README.md

In mdsstat: Statistical Trending for Medical Devices Surveillance

What does mdsstat do?

The mdsstat package:

• Standardizes the output of various statistical trending algorithms
• Allows running of multiple algorithms on the same data
• Allows running of both disproportionality and quality control algorithms
• Creates lightweight analysis definitions and output files for auditability, documentation, and reproducibility

Why?

There are many ways to trend medical device event data. Some are drawn from the quality control discipline, others from disproportionality analysis used in pharmacoepidemiology, and yet others from the general field of statistics.

There is a need to rigorously compare and contrast these various methods to more fully understand their respective performance and applicability in surveillance of medical devices.

How?

The mdsstat package aims to provide a collection of statistical trending algorithms used in medical device surveillance. Furthermore, each algorithm is written with a standardized, reusable framework philosophy. The same input data can be fed through multiple algorithms. All algorithms return results that can be sorted, stacked, and compared.

This package is written in tandem with the mds package. These are complementary in the sense that:

• mds standardizes medical device event data.
• mdsstat standardizes the statistical trending of medical device event data.

While mdsstat algorithms can run on generic R data frames, additional efficiency and traceability benefits are derived by running on data frames generated by mds::time_series() from the mds package.

The Algorithms

This is the current list of algorithms available:

| Function | Description | |:-----------------|:-----------------------------------------------------------| | xbar() | Shewhart x-bar Control Chart with 4 Western Electric Rules | | cusum() | Cumulative Sum Control Chart with 4 Western Electric Rules | | ewma() | Exponentially Weighted Moving Average | | sprt() | Sequential Probability Ratio Test | | prr() | Proportional Reporting Ratio | | ror() | Reporting Odds Ratio | | gps() | Gamma Poisson Shrinker (containing EBGM and EB05) | | bcpnn() | Bayesian Confidence Propagation Neural Network | | cp_mean() | Mean-Shift Changepoint | | poisson_rare() | Poisson Test on Rare Events |

Refer to the package vignette for guided examples.

mdsstat documentation built on March 13, 2020, 2:58 a.m.