{
  "abstract": "The WHO defines health equity as ‘the absence of unfair, avoidable or remediable differences among groups of people based on various dimensions of inequality (eg, sex, gender, ethnicity, disability or sexual orientation)’.1 In the context of clinical trials, equity is entangled with diversity (improving representativeness) and inclusion (eliminating barriers to participation) (DEI: diversity, equity and inclusion). These concepts—which are commonly used interchangeably in the literature—inform the design and conduct of trials that enrol participants targeting populations most likely to benefit.2 Interest in DEI in clinical trials has been increasing for the last two decades.3 However, evidence has shown that participants in randomised controlled trials (RCTs) usually do not fully represent the population afflicted with the condition/disease being studied and underserved groups are often excluded.3 The UK National Institute for Health and Care Research considers 34 underserved groups, classified by four factors: demographic (n=6), social and economic (n=14), health status (n=12), and disease specific (n=2).4 High-income countries are becoming more diverse. In the USA, the need to improve RCT equity has been recently highlighted.3 Investigators aiming to respect equity in their RCTs should use a framework like PROGRESS Plus (Place of residence, Race, Occupation, Gender, Religion, Education, Socio-economic status, Social capital and ‘Plus’ that includes other context specific factors).5",
  "authors": [
    {
      "affiliations": [
        "Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, (IIF-FJD, UAM), Madrid, Spain"
      ],
      "name": "Rafael Dal-Re"
    },
    {
      "affiliations": [
        "Department of Cardiology, Hospital Santa Maria, CAML, Lisbon, Portugal",
        "Faculty of Medicine, University of Lisbon (FMUL), University Hospital of Santa Maria, CHULN, Lisbon, Portugal"
      ],
      "name": "Ana Abreu"
    },
    {
      "affiliations": [
        "Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark",
        "Cardiovascular Non-Invasive Imaging Research Laboratory, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark",
        "Steno Diabetes Center Copenhagen, Copenhagen, Denmark",
        "Department of Cardiology, Copenhagen University Hospital – Rigshospitalet, Copenhagen, Denmark"
      ],
      "name": "Tor Biering-Sørensen"
    },
    {
      "affiliations": [
        "Leeds Institute for Data Analytics, University of Leeds, Leeds, UK",
        "Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK",
        "Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK"
      ],
      "name": "Christopher P Gale"
    },
    {
      "affiliations": [
        "Institute of Clinical Medicine, University of Oslo, Oslo, Norway",
        "Department of Cardiology, Oslo University Hospital Ullevål, Oslo, Norway"
      ],
      "name": "Sigrun Halvorsen"
    },
    {
      "affiliations": [
        "Centre for Social Ethics and Policy, Department of Law, School of Social Sciences, University of Manchester, Manchester, UK",
        "Center for Medical Ethics, HELSAM, Faculty of Medicine, University of Oslo, Oslo, Norway"
      ],
      "name": "Søren Holm"
    },
    {
      "affiliations": [
        "Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain",
        "Department of Cardiology, Health Research Institute-Fundación Jiménez Díaz University Hospital, (IIF-FJD, UAM), Madrid, Spain",
        "CIBERCV, Madrid, Spain"
      ],
      "name": "Borja Ibanez"
    },
    {
      "affiliations": [
        "Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden",
        "Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden"
      ],
      "name": "Stefan James"
    },
    {
      "affiliations": [
        "Department of Acute Brain and Cardiovascular Injury, Institute for Pharmacological Research Mario Negri IRCCS, Milano, Italy"
      ],
      "name": "Roberto Latini"
    },
    {
      "affiliations": [
        "Institute for Biomedical Ethics, University of Basel, Basel, Switzerland",
        "Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands"
      ],
      "name": "David Shaw"
    }
  ],
  "title": "Equity and representativeness in pragmatic drug trials: methodological and ethical considerations",
  "uid": "33e02d6c-4bfc-5c87-ab2a-559638e21b95"
}