Evidence map›Paper›PMID 29854151›Full record

ArticleAMIA ... Annual Symposium proceedings. AMIA Symposium2017

Comparing and Contrasting A Priori and A Posteriori Generalizability Assessment of Clinical Trials on Type 2 Diabetes Mellitus.

Zhe He, Arturo Gonzalez-Izquierdo, Spiros Denaxas, Andrei Sura, Yi Guo, William R Hogan, Elizabeth Shenkman, Jiang Bian

Abstract readComparative Study
In one paragraph

Article in AMIA ... Annual Symposium proceedings. AMIA Symposium, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

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

5 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Contemporary use of real-world data for clinical trial conduct in the United States: a scoping review.Journal of the American Medical Informatics Association : JAMIA · 2021
    Article
  5. 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.

Zhe HeFlorida State University, Tallahassee, FL, USA.
Arturo Gonzalez-IzquierdoUniversity of College London, London, UK.
Spiros DenaxasUniversity of College London, London, UK.
Andrei SuraUniversity of Florida, Gainesville, FL, USA.
Yi GuoUniversity of Florida, Gainesville, FL, USA.
William R HoganUniversity of Florida, Gainesville, FL, USA.
Elizabeth ShenkmanUniversity of Florida, Gainesville, FL, USA.
Jiang BianUniversity of Florida, Gainesville, FL, USA.

Funding

Using social networks to map and evaluate team science across CTSA hubsUL1TR001427 · NCATS · UNIVERSITY OF FLORIDA · PI MITCHELL, DUANE A. · 2015 to 2024
$37.2M
Clinical and Translational Science AwardUL1TR000040 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2012 to 2015
$26.2M
Bridging the Semantic Gap Between Research Eligibility Criteria and Clinical DataR01LM009886 · NLM · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI WENG, CHUNHUA · 2009 to 2020
$5.3M
Medical Research Council MR/K006584/1NCATS NIH HHS UL1 TR000040NCATS NIH HHS UL1 TR001427NLM NIH HHS R01 LM009886
6 · The paper itself

Abstract

Clinical trials are indispensable tools for evidence-based medicine. However, they are often criticized for poor generalizability. Traditional trial generalizability assessment can only be done after the trial results are published, which compares the enrolled patients with a convenience sample of real-world patients. However, the proliferation of electronic data in clinical trial registries and clinical data warehouses offer a great opportunity to assess the generalizability during the design phase of a new trial. In this work, we compared and contrasted a priori (based on eligibility criteria) and a posteriori (based on enrolled patients) generalizability of Type 2 diabetes clinical trials. Further, we showed that comparing the study population selected by the clinical trial eligibility criteria to the real-world patient population is a good indicator of the generalizability of trials. Our findings demonstrate that the a priori generalizability of a trial is comparable to its a posteriori generalizability in identifying restrictive quantitative eligibility criteria.

Indexed as

Clinical Trials as TopicDiabetes Mellitus, Type 2Patient SelectionRegistriesDatabases, FactualDatasets as TopicElectronic Health RecordsEvidence-Based MedicineFemaleHumansMaleUnited KingdomUnited States

Identifiers

PMID29854151
PMCPMC5977671

What OpenQuestion holds

Textmetadata
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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.