DESIGNING CLINICAL RESEARCH
Author: Stephen Hulley, M.D., M.P.H., Steven Cummings, M.D., Warren Browner, M.D., M.P.H., Deborah Grady, M.D., M.P.H., Thomas Newman, M.D., M.P.H.
Publisher: Lippincott Williams & Wilkins
Publication Date: 2007
Publisher: Lippincott Williams & Wilkins
Publication Date: 2007
ISBN 10: 0781782104
ISBN 13: 9780781782104
Edition: 3rd
ISBN 13: 9780781782104
Edition: 3rd
Description:
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
Front Matter
SECTION I Basic Ingredients
- SAMPLE SIZE TECHNIQUES FOR ANALYTIC STUDIES AND EXPERIMENTS
- OTHER CONSIDERATIONS AND SPECIAL ISSUES
- SAMPLE SIZE TECHNIQUES FOR DESCRIPTIVE STUDIES
- WHAT TO DO WHEN SAMPLE SIZE IS FIXED
- STRATEGIES FOR MINIMIZING SAMPLE SIZE AND MAXIMIZING POWER
- HOW TO ESTIMATE SAMPLE SIZE WHEN THERE IS INSUFFICIENT INFORMATION
- COMMON ERRORS TO AVOID
- SUMMARY
- APPENDIX 6A Sample Size Required per Group When Using the t Test to Compare Means of Continuous Variables
- APPENDIX 6B Sample Size Required per Group When Using the Chi-Squared Statistic or Z Test to Compare Proportions of Dichotomous Variables
- APPENDIX 6C Total Sample Size Required When Using the Correlation Coefficient ( r )
- APPENDIX 6D Sample Size for a Descriptive Study of a Continuous Variable
- APPENDIX 6E Sample Size for a Descriptive Study of a Dichotomous Variable
- APPENDIX 6F Use and Misuse of t Tests
- REFERENCES
Getting Started: The Anatomy and Physiology of Clinical Research
Conceiving The Research Question
Choosing the Study Subjects: Specification, Sampling, and Recruitment
Planning the Measurements: Precision and Accuracy
Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles
Estimating Sample Size and Power: Applications and Examples
SECTION II Study Designs
- SPURIOUS ASSOCIATIONS
- REAL ASSOCIATIONS OTHER THAN CAUSE–EFFECT
- COPING WITH CONFOUNDERS IN THE DESIGN PHASE
- COPING WITH CONFOUNDERS IN THE ANALYSIS PHASE
- UNDERESTIMATION OF CAUSAL EFFECTS
- CHOOSING A STRATEGY
- SUMMARY
- APPENDIX 9A Hypothetical Example of Confounding and Interaction
- APPENDIX 9B A Simplified Example of Adjustment
- REFERENCES
- DETERMINING WHETHER A TEST IS USEFUL
- STUDIES OF TEST REPRODUCIBILITY
- STUDIES OF THE ACCURACY OF TESTS
- STUDIES OF THE EFFECT OF TEST RESULTS ON CLINICAL DECISIONS
- STUDIES OF FEASIBILITY, COSTS, AND RISKS OF TESTS
- STUDIES OF THE EFFECT OF TESTING ON OUTCOMES
- PITFALLS IN THE DESIGN OR ANALYSIS OF DIAGNOSTIC TEST STUDIES
- SUMMARY
- APPENDIX 12A Calculation of Kappa to Measure Interobserver Agreement
- APPENDIX 12B Numerical Example of Verification Bias: 1
- APPENDIX 12C Numerical Example of Verification Bias: 2
- REFERENCES
Designing a Cohort Study
Designing Cross-sectional and Case–Control Studies
Enhancing Causal Inference in Observational Studies
Designing a Randomized Blinded Trial
Alternative Trial Designs and Implementation Issues
Designing Studies of Medical Tests
Utilizing Existing Databases
SECTION III Implementation
Exercises
- CHAPTER 1. GETTING STARTED: THE ANATOMY AND PHYSIOLOGY OF CLINICAL RESEARCH
- CHAPTER 2. CONCEIVING THE RESEARCH QUESTION
- CHAPTER 3. CHOOSING THE STUDY SUBJECTS: SPECIFICATION, SAMPLING, AND RECRUITMENT
- CHAPTER 4. PLANNING THE MEASUREMENTS: PRECISION AND ACCURACY
- CHAPTER 5. GETTING READY TO ESTIMATE SAMPLE SIZE: HYPOTHESES AND UNDERLYING PRINCIPLES
- CHAPTER 6. ESTIMATING SAMPLE SIZE AND POWER: APPLICATIONS AND EXAMPLES
- CHAPTER 7. DESIGNING A COHORT STUDY
- CHAPTER 8. DESIGNING CROSS-SECTIONAL AND CASE–CONTROL STUDIES
- CHAPTER 9. ENHANCING CAUSAL INFERENCE IN OBSERVATIONAL STUDIES
- CHAPTER 10. DESIGNING A RANDOMIZED BLINDED TRIAL
- CHAPTER 11. ALTERNATIVE TRIAL DESIGNS AND IMPLEMENTATION ISSUES
- CHAPTER 12. DESIGNING STUDIES OF MEDICAL TESTS
- CHAPTER 13. UTILIZING EXISTING DATABASES
- CHAPTER 14. ADDRESSING ETHICAL ISSUES
- CHAPTER 15. DESIGNING QUESTIONNAIRES AND INTERVIEWS
- CHAPTER 16. DATA MANAGEMENT
- CHAPTER 17. IMPLEMENTING THE STUDY AND QUALITY CONTROL
- CHAPTER 18. COMMUNITY AND INTERNATIONAL STUDIES
- CHAPTER 19. WRITING AND FUNDING A RESEARCH PROPOSAL
