pssmooth: Flexible and Efficient Evaluation of Principal
Surrogates/Treatment Effect Modifiers
Implements estimation and testing procedures for evaluating an intermediate biomarker response as a principal surrogate of a clinical response to treatment (i.e., principal stratification effect modification analysis), as described in Juraska M, Huang Y, and Gilbert PB (2020), Inference on treatment effect modification by biomarker response in a three-phase sampling design, Biostatistics, 21(3): 545-560 <doi:10.1093/biostatistics/kxy074>. The methods avoid the restrictive 'placebo structural risk' modeling assumption common to past methods and further improve robustness by the use of nonparametric kernel smoothing for biomarker density estimation. A randomized controlled two-group clinical efficacy trial is assumed with an ordered categorical or continuous univariate biomarker response measured at a fixed timepoint post-randomization and with a univariate baseline surrogate measure allowed to be observed in only a subset of trial participants with an observed biomarker response (see the flexible three-phase sampling design in the paper for details). Bootstrap-based procedures are available for pointwise and simultaneous confidence intervals and testing of four relevant hypotheses. Summary and plotting functions are provided for estimation results.
| Version: |
1.0.4 |
| Imports: |
graphics, stats, np, chngpt, MASS |
| Suggests: |
knitr, rmarkdown |
| Published: |
2026-10-14 |
| DOI: |
10.32614/CRAN.package.pssmooth |
| Author: |
Michal Juraska [aut, cre],
Sebastien Haneuse [ctb, cph] (author of the included tps() code from
the osDesign package),
Takumi Saegusa [ctb, cph] (author of the included tps() code from the
osDesign package),
Nilanjan Chatterjee [ctb, cph] (author of the included tps() code from
the osDesign package),
Norman Breslow [ctb, cph] (author of the included tps() code from the
osDesign package) |
| Maintainer: |
Michal Juraska <mjuraska at fredhutch.org> |
| BugReports: |
https://github.com/mjuraska/pssmooth/issues |
| License: |
GPL (≥ 3) |
| URL: |
https://github.com/mjuraska/pssmooth |
| NeedsCompilation: |
no |
| Citation: |
pssmooth citation info |
| Materials: |
README, NEWS |
| CRAN checks: |
pssmooth results |
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