Monash University, Melbourne, VIC.
College of Health and Medicine, Australian National University School of Clinical Medicine, Canberra, ACT.
Med J Aust. 2019 Mar;210(4):168-173. doi: 10.5694/mja2.12060. Epub 2018 Dec 21.
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.
Enrolment of GPs; 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).
Numbers of patients per GP screened and randomised to participation; geographic and demographic factors that influenced screening and randomising of patients.
2717 of 5833 GPs 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. GPs 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 GPs in major cities to recruit at least one randomised participant. GPs 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.
General practice can be a rich environment for research when barriers to recruitment are overcome. Including regional GPs 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 GPs.
评估促成澳大利亚有史以来最大规模临床试验（阿司匹林减少老年人事件研究，简称 ASPREE）招募成功的因素。
全科医生的招募；在全科医生数据库中确定潜在参与者；筛选参与者。
地点、参与者：澳大利亚东南部的选定全科医生（塔斯马尼亚州、维多利亚州、澳大利亚首都直辖区、新南威尔士州、南澳大利亚州）。
每位全科医生筛查和随机分配参与的患者人数；影响患者筛查和随机分配的地理和人口统计学因素。
在 5833 名接触到的全科医生中，有 2717 名（47%）参与招募患者参加研究；2053 名（76%）招募了至少一名随机参与者。每位全科医生随机参与者比例最高的是塔斯马尼亚州（中位数为 5；IQR，1-11），这是因为电话筛查的参与者纳入率高。与大城市的全科医生相比，位于内陆地区（调整后的优势比 [aOR]，1.45；95%置信区间 [CI]，1.14-1.84）和偏远地区（aOR，1.86；95%CI，1.19-2.88）的全科医生更有可能招募至少一名随机参与者。在 70 岁或以上人口比例较高的地区，全科医生更有可能随机分配至少一名参与者（每增加一个百分点：aOR，1.10；95%CI，1.05-1.15）。从全科医生招募到第一次随机分配的时间推移，随机患者数量减少。
当克服招募障碍时，全科医疗可以成为研究的丰富环境。包括地区全科医生并在潜在合格参与者比例最高的地区集中精力，可以提高招募率。ASPREE 的成功证明了其研究问题对澳大利亚全科医生的临床重要性。
