International Journal of Technology Assessment in Health Care最新文献

{"title":"The value of qualitative research in randomized controlled trials involving drugs and medical devices: a systematic mapping review.","authors":"Yuan-Tao Huang, Benjamin Gregory, Sharon Greenwood, Evi Germeni","doi":"10.1017/S0266462326103936","DOIUrl":"10.1017/S0266462326103936","url":null,"abstract":"<p><strong>Objective: </strong>The use of qualitative research with randomized controlled trials (RCTs) has grown exponentially over the last decade, but little is known about how it is contributing to trial procedures and interventions. This review systematically mapped the value that qualitative research has had in RCTs of drugs and medical devices.</p><p><strong>Methods: </strong>We searched five electronic databases (MEDLINE, EMBASE, PsycINFO, CINAHL, and ASSIA) and the NIHR Journals Library to identify original, peer-reviewed qualitative research conducted in the context of specific RCTs (pilot or full). Drawing on studies published between January 2019 and December 2020, we identified and classified examples illustrating how qualitative research had contributed to the trial. This created a list of questions qualitative methods can address in RCTs.</p><p><strong>Results: </strong>Of 207 included studies, only 22 percent explicitly articulated their value. Most frequently reported contributions included: (a) explaining trial findings; (b) ensuring that interventions meet the needs of key stakeholders; and (c) making the trial feasible and viable (e.g., through improved trial design and conduct). A total of 776 examples demonstrating how qualitative methods had enhanced the trial were classified into twenty-seven subcategories. A list of sixty potential questions was developed to assist future research design.</p><p><strong>Conclusions: </strong>The value of qualitative research in trials is expanding. While qualitative methods have traditionally been associated with complex interventions, this review highlights their relevance to trials involving drugs and devices. Future trials could benefit from expanding the use of qualitative methods to deepen understanding of outcomes, strengthen measurement validity, and capture experiences of conditions.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e67"},"PeriodicalIF":3.0,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13440445/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148396116","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":"Measuring, valuing, and incorporating patient and caregiver productivity costs in economic evaluations: a scoping review and environmental scan.","authors":"Shant Torkom Yeretzian, Carly Sillcox, Hannah Loshak, Lauren Ramsay, Alex Gregory Rodriguez Barizonte, Emma Shapiro, Yeva Sahakyan, Beate Sander","doi":"10.1017/S0266462326103882","DOIUrl":"10.1017/S0266462326103882","url":null,"abstract":"<p><strong>Objectives: </strong>Economic evaluations adopting societal perspectives often include productivity costs, yet these remain inconsistently measured and valued. We aimed to identify existing measurement instruments, valuation methods, and guidance for incorporating productivity costs in economic evaluations.</p><p><strong>Methods: </strong>We conducted a scoping review of peer-reviewed literature (MEDLINE, Embase, EconLit; 2019-2025) to map methods for measuring and valuing productivity costs, and an environmental scan of grey literature to identify complementary policy and methodological guidance from Health Technology Assessment organizations. Two reviewers independently screened records and extracted data on study characteristics, instruments, valuation methods, and recommendations. We synthesized findings descriptively and thematically.</p><p><strong>Results: </strong>We screened 3,971 records and included 40 studies: 29 on measurement instruments and 11 on valuation methods. Among twenty-five instruments, twenty-three measured productivity loss for patients, two for caregivers; thirteen measured presenteeism only, four captured presenteeism and absenteeism, and eight measured presenteeism, absenteeism, and unpaid work; three were suitable for valuation using the human capital approach (HCA) and friction cost approach (FCA). Studies highlighted limitations, including HCA's tendency to overestimate and FCA's reliance on scarce friction period data. We also identified ten guidance documents: several jurisdictions favored FCA to value paid labor (<i>n</i> = 4) and opportunity cost for unpaid labor (<i>n</i> = 3).</p><p><strong>Conclusions: </strong>There are many productivity cost instruments, but only few are suitable for valuation. Valuation remains contested, and guidance is fragmented: HCA is simple but risks overestimation, whereas FCA better reflects labor markets but requires data on friction periods. Future work should prioritize valuation-ready tools, improved friction period estimation, and harmonized guidance.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e64"},"PeriodicalIF":3.0,"publicationDate":"2026-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13440446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148329748","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":"Assessing cost-effectiveness in oncology treatment sequences: a review of pathway modeling methods for health technology assessment.","authors":"Lucy Beggs, Kusal Lokuge, Ayman Sadek, Nicky J Welton, Amy Finnegan, David Nicholls, Lindsay Claxton","doi":"10.1017/S0266462326103869","DOIUrl":"10.1017/S0266462326103869","url":null,"abstract":"<p><strong>Objectives: </strong>Pathway models incorporate multiple decision nodes to assess the most cost-effective sequence or the optimal point of introduction of a new technology within a treatment pathway. Pathway models are particularly useful in disease areas such as oncology, where patients may have several lines of therapy. We aimed to review methodologies for modeling and evidence synthesis in pathway models that evaluate the cost-effectiveness of treatment strategies within oncology.</p><p><strong>Methods: </strong>We designed a search to identify relevant methodological papers and systematic reviews of oncology pathway models that critique their methodological approaches. We also updated a previous review of studies on methods for evidence synthesis to inform pathway models. Best practice recommendations were extracted and summarized.</p><p><strong>Results: </strong>Nine and five studies were included on methods for model structures and evidence synthesis, respectively. Key themes related to data requirements, including a preference for patient-level model structures and data from multi-line sources. There was limited guidance on alternative model structures in the absence of patient-level data. Multi-state network meta-analysis with flexible survival models was the most appropriate method identified for evidence synthesis; however, due to data limitations, it may be necessary to conduct separate syntheses at each line of therapy.</p><p><strong>Conclusions: </strong>Data limitations may reduce the potential benefits of pathway models. Further method development is needed for pathway models in decision spaces where individual patient data and sources that cover multiple lines of treatment are not available.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e60"},"PeriodicalIF":3.0,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13440441/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148308110","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":"Policy dialogue on health technology assessment in Middle East and North Africa: reporting from an HTAi initiative.","authors":"Mouna Jameleddine, Antonio Migliore, Ann Single, Rabia Sucu, Debjani Mueller, Nicola Vicari, Maitha Musabeh Ali Khalifa Alghfeli, Bader Alkhurainej, Emad Almomani, Hajer Al Mudaihem, Kefah Ali Al Alqawasmeh, Mouza Al Saadi, Anas Hamad, Zakia Ines Harzallah, Nabil Harzallah, Rita Karam, Kamel Mansouri, Said Wani, Amal Yassine, Awad Mataria, George Valiotis","doi":"10.1017/S0266462326103870","DOIUrl":"10.1017/S0266462326103870","url":null,"abstract":"<p><strong>Objectives: </strong>Health technology assessment (HTA) is a multidisciplinary, policy-oriented process designed to inform evidence-based, transparent, and value-based decision making in health systems. Across the Middle East and North Africa (MENA), HTA development remains heterogeneous and unevenly institutionalized. This manuscript reports on a Health Technology Assessment international (HTAi)-led Policy Dialogue designed to identify shared challenges, priorities, and opportunities to strengthen HTA systems across the region.</p><p><strong>Methods: </strong>Insights were generated through an in-person meeting held in Tunisia in 2025, alongside the HTAi MENA Regional Meeting. The dialogue was complemented by an online survey and a follow-up virtual meeting. Data sources included structured survey responses from experts across twelve countries and qualitative inputs from multi-stakeholder discussions involving policymakers, HTA practitioners, academics, and international organization representatives. Findings were synthesized descriptively to capture perceived challenges, priorities, and expectations for regional and international collaboration.</p><p><strong>Results: </strong>Participants emphasized HTA's role in improving resource allocation, transparency, and access to high-value technologies. Key challenges included limited access to high-quality data, workforce capacity constraints, fragmented governance, and weak legal and institutional frameworks. The highest-ranked priorities were establishing formal legal mandates for all actors involved in HTA processes, building technical and system capacity (including institutional governance, processes, and coordination mechanisms), and strengthening health data infrastructure. Strong support emerged for regional cooperation through joint training, shared assessments, and HTA networking, alongside expectations for international organizations to play a catalytic role.</p><p><strong>Conclusions: </strong>HTA is gaining prominence across MENA, but most countries remain in early phases of institutional development. Progress will require coordinated action on governance, capacity, data systems, and implementation.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e62"},"PeriodicalIF":3.0,"publicationDate":"2026-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13440439/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148270583","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":"Practice and challenges of HB-HTA in China: insights from hospital management and clinical perspectives.","authors":"Yujie Xia, Sheng Han, Lanting Lyu","doi":"10.1017/S026646232610381X","DOIUrl":"10.1017/S026646232610381X","url":null,"abstract":"<p><strong>Objectives: </strong>This study aims to investigate the awareness, practices, needs, and challenges of hospital-based health technology assessment (HB-HTA) in China's tertiary public hospitals, drawing on perspectives from both hospital management and clinical practice.</p><p><strong>Methods: </strong>Semi-structured interviews were conducted with seventeen participants representing six major tertiary public hospitals in China. Respondents included vice presidents, clinical department directors, and heads of pharmacy. The questionnaire explored four dimensions consistent with China's national performance appraisal framework: medical quality, operational efficiency, sustainable development, and satisfaction. Data were analyzed using NVivo 14 for qualitative responses and Excel 2021 for quantitative metrics.</p><p><strong>Results: </strong>The findings revealed that 82.35 percent (14/17) of hospitals lacked dedicated HB-HTA teams, with decisions made primarily by coordination between Medical Affairs Offices (28.89 percent, 13/45) and Pharmacy Departments (22.22 percent, 10/45). Safety (28.26 percent, 13/46), effectiveness (23.91 percent, 11/46), and cost-effectiveness (19.57 percent, 9/46) were prioritized criteria, yet only 29.41 percent (5/17) of institutions used formal HB-HTA tools. Divergence persisted between administrators' organizational priorities and clinicians' patient-centered perspectives. Despite barriers reported by 62.8 percent (27/43) of respondents' institutions, 88.24 percent (15/17) expressed an urgent or recognized need for HB-HTA implementation.</p><p><strong>Conclusions: </strong>For effective HB-HTA implementation in China, addressing capacity deficits and reconciling stakeholder perspectives is essential. A project-based strategy, supported by government real-world data platforms and interdisciplinary teams, is recommended for contextually-appropriate evaluation frameworks.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"42 1","pages":"e57"},"PeriodicalIF":3.0,"publicationDate":"2026-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13319477/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148294989","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":"Incorporating climate impact in health care decisions: new criteria to be tested in the Netherlands.","authors":"Johan P Mackenbach, Jacqueline Zwaap, Saskia Knies","doi":"10.1017/S0266462326103845","DOIUrl":"10.1017/S0266462326103845","url":null,"abstract":"<p><p>One of the ways in which healthcare's climate impact can be reduced is by taking greenhouse gas emissions into account when deciding which treatments are reimbursed and/or included in clinical guidelines. In a report for the Minister of Health, Welfare, and Sports in the Netherlands, we explored how this idea could be put into practice. We developed a set of two criteria: greenhouse gas emissions per patient (which can be compared to, for example, QALYs gained), and total amount of greenhouse gas emissions for all patients undergoing the intervention (which can be compared to, e.g., healthcare's remaining carbon budget). In the coming three years, the National Health Care Institute will use these criteria in an experimental setting, to gain practical experience and to assess whether there is sufficient support among policy makers, practitioners, and patients for taking into account climate impact regularly.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e55"},"PeriodicalIF":3.0,"publicationDate":"2026-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13247785/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147981830","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 is new in the early health technology assessment's new definition?","authors":"Manuel Antonio Espinoza","doi":"10.1017/S0266462326103821","DOIUrl":"10.1017/S0266462326103821","url":null,"abstract":"<p><p>Early health technology assessment (HTA) has recently been defined as a process for evaluating the \"potential value\" of technologies at early development stages. This analysis examines how value is characterized in early stages compared to standard HTA. Using the MAPS framework (Methods, Attributes, Procedures, and Social Preferences), the findings indicate that a broader value framework may be applicable to early HTA relative to standard HTA. This framework includes systematic consideration of attributes beyond health-related benefits, such as real option value and innovation, as well as additional methods like fiscal impact analysis and social return on investment. Additionally, there is potential for less variation in early HTA processes globally, given that these assessments are less tied to local funding decisions. Finally, the role of social preferences in early HTA may also involve considering trade-offs and impact modifiers that are particularly relevant in initial stages, and which deserve further research.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e56"},"PeriodicalIF":3.0,"publicationDate":"2026-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13280859/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147981790","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":"Rethinking the role of health technology assessment: from gatekeeper to health system shaper.","authors":"Wija Oortwijn, Saudamini Vishwanath Dabak, Máirín Ryan, Christoph Glaetzer, Andres Pichon-Riviere","doi":"10.1017/S0266462326103833","DOIUrl":"10.1017/S0266462326103833","url":null,"abstract":"<p><strong>Objectives: </strong>The role of health technology assessment (HTA) is evolving. Once seen primarily as a gatekeeper, HTA is increasingly viewed as a potential shaper of health system transformation. The first plenary session of the HTA International 2025 Annual Meeting explored the potential for HTA to adopt this broader role.</p><p><strong>Methods: </strong>Drawing on perspectives from across the globe, it was discussed how HTA can help shape more equitable, responsive, and sustainable health systems by informing benefit package design, supporting universal health coverage, and addressing systemic inequities from a societal perspective.</p><p><strong>Results: </strong>Audience polling and live commentary underscored a shared sense of urgency, as well as recognition of the methodological, political, and practical constraints to this evolution. Rather than a binary choice, a continuum of roles was suggested depending on the context in which HTA is applied.</p><p><strong>Conclusions: </strong>Ultimately, HTA can shape health systems - not through ambition alone, but through evidence-informed, inclusive, and context-aware decision-making.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e53"},"PeriodicalIF":3.0,"publicationDate":"2026-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13247786/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147963682","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":"DIRECTVALU: ASSESSING INDIRECTNESS OF INDIVIDUAL STUDIES THAT MEASURE PEOPLES' VALUES, UTILITIES, OR THE IMPORTANCE OF OUTCOMES.","authors":"Samer G Karam, Yuan Zhang, Hector Pardo-Hernandez, Uwe Siebert, Laura Koopman, Jane Noyes, Jean-Eric Tarride, Adrienne Stevens, Zuleika Saz Parkinson, Brendalynn Ens, Tahira Devji, Feng Xie, Glen Hazlewood, Lawrence Mbuagbaw, Pablo Alonso-Coello, Jan L Brozek, Holger J Schünemann","doi":"10.1017/S0266462326103705","DOIUrl":"https://doi.org/10.1017/S0266462326103705","url":null,"abstract":"","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"1-29"},"PeriodicalIF":3.1,"publicationDate":"2026-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147941604","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing health technology assessment in Taiwan: over 15 years of evidence-based reform, innovation, and patient partnership.","authors":"Li-Ying Huang, Shou-Yu Lin, Ming-Hsun Liu","doi":"10.1017/S0266462326103766","DOIUrl":"10.1017/S0266462326103766","url":null,"abstract":"<p><strong>Objective: </strong>Since 2007, the Taiwan Health Technology Assessment (HTA) system has developed from a review process for new drug reimbursement into a core element of National Health Insurance (NHI) decision-making. This study examines Taiwan's development of a sustainable, learning-oriented HTA ecosystem.</p><p><strong>Methods: </strong>This article synthesizes more than 15 years of HTA development in Taiwan, highlighting recent advancements, including parallel reviews, temporary reimbursement pathways, managed entry agreements (MEAs), real-world evidence (RWE) guidelines, precision medicine frameworks, and structured health technology reassessment. Drawing on national policy sources, administrative datasets, and published evaluations, four interrelated domains were analyzed: institutional development and governance; access pathways for high cost and high clinical impact; infrastructure for evidence generation; and mechanisms to strengthen patient and patient organization involvement (PPI).</p><p><strong>Results: </strong>In 2024, 196 rapid HTA assessments were completed, reflecting increased system capacity and methodological sophistication. This evolution builds on earlier HTA-driven policy experiences, including immune checkpoint inhibitors supported by HTA, MEA design, and national RWD collection. These developments formed the groundwork for managing uncertainty, assessing high-cost therapies, and supporting life cycle evidence. Parallel review improved timely access to novel medicines without compromising assessment rigor. The Taiwan Cancer Drugs Fund provided a structured model for temporary reimbursement and RWD collection. Formal PPI processes expanded the integration of patient voices.</p><p><strong>Conclusions: </strong>Taiwan's HTA system is transitioning into a learning health system that supports adaptive coverage, continuous reassessment, and sustainable access to new medical technologies. Developments offer guidance to health systems seeking to balance access, evidence development, and financial sustainability.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"42 1","pages":"e50"},"PeriodicalIF":3.0,"publicationDate":"2026-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13161923/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147868279","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}