{
  "abstract": "Background Outcome measure choice and definition can determine the result of the study. We describe outcome measures and their definitions for cardiovascular studies in highly cited medical journals.Methods Cardiovascular phase III or IV randomised clinical trials (RCTs) or multicentre observational studies published in the New England Journal of Medicine, Lancet or Journal of the American Medical Association between 1 January 2013 and 6 June 2024 from Embase and Ovid Medline were included. Two independent reviewers selected the studies and extracted the primary and secondary outcome measures from each publication.Results 386 studies (83% RCTs; 17% observational) representing 10 699 147 participants were included. Studies investigated coronary heart disease (51%), cardiomyopathy/heart failure (22%), heart rhythm disease (15%), valvular heart disease (11%) and ‘other’ cardiovascular diseases (1%), with 45% investigating a device and 48% funded by industry. The most frequently reported primary outcome measure was a composite (63%), the most frequent component of which was myocardial infarction (58%). The use of a composite for the primary outcome measure increased from 49% of studies in 2013 to a peak of 85% in 2018. From 2013 to 2023, the median number of secondary outcome measures per study increased for RCTs (3–8) and observational studies (0–7). Definitions for cardiovascular mortality, myocardial infarction and stroke varied across the studies.Conclusions For cardiovascular studies published in highly cited journals, there has been an expansion in the use of primary composite outcome measures and secondary outcome measures, with heterogeneity in the definition of primary outcome measures. A standardised approach to the use of cardiovascular outcomes measures is required.",
  "authors": [
    {
      "affiliations": [
        "Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK",
        "Leeds Institute for Data Analytics, University of Leeds, Leeds, UK"
      ],
      "name": "Asad Bhatty"
    },
    {
      "affiliations": [
        "Hull York Medical School, University of York, York, UK",
        "Academic Cardiovascular Unit, James Cook University Hospital, Middlesbrough, UK"
      ],
      "name": "Chris Wilkinson"
    },
    {
      "affiliations": [
        "Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK",
        "Department of Cardiology, St. Paul’s Hospital, Vancouver, British Columbia, Canada"
      ],
      "name": "Suleman Aktaa"
    },
    {
      "affiliations": [
        "Uppsala Clinical Research Center and Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden"
      ],
      "name": "Gorav Batra"
    },
    {
      "affiliations": [
        "Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK"
      ],
      "name": "Benjamin Beska"
    },
    {
      "affiliations": [
        "Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK"
      ],
      "name": "Phyo H Khaing"
    },
    {
      "affiliations": [
        "Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK",
        "Leeds Institute for Data Analytics, University of Leeds, Leeds, UK"
      ],
      "name": "Ali Wahab"
    },
    {
      "affiliations": [
        "Hull York Medical School, University of York, York, UK",
        "Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK"
      ],
      "name": "Keerthenan Raveendra"
    },
    {
      "affiliations": [
        "Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK"
      ],
      "name": "Ahmed Taha"
    },
    {
      "affiliations": [
        "Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK",
        "Leeds Institute for Data Analytics, University of Leeds, Leeds, UK"
      ],
      "name": "Ramesh Nadarajah"
    },
    {
      "affiliations": [
        "Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, New York, USA"
      ],
      "name": "Deepak L Bhatt"
    },
    {
      "affiliations": [
        "Institute of Cardiovascular Medicine and Science, Liverpool Heart & Chest Hospital NHS Foundation Trust, Liverpool, UK"
      ],
      "name": "Rod Stables"
    },
    {
      "affiliations": [
        "Division of Clinical Sciences, City St George’s Hospital, Tooting, London, UK"
      ],
      "name": "John Camm"
    },
    {
      "affiliations": [
        "Oxford Heart Centre, Oxford University Hospitals NHS Trust, Oxford, UK"
      ],
      "name": "Rajesh K Kharbanda"
    },
    {
      "affiliations": [
        "BHF Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK"
      ],
      "name": "David E Newby"
    },
    {
      "affiliations": [
        "School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK",
        "Golden Jubilee National Hospital, Clydebank, UK"
      ],
      "name": "Mark C Petrie"
    },
    {
      "affiliations": [
        "Wolfson Institute of Population Health, Queen Mary University of London, Barts and The London School of Medicine and Dentistry, London, UK"
      ],
      "name": "Jianhua Wu"
    },
    {
      "affiliations": [
        "MRC Clinical Trials Unit at UCL, University College London, London, UK",
        "BHF Data Science Centre, Health Data Research UK, Redditch, UK"
      ],
      "name": "Matthew R Sydes"
    },
    {
      "affiliations": [
        "Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK",
        "Leeds Institute for Data Analytics, University of Leeds, Leeds, UK"
      ],
      "name": "Chris P Gale"
    }
  ],
  "title": "Outcome measures for randomised clinical trials and multicentre observational studies of cardiovascular diseases published in major clinical journals: systematic review and evidence mapping",
  "uid": "b817076a-40a9-57eb-a345-331f6b54a79f"
}