Barriers to recruitment when conducting a commissioned randomised controlled trial of medication versus psychological therapy for generalised anxiety disorder: some lessons learned

Abstract

Background Poor recruitment is the most common reason for premature discontinuation of randomised controlled trials (RCTs). An RCT of medication versus psychological therapy for generalised anxiety disorder (GAD) was discontinued prematurely by the UK National Institute of Health Research funders because of recruitment failure. In order to inform future research studies, this article explores the reasons for poor recruitment and aspects which could have been improved. Methods The trial recruited participants via psychological well-being practitioners (PWPs) employed within local Improving Assess to Psychological Therapies (IAPT) services at four sites in England. For this study, we initially examined the recruitment data to identify reasons why potential participants were reluctant to participate in the trial. We then investigated reasons the PWPs did not identify more potential participants. Finally, we performed retrospective analyses of a computerised clinical records system used by the IAPT services in this study. These analyses aimed to establish the number of potential participants who had not been approached about the trial as well as whether there were additional factors affecting the numbers of people who might be eligible to take part. Data were obtained for all patients assessed during the period from the date on which recruitment commenced until the closure of the trial. Results Three quarters of those patients identified as possibly suitable for the trial declined to take part; the great majority did so because they did not want to be randomly assigned to receive medication. Our retrospective database analyses showed that only around 12% of potentially eligible patients for the trial were identified by the PWPs at the pilot sites. The results also indicated that only 5% of those noted at entry to the IAPT services to have a score of at least 10 on the GAD-7 questionnaire (a self-completed questionnaire with high sensitivity and specificity for GAD) would have been eligible for the trial. Conclusions Our findings suggest that poor recruitment to RCTs can be significantly affected by participants’ treatment preferences and by factors influencing the recruiting clinicians. It may also be important not to include too many restrictions on inclusion criteria for pragmatic trials aiming for generalisable results. Trial registration ISCRTN14845583 . Registration date: 5 February 2015.

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A dynamic and collaborative approach to trial recruitment in safetxt, a UK sexual health randomised controlled trial

“…1 There are a large number of contextual factors that can influence participant recruitment including site characteristics and capability, topic, and patient population that make trials unique and may make it difficult to generalise strategies from published examples. [3][4][5][6] Furthermore some reports of recruitment strategies such as 'good engagement with sites' lack the detail or practical examples required for others to learn from and adapt the strategy for their own RCTs. Peckham et al 7 also note the CONSORT guidelines do not specify that recruitment strategy is shared in trial reports, meaning many successfully recruiting trials' strategies are not reported in a public domain, and other researchers cannot learn from examples of recruitment success.…”