International Journal of Technology Assessment in Health Care最新文献

{"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}

{"title":"A minimum dataset for destination therapy with left ventricular assist device: the evidence that matters to decision makers.","authors":"Janet Puñal-Riobóo, Maria José Faraldo Vallés, Natalia Nogueira Uzal, Hannah Patrick, Leonor Varela-Lema","doi":"10.1017/S0266462325000054","DOIUrl":"10.1017/S0266462325000054","url":null,"abstract":"<p><strong>Background: </strong>Left ventricular assist devices (LVAD) are a therapeutic option in patients with advanced heart failure (HF) not a candidate for cardiac transplant as destination therapy (DT). However, important uncertainties remain regarding the use of LVAD in the long-term in real practice settings. When planning registries, it is important to choose the appropriate outcomes that ensure comparability and reduce the possibility of bias.</p><p><strong>Aim: </strong>The purpose of this study was to establish a minimum dataset (MDS) that should be collected in all LVAD for DT registries to meet the needs and demands of Health Technology Assessment (HTA) doers and health professionals.</p><p><strong>Methods: </strong>To design the MDS for LVAD, a preliminary list of outcome domains and data items were developed attending to the gaps and research needs derived from existing evidence coming from HTA carried out at the European Network of Health Technology Assessment (EUnetHTA) level. The list of data items and domains was agreed upon by all involved HTA organizations and a three-round Delphi was conducted among an experienced panel of cardiologists to rate the importance of the items for measuring uncertainty gaps.</p><p><strong>Results: </strong>After the three-round Delphi process, the expert panel reached a consensus regarding eighteen outcomes and forty-seven variables divided into seven main domains (safety, effectiveness, patient acceptability, satisfaction, healthcare system impact, pharmaceutical management, and technique-related factors).</p><p><strong>Conclusions: </strong>The MDS of outcomes and measures, developed based on research gaps and needs, can allow for standardizing data collection and improving the quality of data for decision making and practice.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e8"},"PeriodicalIF":2.6,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811952/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005351","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":"A decision-analytic method to evaluate the cost-effectiveness of remote monitoring technology for chronic depression.","authors":"Xiaonan Sun, Lawrence Wissow, Shan Liu","doi":"10.1017/S0266462324004677","DOIUrl":"10.1017/S0266462324004677","url":null,"abstract":"<p><strong>Objectives: </strong>Advances in mobile apps, remote sensing, and big data have enabled remote monitoring of mental health conditions, but the cost-effectiveness is unknown. This study proposed a systematic framework integrating computational tools and decision-analytic modeling to assess cost-effectiveness and guide emerging monitoring technologies development.</p><p><strong>Methods: </strong>Using a novel decision-analytic Markov-cohort model, we simulated chronic depression patients' disease progression over 2 years, allowing treatment modifications at follow-up visits. The cost-effectiveness, from a payer's viewpoint, of five monitoring strategies was evaluated for patients in low-, medium-, and high-risk groups: (i) remote monitoring technology scheduling follow-up visits upon detecting treatment change necessity; (ii) rule-based follow-up strategy assigning the next follow-up based on the patient's current health state; and (iii-v) fixed frequency follow-up at two-month, four-month, and six-month intervals. Health outcomes (effects) were measured in quality-adjusted life-years (QALYs).</p><p><strong>Results: </strong>Base case results showed that remote monitoring technology is cost-effective in the three risk groups under a willingness-to-pay (WTP) threshold of U.S. GDP per capita in year 2023. Full scenario analyses showed that, compared to rule-based follow-up, remote technology is 74 percent, 67 percent, and 74 percent cost-effective in the high-risk, medium-risk, and low-risk groups, respectively, and it is cost-effective especially if the treatment is effective and if remote monitoring is highly sensitive and specific.</p><p><strong>Conclusions: </strong>Remote monitoring for chronic depression proves cost-effective and potentially cost-saving in the majority of simulated scenarios. This framework can assess emerging remote monitoring technologies and identify requirements for the technologies to be cost-effective in psychiatric and chronic care delivery.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"40 1","pages":"e79"},"PeriodicalIF":2.6,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811955/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143005305","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 of a value assessment framework for Health Technology Assessment in rare diseases drugs: insights from a Delphi study in Brazil.","authors":"Luiza Vasconcelos Biglia, Arturo Felippini, Tatiane Bomfim Ribeiro, Tácio de Mendonça Lima, Patricia Melo Aguiar","doi":"10.1017/S0266462324004835","DOIUrl":"10.1017/S0266462324004835","url":null,"abstract":"<p><strong>Objective: </strong>The aim of this study is to propose and validate a value assessment framework for Health Technology Assessment (HTA) for rare diseases drugs in Brazil.</p><p><strong>Methods: </strong>A scoping review was performed to identify criteria used by HTA agencies in countries with public healthcare systems when evaluating orphan drugs. Based on the findings, a criteria framework for rare disease drugs was proposed for Brazil. Content validity was conducted over three rounds using Delphi technique and content validity ratio (CVR) approach was employed to evaluate the ratings from the eighteen stakeholders (experts and patients).</p><p><strong>Results: </strong>Twenty-nine HTA criteria for rare disease drugs were identified to compose the Brazilian framework. After three Delphi rounds, the final value framework comprised fifteen criteria categorized into four domains: disease-related factors, treatment-related factors, social and political factors, and economic factors. Among the most well-rated criteria by the CVR, considering the relevance attribute, were \"relevance of outcomes for a rare disease,\" \"impact on patient's quality of life,\" \"price negotiation,\" and \"adjusted cost-effectiveness threshold.\" On the other hand, \"budget impact threshold,\" \"innovative nature of treatment,\" and \"willingness to accept greater uncertainty in clinical evidence\" received negative evaluations and were excluded from the final framework.</p><p><strong>Conclusions: </strong>A value assessment framework validated by key stakeholders of rare diseases in Brazil could contribute to improve HTA transparency, decision making, and efficiency of the healthcare system, and inspire the development of a local guidance for rare-disease HTA.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":" ","pages":"e6"},"PeriodicalIF":2.6,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11811954/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949001","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 can actuarial science contribute to the field of health technology assessment? An interdisciplinary perspective.","authors":"Oscar Espinosa, Michael Drummond, Ellyn Russo, David Williams, Donna Wix","doi":"10.1017/S0266462324004781","DOIUrl":"https://doi.org/10.1017/S0266462324004781","url":null,"abstract":"<p><p>A reflective analysis is presented on the potential added value that actuarial science can contribute to the field of health technology assessment. This topic is discussed based on the experience of several experts in health actuarial science and health economics. Different points are addressed, such as the role of actuarial science in health, actuarial judgment, data inputs and their quality, modeling methodologies and the use of decision-analytic models in the age of artificial intelligence, and the development of innovative pricing and payment models.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":"41 1","pages":"e3"},"PeriodicalIF":2.6,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142931625","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}