All content on this Wiki is non-binding and any individual opinions expressed should not be considered indicative of the policies or positions of CDISC or any other organization.
Page tree
Skip to end of metadata
Go to start of metadata

The TAUG-Asthma is slated for minor updates in 2017.

This page contains the working list of errata for the provisional version 1.0 of the TAUG-Asthma. These corrections will be incorporated into the next version of the document. 

Asthma User Guide

  • Page 5 / Section 1, Introduction:
    • Second paragraph: The final sentence of this paragraph should be replaced with "See http://cdisc.org/cfast for a list of CFAST participating organizations."
    • Figure 1: This outdated figure should be removed.
  • Page 8 / Section 1.4 and throughout: Concept maps and their keys should be updated to the current coding style.
  • Page 38 / Section 3.1.6, Example 1:

    • first paragraph: "the Device-in-Use (DI) domain" is a typo; the domain code should be DU

    • re.xpt: the value in the "RETESTCD" for Row 3 should be renamed from "PPFEV1" to "FEV1PP"; for Row 4 should be renamed from "PPFVC" to "FVCPP"

  • Pages 41-42 / Section 3.1.6: Example 4 is updated as follows:

    Example 4

    This example captures data about the allergen used by the subject as part of a bronchial allergen challenge (BAC) test. Initially, the subject had a skin prick allergen test (see Section 2.3) to help identify the allergen to be used for the BAC test. The allergens tested were cat dander, house dust mite, and grass. For this subject, grass provided the largest skin test reaction (data not shown), and was the allergen chosen to be used in the BAC test. A predetermined set of ascending doses of the chosen allergen were used in the screening BAC test. The results of the screening BAC were used to choose the allergen dose that would be used in subsequent BAC tests (not shown).

    Allergen Used?

     

    Inhalation End Time

    Allergen Concentration

    Time of FEV1

    FEV1 (L)

    ☐ Cat Dander

     

    SQ-u/mL

    ☐ House Dust Mites

     

    ___:___

    Saline=0

    0

    ___:___

    __.__

    ☐ Grass

     

    ___:___

    Dose1

    250

    ___:___

    __.__

     

     

    ___:___

    Dose2

    1000

    ___:___

    __.__

     

     

    ___:___

    Dose3

    2000

    ___:___

    __.__

    Row 1:The first dose given in the BAC was saline.
    Rows 2-4:Three successively higher doses of grass allergen were given.

    ag.xpt

    ag.xpt

    RowSTUDYIDDOMAINUSUBJIDAGSEQAGTRTAGPRESPAGOCCURAGDOSEAGDOSUAGROUTEVISITAGENDTC

    1

    XYZ

    AG

    XYZ-001-001

    1

    SALINE

    Y

    Y

    0

    SQ-u/mL

    RESPIRATORY (INHALATION)

    SCREENING

    2010-11-07T10:56:00

    2

    XYZ

    AG

    XYZ-001-001

    2

    GRASS

    Y

    Y

    250

    SQ-u/mL

    RESPIRATORY (INHALATION)

    SCREENING

    2010-11-07T11:19:00

    3

    XYZ

    AG

    XYZ-001-001

    3

    GRASS

    Y

    Y

    1000

    SQ-u/mL

    RESPIRATORY (INHALATION)

    SCREENING

    2010-11-07T11:43:00

    4

    XYZ

    AG

    XYZ-001-001

    4

    GRASS

    Y

    Y

    2000

    SQ-u/mL

    RESPIRATORY (INHALATION)

    SCREENING

    2010-11-07T12:06:00

  • Page 67 / Appendix B: This appendix should be removed.
  • Page 68 / Appendix C: The title of this appendix should be changed from "Workgroup" to "CFAST Asthma Team"
  • Page 72 / Appendix F:
    • This appendix should be moved from the TAUG-Asthma itself to a separate document as a ReadMe for Prototype SHARE Metadata for Asthma.
    • Worksheets for Pulmonary Function Tests should be renamed as follows:
      • "PPFVC" to "FVCPP"
      • "PPFEV1" to "FEV1PP"
      • "PPFEF" to "FEF25_75PP"
      • "PPPEF" to "PEFPP"

 

Supplementary Material

SDTMIG Draft Domains

The outdated copies of the draft domains included with the TAUG-Asthma (AG and RE) should be disregarded in favor of Procedure Agents (AG) and Respiratory System Findings (RE), respectively.

Prototype SHARE Metadata: Pulmonary Function Tests

  • Bookmarks should be renamed as follows:
    • "PPFVC" to "FVCPP"
    • "PPFEV1" to "FEV1PP"
    • "PPFEF25-75" to "FEF25-75PP"
    • "PPPEF" to "PEFPP"
  • Page 1 / Introduction: Short names for pulmonary function tests should be renamed as follows:
    • "PPFVC" to "FVCPP"
    • "PPFEV1" to "FEV1PP"
    • "PPFEF25-75" to "FEF25-75PP"
    • "PPPEF" to "PEFPP"
  • Page 2 / Key to Layout: TESTCD should be renamed from "PPFVC" to "FVCPP"
  • Page 5: Title and TESTCD should be renamed from "PPFVC" to "FVCPP"
  • Page 5: The first part of the name for each BRIDG-based concept variable should be renamed from "PPFVC_OBS" and "PPFVC_RES" to "FVCPP_OBS" and "FVCPP_RES"
  • Page 7: Title and TESTCD should be renamed from "PPFEV1" to "FEV1PP"
  • Page 7: The first part of the name for each BRIDG-based concept variable should be renamed from "PPFEV1_OBS" and "PPFEV1_RES" to "FEV1PP_OBS" and "FEV1PP_RES"
  • Page 10: Title and TESTCD should be renamed from "PPFEF25-75" to "FEF25-75PP"
  • Page 10: The first part of the name for each BRIDG-based concept variable should be renamed from "PPFEV1_OBS" and "PPFEV1_RES" to "FEF25-75PP_OBS" and "FEF25-75PP_RES"
  • Page 12: Title and TESTCD should be renamed from "PPPEF" to "PEFPP"
  • Page 12: The first part of the name for each BRIDG-based concept variable should be renamed from "PPPEF_OBS" and "PPPEF_RES" to "PEFPP_OBS" and PEFPP_RES"