PDF(Pubmed)
Abstract：
BACKGROUND: Early identification of an acute respiratory infection is important for reducing transmission and enabling earlier therapeutic intervention. We aimed to prospectively evaluate the feasibility of home-based diagnostic self-testing of viral pathogens in individuals prompted to do so on the basis of self-reported symptoms or individual changes in physiological parameters detected via a wearable sensor.
METHODS: DETECT-AHEAD was a prospective, decentralised, randomised controlled trial carried out in a subpopulation of an existing cohort (DETECT) of individuals enrolled in a digital-only observational study in the USA. Participants aged 18 years or older were randomly assigned (1:1:1) with a block randomisation scheme stratified by under-represented in biomedical research status. All participants were offered a wearable sensor (Fitbit Sense smartwatch). Participants in groups 1 and 2 received an at-home self-test kit (Alveo be.well) for two acute respiratory viral pathogens: SARS-CoV-2 and respiratory syncytial virus. Participants in group 1 could be alerted through the DETECT study app to take the at-home test on the basis of changes in their physiological data (as detected by our algorithm) or due to self-reported symptoms; those in group 2 were prompted via the app to self-test only due to symptoms. Group 3 served as the control group, without alerts or home testing capability. The primary endpoints, assessed on an intention-to-treat basis, were the number of acute respiratory infections presented (self-reported) and diagnosed (electronic health record), and the number of participants using at-home testing in groups 1 and 2. This trial is registered with ClinicalTrials.gov, NCT04336020.
RESULTS: Between Sept 28 and Dec 30, 2021, 450 participants were recruited and randomly assigned to group 1 (n=149), group 2 (n=151), or group 3 (n=150). 179 (40%) participants were male, 264 (59%) were female, and seven (2%) identified as other. 232 (52%) were from populations historically under-represented in biomedical research. 118 (39%) of the 300 participants in groups 1 and 2 were prompted to self-test, with 61 (52%) successfully completing self-testing. Participants were prompted to home-test more frequently due to symptoms (41 [28%] in group 1 and 51 [34%] in group 2) than due to detected physiological changes (26 [17%] in group 1). Significantly more participants in group 1 received alerts to test than did those in group 2 (67 [45%] vs 51 [34%]; p=0·047). Of the 61 individuals who were prompted to test and successfully did so, 19 (31%) tested positive for a viral pathogen-all for SARS-CoV-2. The individuals diagnosed as positive for SARS-CoV-2 in the electronic health record were eight (5%) in group 1, four (3%) in group 2, and two (1%) in group 3, but it was difficult to confirm if they were tied to symptomatic episodes documented in the trial. There were no adverse events.
CONCLUSIONS: In this direct-to-participant trial, we showed early feasibility of a decentralised programme to prompt individuals to use a viral pathogen diagnostic test based on symptoms tracked in the study app or physiological changes detected using a wearable sensor. Barriers to adequate participation and performance were also identified, which would need to be addressed before large-scale implementation.
BACKGROUND: Janssen Pharmaceuticals.
METHODS: DETECT-AHEAD was a prospective, decentralised, randomised controlled trial carried out in a subpopulation of an existing cohort (DETECT) of individuals enrolled in a digital-only observational study in the USA. Participants aged 18 years or older were randomly assigned (1:1:1) with a block randomisation scheme stratified by under-represented in biomedical research status. All participants were offered a wearable sensor (Fitbit Sense smartwatch). Participants in groups 1 and 2 received an at-home self-test kit (Alveo be.well) for two acute respiratory viral pathogens: SARS-CoV-2 and respiratory syncytial virus. Participants in group 1 could be alerted through the DETECT study app to take the at-home test on the basis of changes in their physiological data (as detected by our algorithm) or due to self-reported symptoms; those in group 2 were prompted via the app to self-test only due to symptoms. Group 3 served as the control group, without alerts or home testing capability. The primary endpoints, assessed on an intention-to-treat basis, were the number of acute respiratory infections presented (self-reported) and diagnosed (electronic health record), and the number of participants using at-home testing in groups 1 and 2. This trial is registered with ClinicalTrials.gov, NCT04336020.
RESULTS: Between Sept 28 and Dec 30, 2021, 450 participants were recruited and randomly assigned to group 1 (n=149), group 2 (n=151), or group 3 (n=150). 179 (40%) participants were male, 264 (59%) were female, and seven (2%) identified as other. 232 (52%) were from populations historically under-represented in biomedical research. 118 (39%) of the 300 participants in groups 1 and 2 were prompted to self-test, with 61 (52%) successfully completing self-testing. Participants were prompted to home-test more frequently due to symptoms (41 [28%] in group 1 and 51 [34%] in group 2) than due to detected physiological changes (26 [17%] in group 1). Significantly more participants in group 1 received alerts to test than did those in group 2 (67 [45%] vs 51 [34%]; p=0·047). Of the 61 individuals who were prompted to test and successfully did so, 19 (31%) tested positive for a viral pathogen-all for SARS-CoV-2. The individuals diagnosed as positive for SARS-CoV-2 in the electronic health record were eight (5%) in group 1, four (3%) in group 2, and two (1%) in group 3, but it was difficult to confirm if they were tied to symptomatic episodes documented in the trial. There were no adverse events.
CONCLUSIONS: In this direct-to-participant trial, we showed early feasibility of a decentralised programme to prompt individuals to use a viral pathogen diagnostic test based on symptoms tracked in the study app or physiological changes detected using a wearable sensor. Barriers to adequate participation and performance were also identified, which would need to be addressed before large-scale implementation.
BACKGROUND: Janssen Pharmaceuticals.
摘要：
背景：急性呼吸道感染的早期识别对于减少传播和实现早期治疗干预是重要的。我们旨在前瞻性评估基于自我报告的症状或通过可穿戴传感器检测到的生理参数的个体变化的基础上，对病毒病原体进行家庭诊断自检的可行性。
方法：DETECT-AHEAD是前瞻性的，去中心化,在美国一项仅数字观察性研究中纳入的现有队列(DETECT)个体的一个亚群中进行了随机对照试验.年龄在18岁或以上的参与者被随机分配（1：1：1），并通过在生物医学研究状态中代表性不足进行分层。所有参与者都获得了可穿戴传感器（FitbitSense智能手表）。第1组和第2组的参与者接受了在家自检工具包（Alveobe。良好）两种急性呼吸道病毒病原体：SARS-CoV-2和呼吸道合胞病毒。可以通过DETECT研究应用程序提醒第1组的参与者根据其生理数据的变化（通过我们的算法检测到）或由于自我报告的症状而进行在家测试；第2组的参与者仅由于症状而通过应用程序被提示进行自我测试。第3组作为对照组,没有警报或家庭测试能力。主要终点,在意向治疗的基础上评估，急性呼吸道感染的数量（自我报告）和诊断（电子健康记录），以及第1组和第2组中使用在家测试的参与者数量。该试验已在ClinicalTrials.gov注册，NCT04336020。
结果：在2021年9月28日至12月30日之间，招募了450名参与者，并随机分配到第1组（n=149）。第2组（n=151），或组3（n=150）。179名（40%）参与者为男性，264（59%）为女性，七个（2％）被确定为其他。232人(52%)来自生物医学研究中历史上代表性不足的人群。第1组和第2组的300名参与者中有118名（39%）被提示进行自我测试，61人（52%）成功完成自检。由于症状（第1组41[28％]和第2组51[34％]），参与者被提示更频繁地进行家庭测试，而不是由于检测到的生理变化（第1组26[17％]）。与第2组相比，第1组收到警报的参与者明显更多（67[45％]vs51[34％]；p=0·047）。在被提示测试并成功测试的61个人中，19（31％）的病毒病原体检测呈阳性，全部为SARS-CoV-2。在电子健康记录中被诊断为SARS-CoV-2阳性的个体在第1组中为8（5％），在第2组中为4（3％），在第3组中为2（1％），但是很难确认他们是否与试验中记录的症状发作有关。无不良事件发生。
结论：在这项直接参与者试验中，我们早期证明了分散式程序的可行性,根据研究app中追踪的症状或使用可穿戴传感器检测到的生理变化,提示个体使用病毒病原体诊断测试.还确定了充分参与和绩效的障碍，在大规模实施之前需要解决这个问题。
背景：扬森制药。
方法：DETECT-AHEAD是前瞻性的，去中心化,在美国一项仅数字观察性研究中纳入的现有队列(DETECT)个体的一个亚群中进行了随机对照试验.年龄在18岁或以上的参与者被随机分配（1：1：1），并通过在生物医学研究状态中代表性不足进行分层。所有参与者都获得了可穿戴传感器（FitbitSense智能手表）。第1组和第2组的参与者接受了在家自检工具包（Alveobe。良好）两种急性呼吸道病毒病原体：SARS-CoV-2和呼吸道合胞病毒。可以通过DETECT研究应用程序提醒第1组的参与者根据其生理数据的变化（通过我们的算法检测到）或由于自我报告的症状而进行在家测试；第2组的参与者仅由于症状而通过应用程序被提示进行自我测试。第3组作为对照组,没有警报或家庭测试能力。主要终点,在意向治疗的基础上评估，急性呼吸道感染的数量（自我报告）和诊断（电子健康记录），以及第1组和第2组中使用在家测试的参与者数量。该试验已在ClinicalTrials.gov注册，NCT04336020。
结果：在2021年9月28日至12月30日之间，招募了450名参与者，并随机分配到第1组（n=149）。第2组（n=151），或组3（n=150）。179名（40%）参与者为男性，264（59%）为女性，七个（2％）被确定为其他。232人(52%)来自生物医学研究中历史上代表性不足的人群。第1组和第2组的300名参与者中有118名（39%）被提示进行自我测试，61人（52%）成功完成自检。由于症状（第1组41[28％]和第2组51[34％]），参与者被提示更频繁地进行家庭测试，而不是由于检测到的生理变化（第1组26[17％]）。与第2组相比，第1组收到警报的参与者明显更多（67[45％]vs51[34％]；p=0·047）。在被提示测试并成功测试的61个人中，19（31％）的病毒病原体检测呈阳性，全部为SARS-CoV-2。在电子健康记录中被诊断为SARS-CoV-2阳性的个体在第1组中为8（5％），在第2组中为4（3％），在第3组中为2（1％），但是很难确认他们是否与试验中记录的症状发作有关。无不良事件发生。
结论：在这项直接参与者试验中，我们早期证明了分散式程序的可行性,根据研究app中追踪的症状或使用可穿戴传感器检测到的生理变化,提示个体使用病毒病原体诊断测试.还确定了充分参与和绩效的障碍，在大规模实施之前需要解决这个问题。
背景：扬森制药。
