Revision History

© 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

This document describes the CDISC implementation of the Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0) instrument.

CDISC did not modify this questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards. QRSSUPP-672 - Getting issue details... STATUS

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or implement protocols QRSSUPP-674 - Getting issue details... STATUS . CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument. 

2 Copyright Status

The Critical Path Institute QRSSUPP-675 - Getting issue details... STATUS owns the copyright for the ANSD V1.0 instrument and has granted CDISC permission to include this supplement in the CDISC library of QRS data standards supplements.  Hence, CDISC developed QSTESTCD and QSTEST for each item based on the actual text on the instrument. 

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges the Critical Path Institute for the approval to include the ANSD V1.0 in the CDISC data standards.

References for the ANSD V1.0:

• 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 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the ANSD V1.0 are listed below.

The ANSD V1.0 is a 6-item patient diary PRO instrument QRSSUPP-676 - Getting issue details... STATUS to assess self-reported severity of asthma symptoms during the night. Each item is rated on an 11-point numeric rating scale. A total score is also represented as described in the manual.

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 QRSSUPP-677 - Getting issue details... STATUS for the ANSD V1.0 is populated in the QSEVINTX when the evaluation interval can be precisely described as duration. The evaluation interval for the ANSD V1.0 is, "since you went to bed last night" (QSEVINTX = "SINCE GOING TO BED").

3. The ANSD V1.0 instrument includes an overall score QRSSUPP-678 - Getting issue details... STATUS that is considered as captured data on the instrument and is not considered as derived QRSSUPP-679 - Getting issue details... STATUS in the example below. These scores may be submitted in SDTM or QRSSUPP-680 - Getting issue details... STATUS derived in the Analysis Data Model (ADaM) per scoring instructions from Critical Path Institute.

   1. Subscores and overall scores are represented in--ORRES, --STRESC, and --STRESN.
   2. If subscores or overall scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible. It is the sponsors responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner. QRSSUPP-682 - Getting issue details... STATUS

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 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 QRSSUPP-683 - Getting issue details... STATUS 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.

The table represents the items from the ANSD V1.0 QRSSUPP-684 - Getting issue details... STATUS  instrument as well as the total score. Rows 8-14 show the subject was not evaluated on this instrument at visit 1. Because the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

QSTESTCD="ANSD0101" QSTEST="ANSD01-Rate Breathing at Its Worst" through

QSTESTCD="ANSD0106" QSTEST="ANSD01-Rate Cough at Its Worst"

End of Document