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"clinical trials"

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Current Practice for Patients Undergoing PCI

Presentation: Adjunctive Devices for Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention
Keywords: embolic protection | MACE | major adverse cardiovascular event | PCI | percutaneous coronary intervention | ST-segment elevation myocardial infarction | STEMI | current practice
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Adjunctive Mechanical Thrombectomy Devices Versus PCI Alone in Patients With STEMI: All Outcomes and Adverse Events

Presentation: Adjunctive Devices for Patients With Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention
Keywords: adjunctive device | mechanical thrombectomy | percutaneous coronary intervention | PCI | ST-segment elevation myocardial infarction | STEMI | outcomes | adverse events
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Comparative Effectiveness of Oral Agents: NSAIDs versus Other Agents

Presentation: Analgesics for Osteoarthritis—An Update
Keywords: comparative effectiveness | outcomes | strength of evidence | efficacy | NSAIDs | acetaminophen | glucosamine | chondroitin | pain
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Knowledge Gaps and Future Research Needs (1 of 3)

Presentation: Analgesics for Osteoarthritis—An Update
Keywords: knowledge gaps | future research | CV risks | GI benefits | COX-2 selective NSAIDs
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Knowledge Gaps and Future Research Needs (2 of 3)

Presentation: Analgesics for Osteoarthritis—An Update
Keywords: knowledge gaps | future research | COX-2 inhibitors | risks | CV safety | GI safety | nonselective NSAIDs | aspirin | salsalate | acetaminophen | alternative dosing
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Gaps in Knowledge

Presentation: Angiotensin-Converting Enzyme Inhibitors (ACEIs), Angiotensin II Receptor Antagonists (ARBs), or Direct Renin Inhibitors (DRI) for Adults With Hypertension
Keywords: gaps in knowledge | future research | subgroups | clinical trials
Applicability Resources. Clinical experts and stakeholders can provide general information important to framing applicability issues. What does the population of interest looks like? What types of care or procedures are routine or represent standard of care? Are certain subpopulations characteristically different from others?
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Applicability Resources

Presentation: Assessing Applicability
Keywords: Effective Health Care Program | comparative effectiveness review | stakeholder | population
Other Applicability Resources. Registry or epidemiological information, practice guidelines, consensus papers, book chapters, and general reviews can provide useful applicability information. Applicability issues do not have to be reviewed for each study. They are used to place the available literature in context.
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Other Applicability Resources

Presentation: Assessing Applicability
Keywords: applicability | population
How Individual Studies Consider Applicability. Studies often do not report on factors needed to judge applicability. Increased use of CONSORT diagrams helps, but deficiencies remain. Only a small number of studies are designed with applicability in mind. Most trials are efficacy trials that maximize internal validity at the expense of applicability. CONSORT = Consolidated Standards of Reporting Trials.
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How Individual Studies Consider Applicability

Presentation: Assessing Applicability
Keywords: applicability | transparency | efficacy trials | internal validity | outcomes
Applicability Judged for Each Question. Applicability should be judged separately for each important question. Factors influencing benefits and harms often depend on distinct physiologic processes. The most applicable evidence may differ when considering a benefit or a harm.
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Applicability Judged for Each Question

Presentation: Assessing Applicability
Keywords: applicability | cohort study
Population and Applicability: Examples. In a trial of women with osteoporosis, only 4,000 of the 54,000 women screened were enrolled; the enrollees were younger, healthier, and more adherent to therapy than is typical of women with osteoporosis. A trial of etanercept for juvenile diabetes excluded patients with side effects during an active run-in period; the trial found a low incidence of adverse events. Clinical trials used to inform Medicare decisions enrolled patients who were younger (60 vs. 75 years of age) and more often male (75 vs. 42%) than is typical of Medicare patients with cardiovascular disease.
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Population and Applicability: Examples

Presentation: Assessing Applicability
Keywords: applicability | population | internal validity | exclusion criteria | inclusion criteria
Comparator and Applicability: Examples. A fixed-dose study that compared high-dose duloxetine to low-dose paroxetine. Many trials evaluating magnesium as a treatment for acute myocardial infarction that were conducted before thrombolytic drugs, antiplatelet drugs, beta-blockers, and primary percutaneous coronary intervention (PCI) were used. Only 1 of 23 trials that compared bypass surgery to PCI used drug-eluting stents.
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Comparator and Applicability: Examples

Presentation: Assessing Applicability
Keywords: comparator | applicability
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