Evidence mapPaperPMID 38717556Full record

ArticleEuropean journal of epidemiology2024

Prospective benchmarking of an observational analysis in the SWEDEHEART registry against the REDUCE-AMI randomized trial.

Anthony A Matthews, Issa J Dahebreh, Conor J MacDonald, Bertil Lindahl, Robin Hofmann, David Erlinge, Troels Yndigegn, Anita Berglund, Tomas Jernberg, Miguel A Hernán

Registry-linked trialAbstract read
In one paragraph

Article in European journal of epidemiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03278509 (Randomized Evaluation of Decreased Usage of betablocCkErs After Myocardial Infarction in the SWEDEHEART Registry - A Registry-based, Randomized, Parallel, Open-label, Multicenter Trial), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

NCT03278509 phase4unknown statusnot on this map

Randomized Evaluation of Decreased Usage of betablocCkErs After Myocardial Infarction in the SWEDEHEART Registry - A Registry-based, Randomized, Parallel, Open-label, Multicenter Trial (REDUCE-SWEDEHEART)

TypeinterventionalSponsorKarolinska InstitutetRan2017 to 2025Enrolled5,000ConditionsAcute Myocardial Infarction, Non-ST Elevation Myocardial Infarction, ST Elevation Myocardial InfarctionArmsMetoprolol Succinate, Bisoprolol
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Observational
  6. Article
  7. 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

10 authors.

Anthony A MatthewsUnit of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Nobels Väg 13, 171 65, Solna, Stockholm, Sweden. anthony.matthews@ki.se.ORCID http://orcid.org/0000-0002-1290-271X
Issa J DahebrehCAUSALab, Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, USA.
Conor J MacDonaldUnit of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Nobels Väg 13, 171 65, Solna, Stockholm, Sweden.
Bertil LindahlDepartment of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
Robin HofmannDivision of Cardiology, Department of Clinical Science and Education, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.
David ErlingeDepartment of Cardiology, Clinical Sciences, Skåne University Hospital, Lund University, Lund, Sweden.
Troels YndigegnDepartment of Cardiology, Clinical Sciences, Skåne University Hospital, Lund University, Lund, Sweden.
Anita BerglundUnit of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Nobels Väg 13, 171 65, Solna, Stockholm, Sweden.
Tomas JernbergDepartment of Clinical Sciences, Danderyd University Hospital, Karolinska Institutet, Stockholm, Sweden.
Miguel A HernánUnit of Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Nobels Väg 13, 171 65, Solna, Stockholm, Sweden.

Funding

Forskningsrådet om Hälsa, Arbetsliv och Välfärd 2020-00029Karolinska Institutet Strategic Research Program in EpidemiologyVetenskapsrådet 2018-03028Vetenskapsrådet 2021-02236
6 · The paper itself

Abstract

Prospective benchmarking of an observational analysis against a randomized trial increases confidence in the benchmarking process as it relies exclusively on aligning the protocol of the trial and the observational analysis, while the trials findings are unavailable. The Randomized Evaluation of Decreased Usage of Betablockers After Myocardial Infarction (REDUCE-AMI, ClinicalTrials.gov ID: NCT03278509) trial started recruitment in September 2017 and results are expected in 2024. REDUCE-AMI aimed to estimate the effect of long-term use of beta blockers on the risk of death and myocardial following a myocardial infarction with preserved left ventricular systolic ejection fraction. We specified the protocol of a target trial as similar as possible to that of REDUCE-AMI, then emulated the target trial using observational data from Swedish healthcare registries. Had everyone followed the treatment strategy as specified in the target trial protocol, the observational analysis estimated a reduction in the 5-year risk of death or myocardial infarction of 0.8 percentage points for beta blockers compared with no beta blockers; effects ranging from an absolute reduction of 4.5 percentage points to an increase of 2.8 percentage points in the risk of death or myocardial infarction were compatible with our data under conventional statistical criteria. Once results of REDUCE-AMI are published, we will compare the results of our observational analysis against those from the trial. If this prospective benchmarking is successful, it supports the credibility of additional analyses using these observational data, which can rapidly deliver answers to questions that could not be answered by the initial trial. If benchmarking proves unsuccessful, we will conduct a "postmortem" analysis to identify the reasons for the discrepancy. Prospective benchmarking shifts the investigator focus away from an endeavour to use observational data to obtain similar results as a completed randomized trial, to a systematic attempt to align the design and analysis of the trial and the observational analysis.

Indexed as

Adrenergic beta-AntagonistsBenchmarkingMyocardial InfarctionRegistriesAgedFemaleHumansMaleMiddle AgedProspective StudiesRandomized Controlled Trials as TopicSwedenAdrenergic beta-AntagonistsBenchmarkingCausal inferenceRandomized trialsTarget trials

Identifiers

PMID38717556
PMCPMC11101517

What Socratic holds

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Registered trials

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.