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Calculates equal-allocation sample sizes for a parallel-group one-stage equivalence study with binary endpoints. The treatment effect is the risk difference pT - pC. Equivalence is declared when the posterior probability of abs(pT - pC) < delta is at least gammaeq; meaningful non-equivalence is declared when the posterior probability outside the ROPE is at least gammadiff; otherwise the decision is inconclusive.

Usage

design_twoarm_onestage_rope(
  nmin,
  nmax,
  nstep = 1L,
  delta,
  gammaeq = 0.9,
  gammadiff = gammaeq,
  analysis_prior_C = c(1, 1),
  analysis_prior_T = c(1, 1),
  design_prior_eq_C = NULL,
  design_prior_eq_T = NULL,
  design_prior_eq = NULL,
  design_prior_ne_C,
  design_prior_ne_T,
  targetpower = NULL,
  targettype1 = NULL,
  targetpce_h0 = NULL,
  sustainn = 1L,
  rel.tol = 1e-10,
  integration = c("adaptive", "quantile"),
  quad_nodes = 128L,
  calibration = c("Bayesian", "frequentist", "hybrid", "full"),
  freq_pC = NULL,
  freq_delta = NULL,
  targetfreqpower = NULL,
  targetfreqtype1 = NULL,
  freq_grid_n = 101L,
  freq_pC_range = c(0, 1),
  parallel = FALSE,
  ncores = 1L,
  parallel_backend = c("auto", "psock", "multicore", "none"),
  returngrid = TRUE,
  returnmatrices = FALSE,
  progress = interactive(),
  progress_every = 1L
)

Arguments

nmin, nmax

Minimum and maximum per-arm sample size.

nstep

Positive per-arm sample-size increment.

delta

ROPE half-width on the risk-difference scale.

gammaeq

Posterior threshold for equivalence.

gammadiff

Posterior threshold for meaningful non-equivalence.

analysis_prior_C, analysis_prior_T

Length-two Beta analysis-prior shapes.

design_prior_eq_C, design_prior_eq_T

Legacy equivalence-prior Beta kernels.

design_prior_eq

Optional joint baseline-risk/risk-difference design prior.

design_prior_ne_C, design_prior_ne_T

Non-equivalence-prior Beta kernels.

targetpower

Target Bayesian predictive probability of declaring practical equivalence under the equivalence design distribution G1.

targettype1

Maximum Bayesian predictive probability of falsely declaring practical equivalence under the non-equivalence design distribution G0.

targetpce_h0

Optional minimum Bayesian predictive probability of compelling evidence for meaningful non-equivalence under G0. More precisely, this is the predictive probability of declaring meaningful difference, i.e. the posterior probability of abs(pT - pC) >= delta is at least gammadiff. If supplied, this criterion is enforced for "Bayesian", "hybrid", and "full" calibration.

sustainn

Number of consecutive feasible evaluated sample sizes.

rel.tol

Adaptive-integration relative tolerance.

integration

Either "adaptive" or "quantile".

quad_nodes

Number of Gauss-Legendre nodes for quantile quadrature.

calibration

One of "Bayesian", "frequentist", "hybrid", or "full".

freq_pC

Control response probability for frequentist pointwise power.

freq_delta

Treatment-control difference for frequentist pointwise power.

targetfreqpower

Target pointwise frequentist equivalence power.

targetfreqtype1

Maximum boundary-grid frequentist type-I error.

freq_grid_n

Boundary-grid size.

freq_pC_range

Control-risk interval for boundary-grid evaluation.

parallel

Logical; if TRUE, evaluate candidate per-arm sample sizes in parallel.

ncores

Number of workers if parallel = TRUE.

parallel_backend

Parallel backend. "auto" and "psock" use a PSOCK cluster, which is supported on Windows, macOS, and Linux. "none" evaluates candidates sequentially. "multicore" is retained for compatibility but currently resolves to "psock" because forked processes can be unsafe with threaded numerical libraries.

returngrid

Return the full operating-characteristic grid.

returnmatrices

Retain matrices for the selected design.

progress

Logical; if TRUE, show a progress bar during sequential evaluation. Progress display is disabled for parallel evaluation.

progress_every

Positive integer specifying the interval, in evaluated candidate sample sizes, at which sequential progress is updated.

Value

An object of class "bfbin2armrope2armdesign".