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Real-world cost-effectiveness of targeted temperature management in out-of-hospital cardiac arrest survivors: results from an academic medical center
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作者 Wachira Wongtanasarasin Daniel K.Nishijima +1 位作者 Wanrudee Isaranuwatchai Jeff rey S.Hoch 《World Journal of Emergency Medicine》 2025年第1期28-34,共7页
BACKGROUND: Targeted temperature management(TTM) is a common therapeutic intervention, yet its cost-effectiveness remains uncertain. This study aimed to evaluate the real-world cost-effectiveness of TTM compared with ... BACKGROUND: Targeted temperature management(TTM) is a common therapeutic intervention, yet its cost-effectiveness remains uncertain. This study aimed to evaluate the real-world cost-effectiveness of TTM compared with that of conventional care in adult out-of-hospital cardiac arrest(OHCA) survivors using clinical patient-level data.METHODS: We conducted a retrospective cohort study at an academic medical center in the USA to assess the cost-effectiveness of TTM in adult non-traumatic OHCA survivors between 1 January, 2019 and 30 June, 2023. The primary outcome was survival to hospital discharge. Incremental cost-effectiveness ratios(ICERs) were calculated and compared with various decision makers' willingness to pay. Cost-effectiveness acceptability curves were utilized to evaluate the economic attractiveness of TTM. Uncertainty about the incremental cost and effect was explored with a 95% confidence ellipse.RESULTS: Among 925 non-traumatic OHCA survivors, only 30(3%) received TTM. After adjusting for potential confounders, the TTM group did not demonstrate a significantly lower cost(delta cost-$5,141, 95% confidence interval [95% CI]: $-35,347 to $25,065, P=0.79) and higher survival to hospital discharge(delta effect 6%, 95% CI:-11% to 23%, P=0.41). Additionally, a 95% confidence ellipse indicated uncertainty reflected by evidence that the true value of the ICER could be in any of the quadrants of the cost-effectiveness plane.CONCLUSION: Although TTM did not demonstrate a clear survival benefit in this study, its potential cost-effectiveness warrants further investigation with larger sample sizes. These findings highlight the need for additional research to optimize TTM use in OHCA care and inform resource allocation decisions. 展开更多
关键词 Out-of-hospital cardiac arrest Targeted temperature management COST-EFFECTIVENESS SURVIVAL real-world data
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On Predicaments and way out of Ideological and Political Theory Teaching in University 被引量:1
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作者 季相林 《内蒙古民族大学学报(社会科学版)》 2012年第4期95-98,共4页
在高校开设思想政治理论课始于上世纪50年代,半个多世纪以来,思想政治理论课虽然在培养大学生树立正确的世界观、人生观、价值观、道德观等方面发挥了重要作用,但是由于受各种因素的影响思想政治理论课实际效果并不理想,与人们的期... 在高校开设思想政治理论课始于上世纪50年代,半个多世纪以来,思想政治理论课虽然在培养大学生树立正确的世界观、人生观、价值观、道德观等方面发挥了重要作用,但是由于受各种因素的影响思想政治理论课实际效果并不理想,与人们的期望值相距甚远。究其原因,既有社会的也有学校的,既有教师的也有学生自身的。认真分析这些原因,探寻其对策,对提高政治理论课的教学质量和实际效果具有重要的意义。 展开更多
关键词 高校 思想政治理论课 困境与出路
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Real-world efficacy and safety of tofacitinib treatment in Asian patients with ulcerative colitis 被引量:4
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作者 Kentaro Kojima Kenji Watanabe +9 位作者 Mikio Kawai Soichi Yagi Koji Kaku Maiko Ikenouchi Toshiyuki Sato Koji Kamikozuru Yoko Yokoyama Tetsuya Takagawa Masahito Shimizu Shinichiro Shinzaki 《World Journal of Gastroenterology》 SCIE CAS 2024年第13期1871-1886,共16页
BACKGROUND Real-world data on tofacitinib(TOF)covering a period of more than 1 year for a sufficient number of Asian patients with ulcerative colitis(UC)are scarce.AIM To investigate the long-term efficacy and safety ... BACKGROUND Real-world data on tofacitinib(TOF)covering a period of more than 1 year for a sufficient number of Asian patients with ulcerative colitis(UC)are scarce.AIM To investigate the long-term efficacy and safety of TOF treatment for UC,including clinical issues.METHODS We performed a retrospective single-center observational analysis of 111 UC patients administered TOF at Hyogo Medical University as a tertiary inflammatory bowel disease center.All consecutive UC patients who received TOF between May 2018 and February 2020 were enrolled.Patients were followed up until August 2020.The primary outcome was the clinical response rate at week 8.Secondary outcomes included clinical remission at week 8,cumulative persistence rate of TOF administration,colectomy-free survival,relapse after tapering of TOF and predictors of clinical response at week 8 and week 48.RESULTS The clinical response and remission rates were 66.3%and 50.5%at week 8,and 47.1%and 43.5%at week 48,respectively.The overall cumulative clinical remission rate was 61.7%at week 48 and history of anti-tumor necrosis factor-alpha(TNF-α)agents use had no influence(P=0.25).The cumulative TOF persistence rate at week 48 was significantly lower in patients without clinical remission than in those with remission at week 8(30.9%vs 88.1%;P<0.001).Baseline partial Mayo Score was significantly lower in responders vs non-responders at week 8(odds ratio:0.61,95%confidence interval:0.45-0.82,P=0.001).Relapse occurred in 45.7%of patients after TOF tapering,and 85.7%of patients responded within 4 wk after re-increase.All 6 patients with herpes zoster(HZ)developed the infection after achieving remission by TOF.CONCLUSION TOF was more effective in UC patients with mild activity at baseline and its efficacy was not affected by previous treatment with anti-TNF-αagents.Most relapsed patients responded again after re-increase of TOF and nearly half relapsed after tapering off TOF.Special attention is needed for tapering and HZ. 展开更多
关键词 Ulcerative colitis Tofacitinib Janus kinase inhibitor real-world BIOLOGICS
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Clinical manifestation,lifestyle,and treatment patterns of chronic erosive gastritis:A multicenter real-world study in China 被引量:2
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作者 Ying-Yun Yang Ke-Min Li +18 位作者 Gui-Fang Xu Cheng-Dang Wang Hua Xiong Xiao-Zhong Wang Chun-Hui Wang Bing-Yong Zhang Hai-Xing Jiang Jing Sun Yan Xu Li-Juan Zhang Hao-Xuan Zheng Xiang-Bin Xing Liang-Jing Wang Xiu-Li Zuo Shi-Gang Ding Rong Lin Chun-Xiao Chen Xing-Wei Wang Jing-Nan Li 《World Journal of Gastroenterology》 SCIE CAS 2024年第9期1108-1120,共13页
BACKGROUND Although chronic erosive gastritis(CEG)is common,its clinical characteristics have not been fully elucidated.The lack of consensus regarding its treatment has resulted in varied treatment regimens.AIM To ex... BACKGROUND Although chronic erosive gastritis(CEG)is common,its clinical characteristics have not been fully elucidated.The lack of consensus regarding its treatment has resulted in varied treatment regimens.AIM To explore the clinical characteristics,treatment patterns,and short-term outcomes in CEG patients in China.METHODS We recruited patients with chronic non-atrophic or mild-to-moderate atrophic gastritis with erosion based on endoscopy and pathology.Patients and treating physicians completed a questionnaire regarding history,endoscopic findings,and treatment plans as well as a follow-up questionnaire to investigate changes in symptoms after 4 wk of treatment.RESULTS Three thousand five hundred sixty-three patients from 42 centers across 24 cities in China were included.Epigastric pain(68.0%),abdominal distension(62.6%),and postprandial fullness(47.5%)were the most common presenting symptoms.Gastritis was classified as chronic non-atrophic in 69.9%of patients.Among those with erosive lesions,72.1%of patients had lesions in the antrum,51.0%had multiple lesions,and 67.3%had superficial flat lesions.In patients with epigastric pain,the combination of a mucosal protective agent(MPA)and proton pump inhibitor was more effective.For those with postprandial fullness,acid regurgitation,early satiety,or nausea,a MPA appeared more promising.CONCLUSION CEG is a multifactorial disease which is common in Asian patients and has non-specific symptoms.Gastroscopy may play a major role in its detection and diagnosis.Treatment should be individualized based on symptom profile. 展开更多
关键词 Chronic erosive gastritis SYMPTOM Endoscopic findings Treatment pattern real-world
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The Predicaments and Countermeasures of the Chinese Commercial Bibliographic Databases 被引量:1
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作者 Wang Fengnian 《Journalism and Mass Communication》 2017年第1期17-24,共8页
In China, the vast majority of the bibliographic databases is commercial, such as China National Knowledge Infrastructure (CNKI), Wanfang Database, Longyuan Journal Net, CQVIP Company, however, there are also non-pr... In China, the vast majority of the bibliographic databases is commercial, such as China National Knowledge Infrastructure (CNKI), Wanfang Database, Longyuan Journal Net, CQVIP Company, however, there are also non-profit open access (OA) databases, such as journal database jointly established by Chinese Academy of Social Sciences (CASS) and National Social Science Fund. The commercial bibliographic databases have to face many difficulties: intellectual property disputes, the benefit distribution between the hardcopy periodical and the commercial bibliographic database, the lack of quality assessment about the commercial bibliographic databases, the need of improving digital technology as well as the lack of a unified database regulation, which restricts the development of commercial bibliographic databases. This paper puts forward the countermeasures from the perspective of how to enhance the governmental management; how to protect the intellectual property fight; how to improve the technical standard of the commercial bibliographic databases; how to build interest distribution between the hardcopy periodical and the commercial bibliographic database; how to improve the quality of commercial bibliographic databases; and how to improve the industrial chain of the commercial bibliographic databases. 展开更多
关键词 the commercial bibliographic databases the predicaments of the commercial bibliographic databases the strategies of the commercial bibliographic databases
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Alienation and Existential Predicaments of Clones:Interpreting Never Let Me Go in the Context of Posthumanism
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作者 WEI Li YUAN Jing-jing 《Journal of Literature and Art Studies》 2019年第5期455-463,共9页
The literary background of Kazuo Ishiguro’s novel Never Let Me Go sets in a highly developed scientific and technological world where clones are created by human and“educated”in the Hailsham School for the sake of... The literary background of Kazuo Ishiguro’s novel Never Let Me Go sets in a highly developed scientific and technological world where clones are created by human and“educated”in the Hailsham School for the sake of“donating”their vital organs to human three or four times before death.By depicting miserable fate of clones,the novel conveys deep concerns on the consequences of abusing technology in modern society.Ever since the burgeoning development of life science and artificial intelligence in the 1990s,the trend of posthumanism/transhumanism has emerged.Posthumanism promotes approaches to enhancing human body condition and organism,and extending human lifespan to augment human capacity and well-being by the advancement of technology.In literary field,contemplation on the relationship between human beings and technology has become a major concern of posthumanism.Putting Never Let Me Go in the context of posthumanism,this essay probes into the significant themes of the novel from three aspects:(1)clones’torments in the existential predicaments imposed by human;(2)human’s violation to the principles of bioethics causing the existential predicaments of alienated clones;(3)appealing to human to ruminate on the relationship between scientific technology and ethics. 展开更多
关键词 POSTHUMANISM NEVER LET Me Go human CLONES ALIENATION EXISTENTIAL predicaments bioethical principles
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A Study of Survival Predicaments in Graham Swift’s Waterland from the Perspective of Spatial Theory
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作者 HE Jia-mei 《Journal of Literature and Art Studies》 2023年第8期573-579,共7页
In Waterland,contemporary British writer Graham Swift tells the protagonist Tom,using a mix of reality and history recreates the ecological devastation of the Fens Marsh,the fall of the Atkinson family and the spiritu... In Waterland,contemporary British writer Graham Swift tells the protagonist Tom,using a mix of reality and history recreates the ecological devastation of the Fens Marsh,the fall of the Atkinson family and the spiritual collapse of the people.This paper attempts to explore the dilemma of human existence by starting from Henry’s spatial theory and dividing it into physical space,social space and mental space. 展开更多
关键词 WATERLAND physical space social space mental space survival predicament
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The Complicated Security Dilemma and Armament Trends in the Middle East: The Order and Change Predicaments
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作者 Davoud Gharayagh-Zandi 《International Relations and Diplomacy》 2021年第11期490-499,共10页
The security dilemma is a common problem faced with the states in the ongoing anarchic international system.It does matter in the Middle East like the other ones and also has its impact on the arms races in the region... The security dilemma is a common problem faced with the states in the ongoing anarchic international system.It does matter in the Middle East like the other ones and also has its impact on the arms races in the region too.Meanwhile there are some characters named as the order and change predicaments such as the colonial background,weak infrastructure of state construction,and the identity politics embedded in the region that do convert the current complex security dilemma into a complicated one.Not only does it have effect on the regional order,the arm race and disarmament,and also offense/defense paradox,but also does it get on the violent bandwagon in the region.Synergies of the both dilemmas did lead the region into the domestic environment change alongside of regional disorder too.Non-neutral involving the trans-regional powers into the(in)security situation in the region not only did not mitigate the situation but also volatile it too.In conclusion the paper does strive to introduce three phrased manners for transition of the complicated security dilemma. 展开更多
关键词 complicated security dilemma Middle East ARMAMENT order and change predicament balance of power deterrence.
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ONGOING PREDICAMENTS OF CAPITALISM AND FUTURE TREND OF WORLD ORDER
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作者 LIN YONGLIANG 《Contemporary World》 2017年第3期41-44,共4页
According to the viewpoint of historical materialism,the economic base determines the superstructure.In the long process of its development,capitalism has not only shaped political and economic institutions within cou... According to the viewpoint of historical materialism,the economic base determines the superstructure.In the long process of its development,capitalism has not only shaped political and economic institutions within countries but also profoundly impacted the development and transition of the world order.However,since the international financial crisis 展开更多
关键词 ONGOING predicaments OF CAPITALISM AND FUTURE TREND OF WORLD ORDER TPP World US
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Clinical outcomes of second-line chemotherapy in patients with advanced pancreatic adenocarcinoma:a real-world study
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作者 Yuxiao Liu Xiaofan Guo +6 位作者 Peijun Xu Yuning Song Jing Huang Xingyun Chen Wenbo Zhu Jihui Hao Song Gao 《Cancer Biology & Medicine》 SCIE CAS CSCD 2024年第9期799-812,共14页
Objective:Little progress has been made in recent years using first-line chemotherapy,including gemcitabine combined with nab-paclitaxel,FOLFIRINOX,and NALIRIFOX,for advanced pancreatic adenocarcinoma(APC).In addition... Objective:Little progress has been made in recent years using first-line chemotherapy,including gemcitabine combined with nab-paclitaxel,FOLFIRINOX,and NALIRIFOX,for advanced pancreatic adenocarcinoma(APC).In addition,the optimal second-line chemotherapy regimen has not been determined.This study aimed to compare the effectiveness of different types of second-line chemotherapy for APC.Methods:Patients with APC who received first-line treatment from January 2008 to January 2021 were considered eligible for this retrospective analysis.The primary and secondary endpoints were overall survival(OS)and progression-free survival(PFS),respectively.Results:Four hundred and thirty-seven and 617 patients were treated with 5-fluorouracil-and gemcitabine-based chemotherapy as first-line treatment,respectively.Demographic and clinical features,except age and liver metastasis,were comparable between the two groups(P<0.05).The median OS was 8.8 and 7.8 months in patients who received a 5-fluorouracil-and gemcitabine-based combined regimen for first-line therapy,respectively(HR=1.244,95%CI=1.090–1.419;P<0.001).The median OS was 5.6 and 1.9 months in patients who received second-line chemotherapy and supportive care,respectively(HR=0.766,95%CI=0.677–0.867;P<0.001).The median PFS was not significantly differently between gemcitabine or 5-fluorouracil monotherapy and combination therapy.Conclusions:A 5-fluorouracil-or gemcitabine-based combined regimen was shown to be as effective as a single 5-fluorouracil or gemcitabine regimen as second-line therapy for patients with APC. 展开更多
关键词 Second-line chemotherapy advanced pancreatic adenocarcinoma 5-FLUOROURACIL GEMCITABINE real-world study
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Performance evaluation of seven multi-label classification methods on real-world patent and publication datasets
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作者 Shuo Xu Yuefu Zhang +1 位作者 Xin An Sainan Pi 《Journal of Data and Information Science》 CSCD 2024年第2期81-103,共23页
Purpose:Many science,technology and innovation(STI)resources are attached with several different labels.To assign automatically the resulting labels to an interested instance,many approaches with good performance on t... Purpose:Many science,technology and innovation(STI)resources are attached with several different labels.To assign automatically the resulting labels to an interested instance,many approaches with good performance on the benchmark datasets have been proposed for multi-label classification task in the literature.Furthermore,several open-source tools implementing these approaches have also been developed.However,the characteristics of real-world multi-label patent and publication datasets are not completely in line with those of benchmark ones.Therefore,the main purpose of this paper is to evaluate comprehensively seven multi-label classification methods on real-world datasets.Research limitations:Three real-world datasets differ in the following aspects:statement,data quality,and purposes.Additionally,open-source tools designed for multi-label classification also have intrinsic differences in their approaches for data processing and feature selection,which in turn impacts the performance of a multi-label classification approach.In the near future,we will enhance experimental precision and reinforce the validity of conclusions by employing more rigorous control over variables through introducing expanded parameter settings.Practical implications:The observed Macro F1 and Micro F1 scores on real-world datasets typically fall short of those achieved on benchmark datasets,underscoring the complexity of real-world multi-label classification tasks.Approaches leveraging deep learning techniques offer promising solutions by accommodating the hierarchical relationships and interdependencies among labels.With ongoing enhancements in deep learning algorithms and large-scale models,it is expected that the efficacy of multi-label classification tasks will be significantly improved,reaching a level of practical utility in the foreseeable future.Originality/value:(1)Seven multi-label classification methods are comprehensively compared on three real-world datasets.(2)The TextCNN and TextRCNN models perform better on small-scale datasets with more complex hierarchical structure of labels and more balanced document-label distribution.(3)The MLkNN method works better on the larger-scale dataset with more unbalanced document-label distribution. 展开更多
关键词 Multi-label classification real-world datasets Hierarchical structure Classification system Label correlation Machine learning
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A hierarchical enhanced data-driven battery pack capacity estimation framework for real-world operating conditions with fewer labeled data
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作者 Sijia Yang Caiping Zhang +4 位作者 Haoze Chen Jinyu Wang Dinghong Chen Linjing Zhang Weige Zhang 《Journal of Energy Chemistry》 SCIE EI CAS CSCD 2024年第4期417-432,共16页
Battery pack capacity estimation under real-world operating conditions is important for battery performance optimization and health management,contributing to the reliability and longevity of batterypowered systems.Ho... Battery pack capacity estimation under real-world operating conditions is important for battery performance optimization and health management,contributing to the reliability and longevity of batterypowered systems.However,complex operating conditions,coupling cell-to-cell inconsistency,and limited labeled data pose great challenges to accurate and robust battery pack capacity estimation.To address these issues,this paper proposes a hierarchical data-driven framework aimed at enhancing the training of machine learning models with fewer labeled data.Unlike traditional data-driven methods that lack interpretability,the hierarchical data-driven framework unveils the“mechanism”of the black box inside the data-driven framework by splitting the final estimation target into cell-level and pack-level intermediate targets.A generalized feature matrix is devised without requiring all cell voltages,significantly reducing the computational cost and memory resources.The generated intermediate target labels and the corresponding features are hierarchically employed to enhance the training of two machine learning models,effectively alleviating the difficulty of learning the relationship from all features due to fewer labeled data and addressing the dilemma of requiring extensive labeled data for accurate estimation.Using only 10%of degradation data,the proposed framework outperforms the state-of-the-art battery pack capacity estimation methods,achieving mean absolute percentage errors of 0.608%,0.601%,and 1.128%for three battery packs whose degradation load profiles represent real-world operating conditions.Its high accuracy,adaptability,and robustness indicate the potential in different application scenarios,which is promising for reducing laborious and expensive aging experiments at the pack level and facilitating the development of battery technology. 展开更多
关键词 Lithium-ion battery pack Capacity estimation Label generation Multi-machine learning model real-world operating
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Real-world clinical efficacy of tofacitinib in moderate-to-severe ulcerative colitis
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作者 Sara R Lopes Claudio Martins +1 位作者 Madalena Teixeira David Tomás 《World Journal of Gastroenterology》 SCIE CAS 2024年第34期3929-3931,共3页
Tofacitinib is an oral small-molecule Janus kinase(JAK)inhibitor that preferentially inhibits JAK1 and JAK3.Its efficacy in inducing and maintaining remission in ulcerative colitis(UC)as well as its safety profile has... Tofacitinib is an oral small-molecule Janus kinase(JAK)inhibitor that preferentially inhibits JAK1 and JAK3.Its efficacy in inducing and maintaining remission in ulcerative colitis(UC)as well as its safety profile has been demonstrated in multicenter,randomized,double-blind,placebo-controlled trials.Additionally,real-world studies evaluating the effectiveness and adverse effects of tofacitinib have been conducted,affirming its clinical efficacy in moderate-to-severe UC. 展开更多
关键词 Ulcerative colitis Tofacitinib real-world studies Inflammatory bowel disease Janus kinase inhibitor
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A Comparative Study of Metaheuristic Optimization Algorithms for Solving Real-World Engineering Design Problems
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作者 Elif Varol Altay Osman Altay Yusuf Ovik 《Computer Modeling in Engineering & Sciences》 SCIE EI 2024年第4期1039-1094,共56页
Real-world engineering design problems with complex objective functions under some constraints are relatively difficult problems to solve.Such design problems are widely experienced in many engineering fields,such as ... Real-world engineering design problems with complex objective functions under some constraints are relatively difficult problems to solve.Such design problems are widely experienced in many engineering fields,such as industry,automotive,construction,machinery,and interdisciplinary research.However,there are established optimization techniques that have shown effectiveness in addressing these types of issues.This research paper gives a comparative study of the implementation of seventeen new metaheuristic methods in order to optimize twelve distinct engineering design issues.The algorithms used in the study are listed as:transient search optimization(TSO),equilibrium optimizer(EO),grey wolf optimizer(GWO),moth-flame optimization(MFO),whale optimization algorithm(WOA),slimemould algorithm(SMA),harris hawks optimization(HHO),chimp optimization algorithm(COA),coot optimization algorithm(COOT),multi-verse optimization(MVO),arithmetic optimization algorithm(AOA),aquila optimizer(AO),sine cosine algorithm(SCA),smell agent optimization(SAO),and seagull optimization algorithm(SOA),pelican optimization algorithm(POA),and coati optimization algorithm(CA).As far as we know,there is no comparative analysis of recent and popular methods against the concrete conditions of real-world engineering problems.Hence,a remarkable research guideline is presented in the study for researchersworking in the fields of engineering and artificial intelligence,especiallywhen applying the optimization methods that have emerged recently.Future research can rely on this work for a literature search on comparisons of metaheuristic optimization methods in real-world problems under similar conditions. 展开更多
关键词 Metaheuristic optimization algorithms real-world engineering design problems multidisciplinary design optimization problems
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Treatment of active ulcerative colitis with Yinmei Kuijie decoction combined with 5-aminosalicylic acid:A non-randomized multicenter prospective observational protocol based on real-world conditions
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作者 Xinyu Zhang Yuan Li +5 位作者 Ping Li Yunze Liu Junmei Zhang Jingwei Wu Qi Wang Xia Ding 《Journal of Traditional Chinese Medical Sciences》 CAS 2024年第4期423-427,共5页
Objective:To determine the efficacy and safety of the Yinmei Kuijie decoction combined with 5-ami-nosalicylic acid(5-ASA)in treating mildly to moderately active ulcerative colitis(UC)under real-world conditions.Method... Objective:To determine the efficacy and safety of the Yinmei Kuijie decoction combined with 5-ami-nosalicylic acid(5-ASA)in treating mildly to moderately active ulcerative colitis(UC)under real-world conditions.Methods:This multicenter,prospective,non-randomized,observational study will be conducted in real-world settings.A total of 204 eligible patients will be consecutively enrolled in the study.Patients in the combination treatment group will receive Yinmei Kuijie decoction in combination with 5-ASA,whereas those in the control group will be treated with 5-ASA alone.The primary endpoint will be a clinical response at week 12,defined as a≥3 point and≥30%reduction from baseline in the Mayo total score with≥1 reduction in rectal bleeding or rectal bleeding score=0 or 1.Secondary efficacy endpoints at week 12 will include health-related quality of life,mucosal healing,and inflammation indicators.Conclusion:The results of this study may provide evidence of the efficacy and safety of Yinmei Kuijie decoction combined with 5-ASA in treating patients with mildly to moderately active UC under real-world principles.The results will provide a basis for further confirmatory studies on the efficacy of Yinmei Kuijie decoction. 展开更多
关键词 Chinese medicine 5-aminosalicylic acid Ulcerative colitis real-world study Study protocol Observational study
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Real-World Evidence in Localized Pancreatic: Coping with Uncertainty in Unselected Populations
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作者 María I. Pamies Ramón Diana Ibarra Anguita +8 位作者 Paula Rodríguez Payá Alvaro Muñoz Abad David Sánchez García María Valero Revert Beatriz Grau Mirete Mariano Martínez Marín Alicia Calero Amaro Lorena Rodríguez Cazalla Javier Gallego Plazas 《Journal of Cancer Therapy》 2024年第4期164-178,共15页
Background: Localized pancreatic cancer, including resectable (R), borderline resectable (BR) and locally advanced unresectable disease (LAU), is considered in clinical guidelines for diverse treatment options based o... Background: Localized pancreatic cancer, including resectable (R), borderline resectable (BR) and locally advanced unresectable disease (LAU), is considered in clinical guidelines for diverse treatment options based on clinical trials in selected populations. Hence, exploring with real world evidence (RWE) clinicians’ preferences for treatment options and their results seems pertinent. Methods: In a set of consecutive patients with localized pancreatic cancer assisted in a third level hospital from January 2013 to December 2022, medical records, symptoms, diagnostic process, distribution between subtypes, and treatment plans, with safety and efficacy results, were assessed. Results: A total of 152 patients with localized disease were included (43.4% R, 21.0% BR, 33.6% LAU). The population characteristics exemplified differences between daily practice and clinical trials. Tumor location and symptoms were as expected. Treatment plan was conditioned by PS or comorbidities in 23.0% of patients. In patients with R disease, surgery followed by different adjuvant chemotherapy (CT) regimes was the antineoplastic treatment of choice (64.8%) with efficacy results (OS 37.5 months;95% CI 18.4 - 56.7), in the range of contemporary standards. The common use of neoadjuvant CT for BR disease (94.4%), with surgery in 50% of them, and its results (OS 30.8 months;95% CI 10.5 - 51.2) reflected current controversies of treatment recommendations and evolution in this scenario. Paliative CT with or without radiotherapy was the standard specific treatment in LAU disease (95.1%) with survival results (PFS: 10.8 months;95% CI 8.8 - 12.7. OS: 20.3 months;95% CI 13.5 - 27.2) that justify the distinct character and the specific study of this entity. Conclusion: RWE for localized pancreatic cancer aroused from the analysis of this population confirms the distinct nature of patients assisted in daily practice, as well as mirrors the complexity of decision making in clinical assumptions in which achieving stronger evidence should be paramount. 展开更多
关键词 real-world Evidence LOCALIZED PANCREATIC CANCER
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Application of Real-World Evidence in the Approval of Antitumor Drugs
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作者 Shang Ya’nan Huang Zhe 《Asian Journal of Social Pharmacy》 2024年第4期311-318,共8页
Objective To study the information of real-world evidence(RWE)that can make up the deficiency of RCT results,the unfeasibility of some trials and the possible ethical problems,and to promote the approval of RWE for an... Objective To study the information of real-world evidence(RWE)that can make up the deficiency of RCT results,the unfeasibility of some trials and the possible ethical problems,and to promote the approval of RWE for anti-tumor drugs.Methods Literature analysis,policy analysis and comparative analysis were used.Results and Conclusion The studies and application of RWE in the United States,the European Union,and China were reviewed.The approval of anti-tumor drugs supported by RWE was generally used for external control groups in single arm trials,clinical efficacy and safety of adjuvant support drugs,or background analysis.The types of approvals included innovative anti-tumor drugs,supplemented indications of the approved drugs,expanding patient population,and combination medication.This study can provide reference for the approval of anti-tumor drugs using RWE in China.It is recommended to combine traditional RCT with RWE to promote the approval of anti-tumor drugs. 展开更多
关键词 real-world evidence antitumor drugs APPROVAL
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Utilization of Real-World Data in Drug Development
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作者 Lu Hao 《Proceedings of Anticancer Research》 2024年第3期109-114,共6页
With the rapid development of modern science and technology, traditional randomized controlled trials have become insufficient to meet current scientific research needs, particularly in the field of clinical research.... With the rapid development of modern science and technology, traditional randomized controlled trials have become insufficient to meet current scientific research needs, particularly in the field of clinical research. The emergence of real-world data studies, which align more closely with actual clinical evidence, has garnered significant attention in recent years. The following is a brief overview of the specific utilization of real-world data in drug development, which often involves large sample sizes and analyses covering a relatively diverse population without strict inclusion and exclusion criteria. Real-world data often reflects real clinical practice: treatment options are chosen according to the actual conditions and willingness of patients rather than through random assignment. Analysis based on real-world data also focuses on endpoints highly relevant to clinical benefits and the quality of life of patients. The booming big data technology supports the utilization of real-world data to accelerate new drug development, serving as an important supplement to traditional clinical trials. 展开更多
关键词 real-world data Drug development Data mining
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Toward real-world deployment of machine learning for health care:External validation,continual monitoring,and randomized clinical trials
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作者 Han Yuan 《Health Care Science》 2024年第5期360-364,共5页
1|OVERVIEW.Machine learning(ML)has been increasingly used for tackling various diagnostic,therapeutic,and prognostic tasks owing to its capability to learn and reason without explicit programming[1].Most developed ML ... 1|OVERVIEW.Machine learning(ML)has been increasingly used for tackling various diagnostic,therapeutic,and prognostic tasks owing to its capability to learn and reason without explicit programming[1].Most developed ML models have had their accuracy proven through internal validation using retrospective data.However,external validation using retrospective data,continual monitoring using prospective data,and randomized controlled trials(RCTs)using prospective data are important for the translation of ML models into real-world clinical practice[2]. 展开更多
关键词 machine learning real-world deployment external validation continual monitoring randomized clinical trials
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Discrepancies in walking speed measurements post-bed-rest:a comparative analysis of real-world vs.laboratory assessments
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作者 Marcello Grassi Ramona Ritzmann +5 位作者 Fiona Von Der Straten Jonas Böcker Uwe Mittag Edwin Mulder Martin Daumer Jörn Rittweger 《Translational Exercise Biomedicine》 2024年第3期331-343,共13页
Objectives Understanding differences between real-world walking speed(RWS)and laboratory-measured walking speed(LWS)is crucial for comprehensive mobility assessments,especially in context of prolonged immobilization.T... Objectives Understanding differences between real-world walking speed(RWS)and laboratory-measured walking speed(LWS)is crucial for comprehensive mobility assessments,especially in context of prolonged immobilization.This study aimed to investigate disparities in walking speed following a 60-day bed-rest period.Methods In 11 male participants,RWS was continuously monitored using a tri-axial accelerometer worn on the waist,while LWS was assessed via a 10-m walk test at preferred speed,on three different study days after immobilization.Statistical analyses included Bland–Altman and Pearson’s correlation to evaluate agreement between RWS and LWS,alongside paired-sample t-tests and univariate linear regression models to assess significance of differences and temporal effects on gait speed.Results Results of Bland-Altman analysis showed no agreement between RWS and LWS(mean difference 0.77 m/s)and nonsignificant correlation(r=0.19,p-value=0.3).Paired-sample t-tests indicated significantly lower RWS compared to LWS for all study days(p-value<0.001).Univariate linear regression models demonstrated a significant effect of test day on RWS(p-value<0.001)but not on LWS(p-value=0.23).Conclusions These findings emphasize the importance of integrating both assessments to capture comprehensive mobility changes following prolonged periods of inactivity.Particularly significant is that RWS is constantly lower than LWS,with the former being more representative as it reflects what normally participants would do when not under observation.Lastly,understanding discrepancies between RWS and LWS would allow for more appropriate rehabilitation programs to speed up recovery while simultaneously keeping the rehabilitation safe and tailored. 展开更多
关键词 real-world walking speed laboratory walking speed gait speed comparison accelerometers
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