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. 2023 Jan 10;32(3):572–592. doi: 10.1177/09622802221146305

Table 4.

Gain in concordance and change in equity for alternative designs when compared to the standard, parallel group design.

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.