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. 2018 Mar:95:34-44.
doi: 10.1016/j.jclinepi.2017.11.015. Epub 2017 Nov 27.

Training health professionals to recruit into challenging randomized controlled trials improved confidence: the development of the QuinteT randomized controlled trial recruitment training intervention

Nicola Mills  1 , Daisy Gaunt  2 , Jane M Blazeby  2 , Daisy Elliott  2 , Samantha Husbands  2 , Peter Holding  3 , Leila Rooshenas  2 , Marcus Jepson  2 , Bridget Young  4 , Peter Bower  5 , Catrin Tudur Smith  6 , Carrol Gamble  6 , Jenny L Donovan  7
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Training health professionals to recruit into challenging randomized controlled trials improved confidence: the development of the QuinteT randomized controlled trial recruitment training intervention

Nicola Mills et al. J Clin Epidemiol. 2018 Mar.

Abstract

Objectives: The objective of this study was to describe and evaluate a training intervention for recruiting patients to randomized controlled trials (RCTs), particularly for those anticipated to be difficult for recruitment.

Study design and setting: One of three training workshops was offered to surgeons and one to research nurses. Self-confidence in recruitment was measured through questionnaires before and up to 3 months after training; perceived impact of training on practice was assessed after. Data were analyzed using two-sample t-tests and supplemented with findings from the content analysis of free-text comments.

Results: Sixty-seven surgeons and 32 nurses attended. Self-confidence scores for all 10 questions increased after training [range of mean scores before 5.1-6.9 and after 6.9-8.2 (scale 0-10, all 95% confidence intervals are above 0 and all P-values <0.05)]. Awareness of hidden challenges of recruitment following training was high-surgeons' mean score 8.8 [standard deviation (SD), 1.2] and nurses' 8.4 (SD, 1.3) (scale 0-10); 50% (19/38) of surgeons and 40% (10/25) of nurses reported on a 4-point Likert scale that training had made "a lot" of difference to their RCT discussions. Analysis of free text revealed this was mostly in relation to how to convey equipoise, explain randomization, and manage treatment preferences.

Conclusion: Surgeons and research nurses reported increased self-confidence in discussing RCTs with patients, a raised awareness of hidden challenges and a positive impact on recruitment practice following QuinteT RCT Recruitment Training. Training will be made more available and evaluated in relation to recruitment rates and informed consent.

Keywords: Equipoise; Patient treatment preference; Professional education; Randomized controlled trial; Recruitment to randomized controlled trials; Training health professionals.

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Fig. 1
Fig. 1
Content of the workshops. aCovered in greater depth with surgeons; bCovered in greater depth with research nurses. RCT, randomized controlled trial.
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