Assessing Medical Technologies -- Copyright -- Acknowledgments -- Preface -- PROCEDURE FOR THE STUDY -- AUDIENCE FOR THE STUDY -- Contents -- Summary -- THE SCOPE OF U.S. MEDICAL TECHNOLOGY ASSESSMENT -- Varieties and Expense of Assessment -- Federal Government -- Drug Industry -- Medical Device Industry -- Other Private Sector Assessment Activities -- Lags in Assessment -- Recommendations -- METHODS OF MEDICAL TECHNOLOGY ASSESSMENT -- EFFECTS OF EVALUATION ON DIFFUSION OF TECHNOLOGY -- Diffusion and Its Determinants -- Types of Evaluation That Precede Accepted Medical Practice -- Recommendations -- REIMBURSEMENT AND TECHNOLOGY ASSESSMENT -- Assessment in the New Era of Cost Containment -- Paying for Technology Assessment -- Recommendations -- MEDICAL TECHNOLOGY ASSESSMENT ABROAD -- Recommendations -- CONCLUSIONS AND RECOMMENDATIONS -- The Challenge -- Key Functions for Assessment -- Building a System -- Financing -- Recommendations -- 1 Introduction -- POLIO -- SURGICAL PROCEDURE -- EXAMPLES OF TECHNOLOGY ASSESSMENT -- Electronic Fetal Monitoring -- Computed Tomography Scanning -- Drug Treatment for Hypertension -- Hysterectomy -- Medical Information System -- SOME LESSONS FROM THE EXAMPLES -- COMPREHENSIVE TECHNOLOGY ASSESSMENT -- DIFFERENT PARTIES, DIFFERENT AIMS IN ASSESSMENTS -- REFERENCES -- 2 The Scope of U.S. Medical Technology Assessment -- AN OVERVIEW -- VARIETIES OF MEDICAL TECHNOLOGY ASSESSMENT -- NATIONAL EXPENDITURES FOR HEALTH RESEARCH AND DEVELOPMENT, CLINICAL TRIALS, AND TECHNOLOGY ASSESSMENT -- FEDERAL GOVERNMENT -- National Institutes of Health -- Office of Medical Applications of Research -- Food and Drug Administration -- Office of Technology Assessment -- Prospective Payment Assessment Commission -- Health Care Financing Administration -- National Center for Health Services Research and Health Care Technology Assessment.

Office of Health Technology Assessment -- National Center for Health Statistics -- Veterans Administration -- Centers for Disease Control -- Department of Defense -- DRUG INDUSTRY -- Drug Industry Research and Development -- Assessment of Drugs -- Expenditures for Drug Assessment -- MEDICAL DEVICE INDUSTRY -- Medical Device Industry Research and Development -- Assessment of Medical Devices -- Expenditures for Medical Device Assessment -- OTHER PRIVATE SECTOR ASSESSMENT ACTIVITIES -- Insurers -- Medical Associations -- Policy Research Groups -- Industry Associations -- Provider Institutions -- Academic Institutions -- Employers -- CONCLUSIONS -- RECOMMENDATIONS -- Assessment Concerns -- Coordination of Assessment Information -- Responsibility for Conduct of Assessments -- Evaluation of Assessment Programs -- Financial Support for Medical Technology Assessment -- Amount of Support -- Sources of Support -- A Worthy Investment -- NOTES -- REFERENCES -- 3 Methods of Technology Assessment -- RANDOMIZED CLINICAL TRIALS -- Practical Problems of Comparing Treatments -- The Protocol -- Random Assignment to Treatment -- Limitations of RCTs -- Strengthening RCTs -- A Final Remark -- EVALUATING DIAGNOSTIC TECHNOLOGIES -- Present Evaluation Methods -- Limitations of Present Evaluation Methods -- Strengthening the Method -- Summary -- THE SERIES OF CONSECUTIVE CASES AS A DEVICE FOR ASSESSING OUTCOMES OF INTERVENTION -- Description of a Series -- Needed Information -- Adjustment for Interfering Variables -- Capabilities and Limitations -- Interpretation of Series -- Integrity of Counting -- Consequences of No Protocol -- Consequences of No Randomization -- What about the Clear-Cut Series? -- Some Additional Issues -- Subgroups -- Temporal Drift -- Grab Samples -- Strengthening the Method -- THE CASE STUDY AS A TOOL FOR MEDICAL TECHNOLOGY ASSESSMENT.

What Is a Case Study? -- Case Studies from the Office of Technology Assessment -- Weaknesses of Case Studies -- Strengths of Case Studies -- Strengthening Case Studies -- Conclusions -- REGISTERS AND DATA BASES -- Uses of Registers and Data Bases -- Capabilities and Limitations of Registers and Data Bases -- Strengthening Uses of Registers and Data Bases -- SAMPLE SURVEYS -- Uses of Sample Surveys -- NCHS Surveys -- Health Care Financing Administration Data -- Capabilities and Limitations of Sample Surveys -- Strengthening Uses of Sample Surveys -- EPIDEMIOLOGIC METHODS -- Uses of Epidemiologic Methods -- Cohort Studies -- Case-Control Studies -- Cross-Sectional Studies -- Capabilities and Limitations of Epidemiologic Methods -- Strengthening Uses of Epidemiologic Methods -- SURVEILLANCE -- Uses of Surveillance -- Capabilities and Limitations of Surveillance -- Strengthening Uses of Surveillance -- QUANTITATIVE SYNTHESIS METHODS-META-ANALYSIS -- Voting Methods -- Cumulation of Significance Levels (p-Values) -- Other Statistical Synthesis Procedures -- Example of Synthesis -- GROUP JUDGMENT METHODS -- Formal Group Methods -- Delphi Technique -- Nominal Group Technique -- Group Methods Designed for Health Issues -- NIH Consensus Development Conferences -- State-of-the-Art Diagnosis and Care of COPD -- Medical Practice Information Project -- Rand-UCLA Health Services Utilization -- Computer Knowledge Bases -- Strengthening Group Judgment Efforts -- COST-EFFECTIVENESS AND COST-BENEFIT ANALYSES -- Uses of CEA/CBA -- Capabilities and Limitations -- Strengthening Use of CEA/CBA -- Recommendations -- TECHNOLOGY ASSESSMENT: THE ROLE OF MATHEMATICAL MODELING -- Background -- An Example -- The Role of Models -- Mental Models -- Mathematical Models -- Uses of Mathematical Models in Technology Assessment -- Estimating Outcomes -- Additional Uses.

Types of Mathematical Models -- Validation of Mathematical Models -- Limitations -- Strengthening the Technique -- Conclusion -- SOCIAL AND ETHICAL ISSUES IN TECHNOLOGY ASSESSMENT -- Experience in Addressing Ethical Issues -- Ethics of Investigation -- Initiation -- Conduct -- Termination -- CONCLUSIONS AND RECOMMENDATIONS -- APPENDIX 3-A: EXAMPLE OF COST-BENEFIT ANALYSIS -- Comparison of Programs -- APPENDIX 3-B: AN EXAMPLE OF A MATHEMATICAL MODEL OF MEDICAL TECHNOLOGY -- REFERENCES -- 4 Effects of Clinical Evaluation on the Diffusion of Medical Technology -- EVALUATION -- DIFFUSION -- Determinants of Diffusion -- Prevailing Theory -- The Innovation -- The Clinical Situation -- Advocacy -- The Potential Adopter -- The Practice Setting -- The Decision-Making Process -- Environmental Constraints and Incentives -- Evaluation and Methods of Evaluation -- Channels of Communication -- Measures of Diffusion and Sources of Data -- Diffusion as Affected by Evaluation -- EVIDENCE ABOUT THE EFFECTS OF EVALUATION ON DIFFUSION -- Evaluation and Physician Behavior -- The Impact of Primary Evaluations on Physicians -- Effects of Clinical Trials on Physician Awareness -- Effects of Rcts on Physician Practices -- Types of Evaluation That Precede Accepted Medical Practices -- The Impact of Synthetic Evaluations -- EVALUATION AND POLICY ON REGULATION AND REIMBURSEMENT -- CONCLUSIONS AND RECOMMENDATIONS -- APPENDIX 4-A: SUMMARIES OF STUDIES -- REFERENCES -- 5 Reimbursement and Technology Assessment -- ASSESSMENT IN THE ERA OF RETROSPECTIVE PAYMENTS -- THE NEED FOR ASSESSMENT IN THE NEW ERA OF COST CONTAINMENT -- Leverage of the Reimbursement System Over Institutions -- Capital Acquisition -- Stimulus for Technology Assessment in Reimbursement Policy -- DRG Price Development and Technology Assessment -- Cost-Containment Information: Feedback for Change.

Mechanisms to Promote Appropriate Use of Technology -- PAYING FOR TECHNOLOGY ASSESSMENT -- CONCLUSIONS AND RECOMMENDATIONS -- APPENDIX 5-A: LEGAL CONSIDERATIONS IN PRIVATE HEALTH INSURER'S IDENTIFICATION AND EXCLUSION OF UNNECESSARY, INCOMPETENT… -- REFERENCES -- 6 Medical Technology Assessment in Developed Countries: Trends and Opportunities for Collaboration -- TRENDS IN ASSESSMENT AND REGULATION -- RESEARCH AND DEVELOPMENT -- Clinical Trials -- Consensus Activities -- USE OF TECHNOLOGY IN DIFFERENT COUNTRIES -- ASSESSMENT OF DRUGS IN DIFFERENT COUNTRIES -- France -- West Germany -- HEALTH CARE SYSTEMS IN DIFFERENT COUNTRIES -- Britain -- Japan -- INTERNATIONAL ORGANIZATIONS -- International Pharmaceutical Firms -- International Health Information -- World Health Organization Network on Technology Assessment -- Postmarketing Surveillance of Drugs -- CONCLUSIONS AND RECOMMENDATIONS -- REFERENCES -- 7 Conclusions and Recommendations -- THE CHALLENGE -- KEY FUNCTIONS NEEDING IMPROVEMENT -- Information Monitoring and Acquisition -- Combining Information from Different Sources -- Dissemination of Information -- Identification of Gaps in Knowledge That Require Research -- Data and Information Acquisition -- Priority Setting -- Manpower for Technology Assessment -- Research and Development of Methods for Assessment -- BUILDING A SYSTEM -- ADVANTAGES AND DISADVANTAGES OF VARIOUS INSTITUTIONAL ARRANGEMENTS -- Private-Public Body -- Reestablish the NCHCT -- Development of a System by the DHHS Secretary -- A Separate Federal Agency -- NOT THE REGULATORY APPROACH -- FINANCING -- RECOMMENDATIONS -- CLOSING COMMENT -- REFERENCES -- Appendix A Profiles of 20 Technology Assessment Programs -- TECHNOLOGY -- CONCERNS -- STAGE OF TECHNOLOGIES ASSESSED -- APPLICATION OF TECHNOLOGIES -- ASSESSMENT METHODS -- ACKNOWLEDGMENTS.

JOINT AMERICAN COLLEGE OF CARDIOLOGY/AMERICAN HEART ASSOCIATION TASK FORCE ON ASSESSMENT OF CARDIOVASCULAR PROCEDURES….