NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.
Anzac Research Institute, and Andrology Department, Concord Hospital, Sydney, NSW, Australia.
Trials. 2019 Jun 19;20(1):366. doi: 10.1186/s13063-019-3485-2.
Effective interventions are required to prevent the current rapid increase in the prevalence of Type 2 diabetes. Clinical trials of large-scale interventions to prevent Type 2 diabetes are essential but recruitment is challenging and expensive, and there are limited data regarding the most cost-effective and efficient approaches to recruitment. This paper aims to evaluate the cost and effectiveness of a range of promotional strategies used to recruit men to a large Type 2 diabetes prevention trial.
An observational study was conducted nested within the Testosterone for the Prevention of Type 2 Diabetes (T4DM) study, a large, multi-centre randomised controlled trial (RCT) of testosterone treatment for the prevention of Type 2 diabetes in men aged 50-74 years at high risk of developing diabetes. Study participation was promoted via mainstream media-television, newspaper and radio; direct marketing using mass mail-outs, publicly displayed posters and attendance at local events; digital platforms, including Facebook and Google; and online promotions by community organisations and businesses. For each strategy, the resulting number of participants and the direct cost involved were recorded. The staff effort required for each strategy was estimated based on feedback from staff.
Of 19,022 men screened for the study, 1007 (5%) were enrolled. The most effective recruitment strategies were targeted radio advertising (accounting for 42% of participants), television news coverage (20%) and mass mail-outs (17%). Other strategies, including radio news, publicly displayed posters, attendance at local events, newspaper advertising, online promotions and Google and Facebook advertising, each accounted for no more than 4% of enrolled participants. Recruitment promotions cost an average of AU$594 per randomised participant. The most cost-effective paid strategy was mass mail-outs by a government health agency (AU$745 per participant). Other paid strategies were more expensive: mail-out by general practitioners (GPs) (AU$1104 per participant), radio advertising (AU$1081) and newspaper advertising (AU$1941).
Radio advertising, television news coverage and mass mail-outs by a government health agency were the most effective recruitment strategies. Close monitoring of recruitment outcomes and ongoing enhancement of recruitment activities played a central role in recruitment to this RCT.
ANZCTR, ID: ACTRN12612000287831 . Registered on 12 March 2012.
需要采取有效的干预措施来预防 2 型糖尿病患病率的快速增长。大规模预防 2 型糖尿病干预措施的临床试验至关重要,但招募工作具有挑战性且费用高昂,而且有关最具成本效益和效率的招募方法的数据有限。本文旨在评估一系列用于招募男性参加大型 2 型糖尿病预防试验的推广策略的成本和效果。
本研究是 Testosterone for the Prevention of Type 2 Diabetes(T4DM)研究的一项嵌套观察性研究,该研究是一项大型的多中心随机对照试验(RCT),旨在评估睾丸素治疗 50-74 岁、糖尿病风险较高的男性的 2 型糖尿病预防效果。该研究通过主流媒体(电视、报纸和广播);使用群发邮件、公开张贴海报和参加当地活动的大众营销;数字平台(包括 Facebook 和 Google);以及社区组织和企业的在线推广来推广研究参与。对于每种策略,都记录了参与者的数量和涉及的直接成本。根据工作人员的反馈,估算了每种策略所需的人员投入。
在接受研究筛查的 19022 名男性中,有 1007 名(5%)被纳入。最有效的招募策略是有针对性的广播广告(占参与者的 42%)、电视新闻报道(20%)和群发邮件(17%)。其他策略,包括广播新闻、公开张贴海报、参加当地活动、报纸广告、在线推广以及 Google 和 Facebook 广告,每个策略都不超过 4%的参与者。招募推广活动的平均费用为每位随机参与者 594 澳元。最具成本效益的付费策略是政府卫生机构的群发邮件(每位参与者 745 澳元)。其他付费策略的费用更高:全科医生(GP)的邮件(每位参与者 1104 澳元)、广播广告(每位参与者 1081 澳元)和报纸广告(每位参与者 1941 澳元)。
广播广告、电视新闻报道和政府卫生机构的群发邮件是最有效的招募策略。对招募结果的密切监测和对招募活动的持续改进在这项 RCT 的招募中发挥了核心作用。
ANZCTR,编号:ACTRN12612000287831。于 2012 年 3 月 12 日注册。