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© 2021 2024 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

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

CDISC does did not modify this questionnaires, ratings, and scales

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain 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 data that has been collected in a database, not what should be collected or how to conduct clinical assessments or implement protocols

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

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 .

 NoteNote: 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 the Critical Path Institute for the approval to include the ADSD V1.0 in the CDISC data standards.

References for the ADSD V1.0:

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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; 919:440-450).
  
• 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 SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the ADSD V1.0 are listed below.

The ADSD V1.0 is a 6-item patient diary PRO measure

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 ADSD 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 ADSD V1.0 is populated in the the QSEVINTX when the as an evaluation interval can text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the ADSD V1.0  is is, "since you got up this morning" (QSEVINTX = "SINCE GETTING UP THIS MORNING

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   ").

3. The The ADSD V1.0   instrument includes  a overall scorea total score that is not collected on the ADSD v1.0 CRF but is described in the manual

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   , that is is considered as captured data on the CRF instrument

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   and is not considered as derived in the example below.
   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 written on a CRF will be considered a captured score and not flagged. When subtotal and total scores

   These scores may be submitted in SDTM and

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   derived in the Analysis Data Model (ADaM) per scoring instructions from the user manual.
   1. The overall score is represented in--ORRES, --STRESC, and --STRESN.
   2. If the overall score is received or derived by 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)or derived by the sponsor,

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      it is recommended that they are submitted to SDTM and verified in ADaM. It is the sponsors responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.

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 ADSD V1.0 QS Domain Model

The ADSD V1.0 example below shows the terminology used to implement the instrument

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.

The table represents the items from the ADSD V1.0 instrument instrument as well as the total overall score. Rows 8-14 show how to represent data when the entire instrument was not done due to the subject refusing the test.the subject was not evaluated on this instrument at visit 1. Since this is daily diary data, the date is known and is included in QSDTC for when the visit was planned.

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="ADSD0101" QSTEST="ADSD01-Rate Breathing at Its Worst" through

QSTESTCD="ADSD0106" QSTEST="ADSD01

End of Document