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titleNews and updates
  • 2022-06-28: Addition of six supplements
  • 2021-06-28: Initial version

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Questionnaires, Ratings, and Scales (QRS) are very common in clinical trial protocols. CDISC has published many supplements to provide users information on how to structure the QRS data in a standard format using SDTM. Users can view the normative information regarding relevant CDISC Controlled Terminology (CT) codelists & and terms, and how they map and apply in SDTM datasets. CDISC Library provides users a machine-readable version of this normative information, such as the exact CT term to use in the SDTM --CAT variable, an item's --TEST and --TESTCD, one-to-one pairing of --TEST and --TESTCD, ordering of items, and lastly, response codelists & and terms for each applicable item.

For full details about QRS Supplements to SDTMIG, visit https://www.cdisc.org/foundational/qrs.

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Metadata for these the QRS supplements loaded in CDISC Library are listed below, with short name (--CAT) in parentheses:

Loaded 2021-06-28

  • 6 Minute Walk Test Supplement v1.0 (SIX MINUTE WALK)
  • Clinical Global Impression Supplement v2.1 (CGI) 
  • Patient Global Impression Supplement v1.1 (PGI)

A separate maintenance release after 2021-06-28 will include:

  • Combat Exposure Scale (CES)
    • Eastern Cooperative Oncology Group Performance Status (ECOG

    Loaded 2022-06-27

    • Abnormal Involuntary Movement Scale Supplement v2.0 (AIMS)
    • Acute Physiology and Chronic Health Evaluation II Supplement v1.0 (APACHE II)
    • Age, treatment with systemic antibiotics, leukocyte count, serum albumin, and serum creatinine as a measure of renal function Supplement v1.0 (ATLAS)
    • Hamilton Anxiety Rating Scale Supplement v2.1 (HAM-A)
    • Kurtzke Functional Systems Scores Supplement v2.0 (KFSS)
    • Karnofsky Performance Scale Supplement v2.0 (KPS SCALE)
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    In this short video is a walkthrough of how to access QRS metadata using the Data Standards Browser and download an Excel export.

    View file
    nameposting-clib-dsb-qrs.mp4
    height250

    ...

    --TESTCD = "

    CES0104

    AIMS0110 " --TEST = "

    CES01-Soldiers in Unit KIA, Wounded, MIA

    AIMS01-Patient Awareness Abn Movements "

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    --TESTCD = " AIMS0108 " --TEST = "AIMS01-Severity of Abnormal Movements "

    --TESTCD = "

    CES0103

    AIMS0109 " --TEST = "

    CES01-Ever Surrounded by the Enemy

    AIMS01-Incapacitation due Abn Movements   "

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    Expand
    titleWhy do you provide CT c-codes in the outputs?

    C-code refers to the concept identifier assigned by NCI EVS. For example, C135738 is the c-code assigned to term CGI, which is a member of the QSCAT codelist. CT submission values and other textual attributes may change from publication to publication. Moreover, the use of root codelists and terms in the API response provide users maximum flexibility for choosing an appropriate CT package, i.e., by following the hypermedia links . to the desirable quarterly CT publication.

    Expand
    titleDoes CDISC Library contain QRS responses?

    Yes. Response codelists and terms are new additions to the SDTM CT package, starting in Q2 2021 publication. This set of CT will be integrated into applicable QRS instruments.

    Note that , not all QRS instruments have response codelists, such as CGI. Therefore, /mdr/qrs/instruments/CGI02/versions/2-1/responseGroups will produce an HTTP 404 error.

    Also note that , not all items within a QRS instrument have response codelists. For example, an item's value domain may be just a discrete numerical value (or, a write-in number). SIX MINUTE WALK is a prime example.

    Expand to see details...

    --TESTCD = " AIMS0101 " --TEST = " AIMS01-Muscles of Facial Expression "

    --TESTCD = " AIMS0102 " --TEST = "AIMS01-Lips and Perioral Area"

    --TESTCD = " AIMS0103 " --TEST = "AIMS01-Jaw"

    --TESTCD = "

    CES0101

    AIMS0104 " --TEST = "

    CES01-Ever Combat Patrols/Dangerous Duty

    AIMS01-Tongue"

    -

    -ORRES

    -TESTCD = " AIMS0105 " --TEST = "AIMS01-Upper Extremities"

    --TESTCD = " AIMS0106 " --TEST = "AIMS01-Lower Extremities"

    --TESTCD = "

    CES0102

    AIMS0107 " --TEST = "

    CES01-Were You Ever Under Enemy Fire

    AIMS01-Neck, Shoulders, Hips"

    Expand
    titleWhat is a response group?

    In the CDISC Library API for QRS, users can find endpoints dedicated to response groups. Response groups are unique sets of responses in a given QRS instrument and version. Take CES01 v1 AIMS Supplement v2.0 for example: . This version of CES the AIMS Supplement has 7 12 items. Each Each of the first four items has a unique seven items share one common set of responses . The next three and the eighth and ninth items share one a common set of responses. Therefore, CES01 v1.0 has a total of 5 response groups  The tenth item, AIMS0110, has a unique set of responses, and the last two items, AIMS0111 and 12, share a common set of responses.

    CDISC Library matches the correct response group to each item.

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    title

    --STRESC

    No1
    1-3 times2
    4-12 times3
    13-50 times4
    51+ times5

    --ORRES

    --STRESC

    Never

    None0
    Minimal, may be extreme normal1
    <1 month
    Mild2
    1-3 months
    Moderate3
    4-6 months
    Severe4
    7+ months5

    --ORRES

    --STRESC

    No

    None, Normal0
    Minimal1
    1-2 times
    Mild2
    3-12 times
    Moderate3
    13-25 times
    Severe4
    26+ times5

    --ORRES

    --STRESC

    None

    No awareness0
    Aware, no distress1
    1-25%
    Aware, mild distress2
    26-50%
    Aware, moderate distress3
    51-75%
    Aware, severe distress4
    76% or more5

    --TESTCD = "

    CES0105

    AIMS0111 " --TEST = "

    CES01-How Often Fire Rounds at Enemy

    AIMS01-Current Problems Teeth/Dentures "

    --TESTCD = "

    CES0106

    AIMS0112 " --TEST = "

    CES01-See Someone Hit by Rounds

    AIMS01-Patient Usually Wear Dentures "

    --

    TESTCD = " CES0107 " --TEST = " CES01-In Danger of Being Injured/Killed "--

    ORRES

    --STRESC

    Never
    No0
    1
    Yes1
    -2 times23-12 times313-50 times451+ times
    5

    Note that, when accessing this via the API, an HTTP error will be returned when a version of QRS instrument does not contain any response groups.

    Expand
    titleIs QRS metadata available in the Data Standards Browser?

    Yes. In the Data Standards Browser, users can find QRS instruments arranged by their category, i.e., Clinical Classification (CC), Functional Test (FT), and Questionnaire (QS).

    Expand
    titleCan I export a QRS instrument to Excel?

    Yes. Users can export a QRS instrument from CDISC Library to Excel. The multi-tabbed layout is designed to show relationships from an instrument, to items, and finally to responses. It also aims to provide linkages between published terms across multiple codelists. This metadata can be helpful for CRF building, data mapping, and other data tasks. For details, users can find a Read Me in an Excel export.

    To obtain an Excel export, users can either use the Export button on the Data Standard Browser. Or, or specify Excel media type at the top-level QRS endpoint. An example for CGI02 v2.1, in cURL:

    Code Block
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    curl -X GET \
  https://library.cdisc.org/api/mdr/qrs/instruments/CGI02/versions/2-1 \
  --header 'api-key: abcdef0123456789abcdef0123456789'
  -H 'Accept: application/vnd.ms-excel'
    Expand
    titleAre QRS Supplements to ADaMIG (ADQRS) part of CDISC Library?

    CDISC will be working with the ADQRS team to formalize the metadata. Further details will be furnished.