Department of Primary Care and Public Health, Imperial College London, National Institute of Health Research (NIHR) Applied Research Collaboration (ARC) Northwest London, Charing Cross Campus, London, W6 8RP, UK.
Business School, Centre for Health Economics and Policy Innovation (CHEPI), Imperial College London, Chelsea and Westminster Campus, London, SW10 9N, UK.
Implement Sci. 2023 Oct 27;18(1):55. doi: 10.1186/s13012-023-01311-1.
The status of randomised controlled trials (RCTs) as the 'gold standard' for evaluating efficacy in healthcare interventions is increasingly debated among the research community, due to often insufficient consideration for implementation. Normalisation Process Theory (NPT), which focuses on the work required to embed processes into practice, offers a potentially useful framework for addressing these concerns. While the theory has been deployed in numerous RCTs to date, more work is needed to consolidate understanding of if, and how, NPT may aid implementation planning and processes within RCTs. Therefore, this review seeks to understand how NPT contributes to understanding the dynamics of implementation processes within RCTs. Specifically, this review will identify and characterise NPT operationalisation, benefits and reported challenges and limitations in RCTs.
A qualitative systematic review with narrative synthesis of peer-reviewed journal articles from eight databases was conducted. Studies were eligible for inclusion if they reported sufficient detail on the use of NPT within RCTs in a healthcare domain. A pre-specified data extraction template was developed based on the research questions of this review. A narrative synthesis was performed to identify recurrent findings.
Searches identified 48 articles reporting 42 studies eligible for inclusion. Findings suggest that NPT is primarily operationalised prospectively during the data collection stage, with limited sub-construct utilisation overall. NPT is beneficial in understanding implementation processes by aiding the identification and analysis of key factors, such as understanding intervention fidelity in real-world settings. Nearly three-quarters of studies failed to report the challenges and limitations of utilising NPT, though coding difficulties and data falling outside the NPT framework are most common.
NPT appears to be a consistent and generalisable framework for explaining the dynamics of implementation processes within RCTs. However, operationalisation of the theory to its full extent is necessary to improve its use in practice, as it is currently deployed in varying capacities. Recommendations for future research include investigation of NPT alongside other frameworks, as well as earlier operationalisation and greater use of NPT sub-constructs.
The protocol for this systematic review was accepted for public registration on PROSPERO (registration number: CRD42022345427) on 26 July 2022.
在医疗保健干预措施的疗效评估中，随机对照试验（RCT）作为“金标准”的地位在研究界受到越来越多的质疑，因为其通常对实施情况考虑不足。关注将流程嵌入实践所需工作的规范化进程理论（NPT）为解决这些问题提供了一个潜在有用的框架。尽管该理论迄今为止已在许多 RCT 中得到应用，但仍需要更多的工作来巩固对 NPT 是否以及如何有助于 RCT 中的实施计划和流程的理解。因此，本综述旨在了解 NPT 如何有助于理解 RCT 中实施过程的动态。具体来说，本综述将确定和描述 NPT 的操作化、在 RCT 中的益处以及报告的挑战和局限性。
对来自八个数据库的同行评审期刊文章进行了定性系统评价和叙述性综合。如果研究报告了在医疗保健领域内 RCT 中使用 NPT 的足够详细信息，则符合纳入标准。根据本综述的研究问题，制定了一个预先指定的数据提取模板。进行了叙述性综合，以确定反复出现的发现。
搜索共确定了 48 篇报告 42 项符合纳入标准的研究。研究结果表明，NPT 主要在数据收集阶段进行前瞻性操作化，总体上对次结构的利用有限。通过帮助识别和分析关键因素，如在实际环境中理解干预的一致性，NPT 有利于理解实施过程。近四分之三的研究未能报告使用 NPT 的挑战和局限性，尽管编码困难和数据超出 NPT 框架是最常见的问题。
NPT 似乎是一个一致且可推广的框架，用于解释 RCT 中实施过程的动态。然而，为了提高其在实践中的应用，有必要充分操作化该理论，因为目前它的应用程度各不相同。对未来研究的建议包括调查 NPT 与其他框架的结合使用，以及更早的操作化和更广泛地使用 NPT 的次结构。
本系统评价的方案于 2022 年 7 月 26 日在 PROSPERO（注册号：CRD42022345427）上接受公开注册。
