Value in Health最新文献

{"title":"The Application of Food and Drug Administration Patient-Focused Drug Development Guidance in Rare Patient Populations: Innovation and Flexibility","authors":"Stacie Hudgens MA","doi":"10.1016/j.jval.2026.09.001","DOIUrl":"10.1016/j.jval.2026.09.001","url":null,"abstract":"","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 10","pages":"Pages 1749-1750"},"PeriodicalIF":6.2,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148906755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Preferences, Perceptions, and Influencing Factors in Weight Loss Pharmacotherapy and Bariatric Surgery: A Systematic Literature Review","authors":"Kenechukwu C. Ben-Umeh BPharm,&nbsp;Chia Jie Tan PhD,&nbsp;Juliana S. Simonetti MD,&nbsp;Joseph F. Levy PhD,&nbsp;Daniel M. Witt PharmD,&nbsp;T. Joseph Mattingly II PharmD, MBA, PhD","doi":"10.1016/j.jval.2026.04.001","DOIUrl":"10.1016/j.jval.2026.04.001","url":null,"abstract":"<div><h3>Objectives</h3><div>Understanding features of weight loss treatments that matter most to patients can inform clinical, reimbursement, and policy decisions. This systematic review synthesizes qualitative and quantitative evidence to characterize treatment attributes patients consider most important in weight loss pharmacotherapy and bariatric surgery.</div></div><div><h3>Methods</h3><div>We conducted a systematic search of PubMed, Embase, and the Cochrane Library. Studies were included if they assessed patient perspectives or preferences for weight loss pharmacotherapy or bariatric surgery among adults with overweight or obesity. Data extraction covered study characteristics, methodological features, and key findings. A narrative synthesis was conducted because of methodological heterogeneity. Study quality was assessed using 3 validated tools.</div></div><div><h3>Results</h3><div>Of the 965 articles identified, 14 met inclusion criteria (5 discrete choice experiments [DCEs], 4 surveys, and 5 qualitative studies) from 9 countries. Most were published after 2017. Sample sizes ranged from 10 to 2500. Treatment effectiveness (eg, percentage weight loss, comorbidity resolution) consistently emerged as the most valued attribute, followed by cost and safety (notably gastrointestinal adverse effects). Willingness-to-pay estimates from DCEs showed patients were willing to pay more for greater weight loss, fewer adverse effects, and improved comorbidity outcomes. However, DCE methodologies varied considerably in design and analysis. Qualitative and survey studies further highlighted the influence of social support, stigma, and long-term risk perceptions.</div></div><div><h3>Conclusions</h3><div>Patients prioritize effectiveness, cost, and safety in weight management and are willing to make meaningful trade-offs among these attributes. As the obesity treatment landscape evolves, preference studies using more standardized methods are critical for advancing patient-centered weight management.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 10","pages":"Pages 1917-1929"},"PeriodicalIF":6.2,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147782257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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 an Artificial Intelligence Tool for Automated Population, Intervention, Comparator, Outcome Scoping for the European Joint Clinical Assessment: A Proof of Concept","authors":"Bart-Jan Boverhof MSc,&nbsp;Nikos Takatzoglou MSc,&nbsp;Ken Redekop PhD,&nbsp;Carin Uyl-de Groot PhD,&nbsp;Jacob Jan Visser PhD,&nbsp;Maureen Rutten-van Mölken PhD","doi":"10.1016/j.jval.2026.05.009","DOIUrl":"10.1016/j.jval.2026.05.009","url":null,"abstract":"<div><h3>Objectives</h3><div>The European Union Health Technology Assessment regulation (EU-HTAR) requires laborious population, intervention, comparator, outcome (PICO) scoping and consolidation across member states during joint clinical assessments. We developed a tool to automate PICO extraction from health technology assessment (HTA) documents and clinical guidelines.</div></div><div><h3>Methods</h3><div>We developed a proof-of-concept artificial intelligence (AI) pipeline using retrieval-augmented generation and large language models to process documents, translate to English, extract PICOs, and consolidate findings. The system was validated using 2 oncology cases from nonsmall cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC). We curated data sets for both cases, comprising 49 reports totaling 5463 pages from 16 unique countries. Performance was assessed using recall (sensitivity) and precision (positive predictive value) and compared with human data extraction.</div></div><div><h3>Results</h3><div>The AI system demonstrated strong recall performance, achieving 0.807 for NSCLC and 0.837 for HCC. The AI outperformed human extraction in the NSCLC case (0.81 vs 0.71 recall) while matching human performance in HCC (0.84 vs 0.81). Extraction of the comparator element showed high recall (0.911 NSCLC; 0.967 HCC). The AI pipeline required 96 minutes of computational time beyond translation, saving approximately 25 hours of human screening work.</div></div><div><h3>Conclusions</h3><div>We showed that AI-based PICO extraction was feasible and valuable in 2 use-cases. The system showed good recall and had the potential to reduce workload in the joint clinical assessment. It may be useful for the assessors and coassessors in the EU-HTAR process, the industry in gaining insight into PICO expectations, and national HTA bodies in understanding the expected PICO wishes of other nations.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 10","pages":"Pages 1842-1850"},"PeriodicalIF":6.2,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148253494","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Toward a Vision for Health Economics and Outcomes Research: From Technology Appraisal to Health Policy Science","authors":"Newell E. McElwee PharmD, MSPH,&nbsp;Richard J. Willke PhD,&nbsp;Stephanie Earnshaw PhD,&nbsp;Louis P. Garrison Jr. PhD,&nbsp;Laura T. Pizzi PharmD, MPH","doi":"10.1016/j.jval.2026.05.012","DOIUrl":"10.1016/j.jval.2026.05.012","url":null,"abstract":"","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 10","pages":"Pages 1800-1804"},"PeriodicalIF":6.2,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148284442","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How Much Change Is Meaningful in Global Impression Anchors? Evidence From 5 Rare Diseases","authors":"Courtney Hurt MSW,&nbsp;Maja Kuharic PhD,&nbsp;Somayeh Hashemi MPH,&nbsp;Eloise Salmon MD,&nbsp;Sonya Eremenco MA,&nbsp;David Cella PhD,&nbsp;Karen Kaiser PhD,&nbsp;Chelsea Perschon BA,&nbsp;Sara Shaunfield PhD,&nbsp;John Devin Peipert PhD","doi":"10.1016/j.jval.2026.04.012","DOIUrl":"10.1016/j.jval.2026.04.012","url":null,"abstract":"<div><h3>Objectives</h3><div>Rare diseases pose methodological challenges in determining meaningful change thresholds for clinical outcome assessments (COAs) because of small sample sizes and disease heterogeneity. This article presents qualitative approaches for establishing patient-informed meaningful change thresholds on global impression anchor measures for rare diseases.</div></div><div><h3>Methods</h3><div>Two Food and Drug Administration-funded studies used novel cognitive debriefing methods to determine within-patient meaningful change on custom-developed anchors. Northwestern University Clinical Outcome Assessment Team debriefed Patient Global Impression of Severity and Change anchors referencing 5 physical function performance outcomes with 34 adults with idiopathic pulmonary fibrosis, systemic sclerosis, or myositis. Prepare-NS developed swelling-related patient-reported outcome and observer-reported outcome measures for nephrotic syndrome using Patient Global Impression of Severity/Global Impression of Severity and Change and Observer Global Impression of Severity/Change anchors with 12 patients and 8 caregivers.</div></div><div><h3>Results</h3><div>Qualitative anchor debriefing proved feasible across rare disease populations and COA types. Though many participants identified smaller (eg, 1-category) changes as meaningful, there was strong variation by anchor type and disease group. Anchors focusing on severity (vs impact) tended to require larger changes to be meaningful. In Prepare-NS, most patient-reported outcome participants and all caregivers viewed “No change” after 3 months of hypothetical treatment negatively. In Northwestern University Clinical Outcome Assessment Team, some participants experienced cognitive difficulties with PerfO anchors, struggling to translate objective metrics into meaningful impact.</div></div><div><h3>Conclusions</h3><div>Qualitative methods can provide patient-informed meaningful change thresholds on global impression anchors, although patients may struggle to identify meaningful change for performance anchors. Nonetheless, qualitative patient-informed thresholds can inform quantitative COA interpretation and strengthen endpoint development and regulatory dialog in rare disease clinical trials.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 10","pages":"Pages 1769-1780"},"PeriodicalIF":6.2,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147959348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Modeling Approaches to the Economic Evaluation of Microelimination Strategies for Hepatitis C Virus in High-Risk Populations","authors":"Ying Chen MS,&nbsp;Yun Bao PhD,&nbsp;Yueting Chen MS,&nbsp;Mengxia Yan BS,&nbsp;Kaijie Yao MS,&nbsp;Wen Li BS,&nbsp;Bin Wu PhD","doi":"10.1016/j.jval.2026.03.2248","DOIUrl":"10.1016/j.jval.2026.03.2248","url":null,"abstract":"<div><h3>Objectives</h3><div>Mathematical models inform hepatitis C virus (HCV) microelimination strategies in high-risk groups, but their reliability depends on underlying methodological choices. We systematically appraised the modeling methods used in economic evaluations of HCV microelimination published between 2015 and 2026.</div></div><div><h3>Methods</h3><div>Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (International Prospective Register of Systematic Reviews: CRD420251185978), we searched PubMed/MEDLINE, Embase, and Web of Science for original studies using mathematical models to assess the cost-effectiveness of HCV interventions in high-risk populations. Using a structured extraction tool aligned with modeling best practices, we evaluated model conceptualization, structure, uncertainty handling, and validation. Reporting quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist.</div></div><div><h3>Results</h3><div>Fifty-five studies met the inclusion criteria. Most relied on aggregate-level frameworks, comprising dynamic compartmental models (<em>n</em> = 25) and static Markov/decision-tree structures (<em>n</em> = 18), whereas 12 used individual-based models. People who inject drugs were the primary cohort in 30 evaluations. A pervasive limitation across the literature was the omission of endogenous behavioral feedback, with only 2 models allowing risk behaviors or service uptake to dynamically respond to intervention outcomes. Approximately half of the models (<em>n</em> = 28) synthesized parameters without a formal calibration process. Although parameter uncertainty was universally explored, external validation against real-world data was uncommon (<em>n</em> = 12) and, under our operational definition of distributional equity characterization, no study reported this assessment.</div></div><div><h3>Conclusion</h3><div>Current economic models for HCV microelimination are technically sophisticated but frequently rely on structural simplifications—particularly the lack of dynamic behavioral feedback and network-based transmission—that may limit their real-world policy utility. Future efforts should prioritize data-driven network structures, rigorous external validation, and equity-informative frameworks to better support global elimination targets.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 10","pages":"Pages 1896-1916"},"PeriodicalIF":6.2,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147821377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Exchangeability Assumption in Network Meta-Analysis: Its Meaning and Evaluation","authors":"Yu-Kang Tu DDS, MSc, PhD,&nbsp;James S. Hodges MA, PhD","doi":"10.1016/j.jval.2026.04.013","DOIUrl":"10.1016/j.jval.2026.04.013","url":null,"abstract":"<div><h3>Objectives</h3><div>The validity of network meta-analysis (NMA) relies on 3 assumptions, namely, homogeneity, consistency, and transitivity. A recent article argued that all 3 assumptions can be reduced to the exchangeability assumption. However, it is not entirely clear what is exchangeable in NMA and how the exchangeability assumption can be assessed. In this article, we demonstrate that the contrast-based model for NMA assumes that contrasts between pairs of treatments (treatment contrasts) are exchangeable across studies.</div></div><div><h3>Methods</h3><div>We propose using a simple graphical approach to assessing the validity of exchangeability in NMA by plotting the absolute treatment effects against potential effect modifiers. We also use this graphical approach to show the distinction between absolute and relative effect modifiers. We demonstrate how the concept of exchangeable treatment contrasts is related to consistency and transitivity and the consequence of violating the exchangeability assumption.</div></div><div><h3>Results</h3><div>We use a real NMA from dentistry to illustrate how to apply our method to evaluate the extent to which exchangeable treatment contrasts is a valid assumption. Our method provides valuable insights into the correct interpretation of NMA results when the exchangeability assumption is met or questionable.</div></div><div><h3>Conclusions</h3><div>Our approach demonstrates not only the assumption of exchangeable treatment contrasts but also raises an important issue about designing an NMA: whether a strict selection of studies for NMA should be used to ensure the exchangeability but limited generalizability of results, or a broad selection of studies to explore the conditions under which the results of NMA are applicable.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 10","pages":"Pages 1851-1856"},"PeriodicalIF":6.2,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147983521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cost-Effectiveness of Conditional Cash Transfers With Pre- and Posttest Tuberculosis Counseling in South Africa: A Modeling Analysis","authors":"Lara Goscé PhD,&nbsp;Elena Venero Garcia MSc,&nbsp;Kasim Allel PhD,&nbsp;Judith Mwansa-Kambafwile PhD,&nbsp;Shabir A. Madhi PhD,&nbsp;Shaheed Vally Omar PhD,&nbsp;Harry Moultrie,&nbsp;Nazir Ahmed Ismail PhD,&nbsp;Rein M.G.J. Houben PhD,&nbsp;Ibrahim Abubakar PhD","doi":"10.1016/j.jval.2026.05.004","DOIUrl":"10.1016/j.jval.2026.05.004","url":null,"abstract":"<div><h3>Objectives</h3><div>Tuberculosis (TB) disproportionately affects low-income populations because of socioeconomic barriers. Conditional cash transfers (CCTs) are promising strategies to improve treatment adherence, reduce economic hardship, and enhance health outcomes. However, few studies have examined their cost-effectiveness, especially when combined with TB counseling. The objective of this study is to estimate the long-term epidemiological impact and cost-effectiveness of CCT with pre- and posttest TB counseling in South Africa.</div></div><div><h3>Methods</h3><div>This analysis used results from a trial conducted in South Africa. Trial results on treatment initiation, treatment completion, and on-treatment mortality informed a transmission model of TB, in which a CCT intervention with pre- and posttest TB counseling was offered to all adults diagnosed with drug-susceptible TB between 2025 and 2050. Epidemiological modeling results were combined with cost data to determine the cost-effectiveness of the intervention compared with business as usual from the provider’s perspective.</div></div><div><h3>Results</h3><div>Universally applying the CCT intervention between 2025 and 2050 in South Africa would lead to a cumulative reduction of 5.1% (uncertainty interval [UI]: 4.6%-5.6%) incident cases and 9.5% (UI: 9.1%-10.2%) deaths, compared with business as usual. The incremental cost of the intervention was estimated at $80.4 USD per patient, leading to a total increase of 7.1% (UI:6.8-7.6%) in the TB budget and an incremental cost-effectiveness ratio of $144.45 per disability-adjusted life-years averted, making it cost-effective in South Africa, at a threshold of $3314 USD.</div></div><div><h3>Conclusions</h3><div>CCT interventions with pre- and posttest counseling would be cost-effective in South Africa, leading to a long-term reduction in TB incidence and mortality.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 10","pages":"Pages 1836-1841"},"PeriodicalIF":6.2,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148164715","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"“Adrift From the World”: Exploring the Lived Experiences of Individuals Affected by an Inherited Optic Neuropathy in the United Kingdom—A Qualitative Study","authors":"Benson S. Chen MBChB, PhD,&nbsp;Chloe Seikus MSci,&nbsp;James Ferguson MS,&nbsp;Valerija Tadić PhD,&nbsp;Mike Horton PhD,&nbsp;Patrick Yu-Wai-Man MBBS, PhD,&nbsp;Stephanie Archer PhD","doi":"10.1016/j.jval.2025.07.023","DOIUrl":"10.1016/j.jval.2025.07.023","url":null,"abstract":"<div><h3>Objectives</h3><div>Little is understood about the lived experiences of individuals affected by inherited optic neuropathies (IONs) in the United Kingdom. The aim of this study was to understand how autosomal dominant optic atrophy (DOA) and Leber hereditary optic neuropathy, the 2 more commonly encountered IONs, impact affected individuals and the factors contributing to their vision-related quality of life (VRQoL).</div></div><div><h3>Methods</h3><div>Semistructured qualitative interviews were conducted with 20 individuals with a genetic diagnosis of DOA (10 participants) or Leber hereditary optic neuropathy (10 participants) and affected by vision loss. Eligible participants were purposively sampled to achieve variation in participant age, sex, duration of visual impairment, and location in the United Kingdom. Using inductive thematic analysis, a range of themes and subthemes were developed.</div></div><div><h3>Results</h3><div>Participants’ experiences could be broadly summarized across 4 overarching themes: (1) IONs affected all aspects of life, most notably psychosocial and emotional well-being; (2) participants learned to cope by adapting and adjusting to visual impairment, often on their own, with little external support or resources; (3) participants’ identities as visually impaired people were determined by how they viewed themselves and others’ reactions to their disability; and (4) good VRQoL was defined as having independence with the support of others.</div></div><div><h3>Conclusions</h3><div>Visual impairment due to an ION threatens the independence of affected individuals, leading to psychosocial losses and reduced emotional well-being. Despite the challenges they face, people living with an ION describe a “relatively” good VRQoL, often because of the positive impact of social support, enabling them to lead fulfilling lives.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 10","pages":"Pages 1751-1759"},"PeriodicalIF":6.2,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144800397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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 a Brief Healthcare Insecurity Scale in a Sample of US Adults Living With and Without HIV","authors":"Sigal Maya MS,&nbsp;Hilary J. Bethancourt PhD,&nbsp;Andrea Norcini Pala PhD,&nbsp;Edward A. Frongillo PhD,&nbsp;Mirjam-Colette Kempf PhD,&nbsp;Igho Ofotokun MD,&nbsp;Sarah Krier PhD,&nbsp;Valentina Stosor MD,&nbsp;Sheri D. Weiser MD,&nbsp;Bulent Turan PhD","doi":"10.1016/j.jval.2026.05.017","DOIUrl":"10.1016/j.jval.2026.05.017","url":null,"abstract":"<div><h3>Objectives</h3><div>Healthcare insecurity is pervasive in the United States and abroad, with implications for health, particularly among people living with chronic conditions. Yet, a common definition is lacking and current measures are limited.</div></div><div><h3>Methods</h3><div>We developed and validated an 8-item healthcare insecurity scale (HCIS) using cross-sectional data collected from 2021 to 2022 from individuals living with and without HIV in the United States (<em>n</em> = 2513). Psychometric properties were assessed through confirmatory factor analysis and item response theory models, and measurement invariance was tested. Criterion and convergent validity were evaluated by examining associations between HCIS scores and health insurance status, socioeconomic factors, perceived stress, and self-reported physical, mental, and general health, adjusting for income and demographics.</div></div><div><h3>Results</h3><div>The unidimensional scale demonstrated good local fit and sufficient global fit. Each item was strongly correlated with the latent trait of healthcare insecurity (standardized factor loadings ranging from 0.69 to 0.90). The scale showed strong measurement invariance across groups defined by HIV serostatus and gender. Mean (SD) HCIS scores were 1.2 (2.5). Higher scores among those with no health insurance demonstrated criterion validity. Higher scores among those with lower income, unemployment, or disability, as well as strong positive associations between HCIS scores and perceived stress and self-reported health supported convergent validity.</div></div><div><h3>Conclusions</h3><div>The HCIS is a psychometrically sound tool for comprehensively assessing healthcare insecurity in people living with or vulnerable to HIV, even in a sample highly linked to care. The brevity and scope of HCIS support its applicability in research on healthcare insecurity beyond access to health insurance.</div></div>","PeriodicalId":23508,"journal":{"name":"Value in Health","volume":"29 10","pages":"Pages 1869-1877"},"PeriodicalIF":6.2,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13603063/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148370152","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}