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Proposals for a Phased Evaluation of Medical Tests

Author

Listed:
  • Jeroen G. Lijmer

    (Department of Psychiatry, Waterland Hospital, Purmerend, the Netherlands, Department of Clinical Epidemiology & Biostatistics, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands)

  • Mariska Leeflang

    (Department of Clinical Epidemiology & Biostatistics, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands)

  • Patrick M. M. Bossuyt

    (Department of Clinical Epidemiology & Biostatistics, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands, p.m.bossuyt@amc.nl)

Abstract

Background. In drug development, a 4-phase hierarchical model for the clinical evaluation of new pharmaceuticals is well known. Several comparable phased evaluation schemes have been proposed for medical tests. Purpose. To perform a systematic search of the literature, a synthesis, and a critical review of phased evaluation schemes for medical tests. Data Sources. Literature databases of Medline, Web of Science, and Embase. Study Selection and Data Extraction. Two authors separately evaluated potentially eligible papers and independently extracted data. Results. We identified 19 schemes, published between 1978 and 2007. Despite their variability, these models show substantial similarity. Common phases are evaluations of technical efficacy, diagnostic accuracy, diagnostic thinking efficacy, therapeutic efficacy, patient outcome, and societal aspects. Conclusions. The evaluation frameworks can be useful to distinguish between study types, but they cannot be seen as a necessary sequence of evaluations. The evaluation of tests is most likely not a linear but a cyclic and repetitive process.

Suggested Citation

  • Jeroen G. Lijmer & Mariska Leeflang & Patrick M. M. Bossuyt, 2009. "Proposals for a Phased Evaluation of Medical Tests," Medical Decision Making, , vol. 29(5), pages 13-21, September.
    • Handle: RePEc:sae:medema:v:29:y:2009:i:5:p:e13-e21
    DOI: 10.1177/0272989X09336144
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    Citations

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    Cited by:

    1. Mark Helfand, 2009. "Web Exclusive White Paper Series on Diagnostic Test Evaluation," Medical Decision Making, , vol. 29(5), pages 634-635, September.
    2. Alison Bray & Emmanouela Kampouraki & Amanda Winter & Aaron Jesuthasan & Ben Messer & Sara Graziadio, 2020. "High Variability in Sepsis Guidelines in UK: Why Does It Matter?," IJERPH, MDPI, vol. 17(6), pages 1-18, March.
    3. Thomas A. Trikalinos & Uwe Siebert & Joseph Lau, 2009. "Decision-Analytic Modeling to Evaluate Benefits and Harms of Medical Tests: Uses and Limitations," Medical Decision Making, , vol. 29(5), pages 22-29, September.

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