public.ctn0094extra (version 1.0.4)

CreateCTN30ProtocolHistory: Create a Subject History Table by Protocol

Description

Create a Subject History Table by Protocol

Usage

CreateCTN30ProtocolHistory(
  randCTN30_df,
  start_int = -30,
  phase1Len_int = 98,
  phase2Len_int = 168
)

Value

A tibble with columns who and when. Each subject will have one row for each day in the study range.

Arguments

randCTN30_df

A data frame of subject randomization days for CTN-0030. This data will have columns for who, which, and when.

start_int

When should the protocol timeline start? Defaults to 30 days before consent (allowing for self-reported drug use via Timeline Follow- Back data).

phase1Len_int

When should Phase I end per protocol? Defaults to 98 days (14 weeks).

phase2Len_int

When should Phase II end per protocol? Defaults to 168 days (24 weeks).

Details

We may want to perform SQL-like operations on a set of tables. This data table will form the "backbone" for future join operations. It creates one record per person in a study for each day in that study, and it is designed to work with subject-specific two-arm protocols (where Phase I and Phase II treatments could start on different days for each subject). For subjects who consented to treatment but were never randomized, we use an "intent to treat" philosophy and assign them an empty protocol timeline starting on the day of consent (day 0) until phase1Len_int.

NOTE: We expect this function to be used specifically to create a potential visit backbone for CTN-0030. For studies with fixed protocol lengths, please use CreateSubjectHistory() instead.

Examples

   # Subject A started Phase I on day 2 and was switched from treatment
   #   Phase I to Phase II on day 45. Subject B started Phase I on day 6 and
   #   was never switched to Phase II (either because they dropped out of the
   #   study or because the treatment given to them in Phase I worked).
   rand_df <- data.frame(
     who   = c("A", "A", "B", "B"),
     which = c(  1,   2,   1,   2),
     when  = c(  2,  45,   6,  NA)
   )

   # Based on this example data above, we expect to see potential contact
   #   days per the protocol for subject A to range from -30 to 45 + 168.
   #   For subject B, we expect this range to be from -30 to 6 + 98
   CreateCTN30ProtocolHistory(rand_df)