EClinicalMedicine最新文献

{"title":"Disproportionality analysis of interstitial lung disease associated with novel antineoplastic agents during breast cancer treatment: a pharmacovigilance study.","authors":"Zijun Zhu, Yongxin Li, Chaoyong Zhu, Qiuxia Dong, Yixiao Zhang, Zhilin Liu, Dengfeng Ren, Fuxing Zhao, Jiuda Zhao","doi":"10.1016/j.eclinm.2025.103160","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103160","url":null,"abstract":"<p><strong>Background: </strong>Studies have shown that some antineoplastic agents may be associated with interstitial lung disease (ILD), but large-scale real-world data are lacking. This study aimed to detect signals of disproportionate reporting for ILD associated with novel antineoplastic agents used in breast cancer treatment.</p><p><strong>Methods: </strong>In this pharmacovigilance study, we collected data from the FDA Adverse Event Reporting System (FAERS; Jan 01, 2004-Dec 31, 2023) and the Japanese Adverse Drug Event Report (JADER; Jan 01, 2004-Mar 31, 2024) databases. Data retrieval involved direct download of structured datasets from the FDA and PMDA portals. Participant selection included reports of FDA-approved novel antineoplastic agents for breast cancer with documented ILD as a preferred term, excluding duplicates, non-breast cancer indications, unapproved drugs, and cases where drugs were classified as concomitant or interacting. Signals of disproportionate reporting were assessed using the reporting odds ratio (ROR), with statistical significance defined as a lower 95% confidence interval >1 and ≥3 ILD cases.</p><p><strong>Findings: </strong>A total of 2913 patients with ILD from FAERS and 1868 from JADER were analysed. We identified 9 agents with reporting signals for ILD in FAERS: ROR and 95% confidence interval (CI) for trastuzumab deruxtecan was 12.17 (95% CI 11.04-13.41), atezolizumab 6.04 (5.02-7.28), everolimus 3.21 (2.95-3.50), abemaciclib 2.87 (2.52-3.27), pertuzumab 2.84 (2.49-3.25), olaparib 2.29 (1.65-3.19), trastuzumab emtansine 2.27 (1.91-2.69), pembrolizumab 2.06 (1.65-2.58), and trastuzumab 1.36 (1.25-1.49). 7 drugs associated with ILD in JADER are also captured in FAERS. Fatal cases presented with a shorter median onset time compared to nonfatal cases (56 vs. 71 days in FAERS, <i>P</i> = 0.015; 59 vs. 76.5 days in JADER, <i>P</i> = 0.046). Analyses indicated stronger reporting associations between novel antineoplastic agents and ILD compared to chemotherapeutics (FAERS: OR 2.47, 2.16-2.81; JADER: OR 1.61, 1.37-1.88; <i>P</i> < 0.0001). ILD reports were more frequent among older patients (FAERS: HR 1.0097, 1.0036-1.0159, <i>P</i> = 0.0020; JADER: HR 1.0183, 1.0094-1.0270, <i>P</i> < 0.0001), while higher weight correlated with fewer reports (FAERS: HR 0.9783, 0.9729-0.9836; <i>P</i> < 0.0001).</p><p><strong>Interpretation: </strong>Our study detected signals of disproportionate reporting for ILD with some novel antineoplastic agents in breast cancer, fatal cases had a shorter median onset time than nonfatal ones. Novel antineoplastic agents showed stronger signal of disproportionate reporting associations with ILD than chemotherapeutics. Older age and lower weight were associated with more frequent ILD reports. The limitations-including incomplete data, inherent pharmacovigilance biases, and coprescription bias-preclude causal interpretation of the observed associations and may lead to overestimation or underesti","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"82 ","pages":"103160"},"PeriodicalIF":9.6,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11957809/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adequacy of recommendations for adverse event management in national and international treatment guidelines for rifampicin-susceptible tuberculosis: a systematic review.","authors":"William Burman, Jayne Ellis, Gila Hale, Katherine Hill","doi":"10.1016/j.eclinm.2025.103148","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103148","url":null,"abstract":"<p><strong>Background: </strong>Adverse events during tuberculosis treatment are common and are a major challenge for patients and front-line care providers. We did a systematic review of treatment guidelines for rifampicin-susceptible tuberculosis to evaluate the adequacy of recommendations for adverse event management.</p><p><strong>Methods: </strong>We searched websites, guideline registries, PubMed, and mobile health Apps to identify treatment guidelines published from October 2004 to October 2024. We recorded the presence and evidence base for specific recommendations for management of nausea/vomiting, hepatotoxicity, skin reactions, neuropathy, visual changes, drug fever, and arthralgias.</p><p><strong>Findings: </strong>We included 47 guidelines: 25 from high-burden countries, 12 international and prominent national guidelines, and 10 non-governmental guidelines. 37 guidelines (79%) included recommendations for managing adverse events: 24 (96%) of guidelines from high-burden countries, eight (80%) of those from non-governmental organizations, and four (33%) of international and prominent national guidelines. Four recommendations had formal ratings of supporting evidence.</p><p><strong>Interpretation: </strong>International and prominent national guidelines frequently lack recommendations for adverse event management or had non-specific recommendations. Research on prevention and management of common and serious adverse events should be a priority for improving the patient's experience and the outcomes of tuberculosis treatment.</p><p><strong>Funding: </strong>This research was supported by Wellcome Trust Clinical Grants.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"82 ","pages":"103148"},"PeriodicalIF":9.6,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11957802/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751447","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of tazemetostat in combination with R-CHOP in elderly patients newly diagnosed with diffuse large B cell lymphoma: results of the EpiRCHOP phase II study of the LYSA.","authors":"Clémentine Sarkozy, Thierry Jo Molina, Sydney Dubois, Cédric Portugues, Elodie Bohers, Loic Ysebaert, Roch Houot, Gian Matteo Pica, Philippe Ruminy, Charles Herbaux, Thomas Gastinne, Catherine Thieblemont, Corinne Haioun, Stéphanie Guidez, Christophe Bonnet, Gilles Crochet, Liana Veresezan, Sylvain Choquet, Emmanuel Bachy, Fabrice Jardin, Franck Morschhauser, Vincent Ribrag","doi":"10.1016/j.eclinm.2025.103157","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103157","url":null,"abstract":"<p><strong>Background: </strong>In the phase I Epi-RCHOP study (NCT02889523), we reported that R-CHOP-tazemetostat was well tolerated with the recommended phase II dose, consistent with monotherapy.</p><p><strong>Methods: </strong>Phase II included newly diagnosed diffuse large B cell lymphoma patients aged 60-80 years who received six cycles of rituximab-CHOP (R-CHOP) with continuous tazemetostat (800 mg BID), plus two cycles of tazemetostat and rituximab (cycles 7 and 8), from July 31, 2020 to July 18, 2022. Primary endpoint was positron emission tomography complete metabolic response (CMR). Sample size was calculated with H0 of 70% and H1 assumption of 80%.</p><p><strong>Findings: </strong>The trial enrolled 122 patients: median age 70 (60-80), 90.2% with stage III-IV, and 73.8% with International Prognostic Index 3-5. Overall, 100 patients (82%) received eight cycles, while 22 had premature treatment discontinuation (PTD), including 12 during the first two cycles. Reasons for PTD were consent withdrawal (N = 10), adverse events (N = 6), death (N = 2), protocol deviation (N = 2), progressive disease (N = 1), and physician decision (N = 1). The median percentage of relative dose intensity of tazemetostat and R-CHOP exceeded 90%, but required a protocol amendment and reduction in vincristine dosage at 1 mg full dose. At the end of treatment or PTD, 92/122 patients (75.4%) achieved CMR, eight (6.6%) partial metabolic response, five (4.1%) progressive disease, two (1.6%) died (septic shock), and 15 (12.3%) were not evaluated. Sensitivity analysis, excluding ten non-evaluated patients who withdrew consent, showed CMR in 82.1%. After a median follow-up of 18.5 months (IQR: 15.4-21), estimated progression-free and overall survival at 18 months were 77.7% (95% CI: 67.5-85.1%) and 88.8% (95% CI: 79.9-93.9%), respectively.</p><p><strong>Interpretation: </strong>R-CHOP plus tazemetostat is feasible with a promising CMR in elderly DLBCL patients. Complementary biomarker studies are needed for a more personalized approach.</p><p><strong>Funding: </strong>This study was sponsored under a grant from Ipsen.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"82 ","pages":"103157"},"PeriodicalIF":9.6,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11957796/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"High mortality among patients with tuberculosis accessing primary care facilities: secondary analysis from an open-label cluster-randomised trial.","authors":"Kogieleum Naidoo, Nonhlanhla Yende Zuma, Mikaila Moodley, Felix Made, Rubeshan Perumal, Santhanalakshmi Gengiah, Jacqueline Ngozo, Nesri Padayatchi, Andrew Nunn, Salim Abdool Karim","doi":"10.1016/j.eclinm.2025.103151","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103151","url":null,"abstract":"<p><strong>Background: </strong>Tuberculosis (TB) mortality remains persistently high, despite global TB control efforts. The aim of this study was to assess if a quality improvement (QI) intervention reduced deaths in TB patients accessing primary healthcare (PHC) services.</p><p><strong>Methods: </strong>In this pre specified secondary analysis of a cluster-randomized controlled study conducted in 2016-2018 in South Africa (Clinicaltrials.gov, NCT02654613), we compared 18-month case-fatality rates among newly diagnosed TB patients irrespective of HIV status randomized to clinics receiving the QI intervention and standard of care (SOC) [(eight clusters and 20 clinics per arm)]. Statistical inferences used a <i>t</i>-test from a two-stage approach recommended for cluster-randomized trials with fewer than 15 clusters per arm.</p><p><strong>Findings: </strong>Among the 5817 newly diagnosed TB patients enrolled (intervention = 3473; control = 2344), 562 died by 18-months [case-fatality rate (CFR) = 9·7%]. Ninety percent of the deaths (506/562) occurred within six months of TB treatment initiation. Quality improvement intervention arm clinics compared to control arm clinics did not demonstrate a significant difference in TB CFR. Case-fatality rates were 9·5% [95% Confidence Interval (CI): 6·9-12·9] and 11·3% (95% CI: 8·7-14·7) [adjusted rate ratio (aRR), 0·9 (95% CI: 0·6-1·2)] in the intervention and control arms, respectively. In people living with HIV/AIDS (PLWHA) CFR in the intervention and control arms: were 10·8% (95% CI: 7·8-14·7) and 14·4% (95% CI: 9·3-22·4) in those on antiretroviral therapy (ART) and 18·6 (95% CI: 9·1-38·0) and 33·0 (95% CI: 16·2-67·3), in those with no ART data respectively. In the intervention and control arms CFR in HIV-TB coinfected patients was 6·5 (95% CI: 3·6-11·6) and 11·5 (95% CI: 6·5-20·0) in those on ART with viral loads <200 copies/ml and 22·4 (95% CI: 16·7-30·2) and 19·7 (95% CI: 11·3-34·5) in those with no viral load data as they commenced ART within 12 months before initiating TB treatment, respectively.</p><p><strong>Interpretation: </strong>The quality improvement intervention did not significantly reduce mortality. <i>We observed that TB CFR was higher among PLWHA not on ART and HIV-TB coinfected patients.</i></p><p><strong>Funding: </strong>Research reported in this publication was supported by South African Medical Research Council (SAMRC), and UK Government's Newton Fund through United Kingdom Medical Research Council (UKMRC).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"82 ","pages":"103151"},"PeriodicalIF":9.6,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11957806/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751561","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reservations about the eClinicalMedicine report of a novel glucose-free amino acid oral rehydration solution.","authors":"George J Fuchs, Mathuram Santosham","doi":"10.1016/j.eclinm.2025.103110","DOIUrl":"10.1016/j.eclinm.2025.103110","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103110"},"PeriodicalIF":9.6,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11930142/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691568","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Spatial variation, pooled prevalence, and factors associated with perinatal mortality in Sub-Saharan Africa, evidence from demographic and health surveys 2015-2023: a geospatial regression approach.","authors":"Belayneh Jejaw Abate, Alemakef Wagnew Melesse, Helen Brhan, Muluken Chanie Agimas","doi":"10.1016/j.eclinm.2025.103137","DOIUrl":"10.1016/j.eclinm.2025.103137","url":null,"abstract":"<p><strong>Background: </strong>Sub-Saharan Africa (SSA) bears the greatest burden of perinatal mortality in the world, and the magnitude of the problem varied based on geographical location. A detailed understanding of spatial variation is important to improve the targeting of interventions, to identify the most affected community, and for designing evidence-based health policies. Hence, this study aimed to assess pooled prevalence, spatial variation, and factors contributing to perinatal mortality in SSA.</p><p><strong>Methods: </strong>A cross-sectional study using Demographic and Health Survey datasets (2015-2023) of 25 SSA countries with a total of 201,566 weighted samples was used for this study. The global spatial autocorrelation was explored using global Moran's-I, and the spatial variation of perinatal mortality was examined using hot spot analysis (Local Getis-Ord Gi∗ statistic). Spatial regression analyses (ordinary least squares, spatial error model, spatial lag model, geographically weighted regression, and multiscale geographically weighted regression) were conducted. Models were assessed using corrected Akaike information criteria and adjusted R². A p-value threshold of 0.05 was set to identify statistically significant spatial predictors, and the corresponding local coefficients were illustrated on a map.</p><p><strong>Findings: </strong>The pooled prevalence of perinatal mortality in SSA was 46.63 per 1000 total births (95% CI: 42.48, 51.17), and its spatial distribution was found to be clustered (Global Moran's I = 0.18, p < 0.01). Significant hotspot areas were located in Nigeria, Madagascar, Rwanda, Malawi, Burundi, Gambia, Uganda, Côte d'Ivoire, Angola, Ethiopia, Burkina Faso, and Senegal, while significant cold spots were located in Kenya, Gabon, South Africa, Ghana, Mali, and Mauritania. The multi-scale geographic weighted regression model explained 85% of the spatial variation of perinatal mortality in SSA. No antenatal care visit, birth interval less than 15 months, women undergoing cesarean section delivery, unemployed women, and households without children were significant spatial predictors of perinatal mortality in SSA.</p><p><strong>Interpretation: </strong>Perinatal mortality in SSA was high and varied across regions. We identified five predictors for perinatal mortality that might be a priority for policymakers. Enhancing antenatal care and family planning services and empowering women through employment opportunities is crucial to decreasing perinatal mortality in the region.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103137"},"PeriodicalIF":9.6,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11929057/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pathways through which water, sanitation, hygiene, and nutrition interventions reduce antibiotic use in young children: a mediation analysis of a cohort nested within a cluster-randomized trial.","authors":"Anna T Nguyen, Gabby Barratt Heitmann, Andrew Mertens, Sania Ashraf, Md Ziaur Rahman, Shahjahan Ali, Mahbub Rahman, Benjamin F Arnold, Jessica A Grembi, Audrie Lin, Ayse Ercumen, Jade Benjamin-Chung","doi":"10.1016/j.eclinm.2025.103147","DOIUrl":"10.1016/j.eclinm.2025.103147","url":null,"abstract":"<p><strong>Background: </strong>Low-cost, household-level water, sanitation, and hygiene (WASH) and nutrition interventions can reduce pediatric antibiotic use, but the mechanism through which interventions reduce antibiotic use has not been investigated.</p><p><strong>Methods: </strong>We conducted a causal mediation analysis using data collected between September 2013 and October 2015 from a cohort nested within the WASH Benefits Bangladesh cluster-randomized trial (NCT01590095). Among a subsample of children within the WASH, nutrition, nutrition + WASH, and control arms (N = 1409 children; 267 clusters), we recorded caregiver-reported antibiotic use at ages 14 and 28 months and collected stool at age 14 months. Our primary outcome was any caregiver-reported antibiotic use by index children within the past 30 or 90 days measured at age 14 and 28 months. Mediators included caregiver-reported child diarrhea, acute respiratory infection (ARI), and fever; and enteric pathogen carriage in stool measured by qPCR. Both intervention-mediator and mediator-outcome models were controlled for mediator-outcome confounders.</p><p><strong>Findings: </strong>The receipt of any WASH or nutrition intervention reduced caregiver-reported antibiotic use through all pathways in the past month by 5.5 percentage points (95% CI 1.2, 9.9), from 49.5% (95% CI 45.9%, 53.0%) in the control group to 45.0% (95% CI 42.7%, 47.2%) in the pooled intervention group. When separating this effect into different pathways, we found that interventions reduced antibiotic use by 0.6 percentage points (95% CI 0.1, 1.3) through reduced diarrhea, 0.7 percentage points (95% CI 0.1, 1.5) through reduced ARI with fever, and 1.5 percentage points (95% CI 0.4, 3.0) through reduced prevalence of enteric viruses. Interventions reduced antibiotic use through any of these measured mediators by 2.1 percentage points (95% CI -0.3, 4.5).</p><p><strong>Interpretation: </strong>WASH and nutrition interventions reduced pediatric antibiotic use through the prevention of enteric and respiratory infections in a rural, low-income population. Given that many of these infections are caused by viruses or parasites, WASH and nutrition interventions may help reduce inappropriate antibiotic use in similar settings.</p><p><strong>Funding: </strong>Bill & Melinda Gates Foundation, National Institute of Allergy and Infectious Diseases.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"82 ","pages":"103147"},"PeriodicalIF":9.6,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11928822/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence, disparities, and trends in intimate partner violence against women living in urban slums in 34 low-income and middle-income countries: a multi-country cross-sectional study.","authors":"Shaoru Chen, Ning Ma, Yuhao Kong, Zekun Chen, John Lapah Niyi, Peter Karoli, Hajirani M Msuya, Melkamu Aderajew Zemene, Md Nuruzzaman Khan, Million Phiri, Akanni Ibukun Akinyemi, Rockli Kim, Feng Cheng, Yi Song, Chunling Lu, S V Subramanian, Pascal Geldsetzer, Yue Qiu, Zhihui Li","doi":"10.1016/j.eclinm.2025.103140","DOIUrl":"10.1016/j.eclinm.2025.103140","url":null,"abstract":"<p><strong>Background: </strong>Intimate partner violence (IPV) is a significant public health issue, closely tied to social and neighborhood environments. The impoverished, overcrowded, and stressful conditions in urban slums may heighten IPV risk, yet evidence remains limited. This study aims to assess the prevalence, disparities, and trends of IPV in urban slums across low- and middle-income countries (LMICs).</p><p><strong>Methods: </strong>This cross-sectional study used nationally representative Demographic and Health Surveys data from 2006 to 2023, focusing on countries with available domestic violence data for women aged 15-49. The outcomes measured include past-year exposure to any IPV (primary outcome) and physical IPV, sexual IPV, and psychological IPV (secondary outcomes). We examined both absolute and relative disparities between urban slums, non-slum urban, and rural areas using differences and ratios. Additionally, we used Fairlie decomposition analysis based on a multivariable logistic regression model to examine the contributions of IPV risk factors (i.e., poor partner relationships, gender inequality, and poverty) to the disparities. For countries with multiple surveys, we conducted trend analysis by assessing annual changes in IPV prevalence in urban slums and the disparities.</p><p><strong>Findings: </strong>Among 283,658 women from 34 LMICs, 14,111 (5.0%) lived in urban slums. IPV prevalence in urban slums was notably high, with 18 of the studied countries above 30% for any IPV. Women in urban slums experienced higher IPV rates than those in non-slum urban and rural areas. For example, the prevalence of any IPV in urban slums was 31.4% (95% confidence interval [CI]: 30.7-32.2), which was 5.9 percentage points (95% CI: 5.1-6.7, P < 0.0001) higher than that in non-slum urban areas and 1.2 percentage points (95% CI: 0.4-2.0, P = 0.0022) higher than that in rural areas. Controlling behavior by husbands explained the largest proportion of disparities in all IPV types between urban slums and other areas. For example, 27.2% (95% CI: 25.1-29.3) of the any IPV disparities between urban slums and non-slum urban areas could be explained by this factor. In ten countries with multiple surveys, trend analysis showed rising any IPV prevalence in urban slums of four countries-Sierra Leone, Tanzania, Mali, and Nigeria-with Sierra Leone having the most significant increase (4.6 percentage points, 95% CI: 2.5-6.6, P < 0.0001).</p><p><strong>Interpretation: </strong>Our findings suggest that IPV is more prevalent in urban slums than other areas, underscoring the need for targeted public health strategies, such as addressing harmful partner's behaviors.</p><p><strong>Funding: </strong>This research was supported by China National Natural Science Foundation and the Research Fund, Vanke School of Public Health, Tsinghua University.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103140"},"PeriodicalIF":9.6,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11929056/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143691567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Blood pressure change and hypertension incidence among Ghanaians living in rural Ghana, urban Ghana and The Netherlands: a prospective cohort study.","authors":"Eva L van der Linden, Marieke Hoevenaar-Blom, Erik Beune, Samuel Nkansah Darko, Sampson Twumasi Ankrah, Karlijn A C Meeks, Felix Chilunga, Charles Hayfron-Benjamin, Peter Henneman, Bert-Jan van den Born, Ellis Owusu Dabo, Charles Agyemang","doi":"10.1016/j.eclinm.2025.103141","DOIUrl":"10.1016/j.eclinm.2025.103141","url":null,"abstract":"<p><strong>Background: </strong>Longitudinal data on blood pressure changes in sub-Saharan African populations are limited despite a high hypertension burden. This study analysed systolic blood pressure (SBP) change and hypertension incidence among people from Ghana living in rural Ghana, urban Ghana, people from Ghana living in The Netherlands and a Dutch European population living in Amsterdam, The Netherlands.</p><p><strong>Methods: </strong>The population-based Research on Obesity and Diabetes among African Migrants Prospective (RODAM-Pros) cohort study included adults aged ≥18 years at baseline (2012-2015) and follow-up (2019-2021) to study cardiovascular risk factors. At both timepoints, blood pressure (BP) was measured using a semiautomated device. Hypertension was defined as having a SBP ≥ 140 mmHg, diastolic BP ≥ 90 mmHg or the use of antihypertensive medication. We compared age-standardised SBP change and hypertension incidence between the geographical locations via linear and Poisson regression analyses, with adjustment for age, follow-up time, education, baseline BP, body mass index, renal function, and diabetes mellitus. The study protocol was approved by the respective ethics committees in Ghana and The Netherlands.</p><p><strong>Findings: </strong>Data from 632 people living in rural Ghana, 602 in urban Ghana, 861 Ghanaian, and 2038 Dutch people living in Amsterdam, were analysed (58.3% women, mean age at baseline 46.5 years, follow-up time 6·5 years). SBP increased most in women in rural Ghana (+9.5 mmHg, 95% confidence interval 7·3-11·7 mmHg), compared to +5·7 mmHg (3·6-7·7 mmHg) in urban Ghana, +2·2 mmHg (0·7-3·7 mmHg) in Ghanaian women in Amsterdam and -0·4 mmHg (-1·2 to 0·4 mmHg) in Dutch women. In men, SBP increased +5·5 mmHg (2·6-8·4 mmHg) in rural Ghana, +6·1 mmHg (2·8-9·5 mmHg) in urban Ghana, +2·1 mmHg (0·4-3·8 mmHg) in Ghanaian men in Amsterdam, and +0·3 mmHg (-0·5 to 1·1 mmHg) in Dutch men. Hypertension incidence ranged from 20·7% (95% confidence interval 14·3-29·2%) in men in rural Ghana to 34·2% (23·3-49·1%) in urban Ghana, vs. 27·9% (19·8-38·5%) in Ghanaian men in Amsterdam and 14·5% (11·8-17·6%) in Dutch men. Among women, incidence was 29·0% (23·1-35·9%) in rural Ghana, 27·6% (21·4-35·3%) in urban Ghana, 34·4% (26·0-45·4%) in Ghanaian women in Amsterdam, and 7·2% (5·6-9·2%) in Dutch women. Hypertension incidence rate ratios did not differ across populations, regardless of adjustment for covariates.</p><p><strong>Interpretation: </strong>SBP and hypertension increases were more pronounced in rural and urban Ghana than among migrants from Ghana in The Netherlands, suggesting that urbanisation of cardiovascular risk profile now extends to rural sub-Saharan Africa.</p><p><strong>Funding: </strong>European Research Council (grant number 772244).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103141"},"PeriodicalIF":9.6,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11925589/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669410","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and validation of machine learning models with blood-based digital biomarkers for Alzheimer's disease diagnosis: a multicohort diagnostic study.","authors":"Bin Jiao, Ziyu Ouyang, Xuewen Xiao, Cong Zhang, Tianyan Xu, Qijie Yang, Yuan Zhu, Yiliang Liu, Xixi Liu, Yafang Zhou, Xinxin Liao, Shilin Luo, Beisha Tang, Zhigang Li, Lu Shen","doi":"10.1016/j.eclinm.2025.103142","DOIUrl":"10.1016/j.eclinm.2025.103142","url":null,"abstract":"<p><strong>Background: </strong>Alzheimer's disease (AD) involves complex alterations in biological pathways, making comprehensive blood biomarkers crucial for accurate and earlier diagnosis. However, the cost-effectiveness and operational complexity of method using blood-based biomarkers significantly limit its availability in clinical practice.</p><p><strong>Methods: </strong>We developed low-cost, convenient machine learning-based with digital biomarkers (MLDB) using plasma spectra data to detect AD or mild cognitive impairment (MCI) from healthy controls (HCs) and discriminate AD from different types of neurodegenerative diseases. Retrospective data were gathered for 1324 individuals, including 293 with amyloid beta positive AD, 151 with mild cognitive impairment (MCI), 106 with Lewy body dementia (DLB), 106 with frontotemporal dementia (FTD), 135 with progressive supranuclear palsy (PSP) and 533 healthy controls (HCs) between July 2017 and August 2023.</p><p><strong>Findings: </strong>Random forest classifier and feature selection procedures were used to select digital biomarkers. MLDB achieved area under the curves (AUCs) of 0.92 (AD vs. HC, Sensitivity 88.2%, specificity 84.1%), 0.89 (MCI vs. HC, Sensitivity 88.8%, specificity 86.4%), 0.83 (AD vs. DLB, Sensitivity 77.2%, specificity 74.6%), 0.80 (AD vs. FTD, sensitivity 74.2%, specificity 72.4%), and 0.93 (AD vs. PSP, sensitivity 76.1%, specificity 75.7%). Digital biomarkers distinguishing AD from HC were negatively correlated with plasma p-tau217 (<i>r</i> = -0.22, <i>p</i> < 0.05) and glial fibrillary acidic protein (GFAP) (<i>r</i> = -0.09, <i>p</i> < 0.05).</p><p><strong>Interpretation: </strong>The ATR-FTIR (Attenuated Total Reflectance-Fourier Transform Infrared) plasma spectra features can identify AD-related pathological changes. These spectral features serve as digital biomarkers, providing valuable support in the early screening and diagnosis of AD.</p><p><strong>Funding: </strong>The National Natural Science Foundation of China, STI2030-Major Projects, National Key R&D Program of China, Outstanding Youth Fund of Hunan Provincial Natural Science Foundation, Hunan Health Commission Grant, Science and Technology Major Project of Hunan Province, Hunan Innovative Province Construction Project, Grant of National Clinical Research Center for Geriatric Disorders, Xiangya Hospital and Postdoctoral Fellowship Program of CPSF.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103142"},"PeriodicalIF":9.6,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11925590/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143669413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}