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 -- Timing the Assessment -- Obtaining Institutional Support -- Summary: Planning and Protocol Development -- RECRUITMENT -- Referring Physicians -- Patients and Informed Consent -- Summary: Recruitment -- IMPLEMENTATION -- Logistics of Randomization -- Obstacles to Data Gathering -- COLLECTING INPUT DATA -- PERFORMING THE STUDY TESTS -- FOLLOW-UP STUDIES -- Summary: Implementation -- TEST INTERPRETATION -- Accuracy -- Consistency and Multiple-Test Interpretations -- Objectivity -- REPORTING -- CONCLUSION -- REFERENCES -- 5 Costs and Sources of Funding -- FACTORS THAT AFFECT STUDY COSTS -- Planning and Protocol Development -- PERSONNEL -- PROTOCOL DEVELOPMENT -- SAMPLE SIZE -- Decision-Analytic Modeling -- Implementation -- PATIENT ACCRUAL -- DATA COLLECTION -- PATIENT FOLLOW-UP -- ADDITIONAL MEDICAL EXPENSES -- Data Interpretation -- UNREIMBURSED PATIENT COSTS -- EXAMPLES FROM ACTUAL STUDIES -- Cost of Diagnostic Tests -- Personnel Costs -- Multi-Institutional Studies -- SOURCES OF FUNDING -- Proposals for Funding -- SUMMARY AND CONCLUSIONS.

REFERENCES -- 6 A National Program for Assessing Diagnostic Technology -- A MULTICENTER CONSORTIUM -- CHARACTERISTICS OF THE CENTERS -- Responding to Requests for a Technology Assessment -- Choice of a Study Method -- ESTIMATED TIMETABLE -- REVIEW OF RESULTS AND RECOMMENDATIONS -- STUDY PERSONNEL -- BUDGET -- MULTICENTER STUDIES-A CAUTION -- ONGOING TECHNOLOGY ASSESSMENT BY MEDICAL INSTITUTIONS -- REFERENCES -- 7 Problems of Multi-Institutional Studies -- STUDY STRUCTURE AND ORGANIZATION -- Steering Committee -- Coordinating Center -- Advisory Committee -- Central Observers -- STUDY DESIGN AND PROTOCOL DEVELOPMENT -- Focus and Compromise -- Reproducibility Versus Generalizability -- PATIENT RECRUITMENT -- QUALITY CONTROL AND MONITORING -- SUMMARY AND CONCLUSION -- REFERENCES -- The Authors.