Department of Internal Medicine, The University of Texas Medical Branch at Galveston, Galveston, Texas, USA
Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.
BMJ Open. 2023 Oct 28;13(10):e077819. doi: 10.1136/bmjopen-2023-077819.
Recruitment for clinical studies is challenging. To overcome barriers, investigators have previously established call-to-entry rates to assist in planning. However, rates specific to low-income minority populations are needed to account for additional barriers to enrolment these individuals face.
To obtain a call-to-entry rate in a low-income uninsured Hispanic population with chronic disease.
We used data from four of our randomised clinical studies to determine the call-to-entry rate for individuals (n=1075) with or at risk for type 2 diabetes: participants needed/potential participants contacted=recruitment rate (yield). Research staff contacted potential participants to enrol in a study that evaluated 6 month diabetes programmes at community clinics from 2015 to 2020. We recorded call-to-entry rates, reasons for declining the study, show rates, and attrition.
The call-to-entry rate was 14.5%. Forty per cent of potential participants could not be contacted, and 30.6%, 19.1%, and 5.4% responded , , and , respectively. No show percentages were 54% for and 91.4% for responders. The majority (61.6%) declined due to inability to attend; reasons to decline included work (43%), eligibility (18%), transportation (10%), out of town (9%), did not think they needed the programme (7%) and other/unknown (14%). Being a physician predicted inability to reach participants (adjusted OR 2.91, 95% CI 1.73 to 4.90). Attrition was 6.8%.
We described a call-to-entry rate and detailed recruitment data, including reasons to decline the study. This valuable information can assist investigators in study planning and overcoming enrolment barriers in low-income populations. Telehealth-based or strategies that limit transportation needs may increase participant involvement.
NCT03394456.
临床研究的招募具有挑战性。为了克服障碍，研究人员之前已经建立了进入率来协助计划。然而，需要针对低收入少数族裔群体制定特定的进入率，以说明这些人在入组方面面临的额外障碍。
在患有慢性病的低收入、未参保的西班牙裔人群中获得进入率。
我们使用了来自我们四项随机临床试验的数据，以确定患有或有患 2 型糖尿病风险的个体（n=1075）的进入率：参与者需要/潜在参与者联系=招募率（收益率）。研究人员联系潜在参与者，邀请他们参加一项评估社区诊所 6 个月糖尿病项目的研究，研究时间为 2015 年至 2020 年。我们记录了进入率、拒绝研究的原因、展示率和流失率。
进入率为 14.5%。40%的潜在参与者无法联系，30.6%、19.1%和 5.4%分别回应了 、 、 。失访率分别为 54%和 91.4%。大多数（61.6%）拒绝是因为无法参加；拒绝的原因包括工作（43%）、资格（18%）、交通（10%）、不在当地（9%）、认为自己不需要该项目（7%）和其他/未知（14%）。是否为医生预测了无法联系到参与者（调整后的 OR 2.91，95%CI 1.73 至 4.90）。流失率为 6.8%。
我们描述了进入率和详细的招募数据，包括拒绝研究的原因。这些有价值的信息可以帮助研究人员进行研究计划，并克服低收入人群的入组障碍。基于远程医疗的或限制交通需求的策略可能会增加参与者的参与度。
NCT03394456。
