Ebook Applied epidemiologic principles and concepts - Clinicians’ guide to study design and conduct : Part 1

Part 1 book “Applied epidemiologic principles and concepts - Clinicians’ guide to study design and conduct” has contents: Epidemiologic research conceptualization and rationale, clinical research proposal development and protocol, epidemiology, historical context, and measures of disease occurrence and association,… and other contents.

Applied Epidemiologic Principles and Concepts This book provides practical knowledge to clinicians and biomedical researchers 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 complexity 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 immunology and infectious diseases prior to his expertise in epidemiology-withbiostatistics 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 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 Preface Acknowledgments Author xiii xvii xxv xxvii SECTION I Basic research design principles and study inference 1 Epidemiologic research conceptualization and rationale 1.1 Introduction 3 1.2  Structure and function of research  1.3  Objective of study / research purpose  1.4  Research questions and study hypotheses  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 Clinical research proposal development and protocol 2.1 Introduction 27 2.2 Study conceptualization 28 2.3 Research question 32 2.4 Study background 34 2.5 Protocol implementation 36 27 viii  Contents 2.6  Data collection, management, and analysis  37 2.7 Summary 46 Questions for discussion  47 References 48 3 Epidemiologic 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 Epidemiologic 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 Epidemiology, 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 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 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 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 Cross-sectional studies: Design, conduct, and interpretation 9.1 Introduction 163 9.2 Summary 170 Questions for discussion  172 References 173 163 ... References 202 11 Clinical trials (human experimental designs) 205 11 .1 Introduction 205 11 .2  Phases of CTs  208 11 .3  Types of CT designs and statistical inference  212 11 .4  Elements of a CT  214 11 .5 ... http://taylorandfrancis.com Applied Epidemiologic Principles and Concepts Clinicians’ Guide to Study Design and Conduct Laurens Holmes Jr., MD, DrPH First published 2 018 by Routledge 711 Third Avenue, New York, NY 10 017 ... effect  11 0 Contents ix 5.7  Measures of disease comparison  11 4 5.8  Sources of epidemiologic data  11 7 5.9 Summary 11 7 Questions for discussion  11 9 References 12 0 Epidemiologic study designs: Overview