Pub Date : 2025-12-29DOI: 10.1016/j.lana.2025.101354
Lawrence A. Haber , Katherine LeMasters , Justin Berk
{"title":"Inclusion of incarcerated individuals in wildfire exposure registries","authors":"Lawrence A. Haber , Katherine LeMasters , Justin Berk","doi":"10.1016/j.lana.2025.101354","DOIUrl":"10.1016/j.lana.2025.101354","url":null,"abstract":"","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"55 ","pages":"Article 101354"},"PeriodicalIF":7.0,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145885803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-27DOI: 10.1016/j.lana.2025.101350
Amos Grünebaum , Ruth Landau , Frank A. Chervenak
Background
The safety of out-of-hospital birth in the United States remains contested. A neglected methodological issue is the selective nonreporting of 5-min Apgar scores, which may conceal adverse outcomes and bias safety comparisons. This study examined whether Apgar score missingness differs systematically by birth setting and whether such “informative missingness” alters risk estimates.
Methods
We conducted a population-based analysis of 3,066,021 term, normal-birthweight, midwife-attended singleton births in the United States (2016–2023). Birth settings included hospitals, freestanding birth centers, and planned home births. Missing 5-min Apgar scores were quantified, and deterministic sensitivity analyses modeled the impact of varying assumptions about unrecorded low scores (<4 and <7). Hospital births served as the reference group.
Findings
Five-minute Apgar scores were missing in 0.13% of hospital, 1.9% of birth-center, and 3.1% of home births. Severe compromise (Apgar <4) occurred in 0.17%, 0.20%, and 0.26%, respectively. When half of missing scores were imputed as <4, adjusted odds of severe compromise increased to 7.7 for home and 4.9 for birth-center births vs. hospitals.
Interpretation
This study evaluates documentation integrity of US births. Selective nonreporting of 5-min Apgar scores at out-of-hospital births introduces major bias, distorting apparent safety of out-of-hospital births. Complete and enforceable outcome reporting is essential for scientific validity and ethically sound informed consent.
{"title":"Selective nonreporting of 5-min Apgar scores and its safety assessment of out-of-hospital births: a population-based study of United States’ birth data, 2016–2023 a population based study","authors":"Amos Grünebaum , Ruth Landau , Frank A. Chervenak","doi":"10.1016/j.lana.2025.101350","DOIUrl":"10.1016/j.lana.2025.101350","url":null,"abstract":"<div><h3>Background</h3><div>The safety of out-of-hospital birth in the United States remains contested. A neglected methodological issue is the selective nonreporting of 5-min Apgar scores, which may conceal adverse outcomes and bias safety comparisons. This study examined whether Apgar score missingness differs systematically by birth setting and whether such “informative missingness” alters risk estimates.</div></div><div><h3>Methods</h3><div>We conducted a population-based analysis of 3,066,021 term, normal-birthweight, midwife-attended singleton births in the United States (2016–2023). Birth settings included hospitals, freestanding birth centers, and planned home births. Missing 5-min Apgar scores were quantified, and deterministic sensitivity analyses modeled the impact of varying assumptions about unrecorded low scores (<4 and <7). Hospital births served as the reference group.</div></div><div><h3>Findings</h3><div>Five-minute Apgar scores were missing in 0.13% of hospital, 1.9% of birth-center, and 3.1% of home births. Severe compromise (Apgar <4) occurred in 0.17%, 0.20%, and 0.26%, respectively. When half of missing scores were imputed as <4, adjusted odds of severe compromise increased to 7.7 for home and 4.9 for birth-center births vs. hospitals.</div></div><div><h3>Interpretation</h3><div>This study evaluates documentation integrity of US births. Selective nonreporting of 5-min Apgar scores at out-of-hospital births introduces major bias, distorting apparent safety of out-of-hospital births. Complete and enforceable outcome reporting is essential for scientific validity and ethically sound informed consent.</div></div><div><h3>Funding</h3><div>None declared.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"54 ","pages":"Article 101350"},"PeriodicalIF":7.0,"publicationDate":"2025-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145840622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-26DOI: 10.1016/j.lana.2025.101349
Juan C. Pineda, Diana M. Montano, Liesed N. Urbano
{"title":"Waist-to-height ratio and cardiovascular risk: moving beyond BMI in aging populations","authors":"Juan C. Pineda, Diana M. Montano, Liesed N. Urbano","doi":"10.1016/j.lana.2025.101349","DOIUrl":"10.1016/j.lana.2025.101349","url":null,"abstract":"","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"54 ","pages":"Article 101349"},"PeriodicalIF":7.0,"publicationDate":"2025-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145840105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-26DOI: 10.1016/j.lana.2025.101348
Alessandro R. Marcon
{"title":"Regulatory bodies must critically assess their role in the wellness wave of supplement marketing","authors":"Alessandro R. Marcon","doi":"10.1016/j.lana.2025.101348","DOIUrl":"10.1016/j.lana.2025.101348","url":null,"abstract":"","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"54 ","pages":"Article 101348"},"PeriodicalIF":7.0,"publicationDate":"2025-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145840106","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-26DOI: 10.1016/j.lana.2025.101332
Andrew J. Beamish , Todd Jenkins , Justin R. Ryder , Anita Courcoulas , Robert M. Dorman , Marc Michalsky , Carrol Harmon , Michael Helmrath , Thomas H. Inge
Background
Metabolic and bariatric surgery (MBS) is an effective treatment for adolescent severe obesity. Little is known about subsequent healthcare utilisation for individuals who have undergone MBS as adolescents, both related and unrelated to the surgical intervention. This study aimed to document healthcare utilisation events across 5 years after MBS, comparing procedure types and evaluating factors associated with these events.
Methods
The Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study prospectively enrolled 228 adolescents prior to MBS (Roux-en-Y gastric bypass or vertical sleeve gastrectomy) across 5 US children's hospitals. Healthcare utilisation event data collection was standardised, and rigorously collected; events were categorised by system and classified as related or unrelated to the MBS intervention. Factors influencing/predicting the likelihood of healthcare utilisation events were evaluated using negative binomial regression modelling.
Findings
Mean baseline age and body mass index (BMI) of participants at surgery were 17 ± 1·6 years and 53 kg/m2, respectively. Related healthcare utilisation events numbered 141 in 81 participants (67·3 per 500 person-years, 95% CI 53·4–84·9). A total of 224 unrelated healthcare utilisation events unrelated occurred in 112 individuals (107·4 per 500 person-years, 95% CI 94·2–122·5). Over 5 years, participants with a complication within 30 days of surgery had significantly higher rates of subsequent healthcare utilisation events. No difference in rates by surgical procedures was observed for related events or events with hospital admission. However, among participants without baseline type 2 diabetes, vertical sleeve gastrectomy was associated with higher rates of unrelated events compared to Roux-en-Y gastric bypass. Fifty-two percent of events involved admission to hospital, with no difference by procedure, but higher admission rates were observed with higher BMI and hypertension at baseline.
Interpretation
Healthcare utilisation events were common after bariatric surgery and early post-operative surgical complications predicted later healthcare utilisation events. Healthcare utilisation events were more common after sleeve gastrectomy than RYGB in patients without type 2 diabetes at baseline. Findings will better inform surgical candidates of real-world expectations after surgery, and allow providers to consider closer monitoring of those with a 30-day healthcare utilisation event.
Funding
National Institutes for Health (NIH) research support was provided through the following grants: NIH UM1DK072493 and NIH UM1DK095710. The contents of this manuscript are the authors’ sole responsibility and do not necessarily represent official NIH views.
{"title":"Healthcare utilisation across five years among adolescents following metabolic-bariatric surgery; a prospective observational study","authors":"Andrew J. Beamish , Todd Jenkins , Justin R. Ryder , Anita Courcoulas , Robert M. Dorman , Marc Michalsky , Carrol Harmon , Michael Helmrath , Thomas H. Inge","doi":"10.1016/j.lana.2025.101332","DOIUrl":"10.1016/j.lana.2025.101332","url":null,"abstract":"<div><h3>Background</h3><div>Metabolic and bariatric surgery (MBS) is an effective treatment for adolescent severe obesity. Little is known about subsequent healthcare utilisation for individuals who have undergone MBS as adolescents, both related and unrelated to the surgical intervention. This study aimed to document healthcare utilisation events across 5 years after MBS, comparing procedure types and evaluating factors associated with these events.</div></div><div><h3>Methods</h3><div>The Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study prospectively enrolled 228 adolescents prior to MBS (Roux-en-Y gastric bypass or vertical sleeve gastrectomy) across 5 US children's hospitals. Healthcare utilisation event data collection was standardised, and rigorously collected; events were categorised by system and classified as related or unrelated to the MBS intervention. Factors influencing/predicting the likelihood of healthcare utilisation events were evaluated using negative binomial regression modelling.</div></div><div><h3>Findings</h3><div>Mean baseline age and body mass index (BMI) of participants at surgery were 17 ± 1·6 years and 53 kg/m<sup>2</sup>, respectively. Related healthcare utilisation events numbered 141 in 81 participants (67·3 per 500 person-years, 95% CI 53·4–84·9). A total of 224 unrelated healthcare utilisation events unrelated occurred in 112 individuals (107·4 per 500 person-years, 95% CI 94·2–122·5). Over 5 years, participants with a complication within 30 days of surgery had significantly higher rates of subsequent healthcare utilisation events. No difference in rates by surgical procedures was observed for related events or events with hospital admission. However, among participants without baseline type 2 diabetes, vertical sleeve gastrectomy was associated with higher rates of unrelated events compared to Roux-en-Y gastric bypass. Fifty-two percent of events involved admission to hospital, with no difference by procedure, but higher admission rates were observed with higher BMI and hypertension at baseline.</div></div><div><h3>Interpretation</h3><div>Healthcare utilisation events were common after bariatric surgery and early post-operative surgical complications predicted later healthcare utilisation events. Healthcare utilisation events were more common after sleeve gastrectomy than RYGB in patients without type 2 diabetes at baseline. Findings will better inform surgical candidates of real-world expectations after surgery, and allow providers to consider closer monitoring of those with a 30-day healthcare utilisation event.</div></div><div><h3>Funding</h3><div><span>National Institutes for Health</span> (NIH) research support was provided through the following grants: NIH UM1DK072493 and NIH UM1DK095710. The contents of this manuscript are the authors’ sole responsibility and do not necessarily represent official NIH views.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"54 ","pages":"Article 101332"},"PeriodicalIF":7.0,"publicationDate":"2025-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145840623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-26DOI: 10.1016/j.lana.2025.101346
Longjian Liu , Jintong Hou , Saishi Cui , Xiaopeng Zhao , Zuolu Liu , J. Craig Longenecker , Nathalie S. May , Jin Jun Luo , Rose Ann DiMaria-Ghalili , Howard J. Eisen
Background
Sex differences in the association between vascular factors and cognitive outcomes remain unclear. We aimed to investigate the associations of blood pressure metrics (hypertension, systolic blood pressure [SBP), pulse pressure, ankle and brachial pressures, and ankle to brachial pressure index [ABI]) with the risk of cognitive decline and dementia.
Methods
We conducted a population-based longitudinal analysis using data from the Atherosclerosis Risk in Communities (ARIC) study (begun in 1987–1989) in the United States. We analyzed a total of 12,268 participants aged 45–64 years who had validated exposure measurements, cognitive function tests (first administrated 1990–1992), and followed up for incidence of dementia through December 2019. Cognitive function was assessed using the Digit Symbol Substitution Test, the Delayed Word Recall Test, and the Word Fluency Test. Dementia cases were identified through a standardized clinical evaluation process, mostly adjudicated by expert reviewers. We performed sex-stratified analyses to examine the associations of blood pressure metrics and APOE ε4 allele with the risk of cognitive decline and dementia.
Findings
Over a median follow-up of 26.4 years, 2698 participants developed dementia. Women aged 55–64 had a significantly higher incidence of dementia than men aged 55–64 (14.8 vs. 11.8 per 1000 person-years; p < 0.0001). After adjusting for key covariates, SBP, pulse pressure, ankle and brachial pressures were significantly associated with cognitive decline in women (p < 0.05). In men, pulse pressure and ankle pressure showed a significant association. In longitudinal analyses, baseline hypertension and elevated brachial pressure were significantly associated with increased dementia risk in women, whereas in men, elevated brachial pressure and decreased ABI were significantly associated with dementia risk. Individuals with APOE ε4 allele had significantly higher risk of dementia in both sexes. A joint effect of APOE ε4 allele and elevated blood pressure metrics conferred a greater relative excess risk of dementia in women vs. men.
Interpretation
These findings highlight notable sex differences in the association between vascular factors and cognitive decline and dementia risk. Women appear more vulnerable to both genetic and vascular risk factors, emphasizing the need for sex-specific approaches in research, prevention, and intervention strategies for cognitive impairment.
{"title":"Sex differences in the association of vascular risk and APOE Genotype with cognitive decline and dementia: evidence from a U.S. longitudinal study","authors":"Longjian Liu , Jintong Hou , Saishi Cui , Xiaopeng Zhao , Zuolu Liu , J. Craig Longenecker , Nathalie S. May , Jin Jun Luo , Rose Ann DiMaria-Ghalili , Howard J. Eisen","doi":"10.1016/j.lana.2025.101346","DOIUrl":"10.1016/j.lana.2025.101346","url":null,"abstract":"<div><h3>Background</h3><div>Sex differences in the association between vascular factors and cognitive outcomes remain unclear. We aimed to investigate the associations of blood pressure metrics (hypertension, systolic blood pressure [SBP), pulse pressure, ankle and brachial pressures, and ankle to brachial pressure index [ABI]) with the risk of cognitive decline and dementia.</div></div><div><h3>Methods</h3><div>We conducted a population-based longitudinal analysis using data from the Atherosclerosis Risk in Communities (ARIC) study (begun in 1987–1989) in the United States. We analyzed a total of 12,268 participants aged 45–64 years who had validated exposure measurements, cognitive function tests (first administrated 1990–1992), and followed up for incidence of dementia through December 2019. Cognitive function was assessed using the Digit Symbol Substitution Test, the Delayed Word Recall Test, and the Word Fluency Test. Dementia cases were identified through a standardized clinical evaluation process, mostly adjudicated by expert reviewers. We performed sex-stratified analyses to examine the associations of blood pressure metrics and APOE ε4 allele with the risk of cognitive decline and dementia.</div></div><div><h3>Findings</h3><div>Over a median follow-up of 26.4 years, 2698 participants developed dementia. Women aged 55–64 had a significantly higher incidence of dementia than men aged 55–64 (14.8 vs. 11.8 per 1000 person-years; p < <em>0.0001</em>). After adjusting for key covariates, SBP, pulse pressure, ankle and brachial pressures were significantly associated with cognitive decline in women (p < 0.05). In men, pulse pressure and ankle pressure showed a significant association. In longitudinal analyses, baseline hypertension and elevated brachial pressure were significantly associated with increased dementia risk in women, whereas in men, elevated brachial pressure and decreased ABI were significantly associated with dementia risk. Individuals with APOE ε4 allele had significantly higher risk of dementia in both sexes. A joint effect of APOE ε4 allele and elevated blood pressure metrics conferred a greater relative excess risk of dementia in women vs. men.</div></div><div><h3>Interpretation</h3><div>These findings highlight notable sex differences in the association between vascular factors and cognitive decline and dementia risk. Women appear more vulnerable to both genetic and vascular risk factors, emphasizing the need for sex-specific approaches in research, prevention, and intervention strategies for cognitive impairment.</div></div><div><h3>Funding</h3><div><span>NIH</span>.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"54 ","pages":"Article 101346"},"PeriodicalIF":7.0,"publicationDate":"2025-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145840624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-23DOI: 10.1016/j.lana.2025.101345
Bennett Allen , Adelya Urmanche , Brenda Curtis , Celia Fisher
As predictive analytics become more widely integrated into local public health responses to the United States overdose epidemic, community-based substance use service providers have begun to adopt machine learning-based predictive tools to guide the allocation and delivery of overdose prevention services. While these tools hold promise for anticipating community overdose risk and enhancing the efficiency of overdose prevention resource distribution, outreach, and education efforts, their use in community settings raises substantial ethical and practical challenges. In this Viewpoint, we examine the application of predictive analytics to community-based overdose prevention through a public health ethics lens, drawing on principles of distributive justice, transparency, community participation, and implementation readiness. We outline five key ethical considerations for developers (i.e., institutional responsibility, oversimplification of complex social realities, data and algorithmic bias, community displacement in decision making, and equity trade-offs) and corresponding practical challenges for service providers. We offer five recommendations for developers, public health authorities, and frontline organizations to overcome challenges and ensure responsible, equity-driven implementation. As data-driven approaches to overdose prevention proliferate, ethical and participatory frameworks will be essential to ensure predictive tools strengthen, rather than undermine, community trust and health equity.
{"title":"Ethical challenges and opportunities for integrating predictive analytics in community-based overdose prevention","authors":"Bennett Allen , Adelya Urmanche , Brenda Curtis , Celia Fisher","doi":"10.1016/j.lana.2025.101345","DOIUrl":"10.1016/j.lana.2025.101345","url":null,"abstract":"<div><div>As predictive analytics become more widely integrated into local public health responses to the United States overdose epidemic, community-based substance use service providers have begun to adopt machine learning-based predictive tools to guide the allocation and delivery of overdose prevention services. While these tools hold promise for anticipating community overdose risk and enhancing the efficiency of overdose prevention resource distribution, outreach, and education efforts, their use in community settings raises substantial ethical and practical challenges. In this Viewpoint, we examine the application of predictive analytics to community-based overdose prevention through a public health ethics lens, drawing on principles of distributive justice, transparency, community participation, and implementation readiness. We outline five key ethical considerations for developers (i.e., institutional responsibility, oversimplification of complex social realities, data and algorithmic bias, community displacement in decision making, and equity trade-offs) and corresponding practical challenges for service providers. We offer five recommendations for developers, public health authorities, and frontline organizations to overcome challenges and ensure responsible, equity-driven implementation. As data-driven approaches to overdose prevention proliferate, ethical and participatory frameworks will be essential to ensure predictive tools strengthen, rather than undermine, community trust and health equity.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"55 ","pages":"Article 101345"},"PeriodicalIF":7.0,"publicationDate":"2025-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145842552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-22DOI: 10.1016/j.lana.2025.101356
Sophia Aguiar Monteiro Borges , Erick Ohanesian Polli , Ana Carolina Nonato , Natacha Cerchiari , Stéphane Verguet , Ana Marli Christovam Sartori , Patrícia Coelho de Soárez
Background
In Brazil, respiratory syncytial virus (RSV) is the primary cause of lower respiratory tract infections (LRTI) in children under two years of age. Maternal immunization with the bivalent RSV prefusion F protein vaccine (RSVpreF) has demonstrated high efficacy in protecting infants during their first 6 months of life against RSV-LRTI. We assessed the cost-effectiveness of implementing maternal RSV immunization in Brazil.
Methods
We utilised a decision tree model, following a birth cohort during their first year of life. The model compared two strategies: maternal vaccination and no vaccination, from both healthcare system and societal perspectives. Secondary data from Brazilian Health Information Systems, administrative databases and international literature were used. The primary outcome was the incremental cost-effectiveness ratio (ICER) expressed as incremental cost per disability-adjusted life year (DALY) averted, in 2023 USD. We applied a cost-effectiveness threshold of 8000 USD (40,000 BRL) per DALY based on Brazilian guidelines.
Findings
Introduction of RSV vaccination for pregnant women at 50% coverage would prevent around 37,000 RSV cases annually, including 9400 hospitalizations and 28,000 outpatient visits. The program would avert 80 deaths and 1660 DALYs, with an incremental cost of $49,200,000 USD from the healthcare system perspective (ICER $29,700 per DALY averted) and $48,800,000 USD from the societal perspective (ICER $29,200 per DALY averted). These ICERs exceed the acceptable cost-effectiveness Brazilian threshold. To be considered cost-effective, the vaccine dose price would need to be around $12. In sensitivity analyses, vaccine price and efficacy were the most influential parameters, as testing their uncertainty ranges resulted in the largest changes (i.e., the widest range) in the ICER. In the probabilistic sensitivity analysis, the probability that the maternal RSV immunization program is cost-effective at the Brazilian threshold of $8000 per DALY averted was 0% from the healthcare system perspective and 6% from the societal perspective.
Interpretation
Our findings indicate maternal RSV immunization could substantially reduce disease burden but would require significant price reduction to meet Brazil's cost-effectiveness threshold.
Funding
São Paulo Research Foundation (FAPESP), Pan American Health Organization (PAHO) and Brazilian National Council for Scientific and Technological Development (CNPq).
{"title":"Maternal RSV vaccination to protect infants in Brazil: a model-based cost-effectiveness analysis for incorporation into the National Immunisation Program","authors":"Sophia Aguiar Monteiro Borges , Erick Ohanesian Polli , Ana Carolina Nonato , Natacha Cerchiari , Stéphane Verguet , Ana Marli Christovam Sartori , Patrícia Coelho de Soárez","doi":"10.1016/j.lana.2025.101356","DOIUrl":"10.1016/j.lana.2025.101356","url":null,"abstract":"<div><h3>Background</h3><div>In Brazil, respiratory syncytial virus (RSV) is the primary cause of lower respiratory tract infections (LRTI) in children under two years of age. Maternal immunization with the bivalent RSV prefusion F protein vaccine (RSVpreF) has demonstrated high efficacy in protecting infants during their first 6 months of life against RSV-LRTI. We assessed the cost-effectiveness of implementing maternal RSV immunization in Brazil.</div></div><div><h3>Methods</h3><div>We utilised a decision tree model, following a birth cohort during their first year of life. The model compared two strategies: maternal vaccination and no vaccination, from both healthcare system and societal perspectives. Secondary data from Brazilian Health Information Systems, administrative databases and international literature were used. The primary outcome was the incremental cost-effectiveness ratio (ICER) expressed as incremental cost per disability-adjusted life year (DALY) averted, in 2023 USD. We applied a cost-effectiveness threshold of 8000 USD (40,000 BRL) per DALY based on Brazilian guidelines.</div></div><div><h3>Findings</h3><div>Introduction of RSV vaccination for pregnant women at 50% coverage would prevent around 37,000 RSV cases annually, including 9400 hospitalizations and 28,000 outpatient visits. The program would avert 80 deaths and 1660 DALYs, with an incremental cost of $49,200,000 USD from the healthcare system perspective (ICER $29,700 per DALY averted) and $48,800,000 USD from the societal perspective (ICER $29,200 per DALY averted). These ICERs exceed the acceptable cost-effectiveness Brazilian threshold. To be considered cost-effective, the vaccine dose price would need to be around $12. In sensitivity analyses, vaccine price and efficacy were the most influential parameters, as testing their uncertainty ranges resulted in the largest changes (i.e., the widest range) in the ICER. In the probabilistic sensitivity analysis, the probability that the maternal RSV immunization program is cost-effective at the Brazilian threshold of $8000 per DALY averted was 0% from the healthcare system perspective and 6% from the societal perspective.</div></div><div><h3>Interpretation</h3><div>Our findings indicate maternal RSV immunization could substantially reduce disease burden but would require significant price reduction to meet Brazil's cost-effectiveness threshold.</div></div><div><h3>Funding</h3><div><span>São Paulo Research Foundation</span> (FAPESP), <span>Pan American Health Organization</span> (PAHO) and <span>Brazilian National Council for Scientific and Technological Development</span> (CNPq).</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"53 ","pages":"Article 101356"},"PeriodicalIF":7.0,"publicationDate":"2025-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145839177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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