Evidence map›Paper›PMID 39545867›Full record

SynthesisEuropean heart journal2025

Definitions of clinical study outcome measures for cardiovascular diseases: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart).

Chris Wilkinson, Asad Bhatty, Gorav Batra, Suleman Aktaa, Adam B Smith, Jeremy Dwight, Marcin Ruciński, Sam Chappell, Joakim Alfredsson, David Erlinge and 22 more

Abstract readSystematic Review
In one paragraph

Synthesis in European heart journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Review
  10. Observational
  11. Article
  12. Article
  13. Embracing the promise of patient reported outcome measures in cardiology.European heart journal. Quality of care & clinical outcomes · 2024
    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

32 authors.

Chris WilkinsonHull York Medical School, University of York, YO10 5DD York, UK.ORCID 0000-0003-0748-0150
Asad BhattyLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.ORCID 0009-0003-3254-9508
Gorav BatraDepartment of Medical Sciences, Cardiology and Uppsala Clinical Research Centre, Uppsala University, Uppsala, Sweden.ORCID 0000-0002-2480-9547
Suleman AktaaLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.ORCID 0000-0002-9854-481X
Adam B SmithLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Jeremy DwightEuropean Society of Cardiology Patient Forum.
Marcin RucińskiEuropean Society of Cardiology Patient Forum.
Sam ChappellLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Joakim AlfredssonDepartment of Cardiology, Linköping University Hospital, Linköping, Sweden.ORCID 0000-0002-1415-7178
David ErlingeDepartment of Clinical Sciences, Lund University, Lund, Sweden.
Jorge FerreiraDepartment of Cardiology, Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental, Carnaxide, Portugal.
Ingibjörg J GuðmundsdóttirDepartment of Cardiology, Landspitali University Hospital, Reykjavik, Iceland.
Þórdís Jóna HrafnkelsdóttirDepartment of Cardiology, Landspitali University Hospital, Reykjavik, Iceland.
Inga Jóna IngimarsdóttirDepartment of Cardiology, Landspitali University Hospital, Reykjavik, Iceland.
Alar IrsHeart Clinic, Tartu University Hospital, Tartu, Estonia.
András JánosiGyörgy Gottsegen National Cardiovascular Institute, Budapest, Hungary.
Zoltán JáraiDepartment of Cardiology, South Buda Center Hospital, Szent Imre Teaching Hospital, Budapest, Hungary.
Manuel Oliveira-SantosCardiology Department, Unidade Local de Saúde de Coimbra, Coimbra, Portugal.
Bogdan A PopescuCardiology Clinic, University of Medicine and Pharmacy Carol Davila, Emergency Institute for Cardiovascular Diseases Prof Dr C C Iliescu, Bucharest, Romania.ORCID 0000-0001-6122-8533
Peter VaskoDepartment of Cardiology, Linköping University Hospital, Linköping, Sweden.
Dragos VinereanuCardiology Department, Unidade Local de Saúde de Coimbra, Coimbra, Portugal.
Jonathan YapDepartment of Cardiology, National Heart Centre Singapore, Singapore.
Raffaele BugiardiniDepartment of Experimental, Diagnostic and Specialty Medicine, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.ORCID 0000-0002-6819-6818
Edina CenkoDepartment of Experimental, Diagnostic and Specialty Medicine, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.ORCID 0000-0001-8102-3324
Ramesh NadarajahLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.ORCID 0000-0001-9895-9356
Matthew R SydesBHF Data Science Centre, HDR UK, London, UK.ORCID 0000-0002-9323-1371
Stefan JamesDepartment of Medical Sciences, Cardiology and Uppsala Clinical Research Centre, Uppsala University, Uppsala, Sweden.ORCID 0000-0003-4413-9736
Aldo P MaggioniANMCO Research Centre, Heart Care Foundation, 50121 Florence, Italy.
Lars WallentinDepartment of Medical Sciences, Cardiology and Uppsala Clinical Research Centre, Uppsala University, Uppsala, Sweden.ORCID 0000-0003-0378-6531
Barbara CasadeiDivision of Cardiovascular Medicine, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.ORCID 0000-0002-6801-1617
Chris P GaleLeeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.ORCID 0000-0003-4732-382X
Global Cardiovascular Outcomes Consortium and in collaboration with ACNAP, ACVC, EACVI, EAPC, EAPCI, EHRA, ESC Committee for Young CV Professionals, ESC Registry Committee, HFA, ESC Patient Forum and these Working Groups: aorta and peripheral vascular diseases, atherosclerosis and vascular biology, cardiac cellular electrophysiology, cardiovascular pharmacotherapy, cardiovascular regenerative and restorative medicine, cardiovascular surgery, cellular biology of the heart, e-cardiology, myocardial function, pulmonary circulation and right ventricular function and thrombosis

Funding

Daiichi Sankyo Europe GmbH, AmgenEdwards Lifesciences, Boehringer IngelheimJanssen Global Services LLCMedtronic International Trading SARLNovartis Pharma AGRoche, Swedish Heart Lung FoundationSwedish Heart Lung Foundation
6 · The paper itself

Abstract

BACKGROUND AND

aimsStandardized definitions for outcome measures in randomized clinical trials and observational studies are essential for robust and valid evaluation of medical products, interventions, care, and outcomes. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology aimed to create international data standards for cardiovascular clinical study outcome measures.

methodsThe EuroHeart methods for data standard development were used. From a Global Cardiovascular Outcomes Consortium of 82 experts, five Working Groups were formed to identify and define key outcome measures for: cardiovascular disease (generic outcomes), acute coronary syndrome and percutaneous coronary intervention (ACS/PCI), atrial fibrillation (AF), heart failure (HF) and transcatheter aortic valve implantation (TAVI). A systematic review of the literature informed a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition and categorized the variable as mandatory (Level 1) or optional (Level 2) based on its clinical importance and feasibility.

resultsAcross the five domains, 24 Level 1 (generic: 5, ACS/PCI: 8, AF: 2; HF: 5, TAVI: 4) and 48 Level 2 (generic: 18, ACS-PCI: 7, AF: 6, HF: 2, TAVI: 15) outcome measures were defined.

conclusionsInternationally derived and endorsed definitions for outcome measures for a range of common cardiovascular diseases and interventions are presented. These may be used for data alignment to enable high-quality observational and randomized clinical research, audit, and quality improvement for patient benefit.

Indexed as

Cardiovascular DiseasesRandomized Controlled Trials as TopicRegistriesAcute Coronary SyndromeDelphi TechniqueEuropeHeart FailureHumansOutcome Assessment, Health CarePercutaneous Coronary InterventionTranscatheter Aortic Valve ReplacementAcute coronary syndromeAtrial fibrillationHeart failureOutcomesRegistry, data, EuroHeartTranscatheter aortic valve intervention

Identifiers

PMID39545867
PMCPMC11704390

What OpenQuestion holds

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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.