Dinnes, Jacqueline; Davenport, Clare; Harris, Isobel M; Ferrante di Ruffano, Lavinia; Mallett, Sue; Takwoingi, Yemisi; Deeks, Jonathan J; Dinnes, Jacqueline; Davenport, Clare; Harris, Isobel M; Ferrante di Ruffano, Lavinia; Mallett, Sue; Takwoingi, Yemisi; Deeks, Jonathan J; Hyde, Chris; - view fewer (2025) Methodological review reveals essential gaps and inconsistencies in clinical claims, effects and outcomes in HTA reviews of diagnostic tests. Journal of Clinical Epidemiology , Article 112040. 10.1016/j.jclinepi.2025.112040. (In press).

Preview

Text 1-s2.0-S0895435625003737-main.pdf - Accepted Version Download (1MB) | Preview

Abstract

Background: Essential first steps in performing a health technology assessment (HTA) for a diagnostic test include: consideration of the clinical pathway in which the test will be used, specifying the clinical claim for the test (how the test may add benefit, introduce harm or have other disadvantages beyond impact on the individual patient), and specifying the outcomes that would need to be measured to assess whether the test achieves its aims. We aimed to examine how a test evaluation framework (TEF) outlining the intended and unintended effects of tests could support the HTA process, and to identify additional ways in which tests add benefit or introduce harm. // Method: We included 45 HTAs reporting 50 review questions. The study focused on HTA reports with a full English-language evidence review, clear methods and results sections, and evaluations of a single testing strategy or technology type. We looked for mechanisms of effect included in, and additional to, a TEF previously published by our group. // Results: The clinical pathway and positioning of the new test were described in 98% of review questions (49/50), and illustrated in 62% (31/50). The test’s clinical claims were easily identifiable in 56% (28/50). Claims, mechanisms of effect and pre-specified outcomes were frequently not coherent. For instance, at least one constituent test effect mechanism (mainly timing- and confidence-related mechanisms) could not be linked to pre-specified outcomes in 54% of reviews. Most HTAs (41, 82%) listed outcomes to be evaluated in the evidence reviews that we were unable to link to the claims for the tests (acceptability of the test, test failures, accuracy, therapeutic yield and effectiveness). Four mechanisms of effect additional to those in the existing TEF were identified. Two concerned impact on individuals beyond the person being tested and two concerned organisational impact. // Conclusions: Important gaps and inconsistencies in the reporting of test claims and associated outcomes in HTA reviews risks incomplete appraisal of a test’s impact to patients and the healthcare system. We recommend tools are developed to support and standardise this complex process. This could be facilitated by tools in development and an expanded TEF.

Download activity - last month

Export as JSONXMLCSV

Download activity - last 12 months

Export as XMLCSVJSON

Downloads by country - last 12 months

Export as JSONXMLCSV

Archive Staff Only

View Item