Evidence map›Paper›PMID 34457132›Full record

ArticleAMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science

Exploring the Hazards of Scaling Up Clinical Data Analyses: A Drug Side Effect Discovery Case Report.

Franck Diaz-Garelli, Todd R Johnson, Mohammad H Rahbar, Elmer V Bernstam

Abstract readCase Reports
In one paragraph

Article in AMIA Joint Summits on Translational Science proceedings. AMIA Joint Summits on Translational Science. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Applying Machine Learning Techniques to Predict Drug-Related Side Effect: A Policy Brief.Inquiry : a journal of medical care organization, provision and financing
    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.

Franck Diaz-GarelliUniversity of North Carolina at Charlotte, Charlotte, NC.
Todd R JohnsonThe University of Texas Health Science Center at Houston, TX.
Mohammad H RahbarThe University of Texas Health Science Center at Houston, TX.
Elmer V BernstamThe University of Texas Health Science Center at Houston, TX.

Funding

Wake Forest Clinical and Translational Science AwardUL1TR001420 · NCATS · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI ARD, JAMY D, FOLEY, KRISTIE L · 2015 to 2023
$32.3M
UT Southwestern Center for Translational Medicine (UL1/KL2/TL1)UL1TR001105 · NCATS · UT SOUTHWESTERN MEDICAL CENTER · PI TOTO, ROBERT DANIEL · 2013 to 2017
$24.5M
Center for Clinical and Translational Sciences (CCTS)UL1TR000371 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2012 to 2016
$13.4M
Postdoctoral Research, Instruction, and Mentoring Experience (PRIME)K12GM102773 · NIGMS · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI HOWLETT, ALLYN C · 2013 to 2018
$2.6M
Informatics to enable routine personalized cancer therapyU01CA180964 · NCI · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI BERNSTAM, ELMER V., MERIC-BERNSTAM, FUNDA · 2013 to 2015
$964k
NCATS NIH HHS UL1 TR000371NCATS NIH HHS UL1 TR001105NCATS NIH HHS UL1 TR001420NCI NIH HHS U01 CA180964NIGMS NIH HHS K12 GM102773
6 · The paper itself

Abstract

We assessed the scalability of pharmacological signal detection use case from a single-site CDW to a large aggregated clinical data warehouse (single-site database with 754,214 distinct patient IDs vs. multisite database with 49.8M). We aimed to explore whether a larger clinical dataset would provide clearer signals for secondary analyses such as detecting the known relationship between prednisone and weight. We found significant weight gain rate using the single-site data but not from using aggregated data (0.0104 kg/day, p<0.0001 vs. -0.050 kg/day, p<.0001). This rate was also found more consistently across 30 age and gender subgroups using the single-site data than in the aggregated data (26 vs. 18 significant weight gain findings). Contrary to our expectations, analyses of much larger aggregated clinical datasets did not yield stronger signals. Researchers must check the underlying model assumptions and account for greater heterogeneity when analyzing aggregated multisite data to ensure reliable findings.

Indexed as

Drug-Related Side Effects and Adverse ReactionsDatabases, FactualData WarehousingHumans

Identifiers

PMID34457132
PMCPMC8378643

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.