Evidence map›Paper›PMID 33998290›Full record

Observational studyJournal of the American Heart Association2021

Comparing Effect Estimates in Randomized Trials and Observational Studies From the Same Population: An Application to Percutaneous Coronary Intervention.

Anthony A Matthews, Karolina Szummer, Issa J Dahabreh, Bertil Lindahl, David Erlinge, Maria Feychting, Tomas Jernberg, Anita Berglund, Miguel A Hernán

Open access · goldAbstract readComparative StudyMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of the American Heart Association, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
5.7field-weighted citation impact, top 3% 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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Pooled it
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  6. An Improved Pooled Logistic Regression Implementation.Epidemiology (Cambridge, Mass.) · 2026
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  7. Observational
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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

9 authors at 6 institutions in 2 countries.

Anthony A MatthewsUnit of Epidemiology Institute of Environmental Medicine Karolinska Institutet Stockholm Sweden.
Karolina SzummerDepartment of Cardiology Karolinska University Hospital Stockholm Sweden.
Issa J DahabrehDepartment of Biostatistics Harvard T.H. Chan School of Public Health Boston MA.
Bertil LindahlDepartment of Medical Sciences, Cardiology and Uppsala Clinical Research Center Uppsala University Uppsala Sweden.
David ErlingeDepartment of Cardiology Clinical Sciences Lund UniversitySkåne University Hospital Lund Sweden.
Maria FeychtingUnit of Epidemiology Institute of Environmental Medicine Karolinska Institutet Stockholm Sweden.
Tomas JernbergDepartment of Clinical Sciences Danderyd University Hospital-Karolinska Institute Danderyd Sweden.
Anita BerglundUnit of Epidemiology Institute of Environmental Medicine Karolinska Institutet Stockholm Sweden.
Miguel A HernánUnit of Epidemiology Institute of Environmental Medicine Karolinska Institutet Stockholm Sweden.
Karolinska Institutet · SEHarvard University · USDanderyds sjukhus · SEKarolinska University Hospital · SELund University · SEUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background To understand when results from observational studies and randomized trials are comparable, we performed an observational emulation of a target trial designed to ask similar questions as the VALIDATE (Bivalirudin Versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy) randomized trial. The VALIDATE trial compared the effect of bivalirudin and heparin during percutaneous coronary intervention on the risk of death, myocardial infarction, and bleeding across Sweden. Methods and Results We specified the protocol of a target trial similar to the VALIDATE trial, then emulated the target trial in the period before the VALIDATE trial took place using data from the SWEDEHEART (Swedish Web System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry-the same registry in which the trial was undertaken. The target trial emulation and the VALIDATE trial both estimated little or no effect of bivalirudin versus heparin on the risk of death or myocardial infarction by 180 days (target trial emulation risk ratio for death, 1.21 [95% CI, 0.88 - 1.54]; VALIDATE trial hazard ratio for death, 1.05 [95% CI, 0.78 - 1.41]). The observational data, however, could not capture less severe cases of bleeding, resulting in an inability to define a bleeding outcome like the trial, and could not accurately estimate the comparative risk of death by 14 days, which may be the result of intractable confounding early in follow-up or the inability to precisely emulate the trial's eligibility criteria. Conclusions Using real-world data to emulate a target trial can deliver accurate effect estimates. Yet, even with rich observational data, it is not always possible to estimate the short-term effect of interventions or the effect on outcomes for which data are not routinely collected.

Indexed as

RegistriesAgedAnticoagulantsAntithrombinsFemaleFollow-Up StudiesHeparinHirudinsHumansIncidenceMaleMiddle AgedMyocardial InfarctionPeptide FragmentsPercutaneous Coronary InterventionRandomized Controlled Trials as TopicAnticoagulantsAntithrombinsbivalirudinHeparinHirudinsPeptide FragmentsRecombinant Proteinsmethodologyobservational studiesrandomized controlled trialsregistrySWEDEHEARTtarget trial emulation

Identifiers

PMID33998290
PMCPMC8483524
OpenAlexW3162741043

What OpenQuestion holds

Textmetadata
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.