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Assessment of diagnostic technology in health care [[electronic resource] ] : rationale, methods, problems, and directions / / Harold Sox ... [et al.]
| Assessment of diagnostic technology in health care [[electronic resource] ] : rationale, methods, problems, and directions / / Harold Sox ... [et al.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1989 |
| Descrizione fisica | 1 online resource (152 p.) |
| Disciplina | 616.075 |
| Altri autori (Persone) | SoxHarold C |
| Collana | Monograph of the Council on Health Care Technology |
| Soggetto topico |
Diagnosis - Methodology - Evaluation
Medical technology - Evaluation |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-21418-X
9786610214181 0-309-53588-3 0-585-00192-8 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
""Assessment of Diagnostic Technology in Health Care""; ""Copyright""; ""Preface""; ""Contents""; ""Introduction""; ""REFERENCES""; ""1 Rationale for Assessment of Diagnostic Technology""; ""THE PATIENT'S PERSPECTIVE""; ""Safety""; ""Efficacy""; ""Economic Issues""; ""The Benefits of High-Quality Studies""; ""The Risks of Poor or Absent Assessment Data""; ""Summary: The Patient's Perspective""; ""SOCIETY'S PERSPECTIVE""; ""Safety and Efficacy""; ""Economic Issues""; ""Summary: Society's Perspective""; ""THE PHYSICIAN'S PERSPECTIVE""; ""Safety and Efficacy""; ""Economic Issues""
""Summary: The Physician's Perspective""""SUMMARY""; ""REFERENCES""; ""2 The Use of Diagnostic Tests: A Probabilistic Approach""; ""FIRST PRINCIPLES""; ""INTERPRETING TEST RESULTS: THE POSTTEST PROBABILITY""; ""Important Definitions""; ""The Assumptions of Bayes' Theorem""; ""THE PRETEST PROBABILITY OF DISEASE""; ""MEASURING THE PERFORMANCE CHARACTERISTICS OF DIAGNOSTIC TESTS""; ""Designing Studies of Test Performance""; ""EXPECTED-VALUE DECISIONMAKING""; ""Setting Up the Decision Tree""; ""Weighing the Outcomes for Quality of Life"" ""Calculating the Expected Value of the Treatment Options""""THE CHOICE AMONG DOING NOTHING, TESTING, OR STARTING TREATMENT""; ""SUMMARY""; ""Glossary Of Terms""; ""REFERENCES""; ""3 Assessment: Problems and Proposed Solutions""; ""MEASURES OF CLINICAL EFFICACY""; ""Technical Capability""; ""Sensitivity and Specificity""; ""Diagnostic Impact""; ""Therapeutic Impact""; ""Impact on Clinical Outcomes""; ""THE SYSTEM OF TECHNOLOGY ASSESSMENT IN THE UNITED STATES""; ""The Pyramid""; ""PROBLEMS WITH THE CURRENT SYSTEM""; ""RANDOMIZED TRIALS OF DIAGNOSTIC TESTS"" ""Limitations of Randomized Trials""""Trial Design""; """"OFF THE GOLD STANDARD""""; """"ON THE GOLD STANDARD""""; ""A PROPOSAL FOR MODEL-DRIVEN TECHNOLOGY ASSESSMENT""; ""A Technology Should Be Compared with a Competing Technology""; ""STUDIES SHOULD BE PLANNED BEFORE ENROLLING THE FIRST PATIENT""; ""ALL THE DATA THAT ARE NEEDED FOR CLINICAL DECISION MAKING SHOULD BE COLLECTED""; ""BIAS IN PATIENT SELECTION SHOULD BE AVOIDED""; ""PATIENTS SHOULD BE OBSERVED FOR ADVERSE EFFECTS OF THE INDEX TEST""; ""INTERPRETATION OF DATA SHOULD BE FREE OF BIAS"" ""INTEROBSERVER DISAGREEMENT SHOULD BE MEASURED""""THERE SHOULD BE ENOUGH PATIENTS TO REPORT THE RESULTS IN CLINICALLY USEFUL SUBGROUPS OF PATIENTS""; ""SUMMARY""; ""REFERENCES""; ""4 Primary Assessment of Diagnostic Tests: Barriers to Implementation""; ""PLANNING AND PROTOCOL DEVELOPMENT""; ""Choosing a Clinical Condition""; ""Patient Population""; ""Endpoints and Study Design""; ""ACCURACY""; ""OUTCOME""; ""COMBINED STUDIES: ACCURACY AND OUTCOME""; ""SHORT-TERM OUTCOMES: A SYNTHETIC APPROACH""; ""Economic Analysis""; ""Efficacy Versus Effectiveness""; ""Comparative Assessment"" ""Sample Size"" |
| Record Nr. | UNINA-9910455163803321 |
| Washington, D.C., : National Academy Press, 1989 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Assessment of diagnostic technology in health care [[electronic resource] ] : rationale, methods, problems, and directions / / Harold Sox ... [et al.]
| Assessment of diagnostic technology in health care [[electronic resource] ] : rationale, methods, problems, and directions / / Harold Sox ... [et al.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1989 |
| Descrizione fisica | 1 online resource (152 p.) |
| Disciplina | 616.075 |
| Altri autori (Persone) | SoxHarold C |
| Collana | Monograph of the Council on Health Care Technology |
| Soggetto topico |
Diagnosis - Methodology - Evaluation
Medical technology - Evaluation |
| ISBN |
1-280-21418-X
9786610214181 0-309-53588-3 0-585-00192-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
""Assessment of Diagnostic Technology in Health Care""; ""Copyright""; ""Preface""; ""Contents""; ""Introduction""; ""REFERENCES""; ""1 Rationale for Assessment of Diagnostic Technology""; ""THE PATIENT'S PERSPECTIVE""; ""Safety""; ""Efficacy""; ""Economic Issues""; ""The Benefits of High-Quality Studies""; ""The Risks of Poor or Absent Assessment Data""; ""Summary: The Patient's Perspective""; ""SOCIETY'S PERSPECTIVE""; ""Safety and Efficacy""; ""Economic Issues""; ""Summary: Society's Perspective""; ""THE PHYSICIAN'S PERSPECTIVE""; ""Safety and Efficacy""; ""Economic Issues""
""Summary: The Physician's Perspective""""SUMMARY""; ""REFERENCES""; ""2 The Use of Diagnostic Tests: A Probabilistic Approach""; ""FIRST PRINCIPLES""; ""INTERPRETING TEST RESULTS: THE POSTTEST PROBABILITY""; ""Important Definitions""; ""The Assumptions of Bayes' Theorem""; ""THE PRETEST PROBABILITY OF DISEASE""; ""MEASURING THE PERFORMANCE CHARACTERISTICS OF DIAGNOSTIC TESTS""; ""Designing Studies of Test Performance""; ""EXPECTED-VALUE DECISIONMAKING""; ""Setting Up the Decision Tree""; ""Weighing the Outcomes for Quality of Life"" ""Calculating the Expected Value of the Treatment Options""""THE CHOICE AMONG DOING NOTHING, TESTING, OR STARTING TREATMENT""; ""SUMMARY""; ""Glossary Of Terms""; ""REFERENCES""; ""3 Assessment: Problems and Proposed Solutions""; ""MEASURES OF CLINICAL EFFICACY""; ""Technical Capability""; ""Sensitivity and Specificity""; ""Diagnostic Impact""; ""Therapeutic Impact""; ""Impact on Clinical Outcomes""; ""THE SYSTEM OF TECHNOLOGY ASSESSMENT IN THE UNITED STATES""; ""The Pyramid""; ""PROBLEMS WITH THE CURRENT SYSTEM""; ""RANDOMIZED TRIALS OF DIAGNOSTIC TESTS"" ""Limitations of Randomized Trials""""Trial Design""; """"OFF THE GOLD STANDARD""""; """"ON THE GOLD STANDARD""""; ""A PROPOSAL FOR MODEL-DRIVEN TECHNOLOGY ASSESSMENT""; ""A Technology Should Be Compared with a Competing Technology""; ""STUDIES SHOULD BE PLANNED BEFORE ENROLLING THE FIRST PATIENT""; ""ALL THE DATA THAT ARE NEEDED FOR CLINICAL DECISION MAKING SHOULD BE COLLECTED""; ""BIAS IN PATIENT SELECTION SHOULD BE AVOIDED""; ""PATIENTS SHOULD BE OBSERVED FOR ADVERSE EFFECTS OF THE INDEX TEST""; ""INTERPRETATION OF DATA SHOULD BE FREE OF BIAS"" ""INTEROBSERVER DISAGREEMENT SHOULD BE MEASURED""""THERE SHOULD BE ENOUGH PATIENTS TO REPORT THE RESULTS IN CLINICALLY USEFUL SUBGROUPS OF PATIENTS""; ""SUMMARY""; ""REFERENCES""; ""4 Primary Assessment of Diagnostic Tests: Barriers to Implementation""; ""PLANNING AND PROTOCOL DEVELOPMENT""; ""Choosing a Clinical Condition""; ""Patient Population""; ""Endpoints and Study Design""; ""ACCURACY""; ""OUTCOME""; ""COMBINED STUDIES: ACCURACY AND OUTCOME""; ""SHORT-TERM OUTCOMES: A SYNTHETIC APPROACH""; ""Economic Analysis""; ""Efficacy Versus Effectiveness""; ""Comparative Assessment"" ""Sample Size"" |
| Record Nr. | UNINA-9910778706803321 |
| Washington, D.C., : National Academy Press, 1989 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Assessment of diagnostic technology in health care : rationale, methods, problems, and directions / / Harold Sox ... [et al.]
| Assessment of diagnostic technology in health care : rationale, methods, problems, and directions / / Harold Sox ... [et al.] |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1989 |
| Descrizione fisica | 1 online resource (152 p.) |
| Disciplina | 616.075 |
| Altri autori (Persone) | SoxHarold C |
| Collana | Monograph of the Council on Health Care Technology |
| Soggetto topico |
Diagnosis - Methodology - Evaluation
Medical technology - Evaluation |
| ISBN |
1-280-21418-X
9786610214181 0-309-53588-3 0-585-00192-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
""Assessment of Diagnostic Technology in Health Care""; ""Copyright""; ""Preface""; ""Contents""; ""Introduction""; ""REFERENCES""; ""1 Rationale for Assessment of Diagnostic Technology""; ""THE PATIENT'S PERSPECTIVE""; ""Safety""; ""Efficacy""; ""Economic Issues""; ""The Benefits of High-Quality Studies""; ""The Risks of Poor or Absent Assessment Data""; ""Summary: The Patient's Perspective""; ""SOCIETY'S PERSPECTIVE""; ""Safety and Efficacy""; ""Economic Issues""; ""Summary: Society's Perspective""; ""THE PHYSICIAN'S PERSPECTIVE""; ""Safety and Efficacy""; ""Economic Issues""
""Summary: The Physician's Perspective""""SUMMARY""; ""REFERENCES""; ""2 The Use of Diagnostic Tests: A Probabilistic Approach""; ""FIRST PRINCIPLES""; ""INTERPRETING TEST RESULTS: THE POSTTEST PROBABILITY""; ""Important Definitions""; ""The Assumptions of Bayes' Theorem""; ""THE PRETEST PROBABILITY OF DISEASE""; ""MEASURING THE PERFORMANCE CHARACTERISTICS OF DIAGNOSTIC TESTS""; ""Designing Studies of Test Performance""; ""EXPECTED-VALUE DECISIONMAKING""; ""Setting Up the Decision Tree""; ""Weighing the Outcomes for Quality of Life"" ""Calculating the Expected Value of the Treatment Options""""THE CHOICE AMONG DOING NOTHING, TESTING, OR STARTING TREATMENT""; ""SUMMARY""; ""Glossary Of Terms""; ""REFERENCES""; ""3 Assessment: Problems and Proposed Solutions""; ""MEASURES OF CLINICAL EFFICACY""; ""Technical Capability""; ""Sensitivity and Specificity""; ""Diagnostic Impact""; ""Therapeutic Impact""; ""Impact on Clinical Outcomes""; ""THE SYSTEM OF TECHNOLOGY ASSESSMENT IN THE UNITED STATES""; ""The Pyramid""; ""PROBLEMS WITH THE CURRENT SYSTEM""; ""RANDOMIZED TRIALS OF DIAGNOSTIC TESTS"" ""Limitations of Randomized Trials""""Trial Design""; """"OFF THE GOLD STANDARD""""; """"ON THE GOLD STANDARD""""; ""A PROPOSAL FOR MODEL-DRIVEN TECHNOLOGY ASSESSMENT""; ""A Technology Should Be Compared with a Competing Technology""; ""STUDIES SHOULD BE PLANNED BEFORE ENROLLING THE FIRST PATIENT""; ""ALL THE DATA THAT ARE NEEDED FOR CLINICAL DECISION MAKING SHOULD BE COLLECTED""; ""BIAS IN PATIENT SELECTION SHOULD BE AVOIDED""; ""PATIENTS SHOULD BE OBSERVED FOR ADVERSE EFFECTS OF THE INDEX TEST""; ""INTERPRETATION OF DATA SHOULD BE FREE OF BIAS"" ""INTEROBSERVER DISAGREEMENT SHOULD BE MEASURED""""THERE SHOULD BE ENOUGH PATIENTS TO REPORT THE RESULTS IN CLINICALLY USEFUL SUBGROUPS OF PATIENTS""; ""SUMMARY""; ""REFERENCES""; ""4 Primary Assessment of Diagnostic Tests: Barriers to Implementation""; ""PLANNING AND PROTOCOL DEVELOPMENT""; ""Choosing a Clinical Condition""; ""Patient Population""; ""Endpoints and Study Design""; ""ACCURACY""; ""OUTCOME""; ""COMBINED STUDIES: ACCURACY AND OUTCOME""; ""SHORT-TERM OUTCOMES: A SYNTHETIC APPROACH""; ""Economic Analysis""; ""Efficacy Versus Effectiveness""; ""Comparative Assessment"" ""Sample Size"" |
| Record Nr. | UNINA-9910817742503321 |
| Washington, D.C., : National Academy Press, 1989 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Gulf War and health [[electronic resource] /] / Carolyn E. Fulco, Catharyn T. Liverman, Harold C. Sox, editors ; Committee on Health Effects Associated with Exposures During the Gulf War, Division of Health Promotion and Disease Prevention, Institute of Medicine
| Gulf War and health [[electronic resource] /] / Carolyn E. Fulco, Catharyn T. Liverman, Harold C. Sox, editors ; Committee on Health Effects Associated with Exposures During the Gulf War, Division of Health Promotion and Disease Prevention, Institute of Medicine |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, c2000 |
| Descrizione fisica | 1 online resource (426 p.) |
| Disciplina | 956.7044/27 |
| Altri autori (Persone) |
FulcoCarolyn
LivermanCatharyn T SoxHarold C |
| Collana | Gulf War and health |
| Soggetto topico |
Persian Gulf War, 1991 - Health aspects - United States
Persian Gulf War, 1991 - Veterans - Diseases - United States Persian Gulf syndrome - United States |
| Soggetto genere / forma | Electronic books. |
| ISBN | 0-309-51390-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | v. 1. Depleted uranium, pyridostigmine bromide, sarin, vaccines |
| Record Nr. | UNINA-9910455655403321 |
| Washington, D.C., : National Academy Press, c2000 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Gulf War and health [[electronic resource] /] / Carolyn E. Fulco, Catharyn T. Liverman, Harold C. Sox, editors ; Committee on Health Effects Associated with Exposures During the Gulf War, Division of Health Promotion and Disease Prevention, Institute of Medicine
| Gulf War and health [[electronic resource] /] / Carolyn E. Fulco, Catharyn T. Liverman, Harold C. Sox, editors ; Committee on Health Effects Associated with Exposures During the Gulf War, Division of Health Promotion and Disease Prevention, Institute of Medicine |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, c2000 |
| Descrizione fisica | 1 online resource (426 p.) |
| Disciplina | 956.7044/27 |
| Altri autori (Persone) |
FulcoCarolyn
LivermanCatharyn T SoxHarold C |
| Collana | Gulf War and health |
| Soggetto topico |
Persian Gulf War, 1991 - Health aspects - United States
Persian Gulf War, 1991 - Veterans - Diseases - United States Persian Gulf syndrome - United States |
| ISBN | 0-309-51390-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | v. 1. Depleted uranium, pyridostigmine bromide, sarin, vaccines |
| Record Nr. | UNINA-9910778633903321 |
| Washington, D.C., : National Academy Press, c2000 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Gulf War and health / / Carolyn E. Fulco, Catharyn T. Liverman, Harold C. Sox, editors ; Committee on Health Effects Associated with Exposures During the Gulf War, Division of Health Promotion and Disease Prevention, Institute of Medicine
| Gulf War and health / / Carolyn E. Fulco, Catharyn T. Liverman, Harold C. Sox, editors ; Committee on Health Effects Associated with Exposures During the Gulf War, Division of Health Promotion and Disease Prevention, Institute of Medicine |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, c2000 |
| Descrizione fisica | 1 online resource (426 p.) |
| Disciplina | 956.7044/27 |
| Altri autori (Persone) |
FulcoCarolyn
LivermanCatharyn T SoxHarold C |
| Collana | Gulf War and health |
| Soggetto topico |
Persian Gulf War, 1991 - Health aspects - United States
Persian Gulf War, 1991 - Veterans - Diseases - United States Persian Gulf syndrome - United States |
| ISBN | 0-309-51390-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | v. 1. Depleted uranium, pyridostigmine bromide, sarin, vaccines |
| Record Nr. | UNINA-9910828721003321 |
| Washington, D.C., : National Academy Press, c2000 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
HIV and the blood supply [[electronic resource] ] : an analysis of crisis decisionmaking / / Lauren B. Leveton, Harold C. Sox, Jr., Michael A. Stoto, editors
| HIV and the blood supply [[electronic resource] ] : an analysis of crisis decisionmaking / / Lauren B. Leveton, Harold C. Sox, Jr., Michael A. Stoto, editors |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1995 |
| Descrizione fisica | xi, 334 p. : ill |
| Disciplina | 362.1/969792 |
| Altri autori (Persone) |
LevetonLauren B
SoxHarold C StotoMichael A |
| Soggetto topico |
AIDS (Disease) - United States
Blood banks - Risk management - United States Blood banks - Law and legislation - United States Medical policy - United States |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-19311-5
9786610193110 0-309-58827-8 0-585-00174-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910456066403321 |
| Washington, D.C., : National Academy Press, 1995 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
HIV and the blood supply [[electronic resource] ] : an analysis of crisis decisionmaking / / Lauren B. Leveton, Harold C. Sox, Jr., Michael A. Stoto, editors
| HIV and the blood supply [[electronic resource] ] : an analysis of crisis decisionmaking / / Lauren B. Leveton, Harold C. Sox, Jr., Michael A. Stoto, editors |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1995 |
| Descrizione fisica | xi, 334 p. : ill |
| Disciplina | 362.1/969792 |
| Altri autori (Persone) |
LevetonLauren B
SoxHarold C StotoMichael A |
| Soggetto topico |
AIDS (Disease) - United States
Blood banks - Risk management - United States Blood banks - Law and legislation - United States Medical policy - United States |
| ISBN |
0-309-17613-1
1-280-19311-5 9786610193110 0-309-58827-8 0-585-00174-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910778663503321 |
| Washington, D.C., : National Academy Press, 1995 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
HIV and the blood supply : an analysis of crisis decisionmaking / / Lauren B. Leveton, Harold C. Sox, Jr., Michael A. Stoto, editors
| HIV and the blood supply : an analysis of crisis decisionmaking / / Lauren B. Leveton, Harold C. Sox, Jr., Michael A. Stoto, editors |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1995 |
| Descrizione fisica | xi, 334 p. : ill |
| Disciplina | 362.1/969792 |
| Altri autori (Persone) |
LevetonLauren B
SoxHarold C StotoMichael A |
| Soggetto topico |
AIDS (Disease) - United States
Blood banks - Risk management - United States Blood banks - Law and legislation - United States Medical policy - United States |
| ISBN |
0-309-17613-1
1-280-19311-5 9786610193110 0-309-58827-8 0-585-00174-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
HIV AND THE BLOOD SUPPLY -- Copyright -- Preface -- REFERENCE -- Contents -- Executive Summary -- HISTORY -- The Risk of AIDS -- Immediate Responses to Evidence of Blood-Borne AIDS Transmission -- Opportunities to Reformulate Policy -- Research Activities -- FINDINGS -- Product Treatment -- Donor Screening and Deferral Policies -- Regulations and Recall -- Communication to Physicians and Patients -- CONCLUSIONS -- Decisionmaking Under Uncertainty -- Bureaucratic Management of Potential Crises -- RECOMMENDATIONS -- The Public Health Service -- The Centers for Disease Control and Prevention -- The Food and Drug Administration -- Communication to Physicians and Patients -- REFERENCES -- 1 Introduction -- HIV INFECTION VIA BLOOD TRANSFUSION -- THE COMMITTEE'S CHARGE -- ORGANIZATION OF THE REPORT -- REFERENCES -- 2 The U.S. Blood Supply System -- INTRODUCTION -- BLOOD AND BLOOD PRODUCTS -- Whole Blood and Components -- Plasma and Derivatives -- Plasma Collection -- Plasma Processing -- Blood and Blood Components Distribution -- BLOOD COLLECTION ORGANIZATIONS -- Community Blood Banks -- The American Red Cross Service -- Hospital Blood Banks -- PROFESSIONAL ASSOCIATIONS -- American Association of Blood Banks -- AABB Inspection and Accreditation Program -- Council of Community Blood Centers -- American Blood Resources Association -- HEMOPHILIA ORGANIZATIONS -- The Nature of Hemophilia -- Hemophilia Treatment Centers -- National Hemophilia Foundation -- Medical and Scientific Advisory Council -- ROLE OF THE U.S. PUBLIC HEALTH SERVICE -- National Blood Policy of 1973 -- Public Health Service -- Centers for Disease Control and Prevention -- National Institutes of Health -- National Institute of Allergy and Infectious Diseases -- National Heart, Lung, and Blood Institute -- Food and Drug Administration -- Blood Products Advisory Committee.
BLOOD AND BLOOD PRODUCT REGULATION -- Statutory Background -- Biologics Act -- Public Health Service Act -- Blood Shield Laws -- Federal Licensure of Blood Collection Organizations -- Establishment Licensure and Registration -- Product Licensure -- Other Required Licensure -- REGULATORY AUTHORITY OF THE FDA -- Compliance with Regulations -- Recall Policy -- SUMMARY -- REFERENCES -- 3 History of the Controversy -- INTRODUCTION -- THE RISK OF AIDS -- Kaposi's Sarcoma and PCP in Homosexual Men -- Opportunistic Infections Among Heterosexual Intravenous (IV) Drug Users and Haitian Immigrants -- Increased Risk Among Individuals with Hemophilia and a Similarity to Hepatitis B -- Further Evidence of Sexual and Blood-Borne Transmission of AIDS -- Summary -- IMMEDIATE RESPONSES TO EVIDENCE OF BLOOD-BORNE AIDS TRANSMISSION -- The CDC's Public Meeting -- The Blood Bank Community's Statement -- Position of the National Hemophilia Foundation -- Position of the Plasma Fractionation Industry -- Federal Recommendations on the Prevention of AIDS -- Summary and Comment -- RECONSIDERING THE EVIDENCE: FURTHER ATTEMPTS TO FORMULATE POLICIES -- Summary and Comment -- RESEARCH ACTIVITIES -- The Public Health Service Effort -- Isolation of the Virus and Development of a Screening Test -- Summary and Comment -- REFERENCES -- 4 Product Treatment -- INTRODUCTION -- CRITICAL TIME PERIOD: 1970-1983 -- Hepatitis -- Viral Inactivation of AHF Concentrate -- Early Methods -- Studies by U.S. Plasma Fractionation Companies -- Problems of Viral Inactivation Development -- Impact of the First Reported Cases of AIDS in Individuals with Hemophilia -- Federal Research Support for Viral Inactivation -- Specific Viral Inactivation Methods -- Testing for the Effectiveness of the Inactivation Process -- FDA Approval and Licensing of Treated Factor VIII -- ANALYSIS AND CONCLUSIONS -- SUMMARY. AFTERWARD -- Subsequent Events -- Current Procedures and Challenges -- REFERENCES -- 5 Donor Screening and Deferral -- INTRODUCTION -- Critical Events -- Critical Event 1 -- Critical Event 2 -- Explanatory Hypotheses -- DONOR SCREENING PRACTICES -- Hepatitis -- Donor Pools -- Early Donor Screening Practices -- ANALYSIS AND FINDINGS -- January 4, 1983, CDC Meeting -- Outcomes of the Meeting -- Donor Questioning and Opposition to It -- Surrogate Testing and Opposition to It -- Criticism of the CDC's Data and Motives -- Risk Assessment -- Lack of Leadership -- Conclusions -- December 1983 Blood Products Advisory Committee Meeting -- Interim Local Efforts to Screen Aggressively -- Reliability of Surrogate Tests -- Task Force Report on Surrogate Testing -- Comment on the Blood Products Advisory Committee -- Informing the Public -- AIDS Politics -- CONCLUSIONS -- Hypothesis One -- Hypothesis Two -- Political Factors -- Ideological Factors -- Organizational Factors -- Historical Factors -- AFTERWORD -- Donor Screening 1985-1995 -- HIV -- Hepatitis -- HTLV-I and HTLV-II -- Current Donor Screening Procedures -- Current Infectious Risk Through Blood Transfusion -- REFERENCES -- 6 Regulations and Recall -- INTRODUCTION -- FRAMEWORK OF ANALYSIS -- Critical Events -- Critical Event 1 -- Critical Event 2 -- Critical Event 3 -- Critical Event 4 -- FDA Regulatory Authority and Practice -- Explanatory Hypotheses -- FINDINGS AND CONCLUSIONS -- FDA Letters of March 1983 -- Analysis -- Summary and Conclusions -- Nonautomatic Recalls -- Analysis -- Summary and Conclusions -- Heat-Treated AHF Concentrate and the FDA's Recall Policy -- Analysis -- Summary and Conclusions -- Lookback and Notification of Individuals Transfused with Contaminated Blood Products -- Analysis -- Summary and Conclusions -- INFLUENCE AND RESPONSIBILITIES OF OTHER ORGANIZATIONS. Governmental Organizations -- Nongovernmental Organizations -- Implications -- THE ADVANTAGES OF MARGINAL THINKING -- Lookback and Notification -- Removal of Untreated AHF Concentrate -- Use of Screened Whole Blood -- Destruction of Potentially Contaminated Cryoprecipitate -- Innovative Techniques for Pooling Plasma -- Testing Previously Untested Blood and Plasma for HIV -- SUMMARY -- REFERENCES -- 7 Risk Communication to Physicians and Patients -- INTRODUCTION -- FRAMEWORK FOR ANALYSIS -- Critical Questions -- Critical Factors -- The Role of the National Hemophilia Foundation -- RISK REDUCTION OPTIONS -- Specific Options -- The Process for Developing NHF Guidelines -- CASE STUDIES -- Case Study One: Conviction and Change -- Case Study Two: Reduction in Use of AHF Concentrate -- Case Study Three: Continue AHF Concentrate Treatment -- Case Study Four: Prescribing Cryoprecipitate for a Newborn and Continuing AHF Concentrate Treatment For a Four-Year-Old -- Case Study Five: A Transfusion Case -- Summary of the Case Studies -- OBSTACLES TO COMMUNICATION -- Institutional Obstacles -- Resources and Expertise of the NHF -- The NHF and the Plasma Fractionation Industry -- Communication Style of the NHF -- Social and Cultural Obstacles -- CONCLUSIONS -- REFERENCES -- 8 Conclusions and Recommendations -- GENERAL CONCLUSIONS -- Decisionmaking Under Uncertainty -- Risk Perception -- Risk Assessment Versus Risk Management -- Consider the Full Range of Possibilities -- Risk Reduction Versus Zero Risk -- Risk Communication -- Bureaucratic Management of Potential Crises -- Coordination and Leadership -- Advisory Mechanisms -- Analytic Capability and Long-Range Vision -- Presumptive Regulatory and Public Health Triggers -- Product Treatment -- Donor Screening -- Recall -- Communication to Patients and Providers -- RECOMMENDATIONS -- The Public Health Service. Leadership -- Blood Safety Council -- Compensation Policy -- The Centers for Disease Control and Prevention -- Early Warning Systems -- Surveillance -- The Food and Drug Administration -- Risk Reduction -- Decision Processes -- Regulatory Efforts -- Advisory Committees -- Communication to Physicians and Patients -- Clinical Practice -- Credibility -- REFERENCES -- Appendixes -- A Individuals Interviewed by the Committee -- B Individuals Providing Oral and Written Testimony (for a public meeting held September 12, 1994) -- C Chronological Summary of Critical Events, National Hemophilia Foundation (NHF) Communications, Knowledge Base, Risk Asse... -- D Key Documents Provided to the Committee -- E Glossary of Acronyms and Terms -- Acronyms -- Terms -- SOURCES -- F Committee and Staff Biographies -- COMMITTEE -- STAFF BIOGRAPHIES -- Index. |
| Record Nr. | UNINA-9910811529103321 |
| Washington, D.C., : National Academy Press, 1995 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Setting priorities for health technology assessment [[electronic resource] ] : a model process / / Molla S. Donaldson and Harold C. Sox, Jr., editors
| Setting priorities for health technology assessment [[electronic resource] ] : a model process / / Molla S. Donaldson and Harold C. Sox, Jr., editors |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, 1992 |
| Descrizione fisica | 1 online resource (162 p.) |
| Altri autori (Persone) |
DonaldsonMolla S
SoxHarold C |
| Soggetto topico |
Medical technology - United States - Evaluation
Technology assessment - United States |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-20319-6
9786610203192 0-309-57557-5 0-585-14909-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910456237803321 |
| Washington, D.C., : National Academy Press, 1992 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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