A Bayesian approach based on discounting factor for consistency assessment in multi-regional clinical trial.

Multi-regional clinical trial (MRCT) has become an increasing trend for its supporting simultaneous global drug development. After MRCT, consistency assessment needs to be conducted to evaluate regional efficacy. The weighted Z-test approach is a common consistency assessment approach in which the weighting parameter W does not have a good practical significance; the discounting factor approach improved from the weighted Z-test approach by converting the estimation of W in original weighted Z-test approach to the estimation of discounting factor D. However, the discounting factor approach is an approach of frequency statistics, in which D was fixed as a certain value; the variation of D was not considered, which may lead to un-reasonable results. In this paper, we proposed a Bayesian approach based on D to evaluate the treatment effect for the target region in MRCT, in which the variation of D was considered. Specifically, we first took D random instead of fixed as a certain value and specified a beta distribution for it. According to the results of simulation, we further adjusted the Bayesian approach. The application of the proposed approach was illustrated by Markov Chain Monte Carlo simulation.

[Spatio-temporal Characteristics and Influencing Factors of Ozone Suppression Events Under High Temperature in China].

Temperature is a key meteorological factor affecting ozone formation. In general, a positive correlation is observed between ozone and temperature, that is, ozone concentration increases with the increase in temperature. However, this relationship may change at extremely high temperatures. When the temperature exceeds a threshold value, the ozone concentration tends to decrease, which is referred to as an ozone suppression event. Ozone suppression events lead to greater uncertainties in the prediction of future air quality under climate change. Based on the national air quality monitoring data, reanalysis data, and meteorological observation data, this study used the Z test to systematically analyze the spatio-temporal characteristics of the critical temperature(Tx) and frequency of ozone suppression events in China during the warm season(April to September) from 2013 to 2020 and further analyzed the possible influencing factors for the occurrence of ozone suppression events. The results showed that approximately 18% of the sites in China experienced ozone suppression events in the warm season from 2013 to 2020. The sites with a high frequency of ozone suppression events were mainly distributed in the central and western regions of China, such as Sichuan, Xinjiang, and Shaanxi, with an average frequency of ten times per year. The critical temperature(Tx) ranged from 19.2 to 39.3℃, and the Tx of most sites showed an increasing trend from 2013 to 2020. The high values of Tx were mainly distributed in the central and western regions such as Sichuan, Chongqing, Hunan, and Hubei, whereas the low values of Tx were concentrated in the Qinghai-Tibet Plateau. Contrary to the interannual trend of Tx, the frequency of ozone suppression events decreased significantly in the Beijing-Tianjin-Hebei Region and exhibited a characteristic of "increase-decrease-increase" in the Fenwei Plain, the Yangtze River Delta, and the Chengdu-Chongqing regions. The most significant effect of extreme high temperature on ozone suppresion was found in the Pearl River Delta Region. In addition, ozone precursors(e.g., NO2) and meteorological conditions(wind speed and direction) were possible factors affecting the occurrence of ozone suppression events.

Regional efficacy evaluation in multi-regional clinical trials using a discounting factor weighted Z test.

Multi-regional clinical trial (MRCT) is an efficient design to accelerate drug approval globally. Once the global efficacy of test drug is demonstrated, each local regulatory agency is required to prove effectiveness of test drug in their own population. Meanwhile, the ICH E5/E17 guideline recommends using data from other regions to help evaluate regional drug efficacy. However, one of the most challenges is how to manage to bridge data among multiple regions in an MRCT since various intrinsic and extrinsic factors exist among the participating regions. Furthermore, it is critical for a local agency to determine the proportion of information borrowing from other regions given the ethnic differences between target region and non-target regions. To address these issues, we propose a discounting factor weighted Z statistic to adaptively borrow information from non-target regions. In this weighted Z statistic, the weight is derived from a discounting factor in which the discounting factor denotes the proportion of information borrowing from non-target regions. We consider three ways to construct discounting factors based on the degree of congruency between target and non-target regions either using control group data, or treatment group data, or all data. We use the calibrated power prior to construct discounting factor based on scaled Kolmogorov-Smirnov statistic. Comprehensive simulation studies show that our method has desirable operating characteristics. Two examples are used to illustrate the applications of our proposed approach.

Are out-of-state drivers more seatbelt compliant than in-state drivers in the United States?

INTRODUCTION: This study explored the seatbelt use among in-state and out-of-state drivers in relation to their personal (age, gender, license status, etc.) and crash characteristics (time, location, roadway factors, etc.) using crash data over a 10-year period (2010-2019) from the Fatality Analysis Reporting System (FARS). METHOD: Comparison of seatbelt use between the two groups (in-state vs. out-of-state drivers) were conducted using Z-test statistics. Logistic regression models were developed to examine the probability of seatbelt use among each group. RESULTS: New findings in this study showed that out-of-state drivers were 5% more likely than in-state drivers to use seatbelts. Regardless of the driver's age, gender, license status, vehicle type, and injury severity, seatbelt use was significantly higher among out-of-state drivers. Moreover, irrespective of the location (rural or urban), the season (time, day, or month), road type (arterial, local streets, etc.), and jurisdictional seatbelt law (primary or secondary), out-of-state drivers were more seatbelt compliant than in-state drivers. Finally, out-of-state drivers traveling from states with secondary/no seatbelt laws exhibited higher seatbelt compliance rate in primary seatbelt law states than in states with less strict laws (i.e., secondary/no law). PRACTICAL APPLICATIONS: The findings in this study are critical to addressing a myriad of policy questions related to seatbelt laws and seatbelt use. Future research should focus on the disparity in seatbelt use between the two groups and determine intervention strategies that are effective at promoting seatbelt use across the United States. Additionally, given the significant differences in driver seatbelt use behavior based on the type of seatbelt law, if states with less strict laws upgrade to primary seatbelt laws, there likely will be increases in seatbelt compliance in those states.

Design of a new Z-test for the uncertainty of Covid-19 events under Neutrosophic statistics.

BACKGROUND: The existing Z-test for uncertainty events does not give information about the measure of indeterminacy/uncertainty associated with the test. METHODS: This paper introduces the Z-test for uncertainty events under neutrosophic statistics. The test statistic of the existing test is modified under the philosophy of the Neutrosophy. The testing process is introduced and applied to the Covid-19 data. RESULTS: Based on the information, the proposed test is interpreted as the probability that there is no reduction in uncertainty of Covid-19 is accepted with a probability of 0.95, committing a type-I error is 0.05 with the measure of an indeterminacy 0.10. Based on the analysis, it is concluded that the proposed test is informative than the existing test. The proposed test is also better than the Z-test for uncertainty under fuzzy-logic as the test using fuzz-logic gives the value of the statistic from 2.20 to 2.42 without any information about the measure of indeterminacy. The test under interval statistic only considers the values within the interval rather than the crisp value. CONCLUSIONS: From the Covid-19 data analysis, it is found that the proposed Z-test for uncertainty events under the neutrosophic statistics is efficient than the existing tests under classical statistics, fuzzy approach, and interval statistics in terms of information, flexibility, power of the test, and adequacy.

Recommendations for reporting statistical results when comparing proportions.

This article serves as the first in a series that will offer recommendations for optimal data reporting, specifically focusing on statistical methods most frequently reported by the Cytopathology audience. Recommendations for reporting statistical results when comparing proportions is the first topic in the series since comparing proportions, particularly utilising the chi-square test, was the most commonly reported inferential statistical test category over 2.5 years of Cytopathology articles.1 While this article will provide a summary of common tests used to compare proportions, an extensive review of each method, including test assumptions and calculations, is beyond the scope of this summary. The author recommends consulting a trained statistician prior to data collection to discuss an analytical plan, including determining the appropriate statistical test(s) to use.

Adaptive parameter of standard deviation enhances the power of noninvasive prenatal screens.

PURPOSE: Traditional Z-test methods during noninvasive prenatal screens (NIPS) use the fixed parameter of standard deviation (SD), which ignores the influence of actual sequencing read counts of a sample on the results. The aim of this study is to eliminate the influence of the sequencing depth of individual samples on the results and enhance the power of NIPS. METHODS: In this study, we propose an improved NIPS method, which calculates the SD in the Z-score process adaptively according to the actual read count of the test sample. Our approach obtained the SD linear fitting function along with the read count with a large number of reference samples, in which SD and read count fit well. The effectiveness of our enhanced NIPS method was evaluated on three common trisomy syndromes and five recurrent CNV syndromes with 3219 and 6592 samples based on whole genome sequencing of maternal peripheral blood. RESULTS: A total of 3,219 pregnant samples have been used for validating the proposed method on detecting fetal trisomy syndromes (T13, T18, and T21), in which eight false negative (FN) samples have been corrected as true positive (TP) and eight false positive (FP) samples have been fixed as true negative (TN) with our proposed adaptive-SD method. Another 6592 samples were used to compare the two methods on detecting five recurrent fetal copy number variation (CNV) syndromes, in which the FP samples have decreased from 99 to 39. CONCLUSIONS: Our adaptive-SD NIPS method shows more power on detecting both trisomy syndromes and five recurrent CNVs in the pregnant samples with diverse read counts. Besides, our proposed method contributes to lower FP and FN samples than the traditional Z-test method in NIPS. Our results show that our enhanced NIPS methods are effective in detecting both abnormal fetal trisomy syndromes and recurrent CNV syndromes in pregnant women.

Intra-Operative Discomfort in Photorefractive Keratectomy.

PURPOSE: Photorefractive keratectomy (PRK) remains a viable, safe, and efficacious option for patients wishing to correct refractive errors. One of its most significant drawbacks is pain. While post-operative pain has been well studied with different management options, intra-operative pain has been less well defined. The purpose of this study was to characterize intra-operative pain during PRK in regard to eye operated on, gender, excimer platform used, surgeon, and age. PATIENTS AND METHODS: A total of 134 patients (264 eyes) were prospectively randomized to undergo bilateral PRK of either the right eye first or the left eye first followed immediately by the fellow eye. In the immediate post-operative period they were surveyed using an 11-point Numeric Rating Scale regarding intra-operative pain or discomfort experienced in each eye. Resultant pain scores were then analyzed via two sample z-test and analysis of variance (ANOVA) to characterize pain overall as well as comparing first versus second eye operated on, right versus left eye, male versus female, excimer platform used, inter-surgeon variability, and age. RESULTS: Of 264 eyes surveyed the mean pain experienced on a 0-10 pain scale was 1.13 (minimal discomfort). There was no statistically significant difference in pain or discomfort when comparing first versus second eye operated on, right versus left eye, male versus female, excimer platform used, operating surgeon, or age. CONCLUSION: Intra-operative pain or discomfort experienced by patients is minimal. The absence of statistically significant differences in pain scores studied implies that standard of care procedures achieve adequate analgesia in PRK.

Assessment of hybrid vigour, dominance effect and hybrids regeneration potential in the genus Citrullus.

The current research was directed to explore hybrid vigour for hybrids resulting from crosses among six genotypes of the genus Citrullus, including C. mucosospermus. For such purpose, the mid parent heterosis and the best parent heterosis were assessed. Non parametric method related to homogeneity Chi-square at 5 % likelihood was applied to compare the regeneration potential of progenies. Student's parametric test at 5% was used to separe two means. Six parental genotypes and 16 hybrid families were evaluated for heterosis. The results showed a heterosis effect for all the characters studied nevertheless, this one varies according to the crossing. The observed hybrid vigour would be due to a superdominance or partial dominance effect. In addition, progeny from crosses have the same regenerative potential on both study sites.

Zulliger R-Optimized in the Evaluation of Depressive Characteristics / Zulliger R-Otimizado na Avaliação de Características Depressivas / Zulliger R-Optimizada en la Evaluación de las Características Depresivas

Abstract Depression is one of the most prevalent mental disorders in the world with more than 300 million diagnoses. Studies on the contributions that instruments offer in understanding the functioning of depressive patients are necessary. Therefore, our study aimed to compare the frequency of codes related to depression in Zulliger R-optimized application in a group of depressive individuals with non-clinical group. The study included 86 participants, 43 depressive patients and 43 non-clinical patients. The Escala Baptista de Depressão (EBADEP-A) was used to identify depressive symptoms in the clinical group and Zulliger was administered with R-optimized application. To compare the groups, the t-test and magnitude of differences (d) were used. The results showed differences between groups in the variables Mixed Determinants, Sum of achromatic color responses, pure color responses (C), Mor and AG. We understood that Zulliger R-optimized application may be useful in understanding the functioning of the depressive subject.

Resumo A depressão é um dos transtornos mentais mais prevalentes no mundo com mais de 300 milhões de diagnósticos. Estudos sobre as contribuições que instrumentos oferecem na compreensão do funcionamento de pacientes depressivos são necessários. Este estudo teve por objetivo comparar a frequência dos códigos relacionados à depressão no Zulliger aplicação R-otimizado em um grupo de depressivos com grupo não clínico. O estudo contou com 86 participantes, 43 pacientes depressivos e 43 não clínico. Foi utilizada a Escala Baptista de Depressão (EBADEP-A) para rastrear sintomas depressivos no grupo clínico e o Zulliger foi administrado com aplicação R-otimizada. Para comparar os grupos foi utilizado o teste t e magnitude das diferenças (d). Os resultados demonstraram diferenças entre grupos nas variáveis Determinantes Mistos, Soma de respostas de cor acromática, respostas de cor pura (C), Mor e AG. Entende-se que Zulliger aplicação R-otimizado pode ser útil na compreensão do funcionamento do sujeito depressivo.

Resumen La depresión es uno de los trastornos mentales más frecuentes en el mundo y actualmente cuenta con más de 300 millones de diagnósticos. Se necesitan estudios sobre las contribuciones de los instrumentos para comprender el funcionamiento de los pacientes deprimidos. Este estudio tuvo como objetivo comparar la frecuencia de los códigos relacionados con la depresión en la aplicación R-optimizada en Zulliger entre un grupo de deprimidos y un grupo no clínico. En el estudio participaron 86 personas, de las cuales 43 eran pacientes deprimidos y 43 pacientes no clínicos. La Escala Baptista de Depresión (EBADEP-A) se usó para rastrear los síntomas depresivos en el grupo clínico y el Zulliger se administró con la aplicación R-optimizada. Se utilizaron la prueba t y la magnitud de las diferencias (d) en la comparación entre grupos. Los resultados apuntaron diferencias entre los grupos en las variables Determinantes mixtos, Suma de respuestas de color acromática, respuestas de color puro (C), Mor y AG. La aplicación R-optimizada en Zulliger puede ser útil para comprender el funcionamiento del sujeto deprimido.

Z-test: aportes psicoanalíticos para la interpretación cualitativa / Z-test: psychoanalytical contributions for qualitative interpretation

Las contribuciones para la interpretación psicoanalítica cualitativa de el Z-Test (Zulliger) propuesta aquí se basan en la interpretación de símbolos y los deseos predominantes desde la perspectiva de los conceptos argentinos y freudianos de: Liberman, Maldavsky y Sneiderman. El análisis cualitativo de cada símbolo emergente en el Z-Test y la argumentación de las respuestas consisten en un discurso caracterizado por estilos comunicacionales y corrientes psíquicas que dan forma a la personalidad presente en las fases del desarrollo psicosexual: primario y secundario oral, primario y secundario anal, fálico uretral, fálico genital y libido intrasomática. Este trabajo es um rcorte de la tesis doctoral "Um estudo dos símbolos e dos desejos com o Z-Teste e Questionário Desiderativo na avaliação psicológica da personalidade para uso e o porte de armas de fogo, no Brasil" realizada en el Doctorado en Psicología de UCES(AU)

The contributions for the qualitative psychoanalytic interpretation of the Z-Test (Zulliger) proposed here are based on the interpretation of symbols and the predominant wishes from the perspective of the Argentine and Freudian concepts of: Liberman, Maldavsky and Sneiderman. The qualitative analysis of each emerging symbol in the Z-Test and the argumentation of the answers consist of a discourse characterized by communicational styles and psychic currents that shape the personality present in the phases of psychosexual development: primary and secondary oral, primary and secondary anal, phallic urethral, phallic genital and intrasomatic libido. This work is a part of the doctoral thesis "Um estudo dos símbolos e dos desejos com o Z-Teste e Questionário Desiderativo na avaliação psicológica da personalidade para uso e o porte de armas de fogo, no Brasil" carried out in the Doctorate in Psychology at UCES(AU)

Screening of triploid with low-coverage whole-genome sequencing by a single-nucleotide polymorphism-based test in miscarriage tissue.

PURPOSE: To establish a single-nucleotide polymorphism-based analysis (SBA) method to identify triploidy in the miscarriage tissue by using low-coverage whole-genome sequencing (LC-WGS). METHODS: The method was established by fitting a quadratic curve model by counting the distribution of three heterozygous mutation content intervals. The triploid test result was mainly determined by the opening direction and the axis of symmetry of the quadratic curve, and Z test between the same batch samples was also used for auxiliary judgment. RESULTS: Two hundred thirteen diploid samples and 8 triploid samples were used for establishment of the analytical method and 203 unknown samples were used for blind testing. In the blind testing, we found 2 cases positive for triploidy. After chromosome microarray analysis (CMA) and mass spectrometry verification, we found that both samples were true positives. We randomly selected 5 samples from the negative samples for mass spectrometry verification, and the results showed that these samples were all true negatives. CONCLUSIONS: Our method achieved accurate detection of triploidy in the miscarriage tissue and has the potential to detect more chromosomal abnormality types such as uniparental disomy (UPD) using a single LC-WGS approach.

Cheating on Unproctored Internet Test Applications: An Analysis of a Verification Test in a Real Personnel Selection Context.

This study analyses the extent to which cheating occurs in a real selection setting. A two-stage, unproctored and proctored, test administration was considered. Test score inconsistencies were concluded by applying a verification test (Guo and Drasgow Z-test). An initial simulation study showed that the Z-test has adequate Type I error and power rates in the specific selection settings explored. A second study applied the Z-test statistic verification procedure to a sample of 954 employment candidates. Additional external evidence based on item time response to the verification items was gathered. The results revealed a good performance of the Z-test statistic and a relatively low, but non-negligible, number of suspected cheaters that showed higher distorted ability estimates. The study with real data provided additional information on the presence of suspected cheating in unproctored applications and the viability of using item response times as an additional evidence of cheating. In the verification test, suspected cheaters spent 5.78 seconds per item more than expected considering the item difficulty and their assumed ability in the unproctored stage. We found that the percentage of suspected cheaters in the empirical study could be estimated at 13.84%. In summary, the study provides evidence of the usefulness of the Z-test in the detection of cheating in a specific setting, in which a computerized adaptive test for assessing English grammar knowledge was used for personnel selection.

Feature optimization in high dimensional chemical space: statistical and data mining solutions.

OBJECTIVES: The primary goal of this experiment is to prioritize molecular descriptors that control the activity of active molecules that could reduce the dimensionality produced during the virtual screening process. It also aims to: (1) develop a methodology for sampling large datasets and the statistical verification of the sampling process, (2) apply screening filter to detect molecules with polypharmacological or promiscuous activity. RESULTS: Sampling from large a dataset and its verification were done by applying Z-test. Molecular descriptors were prioritized using principal component analysis (PCA) by eliminating the least influencing ones. The original dimensions were reduced to one-twelfth by the application of PCA. There was a significant improvement in statistical parameter values of virtual screening model which in turn resulted in better screening results. Further improvement of screened results was done by applying Eli Lilly MedChem rules filter that removed molecules with polypharmacological or promiscuous activity. It was also shown that similarities in the activity of compounds were due to the molecular descriptors which were not apparent in prima facie structural studies.

Validity evidence of the Zulliger-SC Test to children's assessment / Evidências de validade do Zulliger-SC para avaliação de crianças / Evidencias de validez del Test Zulliger-SC para evaluación de niños

Due to the demand for instruments to assess aspects of the personality of children, we aimed find evidence for the validity of the Zulliger test in the Comprehensive System (ZSC). 173 children participated in this study of Fortaleza-CE with ages between 6 years and 11 years and 6 months, 48.5% were from public schools and 53.1% female. The children were divided into three age groups, 6 and 7 years, 8 and 9 years and 10 and 11 years. The instruments used were the Zulliger test and the test of Raven's Coloured Progressive Matrices - Special Scale. We made the analysis of descriptive statistics and compared the variables of Zulliger test through the One Way ANOVA test. The significant variables were FQu (p<0.005) and R, ma, D, Xu%, Na, Ls, Fd, (T), GHR and (2) (p<0.05), which contributed with validity evidences of ZSC with children. (AU)

Devido à demanda de instrumentos que avaliem aspectos da personalidade de crianças, objetivou-se buscar evidências de validade para o teste de Zulliger pelo Sistema Compreensivo (ZSC). Participaram dessa pesquisa 173 crianças de Fortaleza-CE com a idade entre 6 e 11 anos e 6 meses, sendo 48,5% de escolas públicas e 53,1% do sexo feminino. As crianças foram divididas em três faixas etárias, a saber, 6 e 7 anos, 8 e 9 anos e 10 e 11 anos. Os instrumentos utilizados foram o teste ZSC e o teste das Matrizes Progressivas Coloridas de Raven ­ Escala Especial. Foram feitas as análises de estatística descritiva e a comparação das variáveis do teste ZSC por meio do teste One Way ANOVA. As variáveis significativas foram FQu (p < 0,005) e R, ma, D, Xu%, Na, Ls, Fd, (T), GHR e (2) (p < 0,05), dados que contribuíram com evidências de validade do ZSC com crianças. (AU)

Debido a la demanda de instrumentos para evaluar aspectos de la personalidad de los niños, el objetivo de este estudio fue encontrar evidencias de vlidez del test Zulliger por el Sistema Comprensivo (ZSC). Participaron de esta investigación 173 niños de Fortaleza-CE con edades entre 6 y 11 años y 6 meses, siendo 48,5% de escuelas públicas y 53,1% de sexo femenino. Los niños fueron divididos en tres grupos por edad, a saber, 6 y 7, 8 y 9, 10 y 11 años. Los instrumentos utilizados fueron el test ZSC y el test de las Matrices Progresivas Coloridas de Raven - Escala Especial. Se hicieron análisis de estadística descriptiva y comparación de las variables del test ZSC por medio del test One Way ANOVA. Las variables significativas fueron FQu (p<0,005) y R, ma, D, Xu%, Na, Ls, Fd, (T), GHR y (2) (p<0,05), datos que contribuyeron con evidencias de validez del ZSC con los niños. (AU)

Stress monitoring through non-invasive instrumental analysis of skin conductivity.

BACKGROUND: This paper envelops the notion of yogic breathing and its applications as one of the techniques for stress management through regulation of skin conductivity among Indian engineering students. Stress perturbs the normal physiological or psychological functioning of an individual. Thus, it is extremely vital to manage stress. OBJECTIVE: To explore the consequence of yogic breathing on skin conductivity using galvanic skin response sensor meter (GSRSM) on engineering students, of different universities. METHODS: The study uses stratified random sampling technique for the experimental study undertaken to measure skin conductivity. 471 Engineering students, in the age group of 18-22 years who gave informed written consent were screened, of which 71 (15%) dropped out and 400 students (84.9%) completed the study. The GSRSM was used to record skin conductivity (pre and post) among experimental (n = 200) and Control group (n = 200) each comprising of 52 females (26%) and 148 males (74%). The Experimental group underwent yogic breathing whereas the Control group did not do so. RESULTS: The experimental group reported reduction in mean value in skin conductivity after deep breathing for the time period (t = 300 sec) as compared to the control group, and this was significant (p < 0.01 and p < 0.05). CONCLUSION: It is recommended that, this uncomplicated and yet extremely effectual ancient technique of yogic breathing could be included in core curriculum to reduce and manage stress among engineering students. The paper thus highlights the use of yogic technique as an effective mode for Stress Management amongst Indian Engineering students.

Validity Evidence of the Z-Test-SC for Use With Children / Evidências de Validade do Zulliger-SC Para Uso com Crianças / Evidencia de Validez de la Prueba Zulliger-SC Para Uso con los Niños

Abstract In Brazil, there is a lack of tools to assess the children's affective and cognitive dynamics and investments are needed in research that seeks evidence of validity of some assessment tools for that public. The Zulliger test in the Comprehensive System (Zulliger-SC) evaluates the adequacy of reality perception, affects, self-perception, interpersonal relationship and cognitive processing and can be used with children, although there are few studies with this purpose in Brazil. Thus, the aim was to contribute in this field, comparing the performances in different stages of development. The participants were 103 children aged 6 and 12 years old, students from public schools in the state of São Paulo, who answered the test individually in the schools. The Zulliger-SC distinguished the children consistently with what is theoretically expected for their age, bringing some evidence of the Zulliger's validity with children.(AU)

Resumo No Brasil, há uma escassez de instrumentos para avaliar a dinâmica afetiva e cognitiva de crianças, sendo necessário investir em pesquisas que busquem evidências de validade de técnicas de avaliação para esse público. O Teste de Zulliger no Sistema Compreensivo (Zulliger-SC) é um instrumento que avalia o modo de apreensão da realidade, afetos, auto-percepção, relacionamento interpessoal e funcionamento cognitivo, sendo indicado para uso com crianças, embora sejam escassos os estudos que demonstrem sua validade. Buscou-se contribuir para preencher essa lacuna, comparando os desempenhos de crianças em diferentes etapas do desenvolvimento. Participaram da pesquisa 103 crianças de 6 e 12 anos, estudantes de escolas públicas do interior do estado de São Paulo, que responderam ao instrumento individualmente, na própria escola. O Zulliger-SC diferenciou os participantes de modo coerente ao esperado teoricamente para suas idades, contribuindo com evidências de validade de uso do Zulliger-SC com crianças.(AU)

Resumen En Brasil, hay relativa falta de herramientas para evaluar la dinámica afectiva y cognitiva de niños, siendo necesario invertir en investigaciones que buscan evidencias de validez de algunas técnicas para esa población. El Zulliger - Sistema Integrado (Zulliger-SI) es un instrumento que evalúa el modo de percibir la realidad, los afectos, la autopercepción, la relación interpersonal y funcionamiento cognitivo y puede ser utilizado con niños, pero hay pocos estudios con ese propósito en Brasil. Por lo tanto, el objetivo fue contribuir en este campo, comparándose las respuestas de niños con distintas edades. Participaran 103 niños de 6 e 12 años, estudiantes de escuelas públicas en el estado de São Paulo, que respondieron al test individualmente en la propia escuela. El Zulliger-SC ha diferenciado los niños consistentemente a lo esperado teóricamente para las edades, contribuyendo para validez de su uso con niños.(AU)

Validity evidence of the z-test-sc for use with children / Evidências de validade do zulliger-sc para uso com crianças / Evidencia de validez de la prueba zulliger-sc para uso con los niños

In Brazil, there is a lack of tools to assess the children's affective and cognitive dynamics and investments are needed in research that seeks evidence of validity of some assessment tools for that public. The Zulliger test in the Comprehensive System (Zulliger-SC) evaluates the adequacy of reality perception, affects, self-perception, interpersonal relationship and cognitive processing and can be used with children, although there are few studies with this purpose in Brazil. Thus, the aim was to contribute in this field, comparing the performances in different stages of development. The participants were 103 children aged 6 and 12 years old, students from public schools in the state of São Paulo, who answered the test individually in the schools. The Zulliger-SC distinguished the children consistently with what is theoretically expected for their age, bringing some evidence of the Zulliger's validity with children.

No Brasil, há uma escassez de instrumentos para avaliar a dinâmica afetiva e cognitiva de crianças, sendo necessário investir em pesquisas que busquem evidências de validade de técnicas de avaliação para esse público. O Teste de Zulliger no Sistema Compreensivo (Zulliger-SC) é um instrumento que avalia o modo de apreensão da realidade, afetos, auto-percepção, relacionamento interpessoal e funcionamento cognitivo, sendo indicado para uso com crianças, embora sejam escassos os estudos que demonstrem sua validade. Buscou-se contribuir para preencher essa lacuna, comparando os desempenhos de crianças em diferentes etapas do desenvolvimento. Participaram da pesquisa 103 crianças de 6 e 12 anos, estudantes de escolas públicas do interior do estado de São Paulo, que responderam ao instrumento individualmente, na própria escola. O Zulliger-SC diferenciou os participantes de modo coerente ao esperado teoricamente para suas idades, contribuindo com evidências de validade de uso do Zulliger-SC com crianças.

En Brasil, hay relativa falta de herramientas para evaluar la dinámica afectiva y cognitiva de niños, siendo necesario invertir en investigaciones que buscan evidencias de validez de algunas técnicas para esa población. El Zulliger - Sistema Integrado (Zulliger-SI) es un instrumento que evalúa el modo de percibir la realidad, los afectos, la autopercepción, la relación interpersonal y funcionamiento cognitivo y puede ser utilizado con niños, pero hay pocos estudios con ese propósito en Brasil. Por lo tanto, el objetivo fue contribuir en este campo, comparándose las respuestas de niños con distintas edades. Participaran 103 niños de 6 e 12 años, estudiantes de escuelas públicas en el estado de São Paulo, que respondieron al test individualmente en la propia escuela. El Zulliger-SC ha diferenciado los niños consistentemente a lo esperado teóricamente para las edades, contribuyendo para validez de su uso con niños.

Statistical Properties of the Design for Simultaneous Global Drug Development Program.

Recently, a design was proposed for the Simultaneous Global Drug Development Program (SGDDP) to assess the impact of ethnic factors on the effect of a new treatment for a targeted ethnic (TE) population. It used weighted Z tests to combine the information collected from the TE and non-TE (NTE) subgroups in the SGDDP based on the fundamental assumption on their shared biological commonality. In this article, we mathematically formulated this assumption as the quantitative interaction between treatment effect and subgroup. We used it to more rigorously describe the hypotheses, and showed the unbiasedness of the weighted Z test. Moreover, to study the loss of efficiency from down weighting the NTE information in this SGDDP design, we compared the power of their test with that of the uniformly most powerful (UMP) test, which we showed was also a weighted Z test. We discussed that the choice of weight should balance the maximization of power when the assumption holds and the minimization of bias otherwise.

A Quantitative Method for Weight Selection in SGDDP.

Ethnic factors pose major challenge to evaluating the treatment effect of a new drug in a targeted ethnic (TE) population in emerging regions based on the results from a multiregional clinical trial (MRCT). To address this issue with statistical rigor, Huang et al. (2012) proposed a new design of a simultaneous global drug development program (SGDDP) which used weighted Z tests to combine the information collected from the nontargeted ethnic (NTE) group in the MRCT with that from the TE group in both the MRCT and a simultaneously designed local clinical trial (LCT). An important and open question in the SGDDP design was how to downweight the information collected from the NTE population to reflect the potential impact of ethnic factors and ensure that the effect size for TE patients is clinically meaningful. In this paper, we will relate the weight selection for the SGDDP to Method 1 proposed in the Japanese regulatory guidance published by the Ministry of Health, Labour and Welfare (MHLW) in 2007. Method 1 is only applicable when true effect sizes are assumed to be equal for both TE and NTE groups. We modified the Method 1 formula for more general scenarios, and use it to develop a quantitative method of weight selection for the design of the SGDDP which, at the same time, also provides sufficient power to descriptively check the consistency of the effect size for TE patients to a clinically meaningful magnitude.