Modern Methods of Clinical Investigation -- Copyright -- Acknowledgments -- Preface -- Contents -- List of Abbreviations -- 1 Medical Technology Development: An Introduction to the Innovation-Evaluation Nexus -- PUTTING CLINICAL EVALUATION IN CONTEXT -- ISSUES IN INNOVATION AND EVALUATION: THE CASE OF STABLE ANGINA PECTORIS -- Beta-Blockers -- Coronary Artery Bypass Grafting -- PTCA Catheter Equipment -- Evaluative Shortcomings in Technology Development -- IMPROVING THE INNOVATION-EVALUATION NEXUS -- The Selection of Endpoints in Evaluative Research -- The Selection of Methods for Clinical Investigation -- Policy Mechanisms for Improving Developmental Decision Making -- REFERENCES -- 2 The Selection of Endpoints in Evaluative Research -- SURROGATE VERSUS CLINICAL ENDPOINTS -- CLINICAL ENDPOINTS -- SURROGATE ENDPOINTS -- REFERENCES -- 3 Advances in Health Status Measurement: The Potential to Improve Experimental and Non-Experimental Data Collection -- THE CONDUCT OF CLINICAL TRIALS -- MEASUREMENT OF QUALITY OF LIFE AND OF HEALTH STATUS -- INCLUSION OF QUALITY OF LIFE AND HEALTH STATUS MEASURES IN CLINICAL TRIALS -- FOUR PROBLEMS REGARDING THE MEASUREMENT OF HEALTH STATUS IN CLINICAL TRIALS -- REFERENCES -- 4 What Is Outcomes Research? -- WHICH RATE IS RIGHT? -- ENGAGING PATIENTS IN THE DECISION PROCESS -- EXTENDING ASSESSMENT TO ALL RELEVANT TREATMENT THEORIES -- THE EVALUATIVE CLINICAL SCIENCES AND THE FUTURE OF MEDICINE -- REFERENCES -- 5 Strengths and Weaknesses of Health Insurance Data Systems for Assessing Outcomes -- STRENGTHS -- System-Wide, Population-Based Data -- Efficacy versus Effectiveness -- Large Numbers and Time Series -- Events Unaffected by Recall -- Unobtrusive Nature -- Multiple Comparisons -- Design Flexibility -- Potential for Multiple Projects -- Focus on Risks -- Clinical Decision Making -- WEAKNESSES.

Structural Limitations -- Bias Due to Reporting and Coding -- Bias Due to Differential Contact -- Benefits of Treatment -- CONTROVERSIAL AREAS -- Risk Adjustment -- Outcome Measures -- EXPANDING DATA BASES -- Record Linkage -- Primary Data Collection -- DISCUSSION -- REFERENCES -- 6 Prescription-Event Monitoring: An Example of Total Population Post-Marketing Drug Surveillance -- "THE NUMBERS GAME" -- VOLUNTARY REPORTING SYSTEMS -- POST-MARKETING SURVEILLANCE -- PRESCRIPTION-EVENT MONITORING -- COMPARATIVE STUDIES OF NSAIDS -- POST-MARKETING SURVEILLANCE AND POST-MARKETING CLINICAL TRIALS -- CONCLUSION -- REFERENCES -- 7 The Role of Decision Analysis in the Translation of Research Findings into Clinical Practice -- DECISION ANALYSIS AT THE INTERFACE BETWEEN CLINICAL INVESTIGATION AND CLINICAL PRACTICE -- WHAT DECISION ANALYSIS IS -- THE LIMITATIONS OF DECISION ANALYSIS: WHAT IT IS NOT -- SETTING PRIORITIES AND PARAMETERS FOR CLINICAL INVESTIGATION -- Synthesizing, Interpreting, and Disseminating Results of Clinical Research -- DISTINCTIONS BETWEEN MATTERS OF FACT, OR EVIDENCE, AND VALUE JUDGMENTS -- PRIORITIES FOR DECISION ANALYSTS -- REFERENCES -- 8 Meta-Analysis: A Quantitative Approach to Research Integration -- CONSTRAINTS ON LITERATURE REVIEW -- QUANTITATIVE APPROACHES TO SUMMARIZING ACROSS STUDIES -- BENEFITS OF META-ANALYSIS -- APPLICATIONS OF META-ANALYSIS IN HEALTH -- A CASE STUDY: ELECTRONIC FETAL MONITORING -- CRITICISMS OF META-ANALYSIS -- EVALUATION OF META-ANALYSIS -- COMMENT -- REFERENCES -- 9 An Introduction to a Bayesian Method for Meta-Analysis: The Confidence Profile Method -- BASIC FORMULAS -- Biases -- Prior Distributions -- Likelihood Functions -- ILLUSTRATION -- BASIC FORMULAS IN THE CONFIDENCE PROFILE METHOD -- ADDITIONAL FORMULAS -- Hierarchical Bayes -- Indirect Evidence -- Technology Families -- Research Planning.

IMPLEMENTATION -- RELATIONSHIP TO OTHER META-ANALYSIS TECHNIQUES -- SUMMARY -- REFERENCES -- 10 Should We Change the Rules for Evaluation Medical Technologies? -- CURRENT EVALUATIVE METHODS -- WHAT ARE WE TRYING TO LEARN? -- QUALITY OF INFORMATION IN DIFFERENT DESIGNS: FACE VALUE -- BIASES -- HEURISTICS -- OPTIONS -- AN EXAMPLE -- IMPLICATIONS FOR DECISION MAKERS -- CONCLUSION -- REFERENCES -- 11 Attitudinal Factors That Influence the Utilization of Modern Evaluative Methods -- THE FOOD AND DRUG LAW AND CLINICAL EVALUATION -- WHAT IS THE VALUE OF THE EVIDENCE PROVIDED BY PRE-MARKETING AND POST-MARKETING STUDIES? -- DISINCENTIVES AND INCENTIVES TO THE GATHERING OF POST-MARKETING DATA -- CONSEQUENCES OF SHIRKED RESPONSIBILITY BY ACADEMICS AND THE PROFESSION -- GATHERING BETTER INFORMATION ON USE AND EFFECTIVENESS DOES NOT MEAN CHANGING REGULATORY POLICY -- REFERENCES -- Appendix A Comparing the Development of Drugs, Devices, and Clinical Procedures -- AN INITIAL CONCEPTUALIZATION OF THE DEVELOPMENT PROCESS -- THE DEVELOPMENT OF DRUGS -- Drug Discovery -- Drug Development -- Drug Diffusion and Post-Marketing Surveillance -- THE DEVELOPMENT OF MEDICAL DEVICES -- The Invention of Medical Devices -- Medical Device Development -- Device Diffusion and Post-Marketing Surveillance -- THE DEVELOPMENT OF CLINICAL PROCEDURES -- Clinical Procedure Development and Adoption -- The Use of Controlled Clinical Studies -- Post-Marketing Surveillance -- IMPROVING THE TRANSLATION OF RESEARCH FINDINGS INTO CLINICAL PRACTICE: SOME OPPORTUNITIES FOR CHANGE -- The Development of Drugs -- The Development of Medical Devices -- The Development of Clinical Procedures -- Comparing the Outcomes of Drugs, Devices, and Clinical Procedures -- ADDENDUM -- NOTES -- REFERENCES -- Appendix B Workshop Agenda -- Appendix C Contributors -- Index.