Survival Analysis A Self Learning Text 3rd Edition

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David G. Kleinbaum Mitchel Klein
Department of Epidemiology Department of Epidemiology
Rollins School of Public Health at Rollins School of Public Health at
Emory University Emory University
1518 Clifton Road NE 1518 Clifton Road NE
Atlanta, GA 30322 Atlanta, GA 30322
USA USA
[email protected] [email protected]

Series Editors
M. Gail K. Krickeberg J.M. Samet
National Cancer Institute Le Ch€atelet Department of Epidemiology
Rockville, MD 20892 F-63270 Manglieu School of Public Health
USA France Johns Hopkins University
615 Wolfe Street
Baltimore, MD 21205
USA

A. Tsiatis W. Wong
Department of Statistics Department of Statistics
North Carolina State University Stanford University
Raleigh, NC 27695 Stanford, CA 94305
USA USA

SAS1 and all other SAS Institute Inc. product or service names are registered trademarks or
trademarks of SAS Institute Inc. in the USA and other countries. 1 indicates USA registration.

SPSS1 is a registered trademark of SPSS Inc.

STATA1 and the STATA1 logo are registered trademarks of StataCorp LP.

ISSN 1431-8776
ISBN 978-1-4419-6645-2 e-ISBN 978-1-4419-6646-9
DOI 10.1007/978-1-4419-6646-9
Springer New York Dordrecht Heidelberg London

Library of Congress Control Number: 2011938018

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To Rachel Robinson

Morris Dees

Aung San Suu Kyi

John Lewis

And

countless other persons, well-known or unknown,

who have had the courage to stand up for their beliefs for the
benefit of humanity.
Preface
This is the third edition of this text on survival analysis,
originally published in 1996. As in the first and second
editions, each chapter contains a presentation of its topic
in “lecture-book” format together with objectives, an out-
line, key formulae, practice exercises, and a test. The “lec-
ture-book” format has a sequence of illustrations and
formulae in the left column of each page and a script in
the right column. This format allows you to read the script
in conjunction with the illustrations and formulae that
highlight the main points, formulae, or examples being
presented.

This third edition has expanded the second edition by

adding one new chapter, additional sections and clarifica-
tions to several chapters, and a revised computer appendix.

The new chapter is Chapter 10, “Design Issues for

Randomized Trials,” which considers how to compute
sample size when designing a randomized trial involving
time-to-event data.

We have expanded Chapter 1 to clarify the distinction

between random, independent, and noninformative cen-
soring assumptions often made about survival data. We
also added a section in Chapter 1 that introduces the
Counting Process data layout that is discussed in later
chapters (3, 6, and 8).

We added sections in Chapter 2 to describe how to obtain

confidence intervals for the Kaplan–Meier (KM) curve and
the median survival time obtained from a KM curve.

We have expanded Chapter 3 on the Cox Proportional

Hazards (PH) Model by describing the use of age as the
time scale instead of time-on-follow-up as the outcome
variable. We also added a section that clarifies how to
obtain confidence intervals for PH models that contain
product terms that reflect effect modification of exposure
variables of interest.

vii
viii Preface

We have added sections that describe the derivation of the

(partial) likelihood functions for the stratified Cox (SC) model
in Chapter 5 and the extended Cox model in Chapter 6.

We have expanded Chapter 9 on competing risks to

describe the Fine and Gray model for a subdistribution
hazard that allows for a multivariable analysis involving a
cumulative incidence curve (CIC). We also added a numer-
ical example to illustrate the calculation of a conditional
probability curve (CPC) defined from a CIC.

The Computer Appendix in the second edition of this text

provided step-by-step instructions for using the computer
packages STATA, SAS, and SPSS to carry out the survival
analyses presented in the main text. We expanded this
Appendix to include the free internet-based computer soft-
ware package call R. We have also updated our description
of STATA (version 10.0), SAS (version 9.2), and SPSS
(version PASW 18). The application of these computer
packages to survival data is described in separate self-
contained sections of the Computer Appendix, with the
analysis of the same datasets illustrated in each section.

In addition to the above new material, the original nine

chapters have been modified slightly to correct for errata
in the second edition and to add or modify exercises
provided at the end of some chapters.

The authors’ Web site for this textbook has the following
Web-link: http://www.sph.emory.edu/dklein/surv3.htm.

This Web site includes information on how to order this

second edition from the publisher and a freely download-
able zip-file containing data-files for examples used in the
textbook.

Suggestions This text was originally intended for self-study, but in the
for Use 15 years since the first edition was published, it has also
been effectively used as a text in a standard lecture-type
classroom format. The text may also be used to supplement
material covered in a course or to review previously
learned material in a self-instructional course or self-
planned learning activity. A more individualized learning
program may be particularly suitable to a working profes-
sional who does not have the time to participate in a regu-
larly scheduled course.
 Preface ix

In working with any chapter, the learner is encouraged

first to read the abbreviated outline and the objectives
and then work through the presentation. The reader is
then encouraged to read the detailed outline for a summary
of the presentation, work through the practice exercises,
and, finally, complete the test to check what has been
learned.

Recommended The ideal preparation for this text on survival analysis is a

Preparation course on quantitative methods in epidemiology and a
course in applied multiple regression. Also, knowledge of
logistic regression, modeling strategies, and maximum-
likelihood techniques is crucial for the material on the
Cox and parametric models described in Chapters 3–9.

Recommended references on these subjects, with sug-

gested chapter readings are:

Kleinbaum D, Kupper L, Nizam A, and Muller K, Applied

Regression Analysis and Other Multivariable Methods,
Fourth Edition, Cengage Publishers, 2007, Chapters 1–16,
22–23.

Kleinbaum D, Kupper L and Morgenstern H, Epidemio-

logic Research: Principles and Quantitative Methods, John
Wiley and Sons, Publishers, New York, 1982, Chapters
20–24.

Kleinbaum D and Klein M, Logistic Regression: A Self-

Learning Text, Third Edition, Springer Publishers,
New York, 2010, Chapters 4–7, 11.

Kleinbaum D, ActivEpi-A CD Rom Electronic Textbook on

Fundamentals of Epidemiology, Springer Publishers,
New York, 2002, Chapters 13–15.

A first course on the principles of epidemiologic research

would be helpful, since all chapters in this text are written
from the perspective of epidemiologic research. In parti-
cular, the reader should be familiar with the basic charac-
teristics of epidemiologic study designs, and should have
some idea of the frequently encountered problem of
controlling for confounding and assessing interaction/
effect modification. The above reference, ActivEpi, pro-
vides a convenient and hopefully enjoyable way to review
epidemiology.
Acknowledgments
We thank Dr. Val Gebski of the NHMRC Clinical Trials
Centre, Sydney, Australia for providing continued insight
on current methods of survival analysis and review of new
additions to the manuscript for this edition.

Finally, David Kleinbaum and Mitch Klein thank Edna

Kleinbaum and Becky Klein for their love, support, com-
panionship, and sense of humor during the writing of this
third edition.

xi
 Contents
Preface vii
Acknowledgments xi

Chapter 1 Introduction to Survival Analysis 1

Introduction 2
Abbreviated Outline 2
Objectives 3
Presentation 4
Detailed Outline 44
Practice Exercises 50
Test 52
Answers to Practice Exercises 54

Chapter 2 Kaplan-Meier Survival Curves

and the Log-Rank Test 55
Introduction 56
Abbreviated Outline 56
Objectives 57
Presentation 58
Detailed Outline 83
Practice Exercises 87
Test 91
Answers to Practice Exercises 93

Chapter 3 The Cox Proportional Hazards

Model and Its Characteristics 97
Introduction 98
Abbreviated Outline 98
Objectives 99
Presentation 100
Detailed Outline 145
Practice Exercises 149
Test 153
Answers to Practice Exercises 157

xiii
xiv Contents

Chapter 4 Evaluating the Proportional Hazards

Assumption 161
Introduction 162
Abbreviated Outline 162
Objectives 163
Presentation 164
Detailed Outline 188
Practice Exercises 191
Test 194
Answers to Practice Exercises 197

Chapter 5 The Stratified Cox Procedure 201

Introduction 202
Abbreviated Outline 202
Objectives 203
Presentation 204
Detailed Outline 228
Practice Exercises 231
Test 234
Answers to Practice Exercises 237

Chapter 6 Extension of the Cox Proportional

Hazards Model for Time-Dependent
Variables 241
Introduction 242
Abbreviated Outline 242
Objectives 243
Presentation 244
Detailed Outline 278
Practice Exercises 281
Test 285
Answers to Practice Exercises 287

Chapter 7 Parametric Survival Models 289

Introduction 290
Abbreviated Outline 290
Objectives 291
Presentation 292
Detailed Outline 345
Practice Exercises 351
Test 356
Answers to Practice Exercises 359
 Contents xv

Chapter 8 Recurrent Event Survival Analysis 363

Introduction 364
Abbreviated Outline 364
Objectives 365
Presentation 366
Detailed Outline 402
Practice Exercises 408
Test 412
Answers to Practice Exercises 422

Chapter 9 Competing Risks Survival Analysis 425

Introduction 426
Abbreviated Outline 428
Objectives 429
Presentation 430
Detailed Outline 474
Practice Exercises 481
Test 486
Answers to Practice Exercises 492

Chapter 10 Design Issues for Randomized Trials 497

Introduction 498
Abbreviated Outline 498
Objectives 499
Presentation 500
Detailed Outline 518
Practice Exercises 521
Test 523
Answers to Practice Exercises 523

Computer Appendix: Survival Analysis

on the Computer 525
A. Stata 527
B. SAS 570
C. SPSS 607
D. R Software 620

Test Answers 665

References 690
Index 695