Kletter Maartje, Norman Gill, Dumville Jo, Wilson Paul
Division of Nursing, Midwifery and Social Work, School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.
NIHR Innovation Observatory, Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne, UK.
Trials. 2025 Jul 30;26(1):263. doi: 10.1186/s13063-025-08910-x.
The United Kingdom Medical Research Council (MRC) guidance for complex interventions recommends the nesting of process evaluations in randomised controlled trials (RCTs) of complex interventions. To date, there has been limited review of how the MRC guidance has been operationalised in RCTs of complex interventions.
This scoping review aimed to identify how process evaluations nested in RCTs on complex interventions have been conducted and reported since the 2015 publication of MRC guidance.
We identified articles in PubMed and Scopus that cited the 2015 main journal article on the MRC guidance and applied an RCT filter to these articles. Studies reporting on RCT nested process evaluations in any field of health or social care were included. Data was extracted about study details, process evaluation study design, including methods used for data collection, data analyses, integration with RCT data and use of theory in process evaluation design.
We identified 160 RCTs and 53 pilot/feasibility RCTs. Most process evaluations included a combination of qualitative and quantitative data collection methods, either triangulated (mixed method studies) or not (multi-method studies). Most studies did not report the use of theory in shaping how the process evaluation was designed. Common methods for data analysis included descriptive statistics and thematic analysis for quantitative and qualitative studies respectively. There was limited triangulation of process evaluation data with RCT outcomes.
Whilst process evaluations can be helpful in explaining outcomes of RCT interventions and subsequent implementation of these intentions, information gathered from process evaluations is often not fully reported in papers. There are currently no suitable reporting guidelines for process evaluations linked to RCTs; work to develop such guidelines, potentially as a StaRI checklist extension, would be valuable.
英国医学研究理事会（MRC）针对复杂干预措施的指南建议在复杂干预措施的随机对照试验（RCT）中纳入过程评估。迄今为止，关于MRC指南在复杂干预措施的RCT中如何实施的综述有限。
本范围综述旨在确定自2015年MRC指南发布以来，在复杂干预措施的RCT中嵌套的过程评估是如何进行和报告的。
我们在PubMed和Scopus中识别引用了2015年关于MRC指南的主要期刊文章的文章，并对这些文章应用RCT筛选器。纳入报告健康或社会护理任何领域中RCT嵌套过程评估的研究。提取有关研究细节、过程评估研究设计的数据，包括用于数据收集、数据分析、与RCT数据整合以及过程评估设计中理论运用的方法。
我们识别出160项RCT和53项试点/可行性RCT。大多数过程评估包括定性和定量数据收集方法的组合，要么是三角互证法（混合方法研究），要么不是（多方法研究）。大多数研究没有报告在塑造过程评估设计方式时理论的运用情况。常见的数据分析方法分别包括定量研究的描述性统计和定性研究的主题分析。过程评估数据与RCT结果的三角互证有限。
虽然过程评估有助于解释RCT干预措施的结果以及这些意图随后的实施情况，但从过程评估中收集的信息在论文中往往没有得到充分报告。目前没有适用于与RCT相关的过程评估的报告指南；制定此类指南的工作，可能作为随机对照试验报告倡议（StaRI）清单的扩展，将是有价值的。
