Designing Clinical Research: An Epidemiologic Approach / Edition 2

Designing Clinical Research: An Epidemiologic Approach / Edition 2

by Steven R. Cummings, Warren S. Browner, Deborah Grady, Norman Hearst
     
 

ISBN-10: 0781722187

ISBN-13: 9780781722186

Pub. Date: 10/28/2000

Publisher: Lippincott Williams & Wilkins

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

Overview

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.

Product Details

ISBN-13:
9780781722186
Publisher:
Lippincott Williams & Wilkins
Publication date:
10/28/2000
Edition description:
Second Edition
Pages:
352
Product dimensions:
7.03(w) x 10.02(h) x 0.68(d)

Table of Contents

Introductionxii
Acknowledgmentsxv
Section IBasic Ingredients
1Getting Started: The Anatomy and Physiology of Clinical Research3
The Anatomy of Research: What It's Made of3
The Physiology of Research: How It Works7
Designing the Study12
Summary13
Exercises14
AppendixStudy Outline15
2Conceiving the Research Question17
Origins of a Research Question17
Characteristics of a Good Research Question19
Developing the Research Question and Study Plan21
Summary22
Exercises23
3Choosing the Study Subjects: Specification, Sampling, and Recruitment25
Basic Terms and Concepts25
Selection Criteria27
Sampling30
Recruitment31
Summary33
Exercises33
AppendixDrawing a Random Sample35
4Planning the Measurements: Precision and Accuracy37
Measurement Scales37
Precision39
Accuracy41
Other Features of Measurement Approaches45
Measurements on Stored Materials46
In Closing47
Summary47
Exercises48
AppendixOperationally Defining a Measurement49
5Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles51
Hypotheses51
Underlying Statistical Principles54
Additional Points58
Summary62
Exercises62
6Estimating Sample Size and Power: The Nitty-gritty65
Sample Size Techniques for Analytic Studies and Experiments65
Other Considerations and Special Issues70
Sample Size Techniques for Descriptive Studies73
What to Do When Sample Size Is Fixed75
Strategies for Minimizing Sample Size and Maximizing Power76
How to Estimate Sample Size When There Is Insufficient Information80
Common Errors to Avoid81
Summary81
Exercises82
AppendixSample Size Tables85
Section IIStudy Designs
7Designing an Observational Study: Cohort Studies95
Prospective Cohort Studies96
Retrospective Cohort Studies97
Nested Case-Control and Case-Cohort Studies99
Multiple-Cohort Studies and External Controls101
Planning a Cohort Study103
Summary104
Exercises105
8Designing an Observational Study: Cross-sectional and Case-control Studies107
Cross-Sectional Studies107
Case-Control Studies110
Choosing Among Observational Designs117
Summary119
Exercises119
AppendixMeasures of Association121
9Enhancing Causal Inference in Observational Studies125
Spurious Associations125
Real Associations Other Than Cause-Effect128
Coping with Confounders in the Design Phase130
Coping with Confounders in the Analysis Phase133
Choosing a Strategy135
Summary136
Exercises137
AppendixConfounding and Adjustment139
10Designing an Experiment: Clinical Trials I143
Selecting the Paticipants143
Measuring Baseline Variables146
Randomizing147
Applying the Interventions149
Summary154
11Designing an Experiment: Clinical Trials II157
Follow-up and Adherence to the Protocol157
Measuring the Outcome160
Analyzing the Results162
Monitoring Clinical Trials164
Alternatives to the Randomized Blinded Trial167
Trials for FDA Approval of New Therapies170
Deciding to Do a Trial171
Summary172
Exercises172
AppendixInterim Monitoring173
12Designing Studies of Medical Tests175
Determining Whether a Test Is Useful175
Studies of Test Reproducibility177
Studies of the Accuracy of Tests179
Studies of the Effect of Test Results on Clinical Decisions183
Studies of Feasibility, Costs, and Risks of Tests184
Studies of the Effect of Testing on Outcomes186
Pitfalls in the Design or Analysis of Diagnostic Test Studies188
Summary189
Exercises190
AppendixInterobserver Reproducibility192
13Research Using Existing Data: Secondary Data Analysis, Ancillary Studies, and Systematic Reviews195
Advantages and Disadvantages195
Secondary Data Analysis196
Ancillary Studies201
Systematic Reviews203
Summary208
Exercises209
AppendixMeta-Analysis Methods211
Section IIIImplementation
14Addressing Ethical Issues215
Ethical Principles215
Federal Regulations for Research on Human Subjects216
Responsibilities of Investigators220
Other Ethical Issues223
Summary225
Exercises225
AppendixInformed Consent228
15Designing Questionnaires and Data Collection Instruments231
Designing Good Questions and Instruments231
Steps in Assembling the Instruments for the Study239
Administering the Instruments241
Summary243
Exercises244
AppendixExample of a Questionnaire245
16Data Management247
Defining the Variables247
Creating the Study Database and Data Dictionary250
Entering the Data and Correcting Errors252
Creating a Dataset for Analysis256
Backing Up and Archiving the Dataset256
Summary256
17Implementing the Study: Pretesting, Quality Control, and Protocol Revisions259
Pretesting259
Quality Control261
Protocol Revisions Once Data Collection Has Begun268
Summary269
Exercises270
AppendixOperations Manual and Checklists271
18.Community and International Studies275
Why Community and International Research?275
Community Research277
International Research278
Summary282
Exercises282
19Writing and Funding a Research Proposal285
Writing Proposals285
Elements of a Proposal288
Characteristics of Good Proposals293
Finding Support for Research294
Summary298
Answers to Chapter Exercises301
Subject Index319

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