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Decision making about healthcare-related tests and diagnostic test strategies. Paper 1: a new series on testing to improve people's health

  • Holger J. Schünemann
    Correspondence
    Corresponding author. Department of Health Research Methods, Evidence, and Impact, McMaster University, HSC Room 2C16, 1280 Main Street, West Hamilton, Ontario L8S 4K1, Canada. Tel.: 905-525-9140x24931; fax: 905-522-9507.
    Affiliations
    Department of Health Research Methods, Evidence, and Impact (formerly Clinical Epidemiology and Biostatistics) & McGRADE Center, McMaster University, Hamilton, Canada

    Department of Medicine, McMaster University, Hamilton, Canada
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  • Reem A. Mustafa
    Affiliations
    Department of Health Research Methods, Evidence, and Impact (formerly Clinical Epidemiology and Biostatistics) & McGRADE Center, McMaster University, Hamilton, Canada

    Department of Medicine, University of Missouri-Kansas City, Kansas City, Missouri, USA
    Search for articles by this author
Published:September 15, 2017DOI:https://doi.org/10.1016/j.jclinepi.2017.09.006
      Over three decades ago, authors suggested that the use of healthcare-related tests must lead to a net health benefit beyond knowing about the presence or absence of disease [
      ,
      • Köbberling J.
      • Trampisch H.J.
      • Windeler J.
      Memorandum for the evaluation of diagnostic measures.
      ,
      • Fryback D.G.
      • Thornbury J.R.
      The efficacy of diagnostic imaging.
      ]. Achieving this net health benefit will depend on the perspective that is taken: in a clinical encounter, from the patient perspective, this net benefit is expected by the patient, whereas in a public health or health policy setting with a health system perspective, this benefit is expected at the population level, for example, through screening programs. The Grading of Recommendations Assessment, Development, and Evaluation working group requires that, to place high confidence in the use of tests in healthcare recommendations, an evaluation and demonstration of patient or population important benefit must be available [
      • Schunemann H.J.
      • Oxman A.D.
      • Brozek J.
      • Glasziou P.
      • Jaeschke R.
      • Vist G.E.
      • et al.
      Grading quality of evidence and strength of recommendations for diagnostic tests and strategies.
      ,
      • Schünemann H.J.
      • Mustafa R.
      • Brozek J.
      • Santesso N.
      • Alonso-Coello P.
      • Guyatt G.
      • et al.
      GRADE Guidelines: 16. GRADE evidence to decision frameworks for tests in clinical practice and public health.
      ]. It specifically asks about the certainty in the evidence (also known as strength of evidence, quality of the evidence or confidence in the estimates) when test accuracy information is linked to evidence about patient or population outcomes. Despite this recognition of the “why and how” about tests in healthcare, from a methodological standpoint, the work presented in this series suggests that surprisingly little progress has been made. Clarity on how to evaluate and use information about this net benefit for decision-making is lacking: the field has not advanced sufficiently in its application for decision-making in healthcare recommendations. For example, debates about systematic reviews evaluating test properties often focus on diagnostic test accuracy making them of little use for direct decision-making. Those developing recommendations about the use of tests in healthcare recognize this limitation but are frequently constrained to making guesses about whether or not the test or a test strategy yields more benefit than harm. They often cannot follow the simple principle described at the outset to cause more benefit than harm through the use of test because they are unable to operationalize the general concepts as a result of lack of resources, time, and instructions. Using mixed-methods, including systematic reviews, qualitative research, and formal user testing of suggested solutions, this series provides a 360° review and evaluation for this field (Table 1).
      Table 1Series on methodological challenges and suggested solutions in decision-making about healthcare-related tests and diagnostic strategies
      • 1.
        A new series on testing to improve people's health (introduction)
      • 2.
        A review of methodological and practical challenges
      • 3.
        A systematic review shows limitations in most tools designed to assess quality and develop recommendations
      • 4.
        International guidelines show variability in their approaches
      • 5.
        A qualitative study with experts suggests that test accuracy data alone is rarely sufficient for decision making
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