Pub Date : 2025-12-01Epub Date: 2025-12-23DOI: 10.1111/jebm.70098
Gordon Guyatt, Luis Enrique Colunga-Lozano
{"title":"Challenges Facing Evidence-Synthesis and Clinical Practice Guidelines, and Their Solutions: Restoring Balance Through Core GRADE.","authors":"Gordon Guyatt, Luis Enrique Colunga-Lozano","doi":"10.1111/jebm.70098","DOIUrl":"10.1111/jebm.70098","url":null,"abstract":"","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":"e70098"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145819664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-12-26DOI: 10.1111/jebm.70099
Ye-Seul Lee, Tae-Hun Kim, Jung-Won Kang, Lin Ang, Jeremy Y Ng, Stephen Birch, Terje Alræk, Lin Yu, Yuting Duan, Zhirui Xu, Myeong Soo Lee
Case reports represent the earliest form of scientific literature to identify and describe adverse events (AEs) associated with medical interventions, and they still represent important educational resources for ensuring the safe practice of such interventions. Although case reports on AEs related to acupuncture continue to be published, detailed information about the acupuncture procedure is often insufficiently reported in these studies, which may introduce an overstatement or exaggeration of the harm of acupuncture. Consequently, these reports fall short of evaluating causality and achieving the educational purpose of preventing future AEs. To help address these limitations, we developed the "REporting guidelines for aCupuncture-related AdverSe Event case reports" (RECASE) based on the CARE (CAse REports) reporting guidelines for case reports using the expert Delphi methodology. This guideline contains essential items for case reports on acupuncture-related AEs. We anticipate that this reporting guideline will encourage greater transparency, fairness, and comprehensiveness in future case reports on acupuncture-related AEs.
{"title":"REporting Guidelines for aCupuncture-Related AdverSe Event Case Reports (RECASE): Elaboration and Explanation.","authors":"Ye-Seul Lee, Tae-Hun Kim, Jung-Won Kang, Lin Ang, Jeremy Y Ng, Stephen Birch, Terje Alræk, Lin Yu, Yuting Duan, Zhirui Xu, Myeong Soo Lee","doi":"10.1111/jebm.70099","DOIUrl":"10.1111/jebm.70099","url":null,"abstract":"<p><p>Case reports represent the earliest form of scientific literature to identify and describe adverse events (AEs) associated with medical interventions, and they still represent important educational resources for ensuring the safe practice of such interventions. Although case reports on AEs related to acupuncture continue to be published, detailed information about the acupuncture procedure is often insufficiently reported in these studies, which may introduce an overstatement or exaggeration of the harm of acupuncture. Consequently, these reports fall short of evaluating causality and achieving the educational purpose of preventing future AEs. To help address these limitations, we developed the \"REporting guidelines for aCupuncture-related AdverSe Event case reports\" (RECASE) based on the CARE (CAse REports) reporting guidelines for case reports using the expert Delphi methodology. This guideline contains essential items for case reports on acupuncture-related AEs. We anticipate that this reporting guideline will encourage greater transparency, fairness, and comprehensiveness in future case reports on acupuncture-related AEs.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":"e70099"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12750481/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145833960","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-10DOI: 10.1111/jebm.70083
Min Chen, RuiRui Wu, Rui Chen, Qiong Guo, Ya Deng, Yuan Wang, Youlin Long
Background: Systematic reviews on acupuncture for obesity report conflicting findings, and the certainty of this evidence remains unclear. This umbrella review appraises the evidence to identify which effects on body mass index (BMI) and body weight (BW) are supported by high-quality findings.
Methods: We conducted an umbrella review by systematically searching PubMed, Embase, and the Cochrane Library through April 28, 2025 to obtain systematic reviews of randomized controlled trials evaluating acupuncture interventions for obesity. Two reviewers independently assessed methodological quality using a measurement tool to assess systematic reviews (AMSTAR) and evidence quality using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). We identified best evidence from high-quality systematic reviews with high or moderate GRADE ratings.
Results: Our analysis included 22 systematic reviews encompassing 60 meta-analyses. Seventeen reviews (77.3%) achieved high methodological quality ratings according to AMSTAR criteria. Five meta-analyses provided high-quality evidence consistently demonstrating significant benefits of acupuncture interventions. The strongest evidence supported acupuncture combined with lifestyle interventions compared to lifestyle interventions alone for both BMI and BW outcomes. Additional high-quality evidence demonstrated significant benefits for acupuncture versus no treatment and versus sham acupuncture. Fourteen meta-analyses provided moderate-quality evidence confirming acupuncture effectiveness, with no significant differences between acupuncture and pharmaceutical treatments.
Conclusions: Based on high-quality evidence, clinicians can recommend acupuncture to patients with obesity, particularly as adjunctive therapy to lifestyle interventions. For patients unable to tolerate pharmacological treatments, acupuncture represents a reasonable alternative. However, optimal benefits require integration with comprehensive lifestyle modifications rather than standalone use.
{"title":"Acupuncture for Treatment of Obesity: An Umbrella Review.","authors":"Min Chen, RuiRui Wu, Rui Chen, Qiong Guo, Ya Deng, Yuan Wang, Youlin Long","doi":"10.1111/jebm.70083","DOIUrl":"10.1111/jebm.70083","url":null,"abstract":"<p><strong>Background: </strong>Systematic reviews on acupuncture for obesity report conflicting findings, and the certainty of this evidence remains unclear. This umbrella review appraises the evidence to identify which effects on body mass index (BMI) and body weight (BW) are supported by high-quality findings.</p><p><strong>Methods: </strong>We conducted an umbrella review by systematically searching PubMed, Embase, and the Cochrane Library through April 28, 2025 to obtain systematic reviews of randomized controlled trials evaluating acupuncture interventions for obesity. Two reviewers independently assessed methodological quality using a measurement tool to assess systematic reviews (AMSTAR) and evidence quality using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). We identified best evidence from high-quality systematic reviews with high or moderate GRADE ratings.</p><p><strong>Results: </strong>Our analysis included 22 systematic reviews encompassing 60 meta-analyses. Seventeen reviews (77.3%) achieved high methodological quality ratings according to AMSTAR criteria. Five meta-analyses provided high-quality evidence consistently demonstrating significant benefits of acupuncture interventions. The strongest evidence supported acupuncture combined with lifestyle interventions compared to lifestyle interventions alone for both BMI and BW outcomes. Additional high-quality evidence demonstrated significant benefits for acupuncture versus no treatment and versus sham acupuncture. Fourteen meta-analyses provided moderate-quality evidence confirming acupuncture effectiveness, with no significant differences between acupuncture and pharmaceutical treatments.</p><p><strong>Conclusions: </strong>Based on high-quality evidence, clinicians can recommend acupuncture to patients with obesity, particularly as adjunctive therapy to lifestyle interventions. For patients unable to tolerate pharmacological treatments, acupuncture represents a reasonable alternative. However, optimal benefits require integration with comprehensive lifestyle modifications rather than standalone use.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":"e70083"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Objective: This study aimed to describe the incidence, mortality, and disease burden of tracheal, bronchial, and lung cancer (TBL) in both China and worldwide.
Methods: We extracted estimates of the incidence, mortality, and disability-adjusted life years (DALYs) for TBL from the Global Burden of Disease 2021 database. The age-period-cohort model was employed to explore the impacts of age, period, and birth cohort on TBL. Joinpoint regression analysis examined long-term trends in TBL incidence, mortality, and DALYs. Correlation analysis was conducted to investigate the relationship between TBL disease burden in 2021 and the economic development level of the regions.
Results: In 2021, the global age-standardized incidence rate (ASIR), age-standardized mortality rate (ASMR), and age-standardized DALYs rate (ASDR) for TBL were 26 (95% uncertainty intervals [UI]: 24-29), 24 (95% UI: 21-26), and 533 (95% UI: 480-586) per 100,000 population. In all regions, regardless of economic level, male TBL incidence, mortality, and DALYs were significantly higher than those in females. After age 45, the ASIR, ASMR, and ASDR for TBL showed a geometric increase, peaking after age 85. Regions with higher economic levels faced higher TBL incidence and disease burden.
Conclusion: In some less developed regions, the disease burden of TBL has shown an upward trend. The heterogeneous long-term trends observed across different sexes and age groups highlight the need for greater attention to issues such as excessive smoking and environmental exposure among middle-aged and elderly populations, particularly women.
{"title":"Epidemiological Trends and Disease Burden of Tracheal, Bronchial, and Lung Cancer in China and Globally From 1990 to 2021: Results From the Global Burden of Disease Study 2021.","authors":"Qianjie Xu, Xiaosheng Li, Lulu Wang, Zuhai Hu, Wei Zhou, Yunyun Zhang, Haike Lei, Yongzhong Wu","doi":"10.1111/jebm.70087","DOIUrl":"10.1111/jebm.70087","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to describe the incidence, mortality, and disease burden of tracheal, bronchial, and lung cancer (TBL) in both China and worldwide.</p><p><strong>Methods: </strong>We extracted estimates of the incidence, mortality, and disability-adjusted life years (DALYs) for TBL from the Global Burden of Disease 2021 database. The age-period-cohort model was employed to explore the impacts of age, period, and birth cohort on TBL. Joinpoint regression analysis examined long-term trends in TBL incidence, mortality, and DALYs. Correlation analysis was conducted to investigate the relationship between TBL disease burden in 2021 and the economic development level of the regions.</p><p><strong>Results: </strong>In 2021, the global age-standardized incidence rate (ASIR), age-standardized mortality rate (ASMR), and age-standardized DALYs rate (ASDR) for TBL were 26 (95% uncertainty intervals [UI]: 24-29), 24 (95% UI: 21-26), and 533 (95% UI: 480-586) per 100,000 population. In all regions, regardless of economic level, male TBL incidence, mortality, and DALYs were significantly higher than those in females. After age 45, the ASIR, ASMR, and ASDR for TBL showed a geometric increase, peaking after age 85. Regions with higher economic levels faced higher TBL incidence and disease burden.</p><p><strong>Conclusion: </strong>In some less developed regions, the disease burden of TBL has shown an upward trend. The heterogeneous long-term trends observed across different sexes and age groups highlight the need for greater attention to issues such as excessive smoking and environmental exposure among middle-aged and elderly populations, particularly women.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":"e70087"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145495766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Aim: Hypokalemia is a prevalent complication following pituitary adenoma (PA) surgery, adversely impacting patient prognosis. Identifying predictors of early postoperative hypokalemia is crucial for managing patients effectively. This study aims to develop an interpretable predictive model to predict postoperative hypokalemia in patients with PA and recognizes individualized significant parameters contributing to the predictive outcomes, thereby facilitating early intervention.
Methods: This retrospective cohort study investigated postoperative hypokalemia in 280 patients with PA. We developed a Transformer-based predictive model, CliTab-Transformer, and compared it with an XGBoost-based model and a multilayer perceptron (MLP)-based deep learning model. Model performance was evaluated using metrics such as accuracy, precision, recall, F1 score, and ROC/PR curves, based on five-fold cross-validation. Model interpretability was assessed using a novel Transformer-Explainability method to identify significant parameters contributing to individual predictions.
Results: CliTab-Transformer outperformed XGBoost and MLP in predicting postoperative hypokalemia, showing higher accuracy (0.836 vs. 0.775 vs. 0.771), F1 score (0.845 vs. 0.792 vs. 0.766), sensitivity (0.838 vs. 0.833 vs. 0.771), and AUC (0.835 vs. 0.807 vs. 0.676). The model's interpretability analysis revealed that the preoperative factors, including gender, hypertension, serum potassium concentration, and disease duration, are significantly predictive of postoperative hypokalemia.
Conclusions: Our model outperforms XGBoost in predicting early postoperative hypokalemia in patients with pituitary adenomas. We systematically explore attention mechanisms in clinical tabular data, demonstrating their effectiveness in capturing complex feature interactions, leading to more individualized, interpretable, and clinically meaningful insights.
目的:低钾血症是垂体腺瘤(PA)手术后常见的并发症,严重影响患者预后。确定术后早期低钾血症的预测因素对于有效地管理患者至关重要。本研究旨在建立一个可解释的预测模型来预测PA患者术后低钾血症,并识别有助于预测结果的个性化重要参数,从而促进早期干预。方法:回顾性队列研究280例PA术后低钾血症患者。我们开发了一个基于transformer的预测模型CliTab-Transformer,并将其与基于xgboost的模型和基于多层感知器(MLP)的深度学习模型进行了比较。基于五重交叉验证,使用准确度、精密度、召回率、F1评分和ROC/PR曲线等指标评估模型性能。模型可解释性评估使用一种新颖的变压器可解释性方法,以确定有助于个体预测的重要参数。结果:CliTab-Transformer在预测术后低钾血症方面优于XGBoost和MLP,准确性(0.836 vs 0.775 vs 0.771)、F1评分(0.845 vs 0.792 vs 0.766)、敏感性(0.838 vs 0.833 vs 0.771)和AUC (0.835 vs 0.807 vs 0.676)更高。该模型的可解释性分析显示,术前因素,包括性别、高血压、血清钾浓度和病程,可显著预测术后低钾血症。结论:我们的模型在预测垂体腺瘤患者术后早期低钾血症方面优于XGBoost。我们系统地探索了临床表格数据中的注意机制,证明了它们在捕捉复杂特征相互作用方面的有效性,从而获得更个性化、可解释和有临床意义的见解。
{"title":"Development of a Novel Interpretable Transformer-Based Deep Learning Model for Predicting Postoperative Hypokalemia in Pituitary Adenomas.","authors":"Zhuoyuan Li, Jie Wang, Yunfeng Wang, Zheng Peng, Xiaojian Li, Chunlei Chen, Huiying Yan, Wei Jin, Yue Lu, Zong Zhuang, Wei Li, Chunhua Hang","doi":"10.1111/jebm.70089","DOIUrl":"10.1111/jebm.70089","url":null,"abstract":"<p><strong>Aim: </strong>Hypokalemia is a prevalent complication following pituitary adenoma (PA) surgery, adversely impacting patient prognosis. Identifying predictors of early postoperative hypokalemia is crucial for managing patients effectively. This study aims to develop an interpretable predictive model to predict postoperative hypokalemia in patients with PA and recognizes individualized significant parameters contributing to the predictive outcomes, thereby facilitating early intervention.</p><p><strong>Methods: </strong>This retrospective cohort study investigated postoperative hypokalemia in 280 patients with PA. We developed a Transformer-based predictive model, CliTab-Transformer, and compared it with an XGBoost-based model and a multilayer perceptron (MLP)-based deep learning model. Model performance was evaluated using metrics such as accuracy, precision, recall, F1 score, and ROC/PR curves, based on five-fold cross-validation. Model interpretability was assessed using a novel Transformer-Explainability method to identify significant parameters contributing to individual predictions.</p><p><strong>Results: </strong>CliTab-Transformer outperformed XGBoost and MLP in predicting postoperative hypokalemia, showing higher accuracy (0.836 vs. 0.775 vs. 0.771), F1 score (0.845 vs. 0.792 vs. 0.766), sensitivity (0.838 vs. 0.833 vs. 0.771), and AUC (0.835 vs. 0.807 vs. 0.676). The model's interpretability analysis revealed that the preoperative factors, including gender, hypertension, serum potassium concentration, and disease duration, are significantly predictive of postoperative hypokalemia.</p><p><strong>Conclusions: </strong>Our model outperforms XGBoost in predicting early postoperative hypokalemia in patients with pituitary adenomas. We systematically explore attention mechanisms in clinical tabular data, demonstrating their effectiveness in capturing complex feature interactions, leading to more individualized, interpretable, and clinically meaningful insights.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":"e70089"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145557056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-12-23DOI: 10.1111/jebm.70100
Ye Xu, Yulong Jia, Qianrui Li, Hao Jiang, Yiquan Xiong, Wengxue Liang, Xuehong Liu, Yunxiang Huang, Kang Zou, Xin Sun, Jing Tan, Yan Ren
Aim: Infertility is a growing global health issue affecting millions worldwide. While endometriosis, polycystic ovarian syndrome (PCOS) and unexplained infertility are recognized as the major contributors, their specific burden and impact on infertility among women of childbearing age (WCBA) remain inadequately quantified. This study aimed to evaluate the global burden of three diseases and infertility attributable to them.
Methods: Using data from Global Burden of Disease Study 2021, we assessed the temporal trends of three diseases by average annual percentage change (AAPC) in age-standardized prevalence rate (ASPR) and DALYs rate (ASDR), and evaluated their correlation with socio-demographic index (SDI). We also calculated the age-standardized prevalence and years lived with disability (YLDs) rates of infertility attributable to three diseases.
Results: In 2021, the global ASPRs of endometriosis, PCOS, and unexplained infertility were 1070.7 (AAPC: -1.02%, declining), 3364.5 (AAPC: 0.74%, increasing), and 5586.2 (AAPC: 0.70%, increasing), and infertility attributable to three diseases were 60.6, 638.2, and 5586.2 per 100,000 population, respectively. Regionally, Oceania had the highest ASPR for endometriosis, East Asia for unexplained infertility, and high-income Asia Pacific for PCOS. Infertility attributable to PCOS exhibited higher age-standardized prevalence and YLDs rates compared to endometriosis in most regions. Notably, ASPRs and ASDRs for endometriosis and unexplained infertility decreased with SDI, while PCOS rates increased with SDI.
Conclusions: The increasing global burden of endometriosis, PCOS, and unexplained infertility among WCBA has significantly contributed to rising infertility rates, with distinct regional and demographic disparities. Targeted public health strategies are needed to address these trends.
{"title":"Global, Regional, and National Burden of Endometriosis, PCOS, and Unexplained Infertility and Their Attribution to Infertility, 1990-2021: Global Burden of Disease Study 2021.","authors":"Ye Xu, Yulong Jia, Qianrui Li, Hao Jiang, Yiquan Xiong, Wengxue Liang, Xuehong Liu, Yunxiang Huang, Kang Zou, Xin Sun, Jing Tan, Yan Ren","doi":"10.1111/jebm.70100","DOIUrl":"10.1111/jebm.70100","url":null,"abstract":"<p><strong>Aim: </strong>Infertility is a growing global health issue affecting millions worldwide. While endometriosis, polycystic ovarian syndrome (PCOS) and unexplained infertility are recognized as the major contributors, their specific burden and impact on infertility among women of childbearing age (WCBA) remain inadequately quantified. This study aimed to evaluate the global burden of three diseases and infertility attributable to them.</p><p><strong>Methods: </strong>Using data from Global Burden of Disease Study 2021, we assessed the temporal trends of three diseases by average annual percentage change (AAPC) in age-standardized prevalence rate (ASPR) and DALYs rate (ASDR), and evaluated their correlation with socio-demographic index (SDI). We also calculated the age-standardized prevalence and years lived with disability (YLDs) rates of infertility attributable to three diseases.</p><p><strong>Results: </strong>In 2021, the global ASPRs of endometriosis, PCOS, and unexplained infertility were 1070.7 (AAPC: -1.02%, declining), 3364.5 (AAPC: 0.74%, increasing), and 5586.2 (AAPC: 0.70%, increasing), and infertility attributable to three diseases were 60.6, 638.2, and 5586.2 per 100,000 population, respectively. Regionally, Oceania had the highest ASPR for endometriosis, East Asia for unexplained infertility, and high-income Asia Pacific for PCOS. Infertility attributable to PCOS exhibited higher age-standardized prevalence and YLDs rates compared to endometriosis in most regions. Notably, ASPRs and ASDRs for endometriosis and unexplained infertility decreased with SDI, while PCOS rates increased with SDI.</p><p><strong>Conclusions: </strong>The increasing global burden of endometriosis, PCOS, and unexplained infertility among WCBA has significantly contributed to rising infertility rates, with distinct regional and demographic disparities. Targeted public health strategies are needed to address these trends.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":"e70100"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12750491/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145819618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-18DOI: 10.1111/jebm.70084
Xiang Li, Ying Han, Yi Zhang, Lei Wang, Huihui Li, Tao Sun, Meng Li, Xu Sun, Yangyang Gao, Lin Jia, Lijun Di, Zheng Lv
Background: Anlotinib, a multi-target small-molecule receptor tyrosine kinase inhibitor, can inhibit tumor angiogenesis proliferation and remains underexplored in metastatic breast cancer (MBC). Therefore, we aimed to analyze the efficacy and safety of anlotinib for MBC treatment in a real-world study.
Methods: In this multicenter, retrospective study, patients with MBC who received anlotinib at four Chinese centers between January 2021 and December 2022 were enrolled (data cut-off date: February 1, 2025). The primary end point was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective response rate, and adverse events (AEs). Statistical significance was defined at p < 0.05.
Results: In total, 153 patients were included in this study (median age, 51 years). Median follow-up time was 30.0 months. A total of 86 (56.2%) patients were hormone receptor-positive/human epidermal growth factor receptor 2-negative, whereas the others were human epidermal growth factor receptor 2-positive (9.8%) or triple-negative breast cancer (34.0%). The median PFS and OS were 6.0 months (95% confidence interval [CI] 4.5-7.5) and 28.5 months (95% CI 20.3-36.7). The number of metastatic sites and Eastern Cooperative Oncology Group performance status were significant in Cox multivariate analysis (p = 0.012 and p = 0.030, respectively) and were significantly associated with PFS of anlotinib. Most AEs were clinically manageable, whereas Grade III/IV AEs included neutropenia (29.4%) and fatigue (6.5%).
Conclusion: Anlotinib exhibits effective and safe anti-tumor activity in the treatment of MBC.
背景:Anlotinib是一种多靶点小分子受体酪氨酸激酶抑制剂,可以抑制肿瘤血管生成增殖,但在转移性乳腺癌(MBC)中的应用尚不充分。因此,我们的目的是在现实世界的研究中分析anlotinib治疗MBC的有效性和安全性。方法:在这项多中心回顾性研究中,纳入了2021年1月至2022年12月在中国四个中心接受anlotinib治疗的MBC患者(数据截止日期:2025年2月1日)。主要终点为无进展生存期(PFS);次要终点包括总生存期(OS)、客观有效率和不良事件(ae)。结果:本研究共纳入153例患者(中位年龄51岁)。中位随访时间为30.0个月。激素受体阳性/人表皮生长因子受体2阴性86例(56.2%),其余为人表皮生长因子受体2阳性(9.8%)或三阴性乳腺癌(34.0%)。中位PFS和OS分别为6.0个月(95%可信区间[CI] 4.5-7.5)和28.5个月(95% CI 20.3-36.7)。Cox多因素分析显示,转移部位数量和东部肿瘤合作组表现状态显著(p = 0.012和p = 0.030),且与anlotinib的PFS显著相关。大多数ae在临床上是可控的,而III/IV级ae包括中性粒细胞减少症(29.4%)和疲劳(6.5%)。结论:安洛替尼治疗MBC具有安全有效的抗肿瘤活性。
{"title":"Efficacy and Safety of Anlotinib-Based Regimens in Metastatic Breast Cancer: A Multicenter Real-World Study.","authors":"Xiang Li, Ying Han, Yi Zhang, Lei Wang, Huihui Li, Tao Sun, Meng Li, Xu Sun, Yangyang Gao, Lin Jia, Lijun Di, Zheng Lv","doi":"10.1111/jebm.70084","DOIUrl":"10.1111/jebm.70084","url":null,"abstract":"<p><strong>Background: </strong>Anlotinib, a multi-target small-molecule receptor tyrosine kinase inhibitor, can inhibit tumor angiogenesis proliferation and remains underexplored in metastatic breast cancer (MBC). Therefore, we aimed to analyze the efficacy and safety of anlotinib for MBC treatment in a real-world study.</p><p><strong>Methods: </strong>In this multicenter, retrospective study, patients with MBC who received anlotinib at four Chinese centers between January 2021 and December 2022 were enrolled (data cut-off date: February 1, 2025). The primary end point was progression-free survival (PFS); secondary endpoints included overall survival (OS), objective response rate, and adverse events (AEs). Statistical significance was defined at p < 0.05.</p><p><strong>Results: </strong>In total, 153 patients were included in this study (median age, 51 years). Median follow-up time was 30.0 months. A total of 86 (56.2%) patients were hormone receptor-positive/human epidermal growth factor receptor 2-negative, whereas the others were human epidermal growth factor receptor 2-positive (9.8%) or triple-negative breast cancer (34.0%). The median PFS and OS were 6.0 months (95% confidence interval [CI] 4.5-7.5) and 28.5 months (95% CI 20.3-36.7). The number of metastatic sites and Eastern Cooperative Oncology Group performance status were significant in Cox multivariate analysis (p = 0.012 and p = 0.030, respectively) and were significantly associated with PFS of anlotinib. Most AEs were clinically manageable, whereas Grade III/IV AEs included neutropenia (29.4%) and fatigue (6.5%).</p><p><strong>Conclusion: </strong>Anlotinib exhibits effective and safe anti-tumor activity in the treatment of MBC.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":"e70084"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145549618","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-10DOI: 10.1111/jebm.70069
Xinyu Cui, Kexin Liu, Yuanyi Ji, Su Han, Yongzhong Cheng
The hierarchical diagnosis and treatment system's two-way referral mechanism is crucial for optimizing medical resource allocation, with medical consortia significantly enhancing this process. It evaluates the implementation dynamics of two-way referral systems within China's medical consortia from 2019 to 2024, focusing on policy evolution, regional disparities, and stakeholder engagement. Despite a positive overall trend, referral rates remain low, with notable regional and institutional disparities. The implementation outcomes span various dimensions, including referral metrics, specific services, timing, and costs; however, these effects are inconsistent and warrant further investigation. The current evaluation index system is diverse but tends to prioritize quantity over quality. Additionally, awareness and satisfaction levels among medical personnel and patients regarding the two-way referral system are uneven and influenced by multiple factors. Currently, China's two-way referral system faces challenges, including low referral volumes, an inadequate evaluation framework, limited research perspectives, and insufficient motivation for stakeholder participation. Future efforts should focus on strengthening primary care infrastructure, enhancing resource collaboration, advancing health insurance reforms, refining the evaluation system, and fostering synergy between hierarchical diagnosis and treatment, the Healthy China strategy, and referral model innovation to advance the hierarchical diagnosis and treatment system. Recommendations emphasize strengthening primary care capacity, reforming insurance payment models, and leveraging digital health technologies to align with the "Healthy China 2030" strategic goals.
{"title":"Two-Way Referrals in Chinese Medical Consortia Under the Framework of Hierarchical Diagnosis and Treatment: Progress and Challenges.","authors":"Xinyu Cui, Kexin Liu, Yuanyi Ji, Su Han, Yongzhong Cheng","doi":"10.1111/jebm.70069","DOIUrl":"10.1111/jebm.70069","url":null,"abstract":"<p><p>The hierarchical diagnosis and treatment system's two-way referral mechanism is crucial for optimizing medical resource allocation, with medical consortia significantly enhancing this process. It evaluates the implementation dynamics of two-way referral systems within China's medical consortia from 2019 to 2024, focusing on policy evolution, regional disparities, and stakeholder engagement. Despite a positive overall trend, referral rates remain low, with notable regional and institutional disparities. The implementation outcomes span various dimensions, including referral metrics, specific services, timing, and costs; however, these effects are inconsistent and warrant further investigation. The current evaluation index system is diverse but tends to prioritize quantity over quality. Additionally, awareness and satisfaction levels among medical personnel and patients regarding the two-way referral system are uneven and influenced by multiple factors. Currently, China's two-way referral system faces challenges, including low referral volumes, an inadequate evaluation framework, limited research perspectives, and insufficient motivation for stakeholder participation. Future efforts should focus on strengthening primary care infrastructure, enhancing resource collaboration, advancing health insurance reforms, refining the evaluation system, and fostering synergy between hierarchical diagnosis and treatment, the Healthy China strategy, and referral model innovation to advance the hierarchical diagnosis and treatment system. Recommendations emphasize strengthening primary care capacity, reforming insurance payment models, and leveraging digital health technologies to align with the \"Healthy China 2030\" strategic goals.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":"e70069"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12750490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145274789","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-28DOI: 10.1111/jebm.70081
Xiaohua Shi, Xianghong Yang, Jingping Yun, Xiangshan Fan, Yingyong Hou, Zhe Wang, Peng Li, Jieyu Chen, Dongxian Jiang, Longyun Chen, Yan Wang, Rubentiran Ramar, Michael Thomas Wong, Song Ling Poon, Zhiyong Liang
Aim: Microsatellite instability (MSI) as a result of deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR) is a key contributor to the development of tumors with a high mutation rate and cancer-specific neoantigens. dMMR identification can be beneficial for selection of immune checkpoint inhibitor (ICI) therapy-eligible patients. While multiple studies have focused on dMMR prevalence in colorectal cancer (CRC), fewer investigate the prevalence of dMMR in tumor types besides CRC, especially in Chinese patients. In this study, we aimed to determine the prevalence of dMMR in China across five gastrointestinal and gynecological tumor types.
Methods: Tissue samples from Chinese patients with advanced endometrial, ovarian, cervical, biliary tract, or gastric metastatic or unresectable solid tumors were tested for dMMR status using immunohistochemistry with the Ventana MMR RxDx panel. Data were analyzed to determine the prevalence of dMMR for each tumor type.
Results: A total of 748 patients were included in the study, representing five tumor types. Prevalence of dMMR varied across tumor types, with an overall prevalence of 9.4%. Patients with endometrial tumors had the highest proportion of patients with dMMR at 49/164 (29.9%). Patients with cervical tumors had the lowest prevalence of dMMR with 6/221 (2.7%) patients. The prevalence of dMMR was similar across most demographic characteristics. In the dMMR population, co-occurring MLH1 and PMS2 protein loss across all tumor types was observed most commonly, in 48/70 (68.6%) patients.
Conclusions: These data highlight the importance of dMMR testing in patients with advanced solid tumors in China to optimize biomarker testing and treatment decisions.
{"title":"Prevalence of DNA Mismatch Repair Deficiencies in Multiple Solid Tumor Types in China.","authors":"Xiaohua Shi, Xianghong Yang, Jingping Yun, Xiangshan Fan, Yingyong Hou, Zhe Wang, Peng Li, Jieyu Chen, Dongxian Jiang, Longyun Chen, Yan Wang, Rubentiran Ramar, Michael Thomas Wong, Song Ling Poon, Zhiyong Liang","doi":"10.1111/jebm.70081","DOIUrl":"10.1111/jebm.70081","url":null,"abstract":"<p><strong>Aim: </strong>Microsatellite instability (MSI) as a result of deficient deoxyribonucleic acid (DNA) mismatch repair (dMMR) is a key contributor to the development of tumors with a high mutation rate and cancer-specific neoantigens. dMMR identification can be beneficial for selection of immune checkpoint inhibitor (ICI) therapy-eligible patients. While multiple studies have focused on dMMR prevalence in colorectal cancer (CRC), fewer investigate the prevalence of dMMR in tumor types besides CRC, especially in Chinese patients. In this study, we aimed to determine the prevalence of dMMR in China across five gastrointestinal and gynecological tumor types.</p><p><strong>Methods: </strong>Tissue samples from Chinese patients with advanced endometrial, ovarian, cervical, biliary tract, or gastric metastatic or unresectable solid tumors were tested for dMMR status using immunohistochemistry with the Ventana MMR RxDx panel. Data were analyzed to determine the prevalence of dMMR for each tumor type.</p><p><strong>Results: </strong>A total of 748 patients were included in the study, representing five tumor types. Prevalence of dMMR varied across tumor types, with an overall prevalence of 9.4%. Patients with endometrial tumors had the highest proportion of patients with dMMR at 49/164 (29.9%). Patients with cervical tumors had the lowest prevalence of dMMR with 6/221 (2.7%) patients. The prevalence of dMMR was similar across most demographic characteristics. In the dMMR population, co-occurring MLH1 and PMS2 protein loss across all tumor types was observed most commonly, in 48/70 (68.6%) patients.</p><p><strong>Conclusions: </strong>These data highlight the importance of dMMR testing in patients with advanced solid tumors in China to optimize biomarker testing and treatment decisions.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":"e70081"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12750482/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145634402","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-12-18DOI: 10.1111/jebm.70094
Zhiling Zhang, Pengxiang Zhou, Na He, Ziyang Wu, Shining Bo, Chao Chen, Shuhong Chi, Ning Hou, Ji Hu, Fanbo Jing, Baohua Li, Ling Li, Shuiqing Li, Yanni Li, Yang Lin, Qipeng Luo, Jiahui Mai, Rong Mu, Ronghui Ouyang, Wangjun Qin, Rong Shao, Jianghua Shen, Xiaoying Sun, Tianlin Wang, Junyan Wu, Han Xie, Xiaoyan Xu, Yingying Yan, Kehu Yang, Zhongqiang Yao, Chaoqun Ye, Yonggui Yuan, Jintao Zhu, Rongsheng Zhao, Daying Zhang, Dongfeng Liang, Xiaofeng Zeng, Bifa Fan, Suodi Zhai
Objective: To develop an evidence-based patient version of guideline (PVG) for fibromyalgia, aiming to improve patients' understanding of disease symptoms and therapeutic options and to enhance their self-management abilities.
Methods: Following the World Health Organization Handbook for Guideline Development (2014), a multidisciplinary working group was established, including patient representatives, physicians, pharmacists, nurses, and methodologists. The process comprised (a) systematic retrieval of clinical practice guidelines and expert consensus statements to establish the evidence base; (b) integration of large language models (LLMs) with expert review to identify and refine key patient-centered concerns; (c) a three-round Delphi consensus guided by the Grading of Recommendations Assessment, Development and Evaluation approach to finalize clinical questions and formulate recommendations; and (d) evaluation of understandability using the Patient Education Materials Assessment Tool for Print Materials (PEMAT-P).
Results: The final PVG covers 13 clinical questions across seven domains, including disease awareness, diagnostic evaluation, pharmacological and non-pharmacological interventions, and long-term management. All recommendations were rated as strong. The guideline emphasizes the importance of pharmacological management, emotional regulation, and exercise in the comprehensive management of fibromyalgia. The PEMAT-P assessment showed an understandability score of 100%.
Conclusions: Developed collaboratively by a multidisciplinary team and patient representatives, this PVG is based on 13 evidence-based fibromyalgia guidelines. Combining LLMs with expert review enhanced question generation and readability. The PVG provides a practical and accessible tool to support early self-management in fibromyalgia.
{"title":"Patient Version of Guideline for Fibromyalgia (2025 Edition).","authors":"Zhiling Zhang, Pengxiang Zhou, Na He, Ziyang Wu, Shining Bo, Chao Chen, Shuhong Chi, Ning Hou, Ji Hu, Fanbo Jing, Baohua Li, Ling Li, Shuiqing Li, Yanni Li, Yang Lin, Qipeng Luo, Jiahui Mai, Rong Mu, Ronghui Ouyang, Wangjun Qin, Rong Shao, Jianghua Shen, Xiaoying Sun, Tianlin Wang, Junyan Wu, Han Xie, Xiaoyan Xu, Yingying Yan, Kehu Yang, Zhongqiang Yao, Chaoqun Ye, Yonggui Yuan, Jintao Zhu, Rongsheng Zhao, Daying Zhang, Dongfeng Liang, Xiaofeng Zeng, Bifa Fan, Suodi Zhai","doi":"10.1111/jebm.70094","DOIUrl":"10.1111/jebm.70094","url":null,"abstract":"<p><strong>Objective: </strong>To develop an evidence-based patient version of guideline (PVG) for fibromyalgia, aiming to improve patients' understanding of disease symptoms and therapeutic options and to enhance their self-management abilities.</p><p><strong>Methods: </strong>Following the World Health Organization Handbook for Guideline Development (2014), a multidisciplinary working group was established, including patient representatives, physicians, pharmacists, nurses, and methodologists. The process comprised (a) systematic retrieval of clinical practice guidelines and expert consensus statements to establish the evidence base; (b) integration of large language models (LLMs) with expert review to identify and refine key patient-centered concerns; (c) a three-round Delphi consensus guided by the Grading of Recommendations Assessment, Development and Evaluation approach to finalize clinical questions and formulate recommendations; and (d) evaluation of understandability using the Patient Education Materials Assessment Tool for Print Materials (PEMAT-P).</p><p><strong>Results: </strong>The final PVG covers 13 clinical questions across seven domains, including disease awareness, diagnostic evaluation, pharmacological and non-pharmacological interventions, and long-term management. All recommendations were rated as strong. The guideline emphasizes the importance of pharmacological management, emotional regulation, and exercise in the comprehensive management of fibromyalgia. The PEMAT-P assessment showed an understandability score of 100%.</p><p><strong>Conclusions: </strong>Developed collaboratively by a multidisciplinary team and patient representatives, this PVG is based on 13 evidence-based fibromyalgia guidelines. Combining LLMs with expert review enhanced question generation and readability. The PVG provides a practical and accessible tool to support early self-management in fibromyalgia.</p>","PeriodicalId":16090,"journal":{"name":"Journal of Evidence‐Based Medicine","volume":" ","pages":"e70094"},"PeriodicalIF":3.5,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12750489/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145774692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}