Randomised control trials (RCT) can be challenging for researchers to recruit for. You need eligible, consenting participants who ideally can be retained throughout the study. It’s essential to have an appropriate sample size to ensure the study’s validity. How can patient and public involvement (PPI) help to improve research recruitment?
In this study, Dwyer et al. (2021) conducted a qualitative study within a trial (SWAT) to interview people on why, after initially expressing interest in participating in a cognitive occupation based RCT (the host trial), they declined to participate.
Interestingly, as part of another SWAT within the host trial, participants were provided with one of two participant information sheets (PIS), one designed by patients and one designed by researchers. You should be able to tell which is which from the images below (Figures 1 & 2).
Interestingly, it didn’t seem to matter which PIS the potential participant received, as those who received the patient designed PIS expressed misinterpretation of the information provided and still declined to participate (Figure 3).
This study had two phases, where the researchers first analysed the interview data, and the second phase where researchers asked the PPI panel the same questions as the decliners, presented them with the decliners’ comments and asked them to comment and review the findings. This helped to address the study limitations of having a small sample size, short interviews, and to elaborate on the findings.
The researchers found that the reasons people declined were mostly personal rather than problems with the study intervention. While participants saw the value of MS research, some misunderstood who the study was for, or what it was about. One theme was the idea that “Ignorance is Bliss” where not taking part in research meant people didn’t have to think about their MS and used denial as a coping mechanism.
The study incorporated PPI input throughout: the development and piloting of the interview guide, developing a patient PIS and getting PPI feedback in the second phase. It would be interesting to know the PPI involvement at the dissemination phase – sharing the study findings with the wider public.
What would help you to take part in research?
A qualitative investigation of reasoning behind decisions to decline participation in a research intervention: A study-within-a-trial
Christopher P Dwyer, Anusha Moses, Fionnuala M Rogers, Dympna Casey, Robert Joyce and Sinéad M Hynes
https://doi.org/10.1177/13591053211037736 Journal of Health Psychology, August 6 2021
The current study-within-a-trial explored individuals’ decisions to decline participation in research trialling a chronic illness-focused therapy (i.e. multiple sclerosis). Four themes were identified from seven semi-structured interviews with participation decliners and were confirmed by the host trial’s Patient & Public Involvement (PPI) panel: acknowledgement of the value of research; ‘fit’ of the study; misinterpretation of participant information; and ‘ignorance is bliss’ – discussed in light of theory and research. This study-within-a-trial extends research on trial recruitment and participation decline; while also suggesting that PPI can be utilised in both a practical and impactful manner.
Disclaimer: Please note that the opinions expressed here are those of the author and do not necessarily reflect the position of the Barts and The London School of Medicine and Dentistry nor Barts Health NHS Trust.
Heather Mah is a PhD researcher at the Wolfson Institute of Population Health at Queen Mary University London exploring the experiences of people with MS and healthcare professionals involved with Patient and Public Involvement (PPI).