Use of research electronic data capture (REDCap) in a sequential multiple assignment randomized trial (SMART): a practical example of automating double randomization
Abstract Background Adaptive interventions are often used in individualized health care to meet the unique needs of clients. Recently, more researchers have adopted the Sequential Multiple Assignment Randomized Trial (SMART), a type of research design, to build optimal adaptive interventions. SMART...
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| Format: | Article |
| Language: | English |
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BMC
2023-07-01
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| Series: | BMC Medical Research Methodology |
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| Online Access: | https://doi.org/10.1186/s12874-023-01986-6 |
| _version_ | 1797784597482700800 |
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| author | Carol A. Lee Danilo Gamino Michelle Lore Curt Donelson Liliane C. Windsor |
| author_facet | Carol A. Lee Danilo Gamino Michelle Lore Curt Donelson Liliane C. Windsor |
| author_sort | Carol A. Lee |
| collection | DOAJ |
| description | Abstract Background Adaptive interventions are often used in individualized health care to meet the unique needs of clients. Recently, more researchers have adopted the Sequential Multiple Assignment Randomized Trial (SMART), a type of research design, to build optimal adaptive interventions. SMART requires research participants to be randomized multiple times over time, depending upon their response to earlier interventions. Despite the increasing popularity of SMART designs, conducting a successful SMART study poses unique technological and logistical challenges (e.g., effectively concealing and masking allocation sequence to investigators, involved health care providers, and subjects) in addition to other challenges common to all study designs (e.g., study invitations, eligibility screening, consenting procedures, and data confidentiality protocols). Research Electronic Data Capture (REDCap) is a secure, browser-based web application widely used by researchers for data collection. REDCap offers unique features that support researchers’ ability to conduct rigorous SMARTs. This manuscript provides an effective strategy for performing automatic double randomization for SMARTs using REDCap. Methods Between January and March 2022, we conducted a SMART using a sample of adult (age 18 and older) New Jersey residents to optimize an adaptive intervention to increase COVID-19 testing uptake. In the current report, we discuss how we used REDCap for our SMART, which required double randomization. Further, we share our REDCap project XML file for future investigators to use when designing and conducting SMARTs. Results We report on the randomization feature that REDCap offers and describe how the study team automated an additional randomization that was required for our SMART. An application programming interface was used to automate the double randomizations in conjunction with the randomization feature provided by REDCap. Conclusions REDCap offers powerful tools to facilitate the implementation of longitudinal data collection and SMARTs. Investigators can make use of this electronic data capturing system to reduce errors and bias in the implementation of their SMARTs by automating double randomization. Trial registration The SMART study was prospectively registered at Clinicaltrials.gov; registration number: NCT04757298, date of registration: 17/02/2021. |
| first_indexed | 2024-03-13T00:42:10Z |
| format | Article |
| id | doaj.art-fbde9d3696d04361825fd62caf393498 |
| institution | Directory Open Access Journal |
| issn | 1471-2288 |
| language | English |
| last_indexed | 2024-03-13T00:42:10Z |
| publishDate | 2023-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Research Methodology |
| spelling | doaj.art-fbde9d3696d04361825fd62caf3934982023-07-09T11:17:18ZengBMCBMC Medical Research Methodology1471-22882023-07-012311910.1186/s12874-023-01986-6Use of research electronic data capture (REDCap) in a sequential multiple assignment randomized trial (SMART): a practical example of automating double randomizationCarol A. Lee0Danilo Gamino1Michelle Lore2Curt Donelson3Liliane C. Windsor4Addiction Center, University of MichiganNorth Jersey Community Research InitiativeInterdisciplinary Health Sciences Institute, University of Illinois at Urbana ChampaignData and Technology Innovation Group, University of Illinois at Urbana ChampaignSchool of Social Work, University of Illinois at Urbana ChampaignAbstract Background Adaptive interventions are often used in individualized health care to meet the unique needs of clients. Recently, more researchers have adopted the Sequential Multiple Assignment Randomized Trial (SMART), a type of research design, to build optimal adaptive interventions. SMART requires research participants to be randomized multiple times over time, depending upon their response to earlier interventions. Despite the increasing popularity of SMART designs, conducting a successful SMART study poses unique technological and logistical challenges (e.g., effectively concealing and masking allocation sequence to investigators, involved health care providers, and subjects) in addition to other challenges common to all study designs (e.g., study invitations, eligibility screening, consenting procedures, and data confidentiality protocols). Research Electronic Data Capture (REDCap) is a secure, browser-based web application widely used by researchers for data collection. REDCap offers unique features that support researchers’ ability to conduct rigorous SMARTs. This manuscript provides an effective strategy for performing automatic double randomization for SMARTs using REDCap. Methods Between January and March 2022, we conducted a SMART using a sample of adult (age 18 and older) New Jersey residents to optimize an adaptive intervention to increase COVID-19 testing uptake. In the current report, we discuss how we used REDCap for our SMART, which required double randomization. Further, we share our REDCap project XML file for future investigators to use when designing and conducting SMARTs. Results We report on the randomization feature that REDCap offers and describe how the study team automated an additional randomization that was required for our SMART. An application programming interface was used to automate the double randomizations in conjunction with the randomization feature provided by REDCap. Conclusions REDCap offers powerful tools to facilitate the implementation of longitudinal data collection and SMARTs. Investigators can make use of this electronic data capturing system to reduce errors and bias in the implementation of their SMARTs by automating double randomization. Trial registration The SMART study was prospectively registered at Clinicaltrials.gov; registration number: NCT04757298, date of registration: 17/02/2021.https://doi.org/10.1186/s12874-023-01986-6Research Electronic Data capture (REDCap)Randomized controlled trials (RCT)Adaptive interventionsSequential multiple assignment Randomized Trial (SMART)RandomizationExperimental design |
| spellingShingle | Carol A. Lee Danilo Gamino Michelle Lore Curt Donelson Liliane C. Windsor Use of research electronic data capture (REDCap) in a sequential multiple assignment randomized trial (SMART): a practical example of automating double randomization BMC Medical Research Methodology Research Electronic Data capture (REDCap) Randomized controlled trials (RCT) Adaptive interventions Sequential multiple assignment Randomized Trial (SMART) Randomization Experimental design |
| title | Use of research electronic data capture (REDCap) in a sequential multiple assignment randomized trial (SMART): a practical example of automating double randomization |
| title_full | Use of research electronic data capture (REDCap) in a sequential multiple assignment randomized trial (SMART): a practical example of automating double randomization |
| title_fullStr | Use of research electronic data capture (REDCap) in a sequential multiple assignment randomized trial (SMART): a practical example of automating double randomization |
| title_full_unstemmed | Use of research electronic data capture (REDCap) in a sequential multiple assignment randomized trial (SMART): a practical example of automating double randomization |
| title_short | Use of research electronic data capture (REDCap) in a sequential multiple assignment randomized trial (SMART): a practical example of automating double randomization |
| title_sort | use of research electronic data capture redcap in a sequential multiple assignment randomized trial smart a practical example of automating double randomization |
| topic | Research Electronic Data capture (REDCap) Randomized controlled trials (RCT) Adaptive interventions Sequential multiple assignment Randomized Trial (SMART) Randomization Experimental design |
| url | https://doi.org/10.1186/s12874-023-01986-6 |
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