Pub Date : 2025-11-01DOI: 10.1016/j.lanepe.2025.101460
Alan G. Fraser , Sergio Buccheri , Robert A. Byrne , Per Kjaersgaard-Andersen , Stefan James , Peter Jüni , Lia Bally , Richard Bulbulia , Berthold V. Koletzko , Martin J. Landray , Claudia Louati , Anne Lübbeke , Perla J. Marang-van de Mheen , Peter McCulloch , Bernadeta Patro-Golab , Frank E. Rademakers , Petra Schnell-Inderst , George C.M. Siontis , Marina Torre , Claudia Wild , Christoph Ziskoven
Before a high-risk medical device is approved for implantation into patients, there should be evidence not only of its performance and safety with a favourable benefit-risk ratio, but also of its clinical efficacy. Regulatory guidance on study methodologies is lacking, however, so the European Commission funded the CORE–MD project (Coordinating Research and Evidence for Medical Devices) to advise regulators on appropriate designs for clinical trials of high-risk devices. The CORE–MD consortium recommends that evaluation should be planned in four stages. Randomised controlled trials should be performed more often, against active comparators reflecting the best available treatment, or using sham interventions with ethical safeguards. Large trials can be managed efficiently using an electronic database or registry. Non-randomised clinical studies can apply objective performance criteria or other validated patient-relevant outcome measures, with adjustments to minimise bias. Full transparency of results from clinical investigations is essential. Proportionate regulation of breakthrough or orphan devices for independently-defined serious unmet needs may involve approval with less evidence, but on condition of subsequent confirmatory studies. These CORE–MD consensus proposals have been submitted to European Union medical device regulators, to be considered as a basis for more transparent and predictable requirements for clinical evidence.
Funding
The CORE–MD project was funded as a Coordination and Support action from the European UnionHorizon 2020 research and innovation programme, under grant agreement 965246.
{"title":"Recommended methodologies for clinical investigations of high-risk medical devices—Conclusions from the European Union CORE–MD Project","authors":"Alan G. Fraser , Sergio Buccheri , Robert A. Byrne , Per Kjaersgaard-Andersen , Stefan James , Peter Jüni , Lia Bally , Richard Bulbulia , Berthold V. Koletzko , Martin J. Landray , Claudia Louati , Anne Lübbeke , Perla J. Marang-van de Mheen , Peter McCulloch , Bernadeta Patro-Golab , Frank E. Rademakers , Petra Schnell-Inderst , George C.M. Siontis , Marina Torre , Claudia Wild , Christoph Ziskoven","doi":"10.1016/j.lanepe.2025.101460","DOIUrl":"10.1016/j.lanepe.2025.101460","url":null,"abstract":"<div><div>Before a high-risk medical device is approved for implantation into patients, there should be evidence not only of its performance and safety with a favourable benefit-risk ratio, but also of its clinical efficacy. Regulatory guidance on study methodologies is lacking, however, so the European Commission funded the CORE–MD project (Coordinating Research and Evidence for Medical Devices) to advise regulators on appropriate designs for clinical trials of high-risk devices. The CORE–MD consortium recommends that evaluation should be planned in four stages. Randomised controlled trials should be performed more often, against active comparators reflecting the best available treatment, or using sham interventions with ethical safeguards. Large trials can be managed efficiently using an electronic database or registry. Non-randomised clinical studies can apply objective performance criteria or other validated patient-relevant outcome measures, with adjustments to minimise bias. Full transparency of results from clinical investigations is essential. Proportionate regulation of breakthrough or orphan devices for independently-defined serious unmet needs may involve approval with less evidence, but on condition of subsequent confirmatory studies. These CORE–MD consensus proposals have been submitted to European Union medical device regulators, to be considered as a basis for more transparent and predictable requirements for clinical evidence.</div></div><div><h3>Funding</h3><div>The CORE–MD project was funded as a Coordination and Support action from the <span>European Union</span> <span>Horizon 2020</span> research and innovation programme, under grant agreement 965246.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"58 ","pages":"Article 101460"},"PeriodicalIF":13.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145465481","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 : 2025-11-01DOI: 10.1016/j.lanepe.2025.101509
Sara Lise Busschaert , Eva Kimpe , Kurt Barbé , Thierry Gevaert , Mark De Ridder , Koen Putman
Background
Deep inspiration breath-hold (DIBH) holds promise in mitigating late cardiac and pulmonary toxicities in breast cancer patients. However, DIBH increases resource demands, potentially compromising operational efficiency and access to radiotherapy (RT). The aim of this study is to compare the operational implications of a targeted RT approach based on cost-effectiveness with those of non-targeted approaches.
Methods
A state-transition microsimulation model was developed to assess the cost-effectiveness of DIBH versus Free Breathing (FB) in Belgian women aged 40–79 years receiving left- or right-sided RT, with or without regional nodal irradiation. Baseline cardiovascular and lung cancer risks were estimated using SCORE2 and PLCOall2014 equations, while post-RT risks were derived using normal tissue complication probability models. A healthcare payer perspective was adopted to estimate the incremental cost-effectiveness ratio (ICER) based on quality-adjusted life years (QALYs) and direct healthcare costs. In parallel, a discrete event simulation model evaluated the operational impact of three RT strategies: (1) 100% FB, (2) 100% DIBH, and (3) targeted DIBH (selective use in cost-effective cases).
Findings
DIBH was cost-effective in 58.3% of patients, exhibiting more pronounced benefits in individuals with left-sided cancer, node-positive disease, smokers, those with elevated baseline CVD risk, and older age groups. Compared with not using DIBH, adopting DIBH universally led to a 21.7% (95% CI [21.2%–22.2%]) decrease in maximum throughput whereas a targeted approach (i.e., 58.3% DIBH) resulted in a 13.1% (95% CI [12.9%–14.0%]) reduction in maximum throughput.
Interpretation
A targeted RT approach prioritises DIBH for those deriving the most benefit, improving RT resource utilisation and supporting value-based healthcare.
Funding
This research was funded by the Strategic Research Programme (zwaartepunt, SRP 53, 2019–2024) ‘Societal Benefit of Markerless Stereotactic Body Radiotherapy: a Statistical Support based on Quantitative Imaging’ (SMARTQI of the Vrije Universiteit Brussel) and the ‘Value-Based Breast Radiotherapy’ research grant from Kom op tegen Kanker (KOTK_VUB/2024/13906).
深度吸气屏气（DIBH）有望减轻乳腺癌患者的晚期心脏和肺毒性。然而，DIBH增加了资源需求，可能影响操作效率和放射治疗（RT）的获得。本研究的目的是比较基于成本效益的靶向RT方法与非靶向RT方法的操作意义。方法建立状态转移微观模拟模型，评估40-79岁比利时女性接受左侧或右侧放射治疗，有或没有区域淋巴结照射的DIBH与自由呼吸（FB）的成本-效果。使用SCORE2和PLCOall2014方程估计基线心血管和肺癌风险，而使用正常组织并发症概率模型推导rt后风险。采用医疗支付者视角，基于质量调整生命年（QALYs）和直接医疗成本估算增量成本-效果比（ICER）。同时，一个离散事件模拟模型评估了三种RT策略的运行影响：(1)100% FB, (2) 100% DIBH和(3)目标DIBH（在经济有效的情况下选择性使用）。研究发现，在58.3%的患者中，dibh具有成本效益，在左侧癌症患者、淋巴结阳性疾病患者、吸烟者、基线CVD风险升高患者和老年人群中表现出更明显的益处。与不使用DIBH相比，普遍采用DIBH导致最大吞吐量下降21.7% (95% CI[21.2%-22.2%])，而靶向方法（即58.3% DIBH）导致最大吞吐量下降13.1% （95% CI[12.9%-14.0%]）。有针对性的放射治疗方法优先为那些获得最大利益的人提供DIBH，改善放射治疗资源的利用并支持基于价值的医疗保健。本研究由战略研究计划（zwaartepunt, SRP 53,2019 - 2024）“无标记立体定向放射治疗的社会效益：基于定量成像的统计支持”（布鲁塞尔自由大学的SMARTQI）和Kom op tegen Kanker的“基于价值的乳房放射治疗”研究资助（KOTK_VUB/2024/13906）。
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Pub Date : 2025-11-01DOI: 10.1016/j.lanepe.2025.101515
The Lancet Regional Health – Europe
{"title":"National investigation must redefine maternity care in the UK","authors":"The Lancet Regional Health – Europe","doi":"10.1016/j.lanepe.2025.101515","DOIUrl":"10.1016/j.lanepe.2025.101515","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"58 ","pages":"Article 101515"},"PeriodicalIF":13.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145465480","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 : 2025-11-01DOI: 10.1016/j.lanepe.2025.101512
Jeffrey V. Lazarus , Camila A. Picchio , Elisa Pose , Paul Brennan
{"title":"Announcing The Lancet Regional Health – Europe Series on ending the chronic liver disease public health threat in Europe","authors":"Jeffrey V. Lazarus , Camila A. Picchio , Elisa Pose , Paul Brennan","doi":"10.1016/j.lanepe.2025.101512","DOIUrl":"10.1016/j.lanepe.2025.101512","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"58 ","pages":"Article 101512"},"PeriodicalIF":13.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145465594","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 : 2025-11-01DOI: 10.1016/j.lanepe.2025.101431
<div><h3>Background</h3><div>Since 1990, major political and economic transformations in Poland have substantially impacted the country's health systems and shaped its health policies. We aimed to better understand the changes in population health in Poland by location and demographic groups, using data from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2023.</div></div><div><h3>Methods</h3><div>GBD 2023 evaluates outcomes for 375 diseases and injuries, 292 causes of death, and 88 risk factors in 204 countries and territories. We analysed mortality, life expectancy, and risk-attributable burden, years lived with disability (YLDs), years of life lost due to premature death (YLLs), and disability-adjusted life-years (DALYs; overall burden as a sum of years of lost life due to premature death and years lived with disability), and included a decomposition of change in life expectancy by cause and location in Poland and its regions (voivodships) between 1990 and 2023 on the background of selected European countries. Estimates were produced for Poland at the national and subnational level by age (25 age groups), sex (males, females, and all sexes combined), location, and year. Final point estimates are reported with 95% uncertainty intervals (UIs) representing the 2.5th and 97.5th percentile of the distribution from 250 draws for each metric.</div></div><div><h3>Findings</h3><div>Between 1990 and 2023, life expectancy in Poland for male and female sexes combined increased from 71.2 (95% UI 71.1–71.3) to 78.6 (78.5–78.7) years. Male life expectancy increased more than female during this period; male life expectancy increased from 66.8 (66.7–66.9) to 74.9 (74.8–75.0), while female life expectancy increased from 75.7 (75.6–75.8) to 82.2 (82.1–82.3). Reductions in deaths from ischaemic heart disease and stroke drove most improvements; in 1990, there were an estimated 109,000 (104,000–115,000) and 68,300 (63,700–73,600) deaths due to IHD and stroke, respectively, and in 2023 there were 85,400 (76,800–90,800) and 39,500 (35,000–42,900). The voivodship with the highest age-standardised DALY rates per 100,000 in 2023 was Łódzkie with 25,607 (22,602–29,217), while the lowest was Małopolskie with 22,113 (19,290–25,418). Nationally, age-standardised DALYs declined 33.9% (30.7–36.8) from 1990 to 2023. Smoking and high blood pressure were the leading risk factors throughout the period of study, while alcohol use showed the greatest increase in DALY rates between 1990 and 2023 with 35.2% (3.5–65.1). Risk-attributable age-standardised DALYs rates declined for high blood pressure (1990: 5723.8 [4759.8–6578.3]; 2023: 2053.7 [1657.2–2362.4]) and high BMI (1990: 2226.4 [966.8–3512.2]; 2023: 1923.4 [839.0–2907.8]).</div></div><div><h3>Interpretation</h3><div>Since 1990, life expectancy has increased in Poland for both males and females, with males gaining more years of expected life. In 2023 it was higher than in eastern and central Europe but behi
{"title":"The burden of diseases, injuries, and risk factors by voivodship in Poland, 1990–2023: a systematic analysis for the Global Burden of Disease Study 2023","authors":"","doi":"10.1016/j.lanepe.2025.101431","DOIUrl":"10.1016/j.lanepe.2025.101431","url":null,"abstract":"<div><h3>Background</h3><div>Since 1990, major political and economic transformations in Poland have substantially impacted the country's health systems and shaped its health policies. We aimed to better understand the changes in population health in Poland by location and demographic groups, using data from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2023.</div></div><div><h3>Methods</h3><div>GBD 2023 evaluates outcomes for 375 diseases and injuries, 292 causes of death, and 88 risk factors in 204 countries and territories. We analysed mortality, life expectancy, and risk-attributable burden, years lived with disability (YLDs), years of life lost due to premature death (YLLs), and disability-adjusted life-years (DALYs; overall burden as a sum of years of lost life due to premature death and years lived with disability), and included a decomposition of change in life expectancy by cause and location in Poland and its regions (voivodships) between 1990 and 2023 on the background of selected European countries. Estimates were produced for Poland at the national and subnational level by age (25 age groups), sex (males, females, and all sexes combined), location, and year. Final point estimates are reported with 95% uncertainty intervals (UIs) representing the 2.5th and 97.5th percentile of the distribution from 250 draws for each metric.</div></div><div><h3>Findings</h3><div>Between 1990 and 2023, life expectancy in Poland for male and female sexes combined increased from 71.2 (95% UI 71.1–71.3) to 78.6 (78.5–78.7) years. Male life expectancy increased more than female during this period; male life expectancy increased from 66.8 (66.7–66.9) to 74.9 (74.8–75.0), while female life expectancy increased from 75.7 (75.6–75.8) to 82.2 (82.1–82.3). Reductions in deaths from ischaemic heart disease and stroke drove most improvements; in 1990, there were an estimated 109,000 (104,000–115,000) and 68,300 (63,700–73,600) deaths due to IHD and stroke, respectively, and in 2023 there were 85,400 (76,800–90,800) and 39,500 (35,000–42,900). The voivodship with the highest age-standardised DALY rates per 100,000 in 2023 was Łódzkie with 25,607 (22,602–29,217), while the lowest was Małopolskie with 22,113 (19,290–25,418). Nationally, age-standardised DALYs declined 33.9% (30.7–36.8) from 1990 to 2023. Smoking and high blood pressure were the leading risk factors throughout the period of study, while alcohol use showed the greatest increase in DALY rates between 1990 and 2023 with 35.2% (3.5–65.1). Risk-attributable age-standardised DALYs rates declined for high blood pressure (1990: 5723.8 [4759.8–6578.3]; 2023: 2053.7 [1657.2–2362.4]) and high BMI (1990: 2226.4 [966.8–3512.2]; 2023: 1923.4 [839.0–2907.8]).</div></div><div><h3>Interpretation</h3><div>Since 1990, life expectancy has increased in Poland for both males and females, with males gaining more years of expected life. In 2023 it was higher than in eastern and central Europe but behi","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"58 ","pages":"Article 101431"},"PeriodicalIF":13.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145465484","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 : 2025-11-01DOI: 10.1016/j.lanepe.2025.101447
Giulia Dallagiacoma , Cecilia Lundholm , Awad I. Smew , Emma Caffrey Osvald , Pekka Vartiainen , Santtu Heinonen , Tobias Alfvén , Catarina Almqvist , Samuel Rhedin
Background
While risk factors for respiratory syncytial virus (RSV) hospitalization are well established, few studies have assessed severe disease outcomes. We investigated risk factors for RSV-associated severe disease outcomes in children 0–18 years.
Methods
A register-based cohort study including all children born in Sweden between 2001 and 2022 was performed. Data on RSV related ICD-10 diagnoses, sociodemographic factors and comorbidities were retrieved from national registers. The outcomes were RSV-associated death, Intensive Care Unit (ICU) admission, and prolonged hospitalization (≥7 days). Adjusted hazard ratios (aHR) and 95% confidence intervals (CI) were calculated using multivariable Cox regression both in the full cohort and in the subpopulation of children with an RSV diagnosis.
Findings
Among 2,354,302 children, 38,919 (1·7%) had an RSV diagnosis. Of these, 4621 (11·9%) had severe disease outcomes. The median age of children admitted to ICU were 1·9 months and 500 (41·3%) had an underlying comorbidity. Birth in winter (HR 2·96, 95% CI: 2·53–3·46), small for gestational age (aHR 3·91, 95% CI: 3·08–4·97), multiple birth (aHR 3·43, 95% CI: 2·80–4·21), having siblings 0–3 years (aHR 2·92, 95% CI: 2·57–3·31), and comorbidities (aHRs > 4) were the factors most strongly associated with ICU admission or death in the full cohort. Similar, but attenuated, associations were seen among children with an RSV diagnosis. Comorbidities were less common in severe cases under 3 months of age than in older children (40·3% vs 71·6%, p < 0·0001).
Interpretation
Severe RSV cases often affect healthy, full-term infants under 3 months, beyond those with severe comorbidities. Risk factors such as small for gestational age, multiple births, and young siblings are not currently included in RSV immunization strategies, but should be considered to better target vulnerable infants.
Funding
Financial support was provided by KID funding from Karolinska Institutet, the Swedish Research Council, the Swedish Heart Lung Foundation, the Swedish Asthma and Allergy Association Research Fund, grants from Region Stockholm, the Strategic Research Program in Epidemiology at Karolinska Institutet, The Society for Child Welfare, Åke Wiberg Foundation, Martin Rind Foundation, Karolinska Institutet Research Foundation Grants, and the Foundation Freemason Children's Home in Stockholm.
{"title":"Risk factors for severe outcomes of respiratory syncytial virus infection in children: a nationwide cohort study in Sweden","authors":"Giulia Dallagiacoma , Cecilia Lundholm , Awad I. Smew , Emma Caffrey Osvald , Pekka Vartiainen , Santtu Heinonen , Tobias Alfvén , Catarina Almqvist , Samuel Rhedin","doi":"10.1016/j.lanepe.2025.101447","DOIUrl":"10.1016/j.lanepe.2025.101447","url":null,"abstract":"<div><h3>Background</h3><div>While risk factors for respiratory syncytial virus (RSV) hospitalization are well established, few studies have assessed severe disease outcomes. We investigated risk factors for RSV-associated severe disease outcomes in children 0–18 years.</div></div><div><h3>Methods</h3><div>A register-based cohort study including all children born in Sweden between 2001 and 2022 was performed. Data on RSV related ICD-10 diagnoses, sociodemographic factors and comorbidities were retrieved from national registers. The outcomes were RSV-associated death, Intensive Care Unit (ICU) admission, and prolonged hospitalization (≥7 days). Adjusted hazard ratios (aHR) and 95% confidence intervals (CI) were calculated using multivariable Cox regression both in the full cohort and in the subpopulation of children with an RSV diagnosis.</div></div><div><h3>Findings</h3><div>Among 2,354,302 children, 38,919 (1·7%) had an RSV diagnosis. Of these, 4621 (11·9%) had severe disease outcomes. The median age of children admitted to ICU were 1·9 months and 500 (41·3%) had an underlying comorbidity. Birth in winter (HR 2·96, 95% CI: 2·53–3·46), small for gestational age (aHR 3·91, 95% CI: 3·08–4·97), multiple birth (aHR 3·43, 95% CI: 2·80–4·21), having siblings 0–3 years (aHR 2·92, 95% CI: 2·57–3·31), and comorbidities (aHRs > 4) were the factors most strongly associated with ICU admission or death in the full cohort. Similar, but attenuated, associations were seen among children with an RSV diagnosis. Comorbidities were less common in severe cases under 3 months of age than in older children (40·3% vs 71·6%, <em>p</em> < 0·0001).</div></div><div><h3>Interpretation</h3><div>Severe RSV cases often affect healthy, full-term infants under 3 months, beyond those with severe comorbidities. Risk factors such as small for gestational age, multiple births, and young siblings are not currently included in RSV immunization strategies, but should be considered to better target vulnerable infants.</div></div><div><h3>Funding</h3><div>Financial support was provided by KID funding from <span>Karolinska Institutet</span>, the <span>Swedish Research Council</span>, the <span>Swedish Heart Lung Foundation</span>, the <span>Swedish Asthma and Allergy Association</span> Research Fund, grants from <span>Region Stockholm</span>, the Strategic Research Program in Epidemiology at <span>Karolinska Institutet</span>, The <span>Society for Child Welfare</span>, <span>Åke Wiberg Foundation</span>, <span>Martin Rind Foundation</span>, <span>Karolinska Institutet Research Foundation</span> Grants, and the <span>Foundation Freemason Children's Home in Stockholm</span>.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"58 ","pages":"Article 101447"},"PeriodicalIF":13.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145465478","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 : 2025-11-01DOI: 10.1016/j.lanepe.2025.101434
Junus M. van der Wal , Frank Pijpers , Gabriela Lunansky , Anja Lok , Mary Nicolaou , Anastasia Korezelidou , Karien Stronks , Claudi L. Bockting
Background
In 2016, the Dutch government initiated a nationwide campaign, aiming to increase mental resilience and reduce the prevalence of major depressive disorder (MDD) through boosting knowledge and awareness, improving attitudes towards talking about MDD, and encouraging people to seek/provide help. Utilizing a dynamical systems perspective, we aimed to examine its impact on mental resilience and subsequently on self-reported mental health and healthcare use, in the Dutch population.
Methods
We used data from the Longitudinal Internet Studies for the Social Sciences (LISS) panel, an online panel representative of the Dutch adult population drawn from nationwide population registries, only excluding non-private households or households where no adult understood the Dutch language (2012–2022, n = 12,420). Yearly 5-item Mental Health Inventory (MHI-5) was used to estimate psychological networks from which population-level resilience proxies were derived (i.e., node threshold, connectivity, stability difference). We tested for change in resilience (i.e., stability difference) between 2012 versus 2019 and 2012 versus 2022 using 95% bias-corrected and accelerated (BCa) bootstrap intervals and descriptively examined changes in other resilience proxies. Interrupted time-series analysis was used to test for trend changes in MHI-5 scores, mental healthcare use, and medication use for depression and/or anxiety after (2016–2019) versus before (2012–2015) start of the campaign. Separate analyses were performed based on gender, social support, and urbanicity for mental resilience, as well as education and migration background for additional outcomes.
Findings
A total of 12,420 participants were included between 5-11-2012 and 31-12-2022, of which 5807 participants were lost to attrition while 5873 participants entered through yearly refreshment samples. Mental resilience showed no improvement after initiation of the campaign (2012 versus 2019: difference −0.153, BCa-interval −0.359 to 0.0152, p = 0.07; 2012 versus 2022: difference −0.0631, BCa-interval −0.262 to 0.153, p = 0.57). There was a trend increase in self-reported mental health problems (2016–2019 versus 2012–2015, beta: 0.11, SE: 0.04, p-value = 0.002), a decrease in medication use (beta: −0.31, SE 0.12, p = 0.01), as well as differential trend changes between 2016 and 2019 versus 2012–2015 in mental healthcare use (decreasing trend change in medium versus low social support, beta: −0.31; SE: 0.15; p-value = 0.04; increasing trend change in non-Dutch with a LMIC background versus Dutch origin, beta: 0.67, SE: 0.25, p = 0.008).
Interpretation
While the naturalistic setting refrains us from attributing results solely to the campaign, we also found no indication that a mental health campaign is able to combat the high burden of MDD through strengthening population-level mental resilience. There i
{"title":"Effect of a national mental health campaign on population mental resilience in the Netherlands: a retrospective longitudinal cohort analysis using a dynamical systems perspective","authors":"Junus M. van der Wal , Frank Pijpers , Gabriela Lunansky , Anja Lok , Mary Nicolaou , Anastasia Korezelidou , Karien Stronks , Claudi L. Bockting","doi":"10.1016/j.lanepe.2025.101434","DOIUrl":"10.1016/j.lanepe.2025.101434","url":null,"abstract":"<div><h3>Background</h3><div>In 2016, the Dutch government initiated a nationwide campaign, aiming to increase mental resilience and reduce the prevalence of major depressive disorder (MDD) through boosting knowledge and awareness, improving attitudes towards talking about MDD, and encouraging people to seek/provide help. Utilizing a dynamical systems perspective, we aimed to examine its impact on mental resilience and subsequently on self-reported mental health and healthcare use, in the Dutch population.</div></div><div><h3>Methods</h3><div>We used data from the Longitudinal Internet Studies for the Social Sciences (LISS) panel, an online panel representative of the Dutch adult population drawn from nationwide population registries, only excluding non-private households or households where no adult understood the Dutch language (2012–2022, n = 12,420). Yearly 5-item Mental Health Inventory (MHI-5) was used to estimate psychological networks from which population-level resilience proxies were derived (i.e., node threshold, connectivity, stability difference). We tested for change in resilience (i.e., stability difference) between 2012 versus 2019 and 2012 versus 2022 using 95% bias-corrected and accelerated (BCa) bootstrap intervals and descriptively examined changes in other resilience proxies. Interrupted time-series analysis was used to test for trend changes in MHI-5 scores, mental healthcare use, and medication use for depression and/or anxiety after (2016–2019) versus before (2012–2015) start of the campaign. Separate analyses were performed based on gender, social support, and urbanicity for mental resilience, as well as education and migration background for additional outcomes.</div></div><div><h3>Findings</h3><div>A total of 12,420 participants were included between 5-11-2012 and 31-12-2022, of which 5807 participants were lost to attrition while 5873 participants entered through yearly refreshment samples. Mental resilience showed no improvement after initiation of the campaign (2012 versus 2019: difference −0.153, BCa-interval −0.359 to 0.0152, p = 0.07; 2012 versus 2022: difference −0.0631, BCa-interval −0.262 to 0.153, p = 0.57). There was a trend increase in self-reported mental health problems (2016–2019 versus 2012–2015, beta: 0.11, SE: 0.04, p-value = 0.002), a decrease in medication use (beta: −0.31, SE 0.12, p = 0.01), as well as differential trend changes between 2016 and 2019 versus 2012–2015 in mental healthcare use (decreasing trend change in medium versus low social support, beta: −0.31; SE: 0.15; p-value = 0.04; increasing trend change in non-Dutch with a LMIC background versus Dutch origin, beta: 0.67, SE: 0.25, p = 0.008).</div></div><div><h3>Interpretation</h3><div>While the naturalistic setting refrains us from attributing results solely to the campaign, we also found no indication that a mental health campaign is able to combat the high burden of MDD through strengthening population-level mental resilience. There i","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"58 ","pages":"Article 101434"},"PeriodicalIF":13.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145465479","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 : 2025-10-30DOI: 10.1016/j.lanepe.2025.101514
Martin McKee
{"title":"The Gastein prescription: health as Europe's path to renewal","authors":"Martin McKee","doi":"10.1016/j.lanepe.2025.101514","DOIUrl":"10.1016/j.lanepe.2025.101514","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"59 ","pages":"Article 101514"},"PeriodicalIF":13.0,"publicationDate":"2025-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145418068","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 : 2025-10-29DOI: 10.1016/j.lanepe.2025.101513
Mikaela Bloomberg , Séverine Sabia , Feifei Bu , Jessica Gong , Andrew Steptoe
Background
While WHO/Europe guidelines promote life-long learning for healthy ageing generally, whether adult education supports healthy cognitive ageing is unclear. We used a matched longitudinal study design to account for reverse causality seen in previous studies and assess whether cognitive trajectories improved following mid-to-late life education using data from a nationally representative UK-based cohort study.
Methods
Data were drawn from 3906 participants aged 50–90 years followed up from 2002-03 to 2021-23. At biennial interviews, participants were asked to report whether they had engaged in continuing education in the last 12 months and were split into ‘single’ (continuing education at one interview) and ‘multiple’ (continuing education at multiple interviews) continuing education groups. We used piecewise linear mixed models to examine memory and fluency decline four years before and eight years after first report of continuing education (corresponding to the median follow-up period) and during the comparable period in a matched control group.
Findings
Cognitive trajectories were comparable between continuing education groups and their controls before participation in continuing education. After participation, cognitive trajectories were still similar; e.g., the difference in eight-year memory decline between the single continuing education group and controls was just −0.026 standard deviations (95% CI = −0.081–0.029) or −0.015 standard deviations (95% CI = −0.067–0.037) between the multiple continuing education group and controls.
Interpretation
There was no evidence of improvement in cognitive trajectories following continuing education. These findings suggest continuing education should not yet be prioritised as a strategy for long-term cognitive health until further evidence demonstrates a clear benefit.
Funding
National Institute for Health and Care Research, National Institute on Aging.
虽然世卫组织/欧洲指南普遍提倡终身学习以实现健康老龄化，但成人教育是否支持健康的认知老龄化尚不清楚。我们使用匹配的纵向研究设计来解释之前研究中看到的反向因果关系，并使用来自全国代表性的英国队列研究的数据评估认知轨迹是否在中晚年教育后得到改善。方法从2002-03年至2021-23年随访的3906名50-90岁的参与者中抽取数据。在两年一次的采访中，参与者被要求报告他们在过去的12个月里是否接受过继续教育，并被分为“单一”（一次面试的继续教育）和“多重”（多次面试的继续教育）继续教育组。我们使用分段线性混合模型来检查在第一次报告继续教育的4年前和8年后（对应于中位随访期）以及在匹配对照组的可比较期间的记忆和流畅性下降。发现继续教育组和对照组在参加继续教育前的认知轨迹具有可比性。参与后，认知轨迹仍然相似；例如，单一继续教育组与对照组在8年记忆衰退方面的差异仅为- 0.026标准差（95% CI = - 0.081-0.029），而多重继续教育组与对照组的差异仅为- 0.015标准差（95% CI = - 0.067-0.037）。解释：没有证据表明继续教育对认知轨迹有改善。这些发现表明，在进一步的证据表明继续教育有明显的好处之前，不应该优先考虑继续教育作为长期认知健康的策略。资助国家健康和护理研究所，国家老龄研究所。
{"title":"Cognitive decline before and after mid-to-late-life continuing education in England: a matched longitudinal analysis of a prospective cohort study","authors":"Mikaela Bloomberg , Séverine Sabia , Feifei Bu , Jessica Gong , Andrew Steptoe","doi":"10.1016/j.lanepe.2025.101513","DOIUrl":"10.1016/j.lanepe.2025.101513","url":null,"abstract":"<div><h3>Background</h3><div>While WHO/Europe guidelines promote life-long learning for healthy ageing generally, whether adult education supports healthy cognitive ageing is unclear. We used a matched longitudinal study design to account for reverse causality seen in previous studies and assess whether cognitive trajectories improved following mid-to-late life education using data from a nationally representative UK-based cohort study.</div></div><div><h3>Methods</h3><div>Data were drawn from 3906 participants aged 50–90 years followed up from 2002-03 to 2021-23. At biennial interviews, participants were asked to report whether they had engaged in continuing education in the last 12 months and were split into ‘single’ (continuing education at one interview) and ‘multiple’ (continuing education at multiple interviews) continuing education groups. We used piecewise linear mixed models to examine memory and fluency decline four years before and eight years after first report of continuing education (corresponding to the median follow-up period) and during the comparable period in a matched control group.</div></div><div><h3>Findings</h3><div>Cognitive trajectories were comparable between continuing education groups and their controls before participation in continuing education. After participation, cognitive trajectories were still similar; e.g., the difference in eight-year memory decline between the single continuing education group and controls was just −0.026 standard deviations (95% CI = −0.081–0.029) or −0.015 standard deviations (95% CI = −0.067–0.037) between the multiple continuing education group and controls.</div></div><div><h3>Interpretation</h3><div>There was no evidence of improvement in cognitive trajectories following continuing education. These findings suggest continuing education should not yet be prioritised as a strategy for long-term cognitive health until further evidence demonstrates a clear benefit.</div></div><div><h3>Funding</h3><div><span>National Institute for Health and Care Research</span>, <span>National Institute on Aging</span>.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"60 ","pages":"Article 101513"},"PeriodicalIF":13.0,"publicationDate":"2025-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145420356","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 : 2025-10-28DOI: 10.1016/j.lanepe.2025.101505
Scott A. McDonald , Norah Palmateer , Andrew McAuley , Rory N. Gunson , Stephen T. Barclay , John F. Dillon , Matthew Hickman , Sharon J. Hutchinson
Background
Reducing the incidence of hepatitis C virus (HCV) infection is a World Health Organization (WHO) elimination goal, but approaches to estimate this from population-level survey data are lacking. We modelled HCV incidence among people who inject drugs (PWID) surveyed over time, to provide evidence on whether Scotland has reached the WHO elimination target of ≤2 per 100 person-years in this population.
Methods
A statistical model was fitted using HCV infection data from five sweeps (2013-14, 2015-16, 2017-18, 2019-20, and 2022-23) of a national bio-behavioural survey, involving 11,651 PWID recruited at sites providing injecting equipment. Per-sweep incidence rates of primary chronic HCV infection, reinfection, and combined primary and reinfection (‘total infection’) were inferred within a Bayesian framework. Incidence rates relate to the number of new infections per 100 person-years for the population at risk of (primary, reinfection and total) infection.
Findings
In 2022-23, the model-estimated total, re-infection and primary infection incidence rates were 3.4 per 100 person-years (95% credible interval (CrI):2.6–4.3), 1.9 (1.3–2.6), and 4.1 (3.0–5.4), respectively. For total new infections, the model-estimated incidence rate decreased by 51% from 7.0 per 100 person-years in 2015-16 to 3.4 in 2022-23 (relating to an absolute decrease of 3.6 per 100 person-years; 95% CrI: 2.0–5.3). Between 2015-16 and 2022-23, model-estimated re-infection and primary infection incidence rates decreased by 78% and 40%, respectively.
Interpretation
Over a period when direct-acting antiviral therapy was scaled-up in Scotland, major reductions in the incidence of primary infection, reinfection, and total HCV infection were evident, indicating that the WHO target is within reach, for a relatively high-risk population of PWID.
Funding
Public Health Scotland (for NESI); NIHR HPRU in Behavioural Science and Evaluation; NIHR Programme Grants for Applied Research programme (reference number RP-PG-0616-20008).
{"title":"Estimating incidence rates of primary infection and reinfection with hepatitis C virus among people who inject drugs in Scotland: a model-based analysis of repeated cross-sectional survey data","authors":"Scott A. McDonald , Norah Palmateer , Andrew McAuley , Rory N. Gunson , Stephen T. Barclay , John F. Dillon , Matthew Hickman , Sharon J. Hutchinson","doi":"10.1016/j.lanepe.2025.101505","DOIUrl":"10.1016/j.lanepe.2025.101505","url":null,"abstract":"<div><h3>Background</h3><div>Reducing the incidence of hepatitis C virus (HCV) infection is a World Health Organization (WHO) elimination goal, but approaches to estimate this from population-level survey data are lacking. We modelled HCV incidence among people who inject drugs (PWID) surveyed over time, to provide evidence on whether Scotland has reached the WHO elimination target of ≤2 per 100 person-years in this population.</div></div><div><h3>Methods</h3><div>A statistical model was fitted using HCV infection data from five sweeps (2013-14, 2015-16, 2017-18, 2019-20, and 2022-23) of a national bio-behavioural survey, involving 11,651 PWID recruited at sites providing injecting equipment. Per-sweep incidence rates of primary chronic HCV infection, reinfection, and combined primary and reinfection (‘total infection’) were inferred within a Bayesian framework. Incidence rates relate to the number of new infections per 100 person-years for the population at risk of (primary, reinfection and total) infection.</div></div><div><h3>Findings</h3><div>In 2022-23, the model-estimated total, re-infection and primary infection incidence rates were 3.4 per 100 person-years (95% credible interval (CrI):2.6–4.3), 1.9 (1.3–2.6), and 4.1 (3.0–5.4), respectively. For total new infections, the model-estimated incidence rate decreased by 51% from 7.0 per 100 person-years in 2015-16 to 3.4 in 2022-23 (relating to an absolute decrease of 3.6 per 100 person-years; 95% CrI: 2.0–5.3). Between 2015-16 and 2022-23, model-estimated re-infection and primary infection incidence rates decreased by 78% and 40%, respectively.</div></div><div><h3>Interpretation</h3><div>Over a period when direct-acting antiviral therapy was scaled-up in Scotland, major reductions in the incidence of primary infection, reinfection, and total HCV infection were evident, indicating that the WHO target is within reach, for a relatively high-risk population of PWID.</div></div><div><h3>Funding</h3><div><span>Public Health Scotland</span> (for NESI); <span>NIHR HPRU in Behavioural Science and Evaluation</span>; <span>NIHR Programme Grants for Applied Research programme</span> (reference number <span><span>RP-PG-0616-20008</span></span>).</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"60 ","pages":"Article 101505"},"PeriodicalIF":13.0,"publicationDate":"2025-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145420065","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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