Designing Clinical Research,9780781782104

Designing Clinical Research

by ; ; ; ;
Edition: 3rd
ISBN13: 9780781782104
ISBN10: 0781782104
Format: Paperback
Pub. Date: 2006-11-27
Publisher(s): LWW
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Summary

Designing Clinical Research sets the standard for providing a practical guide to planning, tabulating, formulating, and implementing clinical research, with an easy-to-read, uncomplicated presentation. This edition incorporates current research methodology--including molecular and genetic clinical research--and offers an updated syllabus for conducting a clinical research workshop. Emphasis is on common sense as the main ingredient of good science. The book explains how to choose well-focused research questions and details the steps through all the elements of study design, data collection, quality assurance, and basic grant-writing. All chapters have been thoroughly revised, updated, and made more user-friendly.

Table of Contents

Contributing Authors xi
Introduction xiii
Acknowledgments xv
Section I: Basic Ingredients
Getting Started: The Anatomy and Physiology of Clinical Research
3(14)
Anatomy of Research: What It's Made Of
3(5)
Physiology of Research: How It Works
8(5)
Designing the Study
13(1)
Summary
14(1)
Appendix 1.1: Outline of a Study
15(1)
Reference
15(2)
Conceiving the Research Question
17(10)
Origins of a Research Question
18(1)
Characteristics of a Good Research Question
19(3)
Developing the Research Question and Study Plan
22(1)
Translational Research
23(2)
Summary
25(1)
References
25(2)
Choosing the Study Subjects: Specification, Sampling, and Recruitment
27(10)
Basic Terms and Concepts
28(1)
Selection Criteria
29(3)
Sampling
32(1)
Recruitment
33(2)
Summary
35(1)
Appendix 3.1: Selecting a Random Sample from a Table of Random Numbers
36(1)
References
36(1)
Planning the Measurements: Precision and Accuracy
37(14)
Measurement Scales
38(1)
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)
Appendix 4.1: Operations Manual: Operational Definition of a Measurement of Grip Strength
48(1)
References
49(2)
Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles
51(14)
Hypotheses
51(3)
Underlying Statistical Principles
54(5)
Additional Points
59(3)
Summary
62(1)
References
63(2)
Estimating Sample Size and Power: Applications and Examples
65(32)
Sample Size Techniques for Analytic Studies and Experiments
65(6)
Other Considerations and Special Issues
71(2)
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(5)
How to Estimate Sample Size When there is Insufficient Information
81(1)
Common Errors to Avoid
82(1)
Summary
83(1)
Appendix 6A: Sample Size Required per Group When Using the t Test to Compare Means of Continuous Variables
84(2)
Appendix 6B: Sample Size Required per Group When Using the Chi-Squared Statistic or Z Test to Compare Proportions of Dichotomous Variables
86(3)
Appendix 6C: Total Sample Size Required When Using the Correlation Coefficient (r)
89(1)
Appendix 6D: Sample Size for a Descriptive Study of a Continuous Variable
90(1)
Appendix 6E: Sample Size for a Descriptive Study of a Dichotomous Variable
91(1)
Appendix 6F: Use and Misuse of t Tests
92(1)
References
93(4)
Section II: Study Designs
Designing a Cohort Study
97(12)
Prospective Cohort Studies
97(2)
Retrospective Cohort Studies
99(1)
Nested Case--Control and Case--Cohort Studies
100(3)
Multiple-Cohort Studies and External Controls
103(1)
Other Cohort Study Issues
104(2)
Summary
106(1)
References
106(3)
Designing Cross-Sectional and Case-Control Studies
109(18)
Cross-Sectional Studies
109(3)
Case-Control Studies
112(9)
Choosing Among Observational Designs
121(1)
Summary
121(1)
Appendix 8A: Calculating Measures of Association
122(1)
Appendix 8B: Why the Odds Ratio Can Be Used as an Estimate for Relative Risk in a Case-Control Study
123(2)
References
125(2)
Enhancing Causal Inference in Observational Studies
127(20)
Spurious Associations
127(4)
Real Associations Other than Cause-Effect
131(1)
Coping With Confounders in the Design Phase
132(5)
Coping with Confounders in the Analysis Phase
137(4)
Underestimation of Causal Effects
141(1)
Choosing a Strategy
141(2)
Summary
143(1)
Appendix 9A: Hypothetical Example of Confounding and Interaction
144(1)
Appendix 9B: A Simplified Example of Adjustment
145(1)
References
146(1)
Designing a Randomized Blinded Trial
147(16)
Selecting the Intervention and Control Conditions
147(3)
Choosing Outcome Measurements
150(2)
Selecting the Participants
152(2)
Measuring Baseline Variables
154(1)
Randomizing and Blinding
155(4)
Summary
159(1)
References
160(3)
Alternative Trial Designs and Implementation Issues
163(20)
Alternative Clinical Trial Designs
163(7)
Conducting a Clinical Trial
170(9)
Summary
179(1)
Appendix 11.1: Interim Monitoring of Trial Outcomes
180(1)
References
181(2)
Designing Studies of Medical Tests
183(24)
Determining Whether a Test is Useful
183(3)
Studies of Test Reproducibility
186(2)
Studies of the Accuracy of Tests
188(4)
Studies of the Effect of Test Results on Clinical Decisions
192(1)
Studies of Feasibility, Costs, and Risks of Tests
193(1)
Studies of the Effect of Testing on Outcomes
194(2)
Pitfalls in the Design or Analysis of Diagnostic Test Studies
196(3)
Summary
199(1)
Appendix 12A: Calculation of Kappa to Measure Interobserver Agreement
200(2)
Appendix 12B: Numerical Example of Verification Bias: 1
202(1)
Appendix 12C: Numerical Example of Verification Bias: 2
203(1)
References
204(3)
Utilizing Existing Databases
207(18)
Advantages and Disadvantages
207(1)
Secondary Data Analysis
208(3)
Ancillary Studies
211(2)
Systematic Reviews
213(5)
Summary
218(1)
Appendix 13.1: Statistical Methods for Meta-Analysis
219(1)
References
220(5)
Section III: Implementation
Addressing Ethical Issues
225(16)
Ethical Principles
225(1)
Federal Regulations for Research on Human Subjects
226(5)
Research Participants who Require Additional Protections
231(1)
Responsibilities of Investigators
232(3)
Ethical Issues Specific to Certain Types of Research
235(1)
Other Issues
236(1)
Summary
237(1)
References
237(4)
Designing Questionnaires and Interviews
241(16)
Designing Good Instruments
241(9)
Steps in Assembling the Instruments for the Study
250(2)
Administering the Instruments
252(1)
Summary
253(1)
Appendix 15.1: An Example of a Questionnaire about Smoking
254(1)
References
255(2)
Data Management
257(14)
Data Tables
257(4)
Data Entry
261(5)
Extracting Data (Queries)
266(1)
Identifying and Correcting Errors in the Data
267(1)
Analysis of the Data
268(1)
Confidentiality and Security
268(1)
Summary
269(1)
References
269(2)
Implementing the Study and Quality Control
271(20)
Assembling Resources
272(4)
Finalizing the Protocol
276(3)
Quality Control During the Study
279(7)
Summary
286(1)
Appendix 17.1: Example of an Operations Manual Table of Contents
286(1)
Appendix 17.2: Quality Control Tables and Checklists
287(2)
References
289(2)
Community and International Studies
291(10)
Why Community and International Research?
291(2)
Community Research
293(1)
International Research
294(5)
Summary
299(1)
References
299(2)
Writing and Funding a Research Proposal
301(16)
Writing Proposals
301(2)
Elements of a Proposal
303(6)
Characteristics of Good Proposals
309(1)
Finding Support for Research
310(5)
Summary
315(1)
References
316(1)
Exercises 317(14)
Answers to Exercises 331(22)
Subject Index 353

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