pragmatic RCTs published in 2015 and then (2) identify all associated publications. We used an operational definition of process evaluation based on the Medical Research Council's process evaluation framework to identify both process evaluations reported separately and process data reported in the trial results papers. We extracted and analysed quantitative and qualitative data to answer review objectives. RESULTS: From an index sample of 31 pragmatic RCTs, we identified 17 separate process evaluation studies. These had varied characteristics and only three were labelled 'process evaluation'. Each of the 31 trial results papers also reported process data, with a median of five different process evaluation components per trial. Reported barriers and facilitators related to real-world collection of process data, recruitment of participants to process evaluations, and health services research regulations. We synthesised a wide range of reported benefits of process evaluations to interventions, trials, and wider knowledge. Visibility was often poor, with 13/17 process evaluations not mentioned in the trial results paper and 12/16 process evaluation journal articles not appearing in the trial registry. CONCLUSIONS: In our sample of reviewed pragmatic RCTs, the meaning of the label 'process evaluation' appears uncertain, and the scope and significance of the term warrant further research and clarification. Although there were many ways in which the process evaluations added value, they often had poor visibility. Our findings suggest approaches that could enhance the planning and utility of process evaluations in the context of pragmatic RCTs. TRIAL REGISTRATION: Not applicable for PROSPERO registration.
背景:在卫生服务干预措施的实用随机对照试验(RCT)中,越来越多地进行了过程评估,为增强对 RCT 结果的理解提供了重要信息。然而,在这种特定背景下,与过程评估相关的问题很少被讨论。我们旨在描述卫生服务研究中实用 RCT 中已发表的过程评估的频率、特征、标签、价值、实际实施问题和可及性。
方法:我们使用了两阶段系统搜索过程,(1)确定了 2015 年发表的报告实用 RCT 主要结局结果的期刊文章的索引样本,然后(2)确定了所有相关出版物。我们使用基于医疗研究委员会的过程评估框架的过程评估操作定义来识别单独报告的过程评估和试验结果论文中报告的过程数据。我们提取和分析定量和定性数据以回答审查目标。
结果:从 31 项实用 RCT 的索引样本中,我们确定了 17 项单独的过程评估研究。这些研究具有不同的特征,只有 3 项被标记为“过程评估”。每个试验结果论文还报告了过程数据,每个试验中位数有 5 个不同的过程评估组成部分。报告的障碍和促进因素与现实世界中过程数据的收集、对过程评估的参与者的招募以及卫生服务研究法规有关。我们综合了广泛的报告过程评估对干预措施、试验和更广泛知识的益处。可见度通常较差,17 项过程评估中有 13 项未在试验结果论文中提及,16 项过程评估期刊文章中有 12 项未出现在试验注册处。
结论:在我们审查的实用 RCT 样本中,“过程评估”标签的含义似乎不确定,该术语的范围和意义需要进一步研究和澄清。尽管过程评估有多种增值方式,但它们的可见度通常较差。我们的研究结果表明,在实用 RCT 背景下,可以采用一些方法来增强过程评估的规划和实用性。
试验注册:不适用 PROSPERO 注册。
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