Comparative Assessment of Completeness of CDISC Controlled Terminology

Anas Elghafari, Joseph Finkelstein

Research output: Chapter in Book/Report/Conference proceedingConference contributionpeer-review

1 Scopus citations

Abstract

The CDISC Controlled Terminology (CT) defines the terms that may be used to represent clinical trial data in the CDISC standards. Despite its unique importance, there has been limited systematic examination of the coverage of this terminology. In this work, we performed an assessment of the completeness of CDISC CT's coverage by comparing clinical outcomes for multiple sclerosis (MS) available in CDISC CT with two independent high-fidelity benchmarks: (1) 71 expert-selected outcomes catalogued by the National Institute of Neurological Disorders and Stroke (NINDS), and, (2) 66 common outcomes used in MS trials registered on ClinicalTrials.gov (CTG). We employed a semi-automated search and term-mapping process to identify possible CDISC equivalents to the benchmarks' measures. We found that 55% of the NINDS outcomes and 52% of the CTG outcomes are absent from the CDISC Terminology, indicating a need for expanding the terminology to take into account other established standards and real-world practice.

Original languageEnglish
Title of host publicationMEDINFO 2021
Subtitle of host publicationOne World, One Health - Global Partnership for Digital Innovation - Proceedings of the 18th World Congress on Medical and Health Informatics
EditorsPaula Otero, Philip Scott, Susan Z. Martin, Elaine Huesing
PublisherIOS Press BV
Pages111-115
Number of pages5
ISBN (Electronic)9781643682648
DOIs
StatePublished - 6 Jun 2022
Event18th World Congress on Medical and Health Informatics: One World, One Health - Global Partnership for Digital Innovation, MEDINFO 2021 - Virtual, Online
Duration: 2 Oct 20214 Oct 2021

Publication series

NameStudies in Health Technology and Informatics
Volume290
ISSN (Print)0926-9630
ISSN (Electronic)1879-8365

Conference

Conference18th World Congress on Medical and Health Informatics: One World, One Health - Global Partnership for Digital Innovation, MEDINFO 2021
CityVirtual, Online
Period2/10/214/10/21

Keywords

  • CDISC
  • Multiple Sclerosis
  • Outcome Measures

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