Versions Compared

Old Version 33

changes.mady.by.user Diane Corey

Saved on

compared with

New Version 34

changes.mady.by.user Steve Kopko

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

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
Date2021-05-0617
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.


...

Revision History

DateVersion
2021-05-63171.0

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

...

  • 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

...

The ANSD V1.0 example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject 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.

...