--- title: "Additional information" output: rmarkdown::html_vignette vignette: > %\VignetteIndexEntry{Additional information} %\VignetteEngine{knitr::rmarkdown} %\VignetteEncoding{UTF-8} --- ## Model formula and outcome.type in cifcurve() and polyreg() **Common ground** - Both functions expect a `Surv()` or `Event()` response on the LHS of the model formula so that follow-up time and event indicators are supplied in the same way. Internally the helpers validate non-negative times, check that the event codes match the user-specified `code.event1` and `code.event2` arguments, and derive indicators used downstream. - The `outcome.type` argument is normalized by the same utility, meaning that the same set of synonyms (e.g. `"C"`, `"competing risk"`, or `"S"`) are accepted in both workflows and mapped onto the canonical labels used in the estimators. **Key differences** - In `cifcurve()` the RHS of the formula specifies the grouping variable whose curves are estimated; weights (if any) are supplied separately. There is no dedicated exposure argument because all strata are handled through the formula term that is turned into a factor for plotting and estimation. - In `polyreg()` the `nuisance.model` formula describes only the outcome and nuisance covariates (i.e. confounders), while **the exposure is passed separately** through the `exposure` argument. The exposure design matrix, reference level handling, and scaling of nuisance covariates are handled explicitly for regression fitting. - `cifcurve()` focuses on two estimands, selecting between the Kaplan-Meier and Aalen-Johansen estimators via `outcome.type = "survival"` or `"competing-risk"`. In contrast, `polyreg()` supports additional **time-constant and binomial estimands** (`"proportional-survival"`, `"proportional-competing-risk"`, `"binomial"`) and enforces time-point requirements accordingly—for example `time.point` is mandatory for the effects at a fixed time, while time-constant-effect (e.g. proportional subdistribution hazards) models can either use all observed event times or a user-specified grid supplied via a (vector) `time.point`. ## Event coding conventions incifmodeling and CDISC ADaM ADTTE When working with survival data, one common source of confusion arises from inconsistent event coding conventions between the standard input of `Surv()`, provided by the `survival` package, and the CDISC ADaM ADTTE (Analysis Data Model for Time-to-Event Endpoints) used in regulatory clinical trials. With `Surv()`, event is often coded as 1 and censoring is coded as 0. By contrast, the CDISC ADaM ADTTE (commonly used in pharmaceutical submissions and SDTM-based analyses) follows the opposite convention. `CNSR = 0` means that event occurred and `CNSR = 1` represents censoring, which aligns with the broader ADaM convention (where `1 = TRUE`). To accommodate differences in coding conventions, one can explicitly specify event and censoring codes using the `code.event1` and `code.censoring` arguments in `cifcurve()`, `cifplot()`, `cifpanel()` and `polyreg()`. This allows users to perform accurate survival analysis using functions from the `cifmodeling` package while maintaining the CDISC ADaM ADTTE coding scheme. ```{r example5, eval=FALSE, warning=FALSE, message=FALSE} polyreg(Event(AVAL, CNSR) ~ ARM, data = adtte, outcome.type = "survival", code.event1=0, code.censoring=1) ``` ## Key arguments of msummary() that are helpful when reporting polyreg() results - `output` controls the destination of the table (e.g., `"markdown"`, `"latex"`, `"html"`, or a file path such as `'results/cif_table.docx'`). - `coef_map` or `coef_rename` renames model terms for interpretability. - `statistic` specifies which uncertainty summaries to display. Examples: `statistic = "p.value"` for p-values, `statistic = "conf.int"` for Wald CIs, `statistic = "t"` for t statistics, `and statistic = "z"` for z statistics, instead of SEs (default). You can also supply multiple model summaries as a named list to compare estimates across specifications in a single table. See `vignette('modelsummary')` for a comprehensive overview of additional layout and styling options. ## Processing pipeline of cifcurve() A user-specified model formula in `Event()` or `Surv()` is first parsed by `util_read_surv()` to extract the time-to-event, the event indicator, optional weights, and any stratification variables. Those components are then passed to the back-end estimators implemented in `src/calculateAJ_Rcpp.cpp`. The C++ routine supports both weighted and stratified data, so the heavy lifting for the Kaplan-Meier or Aalen-Johansen estimates (and associated at-risk, event, censor counts and influence functions) happens efficiently regardless of how the input was specified. The `error` argument determines how SEs are computed. ## Processing pipeline of polyreg() Input pre-processing mirrors the survival workflow by calling `util_check_outcome_type()`, `reg_check_effect.measure()`, and `reg_check_input()` to parse the format of inputs, event codes, exposure levels, and requested estimands before `createAnalysisDataset()` builds the modeling frame and `reg_normalize_covariate()` rescales covariates by default. Starting values are obtained from the nuisance model fits via `getInitialValues()` or `getInitialValuesProportional()`, or, when necessary, from user-supplied data frame of starting values. Inverse-probability-of-censoring weights for survival and competing-risks outcomes are calculated by `calculateIPCW()`, which in turn wraps the `calculateKM()` C++ routine to obtain the Kaplan-Meier estimates of censoring, while the proportional models assemble matrices through `calculateIPCWMatrix()`. The weighted estimating equations are then solved by `solveEstimatingEquation()`, which dispatches to specific score functions such as `estimating_equation_ipcw()`, `estimating_equation_survival()`, and `estimating_equation_proportional()` and iterates with `nleqslv`/Levenberg-Marquardt updates until the convergence criteria in `assessConvergence()` are met. Sandwich variances come from `calculateCov()` or `calculateCovSurvival()` and are rescaled back to the original covariate scale by `reg_normalize_estimate()`, while optional bootstrap intervals reuse the same solver inside the `boot` resampling loop. The resulting influence functions, weights, and fitted CIFs are retained in `diagnostic.statistics` for downstream diagnostics. ## Reproducibility and conventions for polyreg() - If convergence warnings appear, relax/tighten tolerances or cap the parameter bound (`optim.parameter1` to `optim.parameter3`) and inspect `report.optim.convergence = TRUE`. - If necessary, try modifying other `optim.parameter`, providing user-specified initial values, or reducing the number of nuisance parameters (e.g. provide a `time.point` grid that contributes to estimation when using `"proportional-survival"` and `"proportional-competing-risk"`). - Set `boot.seed` for reproducible bootstrap results. - Match CDISC ADaM conventions via `code.event1 = 0`, `code.censoring = 1` (and, if applicable, `code.event2` for competing events).