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1.
Stud Health Technol Inform ; 299: 165-170, 2022 Nov 03.
Article in English | MEDLINE | ID: mdl-36325858

ABSTRACT

Welfare technology is expected to become a larger and more important part of the healthcare sector. This creates a need to understand, which information security risks welfare technology and affiliated devices are exposed to. In a scoping review, we present an extensive overview of relevant threats. Furthermore, some key vulnerabilities in health technologies like IoMTs and welfare technology devices are highlighted. In the conclusions, the risks relevant for welfare technology is discussed, where four top risks are emphasized as a result of the findings.


Subject(s)
Computer Security , Delivery of Health Care , Technology , Biomedical Technology , Health Facilities
2.
Int J Technol Assess Health Care ; 38(1): e78, 2022 Nov 02.
Article in English | MEDLINE | ID: mdl-36321421

ABSTRACT

Health technology assessment (HTA) is commonly used to guide evidence-informed decisions to optimize resource use, prioritize policies, and support countries to achieve universal health coverage. Producing HTAs requires time, scientific expertise, and political commitment, but these are not available in all settings - especially in low- and middle-income countries (LMIC) where HTA processes may be less institutionalized. Transferring and adapting existing HTAs to local settings may offer a solution while reducing duplication efforts. This scoping review aims to provide an overview of tools, methods, approaches, and considerations which can aid HTA transfers. We systematically searched (from 2005 to 2020) six databases and, using predefined inclusion criteria, included twenty-two studies. Data extraction followed a structured process, while synthesis was more iterative. We identified a common approach for HTA transfers. It follows the de novo process of undertaking original HTAs, but with additional steps to assess relevance (applicability), quality, and transferability, as well as steps to adapt parameters where necessary. The EUnetHTA Adaptation Toolkit was the only tool that provided guidance for adapting multiple HTA domains. Other tools were specific to systematic reviews (n = 1) or economic evaluations (n = 12), where one provided guidance for systematic reviews of economic evaluations. Eight papers reported transferring an HTA, with only one transferring to an LMIC. Finally, we reported issues that may facilitate or hinder transferability. In conclusion, we identified fourteen transfer approaches in the form of guidance or checklists, but harmonized and pragmatic guidance for HTA transfers to suit settings with limited HTA capacity seems warranted.


Subject(s)
Checklist , Technology Assessment, Biomedical , Systematic Reviews as Topic , Technology Assessment, Biomedical/methods , Cost-Benefit Analysis , Biomedical Technology
3.
Age Ageing ; 51(11)2022 Nov 02.
Article in English | MEDLINE | ID: mdl-36370146

ABSTRACT

BACKGROUND: The Mobile Health Technology for Improved Screening and Optimized Integrated Care in AF (mAFA-II) randomised trial demonstrated the efficacy of a mobile health (mHealth) technology-implemented 'Atrial fibrillation Better Care' (ABC) pathway-approach (mAFA intervention) in reducing the risk of adverse events in patients with atrial fibrillation (AF). Whether these benefits also apply to older patients is unclear. In this ancillary analysis, we evaluated the effect of mAFA intervention among older AF patients. METHODS: The mAFA-II trial enrolled adult AF patients across 40 centres in China. For this analysis, we defined older patients as those aged ≥75 years. Primary outcome was the composite of ischemic stroke or thromboembolism, all-cause death and rehospitalisation. The effect of mAFA intervention was assessed through multivariable Cox-regression models. We also evaluated the interaction between age and effect of the mAFA intervention in the main trial population. RESULTS: In this analysis, we included 1,163 AF patients ≥75 years (mean age: 82.6 ± 5.3 years, 43.1% females); 520 were allocated to mAFA intervention, 643 to usual care. mAFA intervention was associated with a significant reduction of the primary composite outcome (adjusted hazard ratio [aHR]: 0.58, 95% confidence interval [CI]: 0.35-0.97) and rehospitalisations alone (aHR: 0.47, 95%CI: 0.24-0.91). Significant interaction between age and mAFA intervention effect was observed for both the composite outcome (P = 0.002) and rehospitalisation alone (P = 0.015), with the effect decreasing as age increased, particularly among patients ≥80 years old. CONCLUSIONS: A mHealth technology-implemented ABC pathway is effective in reducing adverse clinical outcomes in older AF patients. The benefits obtained with mAFA intervention were attenuated at extreme ages.


Subject(s)
Atrial Fibrillation , Delivery of Health Care, Integrated , Stroke , Telemedicine , Female , Humans , Aged , Aged, 80 and over , Male , Atrial Fibrillation/diagnosis , Atrial Fibrillation/therapy , Biomedical Technology , Technology , Stroke/complications , Anticoagulants/adverse effects
4.
Biotechnol Adv ; 61: 108056, 2022 12.
Article in English | MEDLINE | ID: mdl-36349602

ABSTRACT

In the biomedical field, researchers are always looking for novel materials with improved qualities that may be used in a variety of applications, including pharmaceutical formulations, drug targeting, MRI, drug delivery systems, prostheses, theranostic, and tissue engineering scaffolds. Despite the undeniable traits of the synthetic polymers, such as their reproducible structure and controlled molecular weight, degradation, and mechanical properties, they typically lack biologically relevant bioactivity, biodegradability, and biocompatibility, which are critical aspects in medicine. It is well acknowledged that materials produced from natural resources, such as polysaccharides, have significant benefits over manufactured materials. These advantages stem not just from polysaccharides' inherent abundance in nature, but also from the fact that their structure is comparable to that of extracellular matrix components. This remarkable property has several advantages in terms of biocompatibility and bioactivity, as the human body readily absorbs natural polymers. We strive to update the most recent results in the field of biomaterials including the usage of primary polysaccharides and their derivatives in this study. Polysaccharides such as (i) cellulose, (ii) chitosan, (iii) pullulan, and (iv) starch are given special attention, although a few additional polysaccharides are briefly discussed as well. Because polysaccharides may not always match the requirements for biological use in their natural state, chemical derivatization is frequently employed to transform them. As a result, the above-mentioned polysaccharides, as well as their derivatives, are examined in terms of their chemical and biological peculiarities.


Subject(s)
Biomedical Technology , Polymers , Humans , Cellulose , Drug Delivery Systems , Starch
5.
Int J Technol Assess Health Care ; 38(1): e77, 2022 Oct 26.
Article in English | MEDLINE | ID: mdl-36286261

ABSTRACT

OBJECTIVES: Wearable digital health technologies (DHTs) have the potential to improve chronic kidney disease (CKD) management through patient engagement. This study aimed to investigate and elicit preferences of individuals with CKD toward wearable DHTs designed to support self-management of their condition. METHODS: Using the results of our review of the published literature and after conducting qualitative patient interviews, five-choice attributes were identified and included in a discrete-choice experiment. The design consisted of 10-choice tasks, each comprising two hypothetical technologies and one opt-out scenario. We collected data from 113 adult patients with CKD stages 3-5 not on dialysis and analyzed their responses via a latent class model to explore preference heterogeneity. RESULTS: Two patient segments were identified. In all preference segments, the most important attributes were the device appearance, format, and type of information provided. Patients within the largest preference class (70 percent) favored information provided in any format except the audio, while individuals in the other class preferred information in text format. In terms of the style of engagement with the device, both classes wanted a device that provides options rather than telling them what to do. CONCLUSIONS: Our analysis indicates that user preferences differ between patient subgroups, supporting the case for offering a different design of the device for different patients' strata, thus moving away from a one-size-fits-all service provision. Furthermore, we showed how to leverage the information from user preferences early in the R&D process to inform and support the provision of nuanced person-centered wearable DHTs.


Subject(s)
Renal Insufficiency, Chronic , Self-Management , Wearable Electronic Devices , Adult , Humans , Patient Preference , Choice Behavior , Renal Insufficiency, Chronic/therapy , Biomedical Technology
6.
Hastings Cent Rep ; 52(5): 3, 2022 09.
Article in English | MEDLINE | ID: mdl-36226879

ABSTRACT

Assessing the safety of biomedical technologies is an essential aspect of any sound ethical assessment. It is, however, not sufficient. Technologies do significantly more than what they are designed to accomplish. Bioethicists should pay more attention to the many ways in which technologies transform our world and ourselves.


Subject(s)
Bioethics , Ethicists , Biomedical Technology , Humans
7.
Clin J Pain ; 38(12): 701-710, 2022 Dec 01.
Article in English | MEDLINE | ID: mdl-36198095

ABSTRACT

OBJECTIVES: People living with chronic pain may use wearable health technology (WHT) in conjunction with an expert-directed pain management program for up to 1 year. WHT use may be associated with improvements in key patient outcomes. METHODS: A 12-month study of WHT use among people with chronic pain was conducted, consisting of iPhone and Apple Watch applications to measure movement, sleep, and self-reported pain. Clinical outcomes among 105 patients enrolled in a multidisciplinary pain program that included WHT use were compared with 146 patients in the same program but without WHT, and to 161 patients receiving medical pain management without WHT. RESULTS: Participants used the WHT on average 143.0 (SD: 117.6) out of 365 days. Mixed-effects models revealed participants who used WHT had decreases in depression scores (-7.83, P <0.01) and prescribed morphine milligram equivalents (-21.55, P =0.04) over 1 year. Control groups also showed decreases in depression scores (-5.08, P =0.01; -5.68, P <0.01) and morphine milligram equivalents (-18.67, P =0.01; -10.99, ns). The estimated slope of change among the WHT was not statistically different than control groups. DISCUSSION: Patients who used WHT as part of their pain management program demonstrated a willingness to do so for extended periods of time despite living with chronic pain and other comorbidities. Data trends suggest that WHT use may positively impact depression and prescribed medication. Additional research is warranted to investigate the potential of WHT to improve the negative consequences of chronic pain.


Subject(s)
Chronic Pain , Wearable Electronic Devices , Humans , Chronic Pain/therapy , Pain Management , Biomedical Technology , Morphine Derivatives
8.
Int J Technol Assess Health Care ; 38(1): e76, 2022 Oct 20.
Article in English | MEDLINE | ID: mdl-36263665

ABSTRACT

Patient engagement in health technology assessment (HTA) has become increasingly important over the past 20 years. Academic and practitioner literature has produced numerous case studies and best practice accounts of patient involvement practices around the world. This text analyzes the experience of being involved in an Institute for Clinical and Economic Review (ICER) HTA review in the United States. The analysis comes from the joint perspective of three patient organizations: Lupus and Allied Diseases Association, Inc.; Lupus Foundation of America; and Black Women's Health Imperative, as well as ICER. We suggest that meaningful, patient-centered engagement, where patient communities are systematically integrated throughout the review, can be a way of returning to the discipline's roots focusing on technologies' societal and ethical impact. It is a process that requires robust commitment from all involved but produces assessments relevant to those directly affected by them.


Subject(s)
Patient Participation , Technology Assessment, Biomedical , Female , Humans , Morals , Biomedical Technology , Patient-Centered Care
9.
Article in English | MEDLINE | ID: mdl-36231319

ABSTRACT

There is growing awareness of the impact health technologies can have on the environment and the negative consequences of these environmental impacts on human health. However, health system decision-makers may lack the expertise, data, or resources to incorporate environmental considerations when making decisions about the adoption and use of health technologies. In this article, we describe how health technology assessment (HTA) is evolving to address climate change by providing health system decision-makers with the information they can use to reduce the impact of health care systems on the environment. Our objective is to consider approaches for including the environment domain when conducting an HTA-in particular, the use of the deliberative process-and for determining when the domain should be included. We explore the challenges of gathering the relevant data necessary to assess the environmental impact of a health technology, and we describe a "triage" approach for determining when an in-depth environmental impact assessment is warranted. We also summarize related initiatives from HTA agencies around the world.


Subject(s)
Biomedical Technology , Technology Assessment, Biomedical , Climate Change , Decision Making , Environment , Humans
10.
Sci Transl Med ; 14(666): eabn6036, 2022 10 12.
Article in English | MEDLINE | ID: mdl-36223451

ABSTRACT

A confluence of advances in biosensor technologies, enhancements in health care delivery mechanisms, and improvements in machine learning, together with an increased awareness of remote patient monitoring, has accelerated the impact of digital health across nearly every medical discipline. Medical grade wearables-noninvasive, on-body sensors operating with clinical accuracy-will play an increasingly central role in medicine by providing continuous, cost-effective measurement and interpretation of physiological data relevant to patient status and disease trajectory, both inside and outside of established health care settings. Here, we review current digital health technologies and highlight critical gaps to clinical translation and adoption.


Subject(s)
Delivery of Health Care , Wearable Electronic Devices , Biomedical Technology , Humans
11.
Nurs Manage ; 53(10): 48, 2022 10 01.
Article in English | MEDLINE | ID: mdl-36190473
12.
BMC Public Health ; 22(1): 1689, 2022 09 06.
Article in English | MEDLINE | ID: mdl-36068516

ABSTRACT

BACKGROUND: Low adoption of effective health technologies increases illness morbidity and mortality worldwide. In the case of malaria, effective tools such as malaria rapid diagnostic tests (RDTs) and artemisinin-combination therapies (ACTs) are both under-used and used inappropriately. Individuals' confidence in RDTs and ACTs likely affects the uptake of these tools. METHODS: In a cohort of 36 households (280 individuals) in Western Kenya observed for 30 months starting in June 2017, we examined if experience with RDTs and ACTs changes people's beliefs about these technologies and how those beliefs affect treatment behavior. Household members requested a free RDT from the study team any time they suspected a malaria illness, and positive RDT results were treated with a free ACT. We conducted annual, monthly, and sick visit surveys to elicit beliefs about the accuracy of malaria RDT results and the effectiveness of ACTs. Beliefs were elicited on a 5-point Likert scale from "very unlikely" to "very likely." RESULTS: Over the study period, the percentage of survey respondents that said a hypothetical negative RDT result was "very likely" to be correct increased from approximately 55% to 75%. Controlling for initial beliefs, people who had been tested at least once with an RDT in the past year had 3.6 times higher odds (95% CI [1 1.718 7.679], P = 0.001) of saying a negative RDT was "very likely" to be correct. Confidence in testing was associated with treatment behavior: those who believed a negative RDT was "very likely" to be correct had 1.78 times higher odds (95% CI [1.079 2.934], P = 0.024) of adhering to a negative RDT result (by not taking ACTs) than those who were less certain about the accuracy of negative RDTs. Adherence to a negative test also affected subsequent beliefs: controlling for prior beliefs, those who had adhered to their previous test result had approximately twice the odds (OR = 2.19, 95% CI [1.661 2.904], P < 0.001) of saying that a hypothetical negative RDT was "very likely" to be correct compared to those who had not adhered. CONCLUSIONS: Our results suggest that greater experience with RDTs can not only increase people's confidence in their accuracy but also improve adherence to the test result.


Subject(s)
Malaria , Biomedical Technology , Diagnostic Tests, Routine/methods , Family Characteristics , Humans , Kenya , Malaria/diagnosis , Malaria/drug therapy , Surveys and Questionnaires
13.
Annu Int Conf IEEE Eng Med Biol Soc ; 2022: 3318-3322, 2022 07.
Article in English | MEDLINE | ID: mdl-36086407

ABSTRACT

Wearable medical technologies (wearables) are a type of digital health technology that have the potential to transform the delivery of healthcare by offering a personalized, predictive, and preventative form of patient care. Unfortunately, the adoption of these technologies remains low, indicating an issue with the innovation ecosystem. Existing literature on innovation ecosystems fails to address wearables and the trade-offs between profitability and health outcomes, hindering discussion on how to promote the widespread adoption of wearables. This paper reviews and synthesizes literature from the business community and healthcare technology community on innovation ecosystems to contribute towards developing a more robust model of the innovation ecosystem for developing wearables. Future work aims to enrich this conceptualization with interviews of key actors in the innovation ecosystem. Clinical Relevance- This establishes the relevance of innovation ecosystems in enabling the usage and uptake of digital health technologies that meet patient needs.


Subject(s)
Ecosystem , Wearable Electronic Devices , Biomedical Technology , Delivery of Health Care , Humans , Technology
14.
Syst Rev ; 11(1): 206, 2022 09 27.
Article in English | MEDLINE | ID: mdl-36167611

ABSTRACT

BACKGROUND: A systematic review (SR) helps us make sense of a body of research while minimizing bias and is routinely conducted to evaluate intervention effects in a health technology assessment (HTA). In addition to the traditional de novo SR, which combines the results of multiple primary studies, there are alternative review types that use systematic methods and leverage existing SRs, namely updates of SRs and overviews of SRs. This paper shares guidance that can be used to select the most appropriate review type to conduct when evaluating intervention effects in an HTA, with a goal to leverage existing SRs and reduce research waste where possible. PROCESS: We identified key factors and considerations that can inform the process of deciding to conduct one review type over the others to answer a research question and organized them into guidance comprising a summary and a corresponding flowchart. This work consisted of three steps. First, a guidance document was drafted by methodologists from two Canadian HTA agencies based on their experience. Next, the draft guidance was supplemented with a literature review. Lastly, broader feedback from HTA researchers across Canada was sought and incorporated into the final guidance. INSIGHTS: Nine key factors and six considerations were identified to help reviewers select the most appropriate review type to conduct. These fell into one of two categories: the evidentiary needs of the planned review (i.e., to understand the scope, objective, and analytic approach required for the review) and the state of the existing literature (i.e., to know the available literature in terms of its relevance, quality, comprehensiveness, currency, and findings). The accompanying flowchart, which can be used as a decision tool, demonstrates the interdependency between many of the key factors and considerations and aims to balance the potential benefits and challenges of leveraging existing SRs instead of primary study reports. CONCLUSIONS: Selecting the most appropriate review type to conduct when evaluating intervention effects in an HTA requires a myriad of factors to be considered. We hope this guidance adds clarity to the many competing considerations when deciding which review type to conduct and facilitates that decision-making process.


Subject(s)
Evidence-Based Medicine , Technology Assessment, Biomedical , Biomedical Technology , Canada , Humans , Systematic Reviews as Topic
15.
J Med Eng Technol ; 46(6): 558-566, 2022 Aug.
Article in English | MEDLINE | ID: mdl-36062509

ABSTRACT

The successful development and implementation of any healthcare technology requires input from multiple stakeholders including clinical leads, trust information technology directorates as well as project management and procurement. In this process however, a key stakeholder that is often overlooked is the patient.This paper illustrates the crucial importance of patient involvement to avoid poor design and poor uptake of technology and subsequently poor health outcomes.To highlight this, we share a case example evidencing involvement of people with lived experience of foot ulcers resulting from Diabetic foot neuropathy throughout identification of unmet technology needs, design requirements for the device and iterative device development and evaluation.


Subject(s)
Diabetes Mellitus , Diabetic Foot , Biomedical Technology , Diabetic Foot/therapy , Humans , Respect , Technology
16.
Enferm. foco (Brasília) ; 13(n.esp1): 1-6, set. 2022. ilus
Article in Portuguese | LILACS, BDENF - Nursing | ID: biblio-1396994

ABSTRACT

Objetivo: Relatar a experiência de acadêmicos de enfermagem no processo de inserção do enfermeiro na visita de acolhimento das gestantes em uma maternidade pública do município de Belém no estado do Pará. Métodos: Trata-se de um estudo descritivo com abordagem qualitativa, do tipo relato de experiência, realizado no período de abril a novembro de 2019. O cenário utilizado foi um hospital público de ensino, da rede estadual, de média e alta complexidade. Participaram do estudo enfermeiras, acadêmicos de enfermagem do quinto semestre e gestantes. Resultados: A experiência demonstrou que a inserção do profissional de enfermagem na visita de acolhimento é essencial para a criação de vínculo entre o profissional que atua no hospital e a gestante e seu acompanhante. Cabe ressaltar que esse momento revelou ser uma oportunidade importante para realização de educação em saúde. A utilização da cartilha, a roda de conversa e o "tour" foram efetivos quanto ao aumento da interação entre os envolvidos. Conclusão: A realização do acolhimento às gestantes foi de fundamental importância para garantir a gestante o acesso a informações referentes ao período gestacional, parto e assistência no ambiente hospitalar. (AU)


Objective: To report the experience of undergraduate nursing students in the process of including nurses in the welcoming visit for pregnant women in a public maternity hospital of Belém in the state of Pará. Methods: A descriptive study with a qualitative approach, of the experience report type, held from April to November 2019. The setting was a public, teaching, medium and high complexity state hospital. Participants included nurses, undergraduate nursing students, and pregnant women. Results: The experience has shown that the inclusion of nurses in the welcoming visit for pregnant women is essential to build a bond between the professional who works at the hospital and the pregnant woman and her companion. It is worth emphasizing that this initial visit proved to be an important opportunity for health education. The use of strategies such as booklets, conversation circles, and hospital tours were effective in increasing the interaction between those involved. Conclusion: The welcoming visit for pregnant women was fundamental to ensure that these patients had access to information regarding the gestational period, delivery, and assistance inside the hospital. (AU)


Objetivo: Reportar la experiencia de los académicos de enfermería en el proceso de inserción del enfermero en la visita preparto de las mujeres embarazadas al hospital público de maternidad de la ciudad de Belém en el estado de Pará. Métodos: Estudio descriptivo con abordaje cualitativo, del tipo informe de experiencia, realizado de abril a noviembre de 2019. El local fue un hospital universitario, de la red estatal, de mediana y alta complejidad. En el estudio participaron enfermeras, académicos de enfermería del quinto semestre y mujeres embarazadas. Resultados: La experiencia demostró que la inserción del profesional de enfermería en la visita preparto es fundamental para crear un vínculo entre el profesional que trabaja en el hospital, la gestante y su acompañante. Cabe mencionar que este momento resultó ser una importante oportunidad para realizar educación en salud. El uso de la cartilla, la rueda de conversación y el "tour" fueron efectivos para aumentar la interacción entre los involucrados. Conclusión: La visita preparto de las gestantes fue demasiado importante para garantizar el acceso a la información sobre el período gestacional, parto y asistencia en el ámbito hospitalario. (AU)


Subject(s)
Obstetric Nursing , Health Education , Community-Institutional Relations , Biomedical Technology
17.
J Comp Eff Res ; 11(16): 1147-1149, 2022 11.
Article in English | MEDLINE | ID: mdl-35998008

ABSTRACT

In this latest update we highlight a recent International Society of Pharmacoeconomics and Outcomes Research Good Practice Report on machine learning (ML) for health economics and outcomes research. We specifically discuss use cases of ML that offer opportunities in the generation of evidence using real-world data, including improvements in the identification of study cohorts, confounder identification and adjustment and estimating treatment effect heterogeneity. Barriers to the wider adoption of ML methods are also discussed.


Subject(s)
Economics, Pharmaceutical , Evidence-Based Medicine , Biomedical Technology , Humans , Outcome Assessment, Health Care/methods , Technology Assessment, Biomedical
18.
Int J Technol Assess Health Care ; 38(1): e68, 2022 Aug 19.
Article in English | MEDLINE | ID: mdl-35983625

ABSTRACT

OBJECTIVES: There has been a lack of health technology assessment (HTA) methods for novel digital health technologies (DHTs) such as mHealth, artificial intelligence, and robotics in Finland. The Digi-HTA method has been developed for this purpose. The aim of this study is to determine whether it would be possible to use Digi-HTA recommendations to support healthcare decision-makers. Secondly, from the perspective of companies offering different types of DHT products, this study assesses the suitability of using the Digi-HTA framework to perform HTAs for their products. METHODS: Feedback about Digi-HTA recommendations was collected from healthcare professionals. DHT companies provided input about the Digi-HTA framework. Data were collected via a web-based survey and were analyzed using qualitative methods. RESULTS: Of the twenty-four healthcare professional respondents, twenty said that the Digi-HTA recommendations contained all the necessary information, and twenty-one found them useful for their work. Respondents hoped that the Digi-HTA recommendations would be better integrated into the decision-making processes and healthcare professionals would be more informed about this new HTA process. The questions of the Digi-HTA framework were applicable for different DHT products based on the responses from DHT companies (n = 8). CONCLUSIONS: According to the study participants, although the Digi-HTA recommendations include clear and beneficial information, their integration into healthcare decision-making processes should be improved. Responses from DHT companies indicate that the Digi-HTA framework would be an appropriate tool for performing assessments for their products. To generalize the findings of this study, more comprehensive studies will be needed.


Subject(s)
Artificial Intelligence , Technology Assessment, Biomedical , Biomedical Technology , Decision Making , Finland , Humans , Research Design , Technology Assessment, Biomedical/methods
19.
BMJ ; 378: o2102, 2022 08 26.
Article in English | MEDLINE | ID: mdl-36028259
20.
Int J Technol Assess Health Care ; 38(1): e52, 2022 Jun 23.
Article in English | MEDLINE | ID: mdl-35959563

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.


Subject(s)
Biomedical Technology , Technology Assessment, Biomedical , Europe , Technology Assessment, Biomedical/methods
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