We are asking all hospital sites to record, with consent, all consultations in which the Best-BRA study and treatment options are discussed, up until the point at which the patient decides to accept or decline study participation.
If patients have not yet been given a PIL but are having an appointment in which the study will be introduced and/or discussed, then sites can take verbal consent for recordings and electronic or written consent can be be sought at their next convenient appointment, or through the post.
Why are we recording consultations?
The recordings are being undertaken to explore how treatment and study information is conveyed to patients. It is part of an intervention (the QuinteT Recruitment Intervention – QRI) to optimise recruitment and informed consent. The QRI is a flexible, tailored intervention to identify and address recruitment difficulties as they arise in study sites1. It has been applied to over 70 RCTs to date, leading to insights about recruitment issues and the development of targeted strategies that have improved recruitment2 3. Further details on this can be found here.
Do I really have to do these recordings and will they help?
The recordings are an essential part of the Best-BRA study and will help us explore how the study and treatment options are discussed with patients at your site. Clinicians involved in previous RCTs with QRI, have commented on how helpful it is to listen back to their recordings. They have perceived them as additional, free training on recruiting participants to RCTs.
Jo Skillman, Consultant Plastic, Reconstructive and Aesthetic Surgeon from Coventry and Warwickshire Partnership NHS Trust and also a member of the Best-BRA Trial Management Group discusses below why the recordings are so important for the Best-BRA study.
1. Donovan JL, Rooshenas L, Jepson M, et al. Optimising recruitment and informed consent in randomised controlled trials: the development and implementation of the Quintet Recruitment Intervention (QRI). Trials 2016;17(1):283. doi: 10.1186/s13063-016-1391-4 [published Online First: 2016/06/10.
2. Rooshenas L, Scott LJ, Blazeby JM, et al. The QuinteT Recruitment Intervention supported five randomized trials to recruit to target: a mixed-methods evaluation. Journal of clinical epidemiology 2019;106:108-20. doi: 10.1016/j.jclinepi.2018.10.004 [published Online First: 2018/10/20.
3. Mills N, Donovan JL, Wade J, et al. Exploring treatment preferences facilitated recruitment to randomized controlled trials. J Clin Epidemiol 2011;64(10):1127-36. doi: 10.1016/j.jclinepi.2010.12.017 [published Online First: 2011/04/12.
Further reading:
An observational study showed that explaining randomization using gambling-related metaphors and computer-agency descriptions impeded randomized clinical trial recruitment.
M Jepson et al., 2018, Journal of Clinical Epidemiology.
The intellectual challenges and emotional consequences of equipoise contributed to the fragility of recruitment in six randomized controlled trials.
J Donovan et al., 2014, Journal of Clinical Epidemiology.
Conveying Equipoise during Recruitment for Clinical Trials: Qualitative Synthesis of Clinicians’ Practices across Six Randomised Controlled Trials.
L Rooshenas et al., 2016, PloS Medicine.