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Empowering clinical research in a decentralized world.在去中心化的世界中推动临床研究。
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The evolution of clinical trials in response to COVID-19.应对新冠疫情的临床试验的演变
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Threats of Bots and Other Bad Actors to Data Quality Following Research Participant Recruitment Through Social Media: Cross-Sectional Questionnaire.社交媒体招募研究参与者后对数据质量的机器人和其他不良行为者的威胁:横断面问卷调查。
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Online mindfulness-based intervention for women with pregnancy distress: design of a randomized controlled trial.在线正念干预对妊娠困扰妇女的影响:一项随机对照试验的设计。
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Indicators of retention in remote digital health studies: a cross-study evaluation of 100,000 participants.远程数字健康研究中的留存指标:对10万名参与者的跨研究评估
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Efficacy of Digital Cognitive Behavioral Therapy for the Treatment of Insomnia Symptoms Among Pregnant Women: A Randomized Clinical Trial.数字认知行为疗法治疗孕妇失眠症状的疗效:一项随机临床试验
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National Institutes of Health Support of Digital Health Behavior Research.美国国立卫生研究院对数字健康行为研究的支持。
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A Group-Based Online Intervention to Prevent Postpartum Depression (Sunnyside): Feasibility Randomized Controlled Trial.一项预防产后抑郁症的基于群组的在线干预措施(阳光计划):可行性随机对照试验
JMIR Ment Health. 2019 May 28;6(5):e10778. doi: 10.2196/10778.
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数字试验中招募和留住孕妇及产后人群的经验教训:观点

Lessons Learned Recruiting and Retaining Pregnant and Postpartum Individuals in Digital Trials: Viewpoint.

作者信息

Parks Amanda M, Duffecy Jennifer, McCabe Jennifer E, Blankstein Breman Rachel, Milgrom Jeannette, Hirshler Yafit, Gemmill Alan W, Segre Lisa S, Felder Jennifer N, Uscher-Pines Lori

机构信息

Department of Psychology, Virginia Commonwealth University, Richmond, VA, United States.

Department of Psychiatry, College of Medicine, University of Illinois at Chicago, Chicago, IL, United States.

出版信息

JMIR Pediatr Parent. 2022 Apr 20;5(2):e35320. doi: 10.2196/35320.

DOI:10.2196/35320
PMID:35107422
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9037306/
Abstract

In an increasingly connected world and in the midst of a global pandemic, digital trials offer numerous advantages over traditional trials that rely on physical study sites. Digital trials have the potential to improve access to research and clinical treatments for the most vulnerable and minoritized, including pregnant and postpartum individuals. However, digital trials are underutilized in maternal and child health research, and there is limited evidence to inform the design and conduct of digital trials. Our research collaborative, consisting of 5 research teams in the U.S. and Australia, aimed to address this gap. We collaborated to share lessons learned from our experiences recruiting and retaining pregnant and postpartum individuals in digital trials of social and behavioral interventions. We first discuss the promise of digital trials in improving participation in research during the perinatal period, as well as the unique challenges they pose. Second, we present lessons learned from 12 completed and ongoing digital trials that have used platforms such as Ovia, Facebook, and Instagram for recruitment. Our trials evaluated interventions for breastfeeding, prenatal and postpartum depression, insomnia, decision making, and chronic pain. We focus on challenges and lessons learned in 3 key areas: (1) rapid recruitment of large samples with a diversity of minoritized identities, (2) retention of study participants in longitudinal studies, and (3) prevention of fraudulent enrollment. We offer concrete strategies that we pilot-tested to address these challenges. Strategies presented in this commentary can be incorporated, as well as formally evaluated, in future studies.

摘要

在一个联系日益紧密的世界以及全球大流行的背景下,与依赖实体研究地点的传统试验相比,数字试验具有诸多优势。数字试验有可能改善最弱势群体和少数群体(包括孕妇和产后女性)参与研究及获得临床治疗的机会。然而,数字试验在母婴健康研究中的应用并不充分,且用于指导数字试验设计与实施的证据有限。我们由美国和澳大利亚的5个研究团队组成的研究合作项目旨在填补这一空白。我们合作分享在社会和行为干预数字试验中招募和留住孕妇及产后女性的经验教训。我们首先讨论数字试验在改善围产期研究参与度方面的前景,以及它们所带来的独特挑战。其次,我们介绍从12项已完成和正在进行的数字试验中吸取的经验教训,这些试验利用了Ovia、Facebook和Instagram等平台进行招募。我们的试验评估了针对母乳喂养、产前和产后抑郁、失眠、决策制定以及慢性疼痛的干预措施。我们关注在三个关键领域所面临的挑战和吸取的经验教训:(1)快速招募具有不同少数群体身份的大样本;(2)在纵向研究中留住研究参与者;(3)防止欺诈性入组。我们提供了为应对这些挑战而进行预测试的具体策略。本评论中提出的策略可在未来研究中加以采用并进行正式评估。