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Placebo-adjusted effect (revision 1)

Old revision·09:00, 7 Oct 2024·DiagramDelphine

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Placebo-adjusted effect
Also calledBetween-group difference, treatment difference
Computed asActive-arm change minus placebo-arm change
Why it mattersThe active-arm change alone is not the drug effect
Topic infobox · conventions

The placebo-adjusted effect is the difference between the change observed in a treatment arm and the change observed in the comparator arm. It is the quantity a randomised trial is designed to estimate, and it is what can be attributed to the treatment.[1]

The active-arm change alone conflates the treatment effect with everything else operating during the trial: regression to the mean, the natural course of the condition, the lifestyle intervention both arms received, and the effects of being observed.[2]

References

  1. ^ International Council for Harmonisation, E9(R1): Estimands and Sensitivity Analysis in Clinical Trials (2019).
  2. ^ Hróbjartsson A, Gøtzsche PC. "Placebo interventions for all clinical conditions." Cochrane Database of Systematic Reviews (1):CD003974 (2010). PMID 20091554.