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* (#23) Initial commit * (#23) Styled file * (#23) Small editorial changes * Moved to templates folder (#23) * Implemented review suggestions (#23) * Added `adsl_vars` as global object (#23) * (#23) Code review suggestions * (#23) Suggestions from code review * (#23) Height measurment set to baseline * Typo Co-authored-by: Andrii Yurovskyi <[email protected]> --------- Co-authored-by: Andrii Yurovskyi <[email protected]>
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# Name: ADVS | ||
# | ||
# Label: Vital Signs Analysis dataset | ||
# | ||
# Input: adsl, vs | ||
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# Attach/load required packages ---- | ||
library(admiral) | ||
library(admiralmetabolic) | ||
library(tibble) | ||
library(dplyr) | ||
library(stringr) | ||
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# Define project options/variables ---- | ||
# Use the admiral option functionality to store subject key variables in one | ||
# place (note: `subject_keys` defaults to STUDYID and USUBJID) | ||
set_admiral_options(subject_keys = exprs(STUDYID, USUBJID)) | ||
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# Store ADSL variables required for derivations as an R object, enabling | ||
# simplified usage throughout the program | ||
adsl_vars <- exprs(TRTSDT, TRTEDT, TRT01P, TRT01A) | ||
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# Read in data ---- | ||
# See the "Read in Data" vignette section for more information: | ||
# (https://pharmaverse.github.io/admiral/articles/bds_finding.html#readdata) | ||
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# Read data | ||
vs_metabolic <- admiralmetabolic::vs_metabolic | ||
adsl <- admiral::admiral_adsl | ||
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# Convert SAS missing character values to NA | ||
advs <- vs_metabolic %>% | ||
convert_blanks_to_na() | ||
adsl <- adsl %>% | ||
convert_blanks_to_na() | ||
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# Merge ADSL variables (stored in `adsl_vars`) needed for ADVS | ||
advs <- advs %>% | ||
derive_vars_merged( | ||
dataset_add = adsl, | ||
new_vars = adsl_vars, | ||
by_vars = get_admiral_option("subject_keys") | ||
) | ||
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# Define parameter look-up table used for merging parameter codes to ADVS | ||
param_lookup <- tribble( | ||
~VSTESTCD, ~PARAMCD, ~PARAM, ~PARAMN, ~PARCAT1, ~PARCAT1N, | ||
"HEIGHT", "HEIGHT", "Height (cm)", 1, "Anthropometric measurement", 1, | ||
"WEIGHT", "WEIGHT", "Weight (kg)", 2, "Anthropometric measurement", 1, | ||
"BMI", "BMI", "Body Mass Index(kg/m2)", 3, "Anthropometric measurement", 1, | ||
"HIPCIR", "HIPCIR", "Hip Circumference (cm)", 4, "Anthropometric measurement", 1, | ||
"WSTCIR", "WSTCIR", "Waist Circumference (cm)", 5, "Anthropometric measurement", 1, | ||
"DIABP", "DIABP", "Diastolic Blood Pressure (mmHg)", 6, "Vital Sign", 2, | ||
"PULSE", "PULSE", "Pulse Rate (beats/min)", 7, "Vital Sign", 2, | ||
"SYSBP", "SYSBP", "Systolic Blood Pressure (mmHg)", 8, "Vital Sign", 2, | ||
"TEMP", "TEMP", "Temperature (C)", 9, "Vital Sign", 2 | ||
) | ||
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# Add parameter (PARAMCD) info to enable later ADVS derivations. Additional | ||
# parameter information will be merged again, after all AVDS derivations are | ||
# completed. | ||
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# See function documentation for `derive_vars_merged_lookup()`: | ||
# (https://pharmaverse.github.io/admiral/reference/derive_vars_merged_lookup.html) | ||
advs <- advs %>% | ||
derive_vars_merged_lookup( | ||
dataset_add = param_lookup, | ||
new_vars = exprs(PARAMCD), | ||
by_vars = exprs(VSTESTCD) | ||
) | ||
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# Derive Date/Time and Analysis Day ---- | ||
# See the "Derive/Impute Numeric Date/Time and Analysis Day" vignette section | ||
# for more information: | ||
# (https://pharmaverse.github.io/admiral/articles/bds_finding.html#datetime) | ||
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# Add vital sign analysis date (ADT) and treatment start date (TRTSDT) | ||
advs <- advs %>% | ||
derive_vars_dt(new_vars_prefix = "A", dtc = VSDTC) %>% | ||
derive_vars_dy(reference_date = TRTSDT, source_vars = exprs(ADT)) | ||
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# Derive visit info ---- | ||
# See the "Visit and Period Variables" vignette for more information: | ||
# (https://pharmaverse.github.io/admiral/articles/visits_periods.html) | ||
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# Derive analysis time point (ATPT, ATPTN) and analysis visit (AVISIT, AVISITN) | ||
advs <- advs %>% | ||
mutate( | ||
ATPT = VSTPT, | ||
ATPTN = VSTPTNUM, | ||
AVISIT = case_when( | ||
is.na(VISIT) ~ NA_character_, | ||
VSTESTCD == "HEIGHT" & VISIT == "SCREENING 1" ~ "Baseline", | ||
str_detect(VISIT, "SCREEN|UNSCHED|RETRIEVAL|AMBUL") ~ NA_character_, | ||
TRUE ~ str_to_title(VISIT) | ||
), | ||
AVISITN = case_when( | ||
VISIT == "BASELINE" | (VSTESTCD == "HEIGHT" & VISIT == "SCREENING 1") ~ 0, | ||
str_detect(VISIT, "WEEK") ~ as.integer(str_extract(VISIT, "\\d+")), | ||
TRUE ~ NA_integer_ | ||
) | ||
) | ||
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# Derive results ---- | ||
# See the "Derive Results (AVAL, AVALC)" vignette section for more information: | ||
# (https://pharmaverse.github.io/admiral/articles/bds_finding.html#aval) | ||
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# Derive analysis result (AVAL) | ||
advs <- advs %>% | ||
mutate(AVAL = VSSTRESN) | ||
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# Derive domain specific variables ---- | ||
# See the "Derive Additional Parameters" vignette section for more information: | ||
# (https://pharmaverse.github.io/admiral/articles/bds_finding.html#derive_param) | ||
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# Derive BMI | ||
advs <- advs %>% | ||
filter(VSTESTCD != "BMI") %>% | ||
derive_param_bmi( | ||
by_vars = exprs( | ||
!!!get_admiral_option("subject_keys"), !!!adsl_vars, | ||
AVISIT, AVISITN, ADT, ADY, ATPT, ATPTN | ||
), | ||
set_values_to = exprs( | ||
PARAMCD = "BMI" | ||
), | ||
get_unit_expr = VSSTRESU, | ||
constant_by_vars = get_admiral_option("subject_keys") | ||
) | ||
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# Derive categorization variables ---- | ||
# See the "Derive Categorization Variables" vignette section for more | ||
# information: | ||
# (https://pharmaverse.github.io/admiral/articles/bds_finding.html#cat) | ||
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# Create analysis categories look-up (conditional look-up) table | ||
avalcat_lookup <- exprs( | ||
~PARAMCD, ~condition, ~AVALCAT1, ~AVALCA1N, | ||
"BMI", AVAL < 18.5, "Underweight", 1, | ||
"BMI", AVAL >= 18.5 & AVAL < 25, "Normal weight", 2, | ||
"BMI", AVAL >= 25 & AVAL < 30, "Overweight", 3, | ||
"BMI", AVAL >= 30 & AVAL < 35, "Obesity class I", 4, | ||
"BMI", AVAL >= 35 & AVAL < 40, "Obesity class II", 5, | ||
"BMI", AVAL >= 40, "Obesity class III", 6, | ||
"BMI", is.na(AVAL), NA_character_, NA_integer_ | ||
) | ||
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# Derive BMI class (AVALCAT1, AVALCA1N) | ||
advs <- advs %>% | ||
derive_vars_cat( | ||
definition = avalcat_lookup, | ||
by_vars = exprs(PARAMCD) | ||
) | ||
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# Derive Baseline variables ---- | ||
# See the "Derive Baseline" and "Derive Change from Baseline " vignette sections | ||
# for more information: | ||
# (https://pharmaverse.github.io/admiral/articles/bds_finding.html#baseline) | ||
# (https://pharmaverse.github.io/admiral/articles/bds_finding.html#bchange) | ||
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# Add baseline flag (ABLFL) | ||
advs <- advs %>% | ||
restrict_derivation( | ||
derivation = derive_var_extreme_flag, | ||
args = params( | ||
by_vars = exprs(!!!get_admiral_option("subject_keys"), PARAMCD), | ||
order = exprs(ADT, ATPTN, AVISITN), | ||
new_var = ABLFL, | ||
mode = "last" | ||
), | ||
filter = (!is.na(AVAL) & ADT <= TRTSDT) | ||
) | ||
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# Derive baseline analysis value (BASE) | ||
advs <- advs %>% | ||
derive_var_base( | ||
by_vars = exprs(!!!get_admiral_option("subject_keys"), PARAMCD), | ||
source_var = AVAL, | ||
new_var = BASE | ||
) | ||
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# Derive absolute (CHG) and relative (PCHG) change from baseline | ||
advs <- advs %>% | ||
restrict_derivation( | ||
derivation = derive_var_chg, | ||
filter = !(is.na(AVISIT) | toupper(AVISIT) %in% "BASELINE") | ||
) %>% | ||
restrict_derivation( | ||
derivation = derive_var_pchg, | ||
filter = !(is.na(AVISIT) | toupper(AVISIT) %in% "BASELINE") | ||
) | ||
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# Derive criterion variables ---- | ||
# See the "Derive Criterion Variables" vignette section for more information: | ||
# (https://pharmaverse.github.io/admiral/articles/bds_finding.html#crit_vars) | ||
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# Set weight loss criterion flags (CRIT1, CRIT1FL) | ||
advs <- advs %>% | ||
restrict_derivation( | ||
derivation = derive_vars_crit_flag, | ||
args = params( | ||
condition = PCHG <= -5 & PARAMCD == "WEIGHT", | ||
description = "Achievement of ≥ 5% weight reduction from baseline", | ||
crit_nr = 1, | ||
values_yn = TRUE, | ||
create_numeric_flag = FALSE | ||
), | ||
filter = AVISITN > 0 & PARAMCD == "WEIGHT" | ||
) %>% | ||
restrict_derivation( | ||
derivation = derive_vars_crit_flag, | ||
args = params( | ||
condition = PCHG <= -10 & PARAMCD == "WEIGHT", | ||
description = "Achievement of ≥ 10% weight reduction from baseline", | ||
crit_nr = 2, | ||
values_yn = TRUE, | ||
create_numeric_flag = FALSE | ||
), | ||
filter = AVISITN > 0 & PARAMCD == "WEIGHT" | ||
) | ||
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# Assign parameter variables ---- | ||
# See the "Assign PARAMCD, PARAM, PARAMN, PARCAT1" vignette section for more | ||
# information: | ||
# (https://pharmaverse.github.io/admiral/articles/bds_finding.html#paramcd) | ||
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# Add all parameter variables (PARAM, PARAMN, PARCAT1, PARCAT1N) | ||
advs <- advs %>% | ||
derive_vars_merged_lookup( | ||
dataset_add = param_lookup, | ||
new_vars = exprs(PARAMCD, PARAM, PARAMN, PARCAT1, PARCAT1N), | ||
by_vars = exprs(PARAMCD) | ||
) | ||
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# Add ADSL variables ---- | ||
# See the "Add ADSL variables" vignette section for more information: | ||
# (https://pharmaverse.github.io/admiral/articles/bds_finding.html#adsl_vars) | ||
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# Add all ADSL variables besides TRTSDT, TRTEDT, TRT01P, TRT01A (stored in | ||
# `adsl_vars`) | ||
advs <- advs %>% | ||
derive_vars_merged( | ||
dataset_add = select(adsl, !!!negate_vars(adsl_vars)), | ||
by_vars = get_admiral_option("subject_keys") | ||
) | ||
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# Add Labels and Attributes ---- | ||
# This process is usually based on one's metadata. As such, no specific example | ||
# will be given. See the "Add Labels and Attributes" vignette section for | ||
# description of several open source R packages which can be used to handle | ||
# metadata. | ||
# (https://pharmaverse.github.io/admiral/articles/bds_finding.html#attributes) | ||
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# Save output ---- | ||
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# Change to whichever directory you want to save the dataset in | ||
dir <- tools::R_user_dir("admiral_templates_data", which = "cache") # Cache | ||
if (!file.exists(dir)) { | ||
# Create the folder | ||
dir.create(dir, recursive = TRUE, showWarnings = FALSE) | ||
} | ||
save(advs, file = file.path(dir, "advs.rda"), compress = "bzip2") |