International Journal of Technology Assessment in Health Care最新文献

{"title":"Reporting Standards for Economic Evaluations of Artificial Intelligence (AI) Interventions: A CHEERS Extension.","authors":"Marina Richardson, Gurdeep S Sagoo","doi":"10.1017/S0266462324004756","DOIUrl":"https://doi.org/10.1017/S0266462324004756","url":null,"abstract":"","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"1-4"},"PeriodicalIF":2.6,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750684","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":"The intersection of prescription drugs and medical devices: the evaluation and funding challenges of two categories of emerging health technologies.","authors":"Caroline Rodrigues, Rui Fu, Turjoy Ghose, Emre Yurga, Eric Nauenberg","doi":"10.1017/S0266462324004768","DOIUrl":"10.1017/S0266462324004768","url":null,"abstract":"<p><p>Health technology assessments (HTAs) are policy analysis frameworks contributing to the approval, reimbursement, and rollout of biotechnology and pharmaceuticals. New innovations in health technologies expose gaps in reimbursement and implementation guidelines. We defined two types of emerging health technologies: (1) therapeutic innovations, such as drug-device combination products or nondrug alternatives to prescription drugs and (2) disruptive health innovations such as novel surgeries and gene replacement therapies. We aimed to determine delineated definitions for these categories through a comprehensive review of HTA guidelines across 20 nations. Utilizing databases such as International Network of Agencies for HTA, International Society for Pharmacoeconomics and Outcomes Research, and European Medical Agency, we identified products falling within these categories. Real-world case studies highlighted the inadequacies stemming from the absence of clear definitions and proposed solutions to enhance current HTA guidelines. These shortcomings apply at the state or provincial level in addition to national jurisdictions as existing funding structures and silos fail to accommodate the unique attributes of these technologies.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e1"},"PeriodicalIF":2.6,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750709","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":"Integrating environmental sustainability into health technology assessment: an international survey of HTA stakeholders.","authors":"Michela Bobini, Americo Cicchetti","doi":"10.1017/S0266462324000631","DOIUrl":"https://doi.org/10.1017/S0266462324000631","url":null,"abstract":"<p><strong>Introduction: </strong>Health technologies play a relevant role in environmental sustainability (ES). However, limited evidence exists on approaches and methods to integrate ES into the Health Technology Assessment (HTA).</p><p><strong>Objectives: </strong>The purpose of this study is: (i) to provide an overview of global HTA organizations' progression toward the integration of ES into HTA; (ii) to investigate various paths for this integration, highlighting obstacles, priorities, potential approaches, and methods.</p><p><strong>Methods: </strong>Data were collected via questionnaires from organizations belonging to HTA networks, International Network of Agencies for Health Technology Assessment, and European Network for HTA. To complement the results of the survey, the authors carried out a desk analysis with strategic documents available on institutional websites.</p><p><strong>Results: </strong>The survey included twenty-six respondents from twenty different countries (thirty-three percent response rate). Among the study's participants, there is a notable acknowledgment of the importance of integrating ES into HTA. However, only nine organizations are actively engaged in these integration efforts, each employing unique methodologies and perspectives. There is a substantial consensus on the application of life cycle assessment, with a particular emphasis on the use of environmentally extended input-output analysis, and a stronger preference for cost-utility analysis. Nevertheless, evidence on integrating ES into HTA remains scarce. Major challenges identified include data collection difficulties and the necessity for interdisciplinary teams.</p><p><strong>Conclusions: </strong>Our study represents a preliminary effort to systematize initiatives aimed at integrating ES into HTA. Further research is required to customize methods and tools for appropriately evaluating the environmental impacts of technologies. The findings suggest that achieving ES-HTA integration demands a multi-tiered, interdisciplinary approach.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"40 1","pages":"e64"},"PeriodicalIF":2.6,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750714","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":"The transition of assessing health technologies to social interventions in Sweden.","authors":"Sophie Söderholm Werkö, Titti Mattsson, Sofia Tranæus, Pernilla Östlund, Knut Sundell","doi":"10.1017/S0266462324000606","DOIUrl":"10.1017/S0266462324000606","url":null,"abstract":"<p><p>Since the 1970s the Swedish government has been promoting social work based on research into methods which work in practice for practitioners and patients. In 2015, the Swedish Agency for Health Technology Assessment (SBU), a government agency instigated in 1987, was commissioned to expand its remit, to review empirical research on social work interventions and to disseminate the results to stakeholders. SBU was then renamed The Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU). This article describes the fusion of health technology assessment (HTA) and Social Intervention Assessment (SIA), including advantages and challenges.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"40 1","pages":"e66"},"PeriodicalIF":2.6,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750717","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":"Impact of COVID-19 pandemic on HTAsiaLink network members.","authors":"Ryan Jonathan Sitanggang, Kinanti Khansa Chavarina, Sarin K C, Raina Wadhwa, Budi Wiweko, Fredrick Dermawan Purba, Izzuna Mudla Mohamed Ghazali, Jonathan Henry Webster Jacobsen, Piyameth Dilokthornsakul, Mayfong Mayxay, Wanrudee Isaranuwatchai, Yaoling Wang, Ying-Li Chen, Benjamin Shao Kiat Ong, Sitanshu Kar, Andrey Avdeyev, Yot Teerawattananon","doi":"10.1017/S0266462324000357","DOIUrl":"https://doi.org/10.1017/S0266462324000357","url":null,"abstract":"<p><strong>Objectives: </strong>This study investigates the impact of coronavirus disease 2019 (COVID-19) pandemic on HTAsiaLink members at the organizational level and provides recommendations for mitigating similar challenges in the future.</p><p><strong>Methods: </strong>A survey was disseminated among HTAsiaLink members to assess the COVID-19 impact in three areas: (i) inputs, (ii) process, and (iii) outputs of the Health Technology Assessment organizations' (HTAOs) research operations and HTA process in general.</p><p><strong>Results: </strong>Survey results showed that most HTAOs hired more staff and secured similar or higher funding levels during COVID-19. Nevertheless, some organizations reported high staff turnover. COVID-19-relevant research was prioritized, and most of the organizations had to adapt their research design to meet the needs of policymakers. Time constraints in conducting research and inability to collect primary data were reported as impacts on the research process. Overall, the number of research projects and accessibility of respondents' publications increased during COVID-19.</p><p><strong>Conclusions: </strong>Research demand for HTAOs increased during COVID-19 and impacted their research process; however, they demonstrated resilience and adaptability to provide timely evidence for policymakers. With the growing reliance on HTA, HTAOs require adequate financial support, continuous capacity building, collaboration, and partnership, innovative HTA methods, and a pragmatic yet robust, evidence-to-policy process in preparation for future pandemics.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"40 1","pages":"e63"},"PeriodicalIF":2.6,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142716216","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":"Impact of indication changes on scoping for European Union Joint Clinical Assessment: scale of the problem and how to address it.","authors":"Inka Heikkinen, Melinda Goodall, Natalie Steck, Maria Poulakou, Katherine Piso","doi":"10.1017/S0266462324004641","DOIUrl":"https://doi.org/10.1017/S0266462324004641","url":null,"abstract":"<p><strong>Objectives: </strong>The European Union Joint Clinical Assessment (JCA) process aligns with the regulatory process to promote faster patient access. The PICO (population, intervention, comparator, and outcome) scoping for the JCA must occur before the regulatory process concludes. The risk of indication change during this period is one of the concerns for the success of the JCA process. We investigated the frequency and type of changes that are made to proposed indications and examined how such changes could impact the PICO scoping for JCA.</p><p><strong>Methods: </strong>Twenty-seven recently approved oncology and 15 Advanced Therapy Medicinal Products (ATMP) products were included. Observed indication changes were categorized into editorial or population changes population changes were graded based on the anticipated impact on JCA scope depending on their nature.</p><p><strong>Results: </strong>The majority of products had only editorial changes between proposed and approved indications (67 percent). Once amended, it was common for the indicated population to be narrowed, and rare for it to be broadened. The most common change observed was the shift to a later treatment line. The greatest risk for PICO rescoping would be when new populations would have been added, or new subpopulations or subgroups would have been omitted from the initial scope.</p><p><strong>Conclusion: </strong>The impact on JCA scope depends on the proposed indication wording and how the PICO scoping would have been conducted. Rescoping warrants a considered decision, and to mitigate the risk of delays, dialogue between the assessors and the developer is recommended for informed decision-making.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"40 1","pages":"e62"},"PeriodicalIF":2.6,"publicationDate":"2024-11-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142710124","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":"Health technology assessment framework for artificial intelligence-based technologies.","authors":"Rossella Di Bidino, Signe Daugbjerg, Sara C Papavero, Ira H Haraldsen, Americo Cicchetti, Dario Sacchini","doi":"10.1017/S0266462324000308","DOIUrl":"https://doi.org/10.1017/S0266462324000308","url":null,"abstract":"<p><strong>Objectives: </strong>Artificial intelligence (AI)-based health technologies (AIHTs) have already been applied in clinical practice. However, there is currently no standardized framework for evaluating them based on the principles of health technology assessment (HTA).</p><p><strong>Methods: </strong>A two-round Delphi survey was distributed to a panel of experts to determine the significance of incorporating topics outlined in the EUnetHTA Core Model and twenty additional ones identified through literature reviews. Each panelist assigned scores to each topic. Topics were categorized as critical to include (scores 7-9), important but not critical (scores 4-6), and not important (scores 1-3). A 70 percent cutoff was used to determine high agreement.</p><p><strong>Results: </strong>Our panel of 46 experts indicated that 48 out of the 65 proposed topics are critical and should be included in an HTA framework for AIHTs. Among the ten most crucial topics, the following emerged: accuracy of the AI model (97.78 percent), patient safety (95.65 percent), benefit-harm balance evaluated from an ethical standpoint (95.56 percent), and bias in data (91.30 percent). Importantly, our findings highlight that the Core Model is insufficient in capturing all relevant topics for AI-based technologies, as 14 out of the additional 20 topics were identified as crucial.</p><p><strong>Conclusion: </strong>It is imperative to determine the level of agreement on AI-relevant HTA topics to establish a robust assessment framework. This framework will play a foundational role in evaluating AI tools for the early diagnosis of dementia, which is the focus of the European project AI-Mind currently being developed.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"40 1","pages":"e61"},"PeriodicalIF":2.6,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142681366","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":"A genuine need or nice to have? Understanding HTA representatives' perspectives on the use of patient preference data.","authors":"Evi Germeni, Simon Fifer, Mickaël Hiligsmann, Barry Stein, Mandy Tonkinson, Maya Joshi, Alissa Hanna, Barry Liden, Deborah A Marshall","doi":"10.1017/S026646232400463X","DOIUrl":"10.1017/S026646232400463X","url":null,"abstract":"<p><strong>Objectives: </strong>The roles and potential value of patient preference (PP) data in health technology assessment (HTA) remain to be fully realized despite an expanding literature and various efforts to establish their utility. This article reports lessons learned through a series of collaborative workshops with HTA representatives, organized by the Health Technology Assessment International's Patient Preferences Project Subcommittee.</p><p><strong>Methods: </strong>Five online workshops were conducted between June 2022 and June 2023, seeking to facilitate collaborative learning and reflection on ways that PP data can be integrated into HTA. Participants included nine HTA representatives from the United States, Canada, Australia, England, and the Netherlands. Workshops were recorded, transcribed, and thematically analyzed.</p><p><strong>Results: </strong>Despite appreciating the value of PP data, participants were ambivalent about their use in HTA. Some felt that they were already getting the information they needed from the cost-effectiveness analysis or existing patient involvement processes. Others thought that PP data would be very helpful at the initial and final stage of the decision-making process and, particularly, in the following cases: (a) when technology has important non-health benefits; (b) when the clinical and/or cost-effectiveness evidence is marginal; and (c) when treatment is indicated for a large and heterogeneous population. Issues related to the validity and reliability of PP studies were frequently raised, with preference heterogeneity at the core of these concerns.</p><p><strong>Conclusions: </strong>Collaborating with HTA representatives in the \"co-creation\" of PP research can help address their concerns and facilitate mutual learning about how PP data can be used in HTA.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"40 1","pages":"e60"},"PeriodicalIF":2.6,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11579672/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142675759","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":"Systematic review of economic evaluations of triage tests for women with atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesions (LSIL).","authors":"Isandra Meirelles, Márcia Pinto, Leticia Barros, Fabio Russomano","doi":"10.1017/S0266462324000540","DOIUrl":"10.1017/S0266462324000540","url":null,"abstract":"<p><strong>Objectives: </strong>To synthesize the results of cost-effectiveness studies of different triage tests in comparison to repeat cytology for women with atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesions (LSIL) results.</p><p><strong>Methods: </strong>Electronic databases (Medline/PubMed, Lilacs, Embase, The Cochrane Library, Scopus, Web of Science, Scielo, The NHS Economic Evaluation Database, Econlit, and CEA Registry) were searched for cost-effectiveness or cost-utility publications. Per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, two independent reviewers selected eligible publications based on the selection criteria and performed data extraction. Methodological quality was assessed using the Quality of Health Economic Studies tool.</p><p><strong>Results: </strong>Five cost-effectiveness analyses were included comparing HPV testing, immediate colposcopy, and liquid-based cytology with HPV testing reflex to repeat cytology. The main outcome adopted was cervical intraepithelial neoplasia level 2 or higher (CIN2+) cases detected. In pairwise comparisons, HPV testing was more frequently observed as the most cost-effective strategy. Incremental cost-effectiveness ratios were very sensitive to costs of test kit variation and accuracy estimates with some sensitivity analysis scenarios showing immediate colposcopy more cost-effective than HPV testing depending on the tests' unitary costs and effectiveness.</p><p><strong>Conclusions: </strong>This systematic review of economic evidence corroborates clinical evidence showing cytology is the least effective, although less costly, triage strategy. Cytology-based triage programs need to be updated to offer timely treatment to women diagnosed with ASC-US/LSIL and better resource allocation.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"40 1","pages":"e58"},"PeriodicalIF":2.6,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11579666/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647829","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 healthcare access and equity in economic evaluations: a scoping review of guidelines.","authors":"Bryony Dawkins, Bethany Shinkins, Tim Ensor, David Jayne, David Meads","doi":"10.1017/S0266462324000618","DOIUrl":"10.1017/S0266462324000618","url":null,"abstract":"<p><strong>Background: </strong>International development agendas increasingly push for access to healthcare for all through universal healthcare coverage. Health economic evaluations and health technology assessment (HTA) could provide evidence to support this but do not routinely incorporate consideration of equitable access.</p><p><strong>Methods: </strong>We undertook an international scoping review of health economic evaluation and HTA guidelines to examine how well issues of healthcare access and equity are represented, evidence recommendations, and gaps in current guidance to support evidence generation in this area. Guidelines were sourced from guideline repositories and websites of international agencies and organizations providing best practice methods guidance. Articles providing methods guidance for the conduct of HTA, or health economic evaluation, were included, except where they were not available in English and a suitable translation could not be obtained.</p><p><strong>Results: </strong>The search yielded forty-seven national, four international, and nine independent guidelines, along with eighty-six articles providing specific methods guidance. The inclusion of equity and access considerations in current guidance is extremely limited. Where they do feature, detail on specific methods for providing evidence on these issues is sparse.</p><p><strong>Discussion: </strong>Economic evaluation could be a valuable tool to provide evidence for the best healthcare strategies that not only maximize health but also ensure equitable access to care for all. Such evidence would be invaluable in supporting progress towards universal healthcare coverage. Clear guidance is required to ensure evaluations provide evidence on the best strategies to support equitable access to healthcare, but such guidance rarely exists in current best practice and guidance documents.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"40 1","pages":"e59"},"PeriodicalIF":2.6,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11579673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647819","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}