Pub Date : 2025-02-01DOI: 10.1016/j.lanwpc.2025.101465
Xiaowen Zhou , Zhenxu Xiao , Wanqing Wu , Yuntao Chen , Changzheng Yuan , Yue Leng , Yao Yao , Qianhua Zhao , Albert Hofman , Eric Brunner , Ding Ding
China accounts for 1/5 of the global population and China faces a particularly heavy dementia burden due to its rapidly ageing population. Unique historical events, genetic background, sociocultural factors, lifestyle, and the COVID-19 pandemic further influence cognitive outcomes in the Chinese population. We searched PubMed, Web of Science, and Embase for community-based cohort studies related to dementia in the Chinese population, and summarized the characteristics, methodologies, and major findings published over the last 25 years from 39 cohorts. We identified critical research gaps and propose future directions, including enhancing sample representativeness, investigating China-specific risk factors, expanding exposure measurements to the whole life-span, collecting objective data, conducting administer-friendly domain-specific cognitive assessments, adopting pathological diagnostic criteria, standardizing biobank construction, verifying multi-modal biomarkers, examining social and genetic-environmental aspects, and monitoring post-COVID cognitive health, to approach high quality of dementia studies that can provide solid evidence to policy making and promote global brain health research.
{"title":"Closing the gap in dementia research by community-based cohort studies in the Chinese population","authors":"Xiaowen Zhou , Zhenxu Xiao , Wanqing Wu , Yuntao Chen , Changzheng Yuan , Yue Leng , Yao Yao , Qianhua Zhao , Albert Hofman , Eric Brunner , Ding Ding","doi":"10.1016/j.lanwpc.2025.101465","DOIUrl":"10.1016/j.lanwpc.2025.101465","url":null,"abstract":"<div><div>China accounts for 1/5 of the global population and China faces a particularly heavy dementia burden due to its rapidly ageing population. Unique historical events, genetic background, sociocultural factors, lifestyle, and the COVID-19 pandemic further influence cognitive outcomes in the Chinese population. We searched PubMed, Web of Science, and Embase for community-based cohort studies related to dementia in the Chinese population, and summarized the characteristics, methodologies, and major findings published over the last 25 years from 39 cohorts. We identified critical research gaps and propose future directions, including enhancing sample representativeness, investigating China-specific risk factors, expanding exposure measurements to the whole life-span, collecting objective data, conducting administer-friendly domain-specific cognitive assessments, adopting pathological diagnostic criteria, standardizing biobank construction, verifying multi-modal biomarkers, examining social and genetic-environmental aspects, and monitoring post-COVID cognitive health, to approach high quality of dementia studies that can provide solid evidence to policy making and promote global brain health research.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101465"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11788756/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123676","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 : 2025-02-01DOI: 10.1016/j.lanwpc.2025.101482
Jiefang Huang
{"title":"Highlights of the ESMO Asia Congress 2024","authors":"Jiefang Huang","doi":"10.1016/j.lanwpc.2025.101482","DOIUrl":"10.1016/j.lanwpc.2025.101482","url":null,"abstract":"","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101482"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143178030","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 : 2025-02-01DOI: 10.1016/j.lanwpc.2025.101483
Xiangyun Mao , Jiachen Xu , Xiaozhen Liu , Shu Kong , Yi Li , Xiaoyin Bai , Jiaxuan Yang , Aaron S. Kesselheim , Guanqiao Li
<div><h3>Background</h3><div>China has historically relied on importing new drugs to fulfill domestic clinical needs. However, stringent requirements for local clinical trials for these imported drugs has often delayed their market approval, restricting timely access for patients. To address this issue, China has implemented regulatory flexibility in certain contexts, allowing for expedited approval processes when appropriate. This study aimed to evaluate the characteristics of novel cancer drugs qualifying for flexible approval in China from 2012 to 2021, focusing on pivotal trials features, clinical benefits, safety profiles, and unmet medical needs.</div></div><div><h3>Methods</h3><div>This cohort study identified all newly imported cancer drugs and their indications approved by the China’s National Medical Products Administration (NMPA) from 2012 to 2021. Indications meeting standard requirements were categorized as regular approvals, while those supported by limited clinical data from Chinese patients were classified as flexible approvals. Development strategies, pivotal trials characteristics, and clinical outcomes were extracted from publicly available review documents and drug labels. Unmet medical needs were assessed based on two dimensions: the availability of standard-of-care treatments and the novelty of medicines. We compared the pivotal trial characteristics, efficacy end points, safety (serious adverse events) and the extent of unmet clinical needs, between flexible and regular approvals using Chi-square tests. A random-effects meta-regression was conducted to examine the association between flexible status and hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS).</div></div><div><h3>Findings</h3><div>Among 59 novel cancer drugs approved for importation to China between 2012 and 2021, 56 products with 92 indications were included in this analysis, based on the availability of their review documents. Of these, 48 indications (52%) qualified for flexible approvals, while 44 indications (48%) received regular approvals. The median number of Chinese patients involved in the datasets for flexible approvals was significantly lower than for regular approvals (27 [IQR, 0–62] vs. 165 [IQR, 99–245], p < 0.001). Flexible approvals were more frequently supported by early-phase (18/61 vs. 1/60, p < 0.001) and single-arm (22/61 vs. 1/60, p < 0.001) pivotal trials, with response rates frequently used as the primary endpoint (24/61 vs. 1/60, p < 0.001). Meta-regression analysis revealed that flexible approvals were associated with improved OS (HR 0.61 vs. 0.72, p < 0.01), and a weaker association for PFS (HR 0.39 vs. 0.51, p = 0.03). The rate of serious adverse events was slightly higher, but not significantly, in the flexible approval group than the regular approval group (43% vs. 35%, p = 0.06). Flexible approvals were more likely to be indicated for diseases with no available existing drugs (31/48 vs.
{"title":"Regulatory flexibilities balancing unmet needs, benefits and risks in the approvals of imported cancer drugs in China: a cohort study from 2012 to 2021","authors":"Xiangyun Mao , Jiachen Xu , Xiaozhen Liu , Shu Kong , Yi Li , Xiaoyin Bai , Jiaxuan Yang , Aaron S. Kesselheim , Guanqiao Li","doi":"10.1016/j.lanwpc.2025.101483","DOIUrl":"10.1016/j.lanwpc.2025.101483","url":null,"abstract":"<div><h3>Background</h3><div>China has historically relied on importing new drugs to fulfill domestic clinical needs. However, stringent requirements for local clinical trials for these imported drugs has often delayed their market approval, restricting timely access for patients. To address this issue, China has implemented regulatory flexibility in certain contexts, allowing for expedited approval processes when appropriate. This study aimed to evaluate the characteristics of novel cancer drugs qualifying for flexible approval in China from 2012 to 2021, focusing on pivotal trials features, clinical benefits, safety profiles, and unmet medical needs.</div></div><div><h3>Methods</h3><div>This cohort study identified all newly imported cancer drugs and their indications approved by the China’s National Medical Products Administration (NMPA) from 2012 to 2021. Indications meeting standard requirements were categorized as regular approvals, while those supported by limited clinical data from Chinese patients were classified as flexible approvals. Development strategies, pivotal trials characteristics, and clinical outcomes were extracted from publicly available review documents and drug labels. Unmet medical needs were assessed based on two dimensions: the availability of standard-of-care treatments and the novelty of medicines. We compared the pivotal trial characteristics, efficacy end points, safety (serious adverse events) and the extent of unmet clinical needs, between flexible and regular approvals using Chi-square tests. A random-effects meta-regression was conducted to examine the association between flexible status and hazard ratios (HRs) for overall survival (OS) and progression-free survival (PFS).</div></div><div><h3>Findings</h3><div>Among 59 novel cancer drugs approved for importation to China between 2012 and 2021, 56 products with 92 indications were included in this analysis, based on the availability of their review documents. Of these, 48 indications (52%) qualified for flexible approvals, while 44 indications (48%) received regular approvals. The median number of Chinese patients involved in the datasets for flexible approvals was significantly lower than for regular approvals (27 [IQR, 0–62] vs. 165 [IQR, 99–245], p < 0.001). Flexible approvals were more frequently supported by early-phase (18/61 vs. 1/60, p < 0.001) and single-arm (22/61 vs. 1/60, p < 0.001) pivotal trials, with response rates frequently used as the primary endpoint (24/61 vs. 1/60, p < 0.001). Meta-regression analysis revealed that flexible approvals were associated with improved OS (HR 0.61 vs. 0.72, p < 0.01), and a weaker association for PFS (HR 0.39 vs. 0.51, p = 0.03). The rate of serious adverse events was slightly higher, but not significantly, in the flexible approval group than the regular approval group (43% vs. 35%, p = 0.06). Flexible approvals were more likely to be indicated for diseases with no available existing drugs (31/48 vs.","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101483"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143178056","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 : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101310
Chaoliang Zhong , Penghao Li , Jia Zhao , Xue Han , Beilei Wang , Gang Jin
Background
Pancreatic cancer (PC) remains a significant public health concern due to its late diagnosis and limited effective screening methods. This study aimed to develop a robust risk prediction model for early detection, utilizing a large prospective cohort to ensure generalizability.
Method
We established a large-scale, continuous, real-world cohort, termed the Artificial Intelligence-based Early Screening of Pancreatic Cancer and High-Risk Tracing (ESPRIT-AI). This cohort encompasses 12 community health centers in Yangpu District, Shanghai, China. Based on this comprehensive dataset, we conducted a prospective, nested case-control study. Nine centers served as the training cohort, while three centers served as the test cohort. A total of 51,490 participants aged 50-75 years underwent annual health examinations from 2021.1 to 2023.12. The risk-related information and informed consent were collected from all the participants. PC diagnosis was obtained from the Center for Disease Control and Prevention's cancer registry. Model training utilized a 1:20 case-control ratio, employing LASSO regression and expert opinion to select features. Multiple machine learning algorithms were compared, with the best performing algorithm selected for the final predictive model, subsequently validated using a real-world external test cohort. The study was registered with ClinicalTrials.gov (NCT04743479).
Findings
The cohort was divided into training (n=39,929, including 45 cases and 900 nested controls) and test (n=11,561, including 15 cases and 11,546 controls) sets. Following variable selection, four optimal variables were identified: Body Mass Index (BMI), Fasting Blood Glucose (FBG), Symptom, and Age. Multiple machine learning algorithms were evaluated, with the Random Forest demonstrating superior performance and selected as the final model. In a large-scale, independent real-world test cohort, the model demonstrated a specificity of 97.21% and sensitivity of 33.33%. The model effectively stratified the population, identifying 316 high-risk individuals (2.73% of the test set), among whom 5 were diagnosed with PC. This resulted in a PC prevalence of 1.58% within the high-risk group, representing a 1.93-fold increase compared to the 0.82% prevalence in newly diagnosed diabetes.
Interpretation
These findings demonstrated our established model’s capacity to effectively identify a subpopulation with significantly elevated PC risk, potentially facilitating targeted imaging-based early detection strategies, balancing screening benefits and burdens.
Funding
This work was funded by the Shanghai Science and Technology Committee Program (grant number 20511101200).
{"title":"A large-scale prospective nested case-control study: developing a comprehensive risk prediction model for early detection of pancreatic cancer in the community-based ESPRIT-AI cohort","authors":"Chaoliang Zhong , Penghao Li , Jia Zhao , Xue Han , Beilei Wang , Gang Jin","doi":"10.1016/j.lanwpc.2024.101310","DOIUrl":"10.1016/j.lanwpc.2024.101310","url":null,"abstract":"<div><h3>Background</h3><div>Pancreatic cancer (PC) remains a significant public health concern due to its late diagnosis and limited effective screening methods. This study aimed to develop a robust risk prediction model for early detection, utilizing a large prospective cohort to ensure generalizability.</div></div><div><h3>Method</h3><div>We established a large-scale, continuous, real-world cohort, termed the Artificial Intelligence-based Early Screening of Pancreatic Cancer and High-Risk Tracing (ESPRIT-AI). This cohort encompasses 12 community health centers in Yangpu District, Shanghai, China. Based on this comprehensive dataset, we conducted a prospective, nested case-control study. Nine centers served as the training cohort, while three centers served as the test cohort. A total of 51,490 participants aged 50-75 years underwent annual health examinations from 2021.1 to 2023.12. The risk-related information and informed consent were collected from all the participants. PC diagnosis was obtained from the Center for Disease Control and Prevention's cancer registry. Model training utilized a 1:20 case-control ratio, employing LASSO regression and expert opinion to select features. Multiple machine learning algorithms were compared, with the best performing algorithm selected for the final predictive model, subsequently validated using a real-world external test cohort. The study was registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (NCT04743479).</div></div><div><h3>Findings</h3><div>The cohort was divided into training (n=39,929, including 45 cases and 900 nested controls) and test (n=11,561, including 15 cases and 11,546 controls) sets. Following variable selection, four optimal variables were identified: Body Mass Index (BMI), Fasting Blood Glucose (FBG), Symptom, and Age. Multiple machine learning algorithms were evaluated, with the Random Forest demonstrating superior performance and selected as the final model. In a large-scale, independent real-world test cohort, the model demonstrated a specificity of 97.21% and sensitivity of 33.33%. The model effectively stratified the population, identifying 316 high-risk individuals (2.73% of the test set), among whom 5 were diagnosed with PC. This resulted in a PC prevalence of 1.58% within the high-risk group, representing a 1.93-fold increase compared to the 0.82% prevalence in newly diagnosed diabetes.</div></div><div><h3>Interpretation</h3><div>These findings demonstrated our established model’s capacity to effectively identify a subpopulation with significantly elevated PC risk, potentially facilitating targeted imaging-based early detection strategies, balancing screening benefits and burdens.</div></div><div><h3>Funding</h3><div>This work was funded by the <span>Shanghai Science and Technology Committee</span> Program (grant number 20511101200).</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101310"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427857","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 : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101385
Menglong Li , Huiming He , Xinyu Zhao , Mengying Guan , Nourhan Khattab , Galal Elshishiney , Hong You , Yifei Hu
<div><h3>Background</h3><div>Liver cancer remains a challenging global health issue. In 2020, China accounted for 45.3% of new liver cancer cases worldwide. The high incidence and mortality rates of liver cancer highlight its profound impact, reflected in a mere 12.1% 5-year survival rate in China, posing significant challenges in managing and treating this disease.</div></div><div><h3>Methods</h3><div>Data on the number of cases, age-specific rates and age-standardized rates (ASRs) of prevalence, incidence, death, and disability-adjusted life year (DALY) attributed to liver cancer (International Classification of Diseases, 10th revision [ICD-10]: C22.0-22.8 and a proportion of C22.9) and its six etiologies (liver cancer due to hepatitis B, hepatitis C, alcohol use, other causes, NASH and hepatoblastoma) in China between 1990 and 2021 were extracted from the Global Burden of Disease Study 2021. Five-year relative survival rates were estimated using the formula (1–mortality/ incidence) ×100. Temporal trends in liver cancer burden were determined by percent changes and average annual percent change (AAPC). Decomposition analysis was conducted to understand the contributions of population aging, population growth, and epidemiological change to the observed trends.</div></div><div><h3>Findings</h3><div>In 2021, the number of liver cancer burden in terms of prevalence, incidence, deaths, and DALYs are 265,539, 196,637, 172,068, and 4,890,023, respectively. The corresponding age-standardized rates were 13.29 (95% UI: 10.75–16.41), 9.52 (95% UI: 7.72–11.78), 8.35 (95% UI: 6.80–10.29), 239.91 (95% UI: 191.98–299.37) per 100,000. The number of prevalence, incidence, deaths and DALYs attributed to liver cancer showed an increasing trend, primarily driven by population aging, then population growth. Meanwhile, decreasing trends were observed in age-standardized death and DALY rates, with AAPCs of –0.32% (95% CI: –0.35% to –0.27%) and –0.79% (95% CI: –0.86% to –0.71%), respectively. Stratified by six etiologies, liver cancer due to hepatitis B, hepatitis C, alcohol use, NASH, and other causes generally showed increasing trends in incidence, prevalence, death and DALYs. Conversely, the burden of hepatoblastoma showed a decreasing trend. The liver cancer burden in 2021 was mainly caused due to hepatitis B, hepatitis C, and alcohol use. Differences in age patterns of liver cancer burden were observed, and the 5-year relative survival rates decreased by age with an overall rate of 12.27%, not far from the goal of 15% by 2030.</div></div><div><h3>Interpretation</h3><div>This study provides a comprehensive overview of the liver cancer burden in China across both sexes and underlying etiologies from 1990 to 2021. The incidence, prevalence, death and DALY attributed to liver cancer have shown an increasing trend, primarily driven by population aging, followed by population growth. In 2021, the burden of liver cancer was mainly caused due to hepatitis B, hepatitis C,
{"title":"Trends in burden of liver cancer and underlying etiologies in China, 1990−2021","authors":"Menglong Li , Huiming He , Xinyu Zhao , Mengying Guan , Nourhan Khattab , Galal Elshishiney , Hong You , Yifei Hu","doi":"10.1016/j.lanwpc.2024.101385","DOIUrl":"10.1016/j.lanwpc.2024.101385","url":null,"abstract":"<div><h3>Background</h3><div>Liver cancer remains a challenging global health issue. In 2020, China accounted for 45.3% of new liver cancer cases worldwide. The high incidence and mortality rates of liver cancer highlight its profound impact, reflected in a mere 12.1% 5-year survival rate in China, posing significant challenges in managing and treating this disease.</div></div><div><h3>Methods</h3><div>Data on the number of cases, age-specific rates and age-standardized rates (ASRs) of prevalence, incidence, death, and disability-adjusted life year (DALY) attributed to liver cancer (International Classification of Diseases, 10th revision [ICD-10]: C22.0-22.8 and a proportion of C22.9) and its six etiologies (liver cancer due to hepatitis B, hepatitis C, alcohol use, other causes, NASH and hepatoblastoma) in China between 1990 and 2021 were extracted from the Global Burden of Disease Study 2021. Five-year relative survival rates were estimated using the formula (1–mortality/ incidence) ×100. Temporal trends in liver cancer burden were determined by percent changes and average annual percent change (AAPC). Decomposition analysis was conducted to understand the contributions of population aging, population growth, and epidemiological change to the observed trends.</div></div><div><h3>Findings</h3><div>In 2021, the number of liver cancer burden in terms of prevalence, incidence, deaths, and DALYs are 265,539, 196,637, 172,068, and 4,890,023, respectively. The corresponding age-standardized rates were 13.29 (95% UI: 10.75–16.41), 9.52 (95% UI: 7.72–11.78), 8.35 (95% UI: 6.80–10.29), 239.91 (95% UI: 191.98–299.37) per 100,000. The number of prevalence, incidence, deaths and DALYs attributed to liver cancer showed an increasing trend, primarily driven by population aging, then population growth. Meanwhile, decreasing trends were observed in age-standardized death and DALY rates, with AAPCs of –0.32% (95% CI: –0.35% to –0.27%) and –0.79% (95% CI: –0.86% to –0.71%), respectively. Stratified by six etiologies, liver cancer due to hepatitis B, hepatitis C, alcohol use, NASH, and other causes generally showed increasing trends in incidence, prevalence, death and DALYs. Conversely, the burden of hepatoblastoma showed a decreasing trend. The liver cancer burden in 2021 was mainly caused due to hepatitis B, hepatitis C, and alcohol use. Differences in age patterns of liver cancer burden were observed, and the 5-year relative survival rates decreased by age with an overall rate of 12.27%, not far from the goal of 15% by 2030.</div></div><div><h3>Interpretation</h3><div>This study provides a comprehensive overview of the liver cancer burden in China across both sexes and underlying etiologies from 1990 to 2021. The incidence, prevalence, death and DALY attributed to liver cancer have shown an increasing trend, primarily driven by population aging, followed by population growth. In 2021, the burden of liver cancer was mainly caused due to hepatitis B, hepatitis C,","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101385"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427861","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 : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101300
Yan Zhao , Wei Bai , Rong Ding , Nan You , Lin Zheng , Lei Li , Jianbin Wu , Peng Zhang , Wukui Huang , Hui Zhang , Yongjin Zhang , Diwen Zhu , Haiping Li , Jie Yuan , Daiming Fan , Yong Lv , Guohong Han
Background
Patients with advanced hepatocellular carcinoma have poor prognosis. We aimed to investigate the efficacy of sorafenib combined with transarterial chemoembolization in patients with advanced hepatocellular carcinoma.
Method
SELECT was a randomized, multi-centre, controlled, phase 3 trial done at twelve centres in China. Eligible patients were aged 18 years or older and had advanced-stage hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage C diseases, Child-Pugh class A liver disease, Eastern Cooperative Oncology Group (ECOG) performance statuses of 0 or 1. Participants were randomly assigned (1:1) with a computer-generated random sequence to sorafenib combined with transarterial chemoembolization or sorafenib alone. The primary endpoint was overall survival. Secondary endpoints were time to progression, tumor response rate, disease control rate and safety. Efficacy was analyzed in the intention-to-treat, per-protocol and as-treated populations. Safety outcomes were analyzed in the safety population. This trial is registered with ClinicalTrials.gov, number NCT01906216.
Findings
Between September 7, 2013, and Dec 4, 2019, 199 patients were randomly assigned, 99 to the combination group and 100 to the sorafenib alone group. Protocol adherence was 86% (85 of 99 patients) in the combination group and 56% (56 of 100 patients) in the sorafenib alone group. The most common reason for discontinuation was disease progression (68 [69%] in the combination group and 80 [80%] in the sorafenib alone group). The median age was 55 years (IQR 46-63). 164 (82.4%) of 199 were male and 35 (17.6%) were female. At a median follow-up of 13.6 months (IQR 6.8-28.2), in the intention-to-treat population, median overall survival was 14.9 months (95%CI 10.5-19.3 months) in the combination group versus 11.9 months (95%CI 9.0-14.8 months) in the sorafenib alone group (HR 0.862 [95%CI 0.645-1.150]; P=0.312). Median time to progression survival was significantly longer in the combination group than the sorafenib alone group (10.0 months [95%CI 6.4-13.6 months] vs 5.9 months [95%CI 3.1-8.7 months]; HR 0.686 [95%CI 0.515-0.954]; P=0.016). In the per-protocol and as-treated analyses, both median overall survival and time to progression was significantly improved in the combination group compared with sorafenib alone group.
Interpretation
In SELECT trial, sorafenib combined with TACE did not show overall survival benefit over sorafenib alone in intention-to-treat analysis; however, significantly longer overall survival benefit and improved time to progression was observed in both per-protocol and as-treated analyses.
{"title":"Sorafenib combined with transarterial chemoembolization compared with sorafenib alone in advanced hepatocellular carcinoma (SELECT): a multicenter, phase 3, randomized, controlled trial","authors":"Yan Zhao , Wei Bai , Rong Ding , Nan You , Lin Zheng , Lei Li , Jianbin Wu , Peng Zhang , Wukui Huang , Hui Zhang , Yongjin Zhang , Diwen Zhu , Haiping Li , Jie Yuan , Daiming Fan , Yong Lv , Guohong Han","doi":"10.1016/j.lanwpc.2024.101300","DOIUrl":"10.1016/j.lanwpc.2024.101300","url":null,"abstract":"<div><h3>Background</h3><div>Patients with advanced hepatocellular carcinoma have poor prognosis. We aimed to investigate the efficacy of sorafenib combined with transarterial chemoembolization in patients with advanced hepatocellular carcinoma.</div></div><div><h3>Method</h3><div>SELECT was a randomized, multi-centre, controlled, phase 3 trial done at twelve centres in China. Eligible patients were aged 18 years or older and had advanced-stage hepatocellular carcinoma, Barcelona Clinic Liver Cancer stage C diseases, Child-Pugh class A liver disease, Eastern Cooperative Oncology Group (ECOG) performance statuses of 0 or 1. Participants were randomly assigned (1:1) with a computer-generated random sequence to sorafenib combined with transarterial chemoembolization or sorafenib alone. The primary endpoint was overall survival. Secondary endpoints were time to progression, tumor response rate, disease control rate and safety. Efficacy was analyzed in the intention-to-treat, per-protocol and as-treated populations. Safety outcomes were analyzed in the safety population. This trial is registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, number NCT01906216.</div></div><div><h3>Findings</h3><div>Between September 7, 2013, and Dec 4, 2019, 199 patients were randomly assigned, 99 to the combination group and 100 to the sorafenib alone group. Protocol adherence was 86% (85 of 99 patients) in the combination group and 56% (56 of 100 patients) in the sorafenib alone group. The most common reason for discontinuation was disease progression (68 [69%] in the combination group and 80 [80%] in the sorafenib alone group). The median age was 55 years (IQR 46-63). 164 (82.4%) of 199 were male and 35 (17.6%) were female. At a median follow-up of 13.6 months (IQR 6.8-28.2), in the intention-to-treat population, median overall survival was 14.9 months (95%CI 10.5-19.3 months) in the combination group versus 11.9 months (95%CI 9.0-14.8 months) in the sorafenib alone group (HR 0.862 [95%CI 0.645-1.150]; P=0.312). Median time to progression survival was significantly longer in the combination group than the sorafenib alone group (10.0 months [95%CI 6.4-13.6 months] vs 5.9 months [95%CI 3.1-8.7 months]; HR 0.686 [95%CI 0.515-0.954]; P=0.016). In the per-protocol and as-treated analyses, both median overall survival and time to progression was significantly improved in the combination group compared with sorafenib alone group.</div></div><div><h3>Interpretation</h3><div>In SELECT trial, sorafenib combined with TACE did not show overall survival benefit over sorafenib alone in intention-to-treat analysis; however, significantly longer overall survival benefit and improved time to progression was observed in both per-protocol and as-treated analyses.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101300"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427888","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 : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101307
Xiujing Lin, Feifei Huang
<div><h3>Background</h3><div>The balance of risks and benefits associated with low-dose CT (LDCT) screening necessitates that high-risk individuals make informed decisions about lung cancer screening (LCS) based on their preferences. Patient decision aids (PDAs) can align these choices with patient values, and research indicates that message framing (gain vs. loss) significantly impacts decision-making. Despite extensive public health research on framing effects, there is limited understanding of how these messages can enhance LCS uptake. To address this gap, our research team developed the first LCS PDA in China, the LCS Loss-Gain Balance (LCS-LG-B), which integrates both gain-framed (emphasizing the benefits of healthy behaviors) and loss-framed (highlighting the costs of inaction) approaches. This study aims to investigate the effects of this PDA-based program on LCS behaviors among high-risk Chinese individuals.</div></div><div><h3>Methods</h3><div>An intervention was designed around the LCS-LG-B to increase LDCT screening rates among high-risk individuals. This intervention included lung cancer risk assessments, education on lung cancer and LCS, shared decision-making exercises, and support for screening behaviors (e.g., smoking cessation resources, LCS information, and patient-doctor communication groups). A randomized clinical pilot trial was conducted with 72 high-risk lung cancer individuals in southeastern China from May 10, 2023, to February 10, 2024, with follow-up until October 10, 2024. Participants were randomly assigned to either the loss-framed or gain-framed version of the LCS-LG-B. Outcomes assessed at baseline (T0), immediately after the intervention (T1), and at one (T2), three (T3), and six months (T4) included LCS knowledge, health beliefs, decision conflict, self-efficacy, preparation, regret, and LDCT rates. Data were analyzed using a generalized linear mixed model and Chi-square tests, and the study is registered at the Chinese Clinical Trial Registry (ChiCTR2300071171).</div></div><div><h3>Findings</h3><div>Sixty participants (30 from each group) completed all outcome measurements. Significant improvements were noted in decision conflict (F = 50.177, P < 0.001), self-efficacy (F = 57.505, P < 0.001), preparation (F = 45.599, P < 0.001), regret (F = 8.886, P < 0.001), LCS knowledge (F = 70.981, P < 0.001), health beliefs (F = 21.149, P < 0.001), perceived barriers (F = 20.020, P < 0.001), and perceived benefits (F = 3.098, P = 0.016). The mean perceived risk score was significantly higher in the loss-framed group at T2 (D = 1.533, P = 0.004), T3 (D = 1.900, P < 0.001), and T4 (D = 1.267, P = 0.017). However, there were no significant differences between groups in decision conflict, self-efficacy, preparation, regret, and LCS knowledge at T1, T2, T3, and T4 (P > 0.050). After the intervention, 12 participants (40.00%) in the loss-framed group underwent LDCT compared to 8 (26.67%) in the gain-fra
{"title":"Framing effects in decision aid-based lung cancer screening: a randomized clinical pilot trial in primary care","authors":"Xiujing Lin, Feifei Huang","doi":"10.1016/j.lanwpc.2024.101307","DOIUrl":"10.1016/j.lanwpc.2024.101307","url":null,"abstract":"<div><h3>Background</h3><div>The balance of risks and benefits associated with low-dose CT (LDCT) screening necessitates that high-risk individuals make informed decisions about lung cancer screening (LCS) based on their preferences. Patient decision aids (PDAs) can align these choices with patient values, and research indicates that message framing (gain vs. loss) significantly impacts decision-making. Despite extensive public health research on framing effects, there is limited understanding of how these messages can enhance LCS uptake. To address this gap, our research team developed the first LCS PDA in China, the LCS Loss-Gain Balance (LCS-LG-B), which integrates both gain-framed (emphasizing the benefits of healthy behaviors) and loss-framed (highlighting the costs of inaction) approaches. This study aims to investigate the effects of this PDA-based program on LCS behaviors among high-risk Chinese individuals.</div></div><div><h3>Methods</h3><div>An intervention was designed around the LCS-LG-B to increase LDCT screening rates among high-risk individuals. This intervention included lung cancer risk assessments, education on lung cancer and LCS, shared decision-making exercises, and support for screening behaviors (e.g., smoking cessation resources, LCS information, and patient-doctor communication groups). A randomized clinical pilot trial was conducted with 72 high-risk lung cancer individuals in southeastern China from May 10, 2023, to February 10, 2024, with follow-up until October 10, 2024. Participants were randomly assigned to either the loss-framed or gain-framed version of the LCS-LG-B. Outcomes assessed at baseline (T0), immediately after the intervention (T1), and at one (T2), three (T3), and six months (T4) included LCS knowledge, health beliefs, decision conflict, self-efficacy, preparation, regret, and LDCT rates. Data were analyzed using a generalized linear mixed model and Chi-square tests, and the study is registered at the Chinese Clinical Trial Registry (ChiCTR2300071171).</div></div><div><h3>Findings</h3><div>Sixty participants (30 from each group) completed all outcome measurements. Significant improvements were noted in decision conflict (F = 50.177, P < 0.001), self-efficacy (F = 57.505, P < 0.001), preparation (F = 45.599, P < 0.001), regret (F = 8.886, P < 0.001), LCS knowledge (F = 70.981, P < 0.001), health beliefs (F = 21.149, P < 0.001), perceived barriers (F = 20.020, P < 0.001), and perceived benefits (F = 3.098, P = 0.016). The mean perceived risk score was significantly higher in the loss-framed group at T2 (D = 1.533, P = 0.004), T3 (D = 1.900, P < 0.001), and T4 (D = 1.267, P = 0.017). However, there were no significant differences between groups in decision conflict, self-efficacy, preparation, regret, and LCS knowledge at T1, T2, T3, and T4 (P > 0.050). After the intervention, 12 participants (40.00%) in the loss-framed group underwent LDCT compared to 8 (26.67%) in the gain-fra","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101307"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427891","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 : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101292
Zhiyuan Fan , Shanrui Ma , Ye Gao , Feifan He , Xinqing Li , Wenqiang Wei
<div><h3>Background</h3><div>Esophageal squamous cell carcinoma (ESCC) and adenocarcinoma of the esophagogastric junction (AEJ) present significant health challenges in China, often diagnosed at advanced stages with poor prognoses. Screening is the pivotal strategy to relieve the burden of ESCC and AEJ in high-risk areas. Even though endoscopy has proven effective in the early detection of both cancers in high-prevalence regions, its invasiveness and resource-intensiveness make it impractical for large-scale screening. Therefore, developing a less invasive and readily accessible method with good diagnostic accuracy to identify high-risk individuals before endoscopy is urgently needed. We aim to evaluate the acceptability and accuracy of artificial intelligence (AI)-assisted sponge cytology tests using a novel cell collection device for ESCC and AEJ screening in Chinese high-risk regions.</div></div><div><h3>Methods</h3><div>Participants aged 50 years or older were recruited in five high-risk regions of ESCC and AEJ. Cells from esophagus and esophagogastric junction were collected using a novel and minimally invasive capsule sponge, and cytology slides were scanned by a trained AI system. The qualitative outcomes (indicating the location of abnormal cells) and quantitative outcomes (counts of total scanned cells, potentially abnormal cells and 105 cytological features) were reported. Participants scored acceptability immediately following the procedure on a scale of 0 (least) to 10 (most acceptable). Endoscopy was performed subsequently with biopsy as needed. Feature selection was performed using Boruta algorithm. Lasso logistic regression model was developed to predict a composite outcome of high-grade lesions (ESCC, AEJ and high-grade intraepithelial neoplasia), with cytological features and epidemiological features as the predictive features. Model performance was primarily measured with the area under the receiver operating characteristic curve (AUC). Internal validation of the prediction models was performed using the 1000-bootstrap resample.</div></div><div><h3>Findings</h3><div>A total of 1852 participants were enrolled and completed the study procedure. No serious adverse events were documented during the cell collection process, and acceptability scores were 10 (72.1%), 9 (19.8%), 8 (3.8%), 7 (1.5%) and 6 (0.9%). 30 (1.6%) participants were diagnosed with high-grade lesions confirmed by endoscopic biopsy. The lasso logistic model achieved an AUC of 0.902 (95%<em>CI</em>: 0.851, 0.952) for detecting high-grade lesions, outperforming that of the cytological diagnosis and the sole use of abnormal cell counts. Internal validation of the model by bootstrap analysis was used, and the mean AUC of the model was 0.9 (95%<em>CI</em>: 0.845, 0.944).</div></div><div><h3>Interpretation</h3><div>We demonstrate the safety and acceptability of AI-assisted sponge cytology in high-risk regions, with high accuracy for detecting ESCC, AEJ and their precursor
{"title":"Acceptability and accuracy of artificial intelligence–assisted sponge cytology for screening of esophageal squamous cell carcinoma and adenocarcinoma of the esophagogastric junction: a multi-center cohort study","authors":"Zhiyuan Fan , Shanrui Ma , Ye Gao , Feifan He , Xinqing Li , Wenqiang Wei","doi":"10.1016/j.lanwpc.2024.101292","DOIUrl":"10.1016/j.lanwpc.2024.101292","url":null,"abstract":"<div><h3>Background</h3><div>Esophageal squamous cell carcinoma (ESCC) and adenocarcinoma of the esophagogastric junction (AEJ) present significant health challenges in China, often diagnosed at advanced stages with poor prognoses. Screening is the pivotal strategy to relieve the burden of ESCC and AEJ in high-risk areas. Even though endoscopy has proven effective in the early detection of both cancers in high-prevalence regions, its invasiveness and resource-intensiveness make it impractical for large-scale screening. Therefore, developing a less invasive and readily accessible method with good diagnostic accuracy to identify high-risk individuals before endoscopy is urgently needed. We aim to evaluate the acceptability and accuracy of artificial intelligence (AI)-assisted sponge cytology tests using a novel cell collection device for ESCC and AEJ screening in Chinese high-risk regions.</div></div><div><h3>Methods</h3><div>Participants aged 50 years or older were recruited in five high-risk regions of ESCC and AEJ. Cells from esophagus and esophagogastric junction were collected using a novel and minimally invasive capsule sponge, and cytology slides were scanned by a trained AI system. The qualitative outcomes (indicating the location of abnormal cells) and quantitative outcomes (counts of total scanned cells, potentially abnormal cells and 105 cytological features) were reported. Participants scored acceptability immediately following the procedure on a scale of 0 (least) to 10 (most acceptable). Endoscopy was performed subsequently with biopsy as needed. Feature selection was performed using Boruta algorithm. Lasso logistic regression model was developed to predict a composite outcome of high-grade lesions (ESCC, AEJ and high-grade intraepithelial neoplasia), with cytological features and epidemiological features as the predictive features. Model performance was primarily measured with the area under the receiver operating characteristic curve (AUC). Internal validation of the prediction models was performed using the 1000-bootstrap resample.</div></div><div><h3>Findings</h3><div>A total of 1852 participants were enrolled and completed the study procedure. No serious adverse events were documented during the cell collection process, and acceptability scores were 10 (72.1%), 9 (19.8%), 8 (3.8%), 7 (1.5%) and 6 (0.9%). 30 (1.6%) participants were diagnosed with high-grade lesions confirmed by endoscopic biopsy. The lasso logistic model achieved an AUC of 0.902 (95%<em>CI</em>: 0.851, 0.952) for detecting high-grade lesions, outperforming that of the cytological diagnosis and the sole use of abnormal cell counts. Internal validation of the model by bootstrap analysis was used, and the mean AUC of the model was 0.9 (95%<em>CI</em>: 0.845, 0.944).</div></div><div><h3>Interpretation</h3><div>We demonstrate the safety and acceptability of AI-assisted sponge cytology in high-risk regions, with high accuracy for detecting ESCC, AEJ and their precursor","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101292"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427600","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 : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101342
Yiwen Lu, Xinyu Ou, Zhihan Liu, Shicheng Su
Background
Tumescence and sharp or electrocautery techniques have been employed during skin flap development in minimal access nipple-sparing mastectomy (NSM) with immediate prosthesis breast reconstruction. Our study evaluated the impact of techniques on complications after this surgery.
Methods
In this real-world retrospective cohort study, 5436 individuals undergoing NSM from 12 centers in China were identified. After exclusions and propensity score matching (PSM), a total of 1252 female breast cancer patients who underwent minimal access NSM with immediate prosthesis breast reconstruction between January 2016 and December 2022 were included. The effect of surgical techniques on the perioperative outcomes and postoperative complications was investigated using logistic regression analysis. The level of significance was set at P< .05.
Findings
After PSM, we found that patients in the tumescence and sharp dissection group (n=313) experienced significantly lower rates of necrotic complications (5.8% vs 13.0%; P= .001), infection (2.6% vs 5.6%; P= .041), implant loss (0.3% vs 2.2%; P= .025), and had shorter mean operation time (median [IQR] min, 177.0 [132.0-219.0] min, and 201.0 [143.0-249.0] min; P< .001), compared with those in the electrocautery dissection group (n=939).
Interpretation
Tumescence and sharp dissection might be a better option in skip flap development during minimal access NSM with immediate prosthesis breast reconstruction, in regard to operation time and surgical complications. A limitation is the variation in surgeons’ skills across multiple centers.
Funding
National Key Research and Development Program of China (2023YFC3404500), the Natural Science Foundation of China (92057210, 82125017, 82173064, 92359302, 82322030), Science and Technology Program of Guangzhou (202103000070, 202201020479), and the New Cornerstone Science Foundation through the New Cornerstone Investigator Program and the XPLORER PRIZE.
{"title":"Tumescence and sharp versus electrocautery dissection in minimal access mastectomy: a real-world retrospective cohort study","authors":"Yiwen Lu, Xinyu Ou, Zhihan Liu, Shicheng Su","doi":"10.1016/j.lanwpc.2024.101342","DOIUrl":"10.1016/j.lanwpc.2024.101342","url":null,"abstract":"<div><h3>Background</h3><div>Tumescence and sharp or electrocautery techniques have been employed during skin flap development in minimal access nipple-sparing mastectomy (NSM) with immediate prosthesis breast reconstruction. Our study evaluated the impact of techniques on complications after this surgery.</div></div><div><h3>Methods</h3><div>In this real-world retrospective cohort study, 5436 individuals undergoing NSM from 12 centers in China were identified. After exclusions and propensity score matching (PSM), a total of 1252 female breast cancer patients who underwent minimal access NSM with immediate prosthesis breast reconstruction between January 2016 and December 2022 were included. The effect of surgical techniques on the perioperative outcomes and postoperative complications was investigated using logistic regression analysis. The level of significance was set at P< .05.</div></div><div><h3>Findings</h3><div>After PSM, we found that patients in the tumescence and sharp dissection group (n=313) experienced significantly lower rates of necrotic complications (5.8% vs 13.0%; P= .001), infection (2.6% vs 5.6%; P= .041), implant loss (0.3% vs 2.2%; P= .025), and had shorter mean operation time (median [IQR] min, 177.0 [132.0-219.0] min, and 201.0 [143.0-249.0] min; P< .001), compared with those in the electrocautery dissection group (n=939).</div></div><div><h3>Interpretation</h3><div>Tumescence and sharp dissection might be a better option in skip flap development during minimal access NSM with immediate prosthesis breast reconstruction, in regard to operation time and surgical complications. A limitation is the variation in surgeons’ skills across multiple centers.</div></div><div><h3>Funding</h3><div><span>National Key Research and Development Program of China</span> (2023YFC3404500), the <span>Natural Science Foundation of China</span> (92057210, 82125017, 82173064, 92359302, 82322030), <span>Science and Technology Program of Guangzhou</span> (202103000070, 202201020479), and the <span>New Cornerstone Science Foundation</span> through the New Cornerstone Investigator Program and the XPLORER PRIZE.</div></div>","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101342"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427607","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 : 2025-02-01DOI: 10.1016/j.lanwpc.2024.101289
Ho Cheung William LI , Wei Xia , Lishan Li , Oi Kwan Chung
<div><h3>Background</h3><div>Smoking causes multiple types of cancers and chronic respiratory diseases. Evidence also shows that exposure to second-hand smoke for non-smoking spouses of smokers increases their risk of developing lung cancer by 20-30%. To better prevent the growth of cancer, it is crucial to help people quit smoking. We evaluated the effectiveness of a brief self-determination theory-based smoking cessation for smokers at emergency departments (ED) in China Hong Kong in real-world settings.</div></div><div><h3>Methods</h3><div>A multicentre, single-arm, open-label, nonrandomized trial was conducted at four EDs of public hospitals in China Hong Kong. Current smokers aged 18 years or older and triaged as semi-urgent or non-urgent were included. Participants received brief counselling using the AWARD (Ask, Warn, Advise, Refer and Do-it-again) model, and active referral provided by trained health care professionals (HCPs). Referred participants received proactive telephone calls offering cessation counselling from the referred smoking cessation service provider. The primary outcome was biochemically validated abstinence at 6 months. The trial was prospectively registered in <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (Identifier <span><span>NCT03818360</span><svg><path></path></svg></span>).</div></div><div><h3>Findings</h3><div>Between 30 August 2019 and 26 November 2021, 1601 eligible individuals were enrolled and included in the analyses. Most participants were males (1443/1601, 90%) and participants' mean age was 48 (standard deviation=15) years. By intention-to-treat analysis, biochemically validated abstinence in the referred group was significantly higher than that in the unreferred group at the 6- (5·3% vs. 3·6%; adjusted OR 1·88, 95% CI, 1·01–3·41; p=0·04) and 12-month follow-up (8·1% vs. 3·5%; adjusted OR 2·98, 95% CI, 1·70–5·19; p<0·001).</div></div><div><h3>Interpretation</h3><div>This trial demonstrated that brief advice and active referral for smokers attending the ED were effective and feasible in real-world settings. This innovative and cost-effective approach could motivate HCPs to assist more smokers with cessation in routine clinical settings and improve smoking abstinence levels. This research could have significant long-term implications for the healthcare industry, particularly in preventing the development of cancers caused by smoking. It will help reduce healthcare expenditure and socioeconomic burden by reducing the risk of morbidity and mortality. Importantly, in the long term, this will help improve the physical health and health-related quality of life of the Chinese public, especially vulnerable groups such as women and children, by avoiding exposure to second-hand smoke. This will ultimately save more lives, protect the environment and promote sustainable development.</div></div><div><h3>Funding</h3><div>Health Care Promotion Scheme, <span>Food and Health Bureau</span>, Hong Ko
{"title":"Better control of cancer in China by helping people quit smoking","authors":"Ho Cheung William LI , Wei Xia , Lishan Li , Oi Kwan Chung","doi":"10.1016/j.lanwpc.2024.101289","DOIUrl":"10.1016/j.lanwpc.2024.101289","url":null,"abstract":"<div><h3>Background</h3><div>Smoking causes multiple types of cancers and chronic respiratory diseases. Evidence also shows that exposure to second-hand smoke for non-smoking spouses of smokers increases their risk of developing lung cancer by 20-30%. To better prevent the growth of cancer, it is crucial to help people quit smoking. We evaluated the effectiveness of a brief self-determination theory-based smoking cessation for smokers at emergency departments (ED) in China Hong Kong in real-world settings.</div></div><div><h3>Methods</h3><div>A multicentre, single-arm, open-label, nonrandomized trial was conducted at four EDs of public hospitals in China Hong Kong. Current smokers aged 18 years or older and triaged as semi-urgent or non-urgent were included. Participants received brief counselling using the AWARD (Ask, Warn, Advise, Refer and Do-it-again) model, and active referral provided by trained health care professionals (HCPs). Referred participants received proactive telephone calls offering cessation counselling from the referred smoking cessation service provider. The primary outcome was biochemically validated abstinence at 6 months. The trial was prospectively registered in <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (Identifier <span><span>NCT03818360</span><svg><path></path></svg></span>).</div></div><div><h3>Findings</h3><div>Between 30 August 2019 and 26 November 2021, 1601 eligible individuals were enrolled and included in the analyses. Most participants were males (1443/1601, 90%) and participants' mean age was 48 (standard deviation=15) years. By intention-to-treat analysis, biochemically validated abstinence in the referred group was significantly higher than that in the unreferred group at the 6- (5·3% vs. 3·6%; adjusted OR 1·88, 95% CI, 1·01–3·41; p=0·04) and 12-month follow-up (8·1% vs. 3·5%; adjusted OR 2·98, 95% CI, 1·70–5·19; p<0·001).</div></div><div><h3>Interpretation</h3><div>This trial demonstrated that brief advice and active referral for smokers attending the ED were effective and feasible in real-world settings. This innovative and cost-effective approach could motivate HCPs to assist more smokers with cessation in routine clinical settings and improve smoking abstinence levels. This research could have significant long-term implications for the healthcare industry, particularly in preventing the development of cancers caused by smoking. It will help reduce healthcare expenditure and socioeconomic burden by reducing the risk of morbidity and mortality. Importantly, in the long term, this will help improve the physical health and health-related quality of life of the Chinese public, especially vulnerable groups such as women and children, by avoiding exposure to second-hand smoke. This will ultimately save more lives, protect the environment and promote sustainable development.</div></div><div><h3>Funding</h3><div>Health Care Promotion Scheme, <span>Food and Health Bureau</span>, Hong Ko","PeriodicalId":22792,"journal":{"name":"The Lancet Regional Health: Western Pacific","volume":"55 ","pages":"Article 101289"},"PeriodicalIF":7.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143427660","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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