Ask the Experts - APACHE and SAPS Scoring
I am trying to determine the importance of Acute Physiology and Chronic Health Evaluation (APACHE) and Simplified Acute Physiology Score (SAPS) scoring in recording or evaluating adverse events and serious adverse events. Does the Food and Drug Administration (FDA) recognize these scoring methods? How does the FDA use them? Do they give any guidance on how to use these severity scores?

I am not aware that the FDA uses APACHE or SAPS scoring except in specific instances in which drug or procedure effectiveness is studied by clinical investigators as part of their research. In those settings, statistically significant changes in the scores, rather than the scores themselves, are what is important. The use of these scores in clinical practice was recently discussed by me in response to a question posed recently in this Ask the Expert section; see "APACHE II vs APACHE III Scoring."