Establishing the Value of Diagnostic and Prognostic Tests in Health Technology Assessment

TY - JOUR

T1 - Establishing the Value of Diagnostic and Prognostic Tests in Health Technology Assessment

AU - Soares, Marta O

AU - Walker, Simon

AU - Palmer, Stephen J

AU - Sculpher, Mark J

N1 - © 2018, The Author(s). This is an author-produced version of the published paper. Uploaded in accordance with the publisher’s self-archiving policy. Further copying may not be permitted; contact the publisher for details

PY - 2018/5

Y1 - 2018/5

N2 - In recent years, Health Technology Assessment (HTA) processes specific to diagnostics and prognostic tests have been created in response to the increased pressure on health systems to decide not only which tests should be used in practice but also the best way to proceed, clinically, from the information they provide. These technologies differ in the way value is accrued to the population of users, depending critically on the value of downstream health care choices. This paper defines an analytical framework for establishing the value of diagnostic and prognostic tests for HTA in a way that is consistent with methods used for the evaluation of other health care technologies. It assumes a linked-evidence approach where modeling is required, and incorporates considerations regarding several different areas of policy, such as personalized medicine. We initially focus on diagnostic technologies with dichotomous results, and then extend the framework by considering diagnostic tests that provide more complex information, such as continuous measures (for example, blood glucose measurements) or multiple categories (such as tumor classification systems). We also consider how the methods of assessment differ for prognostic information or for diagnostics without a reference standard. Throughout, we propose innovative graphical ways of summarizing the results of such complex assessments of value.

AB - In recent years, Health Technology Assessment (HTA) processes specific to diagnostics and prognostic tests have been created in response to the increased pressure on health systems to decide not only which tests should be used in practice but also the best way to proceed, clinically, from the information they provide. These technologies differ in the way value is accrued to the population of users, depending critically on the value of downstream health care choices. This paper defines an analytical framework for establishing the value of diagnostic and prognostic tests for HTA in a way that is consistent with methods used for the evaluation of other health care technologies. It assumes a linked-evidence approach where modeling is required, and incorporates considerations regarding several different areas of policy, such as personalized medicine. We initially focus on diagnostic technologies with dichotomous results, and then extend the framework by considering diagnostic tests that provide more complex information, such as continuous measures (for example, blood glucose measurements) or multiple categories (such as tumor classification systems). We also consider how the methods of assessment differ for prognostic information or for diagnostics without a reference standard. Throughout, we propose innovative graphical ways of summarizing the results of such complex assessments of value.

KW - Journal Article

U2 - 10.1177/0272989X17749829

DO - 10.1177/0272989X17749829

M3 - Article

C2 - 29529918

SN - 0272-989X

VL - 38

SP - 495

EP - 508

JO - Medical Decision Making

JF - Medical Decision Making

IS - 4

ER -