Evidence map›Paper›PMID 33433393›Full record

ArticleJMIR medical informatics2021

Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study.

Christian Gulden, Romina Blasini, Azadeh Nassirian, Alexandra Stein, Fatma Betül Altun, Melanie Kirchner, Hans-Ulrich Prokosch, Martin Boeker

Abstract read
In one paragraph

Article in JMIR medical informatics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

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

  1. Guideline
  2. A standards-based approach to digital health research: implementing the people heart study.Journal of the American Medical Informatics Association : JAMIA · 2025
    Article
  3. Article
  4. Review
  5. Article
  6. HL7 FHIR-based tools and initiatives to support clinical research: a scoping review.Journal of the American Medical Informatics Association : JAMIA · 2022
    Article
  7. Review
  8. Article
  9. 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

8 authors.

Christian GuldenChair of Medical Informatics, Department of Medical Informatics, Biometrics and Epidemiology, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.ORCID https://orcid.org/0000-0003-1261-3691
Romina BlasiniInstitute of Medical Informatics, Justus-Liebig-University Gießen, Gießen, Germany.ORCID https://orcid.org/0000-0003-1049-6102
Azadeh NassirianCarl Gustav Carus Faculty of Medicine, Center for Medical Informatics, Institute for Medical Informatics and Biometry, Dresden University of Technology, Dresden, Germany.ORCID https://orcid.org/0000-0003-3987-1922
Alexandra SteinInstitute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Greifswald, Germany.ORCID https://orcid.org/0000-0002-0600-9861
Fatma Betül AltunMedical Informatics Group, University Hospital Frankfurt, Frankfurt, Germany.ORCID https://orcid.org/0000-0001-9718-1351
Melanie KirchnerMedical Center for Information and Communication Technology, University Hospital Erlangen, Erlangen, Germany.ORCID https://orcid.org/0000-0001-9562-8877
Hans-Ulrich ProkoschChair of Medical Informatics, Department of Medical Informatics, Biometrics and Epidemiology, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, Germany.ORCID https://orcid.org/0000-0001-6200-753X
Martin BoekerInstitute of Medical Biometry and Statistics, Medical Faculty and Medical Center, University of Freiburg, Freiburg, Germany.ORCID https://orcid.org/0000-0003-2972-2042

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical trial registries increase transparency in medical research by making information and results of planned, ongoing, and completed studies publicly available. However, the registration of clinical trials remains a time-consuming manual task complicated by the fact that the same studies often need to be registered in different registries with different data entry requirements and interfaces.

objectiveThis study investigates how Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) may be used as a standardized format for exchanging and storing clinical trial records.

methodsWe designed and prototypically implemented an open-source central trial registry containing records from university hospitals, which are automatically exported and updated by local study management systems.

resultsWe provided an architecture and implementation of a multisite clinical trials registry based on HL7 FHIR as a data storage and exchange format.

conclusionsThe results show that FHIR resources establish a harmonized view of study information from heterogeneous sources by enabling automated data exchange between trial centers and central study registries.

Indexed as

clinical trialsdata sharinghealth information interoperabilityHL7 FHIRtrials registry

Identifiers

PMID33433393
PMCPMC7837997

What OpenQuestion holds

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LicenceCC BY
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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.