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Designing Clinical Research An Epidemiologic Approach

by: Hulley, Stephen B.; Cummings, Steven R.; Browner, Warren S.; Grady, Deborah; Hearst, Norman; Newman, Thomas B.

Designing Clinical Research An Epidemiologic Approach

by: Hulley, Stephen B.; Cummings, Steven R.; Browner, Warren S.; Grady, Deborah; Hearst, Norman; Newman, Thomas B.

ISBN 13:
9780781722186
ISBN 10:
0781722187
Edition: 2nd
Format: Paperback
Copyright: 10/30/2000
Publisher: LWW
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Summary

Designing Clinical Research has set the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy to read, uncomplicated presentation. Updated chapters incorporate current research methodology, with an updated syllabus for conducting a clinical research workshop. A Brandon-Hill recommended title.

Introduction

xii

Acknowledgments

Section I: Basic Ingredients

Getting Started: The Anatomy and Physiology of Clinical Research

(14)

Stephen B. Hulley

Thomas B. Newman

Steven R. Cummings

The Anatomy of Research: What It's Made of

(4)

The Physiology of Research: How It Works

(5)

Designing the Study

(1)

Summary

(1)

Exercises

(1)

Appendix: Study Outline

(2)

Conceiving the Research Question

(8)

Steven R. Cummings

Warren S. Browner

Stephen B. Hulley

Origins of a Research Question

(2)

Characteristics of a Good Research Question

(2)

Developing the Research Question and Study Plan

(1)

Summary

(1)

Exercises

(2)

Choosing the Study Subjects: Specification, Sampling, and Recruitment

(12)

Stephen B. Hulley

Thomas B. Newman

Steven R. Cummings

Basic Terms and Concepts

(2)

Selection Criteria

(3)

Sampling

(1)

Recruitment

(2)

Summary

(1)

Exercises

(2)

Appendix: Drawing a Random Sample

(2)

Planning the Measurements: Precision and Accuracy

(14)

Stephen B. Hulley

Jeffrey N. Martin

Steven R. Cummings

Measurement Scales

(2)

Precision

(2)

Accuracy

(4)

Other Features of Measurement Approaches

(1)

Measurements on Stored Materials

(1)

In Closing

(1)

Summary

(1)

Exercises

(1)

Appendix: Operationally Defining a Measurement

(2)

Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles

(14)

Warren S. Browner

Thomas B. Newman

Norman Hearst

Stephen B. Hulley

Hypotheses

(3)

Underlying Statistical Principles

(4)

Additional Points

(4)

Summary

(1)

Exercises

(3)

Estimating Sample Size and Power: The Nitty-gritty

(30)

Warren S. Browner

Thomas B. Newman

Steven R. Cummings

Stephen B. Hulley

Sample Size Techniques for Analytic Studies and Experiments

(5)

Other Considerations and Special Issues

(3)

Sample Size Techniques for Descriptive Studies

(2)

What to Do When Sample Size Is Fixed

(1)

Strategies for Minimizing Sample Size and Maximizing Power

(4)

How to Estimate Sample Size When There Is Insufficient Information

(1)

Common Errors to Avoid

(1)

Summary

(1)

Exercises

(3)

Appendix: Sample Size Tables

(10)

Section II: Study Designs

Designing an Observational Study: Cohort Studies

(12)

Steven R. Cummings

Thomas B. Newman

Stephen B. Hulley

Prospective Cohort Studies

(1)

Retrospective Cohort Studies

(2)

Nested Case-Control and Case-Cohort Studies

(2)

Multiple-Cohort Studies and External Controls

101

(2)

Planning a Cohort Study

103

(1)

Summary

104

(1)

Exercises

105

(2)

Designing an Observational Study: Cross-sectional and Case-control Studies

107

(18)

Thomas B. Newman

Warren S. Browner

Steven R. Cummings

Stephen B. Hulley

Cross-Sectional Studies

107

(3)

Case-Control Studies

110

(7)

Choosing Among Observational Designs

117

(2)

Summary

119

(1)

Exercises

119

(2)

Appendix: Measures of Association

121

(4)

Enhancing Causal Inference in Observational Studies

125

(18)

Thomas B. Newman

Warren S. Browner

Stephen B. Hulley

Spurious Associations

125

(3)

Real Associations Other Than Cause-Effect

128

(2)

Coping with Confounders in the Design Phase

130

(3)

Coping with Confounders in the Analysis Phase

133

(2)

Choosing a Strategy

135

(1)

Summary

136

(1)

Exercises

137

(2)

Appendix: Confounding and Adjustment

139

(4)

Designing an Experiment: Clinical Trials I

143

(14)

Steven R. Cummings

Deborah Grady

Stephen B. Hulley

Selecting the Paticipants

143

(3)

Measuring Baseline Variables

146

(1)

Randomizing

147

(2)

Applying the Interventions

149

(5)

Summary

154

(3)

Designing an Experiment: Clinical Trials II

157

(18)

Deborah Grady

Steven R. Cummings

Stephen B. Hulley

Follow-up and Adherence to the Protocol

157

(3)

Measuring the Outcome

160

(2)

Analyzing the Results

162

(2)

Monitoring Clinical Trials

164

(3)

Alternatives to the Randomized Blinded Trial

167

(3)

Trials for FDA Approval of New Therapies

170

(1)

Deciding to Do a Trial

171

(1)

Summary

172

(1)

Exercises

172

(1)

Appendix: Interim Monitoring

173

(2)

Designing Studies of Medical Tests

175

(20)

Thomas B. Newman

Warren S. Browner

Steven R. Cummings

Determining Whether a Test Is Useful

175

(2)

Studies of Test Reproducibility

177

(2)

Studies of the Accuracy of Tests

179

(4)

Studies of the Effect of Test Results on Clinical Decisions

183

(1)

Studies of Feasibility, Costs, and Risks of Tests

184

(2)

Studies of the Effect of Testing on Outcomes

186

(2)

Pitfalls in the Design or Analysis of Diagnostic Test Studies

188

(1)

Summary

189

(1)

Exercises

190

(2)

Appendix: Interobserver Reproducibility

192

(3)

Research Using Existing Data: Secondary Data Analysis, Ancillary Studies, and Systematic Reviews

195

(20)

Norman Hearst

Deborah Grady

Hal V. Barron

Karla Kerlikowske

Advantages and Disadvantages

195

(1)

Secondary Data Analysis

196

(5)

Ancillary Studies

201

(2)

Systematic Reviews

203

(5)

Summary

208

(1)

Exercises

209

(2)

Appendix: Meta-Analysis Methods

211

(4)

Section III: Implementation

Addressing Ethical Issues

215

(16)

Bernard Lo

Ethical Principles

215

(1)

Federal Regulations for Research on Human Subjects

216

(4)

Responsibilities of Investigators

220

(3)

Other Ethical Issues

223

(2)

Summary

225

(1)

Exercises

225

(3)

Appendix: Informed Consent

228

(3)

Designing Questionnaires and Data Collection Instruments

231

(16)

Steven R. Cummings

Anita L. Stewart

Stephen B. Hulley

Designing Good Questions and Instruments

231

(8)

Steps in Assembling the Instruments for the Study

239

(2)

Administering the Instruments

241

(2)

Summary

243

(1)

Exercises

244

(1)

Appendix: Example of a Questionnaire

245

(2)

Data Management

247

(12)

Deborah Grady

Thomas B. Newman

Eric Vittinghoff

Defining the Variables

247

(3)

Creating the Study Database and Data Dictionary

250

(2)

Entering the Data and Correcting Errors

252

(4)

Creating a Dataset for Analysis

256

(1)

Backing Up and Archiving the Dataset

256

(1)

Summary

256

(3)

Implementing the Study: Pretesting, Quality Control, and Protocol Revisions

259

(16)

Stephen B. Hulley

Steven R. Cummings

Pretesting

259

(2)

Quality Control

261

(7)

Protocol Revisions Once Data Collection Has Begun

268

(1)

Summary

269

(1)

Exercises

270

(1)

Appendix: Operations Manual and Checklists

271

(4)

Community and International Studies

275

(10)

Norman Hearst

Stephen B. Hulley

Why Community and International Research?

275

(2)

Community Research

277

(1)

International Research

278

(4)

Summary

282

(1)

Exercises

282

(3)

Writing and Funding a Research Proposal

285

(16)

Steven R. Cummings

Elizabeth A. Holly

Stephen B. Hulley

Writing Proposals

285

(3)

Elements of a Proposal

288

(5)

Characteristics of Good Proposals

293

(1)

Finding Support for Research

294

(4)

Summary

298

(3)

Answers to Chapter Exercises

301

(18)

Subject Index

319

Amazon no longer offers textbook rentals. We do!

Designing Clinical Research An Epidemiologic Approach

Designing Clinical Research An Epidemiologic Approach

9780781722186

0781722187

Summary

Table of Contents

Supplemental Materials

Write a Review

Amazon no longer offers textbook rentals. We do!

Designing Clinical Research An Epidemiologic Approach

Designing Clinical Research An Epidemiologic Approach

9780781722186

0781722187

Summary

Table of Contents

Supplemental Materials

Write a Review

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