Revision History
| Date | Version |
|---|---|
| 2024-05-09 | 1.0 Final |
© 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 (ADSD V1.0) instrument.
CDISC did not modify this questionnaires, ratings, and scales QRSSUPP-650 - Getting issue details... STATUS (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.
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-651 - 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-652 - Getting issue details... STATUS owns the copyright for the ADSD 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 ADSD V1.0 in the CDISC data standards.
References for the ADSD 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 ADSD V1.0 are listed below.
The ADSD V1.0 is a 6-item patient diary PRO measure QRSSUPP-653 - Getting issue details... STATUS to assess self-reported severity of asthma symptoms during the day. Each item is rated on an 11-point numeric rating scale. An overall score is also represented as described in the manual. Please refer to the user manual for instructions on how to calculate the overall score.
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.
- The time period of evaluation for the ADSD V1.0 is populated in the QSEVINTX as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the ADSD V1.0 is, "since you got up this morning" (QSEVINTX = "SINCE GETTING UP THIS MORNING QRSSUPP-654 - Getting issue details... STATUS ").
The ADSD V1.0 instrument includes a overall score QRSSUPP-655 - Getting issue details... STATUS that is considered as captured data on the instrument QRSSUPP-656 - Getting issue details... STATUS and is not considered as derived in the example below. These scores may be submitted in SDTM and QRSSUPP-658 - Getting issue details... STATUS derived in the Analysis Data Model (ADaM) per scoring instructions from the user manual.
- The overall score is represented in--ORRES, --STRESC, and --STRESN.
- If the overall score is received or derived by a central provider or vendor or derived by the sponsor, QRSSUPP-659 - Getting issue details... STATUS 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.
Terminology
QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.
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 QRSSUPP-660 - Getting issue details... STATUS in the QS domain. This example shows the self-reported data for 2 subjects collected for the ADSD V1.0 instrument. VISITNUM in this data represents the day the subject reported data. The baseline visit is the first day they record data prior to any treatment. 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 ADSD V1.0 instrument as well as the overall score. Rows 8-14 show 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. QRSSUPP-661 - Getting issue details... STATUS
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-Rate Cough at Its Worst"
| QSORRES | QSSTRESC | QSSTRESN |
| None | 0 | 0 |
| 1 | 1 | 1 |
| 2 | 2 | 2 |
| 3 | 3 | 3 |
| 4 | 4 | 4 |
| 5 | 5 | 5 |
| 6 | 6 | 6 |
| 7 | 7 | 7 |
| 8 | 8 | 8 |
| 9 | 9 | 9 |
| As bad as you can imagine | 10 | 10 |
End of Document
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