International Journal of Technology Assessment in Health Care最新文献

{"title":"Value and Implementation of Patient and Public Involvement and Engagement in Health Technology Assessment for Japan: implications from systematic searches.","authors":"Takako Kaneyasu","doi":"10.1017/S026646232500008X","DOIUrl":"10.1017/S026646232500008X","url":null,"abstract":"<p><strong>Objectives: </strong>This study comprehensively reviewed reports on patient and public involvement and engagement (PPIE) in health technology assessment (HTA) overseas and identified the status and possible future measures, of PPIE in Japanese HTA.</p><p><strong>Methods: </strong>The series of reviews targeted systematic reviews (SR#1), references in SR#1 (SR#2), and new articles after SR#1 (SR#3). The MEDLINE and Embase databases were searched through August 2024 using the terms \"patient involvement/engagement,\" \"patient participation,\" \"community participation,\" \"public involvement/engagement,\" and \"health technology assessment.\" The implementation details were extracted from information published on the websites of the HTA agencies.</p><p><strong>Results: </strong>Three review articles in SR#1, 12 references in SR#2, and 10 articles in SR#3 were selected. The opportunities for countries, including Japan, to participate in discussions on the HTA process did not differ significantly; however, information on PPIE in Japan was scarce and did not indicate their purpose and value.</p><p><strong>Conclusions: </strong>Collected articles indicated that the value of PPIE in HTA includes relevance, equity, fairness, legitimacy, and capacity building. The participation of patient and public representatives in Japanese discussions since 2005 appeared to be very limited to consider PPIE in HTA. In countries that implement PPIE in HTA, the value of PPIE is explicit: the process guidelines are specific and provide an appropriate environment for input that includes education, training, and feedback. Future reforms of the Japanese system will require discussions on PPIE purpose and value, implementation, and creating an environment in which a diverse range of patients and the public can easily express their views.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e14"},"PeriodicalIF":2.6,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11894397/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143523454","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":"Health technology assessment capacity to support Zambia's health benefits package reform policy.","authors":"Warren Mukelabai Simangolwa, Kaymarlin Govender, Josue Mbonigaba","doi":"10.1017/S0266462325000030","DOIUrl":"10.1017/S0266462325000030","url":null,"abstract":"<p><strong>Background: </strong>The need for more local technical capacity in Health Technology Assessment (HTA) is a leading challenge to its use in low- and middle-income countries. Zambia has been considering using HTA to support its universal health coverage initiative, which includes health benefits package design and implementation. This study assesses the local HTA capacity for the steering committee tasked with supporting the design and implementation of the national health benefits package in Zambia.</p><p><strong>Methods: </strong>The study applied a cross-sectional web-based survey design and the consensus-based Checklist for Reporting of Survey Studies. Data were collected from the steering committee of the benefits package working group, tasked with leading the design process of the health benefits package using the Instrument for the Assessment of Skills to Conduct a Health Technology Assessment tool.</p><p><strong>Results: </strong>The majority of respondents had not served on a selection and reimbursement committee. Clinical effectiveness skills in structuring a search strategy, handling missing data, conducting qualitative evidence synthesis, and grading the certainty of evidence were low. Skills for leadership, networking, conflict management, and project coordination, public and patient involvement were mid-level to low. Most of the respondents were aware of ethical issues with health technologies. Health economics skills in economic evaluations and decision analytic modeling, equity and health system efficiency measurement, budget impact analysis, and quality of life were identified for capacity strengthening.</p><p><strong>Conclusion: </strong>Available technical capacities to revise and implement the national benefits package were lower in health economics, synthesis for clinical effectiveness evidence, ethics, patient and public involvement, and soft skills, in that order.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e15"},"PeriodicalIF":2.6,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11894396/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143523442","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":"PERCEPTION OF NON-LAYPERSON ADVISORY COMMITTEE MEMBERS ON THE APPLICATION OF A DISCRETE CHOICE EXPERIMENT INSTRUMENT TO PATIENTS AND ADVISORY COMMITTEE MEMBERS: A QUALITATIVE STUDY.","authors":"Hung Manh Nguyen, Jason Robert Guertin, Daniel Reinharz","doi":"10.1017/S0266462325000029","DOIUrl":"https://doi.org/10.1017/S0266462325000029","url":null,"abstract":"","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"1-30"},"PeriodicalIF":2.6,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143492102","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":"Use of surrogate endpoints in health technology assessment: a review of selected NICE technology appraisals in oncology.","authors":"Lorna Wheaton, Sylwia Bujkiewicz","doi":"10.1017/S0266462325000017","DOIUrl":"10.1017/S0266462325000017","url":null,"abstract":"<p><strong>Objectives: </strong>Surrogate endpoints, used to substitute for and predict final clinical outcomes, are increasingly being used to support submissions to health technology assessment agencies. The increase in the use of surrogate endpoints has been accompanied by literature describing the frameworks and statistical methods to ensure their robust validation. The aim of this review was to assess how surrogate endpoints have recently been used in oncology technology appraisals by the National Institute for Health and Care Excellence (NICE) in England and Wales.</p><p><strong>Methods: </strong>This article identifies technology appraisals in oncology published by NICE between February 2022 and May 2023. Data are extracted on the use and validation of surrogate endpoints including purpose, evidence base, and methods used.</p><p><strong>Results: </strong>Of the 47 technology appraisals in oncology available for review, 18 (38 percent) utilized surrogate endpoints, with 37 separate surrogate endpoints being discussed. However, the evidence supporting the validity of the surrogate relationship varied significantly across putative surrogate relationships with 11 providing randomized controlled trial evidence, 7 providing evidence from observational studies, 12 based on the clinical opinion, and 7 providing no evidence for the use of surrogate endpoints.</p><p><strong>Conclusions: </strong>This review supports the assertion that surrogate endpoints are frequently used in oncology technology appraisals in England and Wales and despite the increasing availability of statistical methods and guidance on appropriate validation of surrogate endpoints, this review highlights that use and validation of surrogate endpoints can vary between technology appraisals, which can lead to uncertainty in decision making.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e11"},"PeriodicalIF":2.6,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11894387/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448363","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":"Development and validation of the NICE artificial intelligence (AI) medical device intervention search filters for MEDLINE and Embase (Ovid).","authors":"Lynda Ayiku, Amy Finnegan, Thomas Hudson, Nicola Walsh, Rachel Adams","doi":"10.1017/S0266462324004823","DOIUrl":"https://doi.org/10.1017/S0266462324004823","url":null,"abstract":"","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"1-27"},"PeriodicalIF":2.6,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382468","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":"Trial-based economic evaluation of the BrainACT study: acceptance and commitment therapy for anxiety and/or depressive symptoms after acquired brain injury.","authors":"Sander Osstyn, Johanne Rauwenhoff, Ron Handels, Marjolein E de Vugt, Silvia Evers, Ghislaine A P G van Mastrigt, Caroline M van Heugten","doi":"10.1017/S0266462324004811","DOIUrl":"10.1017/S0266462324004811","url":null,"abstract":"<p><strong>Introduction: </strong>Following acquired brain injury (ABI), individuals often experience anxiety and/or depressive symptoms. BrainACT is an adapted form of Acceptance and Commitment Therapy (ACT) tailored to this target group. The current study is a trial-based health-economic evaluation comparing BrainACT to a psychoeducation and relaxation control treatment.</p><p><strong>Methods: </strong>An economic evaluation from a societal perspective was conducted in the Netherlands alongside a multicenter randomized controlled two-armed parallel trial including 72 participants. A cost-utility and cost-effectiveness analysis was conducted where incremental costs, quality-adjusted life-years (QALYs), and anxiety/depression (Hospital Anxiety and Depression Scale (HADS) score) were collected and presented over a 1-year follow-up period. Bootstrapping, scenario, and subgroup analyses were performed to test the robustness of the results.</p><p><strong>Results: </strong>The BrainACT arm reported non-significant lower total costs (incremental difference of €-4,881; bootstrap interval €-12,139 to €2,330) combined with significantly decreased anxiety/depression (HADS) (3.2; bootstrap intervals 0.7-5.7). However, the total QALYs were non-significantly lower (-0.008; bootstrap interval -0.060 to 0.042) for BrainACT. The probability of the intervention being cost-effective was 86 percent at a willingness-to-accept threshold of €50,000/QALY. The scenario and subgroup analyses confirmed the robustness of the results.</p><p><strong>Conclusion: </strong>BrainACT may be a more cost-effective alternative to a psychoeducation and relaxation intervention for anxiety and/or depressive symptoms following ABI. Despite limitations, BrainACT appears to be a promising addition to treatment options in the Netherlands. Further research is needed to validate these findings, and consideration should be given to implementing BrainACT in Dutch clinical settings with ongoing monitoring.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e10"},"PeriodicalIF":2.6,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811953/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143382459","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":"Patient perspectives on continuous glucose monitoring system (CGMS) for diabetes in Malaysia: a vital voice in health technology assessment (HTA) informing decision-making.","authors":"Nur Farhana Mohamad, Ana Fizalinda Abdullah Sani, Nurfarah Aqilah Ahmad Nizam, Foo Sze-Shir, Izzuna Mudla Mohamed Ghazali, Roza Sarimin","doi":"10.1017/S0266462325000078","DOIUrl":"10.1017/S0266462325000078","url":null,"abstract":"<p><strong>Objective: </strong>To integrate patient perspectives into Health Technology Assessment (HTA) by exploring the perceived benefits, barriers, and expectations of diabetes patients and their caregivers in Malaysia regarding the use of CGMS.</p><p><strong>Methods: </strong>This qualitative study employed focus group discussions (FGDs) with 30 participants, including adults, adolescents, and caregivers managing insulin-requiring diabetes, conducted between May and September 2023 in Kuala Lumpur and Putrajaya, Malaysia. Participants were recruited through purposive sampling. Data were collected using semi-structured interviews and analyzed thematically to capture insights into CGMS benefits, barriers, and expectations.</p><p><strong>Results: </strong>Participants highlighted CGMS as a transformative tool, offering real-time data, improving glycemic control, and enhancing quality of life by reducing anxiety and the burden of frequent glucose checks. Despite these benefits, significant barriers were identified, including high costs, limited access, technical issues, and social stigma, particularly among adolescents. There was a strong call for government subsidies, better technical support, and healthcare provider training to optimize CGMS use. Patient perspectives were integrated into the HTA alongside systematic reviews and economic evaluations, directly informing policy recommendations, including prioritizing CGMS for high-risk T1DM patients and exploring subsidy frameworks to improve affordability.</p><p><strong>Conclusions: </strong>Patient perspectives serve as a vital voice in HTA, offering real-world insights that enhance the understanding of CGMS in diabetes management. Addressing financial, technical, and social barriers is crucial to improving CGMS accessibility and usability. By embedding patient perspectives into HTA and strengthening partnerships across healthcare systems, patient perspectives become instrumental in shaping patient-centered policies and informing equitable decision-making on CGMS utilization in Malaysia.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e13"},"PeriodicalIF":2.6,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11894388/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254437","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":"Driving policy dialogue on health technology assessment in Eastern Europe and Central Asia: reporting from an initiative of Health Technology Assessment International.","authors":"Antonio Migliore, Nicola Vicari, Eva Turk, Rabia Sucu","doi":"10.1017/S0266462325000066","DOIUrl":"10.1017/S0266462325000066","url":null,"abstract":"<p><p>Eastern Europe and Central Asia (EECA) represents a diverse region facing complex healthcare challenges, including resource constraints, fragmented systems, and limited access to evidence-based decision-making tools. Health technology assessment (HTA) offers a critical framework for addressing these issues by informing efficient allocation of healthcare resources. In April 2024, HTA International (HTAi) convened a policy dialogue in Astana, Kazakhstan, bringing together stakeholders from 12 EECA countries and international experts to discuss HTA advancement in the region. The dialogue highlighted systemic barriers, including political instability, capacity shortages, and fragmented data sources while exploring successful HTA implementation models in some countries. Participants emphasized the importance of political commitment, institutional frameworks, and capacity building, alongside fostering stakeholder collaboration. International organizations such as HTAi and WHO were recognized as vital enablers for technical support and knowledge sharing. Key outcomes included actionable recommendations: strengthening political advocacy, developing legal and institutional frameworks, investing in workforce development, and enhancing multistakeholder engagement. The dialogue underscored HTAi's role in catalyzing regional collaboration, providing platforms for discussion, and offering resources for capacity building. Future initiatives will focus on addressing structural weaknesses, promoting transparency, and embedding HTA into national healthcare systems to ensure equitable and evidence-based decisions. The findings reinforce the potential of HTA to enhance healthcare policy and planning in EECA, fostering resilient systems that better meet population health needs despite ongoing challenges.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e12"},"PeriodicalIF":2.6,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11894386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254344","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":"Implementation of the EU's Health Technology Assessment regulation: where does existing methods guidance require concretization and what are the relevant methodological options?","authors":"Gregor Goetz, Stefan Schandelmaier, Reinhard Busse, Claudia Wild, Dimitra Panteli","doi":"10.1017/S0266462324004793","DOIUrl":"10.1017/S0266462324004793","url":null,"abstract":"<p><strong>Objectives: </strong>The EUnetHTA Core Model^® is well-established in the HTA community. Some recommendations of corresponding guidance documents leave room for alternative methodological choices. Considering the new HTA regulation (HTAR), we aimed to identify needs for concretization (NCs) in EUnetHTA guidance and provide indicative methodological options.</p><p><strong>Methods: </strong>We carried out a qualitative document analysis and structured group discussion. Twenty-two EUnetHTA documents were screened using transparent criteria. Identified NCs were classified into topics according to the PRISMA statement and presented to Austrian HTA practitioners (<i>n</i> = 11) during a structured group discussion. Participants rated NC's importance. To identify potential solutions, selected key handbooks for generic (Cochrane) and HTA-specific (IQWIG/NICE) evidence synthesis were systematically reviewed and matching content was charted against the NCs.</p><p><strong>Results: </strong>Thirty-two topics with varying numbers of NCs were identified, twenty-six during the screening process, and six from the group discussion. Most of the topics related to evidence synthesis methods (nine topics), evidence eligibility criteria (nine topics), risk of bias (three topics), and certainty assessment (three topics). Other topics related to information sources, search strategy, data collection process, data items, effect measures, and reporting bias. One or more methodological approaches and recommendations could be identified for each identified topic from the included methodological handbooks.</p><p><strong>Conclusions: </strong>Our analysis identified a need for concretization in some EUnetHTA guidelines. The structured overview of methodological options may support HTA doers in adapting and applying the guidelines to the national and local practical context.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e9"},"PeriodicalIF":2.6,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811951/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254287","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":"Celebrating 30 years of the international network of agencies for health technology assessment (INAHTA).","authors":"Tracy Merlin, Sophie Söderholm Werkö, Alric Rüther, Tara Schuller, David Hailey","doi":"10.1017/S0266462325000042","DOIUrl":"10.1017/S0266462325000042","url":null,"abstract":"<p><p>It is not often that international collaborations are sustained for any significant period, let alone for three decades. However, despite relying on largely voluntary contributions of individuals within its member institutions, the International Network of Agencies for Health Technology Assessment (INAHTA) has not only been an example of sustained collaboration over 30 years but also an example of how an initially modest collaboration can grow and thrive. Current and former serving Chairs and secretariat of the Network have come together to review network documents and outputs and reflect on the history of INAHTA, since its inception in Paris in 1993. Building on the paper from Hailey et al 2009 that documented the growth of the network after 15 years, we have considered and documented the factors that we believe have helped sustain the network and enable it to flourish in the subsequent 15 years. We have also considered the various challenges experienced along the way, as these too can aid in making a collaboration stronger. Future directions for the network have also been contemplated, given the evolving nature of HTA and the regional collaborations that have recently emerged. We hope that by sharing the lessons learned from this living example of international global collaboration relationships between like-minded organizations can be similarly fostered and enhanced into sustainable collaborations, for the benefit of all.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e7"},"PeriodicalIF":2.6,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811950/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143079876","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}