Pub Date : 2025-12-17DOI: 10.1016/j.lanepe.2025.101554
Kerstin K. Rauwolf , Teresa de Rojas , Miguel Martins , Maria Otth , Uta Dirksen , Delphine Heenen , Lejla Kameric , Pamela Kearns , Ruth Ladenstein , Cormac Owens , Caroline Queiroz , Richard Sullivan , Carmelo Rizzari , Gilles Vassal , European Society for Paediatric Oncology (SIOPE)
There are pronounced inequalities in outcomes of children, adolescents, and young adults (AYA) with cancer across Europe. The OCEAN project aimed at describing the availability of clinical trials for this population, the inequalities between countries, and propose solutions to reduce these disparities. The ClinicalTrials.gov database was searched to identify all European cancer clinical interventional studies including patients <18 years with a start date between 2010 and 2022. The study included 436 cancer-directed trials in 38 European countries. More than half were academic-sponsored (55%), and 49% included exclusively pediatric/AYA patients. Important differences in available trial numbers per country were identified, with more trials observed in Northern and Western Europe as compared to Eastern Europe. There is an urgent need to address differences in clinical trials availability both at European and national levels to advance equity and improve care, research and access to innovation for all pediatric/AYA patients with cancer in Europe.
Funding
This work has been performed as part of WP6 on inequalities in cancer research of the 4.UNCAN.eu Coordination and Support Action (#101069496) funded by the European Union and has been supported by Zoé4Life (MO).
{"title":"Inequalities in availability of clinical trials for pediatric, adolescent, and young adult patients with cancer in Europe: results from the SIOPE OCEAN project","authors":"Kerstin K. Rauwolf , Teresa de Rojas , Miguel Martins , Maria Otth , Uta Dirksen , Delphine Heenen , Lejla Kameric , Pamela Kearns , Ruth Ladenstein , Cormac Owens , Caroline Queiroz , Richard Sullivan , Carmelo Rizzari , Gilles Vassal , European Society for Paediatric Oncology (SIOPE)","doi":"10.1016/j.lanepe.2025.101554","DOIUrl":"10.1016/j.lanepe.2025.101554","url":null,"abstract":"<div><div>There are pronounced inequalities in outcomes of children, adolescents, and young adults (AYA) with cancer across Europe. The OCEAN project aimed at describing the availability of clinical trials for this population, the inequalities between countries, and propose solutions to reduce these disparities. The <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> database was searched to identify all European cancer clinical interventional studies including patients <18 years with a start date between 2010 and 2022. The study included 436 cancer-directed trials in 38 European countries. More than half were academic-sponsored (55%), and 49% included exclusively pediatric/AYA patients. Important differences in available trial numbers per country were identified, with more trials observed in Northern and Western Europe as compared to Eastern Europe. There is an urgent need to address differences in clinical trials availability both at European and national levels to advance equity and improve care, research and access to innovation for all pediatric/AYA patients with cancer in Europe.</div></div><div><h3>Funding</h3><div>This work has been performed as part of WP6 on inequalities in cancer research of the 4.UNCAN.eu Coordination and Support Action (#101069496) funded by the <span>European Union</span> and has been supported by <span>Zoé4Life</span> (MO).</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"62 ","pages":"Article 101554"},"PeriodicalIF":13.0,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145798567","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 : 2025-12-13DOI: 10.1016/j.lanepe.2025.101557
Huei-Tyng Huang, Michael Hewitt, Wenhao Li, William Alazawi
Real-world evidence (RWE), derived from real-world data, offers key insights into metabolic dysfunction-associated steatotic liver disease (MASLD). RWE complements traditional randomised controlled trials by capturing large-scale, diverse patient populations and long-term outcomes. This review interrogates the role of RWE in understanding MASLD epidemiology, natural history, hepatic and extra-hepatic endpoints, including its co-morbid association with cardiovascular and chronic kidney disease, and its use in pharmacovigilance and precision medicine. RWE highlights large regional variations and is increasingly leveraged to advance drug development through target discovery and patient stratification. However, challenges such as data quality and confounding factors persist. In this review, key methodological gaps and future research priorities are identified and highlighted. The potential of artificial intelligence with multi-modal data linkage is considerable but requires rigorous methodologies and collaboration to fully realise the potential of RWE in MASLD research.
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Pub Date : 2025-12-11DOI: 10.1016/j.lanepe.2025.101562
Juliette Brenner , Anna E.M. Bastiaansen , Mar Guasp , Sergio Muñiz-Castrillo , Takahiro Iizuka , Marienke A.A.M. de Bruijn , Amaia Muñoz-Lopetegi , Eugenia Martínez-Hernández , Géraldine Picard , Alberto Vogrig , Mathilde Millot , Carsten Finke , Christian Geis , Jan Lewerenz , Nico Melzer , Harald Prüss , Saskia Räuber , Marius Ringelstein , Kevin Rostàsy , Kurt-Wolfram Sühs , Maarten J. Titulaer
<div><h3>Background</h3><div>Anti-N-methyl-<span>d</span>-aspartate receptor (anti-NMDAR) encephalitis is a severe disease that primarily affects young people and can improve with adequate treatment. We aimed to refine the anti-NMDAR Encephalitis One-year functional Status (NEOS) score by developing NEOS2, an updated model using readily available data at the time of diagnosis. We assessed the predictive value of the NEOS2-score for (1) improvement following first-line treatment, (2) functional outcome at one-year follow-up, and (3) resumption of school or work within three years.</div></div><div><h3>Methods</h3><div>In this international (France, Germany, Japan, the Netherlands and Spain) cohort study in patients with a definite anti-NMDAR encephalitis diagnosis (according to the clinical criteria plus antibody testing in CSF), we performed logistic regression analyses to develop and validate multivariable models to predict -based upon variables available at diagnosis- short (ΔmRS two weeks after first-line treatment), middle (modified Rankin Scale [mRS] at one year), and long-term (return to school or work within three years) outcomes. We included clinical variables and biomarkers available at diagnosis.</div></div><div><h3>Findings</h3><div>We included 702 patients (mean age 23 years, 95%-CI 2–69; 79% female, 21% male) diagnosed between the discovery of the disease in 2007 and 2022. Most patients (96%; 672/702) had received first-line immunotherapy, and 38% (233/615) showed improvement within two weeks. One year after diagnosis, 80% (517/644) had a favourable functional outcome (mRS≤2). At three years, 73% (203/278) had resumed work/school. In multivariable analysis, higher age (odds ratio [OR] 0·35, 95%-CI 0·29–0·43, p < 0·0001), treatment delay (OR 0·49, 95%-CI 0·41–0·58, p < 0·0001), movement disorders (OR 0·32, 95%-CI 0·24–0·41, p < 0·0001), ICU-requirement (OR 0·34, 95%-CI 0·26–0·44, p < 0·0001) and increased CSF leucocyte count (OR 0·65, 95%-CI 0·60–0·71, p < 0·0001) independently predicted poorer outcomes (NEOS2, accuracy AUC 80%, 95%-CI 75–86%). The same variables, excluding age, were relevant in predicting improvement following first-line immunotherapy (NEOS2-T AUC 81–84%, 95%-CI 77–86%). Return-to-work or -school served as a useful measure of longer-term outcomes, predicted with equal accuracy as one-year functional outcome (NEOS2-W AUC 80%, 95%-CI 75–85%). The NEOS2-score, applied as an ordinal measure, enabled nuanced predictions of outcome probabilities across the score spectrum, ranging from a high (80%; n = 20/25) likelihood of improving after first-line immunotherapy and achieving a good outcome (100%; n = 32/32) to a high risk of first-line treatment failure (97%; n = 77/79) and no return to school/work (94%; n = 15/16).</div></div><div><h3>Interpretation</h3><div>The NEOS2-score, readily available at diagnosis and easy to apply, can identify patients with either a favourable or poor prognosis, and those who may
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Pub Date : 2025-12-11DOI: 10.1016/j.lanepe.2025.101552
Marcus Grobe-Einsler , Stéphanie Borel , Maresa Buchholz , Sabrina Sayah , Rania Hilab , Lucie Pierron , Audrey Iskandar , Brittany Humphries , Claire Ewenczyk , Anna Heinzmann , Mariana Atencio , Katrin Feldmann , Vivian Maas , Jennifer Faber , Sylvia Boesch , Elisabetta Indelicato , Kathrin Reetz , Jörg B. Schulz , Almut T. Bischoff , Thomas Klopstock , Bernhard Michalowsky
Background
Friedreich ataxia (FA) is the most common autosomal recessive ataxia. Little attention has been paid to FA's impact on patient-reported, psychosocial, and health-economic outcomes. This study aimed to report these outcomes across FA's disability stages 1–5.
Methods
We assessed patients in Germany, France, and Austria as part of the PROFA study, a European multicenter observational study. The protocol included a study center visit followed by a remote mobile assessment capturing ataxia severity (SARA), daily living deficits (FARS-ADL), cognitive and affective impairments (CCAS), health-related quality of life (HRQoL: PROM-Ataxia short-form, EQ-5D-5L), mental well-being (WEMWBS), communication disabilities (COMATAX), and healthcare and informal care utilization. FARS disability stages were used to demonstrate outcomes with effect size measures (Eta-Squared, Cramér's V). Multivariate regression models evaluated associations between z-standardized outcomes and disability stages.
Findings
One hundred one patients (mean [SD]: age 35.0 [11.5]; GAA-repeat size 657 [299]; 50.5% women) were included. Activities of daily living, HRQoL, communication disabilities, and informal care utilization worsened significantly across disability stages with moderate to high effect sizes. Cognitive-affective impairments and mental well-being showed significant associations with small effect sizes. Twenty-three patients (33.3%) received formal care, while 40 (58.0%) received informal care (mean 12.2 h/week). Omaveloxolone was used by 33 patients (32.7%). Annual healthcare costs excluding Omaveloxolone were €13,620 (payer) and €32,679 (societal perspective, including informal care and productivity losses).
Interpretation
The results emphasize the multidimensional patient, societal, and economic burden of FA and the need for comprehensive care addressing physical, mental, and psychosocial health.
Funding
European Joint Programme on Rare Diseases (EJP RD).
背景弗里德赖希共济失调（FA）是最常见的常染色体隐性共济失调。很少有人关注FA对患者报告、心理社会和健康经济结果的影响。本研究旨在报告FA残疾阶段1-5的这些结果。方法：作为欧洲多中心观察性研究PROFA的一部分，我们评估了德国、法国和奥地利的患者。该方案包括一次研究中心访问，随后进行远程移动评估，包括共济失调严重程度（SARA）、日常生活缺陷（FARS-ADL）、认知和情感障碍（CCAS）、健康相关生活质量（HRQoL: promo - ataxia简式，EQ-5D-5L）、精神健康（WEMWBS）、沟通障碍（COMATAX）以及医疗保健和非正式护理的利用。FARS残疾分期采用效应量测量（Eta-Squared, cram s V）来证明结果。多变量回归模型评估z标准化结果与残疾分期之间的关联。结果纳入101例患者（平均[SD]：年龄35.0 [11.5]；GAA-repeat大小657[299]；50.5%为女性）。日常生活活动、HRQoL、沟通障碍和非正式护理利用在残疾阶段显著恶化，具有中高效应量。认知情感障碍和心理健康在小效应量下显示出显著的关联。23例（33.3%）患者接受正规护理，40例（58.0%）患者接受非正规护理（平均12.2小时/周）。33例（32.7%）患者使用奥马维洛酮。不包括奥马韦洛龙的年度医疗保健费用为13,620欧元（付款人）和32,679欧元（社会角度，包括非正规护理和生产力损失）。研究结果强调了FA的患者、社会和经济负担的多维性，以及对身体、精神和社会心理健康进行综合护理的必要性。资助欧洲罕见病联合规划（EJP RD）。
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Pub Date : 2025-12-11DOI: 10.1016/j.lanepe.2025.101560
Elisabeth Schramm , Nadine Zehender , Christoph Breuninger , Ulrich Hegerl , Anne Elsner , Andy Maun , Marina Schmölz , Christiane Roick , Jörg Sahlmann , Marlon Grodd , Katharina Domschke , Moritz Elsaesser , Erika Graf
Background
Informal caregivers of depressed individuals often report extensive psychological distress with detrimental consequences for their own health and for the course of the depressed person's disease. An online self-help programme was developed involving focus groups of caregivers, affected individuals and clinical experts.
Methods
In this randomised, controlled, open-label superiority trial with three parallel groups (prospective registration: DRKS00025241), stratified randomisation allocated caregivers (≥18 years) of depressed individuals in a 2:2:1 ratio to receiving the programme with either individualised (IND, three weekly e-mails by trained psychologists) or automated (AUT) support messages, or to treatment as usual (TAU; information material, no online programme, no messages). The primary outcome was the change from baseline to four weeks after randomisation in the Kessler Psychological Distress Scale (K-10).
Findings
The trial was conducted between 01 March 2020 and 29 February 2024. In 1640 (IND: n = 651; AUT: n = 659; TAU: n = 330) caregivers (mean[SD] age mage = 42·8 [12·89] years; n = 1300 [79%] female; baseline K-10 score mK-10 = 23·4 [6·09]), both IND and AUT reduced psychosocial distress significantly more than TAU at four weeks after randomisation (adjusted difference mIND/TAU [95%-CI] = –1·45 [–2·19,–0·72], p = 0·0001; mAUT/TAU [95%-CI] = –0·89 [–1·63,–0·14], p = 0·0205; dropout rate: 34%, n = 562). No study-related harms were reported.
Interpretation
Psychological online support for caregivers of depressed individuals with either individualised or automated messages is effective in decreasing their psychosocial distress and could be offered as part of integrated services.
Funding
German Innovation Fund (Federal Joint Committee, 01VSF19054).
背景：抑郁症患者的正式护理人员经常报告说，他们有广泛的心理困扰，这对他们自己的健康和抑郁症患者的病程都有不利的影响。制定了一项在线自助方案，涉及护理人员、受影响个人和临床专家的焦点小组。方法在这项随机、对照、开放标签的优势试验中，有三个平行组（前瞻性注册：DRKS00025241），分层随机分配抑郁症患者的照顾者（≥18岁），以2:2:1的比例接受个性化（IND，每周三次由训练过的心理学家发送的电子邮件）或自动化（AUT）支持信息的方案，或接受常规治疗（TAU；信息材料，无在线方案，无信息）。主要结果是随机化后凯斯勒心理困扰量表（K-10）从基线到四周的变化。该试验于2020年3月1日至2024年2月29日进行。在1640名（IND: n = 651; AUT: n = 659; TAU: n = 330）护理者（平均[SD]年龄mage = 42.8[12.89]岁；n = 1300[79%]名女性；基线K-10评分mK-10 = 23.4[6.09]）中，IND和AUT在随机化后4周显著优于TAU（调整差mIND/TAU [95%-CI] = - 1.45 [- 2.19, - 0.72], p = 0.0001; AUT/TAU [95%-CI] = - 0.89 [- 1.63, - 0.14], p = 0.0205；退学率：34%，n = 562）。没有研究相关的危害报告。通过个性化或自动信息为抑郁症患者的照料者提供心理在线支持，可以有效地减少他们的心理社会困扰，并可作为综合服务的一部分提供。资助德国创新基金（联邦联合委员会，01VSF19054）。
{"title":"Efficacy of an online self-help programme with automated or individualised psychological support versus treatment as usual for caregivers of people with depression: a randomised, controlled, open-label, superiority trial","authors":"Elisabeth Schramm , Nadine Zehender , Christoph Breuninger , Ulrich Hegerl , Anne Elsner , Andy Maun , Marina Schmölz , Christiane Roick , Jörg Sahlmann , Marlon Grodd , Katharina Domschke , Moritz Elsaesser , Erika Graf","doi":"10.1016/j.lanepe.2025.101560","DOIUrl":"10.1016/j.lanepe.2025.101560","url":null,"abstract":"<div><h3>Background</h3><div>Informal caregivers of depressed individuals often report extensive psychological distress with detrimental consequences for their own health and for the course of the depressed person's disease. An online self-help programme was developed involving focus groups of caregivers, affected individuals and clinical experts.</div></div><div><h3>Methods</h3><div>In this randomised, controlled, open-label superiority trial with three parallel groups (prospective registration: DRKS00025241), stratified randomisation allocated caregivers (≥18 years) of depressed individuals in a 2:2:1 ratio to receiving the programme with either individualised (IND, three weekly e-mails by trained psychologists) or automated (AUT) support messages, or to treatment as usual (TAU; information material, no online programme, no messages). The primary outcome was the change from baseline to four weeks after randomisation in the Kessler Psychological Distress Scale (K-10).</div></div><div><h3>Findings</h3><div>The trial was conducted between 01 March 2020 and 29 February 2024. In 1640 (IND: <em>n</em> = 651; AUT: <em>n</em> = 659; TAU: <em>n</em> = 330) caregivers (mean[SD] age <em>m</em><sub><em>age</em></sub> = 42·8 [12·89] years; <em>n</em> = 1300 [79%] female; baseline K-10 score <em>m</em><sub>K-10</sub> = 23·4 [6·09]), both IND and AUT reduced psychosocial distress significantly more than TAU at four weeks after randomisation (adjusted difference <em>m</em><sub><em>IND/TAU</em></sub> [95%-CI] = –1·45 [–2·19,–0·72], <em>p</em> = 0·0001; <em>m</em><sub><em>AUT/TAU</em></sub> [95%-CI] = –0·89 [–1·63,–0·14], <em>p</em> = 0·0205; dropout rate: 34%, <em>n</em> = 562). No study-related harms were reported.</div></div><div><h3>Interpretation</h3><div>Psychological online support for caregivers of depressed individuals with either individualised or automated messages is effective in decreasing their psychosocial distress and could be offered as part of integrated services.</div></div><div><h3>Funding</h3><div><span>German Innovation Fund</span> (Federal Joint Committee, <span><span>01VSF19054</span></span>).</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"62 ","pages":"Article 101560"},"PeriodicalIF":13.0,"publicationDate":"2025-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145749854","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 : 2025-12-11DOI: 10.1016/j.lanepe.2025.101553
Benedetta Armocida , Hanna Tolonen , Ivo Rakovac , Beatrice Formenti , Jill Farrington , Allison Ekberg , Hector Bueno , Giovanni Capelli , Silvia Francisci , Morten S. Frydensberg , Ane Fullaondo , Linda Granlund , Yhasmine Hamu Azcarate , Torben F. Hansen , Emil Høstrup , Tomi Mäki-Opas , Luigi Palmieri , Markku Peltonen , Valentina Possenti , Marco Silano , Gauden Galea
Non-communicable diseases (NCDs) are major drivers of disability, health expenditure, and productivity loss in Europe. Effective surveillance is essential to understand evolving needs, design and evaluate interventions, and ensure accountability. This paper provides a high-level overview of NCD monitoring in Europe, focusing on cardiovascular diseases, cancer, diabetes, chronic respiratory diseases, and major modifiable risk factors. It draws on three complementary sources: the EU Joint Action on Cardiovascular Diseases and Diabetes (JACARDI, 32 countries), the Joint Action on the Prevention of NCDs (JA PreventNCD, 16 countries), and the WHO NCD Country Capacity Survey (2023, 53 WHO European Region Member States). These sources provide a comprehensive assessment of surveillance capacity, infrastructure and gaps, showing that NCD monitoring remains fragmented, underfunded, and limited in equity-sensitive data and policy integration. Strengthening governance, investment, and cross-country collaboration is crucial to build interoperable, and equity-oriented systems supporting evidence-informed decisions, accountability, and the right to health.
{"title":"Strengthening non-communicable diseases monitoring systems in Europe through a multistakeholder collaborative approach: a key priority for advancing data-driven policymaking","authors":"Benedetta Armocida , Hanna Tolonen , Ivo Rakovac , Beatrice Formenti , Jill Farrington , Allison Ekberg , Hector Bueno , Giovanni Capelli , Silvia Francisci , Morten S. Frydensberg , Ane Fullaondo , Linda Granlund , Yhasmine Hamu Azcarate , Torben F. Hansen , Emil Høstrup , Tomi Mäki-Opas , Luigi Palmieri , Markku Peltonen , Valentina Possenti , Marco Silano , Gauden Galea","doi":"10.1016/j.lanepe.2025.101553","DOIUrl":"10.1016/j.lanepe.2025.101553","url":null,"abstract":"<div><div>Non-communicable diseases (NCDs) are major drivers of disability, health expenditure, and productivity loss in Europe. Effective surveillance is essential to understand evolving needs, design and evaluate interventions, and ensure accountability. This paper provides a high-level overview of NCD monitoring in Europe, focusing on cardiovascular diseases, cancer, diabetes, chronic respiratory diseases, and major modifiable risk factors. It draws on three complementary sources: the EU Joint Action on Cardiovascular Diseases and Diabetes (JACARDI, 32 countries), the Joint Action on the Prevention of NCDs (JA PreventNCD, 16 countries), and the WHO NCD Country Capacity Survey (2023, 53 WHO European Region Member States). These sources provide a comprehensive assessment of surveillance capacity, infrastructure and gaps, showing that NCD monitoring remains fragmented, underfunded, and limited in equity-sensitive data and policy integration. Strengthening governance, investment, and cross-country collaboration is crucial to build interoperable, and equity-oriented systems supporting evidence-informed decisions, accountability, and the right to health.</div></div>","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"61 ","pages":"Article 101553"},"PeriodicalIF":13.0,"publicationDate":"2025-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145747383","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 : 2025-12-09DOI: 10.1016/j.lanepe.2025.101558
Santino Severoni
{"title":"Migrants, refugees and displaced populations: a missed opportunity for equity at the 2025 UN High-Level Meeting on NCDs and mental health","authors":"Santino Severoni","doi":"10.1016/j.lanepe.2025.101558","DOIUrl":"10.1016/j.lanepe.2025.101558","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"60 ","pages":"Article 101558"},"PeriodicalIF":13.0,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145736731","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 : 2025-12-09DOI: 10.1016/j.lanepe.2025.101563
Beate Wieseler, Daniela Preukschat, Philip Kranz
{"title":"Generating evidence that meets the requirements of both regulatory agencies and HTA bodies","authors":"Beate Wieseler, Daniela Preukschat, Philip Kranz","doi":"10.1016/j.lanepe.2025.101563","DOIUrl":"10.1016/j.lanepe.2025.101563","url":null,"abstract":"","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"60 ","pages":"Article 101563"},"PeriodicalIF":13.0,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145736733","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 : 2025-12-09DOI: 10.1016/j.lanepe.2025.101555
Anastasia Chatzilena , Catherine Hyams , Robert Challen , Elizabeth Begier , Jo Southern , Maria Lahuerta , Serena McGuinness , Madeleine Clout , James Campling , Jennifer Oliver , Andrew Vyse , Gillian Ellsbury , Nick Maskell , Bradford Gessner , Adam Finn , Leon Danon
<div><h3>Background</h3><div>Surveillance of acute lower respiratory tract disease (aLRTD) is fundamental for understanding population health burden and healthcare needs. COVID-19 altered respiratory infection epidemiology, but the post-pandemic baseline incidence and severity of aLRTD remain underexplored. We describe the incidence and clinical outcomes of acute lower respiratory tract disease (aLRTD) hospitalisations in adults, stratified by clinical presentation and SARS-CoV-2 status.</div></div><div><h3>Methods</h3><div>We conducted a prospective cohort study of adults (≥18 years) admitted with signs/symptoms or diagnoses of aLRTD to two Bristol acute-care hospitals (1 August 2020–31 July 2024). Patients were classified as having pneumonia (radiological changes or clinician diagnosis, in line with the British Thoracic Society (BTS) and National Institute for Health and Care Excellence (NICE) guidance), non-pneumonic lower respiratory tract infection (NP-LRTI; signs and symptoms of infection without radiological change or pneumonia diagnosis), or no evidence of LRTI (principally chronic respiratory disease exacerbations and heart failure). The primary outcome was incidence of aLRTD, stratified by clinical presentation, age, and SARS-CoV-2 status. Secondary outcomes included 30-day mortality, hospital discharge within 30 days, hospital length of stay, Intensive Care Unit (ICU) admission, ICU length of stay, and 1-year mortality. Population denominators were calculated using General Practitioner (GP) registration data linked to hospital admission patterns.</div></div><div><h3>Findings</h3><div>Among 457,112 hospitalisations, 44,766 were attributed to aLRTD (96% with consented data available): 20,639 pneumonia (48.2%), 15,061 NP-LRTI (35.2%), and 7134 no evidence of LRTI (16.7%). Overall, aLRTD incidence peaked in Year 2 (Aug 2021–Jul 2022) at 14.4/1000 person-years, driven primarily by COVID-19 cases, before stabilising around 13.6/1000 in Year 4 (Aug 2023–Jul 2024). SARS-CoV-2 pneumonia decreased from 2.6 in Year 2 to 0.9/1000 in Year 4, while non-COVID pneumonia remained stable (3.6–5.5/1000) between Year 2 and 4. Compared to pneumonia, NP-LRTI (HR 0.32, 95% CI: 0.29–0.35) and no evidence of LRTI (HR 0.43, 95% CI: 0.19–0.97) had lower mortality risk. Age ≥85 years (HR 5.1, 95% CI: 2.8–9.5, compared with 18–64 years) and severe comorbidities (HR 3.4, 95% CI: 2.8–4.1, compared with none) were associated with increased risk of 30-day mortality.</div></div><div><h3>Interpretation</h3><div>XXaLRTD incidence and severity remained substantial throughout and after COVID-19, with non-COVID infections maintaining consistent rates despite public health measures. These findings highlight the persistent burden of hospitalisations for aLRTD, measured in incidence and adverse outcomes and the importance of comprehensive aLRTD surveillance for public health planning.</div></div><div><h3>Funding</h3><div>AvonCAP is an investigator-led project funded under a co
{"title":"Incidence of community acquired lower respiratory tract disease in Bristol, UK, in 2020–2024: a prospective cohort study","authors":"Anastasia Chatzilena , Catherine Hyams , Robert Challen , Elizabeth Begier , Jo Southern , Maria Lahuerta , Serena McGuinness , Madeleine Clout , James Campling , Jennifer Oliver , Andrew Vyse , Gillian Ellsbury , Nick Maskell , Bradford Gessner , Adam Finn , Leon Danon","doi":"10.1016/j.lanepe.2025.101555","DOIUrl":"10.1016/j.lanepe.2025.101555","url":null,"abstract":"<div><h3>Background</h3><div>Surveillance of acute lower respiratory tract disease (aLRTD) is fundamental for understanding population health burden and healthcare needs. COVID-19 altered respiratory infection epidemiology, but the post-pandemic baseline incidence and severity of aLRTD remain underexplored. We describe the incidence and clinical outcomes of acute lower respiratory tract disease (aLRTD) hospitalisations in adults, stratified by clinical presentation and SARS-CoV-2 status.</div></div><div><h3>Methods</h3><div>We conducted a prospective cohort study of adults (≥18 years) admitted with signs/symptoms or diagnoses of aLRTD to two Bristol acute-care hospitals (1 August 2020–31 July 2024). Patients were classified as having pneumonia (radiological changes or clinician diagnosis, in line with the British Thoracic Society (BTS) and National Institute for Health and Care Excellence (NICE) guidance), non-pneumonic lower respiratory tract infection (NP-LRTI; signs and symptoms of infection without radiological change or pneumonia diagnosis), or no evidence of LRTI (principally chronic respiratory disease exacerbations and heart failure). The primary outcome was incidence of aLRTD, stratified by clinical presentation, age, and SARS-CoV-2 status. Secondary outcomes included 30-day mortality, hospital discharge within 30 days, hospital length of stay, Intensive Care Unit (ICU) admission, ICU length of stay, and 1-year mortality. Population denominators were calculated using General Practitioner (GP) registration data linked to hospital admission patterns.</div></div><div><h3>Findings</h3><div>Among 457,112 hospitalisations, 44,766 were attributed to aLRTD (96% with consented data available): 20,639 pneumonia (48.2%), 15,061 NP-LRTI (35.2%), and 7134 no evidence of LRTI (16.7%). Overall, aLRTD incidence peaked in Year 2 (Aug 2021–Jul 2022) at 14.4/1000 person-years, driven primarily by COVID-19 cases, before stabilising around 13.6/1000 in Year 4 (Aug 2023–Jul 2024). SARS-CoV-2 pneumonia decreased from 2.6 in Year 2 to 0.9/1000 in Year 4, while non-COVID pneumonia remained stable (3.6–5.5/1000) between Year 2 and 4. Compared to pneumonia, NP-LRTI (HR 0.32, 95% CI: 0.29–0.35) and no evidence of LRTI (HR 0.43, 95% CI: 0.19–0.97) had lower mortality risk. Age ≥85 years (HR 5.1, 95% CI: 2.8–9.5, compared with 18–64 years) and severe comorbidities (HR 3.4, 95% CI: 2.8–4.1, compared with none) were associated with increased risk of 30-day mortality.</div></div><div><h3>Interpretation</h3><div>XXaLRTD incidence and severity remained substantial throughout and after COVID-19, with non-COVID infections maintaining consistent rates despite public health measures. These findings highlight the persistent burden of hospitalisations for aLRTD, measured in incidence and adverse outcomes and the importance of comprehensive aLRTD surveillance for public health planning.</div></div><div><h3>Funding</h3><div>AvonCAP is an investigator-led project funded under a co","PeriodicalId":53223,"journal":{"name":"Lancet Regional Health-Europe","volume":"62 ","pages":"Article 101555"},"PeriodicalIF":13.0,"publicationDate":"2025-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145705829","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 : 2025-12-02DOI: 10.1016/j.lanepe.2025.101549
Carolina Ortiz-Cortés , Leticia Fernández-Friera , José M. Gámez , Ángel Cequier Fillat , Clara Bonanad Lozano , Antonia Sambola , Lorenzo Fácila Rubio , Luis Rodríguez Padial , Raquel Campuzano Ruíz , Milagros Pedreira Pérez , José M. de la Torre Hernández , Nicolás Rosillo , Sofía Sánchez Fernández , Náyade del Prado , José Luis Bernal , Cristina Fernández Pérez , Diego Alvaredo , Sergio Rico-Martín , Francisco Javier Elola-Somoza
Background
Heart failure remains one of the leading causes of hospital admissions and mortality worldwide, with substantial regional disparities in clinical outcomes. These variations have been linked to differences in socioeconomic conditions, health determinants, and health-care system organisation. The aim of this study was to analyse regional differences in hospitalisation rates and in-hospital mortality for heart failure across Spain’s autonomous communities, and to examine their associations with hospital characteristics and regional health determinants.
Methods
We conducted a nationwide, retrospective, population-based study using Spain’s national hospital discharge database (Conjunto Mínimo Básico de Datos, CMBD) to identify adults (≥18 years) discharged from public general hospitals within the Spanish National Health System (SNS) with a primary diagnosis of heart failure from January 1, 2016, to December 31, 2022. Differences in hospitalisation rates and risk-standardised in-hospital mortality between autonomous communities were analysed, along with associations with hospital characteristics and regional health determinants.
Findings
A total of 764,083 hospitalisations for heart failure were analysed. The mean age of participants was 80.8 ± 10.6 years. The age- and sex-standardised hospitalisation rate was 255 per 100,000 inhabitants, with significant differences between autonomous communities. Crude in-hospital mortality rate was 11.3% (86,426 episodes), with substantial regional variation in risk-standardised mortality rate (ranged from 7.7% to 16.4%) No associations were found between hospital characteristics and risk-standardised mortality rate at the regional level. Regional health determinants were highly collinear; among all determinants assessed, per-capita gross domestic product was independently associated with lower risk-standardised mortality (βGDPpc = −0.77; 95% CI: −1.04 to −0.49; p < 0.001; R2 = 0.77).
Interpretation
Significant regional differences in hospitalisation rates and risk-standardised mortality rates were observed among patients hospitalised for heart failure. Regional disparities in gross domestic product per capita may partly explain these differences. These results have clinical and policy implications, underscoring the need to consider socioeconomic determinants when analysing health outcomes and designing public policies aimed at reducing health inequalities. Our findings might be relevant to other European countries with similar public health systems.
Funding
This work was supported by the Spanish Society of Cardiology (Sociedad Española de Cardiología, SEC).
背景心力衰竭仍然是世界范围内住院和死亡的主要原因之一，在临床结果方面存在很大的地区差异。这些差异与社会经济条件、健康决定因素和卫生保健系统组织的差异有关。本研究的目的是分析西班牙各自治区心力衰竭住院率和住院死亡率的地区差异，并研究其与医院特征和地区健康决定因素的关系。方法：我们利用西班牙国家医院出院数据库（Conjunto Mínimo Básico de Datos， CMBD）开展了一项全国性的、回顾性的、基于人群的研究，以确定2016年1月1日至2022年12月31日期间从西班牙国家卫生系统（SNS）公立综合医院出院、初步诊断为心力衰竭的成年人（≥18岁）。分析了自治区之间住院率和风险标准化住院死亡率的差异，以及与医院特征和区域健康决定因素的关系。研究结果共分析了764,083例心力衰竭住院病例。参与者的平均年龄为80.8±10.6岁。按年龄和性别标准化的住院率为每10万居民255人，各自治区之间存在显著差异。粗住院死亡率为11.3%（86,426例），风险标准化死亡率存在很大的区域差异（范围从7.7%到16.4%）。在区域层面上，医院特征与风险标准化死亡率之间未发现关联。区域健康决定因素高度共线性；在评估的所有决定因素中，人均国内生产总值与较低的风险标准化死亡率独立相关（βGDPpc = - 0.77; 95% CI: - 1.04至- 0.49;p < 0.001; R2 = 0.77）。在因心力衰竭住院的患者中，住院率和风险标准化死亡率存在显著的地区差异。人均国内生产总值（gdp）的地区差异可能在一定程度上解释了这些差异。这些结果具有临床和政策意义，强调在分析健康结果和设计旨在减少健康不平等的公共政策时需要考虑社会经济决定因素。我们的发现可能与其他拥有类似公共卫生系统的欧洲国家有关。这项工作得到了西班牙心脏病学会（Sociedad Española de Cardiología， SEC）的支持。
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