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Comment: Updated due to FDA feedback
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Title

Asthma Daytime Symptom Diary V1.0 (ADSD V1.0)

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

ADSD V1.0

QRS Permission StatusApproved
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.0
StatusFinal
Date20212024-1205-0809
Notes
  • This supplement is
intended
  • available to be used with other CDISC user guides
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    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. (COA #000006, Qualified Clinical Outcome Assessments (COA) | FDA) 


Revision History

DateVersion
20212024-1205-08091.0 Final

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

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

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

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(QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

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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

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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

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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. 

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

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to assess self-reported severity of asthma symptoms during the day. Each item is rated on an 11-point numeric rating scale. A total An overall score is also represented as described in the manualdescribed in the manual. Please refer to the user manual for instructions on how to calculate the overall score.

  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 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, "since you got up this morning" (QSEVINTX = "SINCE GETTING UP THIS MORNING
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    ").
  3. The ADSD The ADSD V1.0 instrument includes a total 0 instrument includes a overall score

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    that is considered is considered as captured data on the CRFinstrument
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    and is not considered as derived in the example below. These scores may be submitted in SDTM orand
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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 a central provider or vendor or derived by the 
    3. 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).

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    4. If scores are received by the sponsor,
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      it is recommended that they are submitted to SDTM and 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.

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

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in the QS domain. This example shows the self-reported data for 2 subjects collected at the baseline visit 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 instrument as well as the total overall score. Rows 8-14 show the 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 Since this is daily diary data, the date is known and is included in QSDTC for when the visit would have occurred.was planned.

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Dataset wrap
Nameqs
Dataset2
RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSSTATQSLOBXFLVISITNUMQSDTCQSEVINTX
1STUDYXQS2324-P00011ADSD0101ADSD01-Rate Breathing at Its WorstADSD V1.0666
Y12015-05-15

SINCE GETTING UP THIS MORNING

2STUDYXQS2324-P00012ADSD0102ADSD01-Rate Wheezing at Its WorstADSD V1.0None00
Y12015-05-15SINCE GETTING UP THIS MORNING
3STUDYXQS2324-P00013ADSD0103ADSD01-Rate Shortness of Breath at WorstADSD V1.0333
Y12015-05-15SINCE GETTING UP THIS MORNING
4STUDYXQS2324-P00014ADSD0104ADSD01-Rate Chest Tightness at Its WorstADSD V1.0222
Y12015-05-15SINCE GETTING UP THIS MORNING
5STUDYXQS2324-P00015ADSD0105ADSD01-Rate Chest Pain at Its WorstADSD V1.0555
Y12015-05-15SINCE GETTING UP THIS MORNING
6STUDYXQS2324-P00016ADSD0106ADSD01-Rate Cough at Its WorstADSD V1.0As bad as you can imagine1010
Y12015-05-15SINCE GETTING UP THIS MORNING
7STUDYXQS2324-P00017ADSD0107ADSD01-Total Score
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ADSD V1.04.3
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4.34.3
Y12015-05-15SINCE GETTING UP THIS MORNING
8STUDYXQS2324-P00201ADSD0101ADSD01-Rate Breathing at Its WorstADSD V1.0


NOT DONE
12015-05-17


9STUDYXQS2324-P00202ADSD0102ADSD01-Rate Wheezing at Its WorstADSD V1.0


NOT DONE
12015-05-17
10STUDYXQS2324-P00203ADSD0103ADSD01-Rate Shortness of Breath at WorstADSD V1.0


NOT DONE
12015-05-17
11STUDYXQS2324-P00204ADSD0104ADSD01-Rate Chest Tightness at Its WorstADSD V1.0


NOT DONE
12015-05-17
12STUDYXQS2324-P00205ADSD0105ADSD01-Rate Chest Pain at Its WorstADSD V1.0


NOT DONE
12015-05-17
13STUDYXQS2324-P00206ADSD0106ADSD01-Rate Cough at Its WorstADSD V1.0


NOT DONE
12015-05-17
14STUDYXQS2324-P00207ADSD0107ADSD01-Total ScoreADSD V1.0


NOT DONE
12015-05-17

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.

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