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

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.

Reducing low-value radiological services in Norway -a qualitative multi-professional study on measures and facilitators for change.

BACKGROUND: Overuse, underuse, and significant variation in the utilisation of radiological services are well documented in the literature. Several radiological examinations are identified as low-value examinations as they do not lead to a change in diagnosis or course of treatment. Even so, such examinations are frequently performed. Many measures for reducing low-value imaging have been carried out with variable outcomes. While there is little evidence as to why some measures work and others do not, adjusting to the context seems important for success. The objective of this study was to investigate which measures stakeholders consider appropriate for reducing the use of low-value imaging and what it takes to make them work. METHODS: Semi-structured interviews were conducted among radiographers, radiologists, radiological department managers, hospital clinicians, general practitioners, and health government/authorities' representatives. The interview guide covered two broad areas: Experience with low-value services, and possible future measures deemed appropriate for reducing low-value services. Data were analysed in line with a qualitative framework analysis. RESULTS: The analysis included information from 27 participants. All participants acknowledged that low-value imaging was a problem, but few had very specific suggestions on reducing this in practice. Suggested measures were to stop referrals from being sent, provide support in assessing referrals, or change the healthcare system. Identified facilitators were categorised as management and resources, evidence, and experienced value. In general, appropriate measures should be practical, well-founded, and valuable. CONCLUSIONS: This study provides insight into various stakeholders' perceptions of suitable interventions to reduce low-value imaging. While many measures for reducing low-value imaging are available, contextual sensitivity is crucial to make them work.

Prioritization of COVID-19 vaccination. The added value of the "VALIDATE" approach.

Prioritization of COVID-19 vaccines is one of the most relevant topics in the current pandemic emergency. Prioritization decisions are political decisions that are value-laden, and as such of ethical nature. Despite the clear political and ethical nature of this topic, prioritization decisions are often interpreted and presented as scientific decisions. The aim of this article is twofold. First, we aim to show critical points that characterize certain pandemic vaccination plans from the ethical viewpoint using four dimensions (problem definitions, incorporation of different perspectives, context, and specification). The four dimensions were drawn from findings of the European project "VALIDATE" (VALues In Doing Assessments of healthcare TEchnologies", https://validatehta.eu). Second, we aim to reframe the issue about prioritization itself in the light of the four dimensions mentioned. Our conclusion is that policy-problem definitions, incorporation of different perspectives, contextual considerations and specification of moral principles seem to be common critical points of some vaccination plan documents. The European project "VALIDATE" seems to be able to provide a useful and profitable approach to address many of these critical points.

What can we learn from the SARS-COV-2 pandemic about the value of specific radiological examinations?

BACKGROUND: The SARS-COV-2 pandemic provides a natural intervention to assess practical priority setting and internal evaluation of specific health services, such as radiological services. Norway makes an excellent case as it had a very low infection rate and very few cases of COVID-19. Accordingly, the objective of this study is to use the changes in performed outpatient radiological examinations during the first stages of the SARS-COV-2 pandemic to assess the practical evaluation of specific radiological examinations in Norway. METHODS: Data was collected retrospectively from the Norwegian Health Economics Administration (HELFO) in the years 2015-2020. Data included the number of performed outpatient imaging examinations at public hospitals and private imaging centers in Norway and was divided in to three periods based on the level of restrictions on elective health services. Results were analyzed with descriptive statistics. RESULTS: In the first period there was a 45% reduction in outpatient radiology compared to the same time period in 2015-2019 while in period 2 and 3 there was a 25 and 6% reduction respectively. The study identified a list of specific potential low-value radiological examinations. While some of these are covered by the Choosing Wisely campaign, others are not. CONCLUSION: By studying the priority setting practice during the initial phases of the pandemic this study identifies a set of potential low value radiological examinations during the initial phases of the SARS-COV-2 pandemic. These examinations are candidates for closer assessments for health services quality improvement.

Back to WHAT? The role of research ethics in pandemic times.

The Covid-19 pandemic creates an unprecedented threatening situation worldwide with an urgent need for critical reflection and new knowledge production, but also a need for imminent action despite prevailing knowledge gaps and multilevel uncertainty. With regard to the role of research ethics in these pandemic times some argue in favor of exceptionalism, others, including the authors of this paper, emphasize the urgent need to remain committed to core ethical principles and fundamental human rights obligations all reflected in research regulations and guidelines carefully crafted over time. In this paper we disentangle some of the arguments put forward in the ongoing debate about Covid-19 human challenge studies (CHIs) and the concomitant role of health-related research ethics in pandemic times. We suggest it might be helpful to think through a lens differentiating between risk, strict uncertainty and ignorance. We provide some examples of lessons learned by harm done in the name of research in the past and discuss the relevance of this legacy in the current situation.

The first casualty of an epidemic is evidence.

BACKGROUND: The COVID-19 has posed a wide range of urgent questions: about the disease, testing, immunity, treatments, and outcomes. Extreme situations, such as pandemics, call for exceptional measures. However, this threatens the production and application of evidence. METHODS: This article applies standard categories in epistemology to analyse the pandemic in terms of four kinds of uncertainty: Risk, Fundamental uncertainty, Ignorance, and Ambiguity. RESULTS: Mapping the uncertainties of the pandemic onto the four types of uncertainty directs evidence production towards specific tasks in order to address the challenges of the pandemic: Eliminating ambiguity, being alert to the unknown, and gathering data to estimate risks are crucial to preserve evidence and save lives. CONCLUSION: In order to avoid fake facts and to provide sustainable solutions, we need to pay attention to the various kinds of uncertainty. Producing high-quality evidence is the solution, not the problem.