Evidence map›Paper›PMID 36845316›Full record

ArticleJournal of clinical and translational science2023

Evaluating automated electronic case report form data entry from electronic health records.

Alex C Cheng, Mary K Banasiewicz, Jakea D Johnson, Lina Sulieman, Nan Kennedy, Francesco Delacqua, Adam A Lewis, Meghan M Joly, Amanda J Bistran-Hall, Sean Collins and 4 more

Abstract read
In one paragraph

Article in Journal of clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
–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

18 citing papers in PubMed.

  1. Observational
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Clinical Research Informatics: a Decade-in-Review.Yearbook of medical informatics · 2024
    Review
  11. Applying Artificial Intelligence in Pediatric Clinical Trials: Potential Impacts and Obstacles.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024
    Article
  12. Article
  13. Review
  14. Automatic Population of the Case Report Forms for an International Multifactorial Adaptive Platform Trial Amid the COVID-19 Pandemic.AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science · 2024
    Article
  15. Review
  16. Article
  17. Review
  18. 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

14 authors.

Alex C ChengVanderbilt University Medical Center, Nashville, TN, USA.ORCID https://orcid.org/0000-0002-1787-691X
Mary K BanasiewiczVanderbilt University Medical Center, Nashville, TN, USA.
Jakea D JohnsonVanderbilt University Medical Center, Nashville, TN, USA.
Lina SuliemanVanderbilt University Medical Center, Nashville, TN, USA.
Nan KennedyVanderbilt University Medical Center, Nashville, TN, USA.ORCID https://orcid.org/0000-0003-1935-2973
Francesco DelacquaVanderbilt University Medical Center, Nashville, TN, USA.
Adam A LewisVanderbilt University Medical Center, Nashville, TN, USA.
Meghan M JolyVanderbilt University Medical Center, Nashville, TN, USA.
Amanda J Bistran-HallVanderbilt University Medical Center, Nashville, TN, USA.
Sean CollinsVanderbilt University Medical Center, Nashville, TN, USA.
Wesley H SelfVanderbilt University Medical Center, Nashville, TN, USA.
Matthew S ShotwellVanderbilt University Medical Center, Nashville, TN, USA.
Christopher J LindsellVanderbilt University Medical Center, Nashville, TN, USA.ORCID https://orcid.org/0000-0002-3297-2811
Paul A HarrisVanderbilt University Medical Center, Nashville, TN, USA.ORCID https://orcid.org/0000-0002-1744-2011

Funding

ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating CenterOT2HL156812 · NHLBI · RESEARCH TRIANGLE INSTITUTE · PI NOLEN, TRACY L, THOMAS, SONIA M · 2020 to 2024
$1270.7M
COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)U24TR001608 · NCATS · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2016 to 2022
$177.0M
Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
Improving Clinical trial Education, Recruitment, and Enrollment at CTSA Hubs (I-CERCH) - HEAL SupplementU24TR001579 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI HARRIS, PAUL A., WILKINS, CONSUELO HOPKINS · 2016 to 2022
$34.1M
NCATS NIH HHS U24 TR001579NCATS NIH HHS U24 TR001608NCATS NIH HHS UL1 TR002243NHLBI NIH HHS OT2 HL156812
6 · The paper itself

Abstract

Background: Many clinical trials leverage real-world data. Typically, these data are manually abstracted from electronic health records (EHRs) and entered into electronic case report forms (CRFs), a time and labor-intensive process that is also error-prone and may miss information. Automated transfer of data from EHRs to eCRFs has the potential to reduce data abstraction and entry burden as well as improve data quality and safety. Methods: We conducted a test of automated EHR-to-CRF data transfer for 40 participants in a clinical trial of hospitalized COVID-19 patients. We determined which coordinator-entered data could be automated from the EHR (coverage), and the frequency with which the values from the automated EHR feed and values entered by study personnel for the actual study matched exactly (concordance). Results: The automated EHR feed populated 10,081/11,952 (84%) coordinator-completed values. For fields where both the automation and study personnel provided data, the values matched exactly 89% of the time. Highest concordance was for daily lab results (94%), which also required the most personnel resources (30 minutes per participant). In a detailed analysis of 196 instances where personnel and automation entered values differed, both a study coordinator and a data analyst agreed that 152 (78%) instances were a result of data entry error. Conclusions: An automated EHR feed has the potential to significantly decrease study personnel effort while improving the accuracy of CRF data.

Indexed as

electronic health recordsembedded clinical trialseSourceFHIRmulti-center clinical trials

Identifiers

PMID36845316
PMCPMC9947602

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.