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Comment: changed "since the patient went to bed the previous night" back to "since you went to bed last night" and quoted it to show it was from the CRF and manual. Upper-cased "if" in 3b. Changed "The following ANSD V1.0 example" back to "The ANSD V10 example below" per the QRS template.

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Page properties


Title

Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0)

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

ANSD V1.0

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusFinal
Date2021-1112-3008
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.
  • This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument.


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Revision History

DateVersion
2021-1112-30081.0 Final

© 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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  • Gater A, Nelsen L, Fleming S, Lundy J.J, Bonner N, Hall R, Marshall C, Staunton H, Krishnan JA, Stoloff S, Schatz M, Haughney J on behalf of the Patient-Reported Outcome Consortium’s Asthma Working Group. Assessing asthma symptoms in adolescents and adults: qualitative research supporting development of the Asthma Daily Symptom Diary. Value in Health 2016; 19:440-450).
  • Patient-Reported Outcome (PRO) Consortium - Asthma Daytime Symptom Diary (ADSD) and Asthma Nighttime Symptom Diary (ANSD) User Manual, Version 1.0: March 30, 2019.

3 TheQSDomain Model

3.1 Assumptions for theQSDomain Model

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  1. The scale points include a 0 to 10 rating with 0 = "None", 10 = "As bad as you can imagine", and all points in between only having a numeric value. For the ANSD V1.0, QSORRES is populated with the text description for "None" and "As bad as you can imagine" and the numeric value for all other answers, while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

  2. The time period of evaluation for the ANSD V1.0 is populated in the QSEVINTX the QSEVINTX when the evaluation interval can be precisely described as duration. The evaluation interval for the ANSD V1.0 is since the patient 0 is, "since you went to bed the previous last night" (QSEVINTX = "SINCE GOING TO BED").

  3. The ANSD V1.0 instrument includes a total score that is considered as captured data on the CRF and is 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 from the user manual.

    1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables).

    2. if If scores are received by the sponsor, it is recommended that they are submitted to SDTM and SDTM and verified in ADaM.

  4. Terminology

    1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the ANSD V1.0 QS Domain Model

The following ANSD V1.0 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 2 subjects collected at the baseline visit for the ANSD V1.0 instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES. This result is then transformed into the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.

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