Use of research electronic data capture (REDCap) in a COVID-19 randomized controlled trial: a practical example.
Use of research electronic data capture (REDCap) in a COVID-19 randomized controlled trial: a practical example.
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新冠肺炎随机对照试验中研究电子数据采集的使用：一个实际例子。
DOI：
10.1186/s12874-021-01362-2
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发表时间：
2021-08-21
影响因子：
4
通讯作者：
Rosenberg M
中科院分区：
文献类型：
--
作者：
Kianersi S;Luetke M;Ludema C;Valenzuela A;Rosenberg M
随机对照试验（RCT）被认为是评价干预措施疗效的理想设计。然而，成功开展随机对照试验存在技术和后勤挑战。随机化过程中的缺陷（例如，分配序列隐藏）和有缺陷的掩蔽可能会使RCT的发现产生偏差。此外，研究者需要解决所有研究设计中常见的其他后勤问题，例如研究邀请、资格筛选、知情同意程序和数据保密协议。Research Electronic Data Capture（REDCap）是一个安全的、基于浏览器的Web应用程序，被研究人员广泛用于调查数据收集。REDCap提供了独特的功能，可用于进行严格的RCT。2020年9月和11月，我们在印第安纳州大学布卢明顿（IUB）本科生中进行了一项平行组RCT，以了解收到SARS-CoV-2抗体检测结果是否改变了学生自我报告的2019冠状病毒病（COVID-19）保护行为。在本报告中，我们讨论了我们如何使用REDCap进行本RCT的不同组成部分。我们进一步分享我们的REDCap项目XML文件和教学视频，研究者可以在设计和进行RCT时使用。我们报告了REDCap为完成大型RCT的各个部分提供的不同功能，包括发送研究邀请和招募、资格筛选、知情同意程序、实验室访视预约和提醒、数据收集和保密、随机化、治疗组分配设盲、返回测试结果和随访调查。REDCap为纵向数据收集和进行严格和成功的RCT提供了强大的工具。研究者可以利用该电子数据采集系统成功完成RCT。RCT前瞻性（在完成数据收集之前）在ClinicalTrials.gov注册;注册号：NCT 04620798，注册日期：2020年11月9日。在线版本包含补充材料，可通过10.1186/s12874-021-01362-2获得。
Randomized controlled trials (RCT) are considered the ideal design for evaluating the efficacy of interventions. However, conducting a successful RCT has technological and logistical challenges. Defects in randomization processes (e.g., allocation sequence concealment) and flawed masking could bias an RCT’s findings. Moreover, investigators need to address other logistics common to all study designs, such as study invitations, eligibility screening, consenting procedure, and data confidentiality protocols. Research Electronic Data Capture (REDCap) is a secure, browser-based web application widely used by researchers for survey data collection. REDCap offers unique features that can be used to conduct rigorous RCTs. In September and November 2020, we conducted a parallel group RCT among Indiana University Bloomington (IUB) undergraduate students to understand if receiving the results of a SARS-CoV-2 antibody test changed the students’ self-reported protective behavior against coronavirus disease 2019 (COVID-19). In the current report, we discuss how we used REDCap to conduct the different components of this RCT. We further share our REDCap project XML file and instructional videos that investigators can use when designing and conducting their RCTs. We reported on the different features that REDCap offers to complete various parts of a large RCT, including sending study invitations and recruitment, eligibility screening, consenting procedures, lab visit appointment and reminders, data collection and confidentiality, randomization, blinding of treatment arm assignment, returning test results, and follow-up surveys. REDCap offers powerful tools for longitudinal data collection and conduct of rigorous and successful RCTs. Investigators can make use of this electronic data capturing system to successfully complete their RCTs. The RCT was prospectively (before completing data collection) registered at ClinicalTrials.gov; registration number: NCT04620798, date of registration: November 9, 2020. The online version contains supplementary material available at 10.1186/s12874-021-01362-2.
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影响因子：
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作者：
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通讯作者：
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DOI：
10.1080/13645579.2019.1661248
发表时间：
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影响因子：
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