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2017 Update Incorporated - Valvular Heart Disease

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63 LEVEL (QUALITY ) OF EVIDENCE c LEVEL A ◼ High-quality evidence c from more than 1 RCT ◼ Meta-analyses of high-quality RCTs ◼ One or more RCTs corroborated by high-quality registry studies LEVEL B-R (Randomized) ◼ Moderate-quality evidence c from 1 or more RCTs ◼ Meta-analyses of moderate-quality RCTs LEVEL B-NR (Nonrandomized) ◼ Moderate-quality evidence c from 1 or more well-designed, well-executed nonrandomized studies, observational studies, or registry studies ◼ Meta-analyses of such studies LEVEL C-LD (Limited Data) ◼ Randomized or nonrandomized observational or registry studies with limitations of design or execution ◼ Meta-analyses of such studies ◼ Physiological or mechanistic studies in human subjects LEVEL C-EO (Expert Opinion) Consensus of expert opinion based on clinical experience COR and LOE are determined independently (any COR may be paired with any LOE). A recommendation with LOE C does not imply that the recommendation is weak. Many important clinical questions addressed in guidelines do not lend themselves to clinical trials. Although RCTs are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective. a The outcome or result of the intervention should be specified (an improved clinical outcome or increased diagnostic accuracy or incremental prognostic information). b For comparative-effectiveness recommendations (COR I and IIa; LOE A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated. c The method of assessing quality is evolving, including the application of standardized, widely used, and preferably validated evidence grading tools; and for systematic reviews, the incorporation of an Evidence Review Committee. COR indicates Class of Recommendation; EO, expert opinion; LD, limited data; LOE, Level of Evidence; NR, nonrandomized; R, randomized; RCT, randomized controlled trial.

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