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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.| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | ADQRS-326 |
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The APACHE II total score must be recalibrated before it can be used in a population other than the general ICU population.| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | ADQRS-327 |
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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.
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The primary source used in the development of this supplement is Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system . Critical Care Medicine 1985; 13(10):818–29[1].| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | ADQRS-328 |
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| Definexmltable |
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| Extra | User Notes |
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| Dataset | ADAPCH |
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| Level | Value |
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| Purpose | Analysis |
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| Name | AVAL |
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Variable | Where | Type | Controlled Terms | Source | Derivation | User Notes |
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AVAL | PARAMCD NOT IN NOTIN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) | Num |
| | Set AVAL=RS.RSSTRESN. | The analysis value is the result copied from SDTM. | AVAL | PARAMCD EQ "APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis) | Num |
| | The sum of RS.RSSTRESN for RS.RSTESTCD in ("APCH101"-"APCH112") if no items are missing. Note that among item pairs RSTESTCD in ("APCH105A", "APCH105B") as well as RSTESTCD in ("APCH106A", "APCH106B") only one item is expected to be answered and not both, respectively. | The expectation is that issues pertaining to conditional branching (e.g., both items answered) are queried and fixed in SDTM RS. If this is not possible, the statistician will provide guidance and documentation of how to conduct the analysis given the circumstance (e.g. worst score).
| AVAL | PARAMCD EQ "APCH1TS" (APCH1-Total APACHE II Score - Analysis) | Num |
| | The sum of RS.RSSTRESN for RS.RSTESTCD in ("APCH101"-"APCH112") and "APCH114", "APCH115" if no items are missing. Note that among item pairs RSTESTCD in ("APCH105A", "APCH105B") as well as RSTESTCD in ("APCH106A", "APCH106B") only one item is expected to be answered and not both, respectively. If a subject dies on or before Day 15, they are assigned the highest observed APACHE II score of any of the subjects at any time during the trial for their Total APACHE II Score at Day 15 (Day of Discharge). | The assignment of the highest observed APACHE II score is for illustration purposes only and not meant as a recommendation. | PARAMCD | PARAMCD NOT IN NOTIN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) | Char | APCH1TC | | See CDISC Controlled Terminology for Clinical Classification Test Codes. RS.RSTESTCD for responses to individual items copied from SDTM. |
| PARAMCD | PARAMCD IN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) | Char | APCH1PC | | See CDISC Controlled Terminology for Parameter Codes. |
| PARAM | PARAMCD NOT IN NOTIN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) | Char | APCH1TN | | See CDISC Controlled Terminology for Clinical Classification Test Names. RS.RSTEST for responses to individual items copied from SDTM. |
| PARAM | PARAMCD IN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) | Char | APCH1PN | | See CDISC Controlled Terminology for Parameter Names. |
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