Pub Date : 2026-03-01Epub Date: 2025-12-20DOI: 10.1016/j.lana.2025.101344
Nélio Cézar de Aquino , Cadiele Oliana Reichert , Luis Alberto de Padua Covas Lage , Hebert Fabricio Culler , Felipe Santa Rosa Roitberg , Vanderson Rocha , Flávia Neves Rocha Alves , Juliana Pereira
Regulatory agencies are increasingly incorporating real-world data (RWD) and real-world evidence (RWE) into decision-making frameworks to complement randomized clinical trials. While some regions, such as the U.S. and EU, have developed structured approaches for RWE use, Brazil's regulatory environment remains comparatively limited. This study examines the status of RWE regulatory integration in Brazil through an analysis of normative documents, institutional publications, and selected case studies, using a comparative policy perspective. Although advances have been made in data standardization and the publication of technical guidelines, such as ANVISA's Guidance No. 64/2023, the practical use of RWE in regulatory processes is still nascent. Key challenges include fragmented data infrastructure, and limited intersectoral coordination. Addressing these gaps will require improved interoperability across health information systems, convergence of methodological standards, and sustained collaboration among regulatory authorities, academia, and data holders to enable consistent and scientifically robust use of RWE in the Brazilian context and, potentially, in other low- and middle-income countries.
{"title":"Advancing real-world evidence in Brazil: regulatory gaps and global lessons","authors":"Nélio Cézar de Aquino , Cadiele Oliana Reichert , Luis Alberto de Padua Covas Lage , Hebert Fabricio Culler , Felipe Santa Rosa Roitberg , Vanderson Rocha , Flávia Neves Rocha Alves , Juliana Pereira","doi":"10.1016/j.lana.2025.101344","DOIUrl":"10.1016/j.lana.2025.101344","url":null,"abstract":"<div><div>Regulatory agencies are increasingly incorporating real-world data (RWD) and real-world evidence (RWE) into decision-making frameworks to complement randomized clinical trials. While some regions, such as the U.S. and EU, have developed structured approaches for RWE use, Brazil's regulatory environment remains comparatively limited. This study examines the status of RWE regulatory integration in Brazil through an analysis of normative documents, institutional publications, and selected case studies, using a comparative policy perspective. Although advances have been made in data standardization and the publication of technical guidelines, such as ANVISA's Guidance No. 64/2023, the practical use of RWE in regulatory processes is still nascent. Key challenges include fragmented data infrastructure, and limited intersectoral coordination. Addressing these gaps will require improved interoperability across health information systems, convergence of methodological standards, and sustained collaboration among regulatory authorities, academia, and data holders to enable consistent and scientifically robust use of RWE in the Brazilian context and, potentially, in other low- and middle-income countries.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"55 ","pages":"Article 101344"},"PeriodicalIF":7.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145792268","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 : 2026-02-01Epub Date: 2025-12-06DOI: 10.1016/j.lana.2025.101325
Sarah McKetta , Kodiak R.S. Soled , Payal Chakraborty , Colleen A. Reynolds , Bethany G. Everett , Daphna Stroumsa , Sebastien Haneuse , S. Bryn Austin , Jorge E. Chavarro , A. Heather Eliassen , Aimee K. Huang , Brittany M. Charlton
Background
The study aim was to quantify differences in risk for Cesarean birth vary by sexual orientation.
Methods
We pooled data from singleton, live births in the Nurses’ Health Studies 2 and 3, and the Growing Up Today Study (N = 102,298 pregnancies). We used generalized estimating equations to fit logistic models for risks of primary Cesarean birth comparing sexual minority (SM) to completely heterosexual participants, controlling for year and age. SM participants were further stratified into heterosexual with prior same-sex experience (i.e., identifying as heterosexual, but with same-sex attractions, behaviors, or prior SM identity), mostly heterosexual, bisexual, and lesbian/gay subgroups. We examined heterogeneity by parity, labor induction, and racialized identity.
Findings
SM participants had higher risks of primary Cesarean birth than their completely heterosexual peers (adjusted odds ratio [OR] = 1.07, 95% confidence interval [CI] 1.01–1.12), with increases most pronounced among pregnancies to heterosexual participants with prior same-sex experience (OR = 1.12, 95% CI 1.04–1.20). Labor induction was associated with a higher magnitude disparity (OR for induced labor = 1.21, 95% CI 1.09–1.35; OR for spontaneous labor = 0.91, 95% CI 0.83–1.01; p-value for interaction = 0.09). Racialized identity or parity did not moderate sexual orientation-related disparities in primary Cesarean birth.
Interpretation
SM people have increased risks for primary Cesarean birth, but these vary across sexual orientation subgroups. We found increased risks for a rarely studied subgroup of sexual minority people, those who identify as heterosexual but have prior same-sex experience. These disparities are most pronounced when labor is induced. All participants were assumed to be women based on surveys querying sex and birth histories, but we were limited in generalizability due to not knowing their gender identities.
Funding
National Institutes of Health (United States).
研究的目的是量化性取向不同的剖宫产风险的差异。方法:我们汇集了来自护士健康研究2和3中的单胎、活产和成长研究(N = 102,298例妊娠)的数据。我们使用广义估计方程来拟合逻辑模型,比较性少数(SM)和完全异性恋参与者的初次剖宫产风险,控制年龄和年龄。SM参与者被进一步划分为有过同性经历的异性恋者(即,自认为是异性恋者,但有同性吸引力、行为或先前的SM身份),主要是异性恋、双性恋和女同性恋/男同性恋亚组。我们通过平等、劳动诱导和种族化身份来检验异质性。研究发现,ssm参与者的初次剖宫产风险高于完全异性恋的同龄人(校正优势比[OR] = 1.07, 95%可信区间[CI] 1.01-1.12),在有过同性经历的异性恋参与者中,这一风险增加最为明显(OR = 1.12, 95% CI 1.04-1.20)。引产与较大的幅度差异相关(引产的OR = 1.21, 95% CI 1.09-1.35;自然分娩的OR = 0.91, 95% CI 0.83-1.01;相互作用的p值= 0.09)。种族化的身份或胎次并不能缓和初次剖宫产中与性取向相关的差异。人们初次剖宫产的风险增加,但这在不同的性取向亚群中有所不同。我们发现,很少研究的性少数人群,即那些认为自己是异性恋但之前有过同性经历的人,风险增加。这些差异在引产时最为明显。根据对性别和出生史的调查,我们假设所有参与者都是女性,但由于不知道他们的性别身份,我们的概括性受到限制。国家卫生研究院(美国)。
{"title":"Disparities in primary Cesarean birth by sexual orientation: a population-based analysis across three longitudinal cohorts","authors":"Sarah McKetta , Kodiak R.S. Soled , Payal Chakraborty , Colleen A. Reynolds , Bethany G. Everett , Daphna Stroumsa , Sebastien Haneuse , S. Bryn Austin , Jorge E. Chavarro , A. Heather Eliassen , Aimee K. Huang , Brittany M. Charlton","doi":"10.1016/j.lana.2025.101325","DOIUrl":"10.1016/j.lana.2025.101325","url":null,"abstract":"<div><h3>Background</h3><div>The study aim was to quantify differences in risk for Cesarean birth vary by sexual orientation.</div></div><div><h3>Methods</h3><div>We pooled data from singleton, live births in the Nurses’ Health Studies 2 and 3, and the Growing Up Today Study (N = 102,298 pregnancies). We used generalized estimating equations to fit logistic models for risks of primary Cesarean birth comparing sexual minority (SM) to completely heterosexual participants, controlling for year and age. SM participants were further stratified into heterosexual with prior same-sex experience (i.e., identifying as heterosexual, but with same-sex attractions, behaviors, or prior SM identity), mostly heterosexual, bisexual, and lesbian/gay subgroups. We examined heterogeneity by parity, labor induction, and racialized identity.</div></div><div><h3>Findings</h3><div>SM participants had higher risks of primary Cesarean birth than their completely heterosexual peers (adjusted odds ratio [OR] = 1.07, 95% confidence interval [CI] 1.01–1.12), with increases most pronounced among pregnancies to heterosexual participants with prior same-sex experience (OR = 1.12, 95% CI 1.04–1.20). Labor induction was associated with a higher magnitude disparity (OR for induced labor = 1.21, 95% CI 1.09–1.35; OR for spontaneous labor = 0.91, 95% CI 0.83–1.01; p-value for interaction = 0.09). Racialized identity or parity did not moderate sexual orientation-related disparities in primary Cesarean birth.</div></div><div><h3>Interpretation</h3><div>SM people have increased risks for primary Cesarean birth, but these vary across sexual orientation subgroups. We found increased risks for a rarely studied subgroup of sexual minority people, those who identify as heterosexual but have prior same-sex experience. These disparities are most pronounced when labor is induced. All participants were assumed to be women based on surveys querying sex and birth histories, but we were limited in generalizability due to not knowing their gender identities.</div></div><div><h3>Funding</h3><div><span>National Institutes of Health</span> (United States).</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"54 ","pages":"Article 101325"},"PeriodicalIF":7.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145683869","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 : 2026-02-01Epub Date: 2026-01-14DOI: 10.1016/j.lana.2026.101377
Taissa Vila, Orison O. Woolcott
{"title":"Advancing maternal and child health and nutrition in Ecuador: a call for research","authors":"Taissa Vila, Orison O. Woolcott","doi":"10.1016/j.lana.2026.101377","DOIUrl":"10.1016/j.lana.2026.101377","url":null,"abstract":"","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"54 ","pages":"Article 101377"},"PeriodicalIF":7.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145976914","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 : 2026-02-01Epub Date: 2026-01-30DOI: 10.1016/j.lana.2026.101378
Orison O. Woolcott
{"title":"The Latin American Diabetes Association 2025 congress","authors":"Orison O. Woolcott","doi":"10.1016/j.lana.2026.101378","DOIUrl":"10.1016/j.lana.2026.101378","url":null,"abstract":"","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"54 ","pages":"Article 101378"},"PeriodicalIF":7.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146077821","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 : 2026-02-01Epub Date: 2025-12-17DOI: 10.1016/j.lana.2025.101331
Patrick Albers , Khalid Amin , Stacey Broomfield , Janis Geary , Joy Pader , Angeline Letendre , Wayne Clark , Amy Colquhoun , Lea Bill , Adam Kinnaird
Background
First Nations men in Canada, one of the three distinct Indigenous groups along with Inuit and Métis, have been reported to present with more aggressive prostate cancers than non-First Nations men. However, the long-term impact on prostate cancer-specific survival remains unclear. This study examines disparities in prostate cancer outcomes between First Nations and non-First Nations men in Alberta.
Methods
Data from the Alberta Cancer Registry (1995–2022) were analyzed for all men aged 18 and above diagnosed with prostate cancer. First Nations status was determined using the Alberta Health Care Insurance Plan registry. The primary outcome was age-standardized prostate cancer mortality; secondary outcomes included age at death and prostate cancer-specific survival. Statistical analyses included t-tests, Chi-squared tests, Kaplan–Meier survival curves, log-rank tests, and Cox proportional hazards models. Data on socioeconomic deprivation were not available, and analyses could not be adjusted for this potential confounder.
Findings
The dataset comprised 1,323,333 person-years for First Nations men and 37,820,148 for non-First Nations men. First Nations men were diagnosed younger (65.8 vs. 67.8 years, p < 0.0001) and died earlier (74.4 vs. 78.9 years, p < 0.0001) across both rural and urban settings. Age-adjusted prostate cancer mortality was higher (41.5 vs. 30.1 per 100,000, p < 0.0001), and Stage IV disease was more common (17.8% vs. 12.2%, p < 0.0001). Prostate cancer-specific survival was worse (HR 1.67, 95% CI 1.43–1.96, p < 0.0001). After adjusting for age, stage, location, and number of malignancies, overall survival was similar (HR 1.06, 95% CI 0.57–1.89, p = 0.84).
Interpretation
First Nations men in Alberta are diagnosed with prostate cancer at a younger age and later stage, leading to higher overall mortality. After adjustment, disease-specific survival is similar to non-First Nations men. These findings indicate disparities may arise from delayed diagnosis, underscoring the need for culturally safe, community-informed initiatives promoting earlier presentation and detection.
Funding
Movember, Alberta Cancer Foundation, Bird Dogs, University Hospital Foundation.
背景:据报道,加拿大的第一民族男性比非第一民族男性更容易患侵袭性前列腺癌,他们与因纽特人和姆萨梅蒂斯人一起是三个不同的土著群体之一。然而,对前列腺癌特异性生存率的长期影响尚不清楚。这项研究调查了阿尔伯塔省第一民族和非第一民族男性前列腺癌预后的差异。方法:对艾伯塔省癌症登记处(1995-2022)的所有18岁及以上诊断为前列腺癌的男性数据进行分析。使用艾伯塔省医疗保险计划登记处确定了原住民地位。主要结局是年龄标准化前列腺癌死亡率;次要结局包括死亡年龄和前列腺癌特异性生存率。统计分析包括t检验、卡方检验、Kaplan-Meier生存曲线、log-rank检验和Cox比例风险模型。没有关于社会经济剥夺的数据,分析也无法针对这一潜在的混杂因素进行调整。研究结果:该数据集包括1323333名第一民族男性和37820148名非第一民族男性。在农村和城市环境中,原住民男性的诊断年龄较年轻(65.8岁对67.8岁,p < 0.0001),死亡时间较早(74.4岁对78.9岁,p < 0.0001)。年龄调整后的前列腺癌死亡率更高(41.5比30.1 / 100000,p < 0.0001), IV期疾病更常见(17.8%比12.2%,p < 0.0001)。前列腺癌特异性生存率较差(HR 1.67, 95% CI 1.43-1.96, p < 0.0001)。在调整年龄、分期、位置和恶性肿瘤数量后,总生存率相似(HR 1.06, 95% CI 0.57-1.89, p = 0.84)。解释:阿尔伯塔省的原住民男性在较年轻和较晚的阶段被诊断出患有前列腺癌,导致较高的总体死亡率。调整后,疾病特异性生存率与非第一民族男性相似。这些发现表明,差异可能是由延迟诊断引起的,强调需要采取文化上安全、社区知情的举措,促进早期表现和发现。资助:Movember, Alberta癌症基金会,Bird Dogs,大学医院基金会。
{"title":"Disparities in prostate cancer outcomes between First Nations and Non-First Nations men in Canada—Cohort study","authors":"Patrick Albers , Khalid Amin , Stacey Broomfield , Janis Geary , Joy Pader , Angeline Letendre , Wayne Clark , Amy Colquhoun , Lea Bill , Adam Kinnaird","doi":"10.1016/j.lana.2025.101331","DOIUrl":"10.1016/j.lana.2025.101331","url":null,"abstract":"<div><h3>Background</h3><div>First Nations men in Canada, one of the three distinct Indigenous groups along with Inuit and Métis, have been reported to present with more aggressive prostate cancers than non-First Nations men. However, the long-term impact on prostate cancer-specific survival remains unclear. This study examines disparities in prostate cancer outcomes between First Nations and non-First Nations men in Alberta.</div></div><div><h3>Methods</h3><div>Data from the Alberta Cancer Registry (1995–2022) were analyzed for all men aged 18 and above diagnosed with prostate cancer. First Nations status was determined using the Alberta Health Care Insurance Plan registry. The primary outcome was age-standardized prostate cancer mortality; secondary outcomes included age at death and prostate cancer-specific survival. Statistical analyses included t-tests, Chi-squared tests, Kaplan–Meier survival curves, log-rank tests, and Cox proportional hazards models. Data on socioeconomic deprivation were not available, and analyses could not be adjusted for this potential confounder.</div></div><div><h3>Findings</h3><div>The dataset comprised 1,323,333 person-years for First Nations men and 37,820,148 for non-First Nations men. First Nations men were diagnosed younger (65.8 vs. 67.8 years, p < 0.0001) and died earlier (74.4 vs. 78.9 years, p < 0.0001) across both rural and urban settings. Age-adjusted prostate cancer mortality was higher (41.5 vs. 30.1 per 100,000, p < 0.0001), and Stage IV disease was more common (17.8% vs. 12.2%, p < 0.0001). Prostate cancer-specific survival was worse (HR 1.67, 95% CI 1.43–1.96, p < 0.0001). After adjusting for age, stage, location, and number of malignancies, overall survival was similar (HR 1.06, 95% CI 0.57–1.89, p = 0.84).</div></div><div><h3>Interpretation</h3><div>First Nations men in Alberta are diagnosed with prostate cancer at a younger age and later stage, leading to higher overall mortality. After adjustment, disease-specific survival is similar to non-First Nations men. These findings indicate disparities may arise from delayed diagnosis, underscoring the need for culturally safe, community-informed initiatives promoting earlier presentation and detection.</div></div><div><h3>Funding</h3><div><span>Movember</span>, <span>Alberta Cancer Foundation</span>, <span>Bird Dogs</span>, <span>University Hospital Foundation</span>.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"54 ","pages":"Article 101331"},"PeriodicalIF":7.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147272037","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 : 2026-02-01Epub 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":"2026-02-01","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 : 2026-02-01Epub Date: 2026-01-07DOI: 10.1016/j.lana.2025.101368
Isobel M.F. Todd , David P. Burgner , Maria C. Magnus , Lars Henning Pedersen , Jessica E. Miller
{"title":"Prenatal and intrapartum antibiotic exposure and childhood infections: considerations and complexities","authors":"Isobel M.F. Todd , David P. Burgner , Maria C. Magnus , Lars Henning Pedersen , Jessica E. Miller","doi":"10.1016/j.lana.2025.101368","DOIUrl":"10.1016/j.lana.2025.101368","url":null,"abstract":"","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"54 ","pages":"Article 101368"},"PeriodicalIF":7.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145925433","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 : 2026-02-01Epub 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":"2026-02-01","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 : 2026-02-01Epub 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":"2026-02-01","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 : 2026-02-01Epub Date: 2025-12-11DOI: 10.1016/j.lana.2025.101334
Marco Antonio Catussi Paschoalotto , Eduardo Alves Lazzari , Rudi Rocha , Adriano Massuda , Marcia C. Castro
Health system resilience (HSR) is essential to sustaining equitable essential functions under acute and chronic stressors in decentralized systems. We developed and validated a Brazil-tailored HSR framework that distinguishes steady-state performance from resilience-specific capacities and assigns responsibilities across federal, state, regional, and municipal levels. Using a three-phase qualitative deductive–inductive approach with 48 international and national experts, we identified nine dimensions, 18 subdimensions, and 65 indicators that prioritise governance coherence, surge workforce strategies, emergency regulation, real-time monitoring, and access to critical technologies. The framework clarifies boundaries between general health system performance and adaptive, absorptive, and transformative functions, and specifies how managers can apply it in practice through structured scoping, mapping, scoring, prioritisation, planning, and monitoring steps. Although designed for Brazil's Unified Health System (SUS), the development logic generalises to other decentralised contexts with appropriate re-allocation of responsibilities and calibration to national financing rules. This policy-facing tool supports actionable resilience strengthening in complex, multi-level systems.
{"title":"Building a health system resilience framework: national, state, regional, and local perspectives","authors":"Marco Antonio Catussi Paschoalotto , Eduardo Alves Lazzari , Rudi Rocha , Adriano Massuda , Marcia C. Castro","doi":"10.1016/j.lana.2025.101334","DOIUrl":"10.1016/j.lana.2025.101334","url":null,"abstract":"<div><div>Health system resilience (HSR) is essential to sustaining equitable essential functions under acute and chronic stressors in decentralized systems. We developed and validated a Brazil-tailored HSR framework that distinguishes steady-state performance from resilience-specific capacities and assigns responsibilities across federal, state, regional, and municipal levels. Using a three-phase qualitative deductive–inductive approach with 48 international and national experts, we identified nine dimensions, 18 subdimensions, and 65 indicators that prioritise governance coherence, surge workforce strategies, emergency regulation, real-time monitoring, and access to critical technologies. The framework clarifies boundaries between general health system performance and adaptive, absorptive, and transformative functions, and specifies how managers can apply it in practice through structured scoping, mapping, scoring, prioritisation, planning, and monitoring steps. Although designed for Brazil's Unified Health System (SUS), the development logic generalises to other decentralised contexts with appropriate re-allocation of responsibilities and calibration to national financing rules. This policy-facing tool supports actionable resilience strengthening in complex, multi-level systems.</div></div>","PeriodicalId":29783,"journal":{"name":"Lancet Regional Health-Americas","volume":"54 ","pages":"Article 101334"},"PeriodicalIF":7.0,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145737800","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}