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Collects the number of AEs of all eligible patients that meet visit_med75 criteria of site. Then calculates poisson.test pvalue and bootstrapped probability of having a lower mean value. Used by simaerep_classic()

Usage

sim_sites(
  df_site,
  df_visit,
  r = 1000,
  poisson_test = TRUE,
  prob_lower = TRUE,
  progress = TRUE,
  under_only = TRUE
)

Arguments

df_site

dataframe created by site_aggr

df_visit

dataframe, created by sim_sites

r

integer, denotes number of simulations, default = 1000

poisson_test

logical, calculates poisson.test pvalue

prob_lower

logical, calculates probability for getting a lower value

progress

logical, display progress bar, Default = TRUE

under_only

compute under-reporting probabilities only, default = TRUE check_df_visit(), computationally expensive on large data sets. Default: TRUE

Value

dataframe with the following columns:

study_id

study identification

site_number

site identification

n_pat

number of patients at site

visit_med75

median(max(visit)) * 0.75

n_pat_with_med75

number of patients at site with med75

mean_ae_site_med75

mean AE at visit_med75 site level

mean_ae_study_med75

mean AE at visit_med75 study level

n_pat_with_med75_study

number of patients at study with med75 excl. site

pval

p-value as returned by poisson.test

prob_low

bootstrapped probability for having mean_ae_site_med75 or lower

Examples

df_visit <- sim_test_data_study(
  n_pat = 100,
  n_sites = 5,
  ratio_out = 0.4,
  factor_event_rate = 0.6
  ) %>%
  # internal functions require internal column names
  dplyr::rename(
    n_ae = n_event,
    site_number = site_id,
    patnum = patient_id
  )

df_site <- site_aggr(df_visit)

df_sim_sites <- sim_sites(df_site, df_visit, r = 100)

df_sim_sites %>%
 knitr::kable(digits = 2)
#> 
#> 
#> |study_id |site_number | n_pat| n_pat_with_med75| visit_med75| mean_ae_site_med75| mean_ae_study_med75| n_pat_with_med75_study| pval| prob_low|
#> |:--------|:-----------|-----:|----------------:|-----------:|------------------:|-------------------:|----------------------:|----:|--------:|
#> |A        |S0001       |    20|               17|          17|              17.24|               12.97|                     61| 1.00|     1.00|
#> |A        |S0002       |    20|               19|          16|              17.68|               12.60|                     68| 1.00|     1.00|
#> |A        |S0003       |    20|               20|          15|              11.30|               14.37|                     71| 0.00|     0.00|
#> |A        |S0004       |    20|               17|          15|              10.88|               14.34|                     74| 0.00|     0.00|
#> |A        |S0005       |    20|               18|          15|              11.78|               14.16|                     73| 0.01|     0.03|