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This Page Intentionally Left Blank
BASIC STATISTICS
This Page Intentionally Left Blank
BASIC STATISTICS
A Primer for the Biomedical Sciences
Fourth Edition

OLIVE JEAN DUNN

VIRGINIA A. CLARK

WILEY
A JOHN WILEY &SONS, INC., PUBLICATION
Copyright 0 2009 by John Wiley & Sons, Inc. All rights reserved.

Published by John Wiley & Sons, Inc., Hoboken, New Jersey

Published simultaneously in Canada.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or
by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as
permitted under Section 107 or 108 of the 1976 United States Copyright Act, without either the prior
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Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts in
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Library of Congress Cataloging-in-Publication Data:

Dunn, Olive Jean.

Basic statistics: a primer for the biomedical sciences / Olive Jean DUM, Virgina A.
Clark. - 4th ed.
p. ; cm.
Includes bibliographical references and index.
ISBN 978-0-470-24879-9 (cloth)
1. Medical statistics. 2. Biometry. I. Clark, Virginia, 1928- 11. Title.
[DNLM: 1. Biometry. 2. Statistics as Topic. WA 950 D923b 20091
RA409.D87 2009
5 19.5'02461-dc22 2009018425

Printed in the United States of America.

1 0 9 8 7 6 5 4 3 2 1
CONTENTS

Preface to the Fourth Edition xiii

1 Initial Steps 1
1.1 Reasons for Studying Biostatistics
1.2 Initial Steps in Designing a Biomedical Study
1.2.1 Setting Objectives
1.2.2 Making a Conceptual Model of the Disease Process
1.2.3 Estimating the Number of Persons with the Risk Factor
or Disease 4
1.3 Common Types of Biomedical Studies 5
1.3.1 Surveys 6
1.3.2 Experiments 7
1.3.3 Clinical Trials 7
1.3.4 Field Trials 9
1.3.5 Prospective Studies 9
1.3.6 Case/Control Studies 10
1.3.7 Other Types of Studies 10
V
CONTENTS

1.3.8 Rating Studies by the Level of Evidence 11

1.3.9 CONSORT 11
Problems 12
References 12

Populations and Samples 13

2.1 Basic Concepts 13
2.2 Definitions of Types of Samples 15
2.2.1 Simple Random Samples 15
2.2.2 Other Types of Random Samples 15
2.2.3 Reasons for Using Simple Random Samples 17
2.3 Methods of Selecting Simple Random Samples 17
2.3.1 Selection of a Small Simple Random Sample 17
2.3.2 Tables of Random Numbers 17
2.3.3 Sampling With and Without Replacement 19
2.4 Application of Sampling Methods in Biomedical Studies 19
2.4.1 Characteristics of a Good Sampling Plan 19
2.4.2 Samples for Surveys 20
2.4.3 Samples for Experiments 21
2.4.4 Samples for Prospective Studies 23
2.4.5 Samples for Case/Control Studies 23
Problems 25
References 26

Collecting and Entering Data 27

3.1 Initial Steps 27
3.1.1 Decide What Data You Need 28
3.1.2 Deciding How to Collect the Data 29
3.1.3 Testing the Collection Process 30
3.2 DataEntry 31
3.3 Screening the Data 33
3.4 CodeBook 33
Problems 34
References 34

FrequencyTables and Their Graphs 35

4.1 Numerical Methods of Organizing Data 36
4.1.1 An Ordered Array 36
 CONTENTS vii

4.1.2 Stem and Leaf Tables 36

4.1.3 The Frequency Table 38
4.1.4 Relative Frequency Tables 40
4.2 Graphs 40
4.2.1 The Histogram: Equal Class Intervals 41
4.2.2 The Histogram: Unequal Class Intervals 41
4.2.3 Areas Under the Histogram 43
4.2.4 The Frequency Polygon 44
4.2.5 Histograms with Small Class Intervals 45
4.2.6 Distribution Curves 45
Problems 47
References 47

5 Measures of Location and Variability 49

5.1 Measures of Location 50
5.1.1 The Arithmetic Mean 50
5.1.2 The Median 51
5.1.3 Other Measures of Location 52
5.2 Measures of Variability 52
5.2.1 The Variance and the Standard Deviation 52
5.2.2 Other Measures of Variability 54
5.3 Sampling Properties of the Mean and Variance 55
5.4 Considerations in Selecting Appropriate Statistics 57
5.4.1 Relating Statistics and Study Objectives 57
5.4.2 Relating Statistics and Data Quality 58
5.4.3 Relating Statistics to the Type of Data 58
5.5 A Common Graphical Method for Displaying Statistics 60
Problems 61
References 62

6 The Normal Distribution 63

6.1 Properties of the Normal Distribution 64
6.2 Areas Under the Normal Curve 65
6.2.1 Computing the Area Under a Normal Curve 66
6.2.2 Linear Interpolation 68
6.2.3 Interpreting Areas as Probabilities 70
6.3 Importance of the Normal Distribution 70
6.4 Examining Data for Normality 72
viii CONTENTS

6.4.1 Using Histograms and Box Plots 72

6.4.2 Using Normal Probability Plots or Quantile-Quantile
Plots 72
6.5 Transformations 75
6.5.1 Finding a Suitable Transformation 76
6.5.2 Assessing the Need for a Transformation 77
Problems 77
References 78

7 Estimation of Population Means: Confidence Intervals 79

7.1 Confidence Intervals 80
7.1.1 An Example 80
7.1.2 Definition of Confidence Interval 81
7.1.3 Choice of Confidence Level 82
7.2 Sample Size Needed for a Desired Confidence Interval 83
7.3 The t Distribution 83
7.4 Confidence Interval for the Mean Using the t Distribution 85
7.5 Estimating the Difference Between Two Means: Unpaired Data 86
7.5.1 The Distribution of - 7, 86
7.5.2 Confidence Intervals for ,LL~ - p2: Known Variance 87
7.5.3 Confidence Intervals for , L L ~- p2: Unknown Variance 88
7.6 Estimating the Difference Between Two Means: Paired
Comparison 89
Problems 91
References 93

8 Tests of Hypotheses on Population Means 95

8.1 Tests of Hypotheses for a Single Mean 96
8.1.1 Test for a Single Mean When u Is Known 96
8.1.2 One-sided Tests When u Is Known 99
8.1.3 Summary of Procedures for Test of Hypotheses 100
8.1.4 Test for a Single Mean When Is Unknown 101
8.2 Tests for Equality of two Means: Unpaired Data 103
8.2.1 Testing for Equality of Means When u Is Known 103
8.2.2 Testing for Equality of Means When 0 Is Unknown 104
8.3 Testing for Equality of Means: Paired Data 107
8.4 Concepts Used in Statistical Testing 108
8.4.1 Decision to Accept or Reject 108
 CONTENTS ix

8.4.2 Two Kinds of Error 109

8.4.3 An Illustration of fi 110
8.5 Sample Size 111
8.6 Confidence Intervals Versus Tests 113
8.7 Correcting for Multiple Testing 114
8.8 Reporting the Results 115
Problems 115
References 116

9 Variances: Estimation and Tests 117

9.1 Point Estimates for Variances and Standard Deviations 118
9.2 Testing Whether Two Variances Are Equal: F Test 118
9.3 Approximate t Test 121
9.4 Other Tests 122
Problems 123
Reference 123

10 Categorical Data: Proportions 125

10.1 Single Population Proportion 126
10.1.1 Graphical Displays of Proportions 126
10.2 Samples from Categorical Data 128
10.3 The Normal Approximation to the Binomial 129
10.3.1 Use of the Normal Approximation to the Binomial 129
10.3.2 Continuity Correction 130
10.4 Confidence Intervals for a Single Population Proportion 130
10.5 Confidence Intervals for the Difference in Two Proportions 131
10.6 Tests of Hypothesis for Population Proportions 133
10.6.1 Tests of Hypothesis for a Single Population Proportion 133
10.6.2 Testing the Equality of Two Population Proportions 134
10.7 Sample Size for Testing Two Proportions 136
10.8 Data Entry and Analysis Using Statistical Programs 137
Problems 138
References 139

11 Categorical Data: Analysis of Two-way Frequency Tables 141

11.1 Different Types of Tables 142
11.1.1 Tables Based on a Single Sample 142
11.1.2 Tables Based on Two Samples 143
X CONTENTS

11.1.3 Tables Based on Matched or Paired Samples 144

11.1.4 Relationship Between Type of Study Design and Type
of Table 145
11.2 Relative Risk and Odds Ratio 146
11.2.1 Relative Risk 146
11.2.2 Odds Ratios 147
11.3 Chi-square Tests for Frequency Tables: Two-by-Two Tables 150
11.3.1 Chi-square Test for a Single Sample: Two-by-Two
Tables 150
11.3.2 Chi-square Test for Two Samples: Two-by-Two Tables 154
11.3.3 Chi-square Test for Matched Samples: Two-by-Two
Tables 155
11.3.4 Assumptions for the Chi-square Test 156
11.3.5 Necessary Sample Size: Two-by-Two Tables 156
11.3.6 The Continuity Correction: Two-by-Two Tables 157
11.4 Chi-square Tests for Larger Tables 158
11.4.1 Chi-square for Larger Tables: Single Sample 158
11.4.2 Interpreting a Significant Test 159
11.4.3 Chi-square Test for Larger Tables; More Than Two
Samples or Outcomes 161
11.4.4 Necessary Sample Size for Large Tables 161
11.5 Remarks 162
Problems 162
References 164

Regression and Correlation 165

12.1 The Scatter Diagram: Single Sample 166
12.2 Linear Regression: Single Sample 168
12.2.1 Least-Squares Regression Line 168
12.2.2 Interpreting the Regression Coefficients 170
12.2.3 Plotting the Regression Line 170
12.2.4 The Meaning of the Least-Squares Line 170
12.2.5 The Variance of the Residuals 171
12.2.6 Model Underlying Single-Sample Linear Regression 172
12.2.7 Confidence Intervals in Single-Sample Linear
Regression 174
12.2.8 Tests of Hypotheses for Regression Line from a Single
Samde 176
 CONTENTS xi

12.3 The Correlation Coefficient for Two Variables From a Single

Sample 177
12.3.1 Calculation of the Correlation Coefficient 177
12.3.2 The Meaning of the Correlation Coefficient 177
12.3.3 The Population Correlation Coefficient 179
12.3.4 Confidence Intervals for the Correlation Coefficient 179
12.3.5 Test of Hypothesis That p = 0 179
12.3.6 Interpreting the Correlation Coefficient 180
12.4 Linear Regression Assuming the Fixed-X Model 180
12.4.1 Model Underlying the Fixed-X Linear Regression 181
12.4.2 Linear Regression Using the Fixed-X Model 181
12.5 Other Topics in Linear Regression 183
12.5.1 Use of Transformations in Linear Regression 183
12.5.2 Effect of Outliers from the Regression Line 184
12.5.3 Multiple Regression 184
Problems 184
References 187

13 Nonparametric Statistics 189

13.1 The Sign Test 190
13.1.1 Sign Test for Large Samples 190
13.1.2 Sign Test When the Sample Size Is Small 191
13.2 The Wilcoxon Signed Ranks Test 192
13.2.1 Wilcoxon Signed Ranks Test for Large Samples 192
13.2.2 Wilcoxon Signed Ranks Test for Small Samples 194
13.3 The Wilcoxon-Mann-Whitney Test 195
13.3.1 Wilcoxon Rank Sum Test for Large Samples 195
13.3.2 Wilcoxon Rank Sum Test for Small Samples 197
13.4 Spearman’s Rank Correlation 198
Problems 199
References 199

14 Introduction to Survival Analysis 201

14.1 Survival Analysis Data 202
14.1.1 Describing Time to an Event 202
14.1.2 Example of Measuring Time to an Event 202
14.2 Survival Functions 204
14.2.1 The Death Density Function 204
xii CONTENTS

14.2.2 The Cumulative Death Distribution Function 205

14.2.3 The Survival Function 206
14.2.4 The Hazard Function 207
14.3 Computing Estimates of f ( t ) ,S(t),and h(t) 208
14.3.1 Clinical Life Tables 209
14.3.2 Kaplan-Meier Estimate 212
14.4 Comparison of Clinical Life Tables and the Kaplan-Meier
Method 214
14.5 Additional Analyses Using Survival Data 215
14.5.1 Comparing the Equality of Survival Functions 215
14.5.2 Regression Analysis of Survival Data 216
Problems 216
References 216

Appendix A: Statistical Tables 219

Appendix B: Answers to Selected Problems 235

Appendix C: Computer Statistical Program Resources 243

C. 1 Computer Systems for Biomedical Education and Research 243
C.2 A Brief Indication of Statistics Computer Program Advances
and Some Relevant Publications Since 2000 244
C.3 Choices of Computer Statistical Software 248

Bibliography 249

Index 253
Preface to the Fourth Edition

This book is designed to serve as a textbook for a one-semester course in biostatistics

for students or reseachers in the biomedical field. We have also included material that
will be useful to physicians, public health workers, and nurses who become involved
in research projects and wish not to only understand the basic concepts of biostatistics
but also to apply them in their research projects.
The mathematics level has been kept deliberately low. We have provided formulas
and examples so that the reader can see how to make the calculations, as this is useful
in understanding what is done. References are provided for statistical programs that
will perform the calculations and graphs for use in research projects.
In line with the dual purpose of including teaching the basic concepts and also
including material that is essential in performing research projects successfully, two
types of chapters are included. One type is concentrated on basic statistical techniques
that are widely used in biomedical and public health research. These include a new
chapter that presents the more widely used nonparametric tests. The second type,
which includes material useful in performing research projects, is represented in
Chapters 1 and 3. In Chapter 1 we present the initial steps in designing a biomedical
study and describe the common types of biomedical studies. Chapter 3 is a new
chapter that was not in our previous editions. It gives the initial steps in planning
a biomedical or public health study, including deciding what data to take, how to
collect it, and how to test the data collection method. Brief introductions to data entry

xiii
xiv PREFACE TO THE FOURTH EDITION

and screening are also given. The remaining chapters are concentrated on statistical
techniques that are widely used in biomedical and public health research.
A short list of references is included at the end of each chapter. The object here
is to include at least one reference that would cover the material mentioned in the
chapter and also to include references that include additional information.
For the instructor who is concerned about covering the text in a single semester or
quarter, note that the chapters are short. The information on tests when the population
variance is known could be mentioned briefly, and the use of confidence limits for the
differences between two means could be omitted. These two topics are not available
in most computer programs. The chapter on survivor analysis may not be as relevant
to public health students as it is to medical researchers.
The fourth edition has benefited from the work of Amy Hendrickson
(TeXnology.com) in checking and preparing early chapters and in final versions of
the book.
I am sorry to report that Jean Dunn died in January 2008. I still regard this as her
book, as she wrote the first two editions and her clarity of thinking and thoughtful
writing is what makes this book a good choice for readers who want to understand
what they are doing.

A . CLARK
OLIVEJEANDUNNA N D VIRGINIA
CHAPTER 1

INITIAL STEPS

Statistical methods have been developed to help in understanding data and to assist in
making decisions when uncertainty exists. Biostatistics is the use of statistics applied
to biological problems and to medicine. In this book, the examples are given using
biomedical and public health data. Bio is taken from the Greek word bios, meaning
“life” so that biology actually includes numerous fields, such as ecology, fisheries,
and agriculture, but examples from those fields are not included in this book.
In Section 1.1 we discuss the two major reasons for using statistics, in Section 1.2
we present the initial steps in the design of biomedical studies, and in Section 1.3 we
define the common types of biomedical studies and describe how medical studies are
rated by level of evidence and how the CONSORT guidelines for randomized clinical
trials are referenced.

1.1 REASONS FOR STUDYING BlOSTATlSTlCS

Statistics has traditionally been used with two purposes in mind. The first is to
summarize data so that it is readily comprehensible; this is called descriptive statis-
tics. Both in the past and recently, considerable effort has gone into devising meth-
ods of describing data that are easy to interpret. The use of computers and their

Basic Statistics: A Primer f o r the Biomedical Sciences, Fourth Edition. 1

By Olive Jean Dunn and Virginia A. Clark
Copyright @ 2009 John Wiley & Sons, Inc.
2 INITIAL STEPS

accompanying graphic programs have made it possible to obtain attractive and mean-
ingful displays of data without having to employ skilled graphic artists.
The second purpose is to draw conclusions that can be applied to other cases; this
is called statistical inference. For example, in studying the effects of a certain drug
on patients with asthma, one may want to do more than describe what happened to
the particular patients under study. One usually wishes to decide how to treat patients
with asthma in the future.
Biostatistical techniques are now widely used both in scientific articles and in
articles appearing in newspapers and on television. Learning to interpret statistical
summaries of data and statistical tests enables people to evaluate what they are reading
or hearing and to decide for themselves whether or not it is sensible.
Biostatistical concepts and techniques are useful for researchers who will be doing
research in medicine or public health. Here, the researchers need to know how to
decide what type of study to use for their research project, how to execute the study
on patients or well people, and how to evaluate the results. In small studies, they may
be totally responsible for the biostatistical analysis, and in large studies, they may
work with a professional biostatistician. In either case, knowing the basic concepts
and vocabulary of biostatistics will improve the research.

1.2 INITIAL STEPS IN DESIGNING A BIOMEDICAL STUDY

In this section we discuss setting study objectives and making a conceptual model of
the disease process. We also give two measures of evaluating how common a disease
condition is.

1.2.1 Setting Objectives

“If you do not know where you are going, any road will get you there” is a disparaging
remark that applies to planning a research project as well as to traveling. Thejirst
step in evaluating a study or in planning for one is to determine the major objective
of the study. Time spent in writing a clear statement of purpose of the study will save
time and energy later, especially in group projects.
In biomedical and public health studies two general types of objectives underlie
many of the studies that are performed. Broadly stated, these objectives are:

1. To determine the desirability of different treatments or preventive measures to

reduce disease.
2. To assess the effects of causal or risk factors on the occurrence or progression
of disease.

Here, the word disease has been used to stand for any unwanted medical or psy-
chological condition. A risk factor may often be a genetic predisposition, an envi-
ronmental exposure, or a patient’s lifestyle, over which the researcher has little or no
control.
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