Integrating Empirical Analysis and Normative Inquiry in Health Technology Assessment: The Values in Doing Assessments of Health Technologies Approach

Abstract

Health technology assessment (HTA) aims, through empirical analysis, to shed light on the value of health technologies (O’Rourke et al. [2020, International Journal of Technology Assessment in Health Care 36, 187–90]). HTA is, then, where facts and values meet. But how, where, and when do facts and values meet in HTA? Currently, HTA is usually portrayed as a sequential process, starting with empirical analysis (assessment), followed by a deliberation on the implications of the findings for a judgment of a health technology’s value (appraisal). In this paper, we will argue that in HTA, empirical analysis and normative inquiry are much more closely entwined. In fact, as we hope to show, normative commitments act as an indispensable guide for the collection and interpretation of empirical evidence. Drawing on policy sciences, we will suggest a concrete methodology that can help HTA practitioners to integrate empirical analysis and normative inquiry in a transparent way. The proposed methodology can be conceived as a concrete means for conducting a scoping exercise in HTA. Moreover, it offers a distinct way of giving stakeholders a structural and constructive role in HTA. This paper outlines the approach developed by the values in doing assessments of health technologies project, a project funded by the Erasmus+ program (contract number 2018-1-NL01-KA203-038960), which is the European Union’s program to support education, training, youth, and sport in Europe. The project has resulted in an E-learning course, an accompanying handbook, and a consensus statement, all freely available from the project’s website www.validatehta.eu.

Learning and practicing more value-reflective, problem-setting health technology assessment: experiences and lessons from the VALIDATE project

“…These outcomes are confirmed by the answers given by six interns (others than the nine above) to open questions in the online evaluation form of their internships (for details, see ). [The internship] “allowed me to apply the notions studied during the VALIDATE course… I found very interesting” (#1); “allowed me to grasp in a more comprehensive way the novelty of the VALIDATE approach: formulating what the problem is and also finding myself dealing with a different problem from the one I was expecting” (#4); For #2 the best part was the “opportunity to see multiple points of view regarding a given health issue, trying to understand what are the reasons of the various actors involved and giving weight and value to their ideas”; for #6, “the greatest discovery was that there are other ways of doing research …, which touches upon personal views and stories. This was an aspect I really missed during my studies.”…”

“…Also, the professional logics informing what facts to collect, and which outcome measures are relevant, are “self-evidently” adopted. Recognizing this, the VALIDATE ( VALues In Doing Assessments of healthcare Technologies ) approach holds that empirical analysis in HTA should always be viewed in conjunction with the interpretive frames (IFs) from which such analysis makes sense (1). An IF is defined as a perspective on a particular issue in a particular context comprising the problem definition and solution assessment of that issue; and generic beliefs that form the lens through which the issue-in-context is perceived: background theories and normative preferences (2).…”

Ethical, Legal, Organisational and Social Issues of Teleneurology: A Scoping Review

“…A detailed protocol for the review was developed by the research team and further approved by the Spanish Ministry of Health (available from the corresponding author on request). The assessment of ethical, legal, organisational and social aspects was carried out by adapting the framework of the Core Model 3.0 of EUnetHTA, the criteria established by the Spanish Network of Agencies for Health Technology Assessment for the National Health Service, and the analysis criteria of the European VALIDATE Project (VALues In Doing Assessments of healthcare TEchnologies) [ 20 , 21 , 22 ]. None of these frameworks addresses patient safety specifically in teleneurology, but rather in general health technology terms.…”

Civil society and medical product access in Africa: Lessons from COVID-19

“…This includes community and non-state stakeholders such as non-governmental and civil society organisations ( 1 , 2 ). Community and patient experiences, burdens of disease, patient needs and issues of equity and stigma are important considerations in health care ( 3 ), where value assessments are influenced by social and historical settings ( 4 ). Some countries may however lack political freedom or will to transparently discuss and define their priorities in building the required resources to deliver on health care.…”