A high-volume, low-cost approach to participant screening and enrolment: Experiences from the T4DM diabetes prevention trial.
Background/aims: 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...
| Publicado en: | Clinical Trials Vol. 16; no. 6; pp. 589 - 599 |
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| Autores principales: | , , , , , , , , , , , , , , , |
| Formato: | pictorial research tables/charts Journal Article |
| Publicado: |
Sage Publications, Ltd.
Dec2019
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=140293281&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 140293281 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 17407745 AB6 jtl: Clinical Trials issn: 17407745 maglogo: N pubinfo: dt: Dec2019 vid: 16 iid: 6 pid: 33180 pub: Sage Publications, Ltd. place: <Blank> artinfo: ui: 140293281 140293281 140293281 10.1177/1740774519872999 140293281 ppf: 589 ppct: 10 formats: tig: atl: A high-volume, low-cost approach to participant screening and enrolment: Experiences from the T4DM diabetes prevention trial. aug: au: 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 affil: NHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australia sug: subj: Diabetes Mellitus, Type 2 Prevention and Control Testosterone Therapeutic Use Randomized Controlled Trials Research Subject Recruitment Methods Health Screening Methods Health Screening Economics Human Male Australia World Wide Web Laboratory Test Panels Data Collection Methods Eligibility Determination Automation Communication Database Management Software Cost Savings Male ab: Background/aims: 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. Methods: 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. Results: 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). Conclusion: 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. pubtype: Academic Journal doctype: pictorial research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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