EClinicalMedicine最新文献

{"title":"Robotic-assisted versus video-assisted lobectomy for resectable non-small-cell lung cancer: the RVlob randomized controlled trial.","authors":"Zhenyi Niu, Yuqin Cao, Mingyuan Du, Siying Sun, Yan Yan, Yuyan Zheng, Yichao Han, Xianfei Zhang, Zhengyuan Zhang, Ye Yuan, Jian Li, Yajie Zhang, Chengqiang Li, Dingpei Han, Hailei Du, Wei Guo, Kai Chen, Jie Xiang, Lianggang Zhu, Jiaming Che, Junbiao Hang, Jian Ren, Toni Lerut, Abbas E Abbas, Jules Lin, Runsen Jin, Hecheng Li","doi":"10.1016/j.eclinm.2024.102707","DOIUrl":"10.1016/j.eclinm.2024.102707","url":null,"abstract":"<p><strong>Background: </strong>The long-term survival and perioperative outcomes of robotic-assisted lobectomy (RAL) and video-assisted lobectomy (VAL) in resectable non-small-cell lung cancer (NSCLC) were found to be comparable in retrospective studies, but they have not been investigated in a randomized trial setting. We conducted the RVlob trial to investigate if RAL was non-inferior to VAL in patients with resectable NSCLC.</p><p><strong>Methods: </strong>In this single-center, open-label, and parallel-arm randomized controlled trial conducted in Ruijin Hospital (Shanghai, China) between May 2017 and May 2020, we randomly assigned patients with resectable NSCLC in a 1:1 ratio to receive either RAL or VAL. One of the primary endpoints was 3-year overall survival. Secondary endpoints included 3-year disease-free survival. The Kaplan-Meier approach was used to calculate overall survival and disease-free survival at 3 years. This study was registered with ClinicalTrials.gov, NCT03134534.</p><p><strong>Findings: </strong>A total of 320 patients were randomized to receive RAL (n = 157) or VAL (n = 163). The baseline characteristics of patients were well balanced between the two groups. After a median follow-up of 58.0 months, the 3-year overall survival was 94.6% (95% confidence interval [CI], 91.0-98.3) in the RAL group and 91.5% (95% CI, 87.2-96.0) in the VAL group (hazard ratio [HR] for death, 0.65; 95% CI, 0.33-1.28; <i>P</i> = 0.21); noninferiority of RAL was confirmed according to the predefined margin of -5% (absolute difference, 2.96%; a one-sided 90% CI, -1.39% to ∞; <i>P</i> = 0.0029 for noninferiority). The 3-year disease-free survival was 88.7% (95% CI, 83.6-94.1) in the RAL group and 85.4% (95% CI, 80.0-91.2) in the VAL group (HR for disease recurrence or death, 0.87; 95% CI, 0.50-1.52; <i>P</i> = 0.62).</p><p><strong>Interpretation: </strong>This study is the first randomized trial to show that RAL resulted in non-inferior overall survival compared with VAL in patients with resectable NSCLC. Based on our results, RAL is an equally oncologically effective treatment and can be considered as an alternative to VAL for resectable NSCLC.</p><p><strong>Funding: </strong>National Natural Science Foundation of China (82072557), National Key Research and Development Program of China (2021YFC2500900), Shanghai Municipal Education Commission-Gaofeng Clinical Medicine Grant (20172005, the 2nd round of disbursement), program of Shanghai Academic Research Leader from Science and Technology Commission of Shanghai Municipality (20XD1402300), Novel Interdisciplinary Research Project from Shanghai Municipal Health Commission (2022JC023), and Interdisciplinary Program of Shanghai Jiao Tong University (YG2023ZD04).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11299594/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141893171","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":"Corrigendum to \"Multidimensional poverty is associated with dementia among adults in Afghanistan\" [eClinicalMedicine 58(2023) 101906].","authors":"Jean-Francois Trani, Yiqi Zhu, Soobin Park, Dauod Khuram, Rahim Azami, Monib Rahim Fazal, Ganesh M Babulal","doi":"10.1016/j.eclinm.2024.102704","DOIUrl":"10.1016/j.eclinm.2024.102704","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1016/j.eclinm.2023.101906.].</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11276918/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141787582","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":"Chronic loneliness and the risk of incident stroke in middle and late adulthood: a longitudinal cohort study of U.S. older adults.","authors":"Yenee Soh, Ichiro Kawachi, Laura D Kubzansky, Lisa F Berkman, Henning Tiemeier","doi":"10.1016/j.eclinm.2024.102639","DOIUrl":"10.1016/j.eclinm.2024.102639","url":null,"abstract":"<p><strong>Background: </strong>Loneliness has been implicated as a stroke risk factor, yet studies have examined loneliness at only one time point. The association of loneliness changes and risk of incident stroke remains understudied. Our aim was to examine the association of loneliness with incident stroke, particularly the role of loneliness chronicity.</p><p><strong>Methods: </strong>This prospective cohort study examined data from the Health and Retirement Study during 2006-2018. For analyses examining baseline loneliness only, we included U.S. adults aged 50 years or older and stroke-free at baseline and excluded individuals missing data on loneliness and those who experienced death at baseline. For analyses examining loneliness changes over two time points, we included those aged 50 years or older at baseline and stroke-free through the exposure measurement period. Individuals missing a loneliness scale measure or those who experienced death during the exposure measurement period were excluded. Loneliness was measured with the 3-item Revised UCLA Loneliness Scale. We constructed loneliness scores (range 3-9), dichotomized loneliness measures (high vs low using a >6 cutoff), and loneliness patterns across two time points (consistently low, remitting, recent onset, consistently high). Cox regression models estimated associations of baseline loneliness (N = 12,161) with incident stroke over a 10-12-year period, and loneliness change patterns (N = 8936) with incident stroke over a subsequent 6-8-year period, adjusting for demographics, health behaviors and health conditions.</p><p><strong>Findings: </strong>Higher loneliness scores at baseline were associated with incident stroke for continuous (hazard ratio [HR]: 1.05, 95% confidence interval [CI]: 1.01-1.08) and dichotomized (HR: 1.25, 95% CI: 1.06-1.47) loneliness measures, and persisted after adjustment for social isolation but not depressive symptoms. Only individuals with a consistently high loneliness pattern over time (vs consistently low) had significantly higher incident stroke risk (HR: 1.56, 95% CI: 1.11-2.18) after adjusting for depressive symptoms and social isolation.</p><p><strong>Interpretation: </strong>Chronic loneliness was associated with higher stroke risk independent of depressive symptoms or social isolation. Addressing loneliness may have an important role in stroke prevention, and repeated assessments of loneliness over time may help identify those particularly at risk.</p><p><strong>Funding: </strong>National Institute on Aging (NIA U01AG009740).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11472377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460596","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":"Lenalidomide and dexamethasone for Rosai-Dorfman disease: a single arm, single center, prospective phase 2 study.","authors":"Long Chang, Min Lang, Ting Liu, He Lin, Zheng-Zheng Liu, Hao Cai, Dao-Bin Zhou, Xin-Xin Cao","doi":"10.1016/j.eclinm.2024.102685","DOIUrl":"10.1016/j.eclinm.2024.102685","url":null,"abstract":"<p><strong>Background: </strong>Rosai-Dorfman disease (RDD) is a rare heterogeneous histiocytic disorder lacking standardized first-line treatment.</p><p><strong>Methods: </strong>This single-center, phase 2 prospective study enrolled 13 newly diagnosed and 10 recurrent RDD patients from June 2021 to March 2023 at Peking Union Medical College Hospital (Beijing, China). Lenalidomide 25 mg days 1-21 plus dexamethasone 40 mg days 1, 8, 15, 22 was administered in 28-day cycles, totaling 12 cycles. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall response rate (ORR) to lenalidomide and dexamethasone (RD) regimen, toxicity, and overall survival (OS) measured from RD start to death or last follow-up. OS and PFS were estimated according to Kaplan-Meier survival analysis and compared with the log-rank test. For OS and OR rate, 95% confidence limits were obtained using the Clopper-Pearson method, with standard methods used for PFS. p < 0.05 was considered statistically significant. The trial was registered with ClinicalTrials.gov (NCT04924647).</p><p><strong>Findings: </strong>The median age was 44 years (IQR 35-54). All patients had extranodal RDD. MAPK pathway alterations occurred in 6/18 (33%). Elevated IL-6 and TNF-α were found in 39% (n = 9) and 70% (n = 16), respectively. All patients received ≥6 cycles (median 12, range 6-12, IQR 10-12). The ORR was 87% (20/23, 95% CI 66%-97%), 30% (n = 7) complete remission, 57% (n = 13) partial remission). Treatment with RD significantly decreased median serum levels of both IL-6 (from 5.9 (IQR 4.2-8.7) to 2.9 (IQR 2.1-5.9) pg/mL, p = 0.031) and TNF-α (from 12.2 (IQR 8.6-17.9) to 8.3 (IQR 6.1-10.5) pg/mL, p = 0.0012). With a median 26 months follow-up (range 6-28, IQR 16-28), 4 patients relapsed and none died. Two-year OS and PFS were 100.0% (95% CI 85%-100%) and 69.0% (95% CI 51%-94%), respectively. No grade 3-4 adverse events or discontinuations due to adverse events occurred. Twelve patients (n = 12, 52%) had grade 1-2 hematological toxicity. Other toxicities included constipation (n = 2, 9%), glucose intolerance (n = 2, 9%), edema (n = 2, 9%), insomnia (n = 1, 4%), and tremor (n = 1, 4%).</p><p><strong>Interpretation: </strong>Lenalidomide and dexamethasone regimen is an effective and safe regimen for newly diagnosed and recurrent RDD.</p><p><strong>Funding: </strong>National Natural Science Foundation of China, Beijing Natural Science Haidian frontier Foundation Funding, and the National High Level Hospital Clinical Research Funding.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11253284/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141632967","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 thresholds and target populations for antiviral COVID-19 treatments to save lives and costs: a modelling study.","authors":"Epke A Le Rutte, Andrew J Shattock, Inês Marcelino, Sophie Goldenberg, Melissa A Penny","doi":"10.1016/j.eclinm.2024.102683","DOIUrl":"10.1016/j.eclinm.2024.102683","url":null,"abstract":"<p><strong>Background: </strong>In 2023 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was declared endemic, yet hospital admissions have persisted and risen within populations at high and moderate risk of developing severe disease, which include those of older age, and those with co-morbidities. Antiviral treatments, currently only available for high-risk individuals, play an important role in preventing severe disease and hospitalisation within this subpopulation. Here, we further explore the public health and economic benefits of extending target populations for treatment, and assess efficacy thresholds for a treatment strategy to be cost-saving.</p><p><strong>Methods: </strong>We adapted an individual-based transmission model of SARS-CoV-2, OpenCOVID, which was calibrated and validated to 2020-2023 Swiss, European, and Northern Hemisphere epidemiological data. We used the model to estimate hospitalisations and overall costs for preventatively treating three risk groups for a full range of treatment efficacies and coverages with, besides vaccination and hospital treatments, no other interventions in place. We further calculated efficacy thresholds for strategies to be cost-saving. A global sensitivity analysis was conducted to test the sensitivity of all outcomes for a wide range of treatment properties, emerging variant properties, and vaccination coverages.</p><p><strong>Findings: </strong>In a high vaccination coverage setting, we found that a high efficacy antiviral treatment given to all those at high-risk could reduce hospitalisations by up to 40%. When expanding treatment coverage to also include all those at moderate-risk, an additional 50% of hospitalisations could be averted. Targeting both high-risk and moderate-risk groups was found to be cost-saving for a treatment efficacy greater than ∼40%. This threshold was found to be robust regardless of vaccination coverage and emerging variant properties, but highly sensitive to treatment costs.</p><p><strong>Interpretation: </strong>For a sufficiently efficacious antiviral treatment, expanding the target population to include both high-risk and moderate-risk groups should be considered. Equitable treatment costs are found crucial in achieving the best possible public health and health economic outcomes.</p><p><strong>Funding: </strong>Botnar Research Centre for Child Health (DZX2165 to MAP), the Swiss National Science Foundation Professorship of MAP (P00P3_203450) and Swiss National Science Foundation NFP 78 Covid-19 2020 (4079P0_198428 to MAP).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11246010/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616092","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":"PeRinatal, neOnatal, and Maternal OuTcomEs with azithromycin prophylaxis in pregnancy and labour (PROMOTE-PROPHYLAXIS): systematic review and meta-analysis.","authors":"Muhammad Aaqib Shamim, Jogender Kumar, Amol N Patil, Krishna Tiwari, Sakshi Sharma, Abhishek Anil, Aswini Saravanan, Mokanpally Sandeep, Shoban Babu Varthya, Surjit Singh, Molla Imaduddin Ahmed, Ahmad Najmi, Muhammad Aasim Shamim, Aravind Gandhi, Prakisini Satapathy, Ranjit Sah, Sarvesh Rustagi, Abhay M Gaidhane, Quazi Syed Zahiruddin, Mahalaqua Nazli Khatib, Bijaya Kumar Padhi, Kuldeep Singh, Pradeep Dwivedi","doi":"10.1016/j.eclinm.2024.102691","DOIUrl":"10.1016/j.eclinm.2024.102691","url":null,"abstract":"<p><strong>Background: </strong>Initial randomised controlled trials (RCTs) showed that prophylactic azithromycin in pregnant women improved maternal and neonatal outcomes; however, the recent evidence did not show any benefit to neonatal survival. There is conflicting evidence over the role of azithromycin prophylaxis in antenatal and intrapartum periods. We explored whether azithromycin prophylaxis in pregnant women improves maternal and neonatal outcomes.</p><p><strong>Methods: </strong>For this systematic review and meta-analysis registered on PROSPERO [CRD42023411093], we searched seven databases (PubMed, Scopus, Embase, Cochrane Library, EBSCOHost, ProQuest, and Web of Science) and clinical trial registries until 04/23/2024, for RCTs evaluating antenatal/intrapartum azithromycin prophylaxis against placebo/routine care in pregnant women. The primary outcome was neonatal mortality. Intrapartum and antenatal administration were assessed separately. We used random-effects meta-analysis. The risk of bias was assessed using the Cochrane RoB 2 tool. The GRADE approach was used to evaluate the certainty of the evidence.</p><p><strong>Findings: </strong>Screening 2161 records retrieved 20 RCTs (56,381 participants). Intrapartum azithromycin may make little or no difference to neonatal mortality [5 RCTs, 44,436 participants; Risk Ratio (RR): 1.02, 95% CI 0.86-1.20, <i>I</i> ^<i>2</i>  = 0%, very low certainty], and maternal mortality [3 RCTs, 44,131 participants, RR: 1.26, 0.65-2.42, <i>I</i> ^<i>2</i>  = 0%, low certainty]. Similarly, antenatal azithromycin may have little or no effect on neonatal mortality [3 RCTs; 5304 participants; RR: 0.74, 0.35-1.56, <i>I</i> ^<i>2</i>  = 43%, very-low certainty] and maternal mortality [3 RCTs; 8167 participants RR: 1.62, 0.67-3.91, <i>I</i> ^<i>2</i>  = 0%, low certainty]. There is no data on long-term adverse outcomes and antimicrobial resistance.</p><p><strong>Interpretation: </strong>Low to very low certainty evidence suggests that intrapartum or antenatal azithromycin prophylaxis in pregnant women might not reduce maternal or neonatal mortality.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11253273/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141632968","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":"Real-life efficacy of immunotherapy for Sézary syndrome: a multicenter observational cohort study.","authors":"Alizée Bozonnat, Marie Beylot-Barry, Olivier Dereure, Michel D'Incan, Gaëlle Quereux, Emmanuella Guenova, Marie Perier-Muzet, Stephane Dalle, Florent Grange, Manuelle-Anne Viguier, Caroline Ram-Wolff, Laurence Feldmeyer, Helmut Beltraminelli, Nathalie Bonnet, Florent Amatore, Eve Maubec, Nathalie Franck, Laurent Machet, François Chasset, Florence Brunet-Possenti, Jean-David Bouaziz, Maxime Battistella, Marie Donzel, Anne Pham-Ledard, Claudia Bejar, Hélène Moins-Teisserenc, Samia Mourah, Philippe Saiag, Ewa Hainaut, Catherine Michel, Guido Bens, Henri Adamski, François Aubin, Serge Boulinguez, Pascal Joly, Billal Tedbirt, Isabelle Templier, Laura Troin, Henri Montaudié, Saskia Ingen-Housz-Oro, Sarah Faiz, Laurent Mortier, Gabor Dobos, Martine Bagot, Matthieu Resche-Rigon, Claire Montlahuc, Arnaud Serret-Larmande, Adèle de Masson","doi":"10.1016/j.eclinm.2024.102679","DOIUrl":"10.1016/j.eclinm.2024.102679","url":null,"abstract":"<p><strong>Background: </strong>Sézary syndrome is an extremely rare and fatal cutaneous T-cell lymphoma (CTCL). Mogamulizumab, an anti-CCR4 monoclonal antibody, has recently been associated with increased progression-free survival in a randomized clinical trial in CTCL. We aimed to evaluate OS and prognostic factors in Sézary syndrome, including treatment with mogamulizumab, in a real-life setting.</p><p><strong>Methods: </strong>Data from patients with Sézary (ISCL/EORTC stage IV) and pre-Sézary (stage IIIB) syndrome diagnosed from 2000 to 2020 were obtained from 24 centers in Europe. Age, disease stage, plasma lactate dehydrogenases levels, blood eosinophilia at diagnosis, large-cell transformation and treatment received were analyzed in a multivariable Cox proportional hazard ratio model. This study has been registered in ClinicalTrials (SURPASSe01 study: NCT05206045).</p><p><strong>Findings: </strong>Three hundred and thirty-nine patients were included (58% men, median age at diagnosis of 70 years, Q1-Q3, 61-79): 33 pre-Sézary (9.7% of 339), 296 Sézary syndrome (87.3%), of whom 10 (2.9%) had large-cell transformation. One hundred and ten patients received mogamulizumab. Median follow-up was 58 months (95% confidence interval [CI], 53-68). OS was 46.5% (95% CI, 40.6%-53.3%) at 5 years. Multivariable analysis showed that age ≥ 80 versus <50 (HR: 4.9, 95% CI, 2.1-11.2, p = 0.001), and large-cell transformation (HR: 2.8, 95% CI, 1.6-5.1, p = 0.001) were independent and significant factors associated with reduced OS. Mogamulizumab treatment was significantly associated with decreased mortality (HR: 0.34, 95% CI, 0.15-0.80, p = 0.013).</p><p><strong>Interpretation: </strong>Treatment with mogamulizumab was significantly and independently associated with decreased mortality in Sézary syndrome.</p><p><strong>Funding: </strong>French Society of Dermatology, Swiss National Science Foundation (IZLIZ3_200253/1) and SKINTEGRITY.CH collaborative research program.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11245986/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616149","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":"Hospital readmissions among adults living with and without HIV in the US: findings from the Nationwide Readmissions Database.","authors":"Xianming Zhu, Eshan U Patel, Stephen A Berry, Mary K Grabowski, Alison G Abraham, Thibaut Davy-Mendez, Brenna Hogan, Keri N Althoff, Andrew D Redd, Oliver Laeyendecker, Thomas C Quinn, Kelly A Gebo, Aaron A R Tobian","doi":"10.1016/j.eclinm.2024.102690","DOIUrl":"10.1016/j.eclinm.2024.102690","url":null,"abstract":"<p><strong>Background: </strong>Thirty-day hospital readmission measures quality of care, but there are limited data among people with HIV (PWH) and people without HIV (PWoH) in the era of universal recommendation for antiretroviral therapy. We descriptively compared 30-day all-cause, unplanned readmission risk between PWH and PWoH.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted using the 2019 Nationwide Readmissions Database (2019/01/01-2019/12/31), an all-payer database that represents all US hospitalizations. Index (initial) admissions and readmissions were determined using US Centers for Medicare & Medicaid Services definitions. Crude and age-adjusted risk ratios (aRR) comparing the 30-day all-cause, unplanned readmission risk between PWH to PWoH were estimated using random effect logistic regressions and predicted marginal estimates. Survey weights were applied to all analyses.</p><p><strong>Findings: </strong>We included 24,338,782 index admissions from 18,240,176 individuals. The median age was 52(IQR = 40-60) years for PWH and 61(IQR = 38-74) years for PWoH. The readmission risk was 20.9% for PWH and 12.2% for PWoH (age-adjusted-RR:1.88 [95%CI = 1.84-1.92]). Stratified by age and sex, young female (age 18-29 and 30-39 years) PWH had a higher readmission risk than young female PWoH (aRR = 3.50 [95%CI = 3.11-3.88] and aRR = 4.00 [95%CI = 3.67-4.32], respectively). While the readmission risk increased with age among PWoH, the readmission risk was persistently high across all age groups among PWH. The readmission risk exceeded 30% for PWH admitted for hypertensive heart disease, heart failure, and chronic kidney disease.</p><p><strong>Interpretation: </strong>PWH have a disproportionately higher risk of readmission than PWoH, which is concerning given the aging profile of PWH. More efforts are needed to address readmissions among PWH.</p><p><strong>Funding: </strong>US National Institutes of Health.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11246008/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616093","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":"The potential role of Artificial Intelligence in transforming childhood cancer care.","authors":"eClinicalMedicine","doi":"10.1016/j.eclinm.2024.102705","DOIUrl":"https://doi.org/10.1016/j.eclinm.2024.102705","url":null,"abstract":"","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11247146/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619529","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":"Pegylated liposomal doxorubicin combined with cyclophosphamide and vincristine in pediatric patients with relapsed/refractory solid tumor: a single-arm, open-label, phase I study.","authors":"Suying Lu, Juan Wang, Junting Huang, Feifei Sun, Jia Zhu, Yi Que, Hui Li, Ying Guo, Ruiqing Cai, Zijun Zhen, Xiaofei Sun, Yizhuo Zhang","doi":"10.1016/j.eclinm.2024.102701","DOIUrl":"10.1016/j.eclinm.2024.102701","url":null,"abstract":"<p><strong>Background: </strong>The combined vincristine, pegylated liposomal doxorubicin (PLD), and cyclophosphamide (VPC) regimen has never been studied in pediatric patients.</p><p><strong>Methods: </strong>This open-label, single-center, single-arm phase I study utilizing a \"3 + 3\" design enrolled children with relapsed/refractory (R/R) solid tumors. Three dose levels of PLD (Duomeisu®) were studied (30, 40, or 50 mg/m²) in combination with cyclophosphamide (1500 mg/m²), mesna (1500 mg/m²), and vincristine (1.5 mg/m², maximum 2 mg) once every 3 weeks. The primary endpoints included safety, the maximum tolerated dose (MTD) of PLD (Duomeisu®), and the recommended phase 2 dose (RP2D) of PLD (Duomeisu®) for further phase 2 investigation. The secondary endpoints were objective response rate (ORR) and disease control rate (DCR). This study is registered with ClinicalTrials.gov, NCT04213612.</p><p><strong>Findings: </strong>Between January 7, 2020, and November 18, 2021, 34 patients were eligible and evaluable for toxicity, while 26 patients were evaluable for response. The MTD of PLD (Duomeisu®) was 30 mg/m². The most common adverse event (AE) was grade 3 or 4 neutropenia (61.8%). The most common grade 1 or 2 non-hematologic AE and cardiotoxicity effects were vomiting (35.3%) and abnormal electrocardiogram T waves (20.6%), respectively. ORR and DCR to VPC regimen after two cycles were 50.0% and 92.3%, respectively. Targeted gene panel sequencing revealed the activation of <i>TP53</i> mutation may be an adverse prognostic factor.</p><p><strong>Interpretation: </strong>The VPC regimen showed a promising safety profile and had preliminary efficacy in children with R/R solid tumors. The RP2D for PLD (Duomeisu®) combined with cyclophosphamide and vincristine is 30 mg/m² once every 3 weeks.</p><p><strong>Funding: </strong>CSPC Ouyi Pharmaceutical Co., Ltd., Shijiazhuang, the National Key Research and Development Program of China [No. 2022YFC2705005], the National Natural Science Foundation of China [No. 82203303], and the Basic and Applied Basic Research Foundation of Guangdong Province [No. 2021A1515110234].</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":null,"pages":null},"PeriodicalIF":9.6,"publicationDate":"2024-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11246015/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616147","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}