Literature DB >> 33936420

Evaluating the Coverage of the HL7 ® FHIR ® Standard to Support eSource Data Exchange Implementations for use in Multi-Site Clinical Research Studies.

Maryam Y Garza1,2, Michael Rutherford1, Sahiti Myneni2, Susan Fenton2, Anita Walden3, Umit Topaloglu4, Eric Eisenstein5, Karan R Kumar5, Kanecia O Zimmerman5, Mitra Rocca6, Gideon Scott Gordon6, Sam Hume7, Zhan Wang8, Meredith Zozus8.   

Abstract

The direct use of EHR data in research, often referred to as 'eSource', has long-been a goal for researchers because of anticipated increases in data quality and reductions in site burden. eSource solutions should rely on data exchange standards for consistency, quality, and efficiency. The utility of any data standard can be evaluated by its ability to meet specific use case requirements. The Health Level Seven (HL7 ® ) Fast Healthcare Interoperability Resources (FHIR ® ) standard is widely recognized for clinical data exchange; however, a thorough analysis of the standard's data coverage in supporting multi-site clinical studies has not been conducted. We developed and implemented a systematic mapping approach for evaluating HL7 ® FHIR ® standard coverage in multi-center clinical trials. Study data elements from three diverse studies were mapped to HL7 ® FHIR ® resources, offering insight into the coverage and utility of the standard for supporting the data collection needs of multi-site clinical research studies. ©2020 AMIA - All rights reserved.

Entities:  

Year:  2021        PMID: 33936420      PMCID: PMC8075534     

Source DB:  PubMed          Journal:  AMIA Annu Symp Proc        ISSN: 1559-4076


  33 in total

Review 1.  An electronic medical records system for clinical research and the EMR EDC interface.

Authors:  Elizabeth C Murphy; Frederick L Ferris; William R O'Donnell
Journal:  Invest Ophthalmol Vis Sci       Date:  2007-10       Impact factor: 4.799

2.  Implementing Single Source: the STARBRITE proof-of-concept study.

Authors:  Rebecca Kush; Liora Alschuler; Roberto Ruggeri; Sally Cassells; Nitin Gupta; Landen Bain; Karen Claise; Monica Shah; Meredith Nahm
Journal:  J Am Med Inform Assoc       Date:  2007-06-28       Impact factor: 4.497

3.  Clinical trials and tribulations. Spiraling costs threaten gridlock.

Authors:  David Malakoff
Journal:  Science       Date:  2008-10-10       Impact factor: 47.728

4.  Opportunities for electronic health record data to support business functions in the pharmaceutical industry--a case study from Pfizer, Inc.

Authors:  Daijin Kim; Steven Labkoff; Samuel H Holliday
Journal:  J Am Med Inform Assoc       Date:  2008-06-25       Impact factor: 4.497

5.  Integrating research data capture into the electronic health record workflow: real-world experience to advance innovation.

Authors:  Marsha Laird-Maddox; Susan B Mitchell; Mark Hoffman
Journal:  Perspect Health Inf Manag       Date:  2014-10-01

6.  eSource for Standardized Health Information Exchange in Clinical Research: A Systematic Review.

Authors:  Maryam Garza; Sahiti Myneni; Amy Nordo; Eric L Eisenstein; W Ed Hammond; Anita Walden; Meredith Zozus
Journal:  Stud Health Technol Inform       Date:  2019

7.  Development of Data Validation Rules for Therapeutic Area Standard Data Elements in Four Mental Health Domains to Improve the Quality of FDA Submissions.

Authors:  Maryam Garza; Emel Seker; Meredith Zozus
Journal:  Stud Health Technol Inform       Date:  2019

8.  Business analysis for a sustainable, multi-stakeholder ecosystem for leveraging the Electronic Health Records for Clinical Research (EHR4CR) platform in Europe.

Authors:  Danielle Dupont; Ariel Beresniak; Mats Sundgren; Andreas Schmidt; John Ainsworth; Pascal Coorevits; Dipak Kalra; Marc Dewispelaere; Georges De Moor
Journal:  Int J Med Inform       Date:  2016-11-15       Impact factor: 4.046

9.  Cost-benefit assessment of using electronic health records data for clinical research versus current practices: Contribution of the Electronic Health Records for Clinical Research (EHR4CR) European Project.

Authors:  Ariel Beresniak; Andreas Schmidt; Johann Proeve; Elena Bolanos; Neelam Patel; Nadir Ammour; Mats Sundgren; Mats Ericson; Töresin Karakoyun; Pascal Coorevits; Dipak Kalra; Georges De Moor; Danielle Dupont
Journal:  Contemp Clin Trials       Date:  2015-11-17       Impact factor: 2.226

10.  Central challenges facing the national clinical research enterprise.

Authors:  Nancy S Sung; William F Crowley; Myron Genel; Patricia Salber; Lewis Sandy; Louis M Sherwood; Stephen B Johnson; Veronica Catanese; Hugh Tilson; Kenneth Getz; Elaine L Larson; David Scheinberg; E Albert Reece; Harold Slavkin; Adrian Dobs; Jack Grebb; Rick A Martinez; Allan Korn; David Rimoin
Journal:  JAMA       Date:  2003-03-12       Impact factor: 56.272

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  5 in total

1.  Extraction of Electronic Health Record Data using Fast Healthcare Interoperability Resources for Automated Breast Cancer Risk Assessment.

Authors:  Julia E McGuinness; Tianmai M Zhang; Kevin Cooper; Arusha Kelkar; Jill Dimond; Virginia Lorenzi; Katherine D Crew; Rita Kukafka
Journal:  AMIA Annu Symp Proc       Date:  2022-02-21

Review 2.  HL7 FHIR-based tools and initiatives to support clinical research: a scoping review.

Authors:  Stephany N Duda; Nan Kennedy; Douglas Conway; Alex C Cheng; Viet Nguyen; Teresa Zayas-Cabán; Paul A Harris
Journal:  J Am Med Inform Assoc       Date:  2022-08-16       Impact factor: 7.942

3.  Evaluating Site-Level Implementations of the HL7 FHIR Standard to Support eSource Data Exchange in Clinical Research.

Authors:  Maryam Y Garza; Michael W Rutherford; Bhargav Adagarla; Eric Eisenstein; Karan R Kumar; Kanecia O Zimmerman; Umit Topaloglu; Meredith Zozus
Journal:  Stud Health Technol Inform       Date:  2021-05-27

Review 4.  Fast Healthcare Interoperability Resources (FHIR) for Interoperability in Health Research: Systematic Review.

Authors:  Carina Nina Vorisek; Moritz Lehne; Sophie Anne Ines Klopfenstein; Paula Josephine Mayer; Alexander Bartschke; Thomas Haese; Sylvia Thun
Journal:  JMIR Med Inform       Date:  2022-07-19

5.  Measuring and controlling medical record abstraction (MRA) error rates in an observational study.

Authors:  Maryam Y Garza; Tremaine Williams; Sahiti Myneni; Susan H Fenton; Songthip Ounpraseuth; Zhuopei Hu; Jeannette Lee; Jessica Snowden; Meredith N Zozus; Anita C Walden; Alan E Simon; Barbara McClaskey; Sarah G Sanders; Sandra S Beauman; Sara R Ford; Lacy Malloch; Amy Wilson; Lori A Devlin; Leslie W Young
Journal:  BMC Med Res Methodol       Date:  2022-08-15       Impact factor: 4.612

  5 in total

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