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Table 2 Mapping of the reporting framework to three selected process evaluations

From: Process evaluations for cluster-randomised trials of complex interventions: a proposed framework for design and reporting

 

Summary of trial being evaluated

Clearly labelled as a process evaluation

Stated purpose

Processes examined

Specify timing

Methods used

Choice of method justified

Report main findings of trial

Nazareth and colleagues[30]

Cluster-randomised trial of a pharmacist-led educational outreach intervention to improve GPs’ prescribing quality

Yes

’To describe the steps leading to the final primary outcome and explore the effect of the intervention on each step of the hypothesised pathway of change in professionals’ prescribing behaviour’

Cluster recruitment, Delivery to clusters, Adoption and Delivery to target population, Quantitative associations with effectiveness (reported in main trial paper)

Retrospective/ post hoc

Reporting of proportion of practices recruited. Association between proportion of GPs in each practice attending education outreach, the intervention and change in prescribing. Mixed-methods assessment of barriers and facilitators to adoption and delivery to target population.

Partly

Trial design, intervention, targeted outcomes and results summarised, main trial paper referenced

Byng and colleagues[11]

Cluster-randomised trial of a complex intervention to promote shared care for people with severe mental health problems

Yes

’To unpick the complexity of the intervention by examining interactions between components and context and then further defining its core functions’

Adoption, Reach and Delivery to target population, Qualitative associations with effectiveness

Retrospective data collection, unclear if planned prospectively

Realistic evaluation, qualitative case study, analysis of interview data with a purposive sample of participating mental health team-practice cases. Case study findings were used to better understand how the intervention changed practice and targeted outcomes.

Yes

Trial design, intervention and results summarised, main trial paper referenced

Fretheim and colleagues[33]

Cluster-randomised trial of a multifaceted intervention (educational outreach, audit and feedback, computerised reminders, patient information) to improve GPs’ prescribing quality

Yes

’The main objective of this analysis was to identify factors that could explain variation in outcomes across practices’

Delivery to clusters, Adoption and Quantitative associations with effectiveness

Prospective / pre-specified

Quantification of GP perceptions of the intervention and the trial, and pharmacist assessment of the quality of educational outreach. Regression analysis of associations with change in prescribing.

Partly

Trial design, intervention, targeted outcomes and results summarised, main trial paper referenced

  1. GP, general practitioner.