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titleInstructions on how to use this template
  1. Copy ADQRS QS Template pages to the Initial development (Not ready for internal review). Please DO NOT OVERWRITE the template pages.
  2. Change the title of the page as follows:
    1. Remove 'Copy of ADQRS QS Template - '. The new title should begin with 'ADaM ADQRS Short_Name...'.
    2. Change 'ADQRS Short_Name' to the short name (QSCAT) for the current measure.
      1. This change needs to be done in the title as well as throughout the document.
    3. The version number will be 'v1' if there has never been a supplement for the measure before. Otherwise, increment as appropriate.
    4. When copyrighted instruments are used, 'Public domain' will need to be changed to 'Approved'. Note that the copyright approval must allow for the creation of analysis supplements.
  3. Replace 'ADQRS Long_Name' and 'ADQRS Short_Name' with the long and short name of the measure that the supplement is being created for.
  4. Replace royal blue text with information pertaining to the measure the supplement is being created for. Delete royal blue text which does not apply to the new measure. Unless otherwise noted, text in black applies to all QRS Questionnaire Supplements and should not be deleted.

  5. Remove all information blocks, except for the one immediately below this called 'Information for Reviewers'.

  6. Keep changes in blue for ease throughout internal and public review. Once the supplement has gone thru public review and all comments are resolved, change all text color to black except for hyperlinks.

Info
titleInformation for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

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Title

Acute Physiology and Chronic Health Evaluation II Clinical Classification (APACHE II)

CDISC ReferenceClinical Classification Supplement to the Analysis Data Model Implementation Guide
QRS Short NameAPACHE II
ADQRS Permission StatusPublic Domain (or 'Approved', as appropriate)
TeamCDISC ADaM Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0 (or higher as appropriate when doing a supplement revision)
StatusDRAFT (or "REVISION DRAFT" or "FINAL", as appropriate). Status will not be considered "Final" until the supplement is ready to be sent for publication.
Date2022 (date current version released, regardless of status)
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Analysis Data Model Implementation Guide. Naming conventions follow ADaMIG v1.1 or higher.


Revision History

DateVersion
2022  (update whenever text is modified below, even during development)1.0 Draft

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

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This section describes the implementation of the analysis dataset for QRS instruments as based on the Basic Data Structure (BDS) described in the Analysis Data Model Implementation Guide (ADaMIG). The ADaMIG can be found on the CDISC website at https://www.cdisc.org/standards/foundational/adam. The BDS was chosen as the model for analysis datasets of QRS instruments because it supports a wide variety of analyses, including summaries of total score by timepoint as well as change from baseline by timepoint. This data structure allows the ADaM variables PARAM and PARAMCD to come directly from Study Data Tabulation Model (SDTM) variables QSRS.QSRSTEST and QSRS.QSRSTESTCD, respectively, for individually captured questions, thus ensuring traceability between SDTM and ADaM data. If other analyses are required that are not supported by the BDS, then consideration would be needed as to the appropriate structure. Analysis requirements always drive the design of the analysis datasets.

This ADaM supplement is based on the Geriatric Depression Scale Short Form Questionnaire Supplement Version 2.0 Acute Physiology and Chronic Health Evaluation II (APACHE II) Clinical Classification Supplement Version 1.1 to the SDTM Implementation Guide for Human Clinical Trials (SDTMIG). The Geriatric Depression Scale Short Form is known by several names, including GDS SHORT FORM, GDS-15, GDS-SF, and Mood Scale. In this document, it will be referred to as the GDS SHORT FORM. 

Note that source SDTM score values may not be suitable for analysis because the values may need to be imputed or transformed. In addition, recalculation of collected values may be needed per analysis rules. In these cases, the derivation of AVAL may not be a simple copying of QSRS.QSRSSTRESN. 

These specific analysis implementation details for the GDS SHORT FORM are APACHE II are meant to be used in conjunction with ADaMIG. All completed questionnaires, ratings, and scales documentation can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

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