Abstract
BackgroundRandomized 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.MethodsIn 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.ResultsWe 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.ConclusionsREDCap 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.Trial registrationThe RCT was prospectively (before completing data collection) registered at ClinicalTrials.gov; registration number: NCT04620798, date of registration: November 9, 2020.
Highlights
Randomized controlled trials (RCT) are considered the ideal design for evaluating the efficacy of interventions
Research Electronic Data Capture (REDCap) offers other useful features that are less commonly used by researchers but could be valuable for conducting randomized controlled trials (RCTs)
Eligibility screening, and consenting procedures Data import tool In our RCT, the sampling frame was the complete list of all Indiana University Bloomington (IUB) undergraduate students enrolled in the fall semester of 2020
Summary
Randomized controlled trials (RCT) are considered the ideal design for evaluating the efficacy of interventions. 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. Research Electronic Data Capture (REDCap) is a secure, browser-based web application available in 141 countries and to around 1.6 million users [1]. RCTs are considered the gold-standard design for evaluating the efficacy of an intervention, because they can remove most of the possible confounding bias, which is an inherent challenge for observational study designs. Consent procedures, data collection, and data security can be time-consuming for investigators, in addition to the thoughtful consideration needed to address any barriers to participation [5]. RCTs are susceptible to flaws in randomization and blinding processes [6]
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