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Why a P value<0.05 does not necessarily mean statistical significance:controversy over overall survival results of the ORIENT-11 trial

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Clinical Cancer Bulletin 2022年第1期1卷 47-48页

作者： Fei LIANG Department of Biostatistics Zhongshan HospitalFudan UniversityShanghai 200032China

On February 10,2022,the *** and Drug Administration(FDA)’s Oncologic Drugs Advisory Committee voted 14-1 against using data from the ORIENT-11 trial to support a biologics license application for sintilimab injection plus pemetrexed and platinum-based chemotherapy as first-line treatment for patients with nonsquamous non-small cell lung cancer(NSCLC)*** major reason was that the FDA claimed overall survival(OS)was not statistically tested in ORIENT-11,while previous regular approvals were granted on the basis of statistically significant improvements in *** may be a surprise to some physicians,as the ORIENT-11 trial previously reported improved OS with a hazard ratio(HR)of 0.60(95%confidence interval[CI]:0.45–0.79)and a P value of 0.00033,which is far below the commonly accepted threshold of 0.05 for declaring statistical *** may argue that the OS results of ORIENT-11 were not considered statistically significant by the FDA because OS was only a secondary ***,in the KEYNOTE-024 trial4,which compared pembrolizumab with chemotherapy in patients with previously untreated advanced NSCLC with PD-L1 expression on at least 50%of tumor cells,OS was also a secondary ***,the OS benefit of the KEYNOTE-024 trial was acknowledged by the FDA and included in the drug *** fundamental reason why OS results of ORIENT-11 were not considered statistically significant by the FDA is that the OS endpoint was not included in the multiplicity control strategy.

关键词： ORIENT-11 trial P value statistical significance

The quest for conditional independence in prospectivity modeling： weights-of-evidence, boost weights-of-evidence, and logistic regression

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Frontiers of Earth Science 2016年第3期10卷 389-408页

作者： Helmut SCHAEBEN Georg SEMMLER Department of Geophysics and Geoinformatics TU Bergakademie Freiberg Freiberg 09596 Germany

The objective of prospectivity modeling is prediction of the conditional probability of the presence T = 1 or absence T = 0 of a target T given favorable or prohibitive predictors B, or construction of a two classes {0,1} classification of T. A special case of logistic regression called weights-of-evidence （WofE） is geolo- gists＇ favorite method of prospectivity modeling due to its apparent simplicity. However, the numerical simplicity is deceiving as it is implied by the severe mathematical modeling assumption of joint conditional independence of all predictors given the target. General weights of evidence are explicitly introduced which are as simple to estimate as conventional weights, i.e., by counting, but do not require conditional independence. Complementary to the regres- sion view is the classification view on prospectivity modeling. Boosting is the construction of a strong classifier from a set of weak classifiers. From the regression point of view it is closely related to logistic regression. Boost weights-of-evidence （BoostWofE） was introduced into prospectivity modeling to counterbalance violations of the assumption of conditional independence even though relaxation of modeling assumptions with respect to weak classifiers was not the （initial） purpose of boosting. In the original publication of BoostWofE a fabricated dataset was used to ＂validate＂ this approach. Using the same fabricated dataset it is shown that BoostWofE cannot generally compensate lacking condi- tional independence whatever the consecutively proces- sing order of predictors. Thus the alleged features of BoostWofE are disproved by way of counterexamples, while theoretical findings are confirmed that logistic regression including interaction terms can exactly com- pensate violations of joint conditional independence if the predictors are indicators.

关键词： general weights of evidence joint conditionalindependence naive Bayes model Hammersley-Cliffordtheorem interaction terms statistical significance

Seismogenic ULF/ELF Wave Phenomena: Recent Advances and Future Perspectives

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Open Journal of Earthquake Research 2023年第3期12卷 45-113页

作者： Masashi Hayakawa Alexander Schekotov Jun Izutsu Alexander P. Nickolaenko Yasuhide Hobara Hayakawa Institute of Seismo Electromagnetics Co. Ltd. (Hi-SEM) UEC Alliance Center #521 Tokyo Japan The University of Electro-Communications (UEC) Advanced & Wireless Communications Research Center (AWCC) Tokyo Japan Institute of Physics of the Earth Russian Academy of Sciences Moscow Russia Chubu University International Digital Earth Applied Science Research Center Kasugai Aichi Japan Usikov Institute for Radio-Physics and Electronics National Academy of Sciences of the Ukraine Kharkov Ukraine UEC Graduate School of Informatics and Engineering Tokyo Japan

There has been enormous progress in the field of electromagnetic phenomena associated with earthquakes (EQs) and EQ prediction during the last three decades, and it is recently agreed that electromagnetic effects do appear prior to an EQ. A few phenomena are well recognized as being statistically correlated with EQs as promising candidates for short-term EQ predictors: the first is ionospheric perturbation not only in the lower ionosphere as seen by subionospheric VLF (very low frequency, 3 kHz f 30 kHz)/LF (low frequency, 30 kHz f 300 kHz) propagation but also in the upper F region as detected by ionosondes, TEC (total electron content) observations, satellite observations, etc, and the second is DC earth current known as SES (Seismic electric signal). In addition to the above two physical phenomena, this review highlights the following four physical wave phenomena in ULF (ultra low frequency, frequency Hz)/ELF (extremely low frequency, 3 Hz frequency 3 kHz) ranges, including 1) ULF lithospheric radiation (i.e., direct radiation from the lithosphere), 2) ULF magnetic field depression effect (as an indicator of lower ionospheric perturbation), 3) ULF/ELF electromagnetic radiation (radiation in the atmosphere), and 4) Schumann resonance (SR) anomalies (as an indicator of the perturbations in the lower ionosphere and stratosphere). For each physical item, we will repeat the essential points and also discuss recent advances and future perspectives. For the purpose of future real EQ prediction practice, we pay attention to the statistical correlation of each phenomenon with EQs, and its predictability in terms of probability gain. Of course, all of those effects are recommended as plausible candidates for short-term EQ prediction, and they can be physically explained in terms of the unified concept of the lithosphere-atmosphere-ionosphere coupling (LAIC) process, so a brief description of this coupling has been carried out by using these four physical parameters though

关键词： ULF/ELF Seismogenic Wave Effects statistical significance Lithosphere-Atmosphere-Ionosphere Coupling

Traditional Chinese Medicine’s Challenge to Clinical Science and Health Policy

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Chinese Medicine and Culture 2018年第2期1卷 97-102页

作者： Justin Thomas Maher Department of Foreign Languages International Education CollegeShanghai University of Traditional Chinese MedicineShanghaiChina

Traditional Chinese medicine(TCM)has been improving human health for *** for that,it has gradually gained the attention of the global scientific *** clinical research progresses,but slowly.I see it as being held back ... 详细信息

关键词： Clinical research policy principal-agent problem statistical significance traditional Chinese medicine

Early Rehabilitation of Acute Stroke Patients with Hemiplegia and Effects of regional Cerebral Blood Flow (rCBF) of the Patients with Cerebral Infarction by Early Rehabiiitation

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中国临床神经科学 2000年第Z1期8卷 68-页

作者： Luo ZuMing Xiong Hai Department of Neurology the First Affilliated Hospital of West China University of Medical Sciences Chengdu 610041 P.R. China Department of Neurology the First Affilliated Hospital of West China University of Medical Sciences Chengdu 610041 P.R. China

Objectives: To investigate whether early rchabilitation could improve obviously clinical prognosis of acute stroke patients. The mechanism of early rehabilitation that could improve brain function was preliminarily studied. Methods: 240 patients with acute hemiplegia were randomly divided into control group (120 cases) and rehabilitation group (120 cases). The control group received general treatment and the latter received early rehabilitation (Bobath methods) besides general treatment. At pre-rehabilitation and the end of 1,2,3,4,5,6 month at post-rehabilitation, the neurological deficit was assessed with modified Edinbcrg-Scandinavian stroke scale (MESSS); the motor function of the hemiplegic limbs were assessed with modified Fugl-meyer motor scale (FM);the ADL were assessed with modified Barthel Index (MBI), and the general secondary complications of both groups were also evaluated. Moreover, rCBF of 72 cases of acute cerebral infarction with hemiplegia (34 in control group, 38 in rehabilitation group) was earned out by SPECT imaging at pre-rehabilitation and at the end of I month at post - *** and Discussion: Compared with those of control group, at the end of 1,2,3,4,5,6 month at post - rehabilitation, the scores of MESSS were more obviously decreased (p＜0.05 and p＜0.01); the scores of MBI and FM were more significantly increased (p＜0.05 and p＜0.01); and morbidity of secondary complications was more significantly decreased (p＜0.05 and p＜0.01). Compared with those of pre-rehabilitation in rehabilitation group, both the decrease of MESS scores and the increase of FM, MBI scores were more obvious (p＜0.01) at the end of 1,2,3 month of post-rehabilitation; however, compared with that of the end of 3 month at post-rehabilitation, at the end of 4,5,6 month of post-rehabilitation in rehabilitation group. Both the decrease of MESSS scores and the increase of FM scores hadn′t statistical significance (p＞0.05). but scores of MBt were obviously increase

关键词： Blood Flow Acute Stroke neurological deficit motor function acute cerebral infarction statistical significance acute stroke negative correlation brain function Barthel Index

A Controlled Clinical Study between Hepatic Arterial Infusion with Embolized Curcuma Aromatic Oil and Chemical Drugs in Treating Primary Liver Cancer

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Chinese Journal of Integrative Medicine 2001年第2期7卷 141-141页

作者：程建华常纲吴万垠刘伟胜杨志钢孟凡喆徐凯李柳宁朱迪盈朱春泳罗海英 Guangdong Provincial Hospital of Traditional Chinese Medicine

Objective: To evaluate the effectiveness, toxicity and prospective application of hepatic arterial infusion (HAI) with embolized Curcuma Aromatic oil (CAO) in treating primary liver cancer (PLC). Methods: In the treated group, 32 patients with PLC were treated by HAI with 1-3 ml embolized CAO and oral administration of Chinese herbal medicine. In the control group, 32 patients with PLC were treated with transcatheter artery chemoembolization (TACE). Results: In the treated group, one patient attained complete remission (CR) and 13 partial remission (PR), the total effective rate being 43.75%. The level of alpha fetal protein (AFP) turned to normal range in 7 cases and decreased in other 7. In the control group, 10 obtained PR and the total effective rate being 31.25%, AFP level turned to normal in 5 and decreased in 2. There was no statistical significance between the two groups. The incidences of post-embolism Sydrome, such as fever, abdominal pain and vomiting were similar between the two groups but no myelosuppression occurred in the treated group with significant difference as comparing with that in the control group (P<0.01). The mean survival time, median survival time, 1-, 2- and 3-year survival rate in the treated group were 11.5 months, 10 months, 37.5%, 13.3% and 6.9% respectively, while in the control group they were 7.25 months, 6 months, 15.6%, 3.2% and 0% respectively. Better result in mean survival time, median survival time and 1-year survival rate was found in the treated group than that of the control group (P<0.05). Conclusion:HAI with embolized CAO showed a similar good effect in treating PLC as that of TACE, but superior to TACE with longer survival time and milder myelosuppression.

关键词： Clinical Study survival time survival rate statistical significance Chinese herbal medicine primary liver cancer oral administration complete remission