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Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent versions of the SDTM and ADaM controlled terminologies should be accessed through the CDISC website (https://www.cdisc.org/standards/terminology).

1.3   Known Issues

The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity of disease measurement and mortality estimation tool for adult subjects applied within 24 hours of admission to an intensive care unit (ICU). The instrument's intended use is for newly admitted subjects to the ICU. The instrument consists of individual items that are summed to create a total score. This instrument is generally collected once at Screening/Baseline. The total score is normally collected as part of the instrument with no instructions provided for handling missing data. In the majority of cases, where APACHE II is only assessed once and the collected total score used as a baseline covariate, the SDTM RS domain may be sufficient to support the analysis requirements, with a variable in ADSL copied directly from a result/value in SDTM.

The APACHE II total score is designed as a mortality prediction tool. It is not intended to influence the medical management or care of subjects during their ICU stay or to be calculated sequentially to show improvement or effect of interventions. The worst values recorded during the initial 24 hours in the ICU are recommended to be used in calculation of the total score but the measurements initially recorded during the subject’s admission can be used for practical reasons. 

Although the APACHE II total score is the most widely used ICU mortality prediction score, it has a number of limitations and shortcomings. The total score is not intended to be applied to specific populations such as liver failure or HIV subjects and is not accurate when dealing with subjects transferred from another unit or another hospital. This is known as lead time bias and is addressed in  APACHE III. The APACHE II total score must be recalibrated before it can be used in a population other than the general ICU population. ICU prediction scores in general need to be periodically recalibrated to reflect changes and improvements in practice and subject demographics. Be sure to discuss the use of this instrument with the appropriate regulatory authorities.

2     Rules and References

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