Evidence map›Paper›PMID 36191949›Full record

Observational studyBMJ (Clinical research ed.)2022

Emulating the GRADE trial using real world data: retrospective comparative effectiveness study.

Yihong Deng, Eric C Polley, Joshua D Wallach, Sanket S Dhruva, Jeph Herrin, Kenneth Quinto, Charu Gandotra, William Crown, Peter Noseworthy, Xiaoxi Yao and 4 more

Open access · hybridFull text readObservational Study
In one paragraph

Observational study in BMJ (Clinical research ed.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 4 pooled it
2.9field-weighted citation impact, top 8% of its field
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

23 citing papers in PubMed, 4 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Effects of newer-generation anti-diabetics on diabetic retinopathy: a critical review.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Pooled it
  4. Pooled it
  5. Trial
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  13. Assessing the replicability of RCTs in RWE emulations.BMC medical research methodology · 2025
    Article
  14. Article
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  18. Beyond glycemia: Comparing tirzepatide to GLP-1 analogues.Reviews in endocrine & metabolic disorders · 2023
    Review
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  20. 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

14 authors at 10 institutions in 1 country.

Yihong DengRobert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.
Eric C PolleyDepartment of Public Health Sciences, University of Chicago, Chicago, IL, USA.
Joshua D WallachDepartment of Environmental Health Sciences, Yale School of Public Health, New Haven, CT, USA.
Sanket S DhruvaSection of Cardiology, San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA.
Jeph HerrinSection of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT, USA.
Kenneth QuintoOffice of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Springs, MD, USA.
Charu GandotraOffice of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Springs, MD, USA.
William CrownFlorence Heller Graduate School, Brandeis University, Waltham, MA, USA.
Peter NoseworthyDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
Xiaoxi YaoRobert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.
Timothy D LyonDepartment of Urology, Mayo Clinic, Jacksonville, FL, USA.
Nilay D ShahDelta Air Lines, Atlanta, GA, USA.
Joseph S RossDepartment of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.
Rozalina G McCoyRobert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA mccoy.rozalina@mayo.edu.ORCID 0000-0002-2289-3183
Mayo Clinic in Arizona · USUnited States Food and Drug Administration · USYale University · USBrandeis University · USChicago Department of Public Health · USDelta Air Lines (United States) · USMayo Clinic · USOptum (United States) · USUniversity of California, San Francisco · USWinnMed · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Identifying Patient Subgroups That Are Most Likely To Benefit From Medications Used To Treat Alcohol Use DisorderK01AA028258 · NIAAA · YALE UNIVERSITY · PI WALLACH, JOSHUA DAVID · 2021 to 2025
$892k
Predicting the Risk of Severe Hypoglycemic and Hyperglycemic Events in Adults with DiabetesK23DK114497 · NIDDK · MAYO CLINIC ROCHESTER · PI MCCOY, ROZALINA GRUBINA · 2017 to 2021
$846k
FDA HHS U01 FD005938NCATS NIH HHS UL1 TR001863NIAAA NIH HHS K01 AA028258NIDDK NIH HHS K23 DK114497
6 · The paper itself

Abstract

objectiveTo emulate the GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) trial using real world data before its publication. GRADE directly compared second line glucose lowering drugs for their ability to lower glycated hemoglobin A

designObservational study.

settingOptumLabs® Data Warehouse (OLDW), a nationwide claims database in the US, 25 January 2010 to 30 June 2019.

participantsAdults with type 2 diabetes and HbA

main outcome measuresThe primary outcome was time to HbA

results8252 people were identified (19.7% of adults starting the study drugs in OLDW) who met eligibility criteria for the GRADE trial (glimepiride arm=4318, liraglutide arm=690, sitagliptin arm=2993, glargine arm=251). The glargine arm was excluded from analyses owing to small sample size. Median times to HbA

conclusionsIn this emulation of the GRADE trial, liraglutide was statistically significantly more effective at maintaining glycemic control than glimepiride or sitagliptin when added to metformin monotherapy. Generating timely evidence on medical treatments using real world data as a complement to prospective trials is of value.

Indexed as

Diabetes Mellitus, Type 2Hypoglycemic AgentsMetforminAdultBlood GlucoseDrug Therapy, CombinationGlycated HemoglobinHumansInsulin GlargineLiraglutideProspective StudiesRandomized Controlled Trials as TopicRetrospective StudiesSitagliptin PhosphateSulfonylurea CompoundsTreatment OutcomeBlood GlucoseglimepirideGlycated HemoglobinHypoglycemic AgentsInsulin GlargineLiraglutideMetforminSitagliptin PhosphateSulfonylurea Compounds

Identifiers

PMID36191949
PMCPMC9527635
OpenAlexW4300862934

What OpenQuestion holds

Textfull text, public
LicenceCC BY
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.