Evidence map›Paper›PMID 18406213›Full record

ArticleContemporary clinical trials2008

Heterogeneous but "standard" coding systems for adverse events: Issues in achieving interoperability between apples and oranges.

Rachel L Richesson, Kin Wah Fung, Jeffrey P Krischer

Abstract read
In one paragraph

Article in Contemporary clinical trials, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Knowledge-guided generative artificial intelligence for automated taxonomy learning from drug labels.Journal of the American Medical Informatics Association : JAMIA · 2024
    Article
  4. Article
  5. Article
  6. Article
  7. Challenges in Using a Graph Database to Represent and Analyze Mappings of Cancer Study Data Standards.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2020
    Article
  8. Article
  9. Article
  10. Extended Analysis of Topological-Pattern-Based Ontology Enrichment.Proceedings. IEEE International Conference on Bioinformatics and Biomedicine · 2018
    Article
  11. Review
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  13. Article
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  15. Article
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  18. Review
  19. Drug safety surveillance using de-identified EMR and claims data: issues and challenges.Journal of the American Medical Informatics Association : JAMIA
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Rachel L RichessonUniversity of South Florida College of Medicine, Tampa, FL, USA.
Kin Wah Fung
Jeffrey P Krischer

Funding

RARE DISEASES DATA AND TECHNOLOGY COORDINATING CENTERU54RR019259 · NCRR · UNIVERSITY OF SOUTH FLORIDA · PI KRISCHER, JEFFREY P · 2003 to 2008
$14.4M
NCRR NIH HHS RR019259NCRR NIH HHS U54 RR019259
6 · The paper itself

Abstract

Monitoring adverse events (AEs) is an important part of clinical research and a crucial target for data standards. The representation of adverse events themselves requires the use of controlled vocabularies with thousands of needed clinical concepts. Several data standards for adverse events currently exist, each with a strong user base. The structure and features of these current adverse event data standards (including terminologies and classifications) are different, so comparisons and evaluations are not straightforward, nor are strategies for their harmonization. Three different data standards - the Medical Dictionary for Regulatory Activities (MedDRA) and the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) terminologies, and Common Terminology Criteria for Adverse Events (CTCAE) classification - are explored as candidate representations for AEs. This paper describes the structural features of each coding system, their content and relationship to the Unified Medical Language System (UMLS), and unsettled issues for future interoperability of these standards.

Indexed as

Adverse Drug Reaction Reporting SystemsBiomedical ResearchSystematized Nomenclature of MedicineUnified Medical Language SystemClinical Trials as TopicForms and Records ControlHuman ExperimentationHumansMedical Informatics ComputingMedical Record LinkageMedical Records Systems, ComputerizedTerminology as TopicVocabulary, Controlled

Identifiers

PMID18406213
PMCPMC2575842

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.