Qualitative Lead(s)
Professor Vanessa Lawrence, Dr Clair Le Boutillier
Project Lead & Team
Chief Investigator: Vishal Patel
Multidisciplinary collaboration including hepatology clinicians, trialists, statisticians, behavioural scientists, and implementation researchers across multiple UK NHS hospital recruitment sites and associated primary care networks.
Project Dates
2020–ongoing
Funding Source(s)
NIHR Health Technology Assessment Programme
Qualitative Design used
- Qualitative Research in Trials
- Implementation Research and Improvement Science
- Evaluating Services and Interventions
Field of Research
Liver disease; cirrhosis; pharmacological trials; recruitment methodology; implementation science
Geographic/Contextual Setting
Multi-centre NHS hospital hepatology services and associated primary care settings across the UK.
Beta-blockers or Placebo for Primary Prophylaxis of Oesophageal Varices
BOPPP is a UK-wide multicentre randomised controlled trial evaluating the clinical and cost-effectiveness of carvedilol for preventing hepatic decompensation in people with cirrhosis and small oesophageal varices. An embedded qualitative research programme examines recruitment processes and implementation pathways across the trial lifecycle, generating evidence to inform recruitment optimisation strategies and to support translation of the intervention from secondary care settings into routine primary care delivery following trial completion.
Qualitative Approach and Methods
Aim of the qualitative component
To understand:
- Recruitment barriers and facilitators operating across patient, staff, organisational, and system levels to inform a tailored, evidence-based strategy to optimise trial recruitment.
- The factors influencing implementation of the secondary care treatment within primary care settings following completion of the trial.
Qualitative methodology
A multi-phase qualitative programme embedded within a pragmatic clinical trial, including recruitment optimisation study using the Theoretical Domains Framework, and implementation research using reflexive thematic analysis.
Which qualitative methods were used?
- Individual interviews with patients who enrolled to participate in the trial, patients who declined to take part and staff who were responsible for recruiting participants to the trial.
- Individual interviews with general practitioners involved in future treatment implementation in primary care.
Sampling & recruitment
Participants were purposively sampled across multiple UK trial sites to capture variation in patient experiences, recruitment roles, and organisational contexts influencing recruitment and implementation.
Data analysis: how the team made sense of the data
Interview data were analysed using thematic and theory-informed behavioural approaches to identify recruitment influences across multiple system levels and to examine organisational and professional factors shaping implementation of the intervention beyond the trial.
Findings, Learning & Impact
Summary of main findings
Qualitative findings identified recruitment influences operating at multiple levels, including patient perceptions of risk and benefit, staff confidence and workload pressures, organisational capacity, and wider system-level trial-delivery processes. Implementation-focused analyses highlighted the importance of clear responsibility pathways between primary and secondary care, clinician confidence in prescribing practices, and organisational readiness to support post-trial treatment adoption.
Why were qualitative methods used in this project, and what did they enable?
Qualitative research enabled the study to:
- Identify multi-level recruitment barriers and facilitators in real time.
- Inform development of tailored recruitment optimisation strategies.
- Examine organisational and professional influences shaping implementation beyond the trial.
- Support translation of trial findings into routine care pathways.
Lessons learnt / reflections?
Embedding qualitative research within pragmatic clinical trials enables responsive recruitment optimisation and provides early insight into implementation challenges, strengthening the likelihood that effective interventions can be successfully adopted in routine care.
Impact & influence
The BOPPP qualitative programme contributes methodological evidence demonstrating how integrated qualitative recruitment and implementation research can strengthen both trial delivery and translation of findings into clinical practice.
Links, Outputs & Resources
Links to publications
- Patel, V. C., McPhail, M. J., Uddin, R., Jafari, H., Lawrence, V., Le Boutillier, C., Shearer, J., Yaziji, N., Cape, A., Ahmed, H., Ward, C., Walsh, P., Besly, K., Zamalloa, A., Kelly, J., Mukhopadhya, A., Vileito, A., Henderson, T., Webb, G., … BOPPP study group. (2024). Beta-blockers or Placebo for Primary Prophylaxis (BOPPP) of oesophageal varices: Study protocol for a randomised controlled trial. Trials, 25(1), 265. Available here.
- Boutillier, C. L., Snowdon, C., Patel, V., McPhail, M., Ward, C., Carter, B., Uddin, R., Zamalloa, A., & Lawrence, V. (2022). Using a theory-informed approach to explore patient and staff perspectives on factors that influence clinical trial recruitment for patients with cirrhosis and small oesophageal varices. PLOS ONE, 17(2), e0263288. Available here.
- Boutillier, C. L., Ahmed, H., Patel, V. C., McPhail, M., Carter, B., Ward, C., & Lawrence, V. (2022). General practitioner perspectives on factors that influence implementation of secondary care-initiated treatment in primary care: Exploring implementation beyond the context of a clinical trial. PLOS ONE, 17(10), e0275668. General practitioner perspectives on factors that influence implementation of secondary care-initiated treatment in primary care: Exploring implementation beyond the context of a clinical trial