splinetrials (version 0.1.1)

change_from_baseline: Calculate the Change from Baseline or Treatment Effects from Estimated Marginal Means

Description

Pass emmeans::emmeans() objects (probably obtained via ncs_emmeans()) to emmeans::contrast() using specially constructed contrast matrices so that change from baseline and treatment effects can be calculated.

• change_from_baseline calculate the change from baseline for each of the different study arms/subgroups.

• treatment_effect() calculate the treatment effect for each study arm when there is no subgroup. When there is a subgroup, calculate the treatment effect between subgroups (examining the differences between the subgroups within each study arm) or within subgroups (examining the differences between the study arms within each subgroup).

Usage

change_from_baseline(
  emmeans,
  time_observed_continuous = emmeans@roles$predictors[2],
  time_scheduled_baseline = 0,
  arm = emmeans@roles$predictors[1],
  subgroup = if (length(emmeans@roles$predictors) == 3) emmeans@roles$predictors[3],
  contrast_args = list(adjust = "none"),
  ...,
  as_tibble = FALSE,
  confint_args = list(level = 0.95)
)
treatment_effect(
  emmeans,
  time_observed_continuous = emmeans@roles$predictors[2],
  time_scheduled_baseline,
  arm = emmeans@roles$predictors[1],
  subgroup = if (length(emmeans@roles$predictors) == 3) emmeans@roles$predictors[3],
  ref_value,
  subgroup_type = c("between", "within"),
  contrast_args = list(adjust = "none"),
  ...,
  as_tibble = FALSE,
  confint_args = list(level = 0.95)
)

Value

When as_tibble = FALSE, the value returned by emmeans::contrast(). If as_tibble = TRUE, a tibble:

1. {column name will be the value of the arm argument}: the study arm.

2. {column name will be the value of the time_observed_continuous argument}: the observed continuous time variable.

3. {column name will be the value of the subgroup argument}: the subgroup. Only present if subgroup is not NULL.

4. estimate: estimate for change from baseline or treatment effect.

5. SE: standard error of estimate.

6. df: degrees of freedom for calculating the confidence interval for and estimating the significance of estimate.

7. lower.CL: lower bound of confidence interval for estimate. Only present if confint_args is not NULL.

8. upper.CL: upper bound of confidence interval for estimate. Only present if confint_args is not NULL.

9. t.ratio: test statistic measuring the significance of estimate.

10. p.value: p-value for the significance of estimate.

Arguments

emmeans

(emmGrid)
an object of class emmGrid, ideally obtained via ncs_emmeans(), which wraps emmeans::emmeans().

time_scheduled_baseline

(scalar numeric)
the continuous time point when baseline was scheduled to occur. Defaults to 0.

arm, time_observed_continuous, subgroup

(string)
strings identifying the study arm variable, observed continuous time variable, and (optionally) subgroup variable supplied to emmeans::emmeans(), probably via ncs_emmeans()). If ncs_emmeans() was indeed used, these strings should be contained in the character vector emmeans@roles$predictors (see the default arguments).

contrast_args, ...

(named list)
arguments to be passed to emmeans::contrast(). Any arguments with the names object or method will be overwritten. Arguments in contrast_args override identically named arguments in ....

as_tibble

(flag)
TRUE or FALSE indicating whether or not the results of emmeans::contrast() should be processed and returned as a tibble.

confint_args

(named list)
arguments to be passed to stats::confint() when calculating confidence intervals. Ignored if as_tibble = FALSE. If NULL, confidence intervals will not be calculated. Defaults to list(level = 0.95).

ref_value

(string)
the value in arm (if subgroup = NULL or if subgroup_type = "within") or the value in subgroup (if subgroup is not NULL and subgroup_type = "between") denoting the control group.

subgroup_type

(string)
either "between" or "within", denoting whether to calculate the treatment effect between subgroups (examining the differences between the subgroups within each study arm) and once within subgroups (examining the differences between the study arms within each subgroup).

Examples

if (FALSE) { # interactive()
# Create a usable data set out of mmrm::fev_data
fev_mod <- mmrm::fev_data
fev_mod$VISITN <- fev_mod$VISITN * 10
fev_mod$time_cont <- fev_mod$VISITN + rnorm(nrow(fev_mod))
fev_mod$obs_visit_index <- round(fev_mod$time_cont)

fit <-
  ncs_mmrm_fit(
    data = fev_mod,
    type = "subgroup_full",
    response = FEV1,
    subject = USUBJID,
    cov_structs = c("ar1", "us"),
    time_observed_continuous = time_cont,
    df = 2,
    time_observed_index = obs_visit_index,
    arm = ARMCD,
    control_group = "PBO",
    subgroup = SEX,
    subgroup_comparator = "Male",
    covariates = ~ FEV1_BL + RACE
  )

marginal_means <-
  ncs_emmeans(
    fit = fit,
    observed_time = "time_cont",
    scheduled_time = "VISITN",
    arm = "ARMCD",
    subgroup = "SEX"
  )

change_from_baseline(
  emmeans = marginal_means,
  time_observed_continuous = "time_cont",
  time_scheduled_baseline = 10,
  arm = "ARMCD",
  subgroup = "SEX"
)

# Same thing as a tibble:
change_from_baseline(
  emmeans = marginal_means,
  time_observed_continuous = "time_cont",
  time_scheduled_baseline = 10,
  arm = "ARMCD",
  subgroup = "SEX",
  as_tibble = TRUE
)

treatment_effect(
  emmeans = marginal_means,
  time_observed_continuous = "time_cont",
  time_scheduled_baseline = 10,
  arm = "ARMCD",
  subgroup = "SEX",
  ref_value = "Male",
  as_tibble = TRUE
)
}