Sam Hume1, Jozef Aerts2, Surendra Sarnikar3, Vojtech Huser4. 1. Dakota State University, College of Business and Information Systems, 820 N Washington Ave, Madison, SD 57042, United States. Electronic address: swhume@gmail.com. 2. FH Joanneum University of Applied Sciences, Eggenberger Allee 11, 8020 Graz, Austria. Electronic address: jozef.aerts@fh-joanneum.at. 3. Dakota State University, College of Business and Information Systems, 820 N Washington Ave, Madison, SD 57042, United States. Electronic address: surendra.sarnikar@dsu.edu. 4. Lister Hill National Center for Biomedical Communications, National Library of Medicine, National Institutes of Health, 8600 Rockville Pike, Bld 38a, Rm 9N919, Bethesda, MD 20894, United States. Electronic address: vojtech.huser@nih.gov.
Abstract
INTRODUCTION: In order to further advance research and development on the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) standard, the existing research must be well understood. This paper presents a methodological review of the ODM literature. Specifically, it develops a classification schema to categorize the ODM literature according to how the standard has been applied within the clinical research data lifecycle. This paper suggests areas for future research and development that address ODM's limitations and capitalize on its strengths to support new trends in clinical research informatics. METHODS: A systematic scan of the following databases was performed: (1) ABI/Inform, (2) ACM Digital, (3) AIS eLibrary, (4) Europe Central PubMed, (5) Google Scholar, (5) IEEE Xplore, (7) PubMed, and (8) ScienceDirect. A Web of Science citation analysis was also performed. The search term used on all databases was "CDISC ODM." The two primary inclusion criteria were: (1) the research must examine the use of ODM as an information system solution component, or (2) the research must critically evaluate ODM against a stated solution usage scenario. Out of 2686 articles identified, 266 were included in a title level review, resulting in 183 articles. An abstract review followed, resulting in 121 remaining articles; and after a full text scan 69 articles met the inclusion criteria. RESULTS: As the demand for interoperability has increased, ODM has shown remarkable flexibility and has been extended to cover a broad range of data and metadata requirements that reach well beyond ODM's original use cases. This flexibility has yielded research literature that covers a diverse array of topic areas. A classification schema reflecting the use of ODM within the clinical research data lifecycle was created to provide a categorized and consolidated view of the ODM literature. The elements of the framework include: (1) EDC (Electronic Data Capture) and EHR (Electronic Health Record) infrastructure; (2) planning; (3) data collection; (4) data tabulations and analysis; and (5) study archival. The analysis reviews the strengths and limitations of ODM as a solution component within each section of the classification schema. This paper also identifies opportunities for future ODM research and development, including improved mechanisms for semantic alignment with external terminologies, better representation of the CDISC standards used end-to-end across the clinical research data lifecycle, improved support for real-time data exchange, the use of EHRs for research, and the inclusion of a complete study design. CONCLUSIONS: ODM is being used in ways not originally anticipated, and covers a diverse array of use cases across the clinical research data lifecycle. ODM has been used as much as a study metadata standard as it has for data exchange. A significant portion of the literature addresses integrating EHR and clinical research data. The simplicity and readability of ODM has likely contributed to its success and broad implementation as a data and metadata standard. Keeping the core ODM model focused on the most fundamental use cases, while using extensions to handle edge cases, has kept the standard easy for developers to learn and use.
INTRODUCTION: In order to further advance research and development on the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) standard, the existing research must be well understood. This paper presents a methodological review of the ODM literature. Specifically, it develops a classification schema to categorize the ODM literature according to how the standard has been applied within the clinical research data lifecycle. This paper suggests areas for future research and development that address ODM's limitations and capitalize on its strengths to support new trends in clinical research informatics. METHODS: A systematic scan of the following databases was performed: (1) ABI/Inform, (2) ACM Digital, (3) AIS eLibrary, (4) Europe Central PubMed, (5) Google Scholar, (5) IEEE Xplore, (7) PubMed, and (8) ScienceDirect. A Web of Science citation analysis was also performed. The search term used on all databases was "CDISC ODM." The two primary inclusion criteria were: (1) the research must examine the use of ODM as an information system solution component, or (2) the research must critically evaluate ODM against a stated solution usage scenario. Out of 2686 articles identified, 266 were included in a title level review, resulting in 183 articles. An abstract review followed, resulting in 121 remaining articles; and after a full text scan 69 articles met the inclusion criteria. RESULTS: As the demand for interoperability has increased, ODM has shown remarkable flexibility and has been extended to cover a broad range of data and metadata requirements that reach well beyond ODM's original use cases. This flexibility has yielded research literature that covers a diverse array of topic areas. A classification schema reflecting the use of ODM within the clinical research data lifecycle was created to provide a categorized and consolidated view of the ODM literature. The elements of the framework include: (1) EDC (Electronic Data Capture) and EHR (Electronic Health Record) infrastructure; (2) planning; (3) data collection; (4) data tabulations and analysis; and (5) study archival. The analysis reviews the strengths and limitations of ODM as a solution component within each section of the classification schema. This paper also identifies opportunities for future ODM research and development, including improved mechanisms for semantic alignment with external terminologies, better representation of the CDISC standards used end-to-end across the clinical research data lifecycle, improved support for real-time data exchange, the use of EHRs for research, and the inclusion of a complete study design. CONCLUSIONS: ODM is being used in ways not originally anticipated, and covers a diverse array of use cases across the clinical research data lifecycle. ODM has been used as much as a study metadata standard as it has for data exchange. A significant portion of the literature addresses integrating EHR and clinical research data. The simplicity and readability of ODM has likely contributed to its success and broad implementation as a data and metadata standard. Keeping the core ODM model focused on the most fundamental use cases, while using extensions to handle edge cases, has kept the standard easy for developers to learn and use.
Authors: Maryam Y Garza; Michael Rutherford; Sahiti Myneni; Susan Fenton; Anita Walden; Umit Topaloglu; Eric Eisenstein; Karan R Kumar; Kanecia O Zimmerman; Mitra Rocca; Gideon Scott Gordon; Sam Hume; Zhan Wang; Meredith Zozus Journal: AMIA Annu Symp Proc Date: 2021-01-25
Authors: Laura C Simko; Liang Chen; Dagmar Amtmann; Nicole Gibran; David Herndon; Karen Kowalske; A Cate Miller; Eileen Bulger; Ryan Friedman; Audrey Wolfe; Kevin K Chung; Michael Mosier; James Jeng; Joseph Giacino; Ross Zafonte; Lewis E Kazis; Jeffrey C Schneider; Colleen M Ryan Journal: Arch Phys Med Rehabil Date: 2018-10-26 Impact factor: 4.060
Authors: Samuel Hume; Anthony Chow; Julie Evans; Frederik Malfait; Julie Chason; J Darcy Wold; Wayne Kubick; Lauren B Becnel Journal: AMIA Jt Summits Transl Sci Proc Date: 2018-05-18
Authors: Barbara Rath; Tim Conrad; Puja Myles; Maren Alchikh; Xiaolin Ma; Christian Hoppe; Franziska Tief; Xi Chen; Patrick Obermeier; Bron Kisler; Brunhilde Schweiger Journal: Expert Rev Anti Infect Ther Date: 2017-05-12 Impact factor: 5.091