Background

Process evaluation is an important aspect of applied health research, which aims to better understand the contextual factors and causal mechanisms behind clinical interventions and research processes [1-4]. Process evaluation may also support refining and shaping those interventions that are tested in research, to ensure that they are practice-ready and easily implemented.

A systematic review of trials published in 2015 identified inconsistent implementation and poor reporting of process evaluation within randomised trials [1]. Subsequently, there has been a notable shift in the research landscape with the MRC issuing guidance for researchers and major funders of trials such as the National Institute of Health and Care Research (NIHR), recognising its importance [2]. This has naturally led to more widespread implementation of process evaluation in randomised trials but notably, without any evidence of its effectiveness.

Aim

To describe how process evaluation is being used within NIHR-funded randomised controlled trials.

Methods

Publications from NIHR-funded trials will be reviewed over a 10-year period to assess the evolution of process evaluation within randomised controlled trials. This will provide a comprehensive picture of why, when and how process evaluation has been used within trials, illustrating:

• The prevalence of process evaluation across different NIHR funding streams
• What approaches, models, theories and tools are being commonly used
• When, in the evidence lifecycle, are process evaluations typically being conducted
• How process evaluations inform other elements of trial conduct

This work will identify a typology of process evaluation methods, which describes why, when and how they are done (i.e., what theories, tools and methods are used).

The findings of this research will also inform a future application to develop guidance for the effective implementation and reporting of process evaluation within and alongside randomised trials.

 

References

1. French C, Pinnock H, Forbes G, Skene I, Taylor SJ. Process evaluation within pragmatic randomised controlled trials: what is it, why is it done, and can we find it?—a systematic review. Trials. 2020 Dec;21(1):1-6.
2. Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O’Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350.
3. Oakley A, Strange V, Bonell C, Allen E, Stephenson J. Process evaluation in randomised controlled trials of complex interventions. BMJ. 2006 Feb 16;332(7538):413-6.
4. Rapport F, Storey M, Porter A, Snooks H, Jones K, Peconi J, Sánchez A, Siebert S, Thorne K, Clement C, Russell I. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit. Trials. 2013 Dec;14(1):1-8.

Funder

National Institute for Health and Care Research (NIHR)