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15 1. Establish initial level of confidence Study Design Initial confidence in an estimate of effect Randomized trials ª High confidence Observational studies ª Low confidence 2. Consider lowering or raising level of confidence Reasons for considering lowering or raising confidence $ Lower if # Higher if Risk of Bias Inconsistency Indirectness Imprecision Publication bias Large effect Dose response All plausible confounding & bias • would reduce a demonstrated effect, or • would suggest a spurious effect if no effect was observed 3. Final level of confidence rating Confidence in an estimate of effect across those considerations H = High M = Moderate L = Low VL = Very Low 1. Rating the quality of the evidence 2. Determinants of the strength of recommendation Quality (certainty) of evidence Balance between benefits, harm & burden Patients' values & preferences Resources and cost W = Weak / C = Conditional S = Strong 3. Implication of the strength of recommendation • Population: Most people in this situation would want the recommended course of action and only a small proportion would not • Health care workers: Most people should receive the recommended course of action • Policy makers: The recommendation can be adapted as a policy in most situations • Population: The majority of people in this situation would want the recommended course of action, but many would not • Health care workers: Be prepared to help people to make a decision that is consistent with their own values/ decsion aids and shared decision making • Policy makers: There is a need for substantial debate and involvement of stakeholders Recommendation Grading Certainty that the desirable consequences exceed the undesirable consequences after considering all of the following:

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