TY - JOUR
T1 - A high-volume, low-cost approach to participant screening and enrolment
T2 - Experiences from the T4DM diabetes prevention trial
AU - Bracken, Karen
AU - Keech, Anthony
AU - Hague, Wendy
AU - Allan, Carolyn
AU - Conway, Ann
AU - Daniel, Mark
AU - Gebski, Val
AU - Grossmann, Mathis
AU - Handelsman, David J.
AU - Inder, Warrick J.
AU - Jenkins, Alicia
AU - McLachlan, Robert
AU - Robledo, Kristy P.
AU - Stuckey, Bronwyn
AU - Yeap, Bu B.
AU - Wittert, Gary
N1 - Funding Information:
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. Randomised controlled trials participant recruitment diabetes prevention men’s health screening and enrolment cost National Health and Medical Research Council https://doi.org/10.13039/501100000925 030123 Bayer https://doi.org/10.13039/100004326 Eli Lilly and Company https://doi.org/10.13039/100004312 edited-state corrected-proof We thank the coordinating centre team: Caitlin Van Holst Pellekaan and Sandra Healey (NHMRC Clinical Trials Centre); the T4DM study nurses: Glenda Fraser (ANZAC Research Institute and Concord Hospital), Jenny Healy (Austin Hospital), Helen Daniels and Chyn Soh (Fremantle Hospital and Fiona Stanley Hospital), Jody Sawyer (Princess Alexandra Hospital), Rosemary Cox and Fiona Cossey (The Queen Elizabeth Hospital), and Lee Mahoney (The Keogh Institute for Medical Research); Sherilyn Goldstone for her assistance with the preparation of this manuscript; and the T4DM study participants. Author contributions G.W., C.A., A.C., M.D., V.G., M.G., W.H., D.J.H., W.J.I., A.J., A.K., R.M., B.S., and B.B.Y. conceived the T4DM study. G.W., W.H., and A.K. conceived the screening process. K.B., with input and oversight from G.W., C.A., A.C., M.D., V.G., M.G., W.H., D.J.H., W.J.I., A.J., A.K., R.M., K.P.R., B.S., and B.B.Y., specified, implemented, and managed the screening process. K.B. collected the data. K.B. and K.P.R. analysed the data. K.B., G.W., W.H., and K.P.R. interpreted the data. K.B. wrote the first draft of the manuscript. K.B., G.W., C.A., A.C., M.D., V.G., M.G., W.H., D.J.H., W.J.I., A.J., A.K., R.M., K.P.R., B.S., and B.B.Y. revised and approved the manuscript. Declaration of conflicting interests G.W. has received research funding from Bayer, Lilly, Lawley Pharmaceuticals, and Weight Watchers and speaker honoraria from Bayer, Lilly, and Besins Health Care. C.A. has received honoraria from Besins Health Care and is an advisory board member for Ferring. M.G. has received research funding from Bayer, Novartis, Weight Watchers, and Lilly and speaker’s honoraria from Besins Healthcare and Otsuka. D.J.H. has received institutional grants for investigator-initiated studies of testosterone pharmacology (Lawley, Besins Healthcare) but no personal income, and has provided expert testimony to anti-doping and professional standards tribunals and testosterone litigation. B.B.Y. has received speaker honoraria and conference support from Bayer, Lilly, and Besins Healthcare, research support from Bayer, Lilly, and Lawley Pharmaceuticals, and has been a member of advisory committees for Lilly, Besins, and Ferring. B.S. has received speaker honoraria from Besins. A.K. has received honoraria from Amgen, Novartis, Mylan, Pfizer, Sanofi, and Bayer. K.B., A.C., M.D., W.H., V.G., W.J.I., A.J., R.M., and K.P.R. declare no relevant conflicts of interest. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported through National Health and Medical Research Council (NHMRC) Project Grant (No. 030123), Bayer, Lilly, and University of Adelaide. Weight Watchers provided enrolment to their programme for trial participants without cost. K.B. was supported by a postgraduate scholarship from the NHMRC Clinical Trials Centre, University of Sydney. ORCID iD Karen Bracken https://orcid.org/0000-0002-6085-445X Trial registration This study was registered under trial ID ACTRN12612 000287831. Supplemental material Supplemental material for this article is available online.
Funding Information:
We thank the coordinating centre team: Caitlin Van Holst Pellekaan and Sandra Healey (NHMRC Clinical Trials Centre); the T4DM study nurses: Glenda Fraser (ANZAC Research Institute and Concord Hospital), Jenny Healy (Austin Hospital), Helen Daniels and Chyn Soh (Fremantle Hospital and Fiona Stanley Hospital), Jody Sawyer (Princess Alexandra Hospital), Rosemary Cox and Fiona Cossey (The Queen Elizabeth Hospital), and Lee Mahoney (The Keogh Institute for Medical Research); Sherilyn Goldstone for her assistance with the preparation of this manuscript; and the T4DM study participants. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported through National Health and Medical Research Council (NHMRC) Project Grant (No. 030123), Bayer, Lilly, and University of Adelaide. Weight Watchers provided enrolment to their programme for trial participants without cost. K.B. was supported by a postgraduate scholarship from the NHMRC Clinical Trials Centre, University of Sydney.
Publisher Copyright:
© The Author(s) 2019.
PY - 2019/12
Y1 - 2019/12
N2 - 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.
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.
KW - cost
KW - diabetes prevention
KW - men’s health
KW - participant recruitment
KW - Randomised controlled trials
KW - screening and enrolment
KW - men's health
KW - Diabetes Mellitus, Type 2/prevention & control
KW - Humans
KW - Middle Aged
KW - Male
KW - Patient Selection
KW - Clinical Trials, Phase III as Topic
KW - Multicenter Studies as Topic
KW - Cost-Benefit Analysis
KW - Aged
KW - Electronic Mail
KW - Internet
KW - Australia
KW - Randomized Controlled Trials as Topic/economics
KW - Research Design
UR - http://www.scopus.com/inward/record.url?scp=85074556228&partnerID=8YFLogxK
UR - http://www.mendeley.com/research/highvolume-lowcost-approach-participant-screening-enrolment-experiences-t4dm-diabetes-prevention-tri
U2 - 10.1177/1740774519872999
DO - 10.1177/1740774519872999
M3 - Article
C2 - 31581816
AN - SCOPUS:85074556228
SN - 1740-7745
VL - 16
SP - 589
EP - 598
JO - Clinical Trials
JF - Clinical Trials
IS - 6
ER -