From aca1f2e8bbccb5ba8aed5f1358141474493614e1 Mon Sep 17 00:00:00 2001 From: Stefan Bundfuss Date: Fri, 10 Jan 2025 14:43:45 +0000 Subject: [PATCH] #276 crpr: describe handling of CR, PR in RECIST vignettes --- NEWS.md | 8 ++++++++ vignettes/adrs.Rmd | 7 +++++++ vignettes/adrs_basic.Rmd | 14 +++++++++++--- 3 files changed, 26 insertions(+), 3 deletions(-) diff --git a/NEWS.md b/NEWS.md index 0fe098b9..761345b1 100644 --- a/NEWS.md +++ b/NEWS.md @@ -1,3 +1,11 @@ +# admiralonco (development version) + +## Documentation + +- The vignettes "Creating a Basic ADRS" and "Creating ADRS (Including +Non-standard Endpoints)" were updated to describe how the case `CR` followed by +`PR` is handled. (#276) + # admiralonco 1.1.0 ## Documentation diff --git a/vignettes/adrs.Rmd b/vignettes/adrs.Rmd index 45ccc079..b8be54f0 100644 --- a/vignettes/adrs.Rmd +++ b/vignettes/adrs.Rmd @@ -30,6 +30,13 @@ implementing other response criteria than RECIST 1.1, e.g., iRECIST or International Myeloma Working Group (IMWG) criteria for the diagnosis of multiple myeloma. +The case that `CR` is followed by `PR` (or `SD`) is considered as a data issue +and the derivations of the parameters don't handle this case specially. It is +recommended to fix the issue in the source data, e.g., by changing the `PR` to +`PD` rather than handling it in the parameter derivations. This ensures +consistency across parameters. However, `admiral::derive_extreme_event()` is so +flexible that it is possible to handle it in the parameter derivations. + Examples are currently presented and tested using `ADSL` (ADaM) and `RS`, `TU` (SDTM) inputs. However, other domains could be used. The functions and workflow could similarly be used to create an intermediary diff --git a/vignettes/adrs_basic.Rmd b/vignettes/adrs_basic.Rmd index 6a618832..3b6dd324 100644 --- a/vignettes/adrs_basic.Rmd +++ b/vignettes/adrs_basic.Rmd @@ -19,9 +19,17 @@ library(admiraldev) # Introduction -This article describes creating an `ADRS` ADaM with common oncology -endpoint parameters based on RECIST v1.1. Therefore response values are -expected as either `CR`, `PR`, `SD`, `NON-CR/NON-PD`, `PD` or `NE`. +This article describes creating an `ADRS` ADaM with common oncology endpoint +parameters based on RECIST v1.1. Therefore response values are expected as +either `CR`, `PR`, `SD`, `NON-CR/NON-PD`, `PD` or `NE`. + +The case that `CR` is followed by `PR` (or `SD`) is considered as a data issue +and the derivations of the parameters don't handle this case specially. The +`{admiralonco}` functions don't provide functionality to handle this case. It is +recommended to fix the issue in the source data, e.g., by changing the `PR` to +`PD` rather than handling it in the parameter derivations. This ensures +consistency across parameters. The functions `derive_param_confirmed_bor()` and +`derive_param_confirmed_resp()` issue a warning if `CR` is followed by `PR`. Please note that this vignette describes the endpoints which were considered by the admiralonco team as the most common ones. The admiralonco functions used to