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Designing Clinical Research An Epidemiologic Approach,9780781722186
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Designing Clinical Research An Epidemiologic Approach

by ; ; ; ; ;
Edition:
2nd
ISBN13:

9780781722186

ISBN10:
0781722187
Format:
Paperback
Pub. Date:
10/30/2000
Publisher(s):
Lippincott Williams & Wilkins

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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.

Table of Contents

Introduction xii
Acknowledgments xv
Section I: Basic Ingredients
Getting Started: The Anatomy and Physiology of Clinical Research
3(14)
Stephen B. Hulley
Thomas B. Newman
Steven R. Cummings
The Anatomy of Research: What It's Made of
3(4)
The Physiology of Research: How It Works
7(5)
Designing the Study
12(1)
Summary
13(1)
Exercises
14(1)
Appendix: Study Outline
15(2)
Conceiving the Research Question
17(8)
Steven R. Cummings
Warren S. Browner
Stephen B. Hulley
Origins of a Research Question
17(2)
Characteristics of a Good Research Question
19(2)
Developing the Research Question and Study Plan
21(1)
Summary
22(1)
Exercises
23(2)
Choosing the Study Subjects: Specification, Sampling, and Recruitment
25(12)
Stephen B. Hulley
Thomas B. Newman
Steven R. Cummings
Basic Terms and Concepts
25(2)
Selection Criteria
27(3)
Sampling
30(1)
Recruitment
31(2)
Summary
33(1)
Exercises
33(2)
Appendix: Drawing a Random Sample
35(2)
Planning the Measurements: Precision and Accuracy
37(14)
Stephen B. Hulley
Jeffrey N. Martin
Steven R. Cummings
Measurement Scales
37(2)
Precision
39(2)
Accuracy
41(4)
Other Features of Measurement Approaches
45(1)
Measurements on Stored Materials
46(1)
In Closing
47(1)
Summary
47(1)
Exercises
48(1)
Appendix: Operationally Defining a Measurement
49(2)
Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles
51(14)
Warren S. Browner
Thomas B. Newman
Norman Hearst
Stephen B. Hulley
Hypotheses
51(3)
Underlying Statistical Principles
54(4)
Additional Points
58(4)
Summary
62(1)
Exercises
62(3)
Estimating Sample Size and Power: The Nitty-gritty
65(30)
Warren S. Browner
Thomas B. Newman
Steven R. Cummings
Stephen B. Hulley
Sample Size Techniques for Analytic Studies and Experiments
65(5)
Other Considerations and Special Issues
70(3)
Sample Size Techniques for Descriptive Studies
73(2)
What to Do When Sample Size Is Fixed
75(1)
Strategies for Minimizing Sample Size and Maximizing Power
76(4)
How to Estimate Sample Size When There Is Insufficient Information
80(1)
Common Errors to Avoid
81(1)
Summary
81(1)
Exercises
82(3)
Appendix: Sample Size Tables
85(10)
Section II: Study Designs
Designing an Observational Study: Cohort Studies
95(12)
Steven R. Cummings
Thomas B. Newman
Stephen B. Hulley
Prospective Cohort Studies
96(1)
Retrospective Cohort Studies
97(2)
Nested Case-Control and Case-Cohort Studies
99(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


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