How to embed qualitative research in trials: insights from the feasibility study of the SAFER trial programme

Abstract

Qualitative research can enhance the design, conduct and interpretation of trials. Despite this, few trials incorporate qualitative methods, and those that do may not realise their full potential. In this commentary, we highlight how qualitative research can contribute to the design, conduct and day-to-day running of a trial, outlining the working arrangements and relationships that facilitate these contributions. In doing so, we draw on (i) existing frameworks on the role of qualitative research alongside trials and (ii) our experience of integrated qualitative research conducted as part of the feasibility study of the SAFER trial (Screening for Atrial Fibrillation with ECG to Reduce stroke), a cluster randomised controlled trial of screening people aged 70 and above for atrial fibrillation in primary care in England. The activities and presence of the qualitative team contributed to important changes in the design, conduct and day-to-day running of the SAFER feasibility study, and the subsequent main trial, informing diverse decisions concerning trial documentation, trial delivery, timing and content of measures and the information given to participating patients and practices. These included asking practices to give screening results to all participants and not just to ‘screen positive’ participants, and greater recognition of the contribution of practice reception staff to trial delivery. These changes were facilitated by a ‘one research team’ approach that underpinned all formal and informal working processes from the outset and maximised the value of both qualitative and trial coordination expertise. The challenging problems facing health services require a combination of research methods and data types. Our experience and the literature show that the benefits of embedding qualitative research in trials are more likely to be realised if attention is given to both structural factors and relationships from the outset. These include sustained and sufficient funding for qualitative research, embedding qualitative research fully within the trial programme, providing shared infrastructure and resources and committing to relationships based on mutual recognition of and respect for the value of different methods and perspectives. We outline key learning for the planning of future trials.Trial registration: Screening for atrial fibrillation with ECG to reduce stroke ISRCTN16939438 (feasibility study); Screening for atrial fibrillation with ECG to reduce stroke – a randomised controlled trial ISRCTN72104369.

Why do people choose not to take part in screening? Qualitative interview study of atrial fibrillation screening nonparticipation

“…Screening programmes seeking to provide sufficient information for invitees to make an informed choice about participation should consider how the evidence about the benefits of screening for older adults is presented, paying particular attention to the wider challenges about the necessity, legitimacy, and utility of AF screening. Embedding qualitative programmes alongside screening trials 38 or co‐designing screening programmes 65 may help to ensure screening programmes address the needs and priorities of potential participants and empower their decision‐making about participating. However, values about screening are ultimately made within the context of an individual's lifeworld, and recognising participants' agency to decide (not) to take part is necessary for understanding screening participation 66 …”

“…The SAFER trial includes an embedded qualitative research programme that contributes to ‘addressing the overall aims of SAFER, namely, to consider the feasibility, harms, effectiveness and cost‐effectiveness of a national screening programme for AF in primary care’. 38 …”

“…The SAFER trial includes an embedded qualitative research programme that contributes to 'addressing the overall aims of SAFER, namely, to consider the feasibility, harms, effectiveness and costeffectiveness of a national screening programme for AF in primary care'. 38 We conducted interviews with people invited to SAFER in the feasibility phases and the internal pilot trial. We sampled participants from (a) those who had declined an invitation to participate in SAFER ('SAFER decliners') and (b) those who consented to take part in SAFER but had declined an invitation to participate in AF screening ('screening decliners').…”

The integration of rapid qualitative research in clinical trials: reflections from the ward-based goal-directed fluid therapy (GDFT) in acute pancreatitis feasibility trial

“…There has been a notable increase in the integration of qualitative studies in randomised controlled trials in healthcare [ 20 , 24 ]. In part, this is due to the demonstrated value of these studies for determining the acceptability and appropriateness of trials for clinical staff and patients.…”

Spontaneous Coronary Artery Dissection Across the Health Care Pathway: A National, Multicenter, Patient‐Informed Investigation

“…Eliciting patient‐reported experiences is essential to understanding complex health‐related problems, 17 particularly those that are underresearched and involve special populations, 18 such as those with SCAD. Patient‐oriented research is used to contextualize cardiovascular risk assessments, outcomes, and health services data, which in tandem can more adequately inform the development of interventions 19 and clinical practice guidelines. 20 Three studies have investigated SCAD from the patients' perspective, 21 , 22 , 23 1 of which was a pilot study informing this current research.…”