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Title

Acute Physiology and Chronic Health Evaluation II (APACHE II)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

APACHE II

QRS Permission StatusPublic Domain
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.0
StatusFINAL
Date2022-08-29
Notes
  • This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.


Revision History

DateVersionSummary of Changes
2022-08-292.0
  • Converted the supplement to the current WIKI QRS supplement template.
  • Annotated CRF updated to the MSG V2.0 annotation guidelines
  • Added assumption 2 to include a record for every item on the instrument. The example was updated to include records for a subject where the instrument was not done.
  • Added assumption 3 to include a record for logically skipped items. The example was updated to include records for these items.
  • The QSEVAL assumption and variable was removed from this supplement, because this is not captured on the CRF and no assumptions are made on the potential values.
  • RSBLFL was updated to RSLOBXFL
2016-06-291.0Initial Final Version

© 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Acute Physiology and Chronic Health Evaluation II (APACHE II) instrument.

 CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols. CDISC disclaims any liability for your use of this material.

2 Copyright Status

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the APACHE II in the CDISC inventory of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrument. There may be many versions of this instrument. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

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

Reference for the APACHE II:

Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Critical Care Medicine 1985; 13(10):818–29. 

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the APACHE II are listed below.

The QRS APACHE II is a severity-of-disease classification system that uses a point score based on the initial values of 12 routine physiologic measurements, age, and previous health status. Scores range from 0 to 71 and higher scores correspond to more severe disease and a higher risk of death. The composite score is based on findings represented in other SDTM domains such as Laboratory Test Results (LB) and Vital Signs (VS).

  1. The APACHE II provides weightings for 12 physiology measures, the sum of which yields a total acute physiology score (APS). This weighting system for 11 of the physiology measures is based on a numeric rating scale (0-4) 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.

    1. For example, the rating of 4 for heart rate (ventricular response) may coincide with multiple definitions depending on whether the abnormality is in the high or low direction (e.g., 4 = ">=180" or 4 = "<=39", respectively).

    2. Note that the score for the Glasgow Coma Score (GCS), the final physiology measure, is the reverse; lower scores indicate mild or no head injury and higher scores represent more severe head injury.

    3. Age and severe chronic health problems reflect diminished physiologic reserve; these have been directly incorporated into APACHE II. Chronological age is a well-documented risk factor for death from acute illness that is independent of severity of disease. This item includes a numeric rating (0, 2, 3, 5, 6) and a definition of what is represented by the rating (e.g., 6 = ">=75" years in age).

    4. Severe chronic organ system insufficiency or immunocompromised state markedly influenced outcome. Nonoperative and emergency surgery admissions had a substantially higher risk for death from prior chronic conditions than did elective surgical admissions. This indicates that patients with the most severe chronic conditions are not considered to be candidates for elective surgery. For patients 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” and 5 is assigned “for nonoperative or emergency postoperative patients”.

    5. For the APACHE II, RSORRES is populated with the text description; the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.

  2. Records are created in rs.xpt (or in split rsap.xpt) for every item on the instrument. 

    1. For items with no data, RSORRES, RSSTRESC, and RSSTRESN are all missing and RSSTAT = "NOT DONE".  If the reason is known then that reason is represented in RSREASND (e.g., RSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then RSSTAT = "NOT DONE" and RSREASND is missing.

  3. Some items on the QRS APACHE II may be not done due to conditional branching per the instrument instructions. 

    1. The equation for computing the alveolar-arterial O2 gradient is heavily dependent on inspired O2 levels, so there are 2 methods for calculating oxygenation. When inspired O2 levels ≥ 0.5 use the alveolar-arterial O2 gradient and complete RSTESTCD = "APCH105A". When inspired O2 levels < 0.5 use the partial pressure of oxygen (PaO2) and complete RSTESTCD = "APCH105B". The other will be treated as not done due to conditional branching.

    2. In addition, arterial pH (RSTESTCD = "APCH106A") is preferred but in cases where oxygenation is normal and blood gases are not measured, serum HCO3 (RSTESTCD = "APCH106B") can be substituted. Only 1 of these 2 physiological parameters will be measured and the other will be treated as not done due to conditional branching. 

    3. In addition, a chronic health response, item RSTESTCD = "APCH115", is only assigned (along with the points) when the patient has a history of severe organ system insufficiency or is immunocompromised. Otherwise it will be not done due to conditional branching.

    4. A record is created in rs.xpt for all items. When an item is considered conditionally branched, it is represented as follows:

      1. RSSTAT = "NOT DONE"       

      2. RSDRVFL = "Y" (the record is derived as a "NOT DONE" record)

      3. QNAM = “RSCBRFL”, QLABEL = “Conditional Branched Item Indicator “, QVAL = “Y” (RS supplemental qualifier variable)
      4. RSORRES, RSSTRESC, and RSSTRESN are set to null (missing)

  4. The APACHE II instrument includes a total APS and total APACHE II score which are considered as captured data on the CRF and not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions on the CRF. If scores are received by the sponsor,

    1. It is recommended that they are submitted to SDTM and verified in ADaM.

  5. Terminology

    1. RSCAT, RSTESTCD, RSTEST, and RSORRESU values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result and unit fields are provided in Section 4, SDTM Mapping Strategy. 

3.2 Example for the QRS APACHE II RS Domain Model

The rsap.xpt dataset represents the items from the APACHE II. The RS domain was split into 2 physically separate datasets: the APACHE II instrument (rsap.xpt) and the GCS (rsgc.xpt). Each dataset represents a subset of the RS domain. Note: In this example, the vital sign and lab values used to answer the APACHE II items were also collected and represented separately in the VS and LB domains. RSLNKID is used to link the APACHE II records to their corresponding findings in their respective source domains. This relationship is defined in the RELREC table.

The APACHE II example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 2 subjects collected at visit 1 for the APACHE II instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, RSCAT, and RSORRESU.  All original results, matching the CRF item response text, are represented in RSORRES. This result is then represented as a standard numeric score in RSSTRESN and as a standard character representation in RSSTRESC

The table represents the items from the APACHE II instrument.

Rows 1-4:Represent the 4 APACHE II items that are based on vital sign measurements.
Rows 5-13:Represent the APACHE II items that are based on lab measurements.
Rows 5-6:

Show that this subject was evaluated for oxygenation (mmHg) where FIO2 is less than 0.5, so PaO2 is recorded. Oxygenation (mmHg) for A-aDO2, where FIO2 is greater than or equal to 0.5, is shown as not done due to conditional branching.

Rows 7-8:

Show that this subject was evaluated for arterial pH. Serum HCO3 (venous mmol/L) is shown as not done due to conditional branching since arterial pH is preferred when arterial blood gases are available.

Row 11:For serum creatinine (mg/dL), subjects will receive double point score for acute renal failure. This subject has normal renal function.
Row 14:Represents the APACHE II item that is based on the score of a separate RS instrument, the GCS. RSORRES, RSSTRESC, and RSSTRESN represent the ordinal value obtained as per the APACHE II instructions. RSGRPID serves to group the full GCS records, which are represented in a separate RS dataset, split by RSCAT.
Row 15:Represents the total APS, which is calculated from the preceding 12 APACHE II measures according to instructions on the instrument.
Rows 16-17:Represent an additional 2 items which are collected on the APACHE II instrument (age points and chronic health points, respectively). The answers to these items are not based on physiological measurements and therefore are not linked to records in any other domains.
Row 18:Represents the total APACHE II score as collected on the instrument according to instructions.
Rows 19-36:

Show the subject was not evaluated on this instrument at visit 1. A record for each item on the instrument is created with a status of "NOT DONE". Since the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred. No assumptions are made about which items were not done based on conditional branching.

rs.xpt

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSGRPIDRSLNKIDRSTESTCDRSTESTRSCATRSORRESRSORRESURSSTRESCRSSTRESNRSSTATRSLOBXFLRSDRVFLVISITNUMRSDTC
1STUDYXRSP00011
AP01APCH101APCH1-Temperature - RectalAPACHE II38.5-38.9C11
Y
12014-06-24
2STUDYXRSP00012
AP02APCH102APCH1-Mean Arterial PressureAPACHE II110-129mmHg22
Y
12014-06-24
3STUDYXRSP00013
AP03APCH103APCH1-Heart RateAPACHE II70-109beats/min00
Y
12014-06-24
4STUDYXRSP00014
AP04APCH104APCH1-Respiratory RateAPACHE II>=50breaths/min44
Y
12014-06-24
5STUDYXRSP00015

APCH105AAPCH1-Oxygenation: A-aDO2APACHE II



NOT DONEYY12014-06-24
6STUDYXRSP00016
AP05APCH105BAPCH1-Oxygenation: PaO2APACHE II61-70mmHg11
Y
12014-06-24
7STUDYXRSP00017
AP06APCH106AAPCH1-Arterial pHAPACHE II<7.15
44
Y
12014-06-24
8STUDYXRSP00018

APCH106BAPCH1-Serum HCO3APACHE II



NOT DONEYY12014-06-24
9STUDYXRSP00019
AP07APCH107APCH1-Serum SodiumAPACHE II150-154mmol/L11
Y
12014-06-24
10STUDYXRSP000110
AP08APCH108APCH1-Serum PotassiumAPACHE II3.5-5.4mmol/L00
Y
12014-06-24
11STUDYXRSP000111
AP09APCH109APCH1-Serum CreatinineAPACHE II<0.6mg/dL22
Y
12014-06-24
12STUDYXRSP000112
AP10APCH110APCH1-HematocritAPACHE II20-29.9%22
Y
12014-06-24
13STUDYXRSP000113
AP11APCH111APCH1-White Blood CountAPACHE II>=4010^9/L44
Y
12014-06-24
14STUDYXRSP0001141
APCH112APCH1-15 Minus Glasgow Coma ScoreAPACHE II3
33
Y
12014-06-24
15STUDYXRSP000115

APCH113APCH1-A: Total Acute Physiology ScoreAPACHE II24
2424
Y
12014-06-24
16STUDYXRSP000116

APCH114APCH1-B: Age PointsAPACHE II65-74YEARS55
Y
12014-06-24
17STUDYXRSP000117

APCH115APCH1-C: Chronic Health PointsAPACHE IIfor elective postoperative patients
22
Y
12014-06-24
18STUDYXRSP000118

APCH116APCH1-Total APACHE II ScoreAPACHE II31
3131
Y
12014-06-24
19STUDYXRSP00021

APCH101APCH1-Temperature - RectalAPACHE II



NOT DONE

1
20STUDYXRSP00022

APCH102APCH1-Mean Arterial PressureAPACHE II



NOT DONE

1
21STUDYXRSP00023

APCH103APCH1-Heart RateAPACHE II



NOT DONE

1
22STUDYXRSP00024

APCH104APCH1-Respiratory RateAPACHE II



NOT DONE

1
23STUDYXRSP00025

APCH105AAPCH1-Oxygenation: A-aDO2APACHE II



NOT DONE

1
24STUDYXRSP00026

APCH105BAPCH1-Oxygenation: PaO2APACHE II



NOT DONE

1
25STUDYXRSP00027

APCH106AAPCH1-Arterial pHAPACHE II



NOT DONE

1
26STUDYXRSP00028

APCH106BAPCH1-Serum HCO3APACHE II



NOT DONE

1
27STUDYXRSP00029

APCH107APCH1-Serum SodiumAPACHE II



NOT DONE

1
28STUDYXRSP000210

APCH108APCH1-Serum PotassiumAPACHE II



NOT DONE

1
29STUDYXRSP000211

APCH109APCH1-Serum CreatinineAPACHE II



NOT DONE

1
30STUDYXRSP000212

APCH110APCH1-HematocritAPACHE II



NOT DONE

1
31STUDYXRSP000213

APCH111APCH1-White Blood CountAPACHE II



NOT DONE

1
32STUDYXRSP000214

APCH112APCH1-15 Minus Glasgow Coma ScoreAPACHE II



NOT DONE

1
33STUDYXRSP000215

APCH113APCH1-A: Total Acute Physiology ScoreAPACHE II



NOT DONE

1
34STUDYXRSP000216

APCH114APCH1-B: Age PointsAPACHE II



NOT DONE

1
35STUDYXRSP000217

APCH115APCH1-C: Chronic Health PointsAPACHE II



NOT DONE

1
36STUDYXRSP000218

APCH116APCH1-Total APACHE II ScoreAPACHE II



NOT DONE

1
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.


The following dataset represents source-data GCS scores which were input into the APACHE II. Note that RSSEQ is set to start at 101 for each subject within this split RS domain as APACHE II is only collected once during the study (at VISITNUM=1). RSGRPID in the split domain below matches RSGRPID for the corresponding record in the preceding RS domain example.

dm.xpt

dm.xpt

RowSTUDYIDDOMAINUSUBJIDSUBJIDSEXBRTHDTCAGEAGEU
11001DM1001-0011F 6/24/197239YEARS
21001DM1001-0022M 2/2/194765

YEARS

Dataset Debug Message

There are two leading, trailing, or non-breaking spaces in the dataset.


The following dataset represents source-data vital signs tests that were input into the APACHE II. Note that the result values fall within the ranges contained in RSORRES in the corresponding RS record. VSLNKID matches RSLNKID for each corresponding record in the RS domain example above.

vs.xpt

vs.xpt

Row

STUDYID

DOMAIN

USUBJID

VSSEQ

VSLNKID

VSTESTCD

VSTEST

VSORRES

VSORRESU

VSSTRESC

VSSTRESN

VSSTRESU

VSLOC

VSBLFL

VISITNUM

VSDTC

1STUDYXVSP00011AP01TEMPTemperature38.9C38.938.9CRECTUMY12014-06-24
2STUDYXVSP00012AP02MAPMean Arterial Pressure117mmHg117117mmHg
Y12014-06-24
3STUDYXVSP00013AP03HRHeart Rate98beats/min9898beats/min
Y12014-06-24
4STUDYXVSP00014AP04RESPRespiratory Rate54breaths/min5454breaths/min
Y12014-06-24
$warningHtml


The following dataset represents the 7 source-data lab tests that were input into the APACHE II. Note that the result values fall within the ranges contained in RSORRES in the corresponding RS record. LBLNKID matches RSLNKID for each corresponding record in the preceding RS domain example.


lb.xpt

lb.xpt

Row

STUDYID

DOMAIN

USUBJID

LBSEQ

LBLNKID

LBTESTCD

LBTEST

LBORRES

LBORRESU

LBSTRESC

LBSTRESN

LBSTRESU

LBSPEC

LBBLFL

VISITNUM

LBDTC

1STUDYXLBP00011AP05PO2Partial Pressure Oxygen65mmHg6565mmHgARTERIAL BLOODY12014-06-24
2STUDYXLBP00012AP06PHpH7.12
7.127.12
ARTERIAL BLOODY12014-06-24
3STUDYXLBP00013AP07SODIUMSodium150mmol/L150150mmol/LSERUMY12014-06-24
4STUDYXLBP00014AP08KPotassium3.7mmol/L3.73.7mmol/LSERUMY12014-06-24
5STUDYXLBP00015AP09CREATCreatinine0.5mg/dL0.50.5mg/dLSERUMY12014-06-24
6STUDYXLBP00016AP10HCTHematocrit24.6%24.624.6%
Y12014-06-24
7STUDYXLBP00017AP11WBCLeukocytes4210^9/L424210^9/L
Y12014-06-24
$warningHtml

The following dataset represents the one-to-one relationship (as defined in RELTYPE) between the RS and VS domains and between the RS and LB domains for the APACHE II.


$titleHtml

relrec.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALRELTYPERELID
1STUDYXRS
RSLNKID
ONE1
2STUDYXVS
VSLNKID
ONE1
3STUDYXRS
RSLNKID
ONE2
4STUDYXLB
LBLNKID
ONE2
$warningHtml

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, RSSTRESN, and RSORRESU) should be populated.

RSTESTCD = "APCH101" RSTEST = "APCH1-Temperature - Rectal"

RSORRES

RSSTRESC

RSSTRESN

>=4144
39-40.933
38.5-38.911
36-38.400
34-35.911
32-33.922
30-31.933
<=29.944
RSORRESU
C

RSTESTCD = "APCH102" RSTEST = "APCH1-Mean Arterial Pressure"

RSORRES

RSSTRESC

RSSTRESN

>=16044
130-15933
110–12922
70–10900
50–6922
<=4944
RSORRESU
mmHg

RSTESTCD = "APCH103" RSTEST = "APCH1-Heart Rate"

RSORRES

RSSTRESC

RSSTRESN

>=18044
140–17933
110–13922
70–10900
55–6922
40–5433
<=3944
RSORRESU
beats/min

RSTESTCD = "APCH104" RSTEST = "APCH1-Respiratory Rate"

RSORRES

RSSTRESC

RSSTRESN

>=5044
35-4933
25-3411
12-2400
10-1111
6-922
<=544
RSORRESU
breaths/min

RSTESTCD = "APCH105A" RSTEST = "APCH1-Oxygenation: A-aDO2"

RSORRES

RSSTRESC

RSSTRESN

>=50044
350-49933
200-34922
<20000
RSORRESU
mmHg

RSTESTCD = "APCH105B" RSTEST = "APCH1-Oxygenation: PaO2"

RSORRES

RSSTRESC

RSSTRESN

>7000
61-7011
55-6033
<5544
RSORRESU
mmHg

RSTESTCD = "APCH106A" RSTEST = "APCH1-Arterial pH"

RSORRES

RSSTRESC

RSSTRESN

>=7.744
7.6-7.6933
7.5-7.5911
7.33-7.4900
7.25-7.3222
7.15-7.2433
<7.1544

RSTESTCD = "APCH106B" RSTEST = "APCH1-Serum HCO3"

RSORRES

RSSTRESC

RSSTRESN

>=5244
41-51.933
32-40.911
22-31.900
18-21.922
15-17.933
<1544
RSORRESU
mmol/L

RSTESTCD = "APCH107" RSTEST = "APCH1-Serum Sodium"

RSORRES

RSSTRESC

RSSTRESN

>=18044
160-17933
155-15922
150-15411
130-14900
120-12922
111-11933
<=11044
RSORRESU
mmol/L

RSTESTCD = "APCH108" RSTEST = "APCH1-Serum Potassium"

RSORRES

RSSTRESC

RSSTRESN

>=744
6-6.933
5.5-5.911
3.5-5.400
3-3.411
2.5-2.922
<2.544
RSORRESU
mmol/L

RSTESTCD = "APCH109" RSTEST = "APCH1-Serum Creatinine"

RSORRES

RSSTRESC

RSSTRESN

>=3.5 and acute renal failure88
2-3.4 and acute renal failure66
1.5-1.9 and acute renal failure44
>=3.544
2-3.433
1.5-1.922
0.6-1.400
<0.622
RSORRESU
mg/dL

RSTESTCD = "APCH110" RSTEST = "APCH1-Hematocrit"

RSORRES

RSSTRESC

RSSTRESN

>=6044
50-59.922
46-49.911
30-45.900
20-29.922
<2044
RSORRESU
%

RSTESTCD = "APCH111" RSTEST = "APCH1-White Blood Count"

RSORRES

RSSTRESC

RSSTRESN

>=4044
20-39.922
15-19.911
3-14.900
1-2.922
<144
RSORRESU
10^9/L

RSTESTCD = "APCH114" RSTEST = "APCH1-B: Age Points"

RSORRES

RSSTRESC

RSSTRESN

<=4400
45-5422
55-6433
65-7455
>=7566
RSORRESU
YEARS

RSTESTCD = "APCH115" RSTEST = "APCH1-C: Chronic Health Points"

RSORRES

RSSTRESC

RSSTRESN

for nonoperative or emergency postoperative patients55
for elective postoperative patients22


End of Document

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