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Pragmatic considerations for negative control outcome studies to guide non‐randomized comparative analyses: A narrative review

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This narrative review describes the application of negative control outcome (NCO) methods to assess potential bias due to unmeasured or mismeasured confounders in non‐randomized comparisons of drug effectiveness and safety.… Click to show full abstract

This narrative review describes the application of negative control outcome (NCO) methods to assess potential bias due to unmeasured or mismeasured confounders in non‐randomized comparisons of drug effectiveness and safety. An NCO is assumed to have no causal relationship with a treatment under study while subject to the same confounding structure as the treatment and outcome of interest; an association between treatment and NCO then reflects the potential for uncontrolled confounding between treatment and outcome.

Keywords: narrative review; negative control; non randomized; control outcome

Journal Title: Pharmacoepidemiology and Drug Safety
Year Published: 2023

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