HLSC 2P27 Lecture Notes - Lecture 8: External Validity, Internal Validity, Null Hypothesis

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Intervention: how do regulatory agencies decide whether or not it is. In whom and for what condition(s) will the intervention be used, and on what schedule: what are the risks, what are the relative benefits, go/no go. Effectiveness: is there a difference: rcts vs routine clinical practice, efficacy the performance of an intervention under controlled clinical conditions. Hlsc 2p27: effectiveness the performance of an intervention/treatment under routine clinical conditions, result of physician clinical evaluation medical history/physical examination, non-randomized selection. Effectiveness: efficacy trials, narrowly focused, more restrictive inclusion criteria, one drug vs another (and/or placebo, primary outcome measures = research rating scales, often focus on single endpoint, less clinical relevance. Internal validity: effectiveness trials, broad spectrum of patients, active treatments compared, outcomes measures more practical, real world, likely to have >1 endpoint, more clinical relevance, external validity (generalizability, applicability) Elements of sample size: treatment effect, power (usually of 80%, control effect, n = sample size.

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