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Publication - Professor Jenny Donovan

    Enabling recruitment success in bariatric surgical trials

    pilot phase of the By-Band-Sleeve study

    Citation

    Paramasivan, S, Rogers, C, Welbourn, R, Byrne, JP, Salter, N, Mahon, D, Noble, H, Kelly, J, Mazza, G, Whybrow, P, Andrews, R, Wilson, C, Blazeby, J & Donovan, J, 2017, ‘Enabling recruitment success in bariatric surgical trials: pilot phase of the By-Band-Sleeve study’. International Journal of Obesity, vol 2017., pp. 1654?1661

    Abstract

    BACKGROUND:
    Randomized controlled trials (RCTs) involving surgical procedures are challenging for recruitment and infrequent in the specialty of bariatrics. The pilot phase of the By-Band-Sleeve study (gastric bypass versus gastric band versus sleeve gastrectomy) provided the opportunity for an investigation of recruitment using a QuinteT Recruitment Intervention (QRI).
    PATIENTS/METHODS:
    The QRI investigated recruitment in two centers in the pilot phase comparing bypass and banding, through the analysis of 12 in-depth staff interviews, 84 audio-recordings of patient consultations, 19 non-participant observations of consultations and patient screening data. QRI findings were developed into a plan of action and fed back to centers to improve information provision and recruitment organization.
    RESULTS:
    Recruitment proved to be extremely difficult with only two patients recruited during the first two months. The pivotal issue in Center A was that an effective and established clinical service could not easily adapt to the needs of the RCT. There was little scope to present RCT details or ensure efficient eligibility assessment, and recruiters struggled to convey equipoise. Following presentation of QRI findings, recruitment in Center A increased from 9% in the first two months (2/22) to 40% (26/65) in the four months thereafter. Center B, commencing recruitment three months after Center A, learnt from the emerging issues in Center A and set up a special clinic for trial recruitment. The trial successfully completed pilot recruitment and progressed to the main phase across 11 centers.
    CONCLUSIONS:
    The QRI identified key issues that enabled the integration of the trial into the clinical setting. This contributed to successful recruitment in the By-Band-Sleeve trial-currently the largest in bariatric practice-and offers opportunities to optimize recruitment in other trials in bariatrics.International Journal of Obesity accepted article preview online, 03 July 2017. doi:10.1038/ijo.2017.153.

    Full details in the University publications repository