When Cochlear implants (CI) were first introduced, only postlingually, profoundly hearing impaired individuals were implanted unilaterally. As experience grew, eligibility was followed by prelingual deaf children, and a second contralateral CI was being considered. Due to surgical and technological improvements, eligibility criteria for CI are now shifting, encompassing patients with more residual hearing. We aimed to explore, ex ante, whether such shift is warranted.

A dynamic, population-based Markov modeling study was conducted. Model parameters were based on available evidence, expert opinion, and calibration. The model mimics Dutch demographic development in three age categories over a period of 20 years. Impact of changing eligibility was explored in terms of number of CI recipients, costs, quality of life and cost-effectiveness from a societal perspective.

If those with severe hearing loss would qualify and opt for CI similar to those with profound hearing loss, this would lead to a fourfold increase of CI recipients (from 8,815 to 35,630) over a 20 year period, resulting in an increase in costs (EUR 550 million) and QALYs (54,000), with an Incremental Cost Utility Ratio of EUR 10,771/QALY (2.5–97.5 percentiles: 1,252–23,171).

Results suggest that expected health gains could be such, that the investment may be considered cost-effective against the backdrop of currently prevailing criteria. However, for this, a substantial increase in operating capacity, follow-up care and rehabilitation are required. Further inquiries are needed to investigate whether such increased capacity can be achieved, to ensure equitable access to those services.

To conduct a formative evaluation of applying the VALIDATE approach in practice by (i) assessing how students appreciated the e-learning course, (ii) exploring how, for what purposes and with what outcomes the acquired VALIDATE competences subsequently were used in internships in different institutional contexts, and how this was shaped by these contexts, and (iii) what this shows on real-world use of VALIDATE.

Comparative discussion of experiences of applying the VALIDATE approach via a semistructured survey and oral feedback from e-course students; final reports on internships in health technology assessment (HTA) practice, followed by semistructured interviews with interns and supervisors to complement and interpret results.

All students considered the VALIDATE approach an enlightening and important addition to current HTA knowledge, especially regarding understanding the relation between empirical analysis and normative inquiry, identifying policy relevant questions and using the method of reconstructing interpretive frames for scoping. The latter appeared intellectually challenging and requiring some prior HTA knowledge. The use the VALIDATE approach in practice shows that interns productively redefined the HTA problem, based on appreciation of different stakeholders’ definition of the issue; they experienced constraints from retrieving all relevant perspectives from existing literature as well as from institutional rules and routines.

Some challenges in applying the VALIDATE approach deserve attention for its future use: currently used research approaches often assume a problem as “given”; and the data needed on different perspectives is often not reported in scientific literature. Finally, data gathering on and evaluation of value dimensions was experienced as challenging.

Healthcare services, such as cochlear implants and subsequent rehabilitation, aim to increase valuable activities and opportunities of those affected. Their impact may be inferred from the extent that they protect or restore capability, which reflects the real freedoms that people have to be or do things they have reason to value. Capability emerges from the dynamic interaction between available resources, individual, social, and environmental conversion factors, and functionings. This model sets the informational requirements of the capability approach.

On the basis of interviews with thirty-three hearing impaired children and thirty hearing peers, information on capability elements (values, resources, conversion factors, and functionings) was collected. Qualitative results were triangulated with standardized clinical audiological and psycholinguistic quantitative measures.

Hearing impaired children and their hearing peers concurred in terms of the doings and beings they valued, but differed in terms of conversion factors to realize capability. Parents of hearing impaired children played a more upfront role, hearing impairment predominated many areas of life, and communicating through hearing aids required more energy than was usually acknowledged by the people around them.

The capability approach offers opportunities not only to assess impact of technology on dimensions that are important to patients, but also to better understand the mechanisms that are involved in value generation.

There is no consensus on who might be qualified to conduct ethical analysis in the field of health technology assessment (HTA). Is there a specific expertise or skill set for doing this work? The aim of this article is to (i) clarify the concept of ethics expertise and, based on this, (ii) describe and specify the characteristics of ethics expertise in HTA.

Based on the current literature and experiences in conducting ethical analysis in HTA, a group of members of the Health Technology Assessment International (HTAi) Interest Group on Ethical Issues in HTA critically analyzed the collected information during two face-to-face workshops. On the basis of the analysis, working definitions of “ethics expertise” and “core competencies” of ethics experts in HTA were developed. This paper reports the output of the workshop and subsequent revisions and discussions online among the authors.

Expertise in a domain consists of both explicit and tacit knowledge and is acquired by formal training and social learning. There is a ubiquitous ethical expertise shared by most people in society; nevertheless, some people acquire specialist ethical expertise. To become an ethics expert in the field of HTA, one needs to acquire general knowledge about ethical issues as well as specific knowledge of the ethical domain in HTA. The core competencies of ethics experts in HTA consist of three fundamental elements: knowledge, skills, and attitudes.

The competencies described here can be used by HTA agencies and others involved in HTA to call attention to and strengthen ethical analysis in HTA.

To report from the Scientific Development and Capacity Building Committee of Health Technology Assessment International (HTAi) on activities that are being undertaken within HTAi regarding the promotion of scientific rigor in the field of health technology assessment (HTA).

Retrieval of definitions of HTA that the SDCB committee considered reflective of the current practice of HTA, followed by a narrative synthesis of the core components of HTA.

Several definitions of HTA have been provided, all sharing the notion that HTA is the formal, systematic, and transparent inquiry into the meaning and value, broadly defined, of health technologies, when used in specific patient populations.

Many frameworks and tools have been developed for assessing the quality of specific tasks that may be conducted in the context of HTA. Collating such frameworks and tools is likely to be helpful in developing standards and in providing guidance as to how the scientific quality of HTA may be secured. Two current trends in HTA were noted: a stronger health systems focus, and the need to involve stakeholders throughout the HTA process. A wider systems’ perspective requires that plausible alternative scenarios are being developed, and wide consultation of various stakeholders is a prerequisite to the development of such scenarios with data from various sources.

Current trends in HTA will lead to different demands on the HTA expert. The task of this emerging policy professional would be not just to provide technical information for problem-solving, but also to combine it with a new function of facilitating public deliberation and learning.

Social and cultural aspects are rarely assessed in health technology assessments (HTA), despite being part of most HTA definitions. One hypothesis for the reason why they are hardly considered in HTA is that we lack relevant assessment methods. Accordingly, this review aims at providing an overview of methodological approaches to address social and cultural aspects related to health technologies in HTA.

We conducted a comprehensive literature search by searching fourteen databases and a hand-search of two pertinent journals. Additionally, we sent a query to all member agencies of the International Network of Agencies for Health Technology Assessment (INAHTA) asking them for methods they use to assess social and cultural aspects.

A total of 125 publications met our inclusion criteria. We grouped the methodological approaches into checklists for experts, literature reviews, stakeholder participatory approaches, primary data collection methods, and combinations of methodological approaches.

There is a wide variety of methods available for assessing social and cultural aspects of health technologies, some of which have been applied in HTA. The presented overview of the different approaches and their merits can facilitate the assessment of these aspects, and improve the knowledge regarding (potential) success and failure of the implementation of a health technology.

Novel health technologies are being developed at a dizzying pace. The need to avoid unnecessary innovations and accelerate the adoption of valuable innovations is among the most important challenges facing healthcare systems today. To contribute to this challenge, we performed 30 so-called ‘early health technology assessments’ (HTA) over the last three years. We quantified the potential value, both in effects and cost. We will present our experience with performing these constructive assessments, as well as their feasibility and value in informing decisions.

We performed secondary analyses on an existing database of 30 assessments. We analyzed the phase of development, stakeholders involved, type of decision informed, and the technology's next steps.

Out of the 30 technologies, four (13 percent) were in the idea screening phase, and had not yet started the development. Here, the room for improvement (headroom) was assessed. For 16 (53 percent) technologies that were under development but not yet studied, we performed headroom and threshold analyses. For the 10 (33 percent) developed technologies where some (pilot) data were already available, scenario and/or cost-effectiveness analyses were performed. The assessments, that were commissioned by developers, clinicians or hospital managers informed evidence-based decisions on (further) development, focus, research design or adoption in clinical practice. Preliminary results suggest that after the assessment, decisions were made to stop further development (n=2), continue outside healthcare (n=1), change the target population (n=3) or change the proposed positioning in the care pathway and/or value proposition (n=4).

Stakeholders deemed an early, formative assessment useful in informing development, research and adoption decisions, in different stages of development. Even before developing a technology, headroom analyses appeared to be feasible and useful. Consequences of the assessments mostly related to a shift in focus, which may result in more efficient research and development, as well as more valuable innovations.

As model-based economic evaluations (MBEEs) are widely used to make decisions in the context of policy, it is imperative that they represent clinical practice. Here, we assess the relevance of MBEEs on dabigatran for the prevention of stroke in patients with atrial fibrillation (AF).

We performed a systematic review on the basis of a developed questionnaire, tailored to oral anticoagulation in patients with AF. Included studies had a full body text in English, compared dabigatran with a vitamin K antagonist, were not dedicated to one or more subgroup(s), and yielded an incremental cost-effectiveness ratio. The relevance of all MBEEs was assessed on the basis of ten context-independent factors, which encompassed clinical outcomes and treatment duration. The MBEEs performed for the United States were assessed on the basis of seventeen context-dependent factors, which were related to the country's target population and clinical environment.

The search yielded twenty-nine MBEEs, of which six were performed for the United States. On average, 54 percent of the context-independent factors were included per study, and 37 percent of the seventeen context-dependent factors in the U.S. studies. The share of relevant factors per study did not increase over time.

MBEEs on dabigatran leave out several relevant factors, limiting their usefulness to decision makers. We strongly urge health economic researchers to improve the relevance of their MBEEs by including context-independent relevance factors, and modeling context-dependent factors befitting the decision context concerned.

Priority setting in health care has been long recognized as an intrinsically complex and value-laden process. Yet, Health Technology Assessment (HTA) agencies presently employ value assessment frameworks that are ill-fitted to capture the range and diversity of stakeholder values, and thereby risk to compromise the legitimacy of their recommendations. We propose ‘evidence-informed deliberative processes’ as an alternative framework with the aim to enhance this legitimacy.

The framework is based on an integration of two increasingly popular and complementary frameworks for priority setting: multi-criteria decision analysis (MCDA) and accountability for reasonableness (A4R), Evidence-informed deliberative processes are, on the one hand, based on early, continued stakeholder deliberation to learn about the importance of relevant social values. On the other hand, they are based on rational decision-making – through evidence-informed evaluation of the identified values.

The framework has important implications for how HTA agencies should ideally organize their processes. Firstly, HTA agencies should take the responsibility to organize stakeholder involvement. Second, agencies are advised to integrate their assessment and appraisal phase, allowing for the timely collection of evidence on values that are considered relevant. Third, HTA agencies should subject their specification of decision-making criteria to public scrutiny. Fourth, agencies are advised to use a checklist of potentially relevant criteria, and to provide argumentation how each criterion affected the recommendation. Fifth, HTA agencies must publish their argumentation and install options for appeal.

Adopting ‘evidence-informed deliberative processes’ as a value assessment framework could be an important step forward for HTA agencies to optimize the legitimacy of their priority setting decisions. Agencies can incorporate elements according to their needs and affordances.