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Optimizing bone health in people living with HIV: insights from a network meta-analysis of randomized controlled trials.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-02-17 eCollection Date: 2025-03-01 DOI: 10.1016/j.eclinm.2025.103103
Jui-Chien Wang, Sun-Mei Chung, Po-Ting Wu, Yu-Kang Tu, Pei-Chun Lai, Ta-Wei Tai, Chih-Hsing Wu, Yin-Fan Chang, Fa-Chuan Kuan, Kai-Lan Hsu, Ching-Ju Fang, Chia-Wen Li, Po-Lin Chen, Chien-An Shih
{"title":"Optimizing bone health in people living with HIV: insights from a network meta-analysis of randomized controlled trials.","authors":"Jui-Chien Wang, Sun-Mei Chung, Po-Ting Wu, Yu-Kang Tu, Pei-Chun Lai, Ta-Wei Tai, Chih-Hsing Wu, Yin-Fan Chang, Fa-Chuan Kuan, Kai-Lan Hsu, Ching-Ju Fang, Chia-Wen Li, Po-Lin Chen, Chien-An Shih","doi":"10.1016/j.eclinm.2025.103103","DOIUrl":"10.1016/j.eclinm.2025.103103","url":null,"abstract":"<p><strong>Background: </strong>With life expectancy for people living with HIV (PLWH) approaching that of the general population, age-related conditions like osteoporosis are increasingly common. Both HIV infection and long-term antiretroviral therapy (ART), particularly tenofovir disoproxil fumarate (TDF), are associated with early-onset osteoporosis. Bisphosphonates are commonly used for treatment, but the optimal strategy for improving bone health in PLWH remains unclear.</p><p><strong>Methods: </strong>We conducted a network meta-analysis (NMA) with component analysis of randomized controlled trials (RCTs) identified from Medline, EMBASE, Cochrane CENTRAL, Scopus, Web of Science and CINAHL EBSCO databases, from inception to December 1, 2024. The study included RCTs comparing zoledronate, alendronate, calcium and vitamin D, and their combinations in PLWH with osteoporosis. The primary outcomes were changes in lumbar spine and total hip bone mineral density (LS-BMD and TH-BMD). Secondary outcomes included changes in bone turnover markers (BTMs)-C-terminal telopeptide of type 1 collagen (CTx) and osteocalcin (OC)-as well as major adverse events associated with anti-osteoporosis medication (AOMs). Data were analyzed using a component NMA approach to compare treatment strategies. The study was prospectively registered on PROSPERO: CRD42023475160.</p><p><strong>Findings: </strong>A total of 11 RCTs involving 816 participants were included. In mixed PLWH populations, zoledronate-based regimens significantly improved LS-BMD [weighted mean difference (wMD): 0.0821-0.0985 g/cm<sup>2</sup>; certainty of evidence (CoE): very low to low] and TH-BMD (wMD: 0.0372-0.0606 g/cm<sup>2</sup>; CoE: low to moderate), with the highest treatment rankings (SUCRA: LS-BMD = 93.2%, TH-BMD = 87.4%). Alendronate-based regimens showed significant reductions in CTx (wMD: -0.3347 ng/ml; CoE: very low) and ranked highest for reducing CTx (SUCRA = 95.7%) but did not significantly improve BMD. No substantial differences were found in changes in OC or the incidence of major adverse events related to AOMs. Component NMA confirmed that intravenous zoledronic acid provided significant incremental benefits across both BMDs and BTMs. Sensitivity analyses by ART status revealed that in ART-experienced patients, zoledronate with calcium and higher-dose vitamin D ranked highest for LS-BMD (SUCRA = 94.4%) and zoledronate with calcium and standard-dose vitamin D for TH-BMD (SUCRA = 87.2%). However, in ART-naïve patients, no treatment demonstrated superiority, with comparable effects across three interventions.</p><p><strong>Interpretation: </strong>While zoledronate-based treatments appear to offer the greatest improvements in bone mineral density in both mixed PLWH populations and ART-experienced PLWH, their effectiveness in ART-naïve populations remains uncertain. The limited evidence and substantial heterogeneity between populations highlight the need for additional trials, particular","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103103"},"PeriodicalIF":9.6,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11876934/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143555420","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}
引用次数: 0
Adjuvant endocrine treatment strategies for non-metastatic breast cancer: a network meta-analysis.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-02-17 eCollection Date: 2025-03-01 DOI: 10.1016/j.eclinm.2025.103116
Andri Papakonstantinou, Guillermo Villacampa, Victor Navarro, Mafalda Oliveira, Antonios Valachis, Tomas Pascual, Alexios Matikas
{"title":"Adjuvant endocrine treatment strategies for non-metastatic breast cancer: a network meta-analysis.","authors":"Andri Papakonstantinou, Guillermo Villacampa, Victor Navarro, Mafalda Oliveira, Antonios Valachis, Tomas Pascual, Alexios Matikas","doi":"10.1016/j.eclinm.2025.103116","DOIUrl":"10.1016/j.eclinm.2025.103116","url":null,"abstract":"<p><strong>Background: </strong>Multiple trials have evaluated escalation strategies of endocrine therapy for early breast cancer, including ovarian function suppression (OFS) and aromatase inhibitors (AI) in premenopausal patients and extended endocrine therapy. However, several aspects remain controversial due to the heterogeneity of study designs and lack of statistical power in relevant subgroups. We aimed to investigate the optimal endocrine therapy strategy.</p><p><strong>Methods: </strong>A systematic literature search was performed and last updated in August 2024 to identify randomized controlled trials (RCT) evaluating endocrine treatment strategies for hormone receptor positive breast cancer. A network meta-analysis with a frequentist framework using random-effects model was used to pool direct and indirect evidence. In addition, an extracted individual patient data meta-analysis was conducted to estimate the absolute differences between treatments. Study endpoints were disease-free survival (DFS), overall survival (OS), and safety. PROSPERO: CRD42023447979.</p><p><strong>Findings: </strong>A total of 37 RCT that had enrolled 107,684 patients were included in the study. During the first five years, OFS + AI was the most effective strategy in premenopausal women, while AI or switch strategy showed the better efficacy results in postmenopausal ones. Following five years of tamoxifen, continuation with five additional years of AI was associated with improved 8-year DFS (85.8%) compared to no extended therapy (78.1%) or five additional years of tamoxifen (81.0%). Following five years of AI or switch strategy, extended treatment with AI improved DFS (Hazard Ratio = 0.81, 95% Confidence Interval 0.73-0.90).</p><p><strong>Interpretation: </strong>This study provides information regarding the optimal endocrine treatment strategies for patients with resected hormone receptor positive early breast cancer.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103116"},"PeriodicalIF":9.6,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11875833/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540564","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}
引用次数: 0
Real-time artificial intelligence-assisted detection and segmentation of nasopharyngeal carcinoma using multimodal endoscopic data: a multi-center, prospective study.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-02-15 eCollection Date: 2025-03-01 DOI: 10.1016/j.eclinm.2025.103120
Rui He, Pengyu Jie, Weijian Hou, Yudong Long, Guanqun Zhou, Shumei Wu, Wanquan Liu, Wenbin Lei, Weiping Wen, Yihui Wen
{"title":"Real-time artificial intelligence-assisted detection and segmentation of nasopharyngeal carcinoma using multimodal endoscopic data: a multi-center, prospective study.","authors":"Rui He, Pengyu Jie, Weijian Hou, Yudong Long, Guanqun Zhou, Shumei Wu, Wanquan Liu, Wenbin Lei, Weiping Wen, Yihui Wen","doi":"10.1016/j.eclinm.2025.103120","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103120","url":null,"abstract":"<p><strong>Background: </strong>Nasopharyngeal carcinoma (NPC) is a common malignancy in southern China, and often underdiagnosed due to reliance on physician expertise. Artificial intelligence (AI) can enhance diagnostic accuracy and efficiency using large datasets and advanced algorithms.</p><p><strong>Methods: </strong>Nasal endoscopy videos with white light imaging (WLI) and narrow-band imaging (NBI) modes from 707 patients treated at one center in China from June 2020 to December 2022 were prospectively collected. A total of 8816 frames were obtained through standardized data procedures. Nasopharyngeal Carcinoma Diagnosis Segmentation Network Framework (NPC-SDNet) was developed and internally tested based on these frames. Two hundred frames were randomly selected to compare the diagnostic performance between NPC-SDNet and rhinologists. Two external testing sets with 2818 images from other hospitals validated the robustness and generalizability of the model. This study was registered at clinicaltrials.gov (NCT04547673).</p><p><strong>Findings: </strong>The diagnostic accuracy, precision, recall, and specificity of NPC-SDNet using WLI were 95.0% (95% CI: 94.1%-96.2%), 93.5% (95% CI: 90.2%-95.2%), 97.2% (95% CI: 96.2%-98.3%), and 93.5% (95% CI: 91.7%-94.0%), respectively, and using NBI were 95.8% (95% CI: 94.0%-96,8%), 93.1% (95% CI: 91.0%-95.6%), 96.0% (95% CI: 95.7%-96.8%), and 97.2% (95% CI: 97.1%-97.4%), respectively. Segmentation performance was also robust, with mean Intersection over Union scores of 83.4% (95% CI: 81.8%-85.6%; NBI) and 83.7% (95% CI: 85.1%-90.1%; WLI). In head-to-head comparisons with rhinologists, NPC-SDNet achieved a diagnostic accuracy of 94.0% (95% CI: 91.5%-95.8%) and processed 1000 frames per minute, outperforming clinicians (68.9%-88.2%) across different expertise levels. External validation further supported the reliability of NPC-SDNet, with area under the receiver operating characteristic curve (AUC) values of 0.998 and 0.977 in NBI images, 0.977 and 0.970 in WLI images.</p><p><strong>Interpretation: </strong>NPC-SDNet demonstrates excellent real-time diagnostic and segmentation accuracy, offering a promising tool for enhancing the precision of NPC diagnosis.</p><p><strong>Funding: </strong>This work was supported by National Key R&D Program of China (2020YFC1316903), the National Natural Science Foundation of China (NSFC) grants (81900918, 82020108009), Natural Science Foundation of Guangdong Province (2022A1515010002), Key-Area Research and Development of Guangdong Province (2023B1111040004, 2020B1111190001), and Key Clinical Technique of Guangzhou (2023P-ZD06).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103120"},"PeriodicalIF":9.6,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11871492/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540574","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}
引用次数: 0
Cost-effectiveness of advanced hybrid closed loop therapy compared to standard insulin therapy for type 1 diabetes in pregnancy: an economic evaluation of the CRISTAL trial.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-02-14 eCollection Date: 2025-03-01 DOI: 10.1016/j.eclinm.2025.103106
Salima Azahaf, Kaat Beunen, Nancy Van Wilder, Dominique Ballaux, Gerd Vanhaverbeke, Youri Taes, Xavier-Philippe Aers, Frank Nobels, Liesbeth Van Huffel, Joke Marlier, Dahae Lee, Joke Cuypers, Vanessa Preumont, Sarah E Siegelaar, Rebecca C Painter, Annouschka Laenen, Pieter Gillard, Chantal Mathieu, Jeroen Luyten, Katrien Benhalima
{"title":"Cost-effectiveness of advanced hybrid closed loop therapy compared to standard insulin therapy for type 1 diabetes in pregnancy: an economic evaluation of the CRISTAL trial.","authors":"Salima Azahaf, Kaat Beunen, Nancy Van Wilder, Dominique Ballaux, Gerd Vanhaverbeke, Youri Taes, Xavier-Philippe Aers, Frank Nobels, Liesbeth Van Huffel, Joke Marlier, Dahae Lee, Joke Cuypers, Vanessa Preumont, Sarah E Siegelaar, Rebecca C Painter, Annouschka Laenen, Pieter Gillard, Chantal Mathieu, Jeroen Luyten, Katrien Benhalima","doi":"10.1016/j.eclinm.2025.103106","DOIUrl":"10.1016/j.eclinm.2025.103106","url":null,"abstract":"<p><strong>Background: </strong>A multicentre, randomised controlled trial (the CRISTAL trial), demonstrated the safety and efficacy of MiniMed™ 780G advanced hybrid closed loop (AHCL) therapy during pregnancy, showing improved glycaemic control overnight, less hypoglycaemia, and improved treatment satisfaction compared to standard insulin therapy (SoC, mainly open-loop insulin pump therapy). This study aimed to assess the cost-effectiveness of AHCL, which has a higher initial cost, compared to SoC in pregnant women with type 1 diabetes (T1D).</p><p><strong>Methods: </strong>A decision tree model was developed to estimate the cost-effectiveness of AHCL compared to SoC in pregnant women with T1D, covering pregnancy to birth and postpartum hospital discharge (a time horizon of 28 weeks). Total costs per strategy (in 2024 euros, €) were calculated from a healthcare payer perspective. The base-case analysis derived prevalence of pregnancy complications and hospitalisations directly related to diabetes management from the CRISTAL trial. Uncertainty was analysed by exploring multiple scenarios and sensitivity analyses.</p><p><strong>Findings: </strong>In the base-case analysis, the cost of using AHCL during pregnancy was estimated at €13,988.75 (95% CI: €12,240 to €16,062) compared to €14,221.33 (95% CI: €12,380 to €16,420) for SoC, indicating cost-savings of €232.57 per individual, alongside the demonstrated clinical benefits of AHCL. The primary cost driver was the AHCL device cost. This cost was offset by savings from shorter and less frequent hospital admissions (mainly due to severe hypoglycaemia and dysregulated diabetes) in the AHCL group compared to SoC. In our probabilistic sensitivity analysis, AHCL was dominant in 73% of the simulated cost-effectiveness pairs.</p><p><strong>Interpretation: </strong>AHCL might be cost-saving compared to SoC for pregnant women with T1D. However, more robust data are needed to assess the potential impact of AHCL therapy on pregnancy and long-term health outcomes.</p><p><strong>Funding: </strong>Diabetes Liga Research Fund and Medtronic.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103106"},"PeriodicalIF":9.6,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874532/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540566","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}
引用次数: 0
Cerebral blood flow and cognitive functioning in patients undergoing transcatheter aortic valve implantation.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-02-14 eCollection Date: 2025-03-01 DOI: 10.1016/j.eclinm.2025.103092
Astrid C van Nieuwkerk, Kimberley I Hemelrijk, Hugo M Aarts, Anna E Leeuwis, Charles B L M Majoie, Mat J A P Daemen, Esther E Bron, Justine E F Moonen, Alexandra de Sitter, Berto J Bouma, Alexander Harms, Wiesje M van der Flier, Jan Baan, Jan J Piek, Geert Jan Biessels, Ronak Delewi
{"title":"Cerebral blood flow and cognitive functioning in patients undergoing transcatheter aortic valve implantation.","authors":"Astrid C van Nieuwkerk, Kimberley I Hemelrijk, Hugo M Aarts, Anna E Leeuwis, Charles B L M Majoie, Mat J A P Daemen, Esther E Bron, Justine E F Moonen, Alexandra de Sitter, Berto J Bouma, Alexander Harms, Wiesje M van der Flier, Jan Baan, Jan J Piek, Geert Jan Biessels, Ronak Delewi","doi":"10.1016/j.eclinm.2025.103092","DOIUrl":"https://doi.org/10.1016/j.eclinm.2025.103092","url":null,"abstract":"<p><strong>Background: </strong>Approximately one-third of patients with symptomatic severe aortic valve stenosis scheduled for transcatheter aortic valve implantation (TAVI) have some degree of cognitive impairment. The effect of TAVI on cardiac output, cerebral blood flow (CBF), and cognitive functioning has not been systematically studied.</p><p><strong>Methods: </strong>CAPITA (NCT05481008) is a prospective longitudinal study assessing cerebral and cognitive outcomes in patients that underwent TAVI between August 2020 and October 2022. At baseline (<24 h before TAVI) and three-month follow-up, patients underwent echocardiography, brain magnetic resonance imaging (MRI), and multidomain neuropsychological assessment. Primary outcome measures were change in CBF (Δml/100 g/min on arterial spin labelling MRI) and change in global cognitive functioning (Δz-scores). Secondary outcomes included cardiac output (L/min), and white matter hyperintensities (mL, number). Differences were tested with paired t-test and associations were tested with linear mixed models.</p><p><strong>Findings: </strong>A total of 148 patients (80.5 ± 5.7 years, 43% female) underwent TAVI. Three months after TAVI, cardiac output increased from 5.9 ± 1.4 L/min to 6.3 ± 1.4 L/min (mean difference 0.37, 95% CI 0.12-0.62, p = 0.004). CBF increased from 52.2 ± 14.5 mL/100 g/min to 55.9 ± 17.7 mL/100 g/min (mean difference 3.8, 95% CI 1.15-6.36, p = 0.005). Global cognitive functioning also increased from 0.02 ± 0.52 to 0.15 ± 0.49 (mean difference 0.13, 95% CI 0.06-0.20, p < 0.001) with most prominent increase in patients with worst baseline cognitive functioning. Patients with cognitive decline (22%), had a higher volume of new in white matter hyperintensities than patients with stable or improved cognition (78%): 1.26 ± 2.96, vs 0.29 ± 0.45, vs 0.31 ± 0.91 mL (p = 0.06).</p><p><strong>Interpretation: </strong>In patients with severe symptomatic aortic valve stenosis undergoing TAVI, cardiac output, CBF, and cognitive functioning improved after three months.</p><p><strong>Funding: </strong>The Heart-Brain Connection crossroad consortium of the Dutch Cardiovascular Alliance. The Netherlands CardioVascular Research Initiative: Dutch Heart Foundation (CVON 2018-28 & 2012-06 Heart Brain Connection).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103092"},"PeriodicalIF":9.6,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11872408/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540565","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}
引用次数: 0
Investigating the presence and detectability of structural peripheral arterial changes in children with well-regulated type 1 diabetes versus healthy controls using ultra-high frequency ultrasound: a single-centre cross-sectional and case-control study.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-02-13 eCollection Date: 2025-03-01 DOI: 10.1016/j.eclinm.2025.103097
Ebba Bergdahl, Gun Forsander, Frida Sundberg, Linda Milkovic, Frida Dangardt
{"title":"Investigating the presence and detectability of structural peripheral arterial changes in children with well-regulated type 1 diabetes versus healthy controls using ultra-high frequency ultrasound: a single-centre cross-sectional and case-control study.","authors":"Ebba Bergdahl, Gun Forsander, Frida Sundberg, Linda Milkovic, Frida Dangardt","doi":"10.1016/j.eclinm.2025.103097","DOIUrl":"10.1016/j.eclinm.2025.103097","url":null,"abstract":"<p><strong>Background: </strong>Children with type 1 diabetes have an increased risk of macrovascular complications. This study used ultra-high frequency ultrasound (UHFUS), enabling differentiation of intima thickness (IT), and media thickness (MT) in peripheral arteries, to examine early peripheral arterial changes in children with type 1 diabetes (CWD).</p><p><strong>Methods: </strong>This cross-sectional and case-control study performed at the Queen Silvia Children's Hospital, Gothenburg, Sweden included CWD, aged 6-15.99 y/o, diabetes duration ≥5 years, compared to age and sex matched healthy controls. Exclusion criteria included other medical conditions or treatments besides insulin, abnormal examination findings or inability to handle extensive examinations. UHFUS measurements from the radial, dorsal pedal (DP), and carotid arteries as well as blood samples, blood pressure (BP)- and BMI z-score were collected from all study participants, and glucometrics from CWD.</p><p><strong>Findings: </strong>Study inclusion was performed during 02/25/2019-06/28/2022, and a total of 50 CWD, and 41 healthy controls were included in the study. Of these, five CWD and four healthy controls were excluded, resulting in 45 (22 girls (49%), 23 boys (51%)) CWD (12.0 (2.3) y/o) and 37 (19 girls (51%), 18 boys (49%)) healthy controls (11.3 (2.5) y/o) included in data analysis. CWD had a mean HbA1c of 6.6% (48.1 mmol/mol), higher DBP z-scores (p = 0.019), DP IT, DP intima-media thickness (IMT), and radial IT compared with controls (p = 0.003, p = 0.008, and p = 0.002, respectively). Carotid IT was correlated with time in range (r = -0.47, p = 0.014), time in tight range (r = -0.64, p < 0.001), and glucose variability (r = 0.40, p = 0.004) in CWD. Time in tight range and longitudinal HbA1c were the strongest determinants for carotid IT in CWD, and type 1 diabetes diagnosis was the strongest determinant for IT across all arteries.</p><p><strong>Interpretation: </strong>Children with well-regulated type 1 diabetes show early vascular changes in radial and DP arteries. Regression analyses indicate significant links between IT and hyperglycaemia and type 1 diabetes diagnosis respectively, indicating that structural arterial changes start in the intima. Our findings further emphasise increased time in normoglycemia as the most crucial action to prevent cardiovascular complications in type 1 diabetes. Additional larger studies are needed to confirm and further interpret the meaning of these results.</p><p><strong>Funding: </strong>ALF-agreement, Child Diabetes Foundation, Swedish Diabetes Foundation, and the Sahlgrenska University Hospital Foundations.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103097"},"PeriodicalIF":9.6,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11872503/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540570","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}
引用次数: 0
Severe maternal morbidity in the high income setting: a systematic review of composite definitions.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-02-13 eCollection Date: 2025-03-01 DOI: 10.1016/j.eclinm.2025.103105
Ian Henderson, Rosie Lynch, Stephen Gerry, Jenny McLeish, Peter Watkinson, Marian Knight
{"title":"Severe maternal morbidity in the high income setting: a systematic review of composite definitions.","authors":"Ian Henderson, Rosie Lynch, Stephen Gerry, Jenny McLeish, Peter Watkinson, Marian Knight","doi":"10.1016/j.eclinm.2025.103105","DOIUrl":"10.1016/j.eclinm.2025.103105","url":null,"abstract":"<p><strong>Background: </strong>Severe maternal morbidity (SMM) is an important indicator for the improvement of maternity care. Measurement of SMM varies, limiting global comparisons. To promote concordance we studied how SMM has been defined in epidemiological practice.</p><p><strong>Methods: </strong>Comprehensive composite definitions of SMM in pregnancy or up to 6 weeks postnatal that captured both obstetric and non-obstetric processes in high-income settings were identified through a prospectively registered (PROSPERO CRD42023421377) systematic search of PubMed, Embase, and Google Scholar 01/01/1993-31/08/2024. Clinical concepts, diagnostic and procedural codes captured by definitions of SMM were compared and the variation between definitions was described.</p><p><strong>Findings: </strong>The initial search identified 7852 records and 40 studies were included: 28 studies that reported 32 definitions of SMM for use with administrative data, with median incidence of 11.4/1000, and 13 studies that reported 13 definitions for use with the primary medical record, with median SMM incidence of 6.7/1000. The majority of definitions included cardiac, respiratory, and renal dysfunction or failure; haemorrhagic, thrombotic or infective morbidity; and critical interventions. Up to 75% of cases of SMM under some definitions involved transfusion. The main source of variation between definitions was the selection and definition of common obstetric diagnoses. Variation in the sources of additional routine data required to construct a definition also limited comparability.</p><p><strong>Interpretation: </strong>Despite common approaches to defining SMM, there are opportunities to improve comparability. No two definitions for use with administrative data in different settings involved a similar incidence and set of components and involved a similar distribution of components among cases. Harmonization of the purpose, constituent codes, and sources of data would facilitate comparisons between maternity systems.</p><p><strong>Funding: </strong>This work was supported by the Medical Research Council [MR/X006115/1] as well as the National Institute for Health Research [NIHR204430].</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103105"},"PeriodicalIF":9.6,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874727/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540575","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}
引用次数: 0
Development and validation of an ultrasound-based interpretable machine learning model for the classification of ≤3 cm hepatocellular carcinoma: a multicentre retrospective diagnostic study.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-02-13 eCollection Date: 2025-03-01 DOI: 10.1016/j.eclinm.2025.103098
Zhicheng Du, Fangying Fan, Jun Ma, Jing Liu, Xing Yan, Xuexue Chen, Yangfang Dong, Jiapeng Wu, Wenzhen Ding, Qinxian Zhao, Yuling Wang, Guojun Zhang, Jie Yu, Ping Liang
{"title":"Development and validation of an ultrasound-based interpretable machine learning model for the classification of ≤3 cm hepatocellular carcinoma: a multicentre retrospective diagnostic study.","authors":"Zhicheng Du, Fangying Fan, Jun Ma, Jing Liu, Xing Yan, Xuexue Chen, Yangfang Dong, Jiapeng Wu, Wenzhen Ding, Qinxian Zhao, Yuling Wang, Guojun Zhang, Jie Yu, Ping Liang","doi":"10.1016/j.eclinm.2025.103098","DOIUrl":"10.1016/j.eclinm.2025.103098","url":null,"abstract":"<p><strong>Background: </strong>Our study aimed to develop a machine learning (ML) model utilizing grayscale ultrasound (US) to distinguish ≤3 cm small hepatocellular carcinoma (sHCC) from non-HCC lesions.</p><p><strong>Methods: </strong>A total of 1052 patients with 1058 liver lesions ≤3 cm from 55 hospitals were collected between May 2017 and June 2021, and 756 liver lesions were randomly allocated into train and internal validation cohorts at a 8:2 ratio for the development and evaluation of ML models based on multilayer perceptron (MLP) and extreme gradient boosting (XGBoost) methods (Model<sup>U</sup> utilizing US imaging features; Model<sup>UR</sup> adding US radiomics features; Model<sup>URC</sup> employing clinical features further). The diagnostic performance of three models was assessed in external validation cohort (312 liver lesions from 14 hospitals). The diagnostic efficacy of the optimal model was compared to that of radiologists in external validation cohort. The SHapley Additive exPlanations (SHAP) method was employed to interpret the optimal ML model by ranking feature importance. The study was registered at ClinicalTrials.gov (NCT03871140).</p><p><strong>Findings: </strong>Model<sup>URC</sup> based XGBoost showed the best performance (AUC = 0.934; 95% CI: 0.894-0.974) in the internal validation cohort. In the external validation cohort, Model<sup>URC</sup> also achieved optimal AUC (AUC = 0.899, 95% CI: 0.861-0.931). Upon conducting a subgroup analysis, no statistically significant differences were observed in the diagnostic performance of the Model<sup>URC</sup> neither between tumor sizes of ≤2.0 cm and 2.1-3.0 cm nor across different HCC risk stratifications. Model<sup>URC</sup> exhibited superior ability compared to all radiologists and Model<sup>URC</sup> assistance significantly improved the diagnostic AUC for all radiologists (all P < 0.0001).</p><p><strong>Interpretation: </strong>A diagnostic model for sHCC was developed and validated using ML and grayscale US from large cohorts. This model significantly improved the diagnostic performance of grayscale US for sHCC compared with experts.</p><p><strong>Funding: </strong>This work was supported by National Key Research and Development Program of China (2022YFC2405500), Major Research Program of the National Natural Science Foundation of China (92159305), National Science Fund for Distinguished Young Scholars (82325027), Key project of National Natural Science Foundation of China (82030047), Military Fund for Geriatric Diseases (20BJZ42), National Natural Science Foundation of China Special Program (82441011). National Natural Science Foundation of China (82402280), National Natural Science Foundation of China (32171363), Key Research and Development Program for Social Development of Yunnan Science and Technology Department (202403AC100014).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103098"},"PeriodicalIF":9.6,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11872562/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540567","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}
引用次数: 0
Measuring the WHO Global Breast Cancer Initiative Pillars' key performance indicators in Sub-Saharan Africa: experience in the African Breast Cancer-Disparities in Outcomes hospital-based cohort study.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-02-13 eCollection Date: 2025-03-01 DOI: 10.1016/j.eclinm.2025.103104
Pauline Boucheron, Annelle Zietsman, Angelica Anele, Awa U Offiah, Moses Galukande, Groesbeck Parham, Leeya Pinder, Tingting Mo, Milena Foerster, Joachim Schüz, Benjamin O Anderson, Mary Nyangasi, Isabel Dos-Santos-Silva, Valerie McCormack
{"title":"Measuring the WHO Global Breast Cancer Initiative Pillars' key performance indicators in Sub-Saharan Africa: experience in the African Breast Cancer-Disparities in Outcomes hospital-based cohort study.","authors":"Pauline Boucheron, Annelle Zietsman, Angelica Anele, Awa U Offiah, Moses Galukande, Groesbeck Parham, Leeya Pinder, Tingting Mo, Milena Foerster, Joachim Schüz, Benjamin O Anderson, Mary Nyangasi, Isabel Dos-Santos-Silva, Valerie McCormack","doi":"10.1016/j.eclinm.2025.103104","DOIUrl":"10.1016/j.eclinm.2025.103104","url":null,"abstract":"<p><strong>Background: </strong>The World Health Organization Global Breast Cancer Initiative aims to reduce breast cancer (BC) mortality through three pillars, whose key performance indicators (KPIs) and benchmarks are: (KPI-1) ≥60% BC diagnosed at early stage (I/II), (KPI-2) all suspected BC diagnosed ≤60 days from health system presentation, and (KPI-3) ≥80% of BC patients completing recommended treatment. We aimed to inform measurement of these KPIs in the context of a multi-country hospital-based study.</p><p><strong>Methods: </strong>We included all women who participated to the African Breast Cancer-Disparities in Outcomes (ABC-DO) prospective cohort study (excluding South Africa), recruited between 2014 and 2017, across five population-race groups spanning low to high survival: Nigeria, Uganda, Zambia, Namibian black and Namibian non-black women. Follow-up was up to five years post-diagnosis. For each KPI, we reported challenges, assumptions and consistencies in measuring them; completeness and group-level estimations of each KPI were assessed using descriptive analyses. To evaluate their discriminatory ability, we assessed group-level correlations between KPI estimates and five-year net survival.</p><p><strong>Findings: </strong>KPI-1 was extracted from study or medical records for 1389/1473 (94%). KPI-2 relied upon the woman's recall of her date of first contact with the healthcare system and a pathology date, both of which were available for 1222/1473 (83%) but inconsistent for 114/1222 (9.3%). KPI-3, estimated using dates of receipt of multiple therapies from medical records and patient interviews over 12 months, was estimated for 1129/1188 (95%), but uncertain in 113/1129 (10%). For each population group, KPIs achievements were similar for KPI-1 and KPI-2, at 22-49%, and lowest for KPI-3 (<30%). Highest KPIs values were observed in Namibian non-black women who had the highest survival.</p><p><strong>Interpretation: </strong>Data collection systems specifically set up for prospective hospital-based studies can be used to collect the necessary data to measure these three GBCI KPIs.</p><p><strong>Funding: </strong>National Cancer Institute (United States).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103104"},"PeriodicalIF":9.6,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11872636/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540572","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}
引用次数: 0
Prevalence of intimate partner violence among child marriage victims and the comparison with adult marriages: a systematic review and meta-analysis.
IF 9.6 1区 医学
EClinicalMedicine Pub Date : 2025-02-13 eCollection Date: 2025-03-01 DOI: 10.1016/j.eclinm.2025.103084
Qing Han, Wenting Ye, Zuyi Fang, Stephanie Eagling-Peche, Yuwei Wang, Bang Zheng, Jamie Lachman
{"title":"Prevalence of intimate partner violence among child marriage victims and the comparison with adult marriages: a systematic review and meta-analysis.","authors":"Qing Han, Wenting Ye, Zuyi Fang, Stephanie Eagling-Peche, Yuwei Wang, Bang Zheng, Jamie Lachman","doi":"10.1016/j.eclinm.2025.103084","DOIUrl":"10.1016/j.eclinm.2025.103084","url":null,"abstract":"<p><strong>Background: </strong>The global prevalence of child marriage remains high. This systematic review and meta-analysis aims to provide global estimates of the prevalence of intimate partner violence (IPV) among women who are, or have been, child brides (i.e., child marriage population), and the relative risks compared with the adult marriage population.</p><p><strong>Methods: </strong>We searched PubMed, Embase, APA PsycArticles, APA PsycInfo, Web of Science Core Collection, EBSCO, and ProQuest Dissertations & Theses Global for studies published from database inception to November 6, 2024. Eligible studies that reported IPV data either in the child marriage population or in both child marriage and adult marriage populations were included. Random effects meta-analyses were conducted to synthesise the data. The study protocol was registered on PROSPERO (CRD42023408835).</p><p><strong>Findings: </strong>A total of 16 studies on IPV experienced in the past 12 months among child brides (N = 232,928) and 23 studies on ever-experienced IPV (N = 196,929) were included. The lifetime prevalence and 12-month prevalence of any IPV in women who underwent child marriage were 35% (95% CI: 28-43) and 24% (95% CI: 16-31), respectively. Compared with women married in adulthood, women married as children had substantially higher odds of experiencing any IPV over lifetime (OR = 1.42, 95% CI: 1.22-1.65) or in the past 12 months (OR = 1.37, 95% CI: 1.18-1.57). The excess risks persisted even after child brides reached adulthood. Consistent findings were obtained after restricting to nationally representative data.</p><p><strong>Interpretation: </strong>Women who underwent child marriage are vulnerable to and disproportionally affected by IPV, emphasising the need for international efforts on targeted IPV interventions and ending child marriage globally to prevent more victims.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"81 ","pages":"103084"},"PeriodicalIF":9.6,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874713/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143540137","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}
引用次数: 0
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