Evidence map›Paper›PMID 34496418›Full record

ArticleApplied clinical informatics2021

A Framework for Systematic Assessment of Clinical Trial Population Representativeness Using Electronic Health Records Data.

Yingcheng Sun, Alex Butler, Ibrahim Diallo, Jae Hyun Kim, Casey Ta, James R Rogers, Hao Liu, Chunhua Weng

Abstract read
In one paragraph

Article in Applied clinical informatics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Interpretable Machine Learning Models Using Peripheral Immune Cells to Predict 90-Day Readmission or Mortality in Acute Heart Failure Patients.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    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.

Yingcheng SunDepartment of Biomedical Informatics, Columbia University, New York, New York, United States.
Alex ButlerDepartment of Biomedical Informatics, Columbia University, New York, New York, United States.
Ibrahim DialloDepartment of Biomedical Informatics, Columbia University, New York, New York, United States.
Jae Hyun KimDepartment of Biomedical Informatics, Columbia University, New York, New York, United States.
Casey TaDepartment of Biomedical Informatics, Columbia University, New York, New York, United States.
James R RogersDepartment of Biomedical Informatics, Columbia University, New York, New York, United States.
Hao LiuDepartment of Biomedical Informatics, Columbia University, New York, New York, United States.
Chunhua WengDepartment of Biomedical Informatics, Columbia University, New York, New York, United States.

Funding

Clinical and Translational Science AwardUL1TR001873 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI REILLY, MUREDACH P · 2016 to 2025
$99.0M
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
Bridging the Semantic Gap Between Research Eligibility Criteria and Clinical DataR01LM009886 · NLM · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI WENG, CHUNHUA · 2009 to 2020
$5.3M
3U24TR001579 National Center for Advancing Clinical and Translational ScienceNCATS NIH HHS U24 TR001579NCATS NIH HHS UL1 TR001873NLM NIH HHS R01 LM009886R01LM009886-11 National Library of MedicineUL1TR001873 National Center for Advancing Clinical and Translational Science
6 · The paper itself

Abstract

backgroundClinical trials are the gold standard for generating robust medical evidence, but clinical trial results often raise generalizability concerns, which can be attributed to the lack of population representativeness. The electronic health records (EHRs) data are useful for estimating the population representativeness of clinical trial study population.

objectivesThis research aims to estimate the population representativeness of clinical trials systematically using EHR data during the early design stage.

methodsWe present an end-to-end analytical framework for transforming free-text clinical trial eligibility criteria into executable database queries conformant with the Observational Medical Outcomes Partnership Common Data Model and for systematically quantifying the population representativeness for each clinical trial.

resultsWe calculated the population representativeness of 782 novel coronavirus disease 2019 (COVID-19) trials and 3,827 type 2 diabetes mellitus (T2DM) trials in the United States respectively using this framework. With the use of overly restrictive eligibility criteria, 85.7% of the COVID-19 trials and 30.1% of T2DM trials had poor population representativeness.

conclusionThis research demonstrates the potential of using the EHR data to assess the clinical trials population representativeness, providing data-driven metrics to inform the selection and optimization of eligibility criteria.

Indexed as

COVID-19Diabetes Mellitus, Type 2Electronic Health RecordsHumansPatient SelectionSARS-CoV-2United States

Identifiers

PMID34496418
PMCPMC8426045

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.