Randomization Analysis of Covariance and Change-Over Designs " (1980)
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A Simple Sample Size Formula for Analysis of Covariance in Randomized Clinical Trials George F
Journal of Clinical Epidemiology 60 (2007) 1234e1238 ORIGINAL ARTICLE A simple sample size formula for analysis of covariance in randomized clinical trials George F. Borma,*, Jaap Fransenb, Wim A.J.G. Lemmensa aDepartment of Epidemiology and Biostatistics, Radboud University Nijmegen Medical Centre, Geert Grooteplein 21, PO Box 9101, NL-6500 HB Nijmegen, The Netherlands bDepartment of Rheumatology, Radboud University Nijmegen Medical Centre, Geert Grooteplein 21, PO Box 9101, NL-6500 HB Nijmegen, The Netherlands Accepted 15 February 2007 Abstract Objective: Randomized clinical trials that compare two treatments on a continuous outcome can be analyzed using analysis of covari- ance (ANCOVA) or a t-test approach. We present a method for the sample size calculation when ANCOVA is used. Study Design and Setting: We derived an approximate sample size formula. Simulations were used to verify the accuracy of the for- mula and to improve the approximation for small trials. The sample size calculations are illustrated in a clinical trial in rheumatoid arthritis. Results: If the correlation between the outcome measured at baseline and at follow-up is r, ANCOVA comparing groups of (1 À r2)n subjects has the same power as t-test comparing groups of n subjects. When on the same data, ANCOVA is usedpffiffiffiffiffiffiffiffiffiffiffiffiffi instead of t-test, the pre- cision of the treatment estimate is increased, and the length of the confidence interval is reduced by a factor 1 À r2. Conclusion: ANCOVA may considerably reduce the number of patients required for a trial. Ó 2007 Elsevier Inc. All rights reserved. Keywords: Power; Sample size; Precision; Analysis of covariance; Clinical trial; Statistical test 1. -
Analysis of Covariance (ANCOVA) in Randomized Trials: More Precision
Johns Hopkins University, Dept. of Biostatistics Working Papers 10-19-2018 Analysis of Covariance (ANCOVA) in Randomized Trials: More Precision, Less Conditional Bias, and Valid Confidence Intervals, Without Model Assumptions Bingkai Wang Department of Biostatistics, Johns Hopkins University Elizabeth Ogburn Department of Biostatistics, Johns Hopkins University Michael Rosenblum Department of Biostatistics, Johns Hopkins University, [email protected] Suggested Citation Wang, Bingkai; Ogburn, Elizabeth; and Rosenblum, Michael, "Analysis of Covariance (ANCOVA) in Randomized Trials: More Precision, Less Conditional Bias, and Valid Confidence Intervals, Without Model Assumptions" (October 2018). Johns Hopkins University, Dept. of Biostatistics Working Papers. Working Paper 292. https://biostats.bepress.com/jhubiostat/paper292 This working paper is hosted by The Berkeley Electronic Press (bepress) and may not be commercially reproduced without the permission of the copyright holder. Copyright © 2011 by the authors Analysis of Covariance (ANCOVA) in Randomized Trials: More Precision, Less Conditional Bias, and Valid Confidence Intervals, Without Model Assumptions BINGKAI WANG, ELIZABETH OGBURN, MICHAEL ROSENBLUM∗ Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Baltimore, Maryland 21205, USA [email protected] Summary \Covariate adjustment" in the randomized trial context refers to an estimator of the average treatment effect that adjusts for chance imbalances between study arms in baseline variables (called \covariates"). The baseline variables could include, e.g., age, sex, disease severity, and biomarkers. According to two surveys of clinical trial reports, there is confusion about the sta- tistical properties of covariate adjustment. We focus on the ANCOVA estimator, which involves fitting a linear model for the outcome given the treatment arm and baseline variables, and trials with equal probability of assignment to treatment and control. -
Statistical Analysis 8: Two-Way Analysis of Variance (ANOVA)
Statistical Analysis 8: Two-way analysis of variance (ANOVA) Research question type: Explaining a continuous variable with 2 categorical variables What kind of variables? Continuous (scale/interval/ratio) and 2 independent categorical variables (factors) Common Applications: Comparing means of a single variable at different levels of two conditions (factors) in scientific experiments. Example: The effective life (in hours) of batteries is compared by material type (1, 2 or 3) and operating temperature: Low (-10˚C), Medium (20˚C) or High (45˚C). Twelve batteries are randomly selected from each material type and are then randomly allocated to each temperature level. The resulting life of all 36 batteries is shown below: Table 1: Life (in hours) of batteries by material type and temperature Temperature (˚C) Low (-10˚C) Medium (20˚C) High (45˚C) 1 130, 155, 74, 180 34, 40, 80, 75 20, 70, 82, 58 2 150, 188, 159, 126 136, 122, 106, 115 25, 70, 58, 45 type Material 3 138, 110, 168, 160 174, 120, 150, 139 96, 104, 82, 60 Source: Montgomery (2001) Research question: Is there difference in mean life of the batteries for differing material type and operating temperature levels? In analysis of variance we compare the variability between the groups (how far apart are the means?) to the variability within the groups (how much natural variation is there in our measurements?). This is why it is called analysis of variance, abbreviated to ANOVA. This example has two factors (material type and temperature), each with 3 levels. Hypotheses: The 'null hypothesis' might be: H0: There is no difference in mean battery life for different combinations of material type and temperature level And an 'alternative hypothesis' might be: H1: There is a difference in mean battery life for different combinations of material type and temperature level If the alternative hypothesis is accepted, further analysis is performed to explore where the individual differences are. -
5. Dummy-Variable Regression and Analysis of Variance
Sociology 740 John Fox Lecture Notes 5. Dummy-Variable Regression and Analysis of Variance Copyright © 2014 by John Fox Dummy-Variable Regression and Analysis of Variance 1 1. Introduction I One of the limitations of multiple-regression analysis is that it accommo- dates only quantitative explanatory variables. I Dummy-variable regressors can be used to incorporate qualitative explanatory variables into a linear model, substantially expanding the range of application of regression analysis. c 2014 by John Fox Sociology 740 ° Dummy-Variable Regression and Analysis of Variance 2 2. Goals: I To show how dummy regessors can be used to represent the categories of a qualitative explanatory variable in a regression model. I To introduce the concept of interaction between explanatory variables, and to show how interactions can be incorporated into a regression model by forming interaction regressors. I To introduce the principle of marginality, which serves as a guide to constructing and testing terms in complex linear models. I To show how incremental I -testsareemployedtotesttermsindummy regression models. I To show how analysis-of-variance models can be handled using dummy variables. c 2014 by John Fox Sociology 740 ° Dummy-Variable Regression and Analysis of Variance 3 3. A Dichotomous Explanatory Variable I The simplest case: one dichotomous and one quantitative explanatory variable. I Assumptions: Relationships are additive — the partial effect of each explanatory • variable is the same regardless of the specific value at which the other explanatory variable is held constant. The other assumptions of the regression model hold. • I The motivation for including a qualitative explanatory variable is the same as for including an additional quantitative explanatory variable: to account more fully for the response variable, by making the errors • smaller; and to avoid a biased assessment of the impact of an explanatory variable, • as a consequence of omitting another explanatory variables that is relatedtoit. -
Analysis of Variance and Analysis of Variance and Design of Experiments of Experiments-I
Analysis of Variance and Design of Experimentseriments--II MODULE ––IVIV LECTURE - 19 EXPERIMENTAL DESIGNS AND THEIR ANALYSIS Dr. Shalabh Department of Mathematics and Statistics Indian Institute of Technology Kanpur 2 Design of experiment means how to design an experiment in the sense that how the observations or measurements should be obtained to answer a qqyuery inavalid, efficient and economical way. The desigggning of experiment and the analysis of obtained data are inseparable. If the experiment is designed properly keeping in mind the question, then the data generated is valid and proper analysis of data provides the valid statistical inferences. If the experiment is not well designed, the validity of the statistical inferences is questionable and may be invalid. It is important to understand first the basic terminologies used in the experimental design. Experimental unit For conducting an experiment, the experimental material is divided into smaller parts and each part is referred to as experimental unit. The experimental unit is randomly assigned to a treatment. The phrase “randomly assigned” is very important in this definition. Experiment A way of getting an answer to a question which the experimenter wants to know. Treatment Different objects or procedures which are to be compared in an experiment are called treatments. Sampling unit The object that is measured in an experiment is called the sampling unit. This may be different from the experimental unit. 3 Factor A factor is a variable defining a categorization. A factor can be fixed or random in nature. • A factor is termed as fixed factor if all the levels of interest are included in the experiment. -
Analysis of Covariance (ANCOVA) with Two Groups
NCSS Statistical Software NCSS.com Chapter 226 Analysis of Covariance (ANCOVA) with Two Groups Introduction This procedure performs analysis of covariance (ANCOVA) for a grouping variable with 2 groups and one covariate variable. This procedure uses multiple regression techniques to estimate model parameters and compute least squares means. This procedure also provides standard error estimates for least squares means and their differences, and computes the T-test for the difference between group means adjusted for the covariate. The procedure also provides response vs covariate by group scatter plots and residuals for checking model assumptions. This procedure will output results for a simple two-sample equal-variance T-test if no covariate is entered and simple linear regression if no group variable is entered. This allows you to complete the ANCOVA analysis if either the group variable or covariate is determined to be non-significant. For additional options related to the T- test and simple linear regression analyses, we suggest you use the corresponding procedures in NCSS. The group variable in this procedure is restricted to two groups. If you want to perform ANCOVA with a group variable that has three or more groups, use the One-Way Analysis of Covariance (ANCOVA) procedure. This procedure cannot be used to analyze models that include more than one covariate variable or more than one group variable. If the model you want to analyze includes more than one covariate variable and/or more than one group variable, use the General Linear Models (GLM) for Fixed Factors procedure instead. Kinds of Research Questions A large amount of research consists of studying the influence of a set of independent variables on a response (dependent) variable. -
THE ONE-SAMPLE Z TEST
10 THE ONE-SAMPLE z TEST Only the Lonely Difficulty Scale ☺ ☺ ☺ (not too hard—this is the first chapter of this kind, but youdistribute know more than enough to master it) or WHAT YOU WILL LEARN IN THIS CHAPTERpost, • Deciding when the z test for one sample is appropriate to use • Computing the observed z value • Interpreting the z value • Understandingcopy, what the z value means • Understanding what effect size is and how to interpret it not INTRODUCTION TO THE Do ONE-SAMPLE z TEST Lack of sleep can cause all kinds of problems, from grouchiness to fatigue and, in rare cases, even death. So, you can imagine health care professionals’ interest in seeing that their patients get enough sleep. This is especially the case for patients 186 Copyright ©2020 by SAGE Publications, Inc. This work may not be reproduced or distributed in any form or by any means without express written permission of the publisher. Chapter 10 ■ The One-Sample z Test 187 who are ill and have a real need for the healing and rejuvenating qualities that sleep brings. Dr. Joseph Cappelleri and his colleagues looked at the sleep difficul- ties of patients with a particular illness, fibromyalgia, to evaluate the usefulness of the Medical Outcomes Study (MOS) Sleep Scale as a measure of sleep problems. Although other analyses were completed, including one that compared a treat- ment group and a control group with one another, the important analysis (for our discussion) was the comparison of participants’ MOS scores with national MOS norms. Such a comparison between a sample’s mean score (the MOS score for par- ticipants in this study) and a population’s mean score (the norms) necessitates the use of a one-sample z test. -
How to Randomize?
TRANSLATING RESEARCH INTO ACTION How to Randomize? Roland Rathelot J-PAL Course Overview 1. What is Evaluation? 2. Outcomes, Impact, and Indicators 3. Why Randomize and Common Critiques 4. How to Randomize 5. Sampling and Sample Size 6. Threats and Analysis 7. Project from Start to Finish 8. Cost-Effectiveness Analysis and Scaling Up Lecture Overview • Unit and method of randomization • Real-world constraints • Revisiting unit and method • Variations on simple treatment-control Lecture Overview • Unit and method of randomization • Real-world constraints • Revisiting unit and method • Variations on simple treatment-control Unit of Randomization: Options 1. Randomizing at the individual level 2. Randomizing at the group level “Cluster Randomized Trial” • Which level to randomize? Unit of Randomization: Considerations • What unit does the program target for treatment? • What is the unit of analysis? Unit of Randomization: Individual? Unit of Randomization: Individual? Unit of Randomization: Clusters? Unit of Randomization: Class? Unit of Randomization: Class? Unit of Randomization: School? Unit of Randomization: School? How to Choose the Level • Nature of the Treatment – How is the intervention administered? – What is the catchment area of each “unit of intervention” – How wide is the potential impact? • Aggregation level of available data • Power requirements • Generally, best to randomize at the level at which the treatment is administered. Suppose an intervention targets health outcomes of children through info on hand-washing. What is the appropriate level of randomization? A. Child level 30% B. Household level 23% C. Classroom level D. School level 17% E. Village level 13% 10% F. Don’t know 7% A. B. C. D. -
Parametric ANCOVA Vs. Rank Transform ANCOVA When
DOCUMENT RESUME ED 231 882 TM 830 499 AUTHOR -01-ejn4-k, Stephen F.; Algina, James TITLE Parametric ANCOVA vs. Rank Transform ANCOVA when Assumptions of Conditional Normality and Homoscedasticity Are Violated4 PUB DATE Apr 83 NOTE 33p.; Paper presented at the Annual Meeting of the American Educational Research Association (67th, Montreal, Quebec, April 11-15, 1983). Table 3 contains small print. PUB TYPE Speeches/Conference Papers (150) -- Reports - Research/Technical (143) EDRS PRICE MF01/PCO2 Plus Postage. DESCRIPTORS *Analysis of Covariance; *Control Groups; *Data Collection; *Error of Measurement; Pretests Posttests; *Research Design; Sample Size; Sampling IDENTIFIERS Computer Simulation; Heteroscedasticity (Statistics); Homoscedasticity (Statistics); *Parametric Analysis; Power (Statistics); *Robustness; Type I Errors ABSTRACT Parametric analysis of covariance was compared to analysis of covariance with data transformed using ranks."Using computer simulation approach the two strategies were compared in terms of the proportion,of TypeI errors made and statistical power s when the conditional distribution of err-ors were: (1) normal and homoscedastic, (2) normal and heteroscedastic, (3) non-normal and homoscedastic, and (4) non-normal and heteroscedastic. The results indicated that parametric ANCOVA was robust to violations of either normality or homoscedasticity. However when both assumptions were violated the observed alpha levels underestimated the nominal 'alpha level when sample sizes were small and alpha=.05. Rank ANCOVA led to a slightly liberal test of the hypothesis when the covariate was non-normal and the errors were heteroscedastic. Practical significant power differences favoring the rank ANCOVA procedure were observed with moderate sample sizes and skewed conditional error distributions. (Author) ************************* *****************************f************** Reproductions supplie by EDRS are the best that can be made from the original document. -
Analysis of Covariance (ANCOVA)
PASS Sample Size Software NCSS.com Chapter 591 Analysis of Covariance (ANCOVA) Introduction A common task in research is to compare the averages of two or more populations (groups). We might want to compare the income level of two regions, the nitrogen content of three lakes, or the effectiveness of four drugs. The one-way analysis of variance compares the means of two or more groups to determine if at least one mean is different from the others. The F test is used to determine statistical significance. Analysis of Covariance (ANCOVA) is an extension of the one-way analysis of variance model that adds quantitative variables (covariates). When used, it is assumed that their inclusion will reduce the size of the error variance and thus increase the power of the design. Assumptions Using the F test requires certain assumptions. One reason for the popularity of the F test is its robustness in the face of assumption violation. However, if an assumption is not even approximately met, the significance levels and the power of the F test are invalidated. Unfortunately, in practice it often happens that several assumptions are not met. This makes matters even worse. Hence, steps should be taken to check the assumptions before important decisions are made. The following assumptions are needed for a one-way analysis of variance: 1. The data are continuous (not discrete). 2. The data follow the normal probability distribution. Each group is normally distributed about the group mean. 3. The variances of the populations are equal. 4. The groups are independent. There is no relationship among the individuals in one group as compared to another. -
ANALYSIS of VARIANCE and MISSING OBSERVATIONS in COMPLETELY RANDOMIZED, RANDOMIZED BLOCKS and LATIN SQUARE DESIGNS a Thesis
ANALYSIS OF VARIANCE AND MISSING OBSERVATIONS IN COMPLETELY RANDOMIZED, RANDOMIZED BLOCKS AND LATIN SQUARE DESIGNS A Thesis Presented to The Department of Mathematics Kansas State Teachers College, Emporia, Kansas In Partial Fulfillment of the Requirements for the Degree Master of Science by Kiritkumar K. Talati May 1972 c; , ACKNOWLEDGEMENTS Sincere thanks and gratitude is expressed to Dr. John Burger for his assistance, patience, and his prompt attention in all directions in preparing this paper. A special note of appreciation goes to Dr. Marion Emerson, Dr. Thomas Davis, Dr. George Poole, Dr. Darrell Wood, who rendered assistance in the research of this paper. TABLE OF CONTENTS CHAPTER I. INTRODUCTION • • • • • • • • • • • • • • • • 1 A. Preliminary Consideration. • • • • • • • 1 B. Purpose and Assumptions of the Analysis of Variance • • • • • • • • •• 1 C. Analysis of Covariance • • • • • • • • • 2 D. Definitions. • • • • • • • • • • • • • • ) E. Organization of Paper. • • • • • • • • • 4 II. COMPLETELY RANDOMIZED DESIGN • • • • • • • • 5 A. Description............... 5 B. Randomization. • • • • • • • • • • • • • 5 C. Problem and Computations •••••••• 6 D. Conclusion and Further Applications. •• 10 III. RANDOMIZED BLOCK DESIGN. • • • • • • • • • • 12 A. Description............... 12 B. Randomization. • • • • • • • • • • • • • 1) C. Problem and Statistical Analysis • • • • 1) D. Efficiency of Randomized Block Design as Compared to Completely Randomized Design. • • • • • • • • • •• 20 E. Missing Observations • • • • • • • • •• 21 F. -
Randomized Experimentsexperiments Randomized Trials
Impact Evaluation RandomizedRandomized ExperimentsExperiments Randomized Trials How do researchers learn about counterfactual states of the world in practice? In many fields, and especially in medical research, evidence about counterfactuals is generated by randomized trials. In principle, randomized trials ensure that outcomes in the control group really do capture the counterfactual for a treatment group. 2 Randomization To answer causal questions, statisticians recommend a formal two-stage statistical model. In the first stage, a random sample of participants is selected from a defined population. In the second stage, this sample of participants is randomly assigned to treatment and comparison (control) conditions. 3 Population Randomization Sample Randomization Treatment Group Control Group 4 External & Internal Validity The purpose of the first-stage is to ensure that the results in the sample will represent the results in the population within a defined level of sampling error (external validity). The purpose of the second-stage is to ensure that the observed effect on the dependent variable is due to some aspect of the treatment rather than other confounding factors (internal validity). 5 Population Non-target group Target group Randomization Treatment group Comparison group 6 Two-Stage Randomized Trials In large samples, two-stage randomized trials ensure that: [Y1 | D =1]= [Y1 | D = 0] and [Y0 | D =1]= [Y0 | D = 0] • Thus, the estimator ˆ ˆ ˆ δ = [Y1 | D =1]-[Y0 | D = 0] • Consistently estimates ATE 7 One-Stage Randomized Trials Instead, if randomization takes place on a selected subpopulation –e.g., list of volunteers-, it only ensures: [Y0 | D =1] = [Y0 | D = 0] • And hence, the estimator ˆ ˆ ˆ δ = [Y1 | D =1]-[Y0 | D = 0] • Only estimates TOT Consistently 8 Randomized Trials Furthermore, even in idealized randomized designs, 1.