Supporting translation of research evidence into practice—the use of Normalisation Process Theory to assess and inform implementation within randomised controlled trials: a systematic review

Abstract

Background 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. Methods 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. Results 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. Conclusions 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. Trial Registration The protocol for this systematic review was accepted for public registration on PROSPERO (registration number: CRD42022345427) on 26 July 2022.

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“…We considered that NPT would be a useful analytical tool because NPT is a robust and highly cited theory of implementation that helps provide awareness of the work involved in embedding and sustaining practices associated with an intervention, and thus aids understanding of what becomes normalised into everyday settings. 28 46 47 NPT is a sociological theory which explains the processes people adopt when implementing new interventions, to allow the intervention to become ‘normalised’ or embedded in routine practice. Four core constructs, each with four subconstructs within them, describe generative mechanisms that facilitate normalisation and help examine: (1) the ways that people make sense of the practice (‘Coherence’); (2) how they engage and participate with it (‘Cognitive participation’); (3) how stakeholders come to engage with or ‘enact’ the practice (‘Collective action’) and (4) how they appraise its effects (‘Reflexive monitoring’).…”

“… 55 56 NPT is beneficial to understanding the complex dynamics of implementation processes and identifying aspects of work that can be improved for sustainable integration into everyday practice. 28 57 58 However, reported challenges of NPT use within RCTs appear to surface when mapping data onto the constructs, as overlap between them has been experienced. 47 59 Introducing NPT from the outset of RCT planning can provide us with the opportunity to overcome these expected challenges.…”

“…Other challenges reported on the use of NPT within RCTs relate to the ability of constructs to cover specific implementation or acceptability aspects emerging from data. 28 60 61 To tackle this challenge, some studies have integrated the NPT framework with other frameworks such as the Theory of Planned Behaviour 62 and the Consolidated Framework for Implementation Research. 63 …”

“…For these reasons, the use of qualitative methods in conjunction with RCTs to facilitate the implementation and evaluation of interventions is on the rise. [27][28][29] The study design includes the following steps (figure 1): 1. Review of literature, document analysis (eg, local protocols) and informal discussions with the clinical team members to have a preliminary 'As-is' (standard of care pathway) and 'To-be' (WB pathway) process map. 2.…”

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“…Additionally, there may be unclear links between the included data, the synthesis conducted, and the ultimate conclusions drawn. Considering that the NPT (Normalization Process Theory) focuses on evaluating and guiding implementation within RCTs across a range of health and social care areas [92], using it in SRs may improve the way results are presented.…”