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La eficacia de una nueva intervención se establece generalmente a través de ensayos clínicos (EC) con asignación aleatoria (AA). Sin embargo, entre otros tantos desafíos metodológicos, el especificar la hipótesis de un EC con AA, sigue siendo un problema complejo de resolver para los investigadores clínicos. En este manuscrito discutimos las características de tres variantes de los EC con AA: EC de superioridad (ECS), EC de no-inferioridad (ECNI), y EC de equivalencia (ECE). Estos tres tipos de EC tienen supuestos diferentes sobre los efectos de una intervención, por lo que plantear hipótesis y definir objetivos requiere conocer algunos supuestos subyacentes a estos EC, incluso hasta elementos relacionados con la estimación del tamaño de muestra para cada cual. El objetivo de este manuscrito fue describir las diferencias metodológicas entre ECS, ECNI y ECE.
Efficacy and effectivity of new interventions are generally established through randomized clinical trials (RCTs). However, among many other methodological challenges, specifying the hypothesis of a RCT remains complex problem for clinical researchers. In this manuscript we discuss the characteristics of three variants of RCTs: superiority RCT (SRCT), non-inferiority RCT (NIRCT), and equivalence RCT (ERCT). These three types of RCT have different assumptions about the effects of an intervention, so setting hypotheses and defining objectives requires knowing some assumptions underlying these RCTs, including elements related to the estimation of the sample size for each one. The aim of this manuscript was to describe methodological differences between SRCT, NIRCT and ERCT.
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Ensaios Clínicos como Assunto , Projetos de Pesquisa , Ensaios Clínicos Controlados não Aleatórios como Assunto , Estudos de Equivalência como AsuntoRESUMO
The spirit of Norman Bethune was formed during the period of the Comprehensive Anti-Japanese War, and played an important role in shaping thought and promoting foreign exchanges in the subsequent inheritance and development process. Promoting the spirit of Norman Bethune in the context of sudden public health crisis, relying on its spiritual strength and extensive influence, and in line with China’s anti-epidemic experience, explaining its principles, methods, organizations, driving forces, and exemplary experiences, so that the Norman Bethune spirit can be promoted and developed in the context of sudden public health crisis, giving its a strong contemporary appeal.
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The appropriate sample size estimation is very important in the design of clinical trials. However, insufficient or inappropriate sample size estimation is still a prominent problem in the currently published acupuncture and moxibustion clinical trials. At present, the superiority test, non-inferiority test and equivalence test have been widely used in acupuncture and moxibustion clinical trials. This article focuses on the application, calculation methods and PASS11 software using of these three hypothesis test types. In view of the problems in the estimation of sample size in acupuncture and moxibustion clinical trials, the particularity of sample size estimation in acupuncture and moxibustion is summarized from the aspects of parameter setting, ratio of intervention group and control group, and multi-group comparison, in order to guide acupuncture clinical researchers to correctly estimate sample size when conducting clinical trials.
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Acupuntura , Terapia por Acupuntura , Ensaios Clínicos como Assunto , Moxibustão , Tamanho da AmostraRESUMO
Objective:To explore the use of Delphi method and superiority chart to construct flipped classroom teaching index evaluation system.Methods:Delphi method was applied to conduct expert consultation, and the superiority chart was used to calculate the weight of each index of the flipped classroom teaching evaluation system. SPSS 17.0 was used to statistically analyze the importance assignment of indicators.Results:After two rounds of correspondence consultation, the evaluation system of flipped classroom teaching mode was established, with 3 first-level indicators with weights of (0.32, 0.56 and 0.12); 6 second-level indicators with weights of (0.45, 0.55, 0.56, 0.44, 0.55 and 0.45) and 20 third-level indicators.Conclusion:Delphi method can not be substituted for other methods of mathematical statistics. In terms of weight determination, compared with analytic hierarchy process (ahp), the superiority chart does not need to establish judgment matrix, or to conduct consistency test. This method is simple to operate, time-saving and labor-saving, and is worthy of extensive promotion.
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Background: Guillain barre syndrome (GBS) is an immune mediated polyneuropathy characterized by progressive weakness and variety of symptoms including muscle paralysis, autonomic dysfunction and respiratory involvement that affect one or two persons in 100,000 population. Although immunotherapies including therapeutic plasma exchange (TPE), immunoglobulins (IVIg) and corticosteroids are the available beneficial modes of treatment, the residual symptoms are disabling and long lasting and require long term rehabilitation. Observational studies and RCT on multi-disciplinary care has proven exercises to be an answer to residual long lasting disability. Supervised individually designed exercise prescription after physiotherapy assessment may play a major role in minimizing disability.Methods: The present study is an open-level, parallel, superiority randomized control trial with blinding of outcome assessors to evaluate the results of the individually designed exercise programme over home based exercise programme. 74 adult referred GBS patients will be recruited and randomize in two groups either to receive 12 weeks individually designed exercise programme or home based exercise programme. The primary outcome shall be assessed as functional independence in activities of daily living and secondary outcomes shall be evaluated in terms of muscle strength, fatigue, pain, and quality of life at baseline, six months and twelve months duration.Conclusions: This is the first randomized control trial to compare the effect of supervised individually designed exercise over home based exercise programme on pwGBS.Trial registration: Currently the trial is ethically approved, prospectively registered CTRI/2016/08/007150 and in the process of recruiting its first subjects.
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To update and improve the Chinese concept of Zhishengquan,a comparative analysis was made of the U.S. military terms and PLA military terms.Zhishengquan is re-defined as "command and superiority in the bio-domain".
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DCD WeChat ethical review had its necessity and superiority but problems and confusion as well. For instance, WeChat review time was urgent and limited;WeChat review discussed insufficiently even hard to car-ry out;the methods of WeChat review were limited;the authenticity of audit opinion was difficult to grasp;the re-view data privacy existed hidden danger;the review quality was difficult to guarantee;WeChat conference content file archive was difficult, and so on. As to this, the author put forward the following countermeasures:giving war-ranty on the ethical review time as far as possible;initiating the committee review by the referee and uploading the review information to WeChat group, then ethical reviewers expressing their opinions in real names to ensure data confidentiality and privacy protection; strengthening the ethics committee education for organ transplantation; im-proving the quality of the review committee members and moral cultivation;archiving the WeChat conference infor-mation.
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The sample size of non-inferiority,equivalence and superiority design in clinical trial was estimated by using PASS 11 software.The result was compared with that by using SAS to evaluate the practicability and accuracy of PASS 11 software for the purpose of providing reference for sample size estimation in clinical trial design.
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The sample size of non-inferiority,equivalence and superiority design in clinical trial was estimated by using PASS 11 software.The result was compared with that by using SAS to evaluate the practicability and accuracy of PASS 11 software for the purpose of providing reference for sample size estimation in clinical trial design.
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Objective To discuss the value of video -assisted thoracoscope technology in diagnosis and treatment of thoracic trauma .Methods Form January 2009 to December 2013, a retrospective analysis was carried out on 43 patients with thoracic trauma .All the patients were treated with video -assisted thoracoscope technology . Results The procedure were successful and all the patients were cured out of hospital .Conclusion It is wide oper-ation indication, little harm, definite treapeutic effect, little complication and fast recovered to treat the patient with thoracic trauma using video -assisted thoracoscope technology , and it is a good choice for diagnosis and treatment in thoracic trauma.
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Chinese medicine dispensing granule is made by qualified decoction pieces with modern pharmaceutical technology, which has the characteristics of flexible prescription, flexible dose, fast onset and easy absorption. However, there is great controversy in whether it has curative effects, also there are problems with non-conformant standard of prescription, high price, and incomplete varieties. In this case, advantages and disadvantages of present Chinese medicine dispensing granule are analyzed and discussed thoroughly in this article so that we can provide references for the benign development of Chinese medicine dispensing granule industry.
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The aim of this study was to evaluate the relationship between severity of dementia and hand dexterity in patients with Alzheimer's disease (AD) using the Purdue Pegboard test including both simple and complex dexterity tasks. Eighty-four patients with AD and 32 non-demented subjects (controls) who were registered in a senior day-care center participated in this study. All of the subjects in this study were right-handed. The AD group consisted of 36 patients with a Clinical Dementia Rating of 1 (CDR 1), 35 with a CDR of 2 (CDR 2), and 13 with the CDR of 3 (CDR 3). For the simple task, right hand scores in the CDR 1, CDR 2, and CDR 3 groups were significantly lower than those of the controls whereas left hand scores were not lower than the controls. While the right hand scores were higher than the left hand scores in the controls and the CDR 1 group, no significant difference was observed between the right and left hand scores in the CDR 2 and 3 groups. Moreover, left hand scores were higher than right hand scores in 19 % of the CDR 1 group, 34% of the CDR 2 group, and 23 % of the CDR 3 group. Differences between right and left hand scores, which is a measure of handedness superiority, were decreased in order from the control group to the CDR 1 group and to the CDR 2 group. There was a relationship between “memory” subscale in the CDR and the differences in right and left hand scores. These results indicated that handedness superiority became unclear or disappeared as memory impairment progressed.
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0.05).Among 67 040 neonates screened by CFELA,11 1/6 096 were found to be defective;194 012 neonates screened by BIA,21 1/9 239 were found to be defective.Conclusion The guantitative CFELA is more sensitive and rapid,and should be a worthy method being recommend for major screening.