NEWS

PhysioTrial 0.5.1

A vignette carries one task end to end on synthetic or bundled data, offline, and is built and run by R CMD check.
Runnable @examples added or corrected across 1 help pages. Each runs offline in seconds, writes nothing outside tempdir(), and is executed by R CMD check; anything needing a device, a download or an optional backend is fenced with the reason stated.

Power and sample-size for rehabilitation trial designs (R/power.R) — the package could previously run and report a trial but not size or power one.

sampleSizeContinuous() / powerContinuous() — two-arm continuous endpoint, cross-validated against base stats::power.t.test; adds unequal allocation, one/two-sided, dropout inflation, and cluster design effect.
sampleSizeANCOVA() — the recommended pre-post analysis, baseline-adjusted (variance x (1 - rho^2)); sampleSizeChangeScore() — change-from-baseline (SD x sqrt(2(1 - rho))); sampleSizeRepeatedMeasures() — mean of repeated post-baseline visits under compound symmetry (Frison & Pocock).
sampleSizeBinary() / powerBinary() — two-proportion / responder endpoint, matching stats::power.prop.test.
powerCurve() for planning; estimateBaselineCorrelation() estimates rho for ANCOVA planning from pilot vectors, a data frame, or a PhysioCohort.
All share cluster (ICC design effect) and dropout modifiers and return a printable trial_power object.

Adds deterministic, linked SDTM-shaped DM, AE, VS, EG, and sponsor-defined XP exports plus validated passthrough domains.
Adds ADaM-shaped ADSL and generic BDS exports preserving explicit analysis-set membership and exclusion metadata.
Adds structural validation and deterministic define.xml metadata stubs without claiming formal regulatory conformance.

Adds explicit ITT and per-protocol analysis sets with deterministic exclusion reasons.
Adds source-order-preserving outcome filtering, LOCF sensitivity handling, and explicit multiple-imputation callbacks.
Adds ANCOVA, delegated MMRM, and delegated MDC/MCID responder summaries.

Adds reconciled CONSORT participant-flow counts and optional DiagrammeR rendering.
Adds SPIRIT schedule-of-events tables and a SPIRIT 2013 checklist helper.
Adds typed adverse-event capture and AE/SAE summaries by arm, severity, and term.

Adds S4 models for trial arms, participants, randomized trials, concealed randomization sequences, and blinding management.
Supports simple, permuted-block, stratified-block, and Pocock-Simon minimization allocation with captured seeds and deterministic fingerprints.
Adds treatment-code management, append-only unblinding logs, and Bang blinding-index estimates.