Some tests with specified size for the behrens-fisher problem

For a given significance level α, Welch's approximate t-test for the Behrens-Fisher Problem is modified to get a test with size α. A useful result for carrying out the Berger and Boos test is provided. Simulation results give power comparisons of several size α tests.     

Graphical displays for clarifying how allocation ratio affects total sample size for the two sample logrank test

For time‐to‐event data, the power of the two sample logrank test for the comparison of two treatment groups can be greatly influenced by the ratio of the number of patients in each of the treatment groups. Despite the possible loss of power, unequal allocations may be of interest due to a need to collect more data on one of the groups or to considerations related to the acceptability of the treatments to patients. Investigators pursuing such designs may be interested in the cost of the unbalanced design relative to a balanced design with respect to the total number of patients required for the study. We present graphical displays to illustrate the sample size adjustment factor, or ratio of the sample size required by an unequal allocation compared to the sample size required by a balanced allocation, for various survival rates, treatment hazards ratios, and sample size allocation ratios. These graphical displays conveniently summarize information in the literature and provide a useful tool for planning sample sizes for the two sample logrank test. Copyright © 2010 John Wiley & Sons, Ltd.     

A four-moment approach and other practical solutions to the behrens-f1sher problem

Fixed sample size approximately similar tests for the Behrens-Fisher problem are studied and compared with various other tests suggested in current sttistical methodelogy texts. Several fourmoment approxiamtely similar tests are developed and offered as alternatives. These tests are shown to be good practical solutions which are easily implemented in practice.     

Optimal sample size allocation for accelerated life test under progressive type-II censoring with competing risks

In this article, we study the optimization problem of sample size allocation when the competing risks data are from a progressive type-II censoring in a constant-stress accelerated life test with multiple levels. The failure times of the individual causes are assumed to be statistically independent and exponentially distributed with different parameters. We obtain the estimates of the unknown parameters through a maximum likelihood method, and also derive the Fisher information matrix. We propose three optimization criteria and two search scenarios to obtain the sample size allocation at each stress level. Some numerical results are studied to illustrate the usage of the proposed methods.     

A group acceptance sampling plan for truncated life test having Weibull distribution

In this paper, a group acceptance sampling plan for a truncated life test is proposed when a multiple number of items as a group can be tested simultaneously in a tester, assuming that the lifetime of a product follows the Weibull distribution with a known shape parameter. The design parameters such as the number of groups and the acceptance number will be determined by satisfying the producer's and the consumer's risks at the specified quality levels, while the termination time and the number of testers are specified. The results are explained with tables and examples.     

A comparison of some conditional and unconditional exact tests for 2x2 contingency tables

In 1935, R.A. Fisher published his well-known “exact” test for 2x2 contingency tables. This test is based on the conditional distribution of a cell entry when the rows and columns marginal totals are held fixed. Tocher (1950) and Lehmann (1959) showed that Fisher s test, when supplemented by randomization, is uniformly most powerful among all the unbiased tests UMPU). However, since all the practical tests for 2x2 tables are nonrandomized - and therefore biased the UMPU test is not necessarily more powerful than other tests of the same or lower size. Inthis work, the two-sided Fisher exact test and the UMPU test are compared with six nonrandomized unconditional exact tests with respect to their power. In both the two-binomial and double dichotomy models, the UMPU test is often less powerful than some of the unconditional tests of the same (or even lower) size. Thus, the assertion that the Tocher-Lehmann modification of Fisher's conditional test is the optimal test for 2x2 tables is unjustified.     

A convenient formula for sample size calculations in clinical trials with multiple co-primary continuous endpoints

The clinical efficacy of a new treatment may often be better evaluated by two or more co-primary endpoints. Recently, in pharmaceutical drug development, there has been increasing discussion regarding establishing statistically significant favorable results on more than one endpoint in comparisons between treatments, which is referred to as a problem of multiple co-primary endpoints. Several methods have been proposed for calculating the sample size required to design a trial with multiple co-primary correlated endpoints. However, because these methods require users to have considerable mathematical sophistication and knowledge of programming techniques, their application and spread may be restricted in practice. To improve the convenience of these methods, in this paper, we provide a useful formula with accompanying numerical tables for sample size calculations to design clinical trials with two treatments, where the efficacy of a new treatment is demonstrated on continuous co-primary endpoints. In addition, we provide some examples to illustrate the sample size calculations made using the formula. Using the formula and the tables, which can be read according to the patterns of correlations and effect size ratios expected in multiple co-primary endpoints, makes it convenient to evaluate the required sample size promptly.     

Optimal sample size allocation for multi-level stress testing with Weibull regression under Type-II censoring

We discuss the optimal allocation problem in a multi-level stress test with Type-II censoring and Weibull (extreme value) regression model. We derive the maximum-likelihood estimators and their asymptotic variance–covariance matrix through the Fisher information. Four optimality criteria are used to discuss the optimal allocation problem. Optimal allocation of units, both exactly for small sample sizes and asymptotically for large sample sizes, for two- and four-stress-level situations are determined numerically. Conclusions and discussions are provided based on the numerical studies.     

A new method for the comparison of survival distributions

The assessment of overall homogeneity of time‐to‐event curves is a key element in survival analysis in biomedical research. The currently commonly used testing methods, e.g. log‐rank test, Wilcoxon test, and Kolmogorov–Smirnov test, may have a significant loss of statistical testing power under certain circumstances. In this paper we propose a new testing method that is robust for the comparison of the overall homogeneity of survival curves based on the absolute difference of the area under the survival curves using normal approximation by Greenwood's formula. Monte Carlo simulations are conducted to investigate the performance of the new testing method compared against the log‐rank, Wilcoxon, and Kolmogorov–Smirnov tests under a variety of circumstances. The proposed new method has robust performance with greater power to detect the overall differences than the log‐rank, Wilcoxon, and Kolmogorov–Smirnov tests in many scenarios in the simulations. Furthermore, the applicability of the new testing approach is illustrated in a real data example from a kidney dialysis trial. Copyright © 2009 John Wiley & Sons, Ltd.     

Testing bioequivalence for multiple formulations with power and sample size calculations

Bioequivalence (BE) trials play an important role in drug development for demonstrating the BE between test and reference formulations. The key statistical analysis for BE trials is the use of two one‐sided tests (TOST), which is equivalent to showing that the 90% confidence interval of the relative bioavailability is within a given range. Power and sample size calculations for the comparison between one test formulation and the reference formulation has been intensively investigated, and tables and software are available for practical use. From a statistical and logistical perspective, it might be more efficient to test more than one formulation in a single trial. However, approaches for controlling the overall type I error may be required. We propose a method called multiplicity‐adjusted TOST (MATOST) combining multiple comparison adjustment approaches, such as Hochberg's or Dunnett's method, with TOST. Because power and sample size calculations become more complex and are difficult to solve analytically, efficient simulation‐based procedures for this purpose have been developed and implemented in an R package. Some numerical results for a range of scenarios are presented in the paper. We show that given the same overall type I error and power, a BE crossover trial designed to test multiple formulations simultaneously only requires a small increase in the total sample size compared with a simple 2 × 2 crossover design evaluating only one test formulation. Hence, we conclude that testing multiple formulations in a single study is generally an efficient approach. The R package MATOST is available at https://sites.google.com/site/matostbe/ . Copyright © 2012 John Wiley & Sons, Ltd.     

A comparison of two approaches for power and sample size calculations in logistic regression models

Whittemore (1981) proposed an approach for calculating the sample size needed to test hypotheses with specified significance and power against a given alternative for logistic regression with small response probability. Based on the distribution of covariate, which could be either discrete or continuous, this approach first provides a simple closed-form approximation to the asymptotic covariance matrix of the maximum likelihood estimates, and then uses it to calculate the sample size needed to test a hypothesis about the parameter. Self et al. (1992) described a general approach for power and sample size calculations within the framework of generalized linear models, which include logistic regression as a special case. Their approach is based on an approximation to the distribution of the likelihood ratio statistic. Unlike the Whittemore approach, their approach is not limited to situations of small response probability. However, it is restricted to models with a finite number of covariate configurations. This study compares these two approaches to see how accurate they would be for the calculations of power and sample size in logistic regression models with various response probabilities and covariate distributions. The results indicate that the Whittemore approach has a slight advantage in achieving the nominal power only for one case with small response probability. It is outperformed for all other cases with larger response probabilities. In general, the approach proposed in Self et al. (1992) is recommended for all values of the response probability. However, its extension for logistic regression models with an infinite number of covariate configurations involves an arbitrary decision for categorization and leads to a discrete approximation. As shown in this paper, the examined discrete approximations appear to be sufficiently accurate for practical purpose.     

A new test for two-sample location problem based on empirical distribution function

We propose a new test for testing the equality of location parameter of two populations based on empirical distribution function (ECDF). The test statistics is obtained as a power divergence between two ECDFs. The test is shown to be distribution free, and its null distribution is obtained. We conducted empirical power comparison of the proposed test with several other available tests in the literature. We found that the proposed test performs better than its competitors considered here under several population structures. We also used two real datasets to illustrate the procedure.     

Sample‐size calculations for multi‐group comparison in population pharmacokinetic experiments

This paper describes an approach for calculating sample size for population pharmacokinetic experiments that involve hypothesis testing based on multi‐group comparison detecting the difference in parameters between groups under mixed‐effects modelling. This approach extends what has been described for generalized linear models and nonlinear population pharmacokinetic models that involve only binary covariates to more complex nonlinear population pharmacokinetic models. The structural nonlinear model is linearized around the random effects to obtain the marginal model and the hypothesis testing involving model parameters is based on Wald's test. This approach provides an efficient and fast method for calculating sample size for hypothesis testing in population pharmacokinetic models. The approach can also handle different design problems such as unequal allocation of subjects to groups and unbalanced sampling times between and within groups. The results obtained following application to a one compartment intravenous bolus dose model that involved three different hypotheses under different scenarios showed good agreement between the power obtained from NONMEM simulations and nominal power. Copyright © 2009 John Wiley & Sons, Ltd.     

A one-sample location test based on weighted averaging of two test statistics when the dimension and the sample size are large

We discuss a one-sample location test that can be used when the dimension and the sample size are large. It is well-known that the power of Hotelling’s test decreases when the dimension is close to the sample size. To address this loss of power, some non exact approaches were proposed, e.g., Dempster (1958 Dempster, A.P. (1958). A high dimensional two sample significance test. Ann. Math. Stat. 29:995–1010.[Crossref] , [Google Scholar], 1960 Dempster, A.P. (1960). A significance test for the separation of two highly multivariate small samples. Biometrics 16:41–50.[Crossref], [Web of Science ®] , [Google Scholar]), Bai and Saranadasa (1996 Bai, Z.D., Saranadasa, H. (1996). Effect of high dimension: by an example of a two sample problem. Stat. Sin. 6:311–329.[Web of Science ®] , [Google Scholar]), and Srivastava and Du (2008 Srivastava, M.S., Du, M. (2008). A test for the mean vector with fewer observations than the dimension. J. Multivariate Anal. 99:386–402.[Crossref], [Web of Science ®] , [Google Scholar]). In this article, we focus on Hotelling’s test and Dempster’s test. The comparative merits and demerits of these two tests vary according to the local parameters. In particular, we consider the situation where it is difficult to determine which test should be used, that is, where the two tests are asymptotically equivalent in terms of local power. We propose a new statistic based on the weighted averaging of Hotelling’s T²-statistic and Dempster’s statistic that can be applied in such a situation. Our weight is determined on the basis of the maximum local asymptotic power on a restricted parameter space that induces local asymptotic equivalence between Hotelling’s test and Dempster’s test. Numerical results show that our test is more stable than Hotelling’s T²-statistic and Dempster’s statistic in most parameter settings.     

Double and group acceptance sampling plan for truncated life test based on inverse log-logistic distribution

This paper introduces a double and group acceptance sampling plans based on time truncated lifetimes when the lifetime of an item follows the inverse log-logistic (ILL) distribution with known shape parameter. The operating characteristic function and average sample number (ASN) values of the double acceptance sampling inspection plan are provided. The values of the minimum number of groups and operating characteristic function for various quality levels are obtained for a group acceptance sampling inspection plan. A comparative study between single acceptance sampling inspection plan and double acceptance sampling inspection plan is carried out in terms of sample size. One simulated example and four real-life examples are discussed to show the applicability of the proposed double and group acceptance sampling inspection plans for ILL distributed quality parameters.     

Measuring effect size: a robust heteroscedastic approach for two or more groups

Motivated by involvement in an intervention study, the paper proposes a robust, heteroscedastic generalization of what is popularly known as Cohen's d. The approach has the additional advantage of being readily extended to situations where the goal is to compare more than two groups. The method arises quite naturally from a regression perspective in conjunction with a robust version of explanatory power. Moreover, it provides a single numeric summary of how the groups compare in contrast to other strategies aimed at dealing with heteroscedasticity. Kulinskaya and Staudte [16 Rousseeuw, P. J. and Leroy, A. M. 1987. Robust Regression & Outlier Detection, New York: Wiley. [Crossref] [Google Scholar]] studied a heteroscedastic measure of effect size similar to the one proposed here, but their measure of effect size depends on the sample sizes making it difficult for applied researchers to interpret the results. The approach used here is based on a generalization of Cohen's d that obviates the issue of unequal sample sizes. Simulations and illustrations demonstrate that the new measure of effect size can make a practical difference regarding the conclusions reached.     

A two-stage group sampling plan based on truncated life tests for a general distribution

A two-stage group acceptance sampling plan based on a truncated life test is proposed, which can be used regardless of the underlying lifetime distribution when multi-item testers are employed. The decision upon lot acceptance can be made in the first or second stage according to the number of failures from each group. The design parameters of the proposed plan such as number of groups required and the acceptance number for each of two stages are determined independently of an underlying lifetime distribution so as to satisfy the consumer's risk at the specified unreliability. Single-stage group sampling plans are also considered as special cases of the proposed plan and compared with the proposed plan in terms of the average sample number and the operating characteristics. Some important distributions are considered to explain the procedure developed here.     

Separated hypotheses testing for autoregressive models with non-negative residuals

Normal residual is one of the usual assumptions in autoregressive model but sometimes in practice we are faced with non-negative residuals. In this paper, we have derived modified maximum likelihood estimators of parameters of the residuals and autoregressive coefficient. Also asymptotic distribution of modified maximum likelihood estimators in both stationary and non-stationary models are computed. So that, we can derive asymptotic distribution of unit root, Vuong's and Cox's tests statistics in stationary situation. Using simulation, it shows that Akaike information criterion and Vuong's test work to select the optimal autoregressive model with non-negative residuals. Sometimes Vuong's test select two competing models as equivalent models. These models may be suitable or unsuitable equivalent models. So we consider Cox's test to make inference after model selection. Kolmogorov–Smirnov test confirms our results. Also we have computed tracking interval for competing models to choosing between two close competing models when Vuong's test and Cox's test cannot detect the differences.     

A statistical method for the serial comparison of vector cardiograms

In the absence of quantitative clinical standards to detect serial changes in cardiograms, statistical procedures are proposed as an alternative. These procedures are preceded by a dimension reducing orthonormal transformation of the original digitized cardiogram into a lower dimensional feature space. In feature space, mul-tivariate test criteria are given for the detection of changes in covariance matrices or mean vectors of the cardiograms. The flexibility is provided to compare the cardiograms of the same individual pairwise or simultaneously. Some pertinent remarks are also made about controlling the overall level of significance and its impact on the application of these techniques to cardiograms of USAF pilots.