Optimising recruitment to the HAND-1 RCT feasibility study: integration of the QuinteT Recruitment Intervention (QRI)

Pilot and Feasibility Studies

Samantha Husbands¹  Nicola Mills²  William Hollingworth²  Jane M. Blazeby²  Daisy Elliott²  Alexia Karantana³  Alan A. Montgomery⁴  Eleanor F. Harrison⁴  Lelia Duley⁴  Kirsty Sprange⁴  Tim R. C. Davis⁵ 

[1] Bristol Medical School, University of Bristol, 1-5 Whiteladies Road, BS8 1NU, Bristol, UK;Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, BS8 2PS, Bristol, UK;Department of Academic Orthopaedics, Trauma and Sports Medicine, School of Medicine, University of Nottingham, NG7 2UH, Nottingham, UK;Nottingham Clinical Trials Unit, University of Nottingham, University Park, NG7 2RD, Nottingham, UK;Nottingham University Hospitals NHS Trust, Queen’s Medical Centre, Derby Road, NG7 2UH, Nottingham, UK;

关键词: Feasibility study;    Randomised controlled trial;    Surgical randomised controlled trial;    Recruitment;    Recruitment obstacles;    Recruitment intervention;    Informed consent;    Qualitative;    Equipoise;   

DOI  :  10.1186/s40814-020-00710-1

来源: Springer

【 摘 要 】

BackgroundRecruitment to randomised controlled trials (RCTs) can be challenging, with most trials not reaching recruitment targets. Randomised feasibility studies can be set up prior to a main trial to identify and overcome recruitment obstacles. This paper reports on an intervention—the QuinteT Recruitment Intervention (QRI)—to optimise recruitment within a randomised feasibility study of surgical treatments for patients with Dupuytren’s contracture (the HAND-1 study).MethodsThe QRI was introduced in 2-phases: phase 1 sought to understand the recruitment challenges by interviewing trial staff, scrutinising screening logs and analysing audio-recorded patient consultations; in phase 2 a tailored plan of action consisting of recruiter feedback and training was delivered to address the identified challenges.ResultsTwo key recruitment obstacles emerged: (1) issues with the recruitment pathway, in particular methods to identify potentially eligible patients and (2) equipoise of recruiters and patients. These were addressed by liaising with centres to share good practice and refine their pathway and by providing bespoke feedback and training on consent discussions to individual recruiters and centres whilst recruitment was ongoing. The HAND-1 study subsequently achieved its recruitment target.ConclusionsTransferable lessons learnt from the QRI in the feasibility study will be implemented in the definitive RCT, enabling a “head start” in the tackling of wider issues around screening methods and consent discussions in the set up/early recruitment study phases, with ongoing QRI addressing specific issues with new centres and recruiters. Findings from this study are likely to be relevant to other surgical and similar trials that are anticipated to encounter issues around patient and recruiter equipoise of treatments and variation in recruitment pathways across centres. The study also highlights the value of feasibility studies in fine-tuning design and conduct issues for definitive RCTs. Embedding a QRI in an RCT, at feasibility or main stage, offers an opportunity for a detailed and nuanced understanding of key recruitment challenges and the chance to address them in “real-time” as recruitment proceeds.

【 授权许可】

CC BY