EHR-based cohort assessment for multicenter RCTs: a fast and flexible model for identifying potential study sites.

Objective: The Recruitment Innovation Center (RIC), partnering with the Trial Innovation Network and institutions in the National Institutes of Health-sponsored Clinical and Translational Science Awards (CTSA) Program, aimed to develop a service line to retrieve study population estimates from elect...

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Publicado en:Journal of the American Medical Informatics Association Vol. 29; no. 4; pp. 652 - 660
Autores principales: Nelson, Sarah J, Drury, Bethany, Hood, Daniel, Harper, Jeremy, Bernard, Tiffany, Weng, Chunhua, Kennedy, Nan, LaSalle, Bernie, Gouripeddi, Ramkiran, Wilkins, Consuelo H, Harris, Paul
Formato: research Journal Article
Publicado: Oxford University Press / USA Apr2022
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Apr2022
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      pub: Oxford University Press / USA
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        10.1093/jamia/ocab265
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        atl: EHR-based cohort assessment for multicenter RCTs: a fast and flexible model for identifying potential study sites.
      aug:
        au:
          Nelson, Sarah J
          Drury, Bethany
          Hood, Daniel
          Harper, Jeremy
          Bernard, Tiffany
          Weng, Chunhua
          Kennedy, Nan
          LaSalle, Bernie
          Gouripeddi, Ramkiran
          Wilkins, Consuelo H
          Harris, Paul
        affil: Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center , Nashville, Tennessee, USA
      sug:
        subj:
          National Institutes of Health (U.S.)
          Research Personnel
          Prospective Studies
          Algorithms
          Study Design
          Human
          United States
          Comparative Studies
          Multicenter Studies
          Evaluation Research
          Validation Studies
          Clinical Assessment Tools
          Scales
      ab: Objective: The Recruitment Innovation Center (RIC), partnering with the Trial Innovation Network and institutions in the National Institutes of Health-sponsored Clinical and Translational Science Awards (CTSA) Program, aimed to develop a service line to retrieve study population estimates from electronic health record (EHR) systems for use in selecting enrollment sites for multicenter clinical trials. Our goal was to create and field-test a low burden, low tech, and high-yield method.Materials and Methods: In building this service line, the RIC strove to complement, rather than replace, CTSA hubs' existing cohort assessment tools. For each new EHR cohort request, we work with the investigator to develop a computable phenotype algorithm that targets the desired population. CTSA hubs run the phenotype query and return results using a standardized survey. We provide a comprehensive report to the investigator to assist in study site selection.Results: From 2017 to 2020, the RIC developed and socialized 36 phenotype-dependent cohort requests on behalf of investigators. The average response rate to these requests was 73%.Discussion: Achieving enrollment goals in a multicenter clinical trial requires that researchers identify study sites that will provide sufficient enrollment. The fast and flexible method the RIC has developed, with CTSA feedback, allows hubs to query their EHR using a generalizable, vetted phenotype algorithm to produce reliable counts of potentially eligible study participants.Conclusion: The RIC's EHR cohort assessment process for evaluating sites for multicenter trials has been shown to be efficient and helpful. The model may be replicated for use by other programs.
      pubtype: Academic Journal
      doctype:
        research
        Journal Article
      ougenre: Article
    language: English
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