title: Validity and treatment dilution in Zelen's single consent design.
abstract: Employing randomization theory, this note examines the manner in which a clinical trial employing Zelen's randomized consent design yields an estimated treatment effect free of selection bias. We also examine the concept of 'treatment dilution' in this design.
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D007258:Informed Consent; D011897:Random Allocation; D013223:Statistics as Topic