Package: pssmooth Type: Package Title: Flexible and Efficient Evaluation of Principal Surrogates/Treatment Effect Modifiers Version: 1.0.4 Authors@R: c(person("Michal", "Juraska", email = "mjuraska@fredhutch.org", role = c("aut", "cre")), person("Sebastien", "Haneuse", role = c("ctb", "cph"), comment = "author of the included tps() code from the osDesign package"), person("Takumi", "Saegusa", role = c("ctb", "cph"), comment = "author of the included tps() code from the osDesign package"), person("Nilanjan", "Chatterjee", role = c("ctb", "cph"), comment = "author of the included tps() code from the osDesign package"), person("Norman", "Breslow", role = c("ctb", "cph"), comment = "author of the included tps() code from the osDesign package")) BugReports: https://github.com/mjuraska/pssmooth/issues Description: 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 . 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. License: GPL (>= 3) URL: https://github.com/mjuraska/pssmooth Encoding: UTF-8 Imports: graphics, stats, np, chngpt, MASS Suggests: knitr, rmarkdown RoxygenNote: 7.3.2 Config/pak/sysreqs: cmake make Repository: https://mjuraska.r-universe.dev Date/Publication: 2026-10-13 23:36:57 UTC RemoteUrl: https://github.com/mjuraska/pssmooth RemoteRef: HEAD RemoteSha: 2ce5120c0b423555fc018845ddf31247f3cf26af NeedsCompilation: no Packaged: 2026-10-14 02:10:23 UTC; root 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