Yost Kathleen J, Carlson Rachel E, Kirt Christine R, Kirsch Emily J, Kneedler Bonny, Laffin Jennifer J, St Sauver Jennifer L, Finney Rutten Lila J, Grimm Jessica A, Olson Janet E
Department of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota, USA
Department of Quantitative Health Sciences, Mayo Clinic, Rochester, Minnesota, USA.
BMJ Open Gastroenterol. 2024 Jul 17;11(1):e001376. doi: 10.1136/bmjgast-2024-001376.
To identify the optimal incentive protocol for maximising participation while managing study costs during the Voyage trial.
Prospective cohort (Voyage trial) of colorectal cancer (CRC) incidence and mortality outcomes in individuals screened with multitarget stool DNA (mt-sDNA) served as the population. A subset was randomised to receive postage stamps as a pre-consent incentive, or as a post-consent incentive after completion of the consent and questionnaire. Descriptive statistics from year 1 are reported.
During year 1 of the Voyage trial, a total of 600 258 individuals with mt-sDNA orders received at Exact Sciences Laboratories were randomly selected and invited to participate. Of those, 26 429 (4.4%) opted in, 14 365 of whom (54.3%) consented. The opt-in and consent samples were similar to the target population with respect to sex but differed by geographic residence and age (p<0.001). For the embedded incentive experiment, 2333 were randomised to the pre-incentive arm, while 2342 were randomised to the post-incentive arm. Overall consent rate in the incentive trial was 56.4% (60.9% for the pre-consent incentive arm (1421/2333) vs 52.0% for the post-consent incentive arm (1217/2342), p<0.001). Cost reduction was observed for the pre-consent incentive group, and higher response rates were seen among older versus younger individuals.
Pre-consent incentive option was associated with a higher participation rate and lower costs and was used for the remainder of study recruitment. CRC incidence and mortality vary with age; thus, adjusting for differential participation by age and region will be important in analyses of Voyage data.
NCT04124406.
在“航行”试验中确定在控制研究成本的同时使参与度最大化的最佳激励方案。
以接受多靶点粪便DNA(mt-sDNA)筛查的个体的结直肠癌(CRC)发病率和死亡率结果的前瞻性队列(“航行”试验)作为研究人群。一个亚组被随机分配接受邮票作为同意前激励,或在完成同意书和问卷后作为同意后激励。报告了第1年的描述性统计数据。
在“航行”试验的第1年,共有600258名在Exact Sciences实验室接受mt-sDNA检测的个体被随机挑选并邀请参与。其中,26429人(4.4%)选择参与,其中14365人(54.3%)同意参与。选择参与和同意参与的样本在性别方面与目标人群相似,但在地理居住和年龄方面存在差异(p<0.001)。对于嵌入式激励实验,2333人被随机分配到激励前组,而2342人被随机分配到激励后组。激励试验中的总体同意率为56.4%(同意前激励组为60.9%(1421/2333),同意后激励组为52.0%(1217/2342),p<0.001)。同意前激励组的成本有所降低,且老年人的反应率高于年轻人。
同意前激励方案与更高的参与率和更低的成本相关,并被用于研究招募的剩余部分。结直肠癌的发病率和死亡率随年龄而异;因此,在分析“航行”数据时,对年龄和地区的不同参与情况进行调整将很重要。
NCT04124406。