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Contents Introduction Acknowledgments Section I: Basic Ingredients 1 Getting Started: The Anatomy and Physiology of Clinical Research Stephen B. Hulley, Thomas B. Newman, and Steven R. Cummings Anatomy of Research: What It¿s Made of Physiology of Research: How It Works Designing the Study Summary Appendix: Study Outline 2 Conceiving the Research Question Steven R. Cummings, Warren S. Browner, and Stephen B. Hulley Origins of a Research Question Characteristics of a Good Research Question Developing the Research Question and Study Plan Translational Research Summary 3 Choosing the Study Subjects: Specification, Sampling, and Recruitment Stephen B. Hulley, Thomas B. Newman, and Steven R. Cummings Basic Terms and Concepts Selection Criteria Sampling Recruitment Summary Appendix: Drawing a Random Sample 4 Planning the Measurements: Precision and Accuracy Stephen B. Hulley and Steven R. Cummings Measurement Scales Precision Accuracy Other Features of Measurement Approaches Measurements on Stored Materials In Closing Summary Appendix: Operationally Defining a Measurement 5 Getting Ready to Estimate Sample Size: Hypotheses and Underlying Principles Warren S. Browner, Thomas B. Newman, and Stephen B. Hulley Hypotheses Underlying Statistical Principles Additional Points Summary 6 Estimating Sample Size and Power: Applications and Examples Warren S. Browner, Thomas B. Newman, and Stephen B. Hulley 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: Sample Size Tables Section II: Study Designs 7 Designing an Observational Study: Cohort Studies Steven R. Cummings, Thomas B. Newman, and Stephen B. Hulley Prospective Cohort Studies Retrospective Cohort Studies Nested Case-control and Case-Cohort Studies Multiple-Cohort Studies and External Controls Other Cohort Study Issues Summary 8 Designing an Observational Study: Cross-sectional and Case-control Studies Thomas B. Newman, Warren S. Browner, Steven R. Cummings, and Stephen B. Hulley Cross-sectional Studies Case-control Studies Choosing Among Observational Designs Summary Appendix: Measures of Association 9 Enhancing Causal Inference in Observational Studies Thomas B. Newman, Warren S. Browner, and Stephen B. Hulley 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: Confounding and Adjustment 10 Designing a Randomized Blinded Trial Steven R. Cummings, Deborah Grady, and Stephen B. Hulley Selecting the Intervention and Control Conditions Choosing Outcome Measurements Selecting the Participants Measuring Baseline Variables Randomizing and Blinding Summary 11 Alternative Trial Designs and Implementation Issues Deborah Grady, Steven R. Cummings, and Stephen B. Hulley Alternative Clinical Trial Designs Conducting a Clinical Trial Summary Appendix: Interim Monitoring 12 Designing Studies of Medical Tests Thomas B. Newman, Warren S. Browner, and Steven R. Cummings 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: Interobserver Reproducibility 13 Research Using Existing Databases: Secondary Data Analysis, Ancillary Studies, and Systematic Reviews Deborah Grady and Norman Hearst Advantages and Disadvantages Secondary Data Analysis Ancillary Studies Systematic Reviews Summary Appendix: Meta-Analysis Methods Section III: Implementation 14 Addressing Ethical Issues Bernard Lo Ethical Principles Federal Regulations for Research on Human Subjects Responsibilities of Investigators Ethical Issues Specific to Certain Types of Research Other Issues Summary Appendix: Informed Consent 15 Designing Questionnaires and Interviews Steven R. Cummings and Stephen B. Hulley Designing Good Instruments Steps in Assembling the Instruments for the Study Administering the Instruments Summary Appendix: Example of a Questionnaire 16 Data Management Michael A. Kohn Data Tables Data Entry Extracting Data (Queries) Analysis of the Data Confidentiality and Security Summary 17 Implementing the Study: Pretesting, Quality Control, and Protocol Revisions Stephen B. Hulley and Steven R. Cummings Pretesting Quality Control Protocol Revisions Once Data Collection Has Begun Summary Appendix: Operations Manual and Checklists 18 Community and International Studies Norman Hearst and Thomas Novotny Why Community and International Research? Community Research International Research Summary 19 Writing and Funding a Research Proposal Steven R. Cummings and Stephen B. Hulley Writing Proposals Elements of a Proposal Characteristics of Good Proposals Finding Support for Research Summary Chapter Exercises Subject Index
Library of Congress Subject Headings for this publication:
Clinical trials.
Medicine -- Research -- Methodology.
Epidemiology -- Research -- Methodology.
Epidemiologic Methods.
Research Design.