EClinicalMedicine最新文献

{"title":"Multi-center external validation of an automated method segmenting and differentiating atypical lipomatous tumors from lipomas using radiomics and deep-learning on MRI.","authors":"D J Spaanderman, S N Hakkesteegt, D F Hanff, A R W Schut, L M Schiphouwer, M Vos, C Messiou, S J Doran, R L Jones, A J Hayes, L Nardo, Y G Abdelhafez, A W Moawad, K M Elsayes, S Lee, T M Link, W J Niessen, G J L H van Leenders, J J Visser, S Klein, D J Grünhagen, C Verhoef, M P A Starmans","doi":"10.1016/j.eclinm.2024.102802","DOIUrl":"10.1016/j.eclinm.2024.102802","url":null,"abstract":"<p><strong>Background: </strong>As differentiating between lipomas and atypical lipomatous tumors (ALTs) based on imaging is challenging and requires biopsies, radiomics has been proposed to aid the diagnosis. This study aimed to externally and prospectively validate a radiomics model differentiating between lipomas and ALTs on MRI in three large, multi-center cohorts, and extend it with automatic and minimally interactive segmentation methods to increase clinical feasibility.</p><p><strong>Methods: </strong>Three study cohorts were formed, two for external validation containing data from medical centers in the United States (US) collected from 2008 until 2018 and the United Kingdom (UK) collected from 2011 until 2017, and one for prospective validation consisting of data collected from 2020 until 2021 in the Netherlands. Patient characteristics, MDM2 amplification status, and MRI scans were collected. An automatic segmentation method was developed to segment all tumors on T1-weighted MRI scans of the validation cohorts. Segmentations were subsequently quality scored. In case of insufficient quality, an interactive segmentation method was used. Radiomics performance was evaluated for all cohorts and compared to two radiologists.</p><p><strong>Findings: </strong>The validation cohorts included 150 (54% ALT), 208 (37% ALT), and 86 patients (28% ALT) from the US, UK and NL. Of the 444 cases, 78% were automatically segmented. For 22%, interactive segmentation was necessary due to insufficient quality, with only 3% of all patients requiring manual adjustment. External validation resulted in an AUC of 0.74 (95% CI: 0.66, 0.82) in US data and 0.86 (0.80, 0.92) in UK data. Prospective validation resulted in an AUC of 0.89 (0.83, 0.96). The radiomics model performed similar to the two radiologists (US: 0.79 and 0.76, UK: 0.86 and 0.86, NL: 0.82 and 0.85).</p><p><strong>Interpretation: </strong>The radiomics model extended with automatic and minimally interactive segmentation methods accurately differentiated between lipomas and ALTs in two large, multi-center external cohorts, and in prospective validation, performing similar to expert radiologists, possibly limiting the need for invasive diagnostics.</p><p><strong>Funding: </strong>Hanarth fonds.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11440245/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343759","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 the Florey Dementia Risk Score web-based tool to screen for Alzheimer's disease in primary care.","authors":"Yijun Pan, Chenyin Chu, Yifei Wang, Yihan Wang, Guangyan Ji, Colin L Masters, Benjamin Goudey, Liang Jin","doi":"10.1016/j.eclinm.2024.102834","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102834","url":null,"abstract":"<p><strong>Background: </strong>It is estimated that ∼60% of people with Alzheimer's disease (AD) are undetected or undiagnosed, with higher rates of underdiagnosis in low-to middle-income areas with limited medical resources. To promote health equity, we have developed a web-based tool that utilizes easy-to-collect clinical data to enhance AD detection rate in primary care settings.</p><p><strong>Methods: </strong>This study was leveraged on the data collected from participants of the Australian Imaging, Biomarker & Lifestyle (AIBL) study and the Religious Orders Study and Memory and Aging Project (ROSMAP). The study included three phases: (1) constructing and evaluating a model on retrospective cohort data (1407 AIBL participants), (2) performing simulated trials to assess model accuracy (30 AIBL participants) and missing data tolerability (30 AIBL participants), and (3) external evaluation using a non-Australian dataset (500 ROSMAP participants). The auto-score machine learning algorithm was employed to develop the Florey Dementia Risk Score (FDRS). All the simulated trials and evaluation were performed using a web-based FDRS tool.</p><p><strong>Findings: </strong>FDRS achieved an area under the curve (AUC) of approximately 0.82 [95% CI, 0.75-0.88], with a sensitivity of 0.74 [0.60-0.86] and a specificity of 0.73 [0.70-0.79]. The accuracy of the simulated pilot trial for 30 AIBL participants with complete record was 87% (26/30 correct), while it only slightly decreased (80.0-83.3%, depending on imputation methods) for another 30 AIBL participants with one or two missing data. FDRS achieved an AUC of 0.82 [0.77-0.86] of 500 ROSMAP participants.</p><p><strong>Interpretation: </strong>The FDRS tool offers a potential low-cost solution to AD screening in primary care. The present study warrants future trials of FDRS for optimization and to confirm its generalizability across a more diverse population, especially people in low-income countries.</p><p><strong>Funding: </strong>National Health and Medical Research Council, Australia (GNT2007912) and Alzheimer's Association, USA (23AARF-1020292).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11426130/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343756","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 and safety of therapeutic alpha-1-microglobulin RMC-035 in reducing kidney injury after cardiac surgery: a multicentre, randomised, double-blind, parallel group, phase 2a trial.","authors":"Alexander Zarbock, Tobias E Larsson, Nicolas Noiseux, C David Mazer, Johannes Böhm, Maxime Laflamme, Klaus Matschke, Jan Burkert, Benoit de Varennes, Andrej Myjavec, Andreas Böning, Jay L Koyner, Dan Engelman, Michael Reusch, Matthias Thielmann","doi":"10.1016/j.eclinm.2024.102830","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102830","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Cardiac surgery invariably triggers acute kidney stress causing adverse renal outcomes. The AKITA study evaluated the efficacy and safety of RMC-035, a novel analogue of alpha-1-microglobulin, for reducing cardiac surgery-associated kidney injury.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;In this randomised double-blind placebo-controlled phase 2a study, we randomly assigned (1:1) adult hospitalised patients undergoing open-chest cardiac surgery at high risk for acute kidney injury (AKI) at 21 sites in North America and Europe to receive either RMC-035 (1.3 or 0.65 mg/kg) or placebo (1:1) for 2 days (5 intravenous infusions), stratified by region and renal function. Eligible patients had at least one pre-defined AKI risk factor. Patients with severe renal impairment (estimated glomerular filtration rate [eGFR] &lt;30 mL/min/1.73 m&lt;sup&gt;2&lt;/sup&gt;) were excluded. The co-primary efficacy and safety endpoints were AKI (Kidney Disease: Improving Global Outcomes definition) within 72 h after surgery and nature, frequency, and severity of treatment-emergent adverse events (TEAEs). Secondary endpoints included eGFR and Major Adverse Kidney Events (MAKE) up to Day 90. Randomised patients who had received at least one dose of study drug were analysed for primary and safety analyses. Participants, investigators and sponsor were masked to treatment allocation. This study is registered at ClinicalTrials.gov (NCT05126303) and EudraCT (2021-004040-19).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Patient enrolment was stopped at interim analysis due to futility. Between March 31, 2022 and July 12, 2023, 177 patients (RMC-035: 89, placebo: 88) were randomised and treated. AKI rate for RMC-035 vs placebo was 50.6% (n = 45) and 39.8% (n = 35) (relative risk [RR]: 1.30, 90% confidence interval [90% CI]: 0.99, 1.71; p = 0.12). A short-lived creatinine increase was observed with the higher RMC-035 dose. Treatment with RMC-035 was associated with improved secondary renal outcomes at Day 90: placebo-adjusted eGFR change from baseline 4.3 mL/min/1.73 m&lt;sup&gt;2&lt;/sup&gt;, 90% CI 0.51-8.12, p = 0.06; and MAKE 6.7% (n = 6) vs 15.9% (n = 14); RR: 0.41, 90% CI: 0.19, 0.88, p = 0.05. The most frequently reported TEAEs for RMC-035 were chills (30.3%), nausea (21.3%), anaemia (20.2%); and atrial fibrillation (29.5%), anaemia (20.5%), hypervolemia (14.8%) for placebo. The majority of TEAEs in both treatment groups were mild or moderate in severity. In the RMC-035 group, 26 (29.2%) patients experienced at least one severe or life-threatening TEAE and in the placebo group 16 (18.2%) patients. There were 4 deaths per treatment arm (one treatment-related, in placebo group).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;In this proof-of-concept study, RMC-035 did not reduce AKI 72 h after cardiac surgery. Evaluations may have been confounded by a drug-induced transient creatinine increase in a subgroup of patients. RMC-035 was associated with improved secondary renal outcomes. These results m","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11421351/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343758","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":"Associations of socioeconomic status and healthy lifestyle with incident dementia and cognitive decline: two prospective cohort studies.","authors":"Kan Wang, Yuan Fang, Ruizhi Zheng, Xuan Zhao, Siyu Wang, Jieli Lu, Weiqing Wang, Guang Ning, Yu Xu, Yufang Bi","doi":"10.1016/j.eclinm.2024.102831","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102831","url":null,"abstract":"<p><strong>Background: </strong>Little is known about the complex associations of socioeconomic status (SES) and healthy lifestyle with cognitive dysfunction.</p><p><strong>Methods: </strong>Using data from the Health and Retirement Study (HRS) [2008-2020] and the English Longitudinal Study of Ageing (ELSA) [2004-2018], SES was constructed by latent class analysis using education level, total household income and wealth. Overall healthy lifestyle was derived using information on never smoking, low to moderate alcohol consumption (drinks/day: (0, 1] for women and (0, 2] for men), top tertile of physical activity, and active social contact.</p><p><strong>Findings: </strong>A total of 12,437 and 6565 participants from the HRS and ELSA were included (40.8% and 46.0% men and mean age 69.3 years and 65.1 years, respectively). Compared with participants of high SES, those of low SES had higher risk of incident dementia (hazard ratio 3.17, 95% confidence interval 2.72-3.69 in the HRS; 1.43, 1.09-1.86 in the ELSA), and the proportions mediated by overall lifestyle were 10.4% (7.3%-14.6%) and 2.7% (0.5%-14.0%), respectively. Compared with participants of high SES and favorable lifestyle, those with low SES and unfavorable lifestyle had a higher risk of incident dementia (4.27, 3.40-5.38 in the HRS; 2.02, 1.25-3.27 in the ELSA) and accelerated rate of global cognitive decline (<i>β</i> = -0.058 SD/year; 95% CI: -0.073, -0.043 in the HRS; <i>β</i> = -0.049 SD/year; 95% CI: -0.063, -0.035 in the ELSA).</p><p><strong>Interpretation: </strong>Unhealthy lifestyle only mediated a small proportion of the socioeconomic inequality in dementia risk in both US and UK older adults.</p><p><strong>Funding: </strong>This work was supported by grants from the National Natural Science Foundation of China (82088102 and 82370819), the National Key R&D Program of China (2023YFC2506700), the Shanghai Municipal Government (22Y31900300), the Shanghai Clinical Research Center for Metabolic Diseases (19MC1910100), the Innovative Research Team of High-Level Local Universities in Shanghai, the Special Project for Clinical Research in Health Industry of Shanghai Municipal Health Commission (202340084), and Ruijin Hospital Youth Incubation Project (KY20240805). Y.X. is supported by the National Top Young Talents program.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11420443/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343753","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":"Comparing approaches for chemoprevention for school-based malaria control in Malawi: an open label, randomized, controlled clinical trial.","authors":"Alick Sixpence, Maclean Vokhiwa, Wangisani Kumalakwaanthu, Nicola J Pitchford, Karl B Seydel, Laurence S Magder, Miriam K Laufer, Don P Mathanga, Lauren M Cohee","doi":"10.1016/j.eclinm.2024.102832","DOIUrl":"10.1016/j.eclinm.2024.102832","url":null,"abstract":"<p><strong>Background: </strong>School-age children in sub-Saharan Africa suffer an underappreciated burden of malaria which threatens their health and education. To address this problem, we compared the efficacy of two school-based chemoprevention approaches: giving all students intermittent preventive treatment (IPT) or screening and treating only students with detected infections (IST).</p><p><strong>Methods: </strong>In a three-arm, open-label, randomized, controlled trial (NCT05244954) in Malawi, 746 primary school students, aged 5-19 years, were individually randomized within each grade-level to IPT (n = 249), IST with a high-sensitivity rapid diagnostic test (hs-RDT, n = 248), or control (n = 249). At six-week intervals three times within the peak malaria transmission season (February-June 2022) treatment with dihydroartemisinin-piperaquine (DP) was administered to girls <10 years and all boys, and chloroquine to older girls. The primary outcome was <i>Plasmodium falciparum</i> (<i>Pf)</i> infection detected by PCR 6-8 weeks after the final intervention. Secondary outcomes included anaemia, clinical malaria, and scores on tests of attention, literacy, and math. Analysis was by modified intention-to-treat.</p><p><strong>Findings: </strong>Outcomes analyses included 727 (97%) participants. At the end of the study, prevalence of <i>Pf</i> infection was 17% (41/243) in the IPT arm, 24% (58/244) in the IST arm, and 53% (127/240) in the control arm. Compared to controls, IPT and IST reduced the odds of <i>Pf</i> infection (IPT adjusted odds ratio [aOR]: 0.18 (95% CI: 0.11, 0.27); p < 0.0001; IST aOR: 0.27 (95% CI: 0.18, 0.40); p < 0.0001). However, only participants receiving IPT had a lower incidence of clinical malaria (0.19 cases per person per six months (95% CI: 0.14, 0.27) vs 0.56 (95% CI: 0.46, 0.68); incidence rate ratio: 0.38 (95% CI: 0.26, 0.55); p < 0.0001)) and prevalence of anaemia (8% [20/243] vs 15% [36/240]; aOR: 0.49 (95% CI: 0.27, 0.91); p = 0.023) compared to controls. Literacy scores were higher in both intervention arms. No between group differences in tests of attention or math or number of serious adverse events were found.</p><p><strong>Interpretation: </strong>Results support implementation of IST with hs-RDTs or IPT for reduction in the prevalence of infection. Based on reductions in clinical malaria, IPT may provide additional benefits warranting further consideration by school-based malaria chemoprevention programs.</p><p><strong>Funding: </strong>Doris Duke Charitable Foundation Clinical Scientist Development Award 2021191, U.S. NIH K24AI114996 & K23AI135076.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11421355/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343755","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":"Early, medium and long-term mental health in cancer survivors compared with cancer-free comparators: matched cohort study using linked UK electronic health records.","authors":"Harriet Forbes, Helena Carreira, Garth Funston, Kirsty Andresen, Urvita Bhatia, Helen Strongman, Esha Abrol, Liza Bowen, Ceinwen Giles, Krishnan Bhaskaran","doi":"10.1016/j.eclinm.2024.102826","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102826","url":null,"abstract":"<p><strong>Background: </strong>We aimed to compare the risk of incident depression, anxiety, non-fatal self-harm and completed suicide in survivors from a wide range of cancers versus cancer-free individuals.</p><p><strong>Methods: </strong>We used electronic health records from the United Kingdom Clinical Practice Research Datalink linked to cancer registry data, hospital admissions data and death records between 1998 and 2021. Adult survivors of the 20 most common cancers were matched (age, sex, general practice) 1:10 to cancer-free individuals. Cox regression models, adjusted for shared risk factors, were used to estimate associations between cancer survivorship and mental health outcomes.</p><p><strong>Findings: </strong>853,177 adults with cancer diagnosed in 1998-2018 were matched to 8,106,643 cancer-free individuals. Survivors of all 20 cancer types under study had a higher risk of experiencing a new episode of anxiety and depression during follow-up compared with cancer-free individuals; there was also evidence of raised risks of non-fatal self-harm in 17/20 cancers and completed suicide in 8/20 cancers. Effect sizes were greatest in cancers with poorer 5-year survival: hazard ratios (HRs) for anxiety and depression of 1.1-1.2 were seen for malignant melanoma survivors, while HRs for both outcomes were >2.5 for lung and oesophageal cancer survivors. HRs were highest in the first year from cancer diagnosis, reducing over time since diagnosis. However, 5-year cancer survivors still experienced elevated risks of a subsequent new episode of anxiety or depression, in 18/20 cancers.</p><p><strong>Interpretation: </strong>Survivors of the 20 most common cancers were at increased risk of experiencing depression and anxiety, and these increased risks persisted in medium-to long-term cancer survivors. Substantially raised risks of non-fatal self-harm and completed suicide were also seen for several types of cancer. The risks of all mental health outcomes were generally higher in survivors of cancers with poorer prognosis. Our findings suggest a need for improved psychological support for all patients with cancer.</p><p><strong>Funding: </strong>Wellcome Trust.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11421364/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343757","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":"Safety and procedural success of daycase-based endovascular procedures in lower extremity arteries of patients with peripheral artery disease: a systematic review and meta-analysis.","authors":"Lydia Hanna, Alexander D Rodway, Puneet Garcha, Luci Maynard, Janane Sivayogi, Oliver Schlager, Juraj Madaric, Vinko Boc, Lucas Busch, Martin B Whyte, Simon S Skene, Jenny Harris, Christian Heiss","doi":"10.1016/j.eclinm.2024.102788","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102788","url":null,"abstract":"<p><strong>Background: </strong>Timely and economic provision of revascularisation procedures is a major healthcare need. We aimed to examine the safety and efficacy of daycase-based lower extremity endovascular revascularisation procedures in patients with peripheral artery disease.</p><p><strong>Methods: </strong>In this systematic review and meta-analysis, we searched MEDLINE and Embase for studies from Jan 01, 2000 through Apr 01, 2024 reporting complications of lower limb endovascular revascularisation procedures with same-day discharge. Eligibility-criteria, complications, and patient characteristics were extracted, methodological quality assessed (adapted Newcastle-Ottawa Scale), and meta-analyses of complications and technical success performed to provide pooled estimates. This study is registered with PROSPERO, CRD42022316466.</p><p><strong>Findings: </strong>Thirty observational studies (17 retrospective, 13 prospective) and 1 RCT reported 2427 minor and 653 major complications after 99,600 daycase procedures (93,344 patients). Eighteen studies reported daycase eligibility-criteria including 'responsible adult companion' (78%), 'proximity to hospital', and 'telephone availability' and excluding unstable and severe co-morbidities, offset coagulation, and severe chronic kidney disease. Pooled incidences of minor (4.7% [95% CI 3.8-5.6%], <i>I</i> ² = 96%) and major (0.64% [95% CI 0.48-0.79%], <i>I</i> ^<i>2</i>  = 46%) complications were low and technical success high (93% [95% CI 91-96%], <i>I</i> ² = 97%). Most complications were related to the puncture site. Pooled conversion-to-hospitalisation rates and re-admission after discharge were 1.6% (95% CI 1.1-2.2%, <i>I</i> ² = 82%) and 0.11% (95% CI 0.095-0.23%, <i>I</i> ² = 97%), respectively. Meta-regression identified that minor complications decreased since 2000. Male sex and coronary artery disease were associated with more frequent, and higher age and closure device use with less minor complications. Diabetes mellitus and chronic kidney disease were associated with less major complications. Six studies reported complication rates both in daycases and inpatients and there was no significant difference (-0.8% [95% CI -1.9 to 0.3%]).</p><p><strong>Interpretation: </strong>After careful evaluation of eligibility, lower limb angioplasty can be performed safely with high technical success in a daycase setting. Most complications arise from the puncture site and not the procedure itself highlighting the importance of optimal access site management. The heterogeneity between studies warrants standardised monitoring of complications and outcomes.</p><p><strong>Funding: </strong>European Partnership on Metrology, co-financed from European Union's Horizon Europe Research and Innovation Programme and UK Research and Innovation, and Medical Research Council.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11406065/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282095","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":"A deep learning model for personalized intra-arterial therapy planning in unresectable hepatocellular carcinoma: a multicenter retrospective study.","authors":"Xiaoqi Lin, Ran Wei, Ziming Xu, Shuiqing Zhuo, Jiaqi Dou, Haozhong Sun, Rui Li, Runyu Yang, Qian Lu, Chao An, Huijun Chen","doi":"10.1016/j.eclinm.2024.102808","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102808","url":null,"abstract":"<p><strong>Background: </strong>Unresectable Hepatocellular Carcinoma (uHCC) poses a substantial global health challenge, demanding innovative prognostic and therapeutic planning tools for improved patient management. The predominant treatment strategies include Transarterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC).</p><p><strong>Methods: </strong>Between January 2014 and November 2021, a total of 1725 uHCC patients [mean age, 52.8 ± 11.5 years; 1529 males] received preoperative CECT scans and were eligible for TACE or HAIC. Patients were assigned to one of the four cohorts according to their treatment, four transformer models (SELECTION) were trained and validated on each cohort; AUC was used to determine the prognostic performance of the trained models. Patients were stratified into high and low-risk groups based on the survival scores computed by SELECTION. The proposed AI-based treatment decision model (ATOM) utilizes survival scores to further inform final therapeutic recommendation.</p><p><strong>Findings: </strong>In this study, the training and validation sets included 1448 patients, with an additional 277 patients allocated to the external validation sets. The SELECTION model outperformed both clinical models and the ResNet approach in terms of AUC. Specifically, SELECTION-TACE and SELECTION-HAIC achieved AUCs of 0.761 (95% CI, 0.693-0.820) and 0.805 (95% CI, 0.707-0.881) respectively, in predicting ORR in their external validation cohorts. In predicting OS, SELECTION-TC and SELECTION-HC demonstrated AUCs of 0.736 (95% CI, 0.608-0.841) and 0.748 (95% CI, 0.599-0.865) respectively, in their external validation sets. SELECTION-derived survival scores effectively stratified patients into high and low-risk groups, showing significant differences in survival probabilities (P < 0.05 across all four cohorts). Additionally, the concordance between ATOM and clinician recommendations was associated with significantly higher response/survival rates in cases of agreement, particularly within the TACE, HAIC, and TC cohorts in the external validation sets (P < 0.05).</p><p><strong>Interpretation: </strong>ATOM was proposed based on SELECTION-derived survival scores, emerges as a promising tool to inform the selection among different intra-arterial interventional therapy techniques.</p><p><strong>Funding: </strong>This study received funding from the Beijing Municipal Natural Science Foundation, China (Z190024); the Key Program of the National Natural Science Foundation of China, China (81930119); The Science and Technology Planning Program of Beijing Municipal Science & Technology Commission and Administrative Commission of Zhongguancun Science Park, China (Z231100004823012); Tsinghua University Initiative Scientific Research Program of Precision Medicine, China (10001020108); and Institute for Intelligent Healthcare, Tsinghua University, China (041531001).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11407998/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282085","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":"Association between substituting macronutrients and all-cause mortality: a network meta-analysis of prospective observational studies.","authors":"Sabina Wallerer, Theodoros Papakonstantinou, Jakub Morze, Julia Stadelmaier, Eva Kiesswetter, Lea Gorenflo, Janett Barbaresko, Edyta Szczerba, Manuela Neuenschwander, William Bell, Tilman Kühn, Szimonetta Lohner, Marta Guasch-Ferré, Georg Hoffmann, Joerg J Meerpohl, Sabrina Schlesinger, Adriani Nikolakopoulou, Lukas Schwingshackl","doi":"10.1016/j.eclinm.2024.102807","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102807","url":null,"abstract":"<p><strong>Background: </strong>Suboptimal diet quality is a key risk factor for premature death. Assuming relatively stable energy intake among individuals, changes in nutrient intakes occur by exchanging different nutrients. Therefore we aimed to examine the association of isocaloric substitution of dietary (macro)nutrients with all-cause mortality using network meta-analysis (NMA).</p><p><strong>Methods: </strong>For this systematic review and NMA of prospective observational studies MEDLINE, Embase, and Scopus were searched from inception to February 13th, 2024. Eligible studies reported substitution analyses for quantity and/or quality of macronutrients, including carbohydrates, proteins, and fatty acids on all-cause mortality. Random-effects NMA were used in order to evaluate the pooled hazard ratios (HR) and 95% confidence intervals (CI) of substituting each included nutrient with another. We assessed risk of bias with the ROBINS-E tool, and the certainty of evidence (CoE) using the Grading of Recommendations Assessment, Development and Evaluations (GRADE) approach. This study is registered with PROSPERO (CRD42023450706).</p><p><strong>Findings: </strong>Thirty-nine studies with 1,737,644 participants, 395,491 deaths, 297 direct comparisons, and seven nutrient-specific networks were included. Moderate CoE was found for an association with lower mortality risk when replacing 5% of energy intake from carbohydrates with polyunsaturated fatty acids (PUFA; HR: 0.90; 95%CI: 0.84, 0.95), n-6 PUFA (0.85; 0.77, 0.94), n-3 PUFA (0.72; 0.59, 0.86), and plant monounsaturated fatty acids (MUFA; 0.90; 0.85, 0.95), and when replacing 5% of energy from saturated fatty acids (SFA) and trans-fatty acids (TFA), with PUFA, MUFA, and plant-MUFA (HR_range: 0.75 to 0.91). A lower mortality risk was additionally found when 5% of animal-MUFA was replaced with plant-MUFA, and when replacing animal protein, and SFA with plant protein (HR_range: 0.81 to 0.87, moderate CoE).</p><p><strong>Interpretation: </strong>Our results provide practical knowledge for public health professionals and can inform upcoming dietary guidelines. The beneficial association of increasing PUFA (both n-3 and n-6) and (plant-) MUFA intake while reducing carbohydrates, SFA and TFA, along with replacing animal protein and animal-MUFA with plant-based sources of protein and fat (MUFA) on the all-cause mortality risk, underscores the importance of plant-based dietary recommendations.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11408053/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282065","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":"Antimicrobial resistance among migrants in Europe: a systematic review and meta-analysis - update from 2017 to 2023.","authors":"Bridget Chukwudile, Daniel Pan, Luisa Silva, Mayuri Gogoi, Amani Al-Oraibi, Paul Bird, Nisha George, Hayley A Thompson, Rebecca F Baggaley, Sally Hargreaves, Manish Pareek, Laura B Nellums","doi":"10.1016/j.eclinm.2024.102801","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102801","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Antimicrobial resistance (AMR) is a critical global health concern. A previous systematic review showed that migrants in Europe are at increased risk of AMR. Since the COVID-19 pandemic there have been rapid changes in patterns of antibiotic use, AMR, and migration. We aimed to present an updated evidence synthesis on the current distribution of AMR among migrants in Europe.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We carried out a systematic review and meta-analysis in accordance with PRISMA guidelines (PROSPERO ID: CRD42022343263). We searched databases (MEDLINE, Embase, PubMed and Scopus) from 18 January 2017 until 18 January 2023 to identify primary data from observational studies reporting any laboratory-confirmed AMR among migrants in the European Economic Area (EEA) and European Union-15 (EU-15) countries using over 7 key search terms for migrants and over 70 terms for AMR and countries in Europe. Outcomes were infection with, or colonisation of AMR bacteria. Methodological quality was assessed using Joanna Briggs Institute Critical Appraisal Checklist for Observational Studies. We meta-analysed the pooled-prevalence of infection and/or colonisation of AMR organisms.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Findings: &lt;/strong&gt;Among 630 articles, 21 observational studies met the inclusion criteria and were included in this review. The pooled prevalence for any detected AMR was 28.0% (95% CI 18.0%-41.0%, &lt;i&gt;I&lt;/i&gt; &lt;sup&gt;&lt;i&gt;2&lt;/i&gt;&lt;/sup&gt;  = 100%) compared to a 25.4% seen in the previous review; gram-negative bacteria 31.0% (95% CI 20.0%-44.0%, &lt;i&gt;I&lt;/i&gt; &lt;sup&gt;&lt;i&gt;2&lt;/i&gt;&lt;/sup&gt;  = 100%), and methicillin-resistant staphylococcus aureus 10.0% (95% CI 5.0%-16.0%, &lt;i&gt;I&lt;/i&gt; &lt;sup&gt;&lt;i&gt;2&lt;/i&gt;&lt;/sup&gt;  = 99%). Drug-resistant bacteria were more prevalent in community settings in large migrant populations (pooled prevalence: 41.0%, 95% CI 24.0%-60.0%, &lt;i&gt;I&lt;/i&gt; &lt;sup&gt;&lt;i&gt;2&lt;/i&gt;&lt;/sup&gt;  = 99%) than in hospitals (21.0%, 95% CI 12.0%-32.0%, &lt;i&gt;I&lt;/i&gt; &lt;sup&gt;&lt;i&gt;2&lt;/i&gt;&lt;/sup&gt;  = 99%). AMR estimates in 'other' migrants were 32.0%, (95% CI 12.0%-57.0%, &lt;i&gt;I&lt;/i&gt; &lt;sup&gt;&lt;i&gt;2&lt;/i&gt;&lt;/sup&gt;  = 100%) and 28.0% (95% CI 18.0%-38.0%, &lt;i&gt;I&lt;/i&gt; &lt;sup&gt;2&lt;/sup&gt; = 100%) in forced migrants. No firm evidence of AMR acquisition with arrival time or length of stay in the host country was found.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Interpretation: &lt;/strong&gt;Studies investigating AMR in migrants are highly heterogenous. However, since the COVID-19 pandemic, migrants may be at higher risk of acquiring resistant bacteria, particularly gram-negative bacteria, within community settings such as refugee camps and detention centres in Europe. Our study highlights the importance of infrastructure and hygiene measures within these settings, to mitigate transmission of resistant pathogens. Policy-makers should screen for AMR in migrants prior to departure from countries of origin, where feasible, and upon arrival to a new country to ensure optimal health screening, infection control and effective treatment.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Funding: &lt;/strong&gt;There wa","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11408055/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282064","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}