Respiratory tract tumours

呼吸道肿瘤
  • 文章类型: Journal Article
    目的:本系统评价的目的是探索肺结节管理中关于共同决策(SDM)的证据。
    方法:定量和定性研究的系统评价。
    方法:截至2022年4月以英文或中文发表的研究来自9个数据库:PubMed,PsycINFO,EMBASE,科克伦图书馆,WebofScience和CINAHL,中国国家知识基础设施,万方数据和中国计量数据。
    方法:如果患者或医疗保健提供者面临肺结节管理选择,或者干预措施或经验侧重于患者与医疗保健提供者的关系或健康教育,增加或支持共同决策。所有类型的研究都包括在内,包括定量和定性研究。灰色文献和未经同行评审的文献被排除。海报摘要和非实证出版物,如社论,信件,意见书和评论文章被排除在外。
    方法:两名评审员独立筛选摘要和全文,使用乔安娜·布里格斯研究所的关键评估工具评估质量,并从纳入的研究中提取数据。专题综合用于确定数据中出现的突出主题。
    结果:共有12项研究符合纳入标准,其中11起是在美国进行的。其中包括六项定性研究和六项定量研究(包括调查和准实验设计)。出现了具有特定子主题的三个主要主题:(1)机会(肺结节的诊断和治疗中的不确定性,参与决策的意愿);(2)能力(患者缺乏知识,医生的经验);和(3)不同的世界观(误解,患者中的痛苦,对诊断和治疗的偏好)。
    结论:肺结节管理的不确定性是实施SDM的机会。病人缺乏知识,苦恼,医疗服务提供者和患者之间的误解是应用SDM的主要障碍和原因。
    OBJECTIVE: The objective of this systematic review was to explore the evidence regarding shared decision-making (SDM) in the management of pulmonary nodules.
    METHODS: Systematic review of quantitative and qualitative studies.
    METHODS: Studies published in English or Chinese up to April 2022 were extracted from nine databases: PubMed, PsycINFO, EMBASE, Cochrane Library, Web of Science and CINAHL, China National Knowledge Infrastructure, Wanfang Data and SinoMed Data.
    METHODS: Studies were eligible if patients or healthcare providers are faced with pulmonary nodule management options or the interventions or experiences were focused on the patient-healthcare provider relationship or health education to make, increase or support shared decisions. All types of studies were included, including quantitative and qualitative studies. Grey literature and literature that had not been peer reviewed were excluded. Poster abstracts and non-empirical publications such as editorials, letters, opinion papers and review articles were excluded.
    METHODS: Two reviewers independently screened abstracts and full texts, assessed quality using Joanna Briggs Institute\'s critical appraisal tools, and extracted data from included studies. Thematic syntheses were used to identify prominent themes emerging from the data.
    RESULTS: A total of 12 studies met the inclusion criteria, 11 of which were conducted in USA. These included six qualitative studies and six quantitative studies (including both survey and quasi-experimental designs). Three major themes with specific subthemes emerged: (1) Opportunity (uncertainty in the diagnosis and treatment of pulmonary nodules, willingness to participate in decision-making); (2) Ability (patient\'s lack of knowledge, physician\'s experience); and (3) Different worldview (misconception, distress among patients, preference for diagnosis and treatment).
    CONCLUSIONS: Uncertainty in the management of pulmonary nodules is the opportunity to implement SDM. Patients\' lack of knowledge, distress, and misunderstandings between healthcare providers and patients are both the main obstacles and the causes of the application of SDM.
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  • 文章类型: Journal Article
    背景:非小细胞肺癌(NSCLC)预后不良。经血管介入是治疗NSCLC的重要方法。药物洗脱珠支气管动脉化学栓塞术(DEB-BACE)是一种使用装载有化疗药物的DEB用于BACE的技术。本研究旨在进行荟萃分析,以全面评估DEB-BACE治疗NSCLC的有效性和安全性,并探讨NSCLC的新治疗策略。
    方法:万方,中国国家知识基础设施,Medline(通过PubMed),科克伦图书馆,Scopus和Embase数据库将于2024年11月进行搜索。将进行荟萃分析以评估DEB-BACE治疗NSCLC的有效性和安全性。将应用以下关键字:“癌症,非小细胞肺\",“非小细胞肺癌”,“药物洗脱珠支气管动脉化疗栓塞”和“药物洗脱珠”。将包括中文或英文报告,比较DEB-BACE与其他NSCLC治疗方案的疗效。病例报告,单臂研究,会议文件,没有全文的摘要和以英文和中文以外的语言发表的报告将不被考虑。Cochrane干预措施系统评价手册将用于独立评估每个纳入研究的偏倚风险。在研究之间存在显著异质性的情况下,异质性的可能来源将通过亚组和敏感性分析进行探索。为了对数据进行统计分析,将使用RevManV.5.3。
    背景:这项荟萃分析将在完成后寻求在同行评审的期刊上发表。这项研究不需要伦理批准,因为它是一项基于数据库的研究。
    CRD42023411392。
    BACKGROUND: Non-small cell lung cancer (NSCLC) has a poor prognosis. Transvascular intervention is an important approach for treating NSCLC. Drug-eluting bead bronchial artery chemoembolisation (DEB-BACE) is a technique of using DEBs loaded with chemotherapeutic drugs for BACE. This study aims to conduct a meta-analysis to comprehensively assess the effectiveness and safety of DEB-BACE in treating NSCLC and investigate a novel therapeutic strategy for NSCLC.
    METHODS: Wanfang, China National Knowledge Infrastructure, Medline (via PubMed), Cochrane Library, Scopus and Embase databases will be searched in November 2024. A meta-analysis will be conducted to assess the effectiveness and safety of DEB-BACE in the treatment of NSCLC. The following keywords will be applied: \"Carcinoma, Non-Small-Cell Lung\", \"Non-Small Cell Lung Cancer\", \"Drug-Eluting Bead Bronchial Arterial Chemoembolization\" and \"drug-eluting beads\". Reports in Chinese or English comparing the efficacy of DEB-BACE with other NSCLC treatment options will be included. Case reports, single-arm studies, conference papers, abstracts without full text and reports published in languages other than English and Chinese will not be considered. The Cochrane Handbook for Systematic Reviews of Interventions will be used to independently assess the risk of bias for each included study. In case of significant heterogeneity between studies, possible sources of heterogeneity will be explored through subgroup and sensitivity analysis. For the statistical analysis of the data, RevMan V.5.3 will be used.
    BACKGROUND: This meta-analysis will seek publication in a peer-reviewed journal on completion. Ethical approval is not required for this study as it is a database-based study.
    UNASSIGNED: CRD42023411392.
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  • 文章类型: Journal Article
    目的:CAPSTONE-1试验表明,对于广泛期小细胞肺癌(ES-SCLC)患者,基于adebrelimab的免疫治疗与化疗相比具有良好的生存获益。本研究旨在从中国医疗系统的角度评估这种免疫治疗治疗ES-SCLC的成本效益。
    方法:使用TreeAgePro软件建立三态分区生存模型。生存数据来自CAPSTONE-1试验(NCT03711305),只包括直接医疗费用。从公开的文献中获得效用值。进行敏感性分析以探索模型的稳健性。通过各种环境中的情景和探索性分析研究了免疫治疗的成本效益。
    方法:总成本,增量成本,生命岁月,质量调整寿命年(QALYs),增量QALY和增量成本效益比(ICER)。
    结果:基本分析显示,adebrelimab组以65385美元的成本获得了总共1.1个QALYs,而安慰剂组以12741美元的成本获得了0.78个QALYs。ICER为163893美元/QALY。敏感性分析证实了该模型是稳健的。情景分析和探索性分析的结果表明,在任何情景下,adebrelimab和化疗的组合均未显示出成本效益。
    结论:从中国医疗体系的角度来看,与化疗相比,adebrelimab联合化疗治疗ES-SCLC并不经济.
    OBJECTIVE: The CAPSTONE-1 trial demonstrated that adebrelimab-based immunotherapy yielded a favourable survival benefit compared with chemotherapy for patients with extensive-stage small cell lung cancer (ES-SCLC). This study aims to evaluate the cost-effectiveness of this immunotherapy in the treatment of ES-SCLC from a healthcare system perspective in China.
    METHODS: The TreeAge Pro software was used to establish a three-state partitioned survival model. Survival data came from the CAPSTONE-1 trial (NCT03711305), and only direct medical costs were included. Utility values were obtained from the published literature. Sensitivity analysis was performed to explore the robustness of the model. The cost-effectiveness of immunotherapy was investigated through scenario and exploratory analyses in various settings.
    METHODS: Total costs, incremental costs, life years, quality-adjusted life-years (QALYs), incremental QALYs and incremental cost-effectiveness ratio (ICER).
    RESULTS: The basic analysis revealed that the adebrelimab group achieved a total of 1.1 QALYs at a cost of US$65 385, while the placebo group attained 0.78 QALYs at a cost of US$12 741. ICER was US$163 893/QALY. Sensitivity analysis confirmed that the model was robust. Results from scenario and exploratory analyses indicated that the combination of adebrelimab and chemotherapy did not demonstrate cost-effectiveness in any scenario.
    CONCLUSIONS: From the perspective of the Chinese healthcare system, adebrelimab in combination with chemotherapy for the treatment of ES-SCLC was not economical compared with chemotherapy.
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  • 文章类型: Journal Article
    目的:本研究的目的是从美国付款人的角度评估Durvalumab联合化疗与单纯化疗作为转移性非小细胞肺癌(NSCLC)一线治疗的成本效益。
    方法:基于POSEIDON临床试验,我们建立了分区生存模型,以比较durvalumab联合化疗与单纯化疗一线治疗转移性NSCLC的成本-效果.该模型的主要结果是成本,生命年(LYs),质量调整LYs(QALYs)和增量成本效益比(ICER)。分析只考虑了直接医疗费用,并使用已发表的文献确定健康效用值。通过概率敏感性分析检验了模型的稳健性。
    结果:与单纯化疗相比,durvalumab和化疗的联合治疗增加了0.713个QALYs的生存率,增加了$64104.638,从美国付款人的角度来看,每QALY的ICER为89908.328美元。基于递增的净健康福利,联合疗法在每QALY15万美元的支付意愿阈值下具有92.3%的成本效益。敏感性分析证实了模型的一致性,并且没有任何参数显着影响结果。
    结论:Durvalumab联合化疗是美国转移性非小细胞肺癌一线治疗与单纯化疗相比更具成本效益的策略。
    The objective of this study was to evaluate the cost-effectiveness of durvalumab in combination with chemotherapy compared with chemotherapy alone as first-line therapy for metastatic non-small-cell lung cancer (NSCLC) from the perspective of the US payer.
    Based on the POSEIDON clinical trial, a partition survival model was developed to compare the cost-effectiveness of durvalumab in combination with chemotherapy versus chemotherapy alone for the first-line treatment of metastatic NSCLC. The model\'s primary outcomes were costs, life years (LYs), quality-adjusted LYs (QALYs) and the incremental cost-effectiveness ratio (ICER). The analysis only considered direct medical costs, and health utility value was determined using published literature. The robustness of the model was tested by probabilistic sensitivity analyses.
    The combination therapy of durvalumab and chemotherapy improved survival by 0.713 QALYs at an incremental cost of $64 104.638 compared with chemotherapy alone, resulting in an ICER of $89 908.328 per QALY gained from the US payer perspective. The combination therapy had a 92.3% probability of being cost-effective at a willingness-to-pay threshold of $150 000 per QALY based on incremental net health benefits. Sensitivity analyses confirmed the model\'s consistency, and none of the parameters significantly influenced the findings.
    Durvalumab in combination with chemotherapy represents a more cost-effective strategy for first-line therapy in patients with metastatic NSCLC in the USA compared with chemotherapy alone.
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  • 文章类型: Journal Article
    背景:肺结节是最常见的疾病之一。医学影像学方法对鉴别恶性结节和良性结节具有较高的假阳性率。因此,开发高精度筛查恶性结节的新技术对肺结节监测具有重要意义。使用流式细胞术检测血液巨噬细胞中的生物标志物(巨噬细胞/巨噬细胞中的表位检测)为癌症的早期和非侵入性诊断开辟了新时代。这项计划中的研究旨在检查外周血巨噬细胞因子Apo10和TKTL1是否准确区分恶性结节和良性结节。
    方法:我们计划在这项研究中招募3825名患有肺结节的参与者,他们将在中山大学肿瘤中心参加他们的年度体检。所有患者的Apo10和TKTL1水平将在他们最后一餐后60分钟在他们的3年随访期间进行测试。将收集活检或手术病理结果作为金标准,以评估Apo10和TKTL1在区分恶性结节和良性结节方面的准确性。敏感性,特异性,正预测值,负预测值和接收工作特性曲线下的面积也将被评估。
    背景:该研究得到了中山大学医学伦理委员会的批准(SL-G2022-005-02)。这项研究的结果将在国际科学会议的同行评审出版物和演讲中传播,也将传播给与会者。
    背景:ChiCTR2300073823;预结果。
    Lung nodules are one of the most prevalent diseases. Medical imaging methods have a high false positive rate for distinguishing malignant nodules from benign nodules. Therefore, developing new technologies with high accuracy for screening malignant nodules is of great importance for lung nodule surveillance. Use of flow cytometry to detect biomarkers in blood macrophages (epitop detect in macrophages/macrophages) has opened a new era for early and noninvasive diagnosis of cancer. This planned study aims to examine whether the peripheral blood macrophage factors Apo10 and TKTL1 accurately distinguish malignant nodules from benign nodules.
    We plan to enrol in this study 3825 participants with lung nodules who will attend their annual physical examination at Sun Yat-sen University Cancer Center. Apo10 and TKTL1 levels in all patients will be tested at 60 min after their last meal every 6 months during their 3-year follow-up. Biopsy or surgical pathology results will be collected as the gold standard to assess the accuracy of Apo10 and TKTL1 in distinguishing malignant nodules from benign nodules. The sensitivity, specificity, positive predictive value, negative predictive value and area under the receiving operating characteristic curve will also be evaluated.
    The study is approved by the medical ethics committee of Sun Yat-sen University (SL-G2022-005-02). The results of this study will be disseminated in peer-reviewed publications and presentations at international scientific meetings and will also be disseminated to the participants.
    ChiCTR2300073823; Pre-results.
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  • 文章类型: Meta-Analysis
    目的:ASTRUM-005试验显示,与化疗相比,serplulimab联合化疗(SEP)治疗小细胞肺癌的生存期明显延长。但是SEP的生存利益成本很高,它的经济并不清楚。因此,本研究旨在从中国医疗保健系统的角度评估SEP的成本效益。
    方法:建立分区生存模型来模拟结果。临床数据来自ASTRUM-005试验,模型中只包含直接医疗费用。效用值参考已发表的文献。情景分析1和2在存在患者援助计划(PAP)和不同模拟时段的情况下探索结果,分别。情景分析3通过网络荟萃分析比较了阿特珠单抗联合化疗(AEP)与SEP的成本-效果。进行敏感性分析以评估结果的稳健性。
    方法:总成本,增量成本,生命岁月,质量调整生命年(QALYs),增量QALY和增量成本效益比(ICER)。
    结果:与化疗相比,SEP实现了额外的0.34QALY,增量成本为41682.63美元,ICER为122378.86美元/QALY。当PAP可用时,ICER为58316.46美元/QALY。在5年和20年的模拟时间内,ICER为132637.97美元/QALY和118054.59美元/QALY,分别。与AEP相比,SEP不仅将成本降低了47244.87美元,而且还增加了0.07个QALY。敏感性分析表明,serplulimab的价格和无进展生存期的效用价值是主要影响参数,结果稳定。
    结论:与化疗相比,从中国医疗保健系统的角度来看,SEP并不划算。然而,与AEP相比,SEP绝对占主导地位。
    The ASTRUM-005 trial showed that serplulimab plus chemotherapy (SEP) significantly extended survival time compared with chemotherapy in the treatment of small cell lung cancer. But the survival benefits of SEP came at high costs, and its economy is not clear. Therefore, this study aimed to evaluate the cost-effectiveness of SEP from the perspective of the Chinese healthcare system.
    A partition survival model was built to simulate the outcomes. The clinical data came from the ASTRUM-005 trial, and only direct medical costs were included in the model. The utility values referred to the published literature. Scenario analyses 1 and 2 explored outcomes in the presence of a patient assistance plan (PAP) and different simulation periods, respectively. Scenario analysis 3 compared the cost-effectiveness of atezolizumab plus chemotherapy (AEP) with SEP by network meta-analysis. Sensitivity analyses were conducted to assess the robustness of the results.
    Total costs, incremental costs, life years, quality-adjusted life years (QALYs), incremental QALYs and incremental cost-effectiveness ratio (ICER).
    Compared with chemotherapy, SEP achieved an additional 0.34 QALYs at incremental costs of US$41 682.63, with an ICER of US$122 378.86/QALY. When PAP was available, ICER was US$58 316.46/QALY. In the simulation time of 5 years and 20 years, the ICER was US$132 637.97/QALY and US$118 054.59/QALY, respectively. When compared with AEP, SEP not only reduced the costs by US$47 244.87 but also gained 0.07 QALYs more. Sensitivity analyses showed that the price of serplulimab and the utility value of the progression-free survival stage were the main influencing parameters, and the results were stable.
    Compared with chemotherapy, SEP was not cost-effective from the perspective of the Chinese healthcare system. However, SEP was absolutely dominant in comparison with AEP.
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  • 文章类型: Journal Article
    目的:2018年12月,中国启动了全国批量采购(NVBP),与制造商协商药品价格。吉非替尼是25种试点药物之一,用于治疗非小细胞肺癌。肺癌是中国最常见的癌症类型,吉非替尼等靶向药物已被证明可以为患者提供临床益处。本研究旨在探讨NVBP政策对抗癌药物使用和支出的影响。
    方法:吉非替尼和替代药物(埃克替尼和厄洛替尼)作为研究对象。使用来自中国9454家医院的中国医院药物审核数据库的季度数据进行分析。以购买量和支出为变量进行描述性分析。中断时间序列(ITS)分析用于进一步分析NVBP政策对研究药物的影响。
    结果:在NVBP政策之前(2018Q2-2019Q1)和之后(2019Q2-2020Q1)的12个月期间,药品采购总量从448万份规定日剂量(DDD)上升到702万份,增长56.66%。吉非替尼和替代药物的采购量增长了100.61%和14.88%,分别。NVBP政策实施后,替代药物的采购量减少72051DDD(p值=0.044),趋势变化减少56738DDD(p值<0.01)。整体开支减少14.7%,吉非替尼的支出减少38.47%,替代药物增加10.70%。ITS分析表明,药物总支出和吉非替尼的水平和趋势变化具有统计学意义。
    结论:本研究提供的证据表明,NVBP政策的实施与第一代抗EGFR肺癌药物的支出减少有关。该政策在保证药品使用的同时,有效控制了相应药品支出的增长。
    In December 2018, China launched national volume-based procurement (NVBP) to negotiate drug prices with manufacturers. Gefitinib was one of the 25 pilot drugs, which is used for treatment of non-small cell lung cancer. Lung cancer is the most common type of cancer in China and targeted drugs like gefitinib have been proven to provide clinical benefits to patients. This study aims to explore the impact of NVBP policy on the usage and expenditure of anticancer drugs.
    Gefitinib and alternative drugs (icotinib and erlotinib) were used as objects of study. Quarterly data from the China Hospital Pharmaceutical Audit database in 9454 hospitals in China were used for analysis. Descriptive analysis was conducted using purchase volume and expenditure as variables. Interrupted time-series (ITS) analysis was applied to further analyse the effect of NVBP policy on the medicines under study.
    During the 12-month period before (2018Q2-2019Q1) and after (2019Q2-2020Q1) the NVBP policy, the total purchase volume of medicines rose from 4.48 million defined daily dose (DDD) to 7.02 million DDD, with an increase of 56.66%. Purchase volume of gefitinib and alternative drugs increased 100.61% and 14.88%, respectively. After the implementation of NVBP policy, procurement volume of alternative drugs decreased by 72 051 DDD (p value=0.044) and trend change decreased by 56 738 DDD (p value<0.01). The overall expenditure reduction was 14.7%, with the expenditure of gefitinib reducing by 38.47% and alternative drugs increasing by 10.70%. ITS analysis indicated statistically significant differences in level and trend changes for expenditure of total drugs and gefitinib.
    The evidence provided in this study indicated that the implementation of NVBP policy was related to the expenditure reduction of the first generation of anti-EGFR lung cancer drugs. The policy effectively controlled the increase in expenditures for corresponding drugs while ensuring the use of drugs.
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  • 文章类型: Clinical Trial Protocol
    背景:肺癌仍然是一种高度致命的疾病。手术切除已被证明是早期肺癌最有效的治疗方法。传统的基于医院的肺康复(PR)被证明可以减轻症状,改善肺癌患者的运动能力并影响其生活质量(QoL)。迄今为止,关于家庭PR对肺癌术后患者的有效性的科学证据很少.我们的目的是探讨肺癌患者手术切除后家庭PR是否不劣于门诊PR。
    方法:这项研究是一项双臂研究,平行组,评估员-盲,单中心,随机对照试验。参加者将从华西医院招募,四川大学以1:1的比例随机分配到门诊组或家庭组。公关计划涉及自我管理和练习。练习包括热身(10分钟),有氧训练(20分钟)阻力训练(15分钟)和降温(10分钟),持续4周,每周两次在家里或门诊。强度将根据每次锻炼前后的感知劳累和心率的修改后的Borg等级进行调整。主要结果是干预后通过EORTCQLQ-C30和LC13测量的QoL。次要结果包括通过6分钟步行测试和爬楼梯测试测量的身体健康,以及通过患者报告的问卷和肺功能测量的症状严重程度。主要假设是,对于手术切除后的肺癌患者,基于家庭的PR不劣于门诊PR。
    背景:该试验已获得华西医院伦理委员会的批准,并在中国临床试验注册中心注册。这项研究的结果将通过同行评审的出版物和在国家和国际会议上的演讲进行传播。
    背景:ChiCTR2100053714。
    Lung cancer remains a highly fatal disease. Surgical resection has been proven to be the most effective treatment for early-stage lung cancer. The conventional hospital-based pulmonary rehabilitation (PR) is shown to reduce symptoms, improve exercise capacity and impact the quality of life (QoL) for lung cancer patients. To date, scientific evidence on the effectiveness of home-based PR for patients with lung cancer following surgery is scarce. We aim to explore if home-based PR is non-inferior to outpatient PR for patients with lung cancer following surgical resection.
    This study is a two-arm, parallel-group, assessor-blind, single-centre, randomised controlled trial. Participants will be recruited from West China Hospital, Sichuan University and randomly allocated to either an outpatient group or a home-based group at a ratio of 1:1. The PR programme involves self-management and exercises. The exercise includes warm-up (10 min), aerobic training (20 min), resistance training (15 min) and cool-down (10 min), lasting 4 weeks, with two sessions per week either at home or in the outpatient setting. The intensity will be adjusted according to the modified Borg rating of perceived exertion and heart rate before and after each exercise session. The primary outcome is QoL measured by EORTC QLQ-C30 & LC 13 after an intervention. Secondary outcomes include physical fitness measured by a 6 min walk test and stair-climbing test and symptom severity measured by patient-reported questionnaires and pulmonary function. The main hypothesis is that home-based PR is non-inferior to outpatient PR for patients with lung cancer following surgical resection.
    The trial has been approved by the Ethical Committee of West China Hospital and is also registered with the Chinese Clinical Trial Registry. The results of this study will be disseminated through peer-reviewed publications and presentations at national and international conferences.
    ChiCTR2100053714.
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  • 文章类型: Journal Article
    背景:术后肺部并发症(PPCs)发生在60%的非心脏胸外科手术(NCTS)后,特别是对于多患老年患者。然而,当前PPC的风险预测模型在推导和验证方面存在主要限制,并且不考虑NCTS患者的特定风险。针对老年NCTS患者的有充分依据和外部验证的模型必须告知同意和治疗决定。
    方法:我们将开发,内部和外部验证多变量风险模型来预测老年NCTS患者的30天PPC。我们的队列将在2021年10月至2023年12月期间在中国南方的三个研究地点生成,目标人群约为1400。根据公布的数据选择了候选预测因子,临床专业知识和流行病学知识。我们的模型将使用多变量逻辑回归和自举技术相结合来减少预测因子。最终模型将使用自举验证技术进行内部验证,并使用来自不同研究地点的数据进行外部验证。然后,将根据逻辑模型得出的β估计得出一个简约的风险评分。模型性能将使用接收器工作特性曲线下的面积进行评估,最大重新缩放Brier分数和校准斜率。在探索性分析中,我们还将使用决策曲线分析在完整队列中评估老年患者中与胸外科手术相关的PPC的净获益概率评分.
    背景:已获得广州医科大学附属肿瘤医院机构审查委员会和研究所的伦理批准,广州中医药大学第二附属医院和香港大学深圳医院,分别。最终的风险预测模型将在适当的期刊上发表,并作为临床应用的在线计算器或列线图进一步传播。将共享批准和匿名数据。
    背景:ChiCTR2100051170。
    Postoperative pulmonary complications (PPCs) occur after up to 60% of non-cardiac thoracic surgery (NCTS), especially for multimorbid elderly patients. Nevertheless, current risk prediction models for PPCs have major limitations regarding derivation and validation, and do not account for the specific risks of NCTS patients. Well-founded and externally validated models specific to elderly NCTS patients are warranted to inform consent and treatment decisions.
    We will develop, internally and externally validate a multivariable risk model to predict 30-day PPCs in elderly NCTS patients. Our cohort will be generated in three study sites in southern China with a target population of approximately 1400 between October 2021 and December 2023. Candidate predictors have been selected based on published data, clinical expertise and epidemiological knowledge. Our model will be derived using the combination of multivariable logistic regression and bootstrapping technique to lessen predictors. The final model will be internally validated using bootstrapping validation technique and externally validated using data from different study sites. A parsimonious risk score will then be developed on the basis of beta estimates derived from the logistic model. Model performance will be evaluated using area under the receiver operating characteristic curve, max-rescaled Brier score and calibration slope. In exploratory analysis, we will also assess the net benefit of Probability of PPCs Associated with THoracic surgery in elderly patients score in the complete cohort using decision curve analysis.
    Ethical approval has been obtained from the Institutional Review Board of the Affiliated Cancer Hospital and Institute of Guangzhou Medical University, the Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine and the University of Hongkong-Shenzhen Hospital, respectively. The final risk prediction model will be published in an appropriate journal and further disseminated as an online calculator or nomogram for clinical application. Approved and anonymised data will be shared.
    ChiCTR2100051170.
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  • 文章类型: Journal Article
    目的:卡利珠单抗是一种选择性的,人性化,抗程序性细胞死亡的高亲和力IgG4κ单克隆抗体1,显示有效的抗肿瘤活性,在多种肿瘤类型中具有可接受的毒性。CameL试验表明,camrelizumab联合化疗(CC)显着延长了晚期非鳞状非小细胞肺癌(NSCLC)患者的中位无进展生存期和中位总生存期。我们的研究旨在调查两种策略在未接受化疗的晚期非鳞状细胞肺癌患者中的成本效益。
    方法:基于CameL试验生成了马尔可夫模拟模型。两种模拟处理包括CC和CA。
    方法:效用来自已发表的文献,费用是根据我们成都医院的费用计算的,中国。计算增量成本效益比(ICER)以比较两个治疗组的成本效益。
    结果:在总体人口中,CC和CA治疗的总费用为27223.40美元和13740.10美元,分别。CC处理产生了1.37个质量调整寿命年(QALYs),CA处理产生1.17个QALY。因此,CC组的患者额外花费了$13483.30,并产生了0.20个QALY的增加,导致每QALY的ICER为67416.50美元。
    结论:对于初治化疗的晚期非鳞状细胞肺癌患者,当考虑到每QALY$31500的支付意愿门槛时,CC与CA在中国不被认为是具有成本效益的治疗。
    背景:NCT03134872。
    OBJECTIVE: Camrelizumab is a selective, humanised, high-affinity IgG4 kappa monoclonal antibody against programmed cell death 1 that shows effective antitumour activity with acceptable toxicity in multiple tumour types. The CameL trial demonstrated that camrelizumab plus chemotherapy (CC) significantly prolonged the median progression-free survival and median overall survival versus chemotherapy alone (CA) in patients with advanced non-squamous non-small cell lung cancer (NSCLC). Our study was conducted to investigate the cost-effectiveness of the two strategies in chemotherapy-naive patients with advanced non-squamous NSCLC.
    METHODS: A Markov simulation model was generated based on the CameL trial. The two simulated treatments included CC and CA.
    METHODS: Utility was derived from published literature, and costs were calculated based on those at our hospital in Chengdu, China. Incremental cost-effectiveness ratios (ICERs) were calculated to compare the cost-effectiveness of the two treatment arms.
    RESULTS: In the overall population, the total costs were $27 223.40 and $13 740.10 for CC and CA treatment, respectively. The CC treatment produced 1.37 quality-adjusted life years (QALYs), and the CA treatment produced 1.17 QALYs. Hence, patients who were in the CC group spent an additional $13 483.30 and generated an increase of 0.20 QALYs, resulting in an ICER of $67 416.50 per QALY.
    CONCLUSIONS: For chemotherapy-naive patients with advanced non-squamous NSCLC, CC is not considered a cost-effective treatment versus CA in China when considering a willingness-to-pay threshold of $31 500 per QALY.
    BACKGROUND: NCT03134872.
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