Premium
Recruiting general practice patients for large clinical trials: lessons from the Aspirin in Reducing Events in the Elderly ( ASPREE ) study
Author(s) -
Lockery Jessica E,
Collyer Taya A,
Abhayaratna Walter P,
Fitzgerald Sharyn M,
McNeil John J,
Nelson Mark R,
Orchard Suzanne G,
Reid Christopher,
Stocks Nigel P,
Trevaks Ruth E,
Woods Robyn
Publication year - 2019
Publication title -
medical journal of australia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 131
eISSN - 1326-5377
pISSN - 0025-729X
DOI - 10.5694/mja2.12060
Subject(s) - medicine , odds ratio , clinical trial , family medicine , phone , general practice , demography , sociology , philosophy , linguistics
Objective To assess the factors that contributed to the successful completion of recruitment for the largest clinical trial ever conducted in Australia, the Aspirin in Reducing Events in the Elderly ( ASPREE ) study. Design Enrolment of GP s; identification of potential participants in general practice databases; screening of participants. Setting, participants Selected general practices across southeast Australia (Tasmania, Victoria, Australian Capital Territory, New South Wales, South Australia). Major outcomes Numbers of patients per GP screened and randomised to participation; geographic and demographic factors that influenced screening and randomising of patients. Results 2717 of 5833 GP s approached (47%) enrolled to recruit patients for the study; 2053 (76%) recruited at least one randomised participant. The highest randomised participant rate per GP was for Tasmania (median, 5; IQR , 1–11), driven by the high rate of participant inclusion at phone screening. GP s in inner regional (adjusted odds ratio [ aOR ], 1.45; 95% CI , 1.14–1.84) and outer regional areas ( aOR , 1.86; 95% CI , 1.19–2.88) were more likely than GP s in major cities to recruit at least one randomised participant. GP s in areas with a high proportion of people aged 70 years or more were more likely to randomise at least one participant (per percentage point increase: aOR , 1.10; 95% CI , 1.05–1.15). The number of randomised patients declined with time from GP enrolment to first randomisation. Conclusion General practice can be a rich environment for research when barriers to recruitment are overcome. Including regional GP s and focusing efforts in areas with the highest proportions of potentially eligible participants improves recruitment. The success of ASPREE attests to the clinical importance of its research question for Australian GP s.