International Journal of Technology Assessment in Health Care最新文献

{"title":"Competencies for health technology assessment professionals: a scoping review and content analysis.","authors":"Liza van Mun, Wietske Kievit, Wija Oortwijn","doi":"10.1017/S0266462326103808","DOIUrl":"10.1017/S0266462326103808","url":null,"abstract":"<p><strong>Objectives: </strong>The European Union health technology assessment (HTA) regulation increases pressure on European HTA organizations' capacity and new domains of expertise continue to emerge quickly in the HTA field. Therefore, this study aimed to identify emerging competencies described in the literature and to update and verify an existing HTA competency framework, encompassing both process-related and domain-specific expertise for conducting HTA.</p><p><strong>Methods: </strong>Using a scoping review approach, PubMed, Embase, PsycINFO, ERIC, CINAHL, and Web of Science were searched from 1 January 2018 until 13 May 2024. The websites of HTA-related societies were searched on 22 April 2024. Documents describing competencies for HTA professionals were included. Deductive content analysis of the identified competencies was performed, utilizing the competencies from the original framework.</p><p><strong>Results: </strong>A total of nineteen documents were included, consisting of six competency frameworks, one handbook, and twelve scientific articles. The identified competencies from these documents mapped appropriately to the original competency framework. New competencies within existing domains that emerged were related to organizational sustainability, patient and public involvement, real-world data, interpreting and developing HTA reports, and stakeholder identification. In addition, three new competency domains were identified, which were artificial intelligence use for HTA, environmental aspects, and performance and achievements.</p><p><strong>Conclusions: </strong>The newly identified competencies and competency domains highlight emerging areas of expertise for HTA professionals and need to be added to the original competency framework. An updated competency framework can support capacity building efforts and the development of training programs to ensure that HTA professionals are well-equipped to address current healthcare challenges.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e54"},"PeriodicalIF":3.0,"publicationDate":"2026-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13247781/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147837840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"What the future holds: the growing role of real-world evidence in health technology assessment in Malaysia.","authors":"Jing Sheng Lim, Kenneth Kwing Chin Lee","doi":"10.1017/S0266462326103699","DOIUrl":"10.1017/S0266462326103699","url":null,"abstract":"<p><p>Health technology assessment (HTA) has long been the cornerstone of evidence-informed policy for healthcare decision-making. While randomized controlled trials (RCTs) remain fundamental, they do not always reflect the realities of everyday clinical practice. Real-world evidence (RWE) is increasingly recognized as an important complement, capable of capturing variations in population, setting, and practice that influence health outcomes. In Malaysia and across ASEAN, the growing focus on RWE reflects both global momentum and regional aspirations to strengthen data-driven policymaking. This perspective reflects on Malaysia's experience in integrating RWE into HTA and considers how this evolution can inform regional efforts. It argues that the adoption of RWE signifies not only a methodological advance but a transformation in how evidence is conceptualized, governed, and applied. Developing robust data systems, analytical expertise, and cross-country collaboration will be essential to ensure that real-world data are translated into meaningful evidence for equitable and sustainable healthcare decisions.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"42 1","pages":"e43"},"PeriodicalIF":3.0,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13161925/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147771389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How users perceive meta-analysis of economic evaluations.","authors":"Sajesh K Veettil, Affan Mahmood, Manuel Meraz, Sitaporn Youngkong, Teerapon Dhippayom, Nathorn Chaiyakunapruk","doi":"10.1017/S0266462326103742","DOIUrl":"10.1017/S0266462326103742","url":null,"abstract":"<p><strong>Objectives: </strong>Meta-analysis of economic evaluations (MAEEs), using the incremental net benefit approach, enables quantitative synthesis of cost-effectiveness evidence and may support policy decisions. However, little is known about users' perceptions or utility of MAEEs. This study examined end users' perceptions and applicability of MAEE findings in real-world decision-making.</p><p><strong>Methods: </strong>A cross-sectional online survey was conducted among individuals attending an ISPOR Real-World Evidence Summit 2025 breakout session on MAEEs. The survey collected data on respondent characteristics, prior awareness of and experience with MAEEs, perceived usefulness, potential applications, and the likelihood of future use. Responses were summarized using descriptive statistics, and associations between participant characteristics and perceptions were analyzed using chi-square tests and odds ratios (95 percent confidence interval).</p><p><strong>Results: </strong>Seventy-six participants completed the survey. Most respondents were from the WHO South-East Asia Region (72 percent) and represented Industry/Pharma/MedTech (36 percent) or Academia/Research (34 percent). Perceptions were positive: 78 percent considered MAEEs \"definitely\" or \"possibly\" beneficial, and 55 percent indicated they would likely or very likely use MAEEs in policymaking. MAEEs were perceived as useful for highlighting variation across studies, reducing single-study bias, and improving precision when multiple EEs exist on the same topic within a country. Potential users included national health authorities, policy makers, hospitals/insurers, and countries with limited EE capacity. No significant associations were observed between respondent characteristics and perceived benefits or likelihood of use (<i>p ></i> 0.05).</p><p><strong>Conclusions: </strong>MAEEs are well-received by participants. Larger surveys and qualitative studies are needed to explore context-specific applicability, refine methodology, and enhance their utility across diverse settings.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e51"},"PeriodicalIF":3.0,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13161930/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147771429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early technology review during prototype development and at proof of concept: the case for developing a sequential versus a single-stage approach to early evidence development for health technologies.","authors":"Leslie Levin, Robert S McDonough, Martin Cheatle, Haytham Kaafarani, Serge Korjian, Richard E Kuntz","doi":"10.1017/S0266462326103596","DOIUrl":"10.1017/S0266462326103596","url":null,"abstract":"<p><p>The effect of Early Technology Review (ETR) through early engagement with multiple stakeholders on strategic development for technologies at prototype development and proof of concept was examined through two generic case studies of relevant outcomes. In both examples, advice to companies could have significantly changed strategic direction to become more relevant to payers and clinical experts. In one instance, the advice was followed and resulted in an expedited first-in-human study and was considered for a second ETR to inform the proof-of-concept study. In the second example, it was reported that changes in strategic direction were being considered.These reports provide descriptive accounts of very early applications of the ETR process that now spans the entire preclinical trajectory. Had the second case study at proof of concept been able to benefit from this approach at the point of prototype development, it could have avoided the costs and research through earlier advice. This begs the question whether a sequential iterative approach to evidentiary multiple stakeholder advice across the technology life cycle may reduce risk and cost while benefitting from efficiencies of applying adaptive design.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"42 1","pages":"e40"},"PeriodicalIF":3.0,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13125767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147771406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"From HTA to the Bedside: Aligning GenAI Validation with Clinical Reality.","authors":"Zekai Yu, Weihao Cheng, Feiwei Qin, Wei Xiong, Yang Hu","doi":"10.1017/S026646232610378X","DOIUrl":"10.1017/S026646232610378X","url":null,"abstract":"","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"1-4"},"PeriodicalIF":3.0,"publicationDate":"2026-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13161922/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147698645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ontology-driven generation of parameters for health technology assessment models: a prompt engineering study.","authors":"Evelio González-González, Iván Castilla-Rodríguez, Joel Aday Dorta-Hernández","doi":"10.1017/S0266462326103754","DOIUrl":"10.1017/S0266462326103754","url":null,"abstract":"<p><strong>Objectives: </strong>Ontologies support transparent and reproducible conceptual modeling in Health Technology Assessment (HTA), but their population remains resource-intensive and reliant on expert input. This study evaluates the feasibility, reliability, and methodological implications of using generative artificial intelligence (GenAI) to populate ontology individuals for HTA applications.</p><p><strong>Methods: </strong>A factorial experimental framework was developed using the Ontology for Simulation Modeling (OSDi) and three HTA-relevant use cases of varying complexity. Two GenAI systems were evaluated under multiple experimental conditions, including prompting strategy, serialization format, and provision of supporting information. Generated ontology individuals were validated by an HTA expert and assessed across four quality dimensions: consistency, relevance, completeness, and adequacy. Multivariate and regression analyses were conducted to examine the effects of experimental factors on quality outcomes and hallucination likelihood.</p><p><strong>Results: </strong>GenAI systems successfully generated ontology individuals across use cases, although performance varied by quality dimension and experimental condition. Iterative prompting significantly improved completeness, while serialization format strongly influenced reliability, with Turtle serialization associated with substantially lower hallucination likelihood compared with XML. Other factors showed dimension-specific effects, highlighting the multidimensional nature of ontology quality. Errors occurred more frequently in structurally complex ontology components, suggesting a relationship between ontological complexity and generative performance.</p><p><strong>Conclusions: </strong>GenAI-assisted ontology population can enhance the efficiency and scalability of HTA conceptual modeling, enhancing the agility of HTA agencies in exploratory phases. Its effective use requires structured prompting, appropriate representation formats, and expert validation. Further research should evaluate its impact on HTA decision modeling workflows and validation frameworks.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e47"},"PeriodicalIF":3.0,"publicationDate":"2026-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13161931/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147690070","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Beyond efficiency: reimagining health technology assessment in the age of artificial intelligence.","authors":"Manuel C Cossio, Ramiro Gilardino","doi":"10.1017/S0266462326103778","DOIUrl":"10.1017/S0266462326103778","url":null,"abstract":"","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e44"},"PeriodicalIF":3.0,"publicationDate":"2026-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13161924/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147690101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Barriers and facilitators to using self-sampled tests for the human papillomavirus (HPV): a mixed-methods study to inform a horizon scan.","authors":"Soheila Ghasri, Eugenie Evelynne Johnson, Bethan Molly Harris, Imogen Forsythe, Claire Eastaugh, Adetutu Sadiq, Nick Meader, Matthew Breckons, Fiona Pearson","doi":"10.1017/S0266462326103729","DOIUrl":"10.1017/S0266462326103729","url":null,"abstract":"<p><strong>Objectives: </strong>Human papillomavirus (HPV), particularly high-risk types such as HPV 16 and 18, is a major cause of cervical cancer and other cancers. Despite the United Kingdom's (UK's) commitment to cervical cancer elimination by 2040, participation in HPV screening is declining, disproportionately affecting underserved groups, including those experiencing poverty, people from minoritized racial, ethnic, gender, or sexual identity groups, and people living with HIV.</p><p><strong>Methods: </strong>We conducted a mixed-methods study to explore awareness, barriers, and facilitators to HPV self-sampling from clinician and public perspectives. A multi-stakeholder survey (<i>n</i> = 105) and two online focus groups with clinicians (<i>n</i> = 4) and members of the public (<i>n</i> = 5) were undertaken.</p><p><strong>Results: </strong>Survey respondents identified accuracy, cost-free availability, ease of use, accessibility, clear instructions, and adequate follow-up as critical test features. Participants emphasized that disability, cultural context, language, and socioeconomic status strongly influence barriers and facilitators to uptake. Focus groups provided contextual depth, illustrating how privacy, logistical and emotional impacts, and supportive follow-up pathways shaped acceptability and trust. Clinicians highlighted the need for integration into healthcare infrastructure to maintain trust and ensure support. Public participants recommended community-driven engagement, including multilingual instructions and tailored communication to encourage adoption among diverse groups. Concerns were raised about unintended consequences, such as anxiety following asymptomatic HPV diagnoses and challenges in managing clinical pathways after positive results. Suggestions included leveraging community organizations to reduce hesitancy.</p><p><strong>Conclusions: </strong>Findings highlight policy and implementation considerations for embedding HPV self-sampling within care pathways to improve uptake and reduce inequalities.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e46"},"PeriodicalIF":3.0,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13161927/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147672889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementing the EU HTA regulation and joint clinical assessment: a multi-stakeholder perspective from Italy.","authors":"Michela Meregaglia, Francesco Costa, Ludovico Cavallaro, Patrizio Armeni, Monica Hildegard Otto","doi":"10.1017/S026646232610364X","DOIUrl":"10.1017/S026646232610364X","url":null,"abstract":"<p><strong>Background: </strong>The Regulation (EU) 2021/2282 on Health Technology Assessment (HTAR), which applies as of January 2025, introduces the Joint Clinical Assessment (JCA) for selected health technologies and establishes a stakeholder network. This study aims to evaluate the expected impact of the implementation of the HTAR from a multi-stakeholder perspective, using Italy as a case study.</p><p><strong>Methods: </strong>A scoping literature review was performed according to the PRISMA guidelines to inform the development of an interview guide. Target participants included Italian stakeholder representatives with an interest in the HTAR. One-on-one semi-structured interviews were conducted virtually at the end of 2024. The questions were categorized into three main topics: expected benefits and opportunities; foreseen risks or challenges; recommended actions. The interviews were transcribed verbatim and analyzed using thematic content analysis techniques.</p><p><strong>Results: </strong>Thirteen participants included representatives from national and regional HTA bodies, health technology developers' associations, health professional associations, patient organizations, and HTA experts. The JCA is expected to enhance the quality of clinical assessment and to result in faster and more equitable access to health innovations. However, the timing will depend on the extent to which Member States require complementary analyses. Health technology developers benefit from submitting a single JCA dossier, but often cope with limited evidence and short-term deadlines. The interviewees recommended harmonizing evidence standards, investing in HTA education and training, and fostering strategic stakeholder collaborations.</p><p><strong>Discussion: </strong>The process of harmonization induced by the HTAR is beneficial to standardize clinical assessment at the EU level, but needs to reconcile different stakeholder perspectives.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"42 1","pages":"e39"},"PeriodicalIF":3.0,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13078104/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147673093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Integrating ethical analysis in health technology assessment: opportunities and challenges.","authors":"Bart Bloemen, Renata Axler, Michael J DiStefano, Wija Oortwijn, Dario Sacchini, Michal Stanak, Duncan Steele, Gert Jan van der Wilt, Pietro Refolo","doi":"10.1017/S0266462326103730","DOIUrl":"10.1017/S0266462326103730","url":null,"abstract":"<p><p>Ethics has been recognized as an integral part of Health Technology Assessment (HTA) since its beginning. However, the integration of ethical analysis in HTA practice has been limited and challenging. Members of the Health Technology Assessment international (HTAi) Interest Group (IG) for Ethical Issues in HTA reflected upon this situation, during a workshop and online meetings, to identify which challenges hinder integration of ethics in HTA and how to move the discipline forward. In this article, we present the results of that discussion, describing different ways that ethical analysis can occupy a more central role in HTA practice. We also describe developments in HTA that create a momentum for reflecting upon such integral role for ethical analysis in HTA: artificial intelligence-based health technologies, changes in the evidence landscape, assessing the environmental impact of health technology, and the new EU regulation on HTA.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e52"},"PeriodicalIF":3.0,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13200155/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147673081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}