Pub Date : 2024-12-09eCollection Date: 2025-01-01DOI: 10.1016/j.eclinm.2024.102995
Jennifer L Nguyen, Marianna Mitratza, Hannah R Volkman, Leonie de Munter, Thao Mai Phuong Tran, Catia Marques, Mustapha Mustapha, Srinivas Valluri, Jingyan Yang, Andrés Antón, Irma Casas, Eduardo Conde-Sousa, Laura Drikite, Beate Grüner, Giancarlo Icardi, Gerrit Luit Ten Kate, Charlotte Martin, Ainara Mira-Iglesias, Alejandro Orrico-Sánchez, Susana Otero-Romero, Gernot Rohde, Luis Jodar, John M McLaughlin, Kaatje Bollaerts
Background: Prior studies have reported lower effectiveness of XBB.1.5-adapted vaccines against hospitalization related to the Omicron JN.1 variant than the XBB variant. This study evaluated the effectiveness and durability of the BNT162b2 XBB.1.5-adapted vaccine against JN.1-related hospitalization during the 2023-2024 season in Europe.
Methods: A test-negative case-control study was carried out in adults (≥18 y) hospitalized between 2 October 2023 and 2 April 2024 with severe acute respiratory infection (SARI) within the id.DRIVE partnership. This study included nine sites across Belgium, Germany, Italy, and Spain. Cases had a laboratory-confirmed JN.1 infection or a positive SARS-CoV-2 test with symptom onset during JN.1 predominance; controls had a negative SARS-CoV-2 test and symptom onset during JN.1 predominance. The primary objective was to estimate BNT162b2 XBB.1.5-adapted vaccine effectiveness (VE) against COVID-19 hospitalization. One case was matched with up to four controls, according to symptom onset date and site. Multivariable analyses were adjusted for symptom onset date, age, sex, and number of chronic conditions.
Findings: Among 308 test-positive cases and 1117 test-negative controls, BNT162b2 XBB.1.5-adapted VE against hospitalization compared to no vaccination this season was 53.8% (95% CI 38.4-65.4) after a median of 63 days following vaccination. Protection was sustained through five months; VE was 52.2% (95% CI 41.3-61.1) 2 to <4 weeks after vaccination, 48.9% (95% CI 17.9-68.2) at 4 to <8 weeks, and ranged from 54.6% to 59.5% at 4-week intervals from 8 to <22 weeks.
Interpretation: BNT162b2 XBB.1.5-adapted vaccine provided protection against JN.1-related hospitalization, regardless of prior vaccination history, with no evidence of waning through five months. These data support yearly vaccination against COVID-19 to prevent severe illness during the respiratory virus season.
Funding: Pfizer.
背景：先前的研究报告了XBB.1.5适应疫苗对与Omicron JN.1变异相关的住院治疗的有效性低于XBB变异。本研究评估了BNT162b2 xbb .1.5适应疫苗在欧洲2023-2024年流感季期间对抗1型流感相关住院治疗的有效性和持久性。方法：对2023年10月2日至2024年4月2日期间住院的严重急性呼吸道感染（SARI）成人（≥18岁）进行检测阴性病例对照研究。开车的伙伴关系。这项研究包括比利时、德国、意大利和西班牙的九个地点。实验室确诊的新型冠状病毒感染或SARS-CoV-2检测阳性，在新型冠状病毒优势期出现症状；对照组的SARS-CoV-2检测呈阴性，症状出现在JN.1优势期。主要目的是评估BNT162b2 xbb .1.5适应疫苗对COVID-19住院的有效性（VE）。根据症状发作日期和部位，1例与最多4例对照。多变量分析校正了症状出现日期、年龄、性别和慢性疾病的数量。结果：在308例检测阳性病例和1117例检测阴性对照中，接种疫苗后中位63天，与本季节未接种疫苗相比，BNT162b2 xbb .1.5适应VE的住院率为53.8% （95% CI 38.4-65.4）。保护持续了五个月；VE为52.2% (95% CI 41.3-61.1) 2.解释：BNT162b2 xbb .1.5适应疫苗提供保护，防止与jn .1相关的住院治疗，无论先前的疫苗接种史如何，在5个月内没有减弱的证据。这些数据支持每年接种COVID-19疫苗，以预防呼吸道病毒季节的严重疾病。资金:辉瑞。
{"title":"Effectiveness of the BNT162b2 XBB.1.5-adapted vaccine against COVID-19 hospitalization related to the JN.1 variant in Europe: a test-negative case-control study using the id.DRIVE platform.","authors":"Jennifer L Nguyen, Marianna Mitratza, Hannah R Volkman, Leonie de Munter, Thao Mai Phuong Tran, Catia Marques, Mustapha Mustapha, Srinivas Valluri, Jingyan Yang, Andrés Antón, Irma Casas, Eduardo Conde-Sousa, Laura Drikite, Beate Grüner, Giancarlo Icardi, Gerrit Luit Ten Kate, Charlotte Martin, Ainara Mira-Iglesias, Alejandro Orrico-Sánchez, Susana Otero-Romero, Gernot Rohde, Luis Jodar, John M McLaughlin, Kaatje Bollaerts","doi":"10.1016/j.eclinm.2024.102995","DOIUrl":"10.1016/j.eclinm.2024.102995","url":null,"abstract":"<p><strong>Background: </strong>Prior studies have reported lower effectiveness of XBB.1.5-adapted vaccines against hospitalization related to the Omicron JN.1 variant than the XBB variant. This study evaluated the effectiveness and durability of the BNT162b2 XBB.1.5-adapted vaccine against JN.1-related hospitalization during the 2023-2024 season in Europe.</p><p><strong>Methods: </strong>A test-negative case-control study was carried out in adults (≥18 y) hospitalized between 2 October 2023 and 2 April 2024 with severe acute respiratory infection (SARI) within the id.DRIVE partnership. This study included nine sites across Belgium, Germany, Italy, and Spain. Cases had a laboratory-confirmed JN.1 infection or a positive SARS-CoV-2 test with symptom onset during JN.1 predominance; controls had a negative SARS-CoV-2 test and symptom onset during JN.1 predominance. The primary objective was to estimate BNT162b2 XBB.1.5-adapted vaccine effectiveness (VE) against COVID-19 hospitalization. One case was matched with up to four controls, according to symptom onset date and site. Multivariable analyses were adjusted for symptom onset date, age, sex, and number of chronic conditions.</p><p><strong>Findings: </strong>Among 308 test-positive cases and 1117 test-negative controls, BNT162b2 XBB.1.5-adapted VE against hospitalization compared to no vaccination this season was 53.8% (95% CI 38.4-65.4) after a median of 63 days following vaccination. Protection was sustained through five months; VE was 52.2% (95% CI 41.3-61.1) 2 to <4 weeks after vaccination, 48.9% (95% CI 17.9-68.2) at 4 to <8 weeks, and ranged from 54.6% to 59.5% at 4-week intervals from 8 to <22 weeks.</p><p><strong>Interpretation: </strong>BNT162b2 XBB.1.5-adapted vaccine provided protection against JN.1-related hospitalization, regardless of prior vaccination history, with no evidence of waning through five months. These data support yearly vaccination against COVID-19 to prevent severe illness during the respiratory virus season.</p><p><strong>Funding: </strong>Pfizer.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102995"},"PeriodicalIF":9.6,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11669791/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142893013","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}
Pub Date : 2024-12-09eCollection Date: 2025-01-01DOI: 10.1016/j.eclinm.2024.102986
Charlotte Ocana de Sentuary, Clara Testard, Marion Lagrée, Maxime Leroy, Lisa Gasnier, Alicia Enes-Dias, Constance Leruste, Diariatou Diallo, Michael Génin, Thameur Rakza, François Dubos
Background: To evaluate the acceptance and safety of the treatment of newborns with nirsevimab (a long-acting monoclonal antibody designed to prevent respiratory syncytial virus infections) during the first season of implementation.
Methods: A longitudinal, prospective, single-centre cohort study was conducted from September 18th, 2023, to January 23rd, 2024 at Lille University Hospital (Lille, France). All newborns admitted to the hospital's maternity department during the study period and whose parents agreed to participate in the study were included. Parents were asked to state whether or not they agreed for their infant to receive nirsevimab. The occurrence of adverse events (AEs) 2 h after nirsevimab treatment and 7, 14 and 30 days after discharge was documented by the mother. The primary endpoint was the nirsevimab treatment acceptance rate. The secondary endpoints were the variables associated with the acceptance of nirsevimab, the reasons for accepting or refusing nirsevimab, and the treatment's real-life safety, relative to a non-treated control group of newborns.
Findings: Of the 1730 infants born in the hospital during the study period, 477 met all the inclusion criteria and were enrolled. The nirsevimab acceptance rate [95% confidence interval] was 91.6% [89.1%-94.2%]. In a multivariable analysis, the mother's age, lower parity and having a partner in work were significantly associated with nirsevimab acceptance. The most common reason for accepting treatment was "to protect my baby", and the most common reason for refusing treatment was the lack of long-term data on nirsevimab. The nirsevimab and control groups did not differ significantly in terms of the types and frequencies of AEs. At least one serious AE was reported for 9.4% of the infants in the nirsevimab group and for 10.3% in the control group. None of the serious AEs were considered to be related to nirsevimab treatment.
Interpretation: The nirsevimab acceptance rate for newborns in the maternity unit was high during the first season of implementation. The safety profile was very good, with no significant differences between the nirsevimab group and the control group.
{"title":"Acceptance and safety of the RSV-preventive treatment of newborns with nirsevimab in the maternity department: a prospective longitudinal cohort study in France.","authors":"Charlotte Ocana de Sentuary, Clara Testard, Marion Lagrée, Maxime Leroy, Lisa Gasnier, Alicia Enes-Dias, Constance Leruste, Diariatou Diallo, Michael Génin, Thameur Rakza, François Dubos","doi":"10.1016/j.eclinm.2024.102986","DOIUrl":"10.1016/j.eclinm.2024.102986","url":null,"abstract":"<p><strong>Background: </strong>To evaluate the acceptance and safety of the treatment of newborns with nirsevimab (a long-acting monoclonal antibody designed to prevent respiratory syncytial virus infections) during the first season of implementation.</p><p><strong>Methods: </strong>A longitudinal, prospective, single-centre cohort study was conducted from September 18th, 2023, to January 23rd, 2024 at Lille University Hospital (Lille, France). All newborns admitted to the hospital's maternity department during the study period and whose parents agreed to participate in the study were included. Parents were asked to state whether or not they agreed for their infant to receive nirsevimab. The occurrence of adverse events (AEs) 2 h after nirsevimab treatment and 7, 14 and 30 days after discharge was documented by the mother. The primary endpoint was the nirsevimab treatment acceptance rate. The secondary endpoints were the variables associated with the acceptance of nirsevimab, the reasons for accepting or refusing nirsevimab, and the treatment's real-life safety, relative to a non-treated control group of newborns.</p><p><strong>Findings: </strong>Of the 1730 infants born in the hospital during the study period, 477 met all the inclusion criteria and were enrolled. The nirsevimab acceptance rate [95% confidence interval] was 91.6% [89.1%-94.2%]. In a multivariable analysis, the mother's age, lower parity and having a partner in work were significantly associated with nirsevimab acceptance. The most common reason for accepting treatment was \"to protect my baby\", and the most common reason for refusing treatment was the lack of long-term data on nirsevimab. The nirsevimab and control groups did not differ significantly in terms of the types and frequencies of AEs. At least one serious AE was reported for 9.4% of the infants in the nirsevimab group and for 10.3% in the control group. None of the serious AEs were considered to be related to nirsevimab treatment.</p><p><strong>Interpretation: </strong>The nirsevimab acceptance rate for newborns in the maternity unit was high during the first season of implementation. The safety profile was very good, with no significant differences between the nirsevimab group and the control group.</p><p><strong>Funding: </strong>None.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102986"},"PeriodicalIF":9.6,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11669793/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142893009","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}
<p><strong>Background: </strong>Prior studies suggest prevalence of heart failure (HF) has remained steady or progressively decreased over past 30 years in the general population. Whether this favourable trend occurred in adolescents and young adults aged 10-24 years has yet to be elucidated. We aim to identify the trends in the burden of HF in this young population from 1990 to 2021 to inform areas for targeted intervention and prevention efforts.</p><p><strong>Methods: </strong>We analyzed data from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2021. The case number and rates per 100,000 population of prevalence and years lived with disability (YLDs) of HF at the global, regional, and national level in the population aged 10-24 years from 1990 to 2021 were reported. In addition, the HF trends by age, sex, and socio-demographic index (SDI) were analyzed. Furthermore, we calculated the average annual percentage changes (AAPC) and identified the year with the most pronounced changes in the trends with the joinpoint regression analysis. In detail, we divided the study population into three age groups: 10-14 years old, 15-19 years old, and 20-24 years old. We also employed the Bayesian age-period-cohort models (BAPC) to predict the future burden of HF up to 2030.</p><p><strong>Findings: </strong>Globally, the prevalence and YLDs rates of HF among adolescents and young adults in 2021 were 148.1 (95% uncertainty interval [UI]: 118.8-185.7) and 14.4 (9.2-21.2) per 100 000 population, increased from 125.5 (100.0-157.7) and 12.2 (7.8-17.8) in 1990 respectively. Noticeable changes in HF prevalence were found in 1994, 2001, 2004, 2010, and 2018. Regionally, East Asia had the most pronounced increase in HF prevalence rate (AAPC = 1.35 [1.28-1.43]) and YLDs rate (AAPC = 1.32 [1.27-1.38]), while the highest HF prevalence rates per 100,000 population were observed in High-income North America (232 [185.4-292]). The prevalence and YLDs of HF increased in most countries except Australia, Canada, and Spain. The largest increase in HF prevalence rate was observed in China (AAPC = 1.39 [1.31-1.48]). By SDI quintile, the middle-SDI quintile countries had the largest increase in prevalence and YLDs rates. By sex, males had a higher prevalence rate per 100,000 population than females (158.0 [95% UI: 126.7-198.9] vs 137.6 [95% UI: 110.0-172.2]) in 2021. Among three age groups, the largest increase in HF prevalence from 1990 to 2021 was found in individuals aged 20-24 years (AAPC = 0.61 [0.6-0.61]). Among all causes of HF, cardiomyopathy and myocarditis accounted for the highest proportion (32.7%) of prevalence cases of HF in 2021, followed by congenital birth defects (27.3%), and rheumatic heart disease (23.8%). The BAPC analysis predicted that the cases of HF prevalence and YLDs would show a rising trend from 2022 to 2030.</p><p><strong>Interpretation: </strong>The burden of HF in adolescents and young adults aged 10-24 years was still increasi
{"title":"Global, regional, and national burdens of heart failure in adolescents and young adults aged 10-24 years from 1990 to 2021: an analysis of data from the Global Burden of Disease Study 2021.","authors":"Chengzhi Yang, Yuhe Jia, Changlin Zhang, Zening Jin, Yue Ma, Xuanye Bi, Aiju Tian","doi":"10.1016/j.eclinm.2024.102998","DOIUrl":"10.1016/j.eclinm.2024.102998","url":null,"abstract":"<p><strong>Background: </strong>Prior studies suggest prevalence of heart failure (HF) has remained steady or progressively decreased over past 30 years in the general population. Whether this favourable trend occurred in adolescents and young adults aged 10-24 years has yet to be elucidated. We aim to identify the trends in the burden of HF in this young population from 1990 to 2021 to inform areas for targeted intervention and prevention efforts.</p><p><strong>Methods: </strong>We analyzed data from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2021. The case number and rates per 100,000 population of prevalence and years lived with disability (YLDs) of HF at the global, regional, and national level in the population aged 10-24 years from 1990 to 2021 were reported. In addition, the HF trends by age, sex, and socio-demographic index (SDI) were analyzed. Furthermore, we calculated the average annual percentage changes (AAPC) and identified the year with the most pronounced changes in the trends with the joinpoint regression analysis. In detail, we divided the study population into three age groups: 10-14 years old, 15-19 years old, and 20-24 years old. We also employed the Bayesian age-period-cohort models (BAPC) to predict the future burden of HF up to 2030.</p><p><strong>Findings: </strong>Globally, the prevalence and YLDs rates of HF among adolescents and young adults in 2021 were 148.1 (95% uncertainty interval [UI]: 118.8-185.7) and 14.4 (9.2-21.2) per 100 000 population, increased from 125.5 (100.0-157.7) and 12.2 (7.8-17.8) in 1990 respectively. Noticeable changes in HF prevalence were found in 1994, 2001, 2004, 2010, and 2018. Regionally, East Asia had the most pronounced increase in HF prevalence rate (AAPC = 1.35 [1.28-1.43]) and YLDs rate (AAPC = 1.32 [1.27-1.38]), while the highest HF prevalence rates per 100,000 population were observed in High-income North America (232 [185.4-292]). The prevalence and YLDs of HF increased in most countries except Australia, Canada, and Spain. The largest increase in HF prevalence rate was observed in China (AAPC = 1.39 [1.31-1.48]). By SDI quintile, the middle-SDI quintile countries had the largest increase in prevalence and YLDs rates. By sex, males had a higher prevalence rate per 100,000 population than females (158.0 [95% UI: 126.7-198.9] vs 137.6 [95% UI: 110.0-172.2]) in 2021. Among three age groups, the largest increase in HF prevalence from 1990 to 2021 was found in individuals aged 20-24 years (AAPC = 0.61 [0.6-0.61]). Among all causes of HF, cardiomyopathy and myocarditis accounted for the highest proportion (32.7%) of prevalence cases of HF in 2021, followed by congenital birth defects (27.3%), and rheumatic heart disease (23.8%). The BAPC analysis predicted that the cases of HF prevalence and YLDs would show a rising trend from 2022 to 2030.</p><p><strong>Interpretation: </strong>The burden of HF in adolescents and young adults aged 10-24 years was still increasi","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102998"},"PeriodicalIF":9.6,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11683260/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142906728","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}
Pub Date : 2024-12-07eCollection Date: 2025-01-01DOI: 10.1016/j.eclinm.2024.102999
Jiayidaer Huan, Minghong Yao, Yu Ma, Fan Mei, Yanmei Liu, Lu Ma, Xiaochao Luo, Jiali Liu, Jianguo Xu, Chao You, Hunong Xiang, Kang Zou, Xiao Liang, Xin Hu, Ling Li, Xin Sun
<p><strong>Background: </strong>Surgical interventions for spontaneous supratentorial intracerebral haemorrhage (ICH) include conventional craniotomy (CC), decompressive craniectomy (DC), and minimally invasive surgery (MIS), with the latter encompassing endoscopic surgery (ES) and minimally invasive puncture surgery (MIPS). However, the superiority of surgery over conservative medical treatment (CMT) and the comparative benefits of different surgical procedures remain unclear. We aimed to evaluate the efficacy and safety of various surgical interventions for treating ICH.</p><p><strong>Methods: </strong>In this systematic review and network meta-analysis, we searched PubMed, Cochrane Central Register of Controlled Trials, Embase, and ClinicalTrials.gov from inception to June 16, 2024. Eligible studies were randomised controlled trials (RCTs) comparing surgery (i.e., CC, ES, MIPS, or DC) with CMT or comparing different types of surgeries in patients with spontaneous supratentorial ICH. Paired reviewers independently screened citations, assessed the risk of bias of included trials, and extracted data. Primary outcomes were good functional outcome and mortality at 6 months. Secondary outcomes were good functional outcome and mortality at different follow-up times, complications (rebleeding, brain infection, pulmonary infection), and hematoma evacuation rate. The frequentist pairwise and network meta-analysis (NMA) were performed. The GRADE approach was used to evaluate the certainty of evidence. This study is registered with PROSPERO, CRD42024518961.</p><p><strong>Findings: </strong>Of the 8573 total records identified by our searches, 31 studies (6448 patients) were eligible for the systematic review and network analysis. Compared with CMT, moderate certainty evidence showed that surgery improved good functional outcome (risk ratio [RR] 1.31, 95% CI 1.13-1.52; risk difference [RD] 9.1%, 95% CI 3.8 to 15.3; <i>I</i> <sup><i>2</i></sup> = 36%) and reduced mortality (RR 0.82, 95% CI 0.71-0.95; RD -5.1%, 95% CI -8.2 to -1.4; <i>I</i> <sup><i>2</i></sup> = 14%). Moderate certainty evidence from NMA suggested that compared with CMT, both ES (RR 1.51, 95% CI 1.18-1.93; RD 9.4%, 95% CI 3.3-17.1) and MIPS (RR 1.48, 95% CI 1.24-1.76; RD 15.7%, 95% CI 7.9-24.9) improved good functional outcome at 6 months, and both ES (RR 0.66, 95% CI 0.52-0.85; RD -17.0%, 95% CI -24.0 to -7.5) and CC (RR 0.75, 95% CI 0.60-0.94; RD -6.3%, 95% CI -10.1 to -1.5) reduced mortality at 6 months, whereas MIPS and DC showed a trend, although not statistically significant, towards a reduction in mortality. ES and MIPS also reduced pulmonary infection risk (ES RR 0.39, 95% CI 0.23-0.69; MIPS RR 0.35, 95% CI 0.20-0.60; RD -5.3%, 95% CI -6.6 to -3.3). ES showed higher hematoma evacuation than CC (MD: 7.03, 95% CI: 3.42-10.65; <i>I</i> <sup><i>2</i></sup> = 94%). No difference in rebleeding or brain infection was found between CC and MIS.</p><p><strong>Interpretation: </strong>Curren
背景：自发性幕上脑出血（ICH）的手术干预包括常规开颅术（CC）、减压术（DC）和微创手术（MIS），后者包括内窥镜手术（ES）和微创穿刺手术（MIPS）。然而，手术优于保守医学治疗（CMT）的优势和不同手术方法的比较效益仍不清楚。我们的目的是评估各种手术干预治疗脑出血的有效性和安全性。方法：在本系统综述和网络荟萃分析中，我们检索了PubMed、Cochrane中央对照试验注册库、Embase和ClinicalTrials.gov，检索时间从成立到2024年6月16日。符合条件的研究是比较手术（即CC、ES、MIPS或DC）与CMT或比较自发性幕上脑出血患者不同类型手术的随机对照试验（RCTs）。配对审稿人独立筛选引文，评估纳入试验的偏倚风险，并提取数据。主要结局是良好的功能结局和6个月死亡率。次要结局是良好的功能结局和不同随访时间的死亡率、并发症（再出血、脑感染、肺部感染）和血肿排出率。进行频率配对分析和网络元分析（NMA）。GRADE方法用于评估证据的确定性。本研究已注册为PROSPERO， CRD42024518961。结果：在我们检索到的8573条记录中，31项研究（6448例患者）符合系统评价和网络分析的要求。与CMT相比，中度确定性证据显示手术改善了良好的功能结果(风险比[RR] 1.31, 95% CI 1.13-1.52；风险差异[RD] 9.1%, 95% CI 3.8 ~ 15.3；i2 = 36%)和降低死亡率(RR 0.82, 95% CI 0.71-0.95；RD -5.1%, 95% CI -8.2 ~ -1.4；i2 = 14%)。来自NMA的中等确定性证据表明，与CMT相比，ES (RR 1.51, 95% CI 1.18-1.93；RD 9.4%, 95% CI 3.3-17.1)和MIPS (RR 1.48, 95% CI 1.24-1.76；RD 15.7%, 95% CI 7.9-24.9)改善了6个月时良好的功能结局，两种ES (RR 0.66, 95% CI 0.52-0.85；RD -17.0%, 95%可信区间-24.0到-7.5)和CC(相对危险度0.75,95%可信区间0.60 - -0.94;RD （-6.3%, 95% CI -10.1至-1.5）降低了6个月时的死亡率，而MIPS和DC显示了死亡率降低的趋势，尽管没有统计学意义。ES和MIPS也降低了肺部感染的风险(ES RR 0.39, 95% CI 0.23-0.69；MIPS rr 0.35, 95% ci 0.20-0.60；RD -5.3%, 95% CI -6.6至-3.3)。ES显示血肿排出量高于CC (MD: 7.03, 95% CI: 3.42-10.65；i2 = 94%)。CC和MIS在再出血和脑感染方面没有差异。解释：目前的中等确定性证据表明，自发性幕上脑出血的手术干预可能与改善功能结局和降低6个月死亡风险有关。当使用包括ES和MIPS在内的MIS时，手术血肿去除的优势尤为明显。ES可以改善功能预后，降低死亡和肺部感染的风险，血肿排出率高，提示其可能是最佳的手术治疗方法。资助项目：国家自然科学基金、国家杰出青年科学基金、中央公益性科研院所基本科研业务费、四川大学华西医院1·3·5优秀学科项目。
{"title":"Surgical interventions for spontaneous supratentorial intracerebral haemorrhage: a systematic review and network meta-analysis.","authors":"Jiayidaer Huan, Minghong Yao, Yu Ma, Fan Mei, Yanmei Liu, Lu Ma, Xiaochao Luo, Jiali Liu, Jianguo Xu, Chao You, Hunong Xiang, Kang Zou, Xiao Liang, Xin Hu, Ling Li, Xin Sun","doi":"10.1016/j.eclinm.2024.102999","DOIUrl":"10.1016/j.eclinm.2024.102999","url":null,"abstract":"<p><strong>Background: </strong>Surgical interventions for spontaneous supratentorial intracerebral haemorrhage (ICH) include conventional craniotomy (CC), decompressive craniectomy (DC), and minimally invasive surgery (MIS), with the latter encompassing endoscopic surgery (ES) and minimally invasive puncture surgery (MIPS). However, the superiority of surgery over conservative medical treatment (CMT) and the comparative benefits of different surgical procedures remain unclear. We aimed to evaluate the efficacy and safety of various surgical interventions for treating ICH.</p><p><strong>Methods: </strong>In this systematic review and network meta-analysis, we searched PubMed, Cochrane Central Register of Controlled Trials, Embase, and ClinicalTrials.gov from inception to June 16, 2024. Eligible studies were randomised controlled trials (RCTs) comparing surgery (i.e., CC, ES, MIPS, or DC) with CMT or comparing different types of surgeries in patients with spontaneous supratentorial ICH. Paired reviewers independently screened citations, assessed the risk of bias of included trials, and extracted data. Primary outcomes were good functional outcome and mortality at 6 months. Secondary outcomes were good functional outcome and mortality at different follow-up times, complications (rebleeding, brain infection, pulmonary infection), and hematoma evacuation rate. The frequentist pairwise and network meta-analysis (NMA) were performed. The GRADE approach was used to evaluate the certainty of evidence. This study is registered with PROSPERO, CRD42024518961.</p><p><strong>Findings: </strong>Of the 8573 total records identified by our searches, 31 studies (6448 patients) were eligible for the systematic review and network analysis. Compared with CMT, moderate certainty evidence showed that surgery improved good functional outcome (risk ratio [RR] 1.31, 95% CI 1.13-1.52; risk difference [RD] 9.1%, 95% CI 3.8 to 15.3; <i>I</i> <sup><i>2</i></sup> = 36%) and reduced mortality (RR 0.82, 95% CI 0.71-0.95; RD -5.1%, 95% CI -8.2 to -1.4; <i>I</i> <sup><i>2</i></sup> = 14%). Moderate certainty evidence from NMA suggested that compared with CMT, both ES (RR 1.51, 95% CI 1.18-1.93; RD 9.4%, 95% CI 3.3-17.1) and MIPS (RR 1.48, 95% CI 1.24-1.76; RD 15.7%, 95% CI 7.9-24.9) improved good functional outcome at 6 months, and both ES (RR 0.66, 95% CI 0.52-0.85; RD -17.0%, 95% CI -24.0 to -7.5) and CC (RR 0.75, 95% CI 0.60-0.94; RD -6.3%, 95% CI -10.1 to -1.5) reduced mortality at 6 months, whereas MIPS and DC showed a trend, although not statistically significant, towards a reduction in mortality. ES and MIPS also reduced pulmonary infection risk (ES RR 0.39, 95% CI 0.23-0.69; MIPS RR 0.35, 95% CI 0.20-0.60; RD -5.3%, 95% CI -6.6 to -3.3). ES showed higher hematoma evacuation than CC (MD: 7.03, 95% CI: 3.42-10.65; <i>I</i> <sup><i>2</i></sup> = 94%). No difference in rebleeding or brain infection was found between CC and MIS.</p><p><strong>Interpretation: </strong>Curren","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102999"},"PeriodicalIF":9.6,"publicationDate":"2024-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11667076/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142884790","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}
Pub Date : 2024-12-07eCollection Date: 2025-01-01DOI: 10.1016/j.eclinm.2024.102997
Xiangyang Yu, Chujian Huang, Longde Du, Chunguang Wang, Yikun Yang, Xin Yu, Shengcheng Lin, Chenglin Yang, Hongbo Zhao, Songhua Cai, Zhe Wang, Lixu Wang, Xiaotong Guo, Baihua Zhang, Zhentao Yu, Jie He, Kai Ma
<p><strong>Background: </strong>The absolute overall survival (OS) improvement with preoperative chemotherapy or chemoradiotherapy in locally advanced non-small cell lung cancer (NSCLC) patients is controversial and unsatisfactory. We designed this trial to explore the efficacy and safety of perioperative sintilimab plus platinum-based chemotherapy for potentially resectable stage IIIB NSCLC to facilitate further optimization of this therapeutic strategy.</p><p><strong>Methods: </strong>Patients diagnosed with stage IIIB NSCLC through invasive staging approaches and/or PET/CT scans and evaluated as having a high probability of radical resection of the primary lesion and metastatic lymph nodes with clear pathological margins by a multidisciplinary team were enrolled in this open-label, single-arm, phase II trial at a single centre in China. The participants received two cycles of intravenous neoadjuvant treatment with PD-1 inhibitor sintilimab (200 mg), pemetrexed (500 mg/m<sup>2</sup>) for adenocarcinoma, paclitaxel (175 mg/m<sup>2</sup>) or nab-paclitaxel (260 mg/m<sup>2</sup>) for other histological subtypes, plus carboplatin (area under the curve 5) or cisplatin (75 mg/m<sup>2</sup>) on the first day of each 3-week cycle. Surgical resection was performed 28-42 days later. After recovery from surgery, two cycles of adjuvant treatment were carried out in strict conformity with the neoadjuvant regimen, and then sintilimab maintenance monotherapy were given. The primary endpoint was major pathological response (MPR). The key secondary endpoints included the objective response rate (ORR), radical resection (R0) rate, pathological complete response (pCR) rate, event-free survival (EFS), disease-free survival (DFS), OS, treatment-related adverse events (TRAEs), surgical complications, and surgery delay rate. This trial is registered with the Chinese Clinical Trial Registry (ChiCTR2000040673).</p><p><strong>Findings: </strong>Forty-one patients were assessed for eligibility between December 2020 and August 2022; 30 patients were enrolled and given two cycles of neoadjuvant chemoimmunotherapy (neoCIT). Nineteen patients achieved a radiographic partial response, resulting in an ORR of 63.3%. Although 26 patients (86.7%) experienced TRAEs during the neoadjuvant phase, only two patients (6.7%) had ≥ grade 3 TRAEs. Surgical resection was performed on 27 patients (90%), with two patients experienced surgical delay because of coronavirus disease 2019, and the R0 rate was 96.4%. Twelve patients (44.4%) in the per-protocol (PP) population achieved an MPR, including six patients (22.2%) with a pCR. The most common postoperative complications were atrial fibrillation (6, 22.2%), pneumonitis (5, 18.5%), and heart failure (4, 14.8%); no deaths occurred within 90 days after surgery. As of October 31, 2024, the median follow-up was 34.7 months. The estimated EFS and OS rates at 36 months in the intention-to-treat population were 42.8% and 70.1%, respectively, and th
{"title":"Efficacy and safety of perioperative sintilimab plus platinum-based chemotherapy for potentially resectable stage IIIB non-small cell lung cancer (periSCOPE): an open-label, single-arm, phase II trial.","authors":"Xiangyang Yu, Chujian Huang, Longde Du, Chunguang Wang, Yikun Yang, Xin Yu, Shengcheng Lin, Chenglin Yang, Hongbo Zhao, Songhua Cai, Zhe Wang, Lixu Wang, Xiaotong Guo, Baihua Zhang, Zhentao Yu, Jie He, Kai Ma","doi":"10.1016/j.eclinm.2024.102997","DOIUrl":"10.1016/j.eclinm.2024.102997","url":null,"abstract":"<p><strong>Background: </strong>The absolute overall survival (OS) improvement with preoperative chemotherapy or chemoradiotherapy in locally advanced non-small cell lung cancer (NSCLC) patients is controversial and unsatisfactory. We designed this trial to explore the efficacy and safety of perioperative sintilimab plus platinum-based chemotherapy for potentially resectable stage IIIB NSCLC to facilitate further optimization of this therapeutic strategy.</p><p><strong>Methods: </strong>Patients diagnosed with stage IIIB NSCLC through invasive staging approaches and/or PET/CT scans and evaluated as having a high probability of radical resection of the primary lesion and metastatic lymph nodes with clear pathological margins by a multidisciplinary team were enrolled in this open-label, single-arm, phase II trial at a single centre in China. The participants received two cycles of intravenous neoadjuvant treatment with PD-1 inhibitor sintilimab (200 mg), pemetrexed (500 mg/m<sup>2</sup>) for adenocarcinoma, paclitaxel (175 mg/m<sup>2</sup>) or nab-paclitaxel (260 mg/m<sup>2</sup>) for other histological subtypes, plus carboplatin (area under the curve 5) or cisplatin (75 mg/m<sup>2</sup>) on the first day of each 3-week cycle. Surgical resection was performed 28-42 days later. After recovery from surgery, two cycles of adjuvant treatment were carried out in strict conformity with the neoadjuvant regimen, and then sintilimab maintenance monotherapy were given. The primary endpoint was major pathological response (MPR). The key secondary endpoints included the objective response rate (ORR), radical resection (R0) rate, pathological complete response (pCR) rate, event-free survival (EFS), disease-free survival (DFS), OS, treatment-related adverse events (TRAEs), surgical complications, and surgery delay rate. This trial is registered with the Chinese Clinical Trial Registry (ChiCTR2000040673).</p><p><strong>Findings: </strong>Forty-one patients were assessed for eligibility between December 2020 and August 2022; 30 patients were enrolled and given two cycles of neoadjuvant chemoimmunotherapy (neoCIT). Nineteen patients achieved a radiographic partial response, resulting in an ORR of 63.3%. Although 26 patients (86.7%) experienced TRAEs during the neoadjuvant phase, only two patients (6.7%) had ≥ grade 3 TRAEs. Surgical resection was performed on 27 patients (90%), with two patients experienced surgical delay because of coronavirus disease 2019, and the R0 rate was 96.4%. Twelve patients (44.4%) in the per-protocol (PP) population achieved an MPR, including six patients (22.2%) with a pCR. The most common postoperative complications were atrial fibrillation (6, 22.2%), pneumonitis (5, 18.5%), and heart failure (4, 14.8%); no deaths occurred within 90 days after surgery. As of October 31, 2024, the median follow-up was 34.7 months. The estimated EFS and OS rates at 36 months in the intention-to-treat population were 42.8% and 70.1%, respectively, and th","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102997"},"PeriodicalIF":9.6,"publicationDate":"2024-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11667015/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885185","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}
Pub Date : 2024-12-06eCollection Date: 2025-01-01DOI: 10.1016/j.eclinm.2024.102971
Ruijie Xie, Christian Herder, Sha Sha, Lei Peng, Hermann Brenner, Ben Schöttker
<p><strong>Background: </strong>We aimed to evaluate the incremental predictive value of metabolomic biomarkers for assessing the 10-year risk of type 2 diabetes when added to the clinical Cambridge Diabetes Risk Score (CDRS).</p><p><strong>Methods: </strong>We utilized 86,232 UK Biobank (UKB) participants (recruited between 13 March 2006 and 1 October 2010) for model derivation and internal validation. Additionally, we included 4383 participants from the German ESTHER cohort (recruited between 1 July 2000 and 30 June 2002 for external validation). Participants were followed up for 10 years to assess the incidence of type 2 diabetes. A total of 249 NMR-derived metabolites were quantified using nuclear magnetic resonance (NMR) spectroscopy. Metabolites were selected with LASSO regression and model performance was evaluated with Harrell's C-index.</p><p><strong>Findings: </strong>11 metabolomic biomarkers, including glycolysis related metabolites, ketone bodies, amino acids, and lipids, were selected. In internal validation within the UKB, adding these metabolites significantly increased the C-index (95% confidence interval (95% CI)) of the clinical CDRS from 0.815 (0.800, 0.829) to 0.834 (0.820, 0.847) and the continuous net reclassification index (NRI) with 95% CI was 39.8% (34.6%, 45.0%). External validation in the ESTHER cohort showed a comparable statistically significant C-index increase from 0.770 (0.750, 0.791) to 0.798 (0.779, 0.817) and a continuous NRI of 33.8% (26.4%, 41.2%). A concise model with 4 instead of 11 metabolites yielded similar results.</p><p><strong>Interpretation: </strong>Adding 11 metabolites to the clinical CDRS led to a novel type 2 diabetes prediction model, we called UK Biobank Diabetes Risk Score (UKB-DRS), substantially outperformed the clinical CDRS. The concise version with 4 metabolites performed comparably. As only very few clinical information and a blood sample are needed for the UKB-DRS, and as high-throughput NMR metabolomics are becoming increasingly available at low costs, these models have considerable potential for routine clinical application in diabetes risk assessment.</p><p><strong>Funding: </strong>The ESTHER study was funded by grants from the Baden-Württemberg state Ministry of Science, Research and Arts (Stuttgart, Germany), the Federal Ministry of Education and Research (Berlin, Germany), the Federal Ministry of Family Affairs, Senior Citizens, Women and Youth (Berlin, Germany), and the Saarland State Ministry of Health, Social Affairs, Women and the Family (Saarbrücken, Germany). The UK Biobank project was established through collaboration between various entities including the Wellcome Trust, the Medical Research Council, Department of Health, Scottish Government, and the Northwest Regional Development Agency. Additional funding was provided by the Welsh Assembly Government, British Heart Foundation, Cancer Research UK, and Diabetes UK, with support from the National Health Service (NHS). The
{"title":"Novel type 2 diabetes prediction score based on traditional risk factors and circulating metabolites: model derivation and validation in two large cohort studies.","authors":"Ruijie Xie, Christian Herder, Sha Sha, Lei Peng, Hermann Brenner, Ben Schöttker","doi":"10.1016/j.eclinm.2024.102971","DOIUrl":"10.1016/j.eclinm.2024.102971","url":null,"abstract":"<p><strong>Background: </strong>We aimed to evaluate the incremental predictive value of metabolomic biomarkers for assessing the 10-year risk of type 2 diabetes when added to the clinical Cambridge Diabetes Risk Score (CDRS).</p><p><strong>Methods: </strong>We utilized 86,232 UK Biobank (UKB) participants (recruited between 13 March 2006 and 1 October 2010) for model derivation and internal validation. Additionally, we included 4383 participants from the German ESTHER cohort (recruited between 1 July 2000 and 30 June 2002 for external validation). Participants were followed up for 10 years to assess the incidence of type 2 diabetes. A total of 249 NMR-derived metabolites were quantified using nuclear magnetic resonance (NMR) spectroscopy. Metabolites were selected with LASSO regression and model performance was evaluated with Harrell's C-index.</p><p><strong>Findings: </strong>11 metabolomic biomarkers, including glycolysis related metabolites, ketone bodies, amino acids, and lipids, were selected. In internal validation within the UKB, adding these metabolites significantly increased the C-index (95% confidence interval (95% CI)) of the clinical CDRS from 0.815 (0.800, 0.829) to 0.834 (0.820, 0.847) and the continuous net reclassification index (NRI) with 95% CI was 39.8% (34.6%, 45.0%). External validation in the ESTHER cohort showed a comparable statistically significant C-index increase from 0.770 (0.750, 0.791) to 0.798 (0.779, 0.817) and a continuous NRI of 33.8% (26.4%, 41.2%). A concise model with 4 instead of 11 metabolites yielded similar results.</p><p><strong>Interpretation: </strong>Adding 11 metabolites to the clinical CDRS led to a novel type 2 diabetes prediction model, we called UK Biobank Diabetes Risk Score (UKB-DRS), substantially outperformed the clinical CDRS. The concise version with 4 metabolites performed comparably. As only very few clinical information and a blood sample are needed for the UKB-DRS, and as high-throughput NMR metabolomics are becoming increasingly available at low costs, these models have considerable potential for routine clinical application in diabetes risk assessment.</p><p><strong>Funding: </strong>The ESTHER study was funded by grants from the Baden-Württemberg state Ministry of Science, Research and Arts (Stuttgart, Germany), the Federal Ministry of Education and Research (Berlin, Germany), the Federal Ministry of Family Affairs, Senior Citizens, Women and Youth (Berlin, Germany), and the Saarland State Ministry of Health, Social Affairs, Women and the Family (Saarbrücken, Germany). The UK Biobank project was established through collaboration between various entities including the Wellcome Trust, the Medical Research Council, Department of Health, Scottish Government, and the Northwest Regional Development Agency. Additional funding was provided by the Welsh Assembly Government, British Heart Foundation, Cancer Research UK, and Diabetes UK, with support from the National Health Service (NHS). The","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102971"},"PeriodicalIF":9.6,"publicationDate":"2024-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11667638/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885391","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}
Background: Ovarian cancer (OC) is a heterogeneous malignancy with multiple histological subtypes, showing global variability in incidence. Temporal changes in diagnostic criteria and risk factors might influence the incidence and distribution of OC and its subtypes.
Methods: This study analyzed incidence patterns (2013-2017) and trends (1988-1992 to 2013-2017) of OC and its subtypes across 65 and 40 countries, respectively. Data were extracted from the Cancer Incidence in Five Continents (CI5 Ⅻ) and CI5plus databases (accessed in June 2024). Annual percent changes were computed to describe trends in age-standardized rates (ASRs) of OC and its subtypes. Proportions of ASR for each subtype relative to the ASR of OC for individual countries were calculated.
Findings: The incidence of OC displayed marked disparities across regions and Human Development Index (HDI), with the highest ASRs in Eastern and Central Europe and very high HDI regions, and the lowest in Africa, Asia, and medium HDI regions. Despite stable trend in ASRs of OC globally, notable declines were observed in Europe, America, and Oceania, in contrast to increases in Asian countries like Japan and South Korea. Globally, serous carcinomas remained the most prevalent subtype. European countries exhibited a higher proportion of serous carcinomas, while Asian countries had a higher proportion of endometrioid and clear cell carcinomas. Although trends in subtypes also remained stable, ASRs increased over time for serous carcinomas and germ cell tumor in most countries, while mucinous carcinomas and adenocarcinoma NOS showed a decline.
Interpretation: Variations in global patterns and trends in OC incidence and its subtypes might be influenced by genetic and reproductive factors. Consequently, region-specific prevention strategies and ongoing surveillance are essential to mitigate the burden of OC.
Funding: The National Key Research and Development Program of China (No.2022YFC2704205), the Natural Science Foundation of China (No.82073647, 82373674, and 82103914), Outstanding Scientific Fund of Shengjing Hospital, 345 Talent Project of Shengjing Hospital of China Medical University, the Max Planck - University of Helsinki Center from the Jane and Aatos Erkko Foundation (No.210046), the Max Planck Society (No.5714240218), the University of Helsinki (No.77204227), and the European Union (ERC Synergy, BIOSFER, 101071773).
{"title":"Worldwide patterns and trends in ovarian cancer incidence by histological subtype: a population-based analysis from 1988 to 2017.","authors":"Yi-Fan Wei, Li Ning, Yi-Lin Xu, Jing Ma, Dong-Run Li, Zan-Fei Feng, Fang-Hua Liu, Yi-Zi Li, He-Li Xu, Peng Li, Yong-Pei Yu, Dong-Hui Huang, Xiao-Ying Li, Song Gao, Chun-Qing Lin, Ting-Ting Gong, Qi-Jun Wu, Jing-He Lang","doi":"10.1016/j.eclinm.2024.102983","DOIUrl":"10.1016/j.eclinm.2024.102983","url":null,"abstract":"<p><strong>Background: </strong>Ovarian cancer (OC) is a heterogeneous malignancy with multiple histological subtypes, showing global variability in incidence. Temporal changes in diagnostic criteria and risk factors might influence the incidence and distribution of OC and its subtypes.</p><p><strong>Methods: </strong>This study analyzed incidence patterns (2013-2017) and trends (1988-1992 to 2013-2017) of OC and its subtypes across 65 and 40 countries, respectively. Data were extracted from the Cancer Incidence in Five Continents (CI5 Ⅻ) and CI5plus databases (accessed in June 2024). Annual percent changes were computed to describe trends in age-standardized rates (ASRs) of OC and its subtypes. Proportions of ASR for each subtype relative to the ASR of OC for individual countries were calculated.</p><p><strong>Findings: </strong>The incidence of OC displayed marked disparities across regions and Human Development Index (HDI), with the highest ASRs in Eastern and Central Europe and very high HDI regions, and the lowest in Africa, Asia, and medium HDI regions. Despite stable trend in ASRs of OC globally, notable declines were observed in Europe, America, and Oceania, in contrast to increases in Asian countries like Japan and South Korea. Globally, serous carcinomas remained the most prevalent subtype. European countries exhibited a higher proportion of serous carcinomas, while Asian countries had a higher proportion of endometrioid and clear cell carcinomas. Although trends in subtypes also remained stable, ASRs increased over time for serous carcinomas and germ cell tumor in most countries, while mucinous carcinomas and adenocarcinoma NOS showed a decline.</p><p><strong>Interpretation: </strong>Variations in global patterns and trends in OC incidence and its subtypes might be influenced by genetic and reproductive factors. Consequently, region-specific prevention strategies and ongoing surveillance are essential to mitigate the burden of OC.</p><p><strong>Funding: </strong>The National Key Research and Development Program of China (No.2022YFC2704205), the Natural Science Foundation of China (No.82073647, 82373674, and 82103914), Outstanding Scientific Fund of Shengjing Hospital, 345 Talent Project of Shengjing Hospital of China Medical University, the Max Planck - University of Helsinki Center from the Jane and Aatos Erkko Foundation (No.210046), the Max Planck Society (No.5714240218), the University of Helsinki (No.77204227), and the European Union (ERC Synergy, BIOSFER, 101071773).</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102983"},"PeriodicalIF":9.6,"publicationDate":"2024-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11667631/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885008","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}
Pub Date : 2024-12-06eCollection Date: 2025-01-01DOI: 10.1016/j.eclinm.2024.102968
Tim Schubert, Tim Oosterlinck, Robert D Stevens, Patrick H Maxwell, Mihaela van der Schaar
Rapid advancements in medical AI necessitate targeted educational initiatives for clinicians to ensure AI tools are safe and used effectively to improve patient outcomes. To support decision-making among stakeholders in medical education, we propose three tiers of medical AI expertise and outline the challenges for medical education at different educational stages. Additionally, we offer recommendations and examples, encouraging stakeholders to adapt and shape curricula for their specific healthcare setting using this framework.
{"title":"AI education for clinicians.","authors":"Tim Schubert, Tim Oosterlinck, Robert D Stevens, Patrick H Maxwell, Mihaela van der Schaar","doi":"10.1016/j.eclinm.2024.102968","DOIUrl":"10.1016/j.eclinm.2024.102968","url":null,"abstract":"<p><p>Rapid advancements in medical AI necessitate targeted educational initiatives for clinicians to ensure AI tools are safe and used effectively to improve patient outcomes. To support decision-making among stakeholders in medical education, we propose three tiers of medical AI expertise and outline the challenges for medical education at different educational stages. Additionally, we offer recommendations and examples, encouraging stakeholders to adapt and shape curricula for their specific healthcare setting using this framework.</p>","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102968"},"PeriodicalIF":9.6,"publicationDate":"2024-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11667627/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885207","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}
Pub Date : 2024-12-06eCollection Date: 2025-01-01DOI: 10.1016/j.eclinm.2024.102962
Qiong Wu, Bingyu Zhang, Jiayi Tong, L Charles Bailey, H Timothy Bunnell, Jiajie Chen, Elizabeth A Chrischilles, Dimitri A Christakis, Stephen M Downs, Kathryn Hirabayashi, Aaron D Mishkin, Abu S M Mosa, Nathan M Pajor, Suchitra Rao, Hanieh Razzaghi, Hayden T Schwenk, Marion R Sills, Huiyuan Wang, Linbo Wang, Yudong Wang, Dazheng Zhang, Ting Zhou, Ravi Jhaveri, Eric J Tchetgen Tchetgen, Jeffrey S Morris, Christopher B Forrest, Yong Chen
<p><strong>Background: </strong>The impact of pre-infection vaccination on the risk of long COVID remains unclear in the pediatric population. We aim to assess the effectiveness of BNT162b2 on long COVID risks with various strains of the SARS-CoV-2 virus in children and adolescents, using comparative effectiveness methods. We further explore if such pre-infection vaccination can mitigate the risk of long COVID beyond its established protective benefits against SARS-CoV-2 infection using causal mediation analysis.</p><p><strong>Methods: </strong>We conducted real-world vaccine effectiveness study and mediation analysis using data from twenty health systems in the RECOVER PCORnet electronic health record (EHR) Program. Three independent cohorts were constructed including adolescents (12-20 years) during the Delta phase (July 1-November 30, 2021), children (5-11 years) and adolescents (12-20 years) during the Omicron phase (January 1-November 30, 2022). The intervention is first dose of the BNT162b2 vaccine in comparison with no receipt of COVID-19 vaccine. The outcomes of interest include conclusive or probable diagnosis of long COVID following a documented SARS-CoV-2 infection, and body-system-specific condition clusters of post-acute sequelae of SARS-CoV-2 infection (PASC), such as cardiac, gastrointestinal, musculoskeletal, respiratory, and syndromic categories. The effectiveness was reported as (1-relative risk)∗100 and mediating effects were reported as relative risks.</p><p><strong>Findings: </strong>112,590 adolescents (88,811 vaccinated) were included in the cohort for the analysis against Delta variant, and 188,894 children (101,277 vaccinated), and 84,735 adolescents (37,724 vaccinated) were included for the analysis against Omicron variant. During the Delta period, the estimated effectiveness of the BNT162b2 vaccine against long COVID among adolescents was 95.4% (95% CI: 90.9%-97.7%). During the Omicron phase, the estimated effectiveness against long COVID among children was 60.2% (95% CI: 40.3%-73.5%) and 75.1% (95% CI: 50.4%-87.5%) among adolescents. The direct effect of vaccination, defined as the effect beyond their impact on SARS-CoV-2 infections, was found to be statistically non-significant in all three study cohorts, with estimated relative risk of 1.08 (95% CI: 0.75-1.55) in the Delta study among adolescents, 1.24 (95% CI: 0.92-1.66) among children and 0.91 (95% CI: 0.69-1.19) among adolescents in the Omicron studies. Meanwhile, the estimated indirect effects, which are effects through protecting SARS-CoV-2 infections, were estimated as 0.04 (95% CI: 0.03-0.05) among adolescents during Delta phase, 0.31 (95% CI: 0.23-0.42) among children and 0.21 (95% CI: 0.16-0.27) among adolescents during the Omicron period.</p><p><strong>Interpretation: </strong>Our study suggests that BNT162b2 was effective in reducing risk of long COVID outcomes in children and adolescents during the Delta and Omicron periods. The mediation analysis indicat
{"title":"Real-world effectiveness and causal mediation study of BNT162b2 on long COVID risks in children and adolescents.","authors":"Qiong Wu, Bingyu Zhang, Jiayi Tong, L Charles Bailey, H Timothy Bunnell, Jiajie Chen, Elizabeth A Chrischilles, Dimitri A Christakis, Stephen M Downs, Kathryn Hirabayashi, Aaron D Mishkin, Abu S M Mosa, Nathan M Pajor, Suchitra Rao, Hanieh Razzaghi, Hayden T Schwenk, Marion R Sills, Huiyuan Wang, Linbo Wang, Yudong Wang, Dazheng Zhang, Ting Zhou, Ravi Jhaveri, Eric J Tchetgen Tchetgen, Jeffrey S Morris, Christopher B Forrest, Yong Chen","doi":"10.1016/j.eclinm.2024.102962","DOIUrl":"10.1016/j.eclinm.2024.102962","url":null,"abstract":"<p><strong>Background: </strong>The impact of pre-infection vaccination on the risk of long COVID remains unclear in the pediatric population. We aim to assess the effectiveness of BNT162b2 on long COVID risks with various strains of the SARS-CoV-2 virus in children and adolescents, using comparative effectiveness methods. We further explore if such pre-infection vaccination can mitigate the risk of long COVID beyond its established protective benefits against SARS-CoV-2 infection using causal mediation analysis.</p><p><strong>Methods: </strong>We conducted real-world vaccine effectiveness study and mediation analysis using data from twenty health systems in the RECOVER PCORnet electronic health record (EHR) Program. Three independent cohorts were constructed including adolescents (12-20 years) during the Delta phase (July 1-November 30, 2021), children (5-11 years) and adolescents (12-20 years) during the Omicron phase (January 1-November 30, 2022). The intervention is first dose of the BNT162b2 vaccine in comparison with no receipt of COVID-19 vaccine. The outcomes of interest include conclusive or probable diagnosis of long COVID following a documented SARS-CoV-2 infection, and body-system-specific condition clusters of post-acute sequelae of SARS-CoV-2 infection (PASC), such as cardiac, gastrointestinal, musculoskeletal, respiratory, and syndromic categories. The effectiveness was reported as (1-relative risk)∗100 and mediating effects were reported as relative risks.</p><p><strong>Findings: </strong>112,590 adolescents (88,811 vaccinated) were included in the cohort for the analysis against Delta variant, and 188,894 children (101,277 vaccinated), and 84,735 adolescents (37,724 vaccinated) were included for the analysis against Omicron variant. During the Delta period, the estimated effectiveness of the BNT162b2 vaccine against long COVID among adolescents was 95.4% (95% CI: 90.9%-97.7%). During the Omicron phase, the estimated effectiveness against long COVID among children was 60.2% (95% CI: 40.3%-73.5%) and 75.1% (95% CI: 50.4%-87.5%) among adolescents. The direct effect of vaccination, defined as the effect beyond their impact on SARS-CoV-2 infections, was found to be statistically non-significant in all three study cohorts, with estimated relative risk of 1.08 (95% CI: 0.75-1.55) in the Delta study among adolescents, 1.24 (95% CI: 0.92-1.66) among children and 0.91 (95% CI: 0.69-1.19) among adolescents in the Omicron studies. Meanwhile, the estimated indirect effects, which are effects through protecting SARS-CoV-2 infections, were estimated as 0.04 (95% CI: 0.03-0.05) among adolescents during Delta phase, 0.31 (95% CI: 0.23-0.42) among children and 0.21 (95% CI: 0.16-0.27) among adolescents during the Omicron period.</p><p><strong>Interpretation: </strong>Our study suggests that BNT162b2 was effective in reducing risk of long COVID outcomes in children and adolescents during the Delta and Omicron periods. The mediation analysis indicat","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102962"},"PeriodicalIF":9.6,"publicationDate":"2024-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11667630/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885399","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}
<p><strong>Background: </strong>Depression is a severe mental disorder commonly co-morbid with diabetes, but it remains to elucidate whether depression is associated with the risks of a wide range of vascular complications in people with type 2 diabetes mellitus (T2DM) and whether metabolic biomarkers may mediate this pathway.</p><p><strong>Methods: </strong>We conducted this prospective analysis among the participants of the UK Biobank who were diagnosed with T2DM and free of vascular complications at baseline between March 13, 2006 and September 30, 2010. Major depressive disorder (MDD) was ascertained according to the hospital admission records and self-report of doctor-diagnosed conditions, while the presence of depressive symptoms was assessed using the Patient Health Questionnaire-2. Cox proportional hazards models were performed to estimate the hazard ratios (HRs) and 95% confidence intervals (CIs) of MDD and depressive symptoms with the risks of incident heart failure (HF); total and individual atherosclerotic cardiovascular disease (ASCVD) including coronary artery disease (CAD), ischemic stroke (IS), and peripheral artery disease (PAD); total and individual microvascular complications of diabetic kidney disease (DKD), diabetic retinopathy (DR), and diabetic neuropathy (DN). Mediation analyses were conducted to quantify the potential mediation effects of circulating metabolites (involved in insulin-resistance, lipid profile, liver function, renal function, and inflammation) in the association of MDD with the outcomes.</p><p><strong>Findings: </strong>Of the total 23,856 patients with T2DM in the UK Biobank, 13,706 participants (61% males) were eligible and included in this study. During an average of 13 years of follow-up, 2927 (21.36%) ASCVD, 1070 (7.81%) HF, and 2579 (18.82%) microvascular complications occurred. The adjusted HR (95% CI) for MDD was 1.32 (1.09-1.61) with HF, 1.17 (1.03-1.32) with ASCVD, and 1.29 (1.14-1.46) with microvascular complications, while those for depressive symptoms were 1.47 (1.20-1.79), 1.25 (1.10-1.42) and 1.20 (1.05-1.37), respectively. The HRs ranged from 1.26 (1.09-1.44) to 1.96 (1.57-2.45) for MDD with individual complications and mortality, and from 1.26 (1.08-1.47) to 1.49 (1.16-1.93) for depressive symptoms. Up to 7.8% of adverse complications were attributable to MDD and 3.8% to depressive symptoms. A series of circulating metabolites involving lipid profile, renal function, and inflammation were observed to mediate the associations of MDD with vascular complications. The identified mediators jointly accounted for 7.29%-26.87% of the disparities in incident vascular complications between patients with and without MDD.</p><p><strong>Interpretation: </strong>Our findings highlight the role of MDD and depressive symptoms in the development of vascular complications among people with T2DM, and suggest that the effect of improving mental health on vascular outcomes in patients with T2DM should be invest
{"title":"Association between major depressive disorder or depressive symptoms and the risk of vascular complications among patients with type 2 diabetes, and the mediating role of metabolic biomarkers: an analysis of the UK Biobank cohort.","authors":"Guochen Li, Yongfu Yu, Chunqing Lin, Shichen Zheng, Hong Tu, Wanghong Xu","doi":"10.1016/j.eclinm.2024.102982","DOIUrl":"10.1016/j.eclinm.2024.102982","url":null,"abstract":"<p><strong>Background: </strong>Depression is a severe mental disorder commonly co-morbid with diabetes, but it remains to elucidate whether depression is associated with the risks of a wide range of vascular complications in people with type 2 diabetes mellitus (T2DM) and whether metabolic biomarkers may mediate this pathway.</p><p><strong>Methods: </strong>We conducted this prospective analysis among the participants of the UK Biobank who were diagnosed with T2DM and free of vascular complications at baseline between March 13, 2006 and September 30, 2010. Major depressive disorder (MDD) was ascertained according to the hospital admission records and self-report of doctor-diagnosed conditions, while the presence of depressive symptoms was assessed using the Patient Health Questionnaire-2. Cox proportional hazards models were performed to estimate the hazard ratios (HRs) and 95% confidence intervals (CIs) of MDD and depressive symptoms with the risks of incident heart failure (HF); total and individual atherosclerotic cardiovascular disease (ASCVD) including coronary artery disease (CAD), ischemic stroke (IS), and peripheral artery disease (PAD); total and individual microvascular complications of diabetic kidney disease (DKD), diabetic retinopathy (DR), and diabetic neuropathy (DN). Mediation analyses were conducted to quantify the potential mediation effects of circulating metabolites (involved in insulin-resistance, lipid profile, liver function, renal function, and inflammation) in the association of MDD with the outcomes.</p><p><strong>Findings: </strong>Of the total 23,856 patients with T2DM in the UK Biobank, 13,706 participants (61% males) were eligible and included in this study. During an average of 13 years of follow-up, 2927 (21.36%) ASCVD, 1070 (7.81%) HF, and 2579 (18.82%) microvascular complications occurred. The adjusted HR (95% CI) for MDD was 1.32 (1.09-1.61) with HF, 1.17 (1.03-1.32) with ASCVD, and 1.29 (1.14-1.46) with microvascular complications, while those for depressive symptoms were 1.47 (1.20-1.79), 1.25 (1.10-1.42) and 1.20 (1.05-1.37), respectively. The HRs ranged from 1.26 (1.09-1.44) to 1.96 (1.57-2.45) for MDD with individual complications and mortality, and from 1.26 (1.08-1.47) to 1.49 (1.16-1.93) for depressive symptoms. Up to 7.8% of adverse complications were attributable to MDD and 3.8% to depressive symptoms. A series of circulating metabolites involving lipid profile, renal function, and inflammation were observed to mediate the associations of MDD with vascular complications. The identified mediators jointly accounted for 7.29%-26.87% of the disparities in incident vascular complications between patients with and without MDD.</p><p><strong>Interpretation: </strong>Our findings highlight the role of MDD and depressive symptoms in the development of vascular complications among people with T2DM, and suggest that the effect of improving mental health on vascular outcomes in patients with T2DM should be invest","PeriodicalId":11393,"journal":{"name":"EClinicalMedicine","volume":"79 ","pages":"102982"},"PeriodicalIF":9.6,"publicationDate":"2024-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11665660/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885208","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}
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