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Mechanical Circulatory Support

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Applying Classification of Recommendations and Lev Estimate of Certainty (precision) of Treatment Effect Size of Treatment Effect CLASS I Benefit >>> Risk Procedure/Treatment SHOULD be performed/ administered CLASS IIa Benefit >> Risk Additional studies with focused objectives needed IT IS REASONABLE to perform procedure/  administer treatment LEVEL A Multiple populations evaluateda ▪Recommendation that procedure or treatment is useful/effective ▪Recommendation in favor of treatment or procedure being useful/effective Data derived from multiple randomized clinical trials or meta-analyses LEVEL B Limited populations evaluateda ▪Sufficient evidence from multiple randomized trials or meta-analyses ▪Recommendation that procedure or treatment is useful/effective ▪Some conflicting evidence from multiple randomized trials or meta-analyses ▪Recommendation in favor of treatment or procedure being useful/effective Data derived from a single randomized trial or nonrandomized studies LEVEL C Very limited populations evaluateda Only consensus opinion of experts, case studies, or standards of care ▪Evidence from single randomized trial or nonrandomized studies ▪Recommendation that procedure or treatment is useful/effective ▪Some conflicting evidence from single randomized trial or nonrandomized studies ▪Recommendation in favor of treatment or procedure being useful/effective ▪Only expert opinion, case studies, or standard of care ▪Only diverging expert opinion, case studies, or standard of care Suggested phrases for writing should recommendations is recommended is indicated is useful/effective/beneficial is reasonable can be useful/effective/beneficial is probably recommended or indicated Comparative effectiveness phrasesb treatment/strategy A is probably recommended/indicated in preference to treatment B it is reasonable to choose treatment A over treatment B treatment/strategy A is recommended/indicated in preference to treatment B treatment A should be chosen over treatment B A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Although randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective.

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