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{
    "pk": 11696,
    "title": "Understanding the Use of Composite Endpoints in Clinical Trials",
    "subtitle": null,
    "abstract": "Clinicians, institutions, healthcare networks, and policymakers use outcomes reported in clinical trials as the basis for medical decision-making when managing individual patients or populations. Therefore, the choice of a valid primary endpoint is crucial for randomized controlled trials (RCT) to demonstrate efficacy of new therapies. Recent improvements in treatment, however, have led to a decline in the morbidity and mortality of several common diseases, resulting in a reduction in relevant outcomes that can be used as clinical trial endpoints. Composite endpoints have been used as a solution to maintain the feasibility of RCTs, particularly when facing low event rates, high cost, and long follow-up. However, the benefits of using composite endpoints must be weighed against the risks of misinterpretation by clinicians and policymakers, as incorrect interpretation may have a detrimental effect on patients and populations. This paper defines a composite endpoint, discusses the rationale for its use, and provides a practical approach to interpreting results to aid in medical decision-making.",
    "language": "en",
    "license": {
        "name": "Creative Commons Attribution 4.0",
        "short_name": "CC BY 4.0",
        "text": "Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.\r\n\r\nNo additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.",
        "url": "https://creativecommons.org/licenses/by/4.0"
    },
    "keywords": [
        {
            "word": "Composite end point, composite endpoint, composite outcome, randomized clinical trial, evidence-based medicine"
        }
    ],
    "section": "Population Health Research Design",
    "is_remote": true,
    "remote_url": "https://escholarship.org/uc/item/4693j9pv",
    "frozenauthors": [
        {
            "first_name": "C.",
            "middle_name": "Eric",
            "last_name": "McCoy",
            "name_suffix": "",
            "institution": "UC Irvine School of Medicine, Department of Emergency Medicine, Orange, California",
            "department": "None"
        }
    ],
    "date_submitted": "2018-03-21T04:54:11Z",
    "date_accepted": "2018-03-21T04:54:11Z",
    "date_published": "2018-06-04T20:50:37Z",
    "render_galley": null,
    "galleys": [
        {
            "label": "",
            "type": "pdf",
            "path": "https://journalpub.escholarship.org/westjem/article/11696/galley/6287/download/"
        }
    ]
}