Mezlini Aziz M, Caddigan Eamon, Shapiro Allison, Ramirez Ernesto, Kondow-McConaghy Helena M, Yang Justin, DeMarco Kerry, Naraghi-Arani Pejman, Foschini Luca
Evidation Health, Inc., 63 Bovet Rd. #146, San Mateo, CA 94402, USA.
Oak Ridge Institute of Science and Education, 1299 Bethel Valley Rd, Oak Ridge, TN 37830, USA.
Contemp Clin Trials Commun. 2023 Jun;33:101113. doi: 10.1016/j.conctc.2023.101113. Epub 2023 Mar 11.
Studies for developing diagnostics and treatments for infectious diseases usually require observing the onset of infection during the study period. However, when the infection base rate incidence is low, the cohort size required to measure an effect becomes large, and recruitment becomes costly and prolonged. We developed a model for reducing recruiting time and resources in a COVID-19 detection study by targeting recruitment to high-risk individuals.
We conducted an observational longitudinal cohort study at individual sites throughout the U.S., enrolling adults who were members of an online health and research platform. Through direct and longitudinal connection with research participants, we applied machine learning techniques to compute individual risk scores from individually permissioned data about socioeconomic and behavioral data, in combination with predicted local prevalence data. The modeled risk scores were then used to target candidates for enrollment in a hypothetical COVID-19 detection study. The main outcome measure was the incidence rate of COVID-19 according to the risk model compared with incidence rates in actual vaccine trials.
When we used risk scores from 66,040 participants to recruit a balanced cohort of participants for a COVID-19 detection study, we obtained a 4- to 7-fold greater COVID-19 infection incidence rate compared with similar real-world study cohorts.
This risk model offers the possibility of reducing costs, increasing the power of analyses, and shortening study periods by targeting for recruitment participants at higher risk.
开发传染病诊断方法和治疗手段的研究通常需要在研究期间观察感染的发生情况。然而,当感染基线发病率较低时,为了测量某种效应所需的队列规模会变得很大,招募工作会变得成本高昂且耗时长久。我们开发了一种模型,通过将招募目标设定为高风险个体,来减少新冠病毒检测研究中的招募时间和资源。
我们在美国各地的各个研究点开展了一项观察性纵向队列研究,招募在线健康与研究平台的成年会员。通过与研究参与者进行直接和纵向联系,我们应用机器学习技术,根据有关社会经济和行为数据的个人授权数据以及预测的当地流行率数据来计算个体风险评分。然后,这些建模得出的风险评分被用于确定假设的新冠病毒检测研究的招募候选人。主要结局指标是根据风险模型得出的新冠病毒发病率,并与实际疫苗试验中的发病率进行比较。
当我们使用来自66,040名参与者的风险评分来为新冠病毒检测研究招募均衡的参与者队列时,与类似的真实世界研究队列相比,我们获得的新冠病毒感染发病率高出4至7倍。
这种风险模型提供了通过将招募目标设定为高风险参与者来降低成本、提高分析效能并缩短研究周期的可能性。