Publication Digest: Methodological review reveals essential gaps and inconsistencies in clinical claims, effects, and outcomes in HTA reviews of diagnostic tests

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. 

In a recent publication, Dinnes et al. conducted a methodological review of 45 HTAs (50 review questions) of diagnostic tests to assess how clearly clinical pathways, test claims, and outcomes are specified within existing HTAs. Although 98% of HTAs described the clinical pathway, only 56% clearly articulated clinical claims, and in 54% at least one test effect mechanism could not be linked to prespecified outcomes. Moreover, 82% of HTAs reported outcomes that were not aligned with stated claims. These methodological gaps and inconsistencies risk under- or overestimating the true value of diagnostic technologies, highlighting the need for standardized tools to systematically define clinical pathways, test claims, and outcomes.

Access the full-text article here.