Applied Epidemiologic Principles and Concepts: Clinicians' Guide to Study Design and Conduct

345 Pages·2018·22.273 MB·English

by  Laurens Holmes Jr

Applied Epidemiologic Principles and Concepts
This book provides practical knowledge to clinicians and biomedical research-
ers using biological and biochemical specimen/samples in order to understand
health and disease processes at cellular, clinical, and population levels. The
concepts and techniques provided will help researchers design and conduct
studies, then translate data from bench to clinics in an attempt to improve the
health of patients and populations. This book presents the extreme complex-
ity of epidemiologic research in a concise manner that will address the issue
of confounders, thus allowing for more valid inferences and yielding results
that are more reliable and accurate.
Laurens Holmes Jr. was trained in internal medicine, specializing in immu-
nology and infectious diseases prior to his expertise in epidemiology-with-
biostatistics. Over the past two decades, Dr. Holmes had been working in
cancer epidemiology, control, and prevention. His involvement in chronic
disease epidemiology, control, and prevention includes signal amplification
and stratification in risk modeling and health disparities in hypertension, and
diabetes mellitus with large legacy (preexisting U.S. National Health Statistics
Center) data.
http://taylorandfrancis.com
Applied Epidemiologic Principles and
Concepts
Clinicians’ Guide to Study Design and Conduct
Laurens Holmes Jr., MD, DrPH
First published 2018
by Routledge
711 Third Avenue, New York, NY 10017
and by Routledge
2 Park Square, Milton Park, Abingdon, Oxon, OX14 4RN
Routledge is an imprint of the Taylor & Francis Group, an informa business
© 2018 Taylor & Francis
The right of L. Holmes to be identified as author of this work has been asserted by him in accordance
with sections 77 and 78 of the Copyright, Designs and Patents Act 1988.
All rights reserved. No part of this book may be reprinted or reproduced or utilised in any form or by
any electronic, mechanical, or other means, now known or hereafter invented, including photocopying
and recording, or in any information storage or retrieval system, without permission in writing from
the publishers.
Trademark notice: Product or corporate names may be trademarks or registered trademarks, and are
used only for identification and explanation without intent to infringe.
Library of Congress Cataloging‑in‑Publication Data
Names: Holmes, Larry, Jr., 1960- author.
Title: Applied epidemiologic principles and concepts : clinicians’ guide to
study design and conduct / Laurens Holmes Jr.
Description: Abingdon, Oxon ; New York, NY : Routledge, 2018. | Includes
bibliographical references and index.
Identifiers: LCCN 2017018332| ISBN 9781498733786 (hardback) | ISBN
9781315369761 (ebook)
Subjects: | MESH: Epidemiologic Research Design
Classification: LCC RA651 | NLM WA 950 | DDC 614.4072--dc23
LC record available at https://lccn.loc.gov/2017018332
ISBN: 978-1-4987-3378-6 (hbk)
ISBN: 9781315369761 (ebk)
Dedicated to Palmer Beasly, MD, MPH (Dean
Emeritus, UTSPH), and James Steele, DVM, MPH
(Retired Assistant US Surgeon General and Professor
Emeritus, UTSPH), both in memoriam!
http://taylorandfrancis.com
Contents
Foreword xiii
Preface xvii
Acknowledgments xxv
Author xxvii
SECTION I
Basic research design principles and study inference 1
1 E pidemiologic research conceptualization and rationale 3
1.1 Introduction 3
1.2 Structure and function of research 4
1.3 Objective of study / research purpose 7
1.4 Research questions and study hypotheses 9
1.5 Primary versus secondary outcomes 12
1.6 Study subjects 19
1.7 Sampling 19
1.8 Generalization 21
1.9 Sample size and power estimations 22
1.10 Summary 23
Questions for discussion 24
References 24
2 Clinical research proposal development and protocol 27
2.1 Introduction 27
2.2 Study conceptualization 28
2.3 Research question 32
2.4 Study background 34
2.5 Protocol implementation 36
viii Contents
2.6 Data collection, management, and analysis 37
2.7 Summary 46
Questions for discussion 47
References 48
3 E pidemiologic design challenges: Confounding and effect
measure modifier 49
3.1 Introduction 49
3.2 Confounding, covariates, and mediation 50
3.3 Assessment for confounding 51
3.4 Confounding, covariates, and mediation 54
3.5 Types of confounding 55
3.6 Confounding and biased estimate 58
3.7 Effect measure modifier 60
3.8 Interaction: Statistical versus biologic 63
3.9 Summary 68
Questions for discussion 69
References 70
4 E pidemiologic case ascertainment: Disease screening
and diagnosis 71
4.1 Introduction 71
4.2 Screening (detection) and diagnostic (confirmation) tests 71
4.3 Disease screening: Principles, advantages, and limitations 78
4.4 Balancing benefits and harmful effects in medicine 84
4.5 Summary 86
Questions for discussion 87
References 88
SECTION II
Epidemiologic concepts and methods 91
5 E pidemiology, historical context, and measures of disease
occurrence and association 93
5.1 Introduction 93
5.2 Epidemiology, clinical medicine, and public health research 97
5.3 The history and modern concept of epidemiology 99
5.4 Models of disease causation 99
5.5 Measures of disease frequency, occurrence, and association 101
5.6 Measures of disease association or effect 110
Contents ix
5.7 Measures of disease comparison 114
5.8 Sources of epidemiologic data 117
5.9 Summary 117
Questions for discussion 119
References 120
6 Epidemiologic study designs: Overview 121
6.1 Introduction 121
6.2 Nonexperimental versus experimental design 125
6.3 Descriptive and analytic epidemiology 129
6.4 Summary 130
Questions for discussion 130
References 131
7 Ecologic studies: Design, conduct, and interpretation 133
7.1 Introduction 133
7.2 Ecologic studies: Description 133
7.3 Statistical analysis in ecologic design 137
7.4 Ecologic evidence: Association or causation? 138
7.5 Limitations of ecologic study design 138
7.6 Summary 140
Questions for discussion 141
References 142
8 Case-control studies: Design, conduct, and interpretation 143
8.1 Introduction 143
8.2 Basis of case-control design 146
8.3 Variance of case-control design 152
8.4 Scientific reporting in case-control studies:
Methods and results 156
8.5 Summary 160
Questions for discussion 161
References 162
9 Cross-sectional studies: Design, conduct, and interpretation 163
9.1 Introduction 163
9.2 Summary 170
Questions for discussion 172
References 173