Reproducible R Code for Sample Size Estimation and Alarm Definition in the Spanish Monitoring Study on High-Intensity Focused Ultrasound (HIFU) for Movement Disorders

This repository contains the R code used to support the methodological design of the Spanish national Monitoring Study (Estudio de Monitorización, EM) on High-Intensity Focused Ultrasound (HIFU) for movement disorders within the framework of RedETS (Spanish Network of Health Technology Assessment Agencies). Specifically, it includes: Sample size estimation procedures based on predefined clinical and statistical assumptions. An algorithm for defining safety and/or effectiveness alarm criteria during follow-up, in accordance with the monitoring requirements established under Spanish regulatory framework. The code was developed to ensure: Transparency in methodological decision-making. Reproducibility of statistical calculations. Consistency with real-world evidence generation principles. This repository does not contain patient-level data. Only analytical scripts are provided.