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    Setting clinical performance specifications to develop and evaluate biomarkers for clinical use

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    Authors
    Lord, SJ
    St John, A
    Bossuyt, PM
    Sandberg, S
    Monaghan, Phillip J
    O'Kane, M
    Cobbaert, CM
    Roddiger, R
    Lennartz, L
    Gelfi, C
    Horvath, AR
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    Affiliation
    School of Medicine, University of Notre Dame, Darlinghurst, New South Wales, Australia
    Issue Date
    2019
    
    Metadata
    Show full item record
    Abstract
    BACKGROUND: Biomarker discovery studies often claim 'promising' findings, motivating further studies and marketing as medical tests. Unfortunately, the patient benefits promised are often inadequately explained to guide further evaluation, and few biomarkers have translated to improved patient care. We present a practical guide for setting minimum clinical performance specifications to strengthen clinical performance study design and interpretation. METHODS: We developed a step-by-step approach using test evaluation and decision-analytic frameworks and present with illustrative examples. RESULTS: We define clinical performance specifications as a set of criteria that quantify the clinical performance a new test must attain to allow better health outcomes than current practice. We classify the proposed patient benefits of a new test into three broad groups and describe how to set minimum clinical performance at the level where the potential harm of false-positive and false-negative results does not outweigh the benefits. (1) For add-on tests proposed to improve disease outcomes by improving detection, define an acceptable trade-off for false-positive versus true-positive results; (2) for triage tests proposed to reduce unnecessary tests and treatment by ruling out disease, define an acceptable risk of false-negatives as a safety threshold; (3) for replacement tests proposed to provide other benefits, or reduce costs, without compromising accuracy, use existing tests to benchmark minimum accuracy levels. CONCLUSIONS: Researchers can follow these guidelines to focus their study objectives and to define statistical hypotheses and sample size requirements. This way, clinical performance studies will allow conclusions about whether test performance is sufficient for intended use. KEYWORDS: Test evaluation; biomarker; clinical accuracy; clinical performance; medical tests; research methods
    Citation
    Lord SJ, St John A, Bossuyt PM, Sandberg S, Monaghan PJ, O'Kane M, et al. Setting clinical performance specifications to develop and evaluate biomarkers for clinical use. Ann Clin Biochem. 2019 Apr 16:4563219842265.
    Journal
    Annals of Clinical Biochemistry
    URI
    http://hdl.handle.net/10541/621856
    DOI
    10.1177/0004563219842265
    PubMed ID
    30987429
    Additional Links
    https://dx.doi.org/10.1177/0004563219842265
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1177/0004563219842265
    Scopus Count
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    All Christie Publications

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