Evidence map›Paper›PMID 25615940›Full record

ArticleJournal of biomedical informatics2015

Visual aggregate analysis of eligibility features of clinical trials.

Zhe He, Simona Carini, Ida Sim, Chunhua Weng

Abstract read
In one paragraph

Article in Journal of biomedical informatics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 citing papers in PubMed.

  1. Article
  2. A knowledge base of clinical trial eligibility criteria.Journal of biomedical informatics · 2021
    Article
  3. Article
  4. EliIE: An open-source information extraction system for clinical trial eligibility criteria.Journal of the American Medical Informatics Association : JAMIA · 2017
    Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Assessing the population representativeness of colorectal cancer treatment clinical trials.Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference · 2016
    Article
  10. Article
  11. Article
  12. Article
  13. Simulation-based Evaluation of the Generalizability Index for Study Traits.AMIA ... Annual Symposium proceedings. AMIA Symposium · 2015
    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

4 authors.

Zhe HeDepartment of Biomedical Informatics, Columbia University, New York, NY 10032, USA.
Simona CariniDivision of General Internal Medicine, University of California, San Francisco, San Francisco, CA 94143, USA.
Ida SimDivision of General Internal Medicine, University of California, San Francisco, San Francisco, CA 94143, USA.
Chunhua WengDepartment of Biomedical Informatics, Columbia University, New York, NY 10032, USA. Electronic address: cw2384@cumc.columbia.edu.

Funding

Clinical and Translational Science AwardUL1TR000040 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2012 to 2015
$26.2M
Institutional Career Development CoreKL2TR001874 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GENKINGER, JEANINE M., SHIMBO, DAICHI · 2016 to 2025
$13.6M
Bridging the Semantic Gap Between Research Eligibility Criteria and Clinical DataR01LM009886 · NLM · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI WENG, CHUNHUA · 2009 to 2020
$5.3M
NCATS NIH HHS KL2 TR001874NCATS NIH HHS UL1 TR000040NLM NIH HHS R01 LM009886NLM NIH HHS R01LM009886
6 · The paper itself

Abstract

objectiveTo develop a method for profiling the collective populations targeted for recruitment by multiple clinical studies addressing the same medical condition using one eligibility feature each time.

methodsUsing a previously published database COMPACT as the backend, we designed a scalable method for visual aggregate analysis of clinical trial eligibility features. This method consists of four modules for eligibility feature frequency analysis, query builder, distribution analysis, and visualization, respectively. This method is capable of analyzing (1) frequently used qualitative and quantitative features for recruiting subjects for a selected medical condition, (2) distribution of study enrollment on consecutive value points or value intervals of each quantitative feature, and (3) distribution of studies on the boundary values, permissible value ranges, and value range widths of each feature. All analysis results were visualized using Google Charts API. Five recruited potential users assessed the usefulness of this method for identifying common patterns in any selected eligibility feature for clinical trial participant selection.

resultsWe implemented this method as a Web-based analytical system called VITTA (Visual Analysis Tool of Clinical Study Target Populations). We illustrated the functionality of VITTA using two sample queries involving quantitative features BMI and HbA1c for conditions "hypertension" and "Type 2 diabetes", respectively. The recruited potential users rated the user-perceived usefulness of VITTA with an average score of 86.4/100.

conclusionsWe contributed a novel aggregate analysis method to enable the interrogation of common patterns in quantitative eligibility criteria and the collective target populations of multiple related clinical studies. A larger-scale study is warranted to formally assess the usefulness of VITTA among clinical investigators and sponsors in various therapeutic areas.

Indexed as

InternetPatient SelectionBiomedical ResearchClinical Trials as TopicDatabases, FactualData MiningFemaleHumansMaleModels, TheoreticalClinical trialKnowledge managementPatient selectionSelection bias

Identifiers

PMID25615940
PMCPMC4408222

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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.