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Health technology assessment of diagnostic tests: a state of the art review of methods guidance from international organizations

Ferrante di Ruffano, L; Harris, IM; Zhelev, Z; Davenport, C; Mallett, S; Peters, J; Takwoingi, Y; ... Hyde, C; + view all (2023) Health technology assessment of diagnostic tests: a state of the art review of methods guidance from international organizations. International journal of technology assessment in health care , 39 (1) , Article e14. 10.1017/S0266462323000065. Green open access

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Abstract

OBJECTIVES: To identify which international health technology assessment (HTA) agencies are undertaking evaluations of medical tests, summarize commonalities and differences in methodological approach, and highlight examples of good practice. METHODS: A methodological review incorporating: systematic identification of HTA guidance documents mentioning evaluation of tests; identification of key contributing organizations and abstraction of approaches to all essential HTA steps; summary of similarities and differences between organizations; and identification of important emergent themes which define the current state of the art and frontiers where further development is needed. RESULTS: Seven key organizations were identified from 216 screened. The main themes were: elucidation of claims of test benefits; attitude to direct and indirect evidence of clinical effectiveness (including evidence linkage); searching; quality assessment; and health economic evaluation. With the exception of dealing with test accuracy data, approaches were largely based on general approaches to HTA with few test-specific modifications. Elucidation of test claims and attitude to direct and indirect evidence are where we identified the biggest dissimilarities in approach. CONCLUSIONS: There is consensus on some aspects of HTA of tests, such as dealing with test accuracy, and examples of good practice which HTA organizations new to test evaluation can emulate. The focus on test accuracy contrasts with universal acknowledgment that it is not a sufficient evidence base for test evaluation. There are frontiers where methodological development is urgently required, notably integrating direct and indirect evidence and standardizing approaches to evidence linkage.

Type: Article
Title: Health technology assessment of diagnostic tests: a state of the art review of methods guidance from international organizations
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1017/S0266462323000065
Publisher version: https://doi.org/10.1017/S0266462323000065
Language: English
Additional information: © The Author(s), 2023. Published by Cambridge University Press. This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.
Keywords: Diagnostic tests, health technology assessment, methods, Technology Assessment, Biomedical, Attitude, Cost-Benefit Analysis, Consensus, International Agencies
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Experimental and Translational Medicine
URI: https://discovery.ucl.ac.uk/id/eprint/10165781
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