placeboNonResponder {SPCDAnalyze} | R Documentation |
Example of helper function for determining placebo nonresponse
Description
The input to SPCDcontinuous
requires a logical field which says that the patient was not a placebo responder in the the first phase of the study. Usually this is determined by whether their outcome was greater than a specified value but could have other criteria. This an example program which specifies non-responders as patients whose first phase results were greater than a constant.
Usage
placeboNonResponder(data, ID = "ID", k = 0)
Arguments
data |
The data file to use to determine non-response. |
ID |
Text field indicating the name of the Patient ID variable. |
k |
A numeric constant. A patient is a non-responder if their change from baseline was greater than k. |
Value
A new data frame with a variable named nonResponder
.
Note
The choice of criteria should be specified in the protocol. One suggesting is to consider a non responder to be a patient who would still be eligible for the study.
Author(s)
David A. Schoenfeld, dschoenfeld@mgh.harvard.edu
References
Chen, Y. F., Yang, Y., Hung, H. J., & Wang, S. J. (2011). Evaluation of performance of some enrichment designs dealing with high placebo response in psychiatric clinical trials. Contemporary clinical trials, 32,4, 592-604.
Examples
data1=createTestData(times=0:11,n=c(50,50,50),transition=5,rx1=0,rx2=0)
data1=placeboNonResponder(data1,k=0)