R/print_evaltsd.R

In Power2Stage: Power and Sample-Size Distribution of 2-Stage Bioequivalence Studies

### S3 print method for class evaltsd ------------------------------------------

print.evaltsd <- function(x, ...) {
  ### General information ------------------------------------------------------
  cat("TSD with 2x2 crossover\n")
  cat("Inverse Normal approach\n")
  if (x$max.comb.test) cat(" - Maximum") else cat(" - Standard")
  cat(" combination test with weight")
  cat(if (x$max.comb.test) "s" else "")
  cat(" for stage 1 =", round(x$weight, 5), "\n")
  cat(" - Significance levels (s1/s2) =", round(x$alpha, 5), "\n")
  cat(" - Critical values (s1/s2) =", round(x$cval, 5), "\n")
  cat(" - BE acceptance range = ", x$theta1," ... ", x$theta2, "\n", sep = "")

  ### Derived values -----------------------------------------------------------
  if (x$stage == 1) {
    not_pe <- if (x$usePE) "" else "not "
    cat(" - Observed point estimate from stage 1 is ", not_pe, "used for SSR\n",
        sep = "")
    if (x$ssr.conditional == "no") {
      cat(" - Without conditional error rates and conditional estimated target power\n")
    } else {
      cat(" - With ")
      if (x$ssr.conditional == "error") {
        cat("conditional error rates\n")
      } else {
        if (x$fCpower > x$targetpower)
          cat("conditional error rates\n")
        else if ((!x$stop_BE) && (x$'Power Stage 1' >= x$fCpower))
          cat("conditional error rates\n")
        else
          cat("conditional error rates and conditional estimated target power\n")
      }
    }
    cat("\nInterim analysis after first stage\n")
    cat("- Derived key statistics:\n")
    cat(sprintf("  z1 = %.5f, z2 = %.5f", x$z1, x$z2), "\n", sep = "")
    cat("  Repeated CI = ",
        sprintf("(%.5f, %.5f)", x$RCI[[1]], x$RCI[[2]]), "\n", sep = "")
    cat("  Median unbiased estimate = ", sprintf("%.4f", x$MEUE), "\n",
        sep = "")
    if (x$stop_fut) {
      cat("- Futility criterion met:\n")
      if (x$futility[[1]] == 1) {
        cat("  - BE not declared and Power of first stage ",
            sprintf("(%.4f)", x$`Power Stage 1`), " > ",
            sprintf("%.4f", x$fCpower), "\n", sep = "")
      }
      if (x$futility[[2]] == 1) {
        fCrit <- x$fCrit
        if ("ci" %in% fCrit) {
          fCrit <- paste("90% CI", sprintf("(%.4f, %.4f)", x$CI90[[1]],
                                           x$CI90[[2]]))
        } else if ("pe" %in% fCrit) {
          fCrit <- "PE"
        }
        cat("  - ", fCrit," outside ", sprintf("%.4f", x$fCrange[1L]), " ... ", sprintf("%.4f", x$fCrange[2L]), "\n", sep = "")
      }
      if (x$futility[[1]] != 1 && x$futility[[3]] == 1) {
        cat("  - n2 = ", x$n2, " such that n1 + n2 > ", x$fCNmax, "\n", sep = "")
      }
      not_be <- if (x$stop_BE) "" else "not "
      cat("- Test for BE ", not_be,
          "positive (not considering any futility rule)\n", sep = "")
      if (x$stop_BE) {
        # Give recommendation to ignore futility criterion and to stop
        cat("- Decision: Recommend to stop due to BE.\n")
      } else {
        if (!is.na(x$n2)) cat("- Calculated n2 = ", x$n2, "\n", sep = "")
        cat("- Decision: Recommend to stop due to futility.\n")
      }
    } else {
      cat("- No futility criterion met\n")
      not_be <- if (x$stop_BE) "" else "not "
      cat("- Test for BE ", not_be,
          "positive (not considering any futility rule)\n", sep = "")
      if (x$stop_BE) {
        cat("- Decision: Stop due to BE\n")
      } else {
        cat("- Calculated n2 = ", x$n2, "\n", sep = "")
        cat("- Decision: Continue to stage 2 with ", x$n2, " subjects\n",
            sep = "")
      }
    }
    if ((x$ssr.conditional == "error_power") && (x$fCpower > x$targetpower))
      message("\nNote: ssr.conditional has been set to \"error\".")
    if ((!x$stop_BE) && (x$'Power Stage 1' >= x$fCpower) && (x$ssr.conditional == "error_power"))
      message("\nNote: n2 was calculated by setting ssr.conditional to \"error\".")
  } else {
    cat("\nFinal analysis after second stage\n")
    cat("- Derived key statistics:\n")
    cat(sprintf("  z1 = %.5f, z2 = %.5f", x$z1, x$z2), "\n", sep = "")
    cat("  Repeated CI = ",
        sprintf("(%.5f, %.5f)", x$RCI[[1]], x$RCI[[2]]), "\n", sep = "")
    cat("  Median unbiased estimate = ", sprintf("%.4f", x$MEUE), "\n",
        sep = "")
    cat("- Decision: ")
    if (x$stop_BE) {
      cat("BE achieved\n")
    } else {
      cat("BE not achieved\n")
    }
  }
}