Table 4.
Two-stage | Zelen single consent, treatments concealed | Zelen single consent, treatments revealed | Zelen double consent, treatments concealed | Zelen double consent, treatments revealed | |
---|---|---|---|---|---|
Gain in Concordance rate for patients who prefer treatment A | θ(1 − ρ) | θφ − ρ | θ − ρ | 1 − φ(1 − θ) − ρ | 1 − ρ |
Gain in concordance rate for patients who prefer treatment B | θρ | ρ − θφ | ρ | ρ − θφ | ρ |
Gain in overall concordance rate | θ[1 − αρ − β(1 − ρ) − γ] = θ [α (1 − ρ) + βρ] | (α − β)(θφ − ρ) | α(θ − ρ) + βρ | (α − β)(θφ − ρ) + α(1 − φ) | α(1 − ρ) + βρ |
Change in equity (A vs. B) | −θ(2ρ − 1) | 2(θφ − ρ) | θ − 2ρ | φ(2θ − 1) − (2ρ − 1) | 1 − 2ρ |
ρ = proportion randomised to treatment A in standard design, and in a random arm of 2-stage design; (α, β) = preference rates for treatment A or B; γ = undecided rate; θ = proportion randomised to choice arm in two-stage design, or to A-consent arms in Zelen designs; φ = proportion of patients who consent to randomised treatment in Zelen concealed designs.