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The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity of disease measurement and mortality estimation tool for adult patients subjects applied within 24 hours of admission to an intensive care unit (ICU). The instrument's intended use is for newly admitted patients subjects to the ICU. The instrument consists of individual items that are summed up 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, as 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 patients 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 patient’s 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 patients subjects and is not accurate when dealing with patients 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 patient subject demographics. Be sure to discuss the use of this instrument with the appropriate regulatory authorities.

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The computed total score consists of integer values ranging from 0 to 71. The classification system consists of 11 physiology measures based on a numeric rating scale 0 to 4 where 0 reflects values within the normal range and an increase in the numeric rating scale represents an increase in the abnormality of the physiology measure in either the high or low direction. For Serum Creatinine, the measure is assessed on the same scale but double points assigned for subjects with acute renal failure. The measure evaluating extent of impaired consciousness, is calculated as 15 minus the Glasgow Coma Scale (GCS) Score; so that lower scores indicate mild or no impairment and higher scores represent more severe impairment (possible head and/or central nervous system injury) and range from 0 to 12. Chronological age is divided into age groups which are assigned values of 0, 2, 3, 5, 6. For patients subjects with a history of severe organ system insufficiency or who are immunocompromised, a numeric rating of 2 or 5 is assigned for chronic health points, where 2 is assigned “for elective postoperative patients” subjects” and 5 is assigned “for nonoperative or emergency postoperative patients”subjects”. For subjects who do not have a history of severe organ system insufficiency or who are not immunocompromised, a NOT DONE record may be retained from the source RS domain with the conditional branching flag.

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In the example presented here, it is assumed that the final APACHE II analysis dataset (ADAPCH) contains all of the original records, plus a record for the computed total acute physiology score and a record for the computed total APACHE II for each patient subject and assessment timepoint. The date of the assessment—and time of the assessment, if collected—should also be included in the dataset. For traceability, raw item-level responses from the SDTM RS.RSORRES variable, stored separately from the analysis variable AVAL, are included. Derivation type (DTYPE) should be used to clearly indicate records where missing values have been imputed using sponsor-defined imputation methods. If useful for analysis, a summary analysis dataset which includes only the computed total score records may also be created.

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The APACHE II Analysis Dataset tables below show the terminology and variables for implementing the example analysis dataset for this instrument in the BDS. This specific example is taken from a Phase II, randomized, controlled, open label multi-center study to assess the efficacy and safety of Drug A for the treatment of SARS-CoV-2 infected patients subjects with COVID-19 pneumonia and impaired respiratory function. The primary outcome measure is APACHE II Severity of Disease Score on Day 15 or on the Day of Discharge (Whichever is Earlier). This measure compares Drug A + Standard of Care (SOC) versus the Standard of Care (SOC). 

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