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Record Nr. |
UNINA9910957771403321 |
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Titolo |
Modern methods of clinical investigation / / Annetine C. Gelijns, editor ; Committee on Technological Innovation in Medicine, Institute of Medicine |
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Pubbl/distr/stampa |
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Washington, D.C., : National Academy Press, 1990 |
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ISBN |
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9786610212255 |
9781280212253 |
128021225X |
9780309543569 |
0309543568 |
9780585125244 |
0585125244 |
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Edizione |
[1st ed.] |
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Descrizione fisica |
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1 online resource (244 p.) |
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Collana |
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Medical innovation at the crossroads ; ; v. 1 |
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Altri autori (Persone) |
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Disciplina |
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Soggetti |
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Medical technology - Evaluation |
Medical innovations - Evaluation |
Medical care - Technological innovations |
Meta-analysis |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Proceedings of a workshop held on May 3-4, 1989, supported by the Howard Hughes Medical Institute and the National Center for Health Services Research of the Department of Health and Human Services (grant 5 RO9 HS055 26 02). |
Includes index. |
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Nota di bibliografia |
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Includes bibliographical references. |
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Nota di contenuto |
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""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- |
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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"" |
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Sommario/riassunto |
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Focuses on strategies for clinical evaluation and their role in revealing the actual benefits and risks of medical innovation. Essays explore differences in current systems for developing and evaluating drugs, medical devices, and clinical procedures; the use of quality of life measures in clinical trials; health insurance databases as a tool for assessing treatment outcomes; and the role of the medical profession, the FDA, and industry in stimulating the use of evaluative methods throughout the different stages of the innovation spectrum. Annotation copyrighted by Book News, Inc., Portland, OR |
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