Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/21874
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dc.contributor.authorBracken, Karen-
dc.contributor.authorKeech, Anthony-
dc.contributor.authorHague, Wendy-
dc.contributor.authorAllan, Carolyn-
dc.contributor.authorConway, Ann-
dc.contributor.authorDaniel, Mark-
dc.contributor.authorGebski, Val-
dc.contributor.authorGrossmann, Mathis-
dc.contributor.authorHandelsman, David J-
dc.contributor.authorInder, Warrick J-
dc.contributor.authorJenkins, Alicia-
dc.contributor.authorMcLachlan, Robert-
dc.contributor.authorRobledo, Kristy P-
dc.contributor.authorStuckey, Bronwyn-
dc.contributor.authorYeap, Bu B-
dc.contributor.authorWittert, Gary-
dc.date2019-10-03-
dc.date.accessioned2019-10-07T21:40:27Z-
dc.date.available2019-10-07T21:40:27Z-
dc.date.issued2019-12-
dc.identifier.citationClinical Trials 2019; 16(6): 589-598en_US
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/21874-
dc.description.abstractParticipant 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.en_US
dc.language.isoeng-
dc.subjectRandomised controlled trialsen_US
dc.subjectcosten_US
dc.subjectdiabetes preventionen_US
dc.subjectmen’s healthen_US
dc.subjectparticipant recruitmenten_US
dc.subjectscreening and enrolmenten_US
dc.titleA high-volume, low-cost approach to participant screening and enrolment: Experiences from the T4DM diabetes prevention trial.en_US
dc.typeJournal Articleen_US
dc.identifier.journaltitleClinical Trials (London, England)en_US
dc.identifier.affiliationUniversity of Canberra, Canberra, ACT, Australiaen_US
dc.identifier.affiliationPrincess Alexandra Hospital and The University of Queensland, Brisbane, QLD, Australiaen_US
dc.identifier.affiliationANZAC Research Institute, University of Sydney, Concord Hospital, Sydney, NSW, Australiaen_US
dc.identifier.affiliationUniversity of Melbourne, Melbourne, Victoria, Australiaen_US
dc.identifier.affiliationFreemasons Foundation Centre for Men's Health, Adelaide Medical School, The University of Adelaide, Adelaide, SA, Australiaen_US
dc.identifier.affiliationMedical School, The University of Western Australia and Department of Endocrinology and Diabetes, Fiona Stanley Hospital, Perth, WA, Australiaen_US
dc.identifier.affiliationKeogh Institute of Medical Research and The University of Western Australia, Perth, WA, Australiaen_US
dc.identifier.affiliationNHMRC Clinical Trials Centre, The University of Sydney, Sydney, NSW, Australiaen_US
dc.identifier.affiliationHudson Institute of Medical Research, Monash University, Melbourne, Victoria, Australiaen_US
dc.identifier.affiliationAustin Healthen_US
dc.identifier.doi10.1177/1740774519872999en_US
dc.type.contentTexten_US
dc.identifier.orcid0000-0002-6085-445Xen_US
dc.identifier.pubmedid31581816-
dc.type.austinJournal Article-
local.name.researcherGrossmann, Mathis
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.languageiso639-1en-
item.openairetypeJournal Article-
crisitem.author.deptEndocrinology-
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