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Title: A high-volume, low-cost approach to participant screening and enrolment: Experiences from the T4DM diabetes prevention trial.
Austin Authors: Bracken, Karen;Keech, Anthony;Hague, Wendy;Allan, Carolyn;Conway, Ann;Daniel, Mark;Gebski, Val;Grossmann, Mathis ;Handelsman, David J;Inder, Warrick J;Jenkins, Alicia;McLachlan, Robert;Robledo, Kristy P;Stuckey, Bronwyn;Yeap, Bu B;Wittert, Gary
Affiliation: University of Canberra, Canberra, ACT, Australia
Princess Alexandra Hospital and The University of Queensland, Brisbane, QLD, Australia
ANZAC Research Institute, University of Sydney, Concord Hospital, Sydney, NSW, Australia
University of Melbourne, Melbourne, Victoria, Australia
Freemasons Foundation Centre for Men's Health, Adelaide Medical School, The University of Adelaide, Adelaide, SA, Australia
Medical School, The University of Western Australia and Department of Endocrinology and Diabetes, Fiona Stanley Hospital, Perth, WA, Australia
Keogh Institute of Medical Research and The University of Western Australia, Perth, WA, Australia
NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia
Hudson Institute of Medical Research, Monash University, Melbourne, Victoria, Australia
Austin Health, Heidelberg, Victoria, Australia
Issue Date: Dec-2019 2019-10-03
Publication information: Clinical trials 2019; 16(6): 589-598
Abstract: Participant recruitment to diabetes prevention randomised controlled trials is challenging and expensive. The T4DM study, a multicentre, Australia-based, Phase IIIb randomised controlled trial of testosterone to prevent Type 2 diabetes in men aged 50-74 years, faced the challenge of screening a large number of prospective participants at a small number of sites, with few staff, and a limited budget for screening activities. This article evaluates a high-volume, low-cost, semi-automated approach to screen and enrol T4DM study participants. We developed a sequential multi-step screening process: (1) web-based pre-screening, (2) laboratory screening through a network of third-party pathology centres, and (3) final on-site screening, using online data collection, computer-driven eligibility checking, and automated, email-based communication with prospective participants. Phone- and mail-based data collection and communication options were available to participants at their request. The screening process was administered by the central coordinating centre through a central data management system. Screening activities required staffing of approximately 1.6 full-time equivalents over 4 years. Of 19,022 participants pre-screened, 13,108 attended a third-party pathology collection centre for laboratory screening, 1217 received final, on-site screening, and 1007 were randomised. In total, 95% of the participants opted for online pre-screening over phone-based pre-screening. Screening costs, including both direct and staffing costs, totalled AUD1,420,909 (AUD75 per subject screened and AUD1411 per randomised participant). A multi-step, semi-automated screening process with web-based pre-screening facilitated low-cost, high-volume participant enrolment to this large, multicentre randomised controlled trial. Centralisation and automation of screening activities resulted in substantial savings compared to previous, similar studies. Our screening approach could be adapted to other randomised controlled trial settings to minimise the cost of screening large numbers of participants.
DOI: 10.1177/1740774519872999
ORCID: 0000-0002-6085-445X
PubMed URL: 31581816
Type: Journal Article
Subjects: Randomised controlled trials
diabetes prevention
men’s health
participant recruitment
screening and enrolment
Appears in Collections:Journal articles

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