Evidence map›Paper›PMID 25432086›Full record

ArticleJournal of clinical epidemiology2015

Observational and clinical trial findings on the comparative effectiveness of diabetes drugs showed agreement.

James H Flory, Alvin I Mushlin

Abstract readValidation Study
In one paragraph

Article in Journal of clinical epidemiology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

2 authors.

James H FloryDivision of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Weill Cornell Medical College, 525 E 68th Street, 20th Floor Baker Pavilion, New York, NY 10021, USA. Electronic address: jaf9052@nyp.org.
Alvin I MushlinDepartment of Public Health, Weill Cornell Medical College, 425 E 61st Street, 3rd Floor, Suite 301, New York, NY 10065, USA.

Funding

Disparities in COVID Disease Severity and Outcomes in New York CityUL1TR002384 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI JULIANNE L IMPERATO-MCGINLEY · 2017 to 2026
$86.2M
Clinical and Translational Science CenterUL1TR000457 · NCATS · WEILL MEDICAL COLL OF CORNELL UNIV · PI IMPERATO-MCGINLEY, JULIANNE L · 2012 to 2016
$46.0M
Intramural NIH HHSNCATS NIH HHS UL1 TR000457NCATS NIH HHS UL1 TR002384NIDDK NIH HHS L30 DK099830
6 · The paper itself

Abstract

objectivesThis study compares an observational study of diabetes treatment effectiveness to randomized controlled trials to assess their convergent validity. STUDY DESIGN AND

settingMultivariate models were developed using observational data to describe change in hemoglobin A1c (HbA1c; % unit) and weight (kilograms) after addition of a second-line oral diabetes drug to metformin monotherapy. Randomized trials of these scenarios were systematically identified. The models were used to simulate each trial, and simulated and actual results were compared by linear regression and meta-analysis.

resultsThirty-two randomized trials of second-line diabetes oral therapy were identified. For all outcomes and drugs studied, simulation and actual results correlated (P < 0.001). There were no statistically significant differences between meta-analyzed randomized and simulated results for effect on HbA1c. For effect on weight, results were qualitatively comparable, but for sulfonylureas, the simulated weight gain was nominally greater than seen in the randomized controlled trials.

conclusionAn observational study of diabetes drug effectiveness showed convergent validity with randomized data. This supports cautious use of the observational research to draw conclusions about drug effectiveness in populations not studied in clinical trials. This approach may be useful in other situations where observational and randomized data need integration.

Indexed as

Body WeightDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansHypoglycemic AgentsMetforminMiddle AgedMultivariate AnalysisObservational Studies as TopicRandomized Controlled Trials as TopicSulfonylurea CompoundsTreatment OutcomeWeight GainGlycated HemoglobinHypoglycemic AgentsMetforminSulfonylurea CompoundsComparative effectiveness dataDiabetesHbA1cPharmacoepidemiologyValidationWeight

Identifiers

PMID25432086
PMCPMC4349393

What OpenQuestion holds

Texttitle and abstract
LicenceTDM
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.