Evidence map›Paper›PMID 32194148›Full record

ArticleJournal of clinical epidemiology2020

Prior event rate ratio adjustment produced estimates consistent with randomized trial: a diabetes case study.

Lauren R Rodgers, John M Dennis, Beverley M Shields, Luke Mounce, Ian Fisher, Andrew T Hattersley, William E Henley, MASTERMIND Consortium

Open access · hybridFull text read
In one paragraph

Article in Journal of clinical epidemiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.2field-weighted citation impact, top 11% 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

9 citing papers in PubMed, 17 citations in OpenAlex.

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  7. The Effect of Buprenorphine on Human Immunodeficiency Virus Viral Suppression.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
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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 at 4 institutions in 1 country.

Lauren R RodgersInstitute of Health Research, University of Exeter Medical School, Exeter, UK. Electronic address: L.R.Rodgers@exeter.ac.uk.
John M DennisInstitute of Health Research, University of Exeter Medical School, Exeter, UK.
Beverley M ShieldsNIHR Exeter Clinical Research Facility, University of Exeter Medical School, Exeter, UK.
Luke MounceInstitute of Health Research, University of Exeter Medical School, Exeter, UK.
Ian FisherIQVIA, London UK.
Andrew T HattersleyDepartment of Diabetes and Endocrinology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.
William E HenleyInstitute of Health Research, University of Exeter Medical School, Exeter, UK.
MASTERMIND Consortium
University of Exeter · GBIQVIA (United Kingdom) · GBNIHR Exeter Clinical Research Facility · GBRoyal Devon & Exeter NHS Foundation Trust · GB

Funding

Medical Research Council MR/N00633X/1
6 · The paper itself

Abstract

objectivesElectronic health records (EHR) provide a valuable resource for assessing drug side-effects, but treatments are not randomly allocated in routine care creating the potential for bias. We conduct a case study using the Prior Event Rate Ratio (PERR) Pairwise method to reduce unmeasured confounding bias in side-effect estimates for two second-line therapies for type 2 diabetes, thiazolidinediones, and sulfonylureas. STUDY DESIGN AND SETTINGS: Primary care data were extracted from the Clinical Practice Research Datalink (n = 41,871). We utilized outcomes from the period when patients took first-line metformin to adjust for unmeasured confounding. Estimates for known side-effects and a negative control outcome were compared with the A Diabetes Outcome Progression Trial (ADOPT) trial (n = 2,545).

resultsWhen on metformin, patients later prescribed thiazolidinediones had greater risks of edema, HR 95% CI 1.38 (1.13, 1.68) and gastrointestinal side-effects (GI) 1.47 (1.28, 1.68), suggesting the presence of unmeasured confounding. Conventional Cox regression overestimated the risk of edema on thiazolidinediones and identified a false association with GI. The PERR Pairwise estimates were consistent with ADOPT: 1.43 (1.10, 1.83) vs. 1.39 (1.04, 1.86), respectively, for edema, and 0.91 (0.79, 1.05) vs. 0.94 (0.80, 1.10) for GI.

conclusionThe PERR Pairwise approach offers potential for enhancing postmarketing surveillance of side-effects from EHRs but requires careful consideration of assumptions.

Indexed as

AdultAgedAged, 80 and overDiabetes Mellitus, Type 2FemaleHumansHypoglycemic AgentsMaleMetforminMiddle AgedRandomized Controlled Trials as TopicResearch DesignSulfonylurea CompoundsTreatment OutcomeHypoglycemic AgentsMetforminSulfonylurea CompoundsElectronic health recordObservational dataPERR PairwisePharmacovigilanceSide-effectsUnmeasured confounding

Identifiers

PMID32194148
PMCPMC7262589
OpenAlexW3011118450

What Socratic 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 Socratic graph.