Designing Clinical Research / Edition 4

Designing Clinical Research / Edition 4

by Stephen B Hulley, Steven R Cummings, Warren S Browner, Deborah G Grady
     
 

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ISBN-10: 1608318044

ISBN-13: 9781608318049

Pub. Date: 07/01/2013

Publisher: Lippincott Williams & Wilkins

Designing Clinical Research has been extensively revised and continues to set the standard as a practical guide for doctors, nurses, pharmacists, and other health professionals involved in all forms of clinical, translational, and public health research. It presents advanced epidemiologic concepts in a reader-friendly way, and suggests common sense approaches

Overview

Designing Clinical Research has been extensively revised and continues to set the standard as a practical guide for doctors, nurses, pharmacists, and other health professionals involved in all forms of clinical, translational, and public health research. It presents advanced epidemiologic concepts in a reader-friendly way, and suggests common sense approaches to the challenging judgments involved in designing, funding, and implementing.

New to this edition:

  • Expanded and updated content in every chapter, with new material on: • non-inferiority trials for comparative effectiveness research • incidence-density case-control studies • confounding and effect modification • diagnostic test studies to inform prediction rules • ethical aspects of whole genome sequencing • automated data management approaches • new NIH grant-writing requirements
  • Color format, and Electronic access, powered by Inkling™ as a free companion to the text • viewable through your browser or as a download to tablet or smartphone • the complete text with optimized navigation • note-sharing, highlighting and bookmarking capability • cross-linking of references and content • rapid search options linked to the new glossary

Product Details

ISBN-13:
9781608318049
Publisher:
Lippincott Williams & Wilkins
Publication date:
07/01/2013
Edition description:
Fourth
Pages:
378
Sales rank:
111,156
Product dimensions:
6.90(w) x 9.90(h) x 0.60(d)

Table of Contents

Contributing Authors ix

Introduction xi

Acknowledgments xiii

Section I Basic Ingredients 1

1 Getting Started: The Anatomy and Physiology of Clinical Research Stephen B. Hulley Thomas B. Newman Steven R. Cummings 2

2 Conceiving the Research Question and Developing the Study Plan Steven R. Cummings Warren S. Browner Stephen B. Hulley 14

3 Choosing the Study Subjects: Specification, Sampling, and Recruitment Stephen B. Hulley Thomas B. Newman Steven R. Cummings 23

4 Planning the Measurements: Precision, Accuracy, and Validity Stephen B. Hulley Thomas B. Newman Steven R. Cummings 32

5 Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles Warren S. Browner Thomas B. Newman Stephen B. Hulley 43

6 Estimating Sample Size and Power: Applications and Examples Warren S. Browner Thomas B. Newman Stephen B. Hulley 55

Section II Study Designs 84

7 Designing Cross-Sectional and Cohort Studies Stephen B. Hulley Steven R. Cummings Thomas B. Newman 85

8 Designing Case-Control Studies Thomas B. Newman Warren S. Browner Steven R. Cummings Stephen B. Hulley 97

9 Enhancing Causal Inference in Observational Studies Thomas B. Newman Warren S. Browner Stephen B. Hulley 117

10 Designing a Randomized Blinded Trial Steven R. Cummings Deborah G. Grady Stephen B. Hulley 137

11 Alternative Clinical Trial Designs and Implementation Issues Deborah G. Grady Steven R. Cummings Stephen B. Hulley 151

12 Designing Studies of Medical Tests Thomas B. Newman Warren S. Browner Steven R. Cummings Stephen B. Hulley 171

13 Research Using Existing Data Deborah G. Grady Steven R. Cummings Stephen B. Hulley 192

Section III Implementation 208

14 Addressing Ethical Issues Bernard Lo Deborah G. Grady 209

15 Designing Questionnaires, Interviews, and Online Surveys Steven R. Cummings Michael A. Kohn Stephen B. Hulley 223

16 Data Management Michael A. Kohn Thomas B. Newman Stephen B. Hulley 237

17 Implementing the Study and Quality Control Deborah G. Grady Stephen B. Hulley 250

18 Community and International Studies Norman Hearst Thomas Novotny 268

19 Writing a Proposal for Funding Research Steven R. Cummings Deborah G. Grady Stephen B. Hulley 277

Exercises 292

Answers to Exercises 306

Glossary 327

Index 351

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