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From page 247... ... , Center for Medical Effectiveness 65, 122-123 Research, 27 American Association of Clinical comparative effectiveness methods, 87 Chemistry, 65 n.6, 104 American Association of Health Plans, 27 Effective Health Care Program, 28, 43, American Board of Medical Specialties, 60, 61, 72, 76, 83, 104, 164, 189 187 Evidence-based Practice Centers (EPCs) , American College of Cardiology (ACC) Read the entire page →
From page 248... ... Instrument, Case-control studies, 4, 23, 24, 91, 92, 223 136-137, 155, 231-232 Case series, 4, 23, 24, 91, 92, 102, 103 AQA Alliance, 48 Center for Biologics Evaluation and Australia, national programs, 124, 160, Research, 42 161, 162, 163 Center for Devices and Radiological Autologous bone marrow transplant, 64 Health, 42 65, 68 Center for Drug Evaluation and Research (CDER) , 42 Center for Medical Effectiveness Research, B 27 Back pain, 68, 69, 70, 95, 96, 139, 157 Centers for Disease Control and Benchmarks of appropriate care, 39, 40, 43 Prevention, 42, 65, 83-84, 206, 217 Bevacizumab (Avastin®) Read the entire page →
From page 249... ... empirical evidence, Clinical effectiveness research. See also 41, 124, 125, 127 Systematic reviews external review, 141, 147 challenges, 47, 49-52 gaps and overlaps, 8, 134, 140-141, conflicts of interest in, 25, 97 156 context for, 34-36 grading strength of recommendations, current landscape, 5-6, 41-52 49, 90, 123, 128, 129, 132-133, duplication of effort, 5, 6, 51-52, 66- 135-136, 140, 141-142, 146, 234 68, 69-70, 73, 156 historical context for, 24-25, 26-28, estimate of effect, 101 122-123 evidence base, 35-36, 92-94, 127 improving current guidelines, 134-137, external validity, 101 139 grading systems for strength of information quality, 8-9, 36, 126-132 evidence, 7, 9, 49, 108, 123, 134 language standardization, 126, 141 health policy challenges and, 36-41 142, 146-147, 167 individual studies and, 82-83 limitations of, 8-9, 121, 138, 165-166 information needs, 47, 49 methodological rigor, 15, 127-129, 130, key players, 42-47 139, 165 performance measurement, 40, 43, 47, multiple conflicting guidelines, 126, 48, 122, 137, 147 133-134, 138, 140-141 political pressures, 157 objectivity, 50-51, 121, 122, 127, 128 quality of evidence, 90, 93-94, 100-104, 129, 139, 140, 165 108, 159 panel composition, 121, 129-130, 134 strength of findings, 101, 108 135, 140, 143, 144, 145-146 subpopulations, 8, 59, 61, 93, 94, 96, quality issues, 9, 12, 47, 123, 125-132, 105, 166, 199, 200, 202 135, 142, 153, 154 synthesis of available evidence, 25, 42, recommendations, 11, 15, 121, 139, 43-45 145, 146, 173 transparency, 7, 49-50, 51 resource requirements, 124, 126, 156 Clinical practice guideline development standardization and consistency in, 11, adherence to standards in, 11, 15, 121, 121, 126, 134, 135-137, 139-142, 122, 124, 139-140, 142, 146-147, 146-147, 231-235 155 systematic reviews and, 83, 85, 105, AGREE Instrument, 231-232 111, 123, 127, 133, 134 benefit assessments, 128-129, 142 transparency, 11, 50, 121, 125, 126, bias, 11, 15, 121, 122, 129-132, 136, 139-140, 144, 147 139, 140, 142-146 updating/currency, 124, 125, 138, COGS Checklist, 233-235 140-141 comorbidities and, 48 USPSTF model, 8, 45-47, 94, 123, 124, conflicts of interest, 11, 15, 121, 122, 125, 132-133, 139, 186, 191 124, 130-132, 140, 142-146, 154 Cochrane Central Register of Controlled consensus building, 9, 134-135, 140, Trials, 99, 112 141 Read the entire page →
From page 250... ... , 99, 100, 110, Consumers Union's Best Buy Drugs 112, 218, 220 Program, 20, 186 End-of-life care, 2, 13, 18, 38, 59, 66, 76, Cost criteria for priority setting, 6, 11, 13, 190 71, 72, 73, 74, 76, 133, 173, 174, Epilepsy guidelines, 134 197, 232 Erythropoietin, 50-51 Cost-effectiveness analysis, 19, 27, 71, 72, European Network for Health Technology 73, 161, 162, 163, 174, 195, 207, Assessment, 160 214, 226, 228 Evidence assessment. See Clinical Costs of health care, 1, 3, 17-18, 19, 27, effectiveness research; Priority 33, 34-35, 36, 40, 44, 45, 67, 160, setting for evidence assessment; 197 Systematic reviews Medicare expenditures, 37, 38, 39, 50- Evidence of effectiveness, defined, 3, 21 51, 163 as selection criterion, 6, 9, 71, 72, Council of Linkages Between Academia 90-92 and Public Health Practice, 65 Experimental studies. Read the entire page →
From page 251... ... See also Centers for Technologies, 58, 155 Medicare & Medicaid Services Committee on Quality of Health Care decisions, 5, 33, 140 in America, 155 experimental or investigational services, Committee on Setting Priorities for 41 Guidelines Development, 155 FDA approval and, 41 Committee to Advise the Public medical necessity, 41, 51 Health Service on Clinical Practice priorities for evidence reviews, 72-73 Guidelines, 130 synthesis of evidence for, 43, 83, 85 reports with recommendations related Health Plan Employer Data and to priority setting, 59 n.1 Information Set, 48, 187 Insurance. See Health plan coverage Health policy challenges, 36 International initiatives, 84, 124, 135 consumer-directed care, 5, 33, 40 136, 137. Read the entire page →
From page 252... ... , 105-108, 159, 202-203 Myocardial infarction, 38, 51, 66, 68, 82 K Kaiser Permanente, 44, 67, 69-70 Kefauver-Harris Drug Amendments, 26 N Knowledge transfer issues, 19 National Center for Biotechnology Information, 36 National Center for Health Care L Technology, 26 Language/terminology standards, 7, 9-10, National Center of Complementary and 11, 14, 81, 104, 108, 126, 141-142, Alternative Medicine, 65 146-147, 155-156, 159, 167, 171, National Cholesterol Education Program, 172, 173 133, 135 Latin American Caribbean Health Sciences National clinical effectiveness assessment Literature (LILACS) , 99 program Literature reviews, 86-87 accountability, 12, 155, 156, 167 Lung cancer, 66, 92, 94, 96 administrative structure, 165, 170 alternative approaches compared, 153, 164-170 M central agency model, 153, 165, 166-170 Macular degeneration, 20, 68, 92, 95, 182, consistency, 12, 155-156, 160, 167 183 efficiency, 12, 156-157, 168 Mathematical modeling, 95 evaluation of Program, 172-173 Medicaid, 37, 38, 45, 60, 62, 163, 197. Read the entire page →
From page 253... ... , 20, 48, analytic framework for systematic 155, 187 reviews, 89-90, 92 National Rural Health Association, 65 study designs, 7, 91, 92 New-evidence criterion, 6, 71, 72, 73, 77, for subpopulation, 94, 96 111, 141, 158 topic nominations, 63, 64, 66, 94, 96 USPSTF recommendations, 8, 45-47, O 94, 123, 125, 132-133, 186, 191 Objectivity Priority Setting Advisory Committee in guideline development, 50-51, 121, (PSAC) , 13 122, 127, 128-129, 139, 140, 165 composition and size, 13-14 in priority setting, 75-76 meeting frequency, 77 in systematic reviews, 6, 7, 86, 157, membership, 13, 57, 74-75 165 mission, 73, 165, 170 Observational or nonexperimental studies nomination process, 14 defined, 24 scope of topics, 76 journal reporting standards for meta- transparency, 76 analyses, 105, 159, 202-203 Read the entire page →
From page 254... ... See also individual Saliba Burns Institute, 65 societies Scientific rigor, 15, 127-129, 130, 139, 165 clinical practice guideline development, Scope of this study, 18-20 2, 8, 12, 22, 43, 45, 47, 111, 124, Scotland, national program, 161, 163 125, 126, 134, 139, 170 Scottish Intercollegiate Guidelines conflicts of interest, 144 Network, 103, 124, 126, 163 evidence assessments, 51, 60, 61, 156 Scottish Medicines Consortium, 161, 163 intellectual bias, 75, 129-130 Selection criteria "ownership" of medical conditions, for high-priority topics, 5, 6, 11, 13, 134 57, 58, 71-72, 73, 74, 76-77, 172 quality of guidelines, 125, 139 173, 197 topic nominations, 63, 64, 193-198 for systematic reviews, 89-92, 110, 127 Prostate cancer, 22, 69, 88, 92, 94, 95, 96, Singapore, national program, 160 134 Society of Vascular Surgery, 65 Public controversy criterion, 6, 71, 72 Spinal Cord Consortium, 65 Public/provider interest criterion, 71, 72 Stakeholders, 13-14, 25, 48, 51, 74-75, PubMed database, 36, 84, 209-214, 225 132, 135, 144, 185, 190-191 Standards for Reporting of Diagnostic Accuracy (STARD) , 105 Q State Children's Health Insurance Program, Quality of health care, 1, 2, 5, 21, 122 163 IOM aims for patient care, 40 Strengthening the Reporting of Quality of life, 51, 72, 88, 133 Observational Studies in Quality of Reporting of Meta-analyses Epidemiology (STROBE) Read the entire page →
From page 255... ... subscription fees, 84 See also Meta-analyses synthesis of results of studies, 7-8, 45, Systematic reviews 49, 82, 104-108, 109, 110, 126 analytic framework, 89-95 132, 159; see also Meta-analyses appraising evidence, 100-104, 110 transparency, 7, 49-50, 51, 86, 104, availability of evidence, 93-94 105, 155, 159 best-evidence approach, 91, 92, 98 updating, 73, 111, 158 bias, 7, 8, 91, 97-98, 100, 102, 108, value of, 3, 6-8, 82, 83 158, 159 and clinical practice guideline development, 83, 85, 105, 111, 123, T 127, 133, 134 Technology assessments data extraction errors, 102 defined, 24 database searches, 98-99, 101 milestones, 25, 26 defined, 3, 24, 82-83 priority setting, 6 fundamentals, 14-15, 87-108 producers, 43, 44, 163 hand searches, 99-100 Transatlantic Inter-Society Consensus, 65 hierarchies of evidence, 7, 102-104, 108 Transparency international efforts, 84 in guideline development, 11, 50, 121, journal standards for reporting, 105 125, 126, 139-140, 144, 147 108, 155, 159, 199-203 in systematic reviews, 7, 49-50, 51, 86, language/terminology standards, 7, 104, 105 9-10, 11, 14, 81, 104, 108, 146, 155-156, 159, 166, 171, 172, 173 methods, 6-8, 14-15, 81, 85-87, 109, 110, 154, 159 U new and emerging technologies, 6, 111- Union County Health Committee, 65 112, 166 United Kingdom, national program, number annually, 58, 59 161-163 objectivity, 6, 7, 86, 157, 165 UnitedHealthcare, 20, 66, 67-68, 189 origins, 85-87 University of California at Los Angeles, priority setting for, 13-14, 62-63 130 producers and users, 43, 46-47, 61, 83- Up-to-Date database, 47 85, 133, 156-157, 186 U.S. Breastfeeding Committee, 65 public access to, 84, 155 U.S. Read the entire page →
From page 256... ... , 89-90, 93-94, 96, 123, 125, 128, 26, 42, 83, 84, 103, 136, 163 132-133, 135, 139, 186, 191 U.S. Public Health Service, 46 Utilization of health services W benchmarks for optimal use, 39-40 Web of Science, 99 geographic variation in, 5, 37-40 WellPoint, 67, 69-70 insurance coverage and, 51 Workforce qualifications and training, 8, and outcomes, 39 11, 14-15, 36, 82, 109-110 variation as selection criterion, 6, 71, World Health Organization (WHO) Read the entire page →

From page 247...

... , Center for Medical Effectiveness 65, 122-123 Research, 27 American Association of Clinical comparative effectiveness methods, 87 Chemistry, 65 n.6, 104 American Association of Health Plans, 27 Effective Health Care Program, 28, 43, American Board of Medical Specialties, 60, 61, 72, 76, 83, 104, 164, 189 187 Evidence-based Practice Centers (EPCs) , American College of Cardiology (ACC)

Read the entire page →

From page 248...

... Instrument, Case-control studies, 4, 23, 24, 91, 92, 223 136-137, 155, 231-232 Case series, 4, 23, 24, 91, 92, 102, 103 AQA Alliance, 48 Center for Biologics Evaluation and Australia, national programs, 124, 160, Research, 42 161, 162, 163 Center for Devices and Radiological Autologous bone marrow transplant, 64 Health, 42 65, 68 Center for Drug Evaluation and Research (CDER) , 42 Center for Medical Effectiveness Research, B 27 Back pain, 68, 69, 70, 95, 96, 139, 157 Centers for Disease Control and Benchmarks of appropriate care, 39, 40, 43 Prevention, 42, 65, 83-84, 206, 217 Bevacizumab (Avastin®)

Read the entire page →

From page 249...

... empirical evidence, Clinical effectiveness research. See also 41, 124, 125, 127 Systematic reviews external review, 141, 147 challenges, 47, 49-52 gaps and overlaps, 8, 134, 140-141, conflicts of interest in, 25, 97 156 context for, 34-36 grading strength of recommendations, current landscape, 5-6, 41-52 49, 90, 123, 128, 129, 132-133, duplication of effort, 5, 6, 51-52, 66- 135-136, 140, 141-142, 146, 234 68, 69-70, 73, 156 historical context for, 24-25, 26-28, estimate of effect, 101 122-123 evidence base, 35-36, 92-94, 127 improving current guidelines, 134-137, external validity, 101 139 grading systems for strength of information quality, 8-9, 36, 126-132 evidence, 7, 9, 49, 108, 123, 134 language standardization, 126, 141 health policy challenges and, 36-41 142, 146-147, 167 individual studies and, 82-83 limitations of, 8-9, 121, 138, 165-166 information needs, 47, 49 methodological rigor, 15, 127-129, 130, key players, 42-47 139, 165 performance measurement, 40, 43, 47, multiple conflicting guidelines, 126, 48, 122, 137, 147 133-134, 138, 140-141 political pressures, 157 objectivity, 50-51, 121, 122, 127, 128 quality of evidence, 90, 93-94, 100-104, 129, 139, 140, 165 108, 159 panel composition, 121, 129-130, 134 strength of findings, 101, 108 135, 140, 143, 144, 145-146 subpopulations, 8, 59, 61, 93, 94, 96, quality issues, 9, 12, 47, 123, 125-132, 105, 166, 199, 200, 202 135, 142, 153, 154 synthesis of available evidence, 25, 42, recommendations, 11, 15, 121, 139, 43-45 145, 146, 173 transparency, 7, 49-50, 51 resource requirements, 124, 126, 156 Clinical practice guideline development standardization and consistency in, 11, adherence to standards in, 11, 15, 121, 121, 126, 134, 135-137, 139-142, 122, 124, 139-140, 142, 146-147, 146-147, 231-235 155 systematic reviews and, 83, 85, 105, AGREE Instrument, 231-232 111, 123, 127, 133, 134 benefit assessments, 128-129, 142 transparency, 11, 50, 121, 125, 126, bias, 11, 15, 121, 122, 129-132, 136, 139-140, 144, 147 139, 140, 142-146 updating/currency, 124, 125, 138, COGS Checklist, 233-235 140-141 comorbidities and, 48 USPSTF model, 8, 45-47, 94, 123, 124, conflicts of interest, 11, 15, 121, 122, 125, 132-133, 139, 186, 191 124, 130-132, 140, 142-146, 154 Cochrane Central Register of Controlled consensus building, 9, 134-135, 140, Trials, 99, 112 141

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From page 250...

... , 99, 100, 110, Consumers Union's Best Buy Drugs 112, 218, 220 Program, 20, 186 End-of-life care, 2, 13, 18, 38, 59, 66, 76, Cost criteria for priority setting, 6, 11, 13, 190 71, 72, 73, 74, 76, 133, 173, 174, Epilepsy guidelines, 134 197, 232 Erythropoietin, 50-51 Cost-effectiveness analysis, 19, 27, 71, 72, European Network for Health Technology 73, 161, 162, 163, 174, 195, 207, Assessment, 160 214, 226, 228 Evidence assessment. See Clinical Costs of health care, 1, 3, 17-18, 19, 27, effectiveness research; Priority 33, 34-35, 36, 40, 44, 45, 67, 160, setting for evidence assessment; 197 Systematic reviews Medicare expenditures, 37, 38, 39, 50- Evidence of effectiveness, defined, 3, 21 51, 163 as selection criterion, 6, 9, 71, 72, Council of Linkages Between Academia 90-92 and Public Health Practice, 65 Experimental studies.

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From page 251...

... See also Centers for Technologies, 58, 155 Medicare & Medicaid Services Committee on Quality of Health Care decisions, 5, 33, 140 in America, 155 experimental or investigational services, Committee on Setting Priorities for 41 Guidelines Development, 155 FDA approval and, 41 Committee to Advise the Public medical necessity, 41, 51 Health Service on Clinical Practice priorities for evidence reviews, 72-73 Guidelines, 130 synthesis of evidence for, 43, 83, 85 reports with recommendations related Health Plan Employer Data and to priority setting, 59 n.1 Information Set, 48, 187 Insurance. See Health plan coverage Health policy challenges, 36 International initiatives, 84, 124, 135 consumer-directed care, 5, 33, 40 136, 137.

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From page 252...

... , 105-108, 159, 202-203 Myocardial infarction, 38, 51, 66, 68, 82 K Kaiser Permanente, 44, 67, 69-70 Kefauver-Harris Drug Amendments, 26 N Knowledge transfer issues, 19 National Center for Biotechnology Information, 36 National Center for Health Care L Technology, 26 Language/terminology standards, 7, 9-10, National Center of Complementary and 11, 14, 81, 104, 108, 126, 141-142, Alternative Medicine, 65 146-147, 155-156, 159, 167, 171, National Cholesterol Education Program, 172, 173 133, 135 Latin American Caribbean Health Sciences National clinical effectiveness assessment Literature (LILACS) , 99 program Literature reviews, 86-87 accountability, 12, 155, 156, 167 Lung cancer, 66, 92, 94, 96 administrative structure, 165, 170 alternative approaches compared, 153, 164-170 M central agency model, 153, 165, 166-170 Macular degeneration, 20, 68, 92, 95, 182, consistency, 12, 155-156, 160, 167 183 efficiency, 12, 156-157, 168 Mathematical modeling, 95 evaluation of Program, 172-173 Medicaid, 37, 38, 45, 60, 62, 163, 197.

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From page 253...

... , 20, 48, analytic framework for systematic 155, 187 reviews, 89-90, 92 National Rural Health Association, 65 study designs, 7, 91, 92 New-evidence criterion, 6, 71, 72, 73, 77, for subpopulation, 94, 96 111, 141, 158 topic nominations, 63, 64, 66, 94, 96 USPSTF recommendations, 8, 45-47, O 94, 123, 125, 132-133, 186, 191 Objectivity Priority Setting Advisory Committee in guideline development, 50-51, 121, (PSAC) , 13 122, 127, 128-129, 139, 140, 165 composition and size, 13-14 in priority setting, 75-76 meeting frequency, 77 in systematic reviews, 6, 7, 86, 157, membership, 13, 57, 74-75 165 mission, 73, 165, 170 Observational or nonexperimental studies nomination process, 14 defined, 24 scope of topics, 76 journal reporting standards for meta- transparency, 76 analyses, 105, 159, 202-203

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From page 254...

... See also individual Saliba Burns Institute, 65 societies Scientific rigor, 15, 127-129, 130, 139, 165 clinical practice guideline development, Scope of this study, 18-20 2, 8, 12, 22, 43, 45, 47, 111, 124, Scotland, national program, 161, 163 125, 126, 134, 139, 170 Scottish Intercollegiate Guidelines conflicts of interest, 144 Network, 103, 124, 126, 163 evidence assessments, 51, 60, 61, 156 Scottish Medicines Consortium, 161, 163 intellectual bias, 75, 129-130 Selection criteria "ownership" of medical conditions, for high-priority topics, 5, 6, 11, 13, 134 57, 58, 71-72, 73, 74, 76-77, 172 quality of guidelines, 125, 139 173, 197 topic nominations, 63, 64, 193-198 for systematic reviews, 89-92, 110, 127 Prostate cancer, 22, 69, 88, 92, 94, 95, 96, Singapore, national program, 160 134 Society of Vascular Surgery, 65 Public controversy criterion, 6, 71, 72 Spinal Cord Consortium, 65 Public/provider interest criterion, 71, 72 Stakeholders, 13-14, 25, 48, 51, 74-75, PubMed database, 36, 84, 209-214, 225 132, 135, 144, 185, 190-191 Standards for Reporting of Diagnostic Accuracy (STARD) , 105 Q State Children's Health Insurance Program, Quality of health care, 1, 2, 5, 21, 122 163 IOM aims for patient care, 40 Strengthening the Reporting of Quality of life, 51, 72, 88, 133 Observational Studies in Quality of Reporting of Meta-analyses Epidemiology (STROBE)

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From page 255...

... subscription fees, 84 See also Meta-analyses synthesis of results of studies, 7-8, 45, Systematic reviews 49, 82, 104-108, 109, 110, 126 analytic framework, 89-95 132, 159; see also Meta-analyses appraising evidence, 100-104, 110 transparency, 7, 49-50, 51, 86, 104, availability of evidence, 93-94 105, 155, 159 best-evidence approach, 91, 92, 98 updating, 73, 111, 158 bias, 7, 8, 91, 97-98, 100, 102, 108, value of, 3, 6-8, 82, 83 158, 159 and clinical practice guideline development, 83, 85, 105, 111, 123, T 127, 133, 134 Technology assessments data extraction errors, 102 defined, 24 database searches, 98-99, 101 milestones, 25, 26 defined, 3, 24, 82-83 priority setting, 6 fundamentals, 14-15, 87-108 producers, 43, 44, 163 hand searches, 99-100 Transatlantic Inter-Society Consensus, 65 hierarchies of evidence, 7, 102-104, 108 Transparency international efforts, 84 in guideline development, 11, 50, 121, journal standards for reporting, 105 125, 126, 139-140, 144, 147 108, 155, 159, 199-203 in systematic reviews, 7, 49-50, 51, 86, language/terminology standards, 7, 104, 105 9-10, 11, 14, 81, 104, 108, 146, 155-156, 159, 166, 171, 172, 173 methods, 6-8, 14-15, 81, 85-87, 109, 110, 154, 159 U new and emerging technologies, 6, 111- Union County Health Committee, 65 112, 166 United Kingdom, national program, number annually, 58, 59 161-163 objectivity, 6, 7, 86, 157, 165 UnitedHealthcare, 20, 66, 67-68, 189 origins, 85-87 University of California at Los Angeles, priority setting for, 13-14, 62-63 130 producers and users, 43, 46-47, 61, 83- Up-to-Date database, 47 85, 133, 156-157, 186 U.S. Breastfeeding Committee, 65 public access to, 84, 155 U.S.

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From page 256...

... , 89-90, 93-94, 96, 123, 125, 128, 26, 42, 83, 84, 103, 136, 163 132-133, 135, 139, 186, 191 U.S. Public Health Service, 46 Utilization of health services W benchmarks for optimal use, 39-40 Web of Science, 99 geographic variation in, 5, 37-40 WellPoint, 67, 69-70 insurance coverage and, 51 Workforce qualifications and training, 8, and outcomes, 39 11, 14-15, 36, 82, 109-110 variation as selection criterion, 6, 71, World Health Organization (WHO)

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Index Pages 247-256

Index
Pages 247-256