LEADER 06385nam 2200853 a 450 001 9910957771403321 005 20251017110115.0 010 $a9786610212255 010 $a9781280212253 010 $a128021225X 010 $a9780309543569 010 $a0309543568 010 $a9780585125244 010 $a0585125244 035 $a(CKB)111004366659530 035 $a(EBL)3376920 035 $a(SSID)ssj0000204431 035 $a(PQKBManifestationID)11954473 035 $a(PQKBTitleCode)TC0000204431 035 $a(PQKBWorkID)10174978 035 $a(PQKB)10716050 035 $a(MiAaPQ)EBC3376920 035 $a(Au-PeEL)EBL3376920 035 $a(CaPaEBR)ebr10062761 035 $a(CaONFJC)MIL21225 035 $a(OCoLC)923266968 035 $a(Perlego)4736174 035 $a(DNLM)679261 035 $a(BIP)1017060 035 $a(EXLCZ)99111004366659530 100 $a19900501d1990 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aModern methods of clinical investigation /$fAnnetine C. Gelijns, editor ; Committee on Technological Innovation in Medicine, Institute of Medicine 205 $a1st ed. 210 $aWashington, D.C. $cNational Academy Press$d1990 215 $a1 online resource (244 p.) 225 1 $aMedical innovation at the crossroads ;$vv. 1 300 $aProceedings 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). 300 $aIncludes index. 311 08$a9780309042864 311 08$a0309042860 320 $aIncludes bibliographical references. 327 $a""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"" 327 $a""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"" 327 $a""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"" 327 $a""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 "" 327 $a""""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"" 327 $a""SETTING PRIORITIES AND PARAMETERS FOR CLINICAL INVESTIGATION"" 330 $aFocuses on strategies for clinical evaluation and their role in revealing the actual benefits and risks of medical innovation. Essays explore differences in current systems for developing and evaluating drugs, medical devices, and clinical procedures; the use of quality of life measures in clinical trials; health insurance databases as a tool for assessing treatment outcomes; and the role of the medical profession, the FDA, and industry in stimulating the use of evaluative methods throughout the different stages of the innovation spectrum. Annotation copyrighted by Book News, Inc., Portland, OR 410 0$aMedical innovation at the crossroads ;$vv. 1. 606 $aMedical technology$xEvaluation$vCongresses 606 $aMedical innovations$xEvaluation$vCongresses 606 $aMedical care$xTechnological innovations$vCongresses 606 $aMeta-analysis$vCongresses 615 0$aMedical technology$xEvaluation 615 0$aMedical innovations$xEvaluation 615 0$aMedical care$xTechnological innovations 615 0$aMeta-analysis 676 $a610/.72 701 $aGelijns$b Annetine$01808050 712 02$aInstitute of Medicine (U.S.).$bCommittee on Technological Innovation in Medicine. 712 02$aHoward Hughes Medical Institute. 712 02$aNational Center for Health Services Research. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910957771403321 996 $aModern methods of clinical investigation$94358207 997 $aUNINA