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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) standardsthe ASSIGN CVD 10-YEAR RISK composite score of cardiovascular risk. 

The ASSIGN CVD 10-YEAR RISK does not have a CRF and the algorithm to calculate the ASSIGN CVD 10-YEAR RISK is in the public domain.

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

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

The CDISC Intellectual Property Policy can be found on the CDISC website web site at: https(http://www.cdisc.org/about/bylawsbylaws-and-policies).

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG Study Data Tabulation Model Implementation Guide 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 This measure is 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. . CDISC has included the ASSIGN Cardiovascular Disease 10-Year Risk Score (ASSIGN CVD 10-YEAR RISK) as part of CDISC Data Standards. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrument. the ASSIGN Cardiovascular Disease 10-Year Risk Score. There may be many versions of this instrumentthis questionnaire in the public domain or copyright questionnaire. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument measure 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 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. (http:https://www.cdisc.org/standards/terminology/controlled-terminology.

Reference for the APACHE II:

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Further information about the ASSIGN CVD 10-YEAR RISK can be found in the following article: Woodward M, Brindle P, Tunstall-Pedoe H, for the SIGN group on risk estimation. Adding social deprivation and family history to cardiovascular risk assessment: the ASSIGN score from the Scottish Heart Health Extended Cohort (SHHEC). Heart 2007; 93: 172-176.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

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