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Title Asthma Nighttime Symptom Diary V1.0 (ANSD V1.0) CDISC Reference Questionnaire Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials QRS Short Name ANSD V1.0 QRS Permission Status Approved Team CDISC Questionnaires, Ratings, and Scales (QRS) Subteam Supplement Version 1.0 Status Final Date 20212024-1202-0809 Notes This supplement is intended available to be used with other CDISC user guides Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-673 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)

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

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

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

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The ANSD V1.0 is a 6-item patient diary PRO measureinstrument

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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

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   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 The ANSD V1.0 instrument includes a total 0 instrument includes an overall score

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   that is considered is considered as captured data on the CRF instrument and is not considered as derived

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   in the example below. These scores may be submitted in SDTM or

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   derived in the Analysis Data Model (ADaM) per scoring instructions from the user manual.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.If operationally defined by the sponsor,

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      681 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).
   3. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.

   4. 682

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 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

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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 instrument as 0

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 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.

Dataset wrap
Name qs
Dataset2 Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN QSSTAT QSLOBXFL VISITNUM QSDTC QSEVINTX 1 STUDYX QS 2324-P0001 1 ANSD0101 ANSD01-Rate Breathing at Its Worst ANSD V1.0 6 6 6 Y Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-685 1 2015-05-15 SINCE GOING TO BED 2 STUDYX QS 2324-P0001 2 ANSD0102 ANSD01-Rate Wheezing at Its Worst ANSD V1.0 None 0 0 Y 1 2015-05-15 SINCE GOING TO BED 3 STUDYX QS 2324-P0001 3 ANSD0103 ANSD01-Rate Shortness of Breath at Worst ANSD V1.0 3 3 3 Y 1 2015-05-15 SINCE GOING TO BED 4 STUDYX QS 2324-P0001 4 ANSD0104 ANSD01-Rate Chest Tightness at Its Worst ANSD V1.0 2 2 2 Y 1 2015-05-15 SINCE GOING TO BED 5 STUDYX QS 2324-P0001 5 ANSD0105 ANSD01-Rate Chest Pain at Its Worst ANSD V1.0 5 5 5 Y 1 2015-05-15 SINCE GOING TO BED 6 STUDYX QS 2324-P0001 6 ANSD0106 ANSD01-Rate Cough at Its Worst ANSD V1.0 As bad as you can imagine 10 10 Y 1 2015-05-15 SINCE GOING TO BED 7 STUDYX QS 2324-P0001 7 ANSD0107 ANSD01-Total Score Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-686 ANSD V1.0 4.3 Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-687 4.3 4.3 Y 1 2015-05-15 SINCE GOING TO BED 8 STUDYX QS 2324-P0020 1 ANSD0101 ANSD01-Rate Breathing at Its Worst ANSD V1.0 NOT DONE 1 9 STUDYX QS 2324-P0020 2 ANSD0102 ANSD01-Rate Wheezing at Its Worst ANSD V1.0 NOT DONE 1 10 STUDYX QS 2324-P0020 3 ANSD0103 ANSD01-Rate Shortness of Breath at Worst ANSD V1.0 NOT DONE 1 11 STUDYX QS 2324-P0020 4 ANSD0104 ANSD01-Rate Chest Tightness at Its Worst ANSD V1.0 NOT DONE 1 12 STUDYX QS 2324-P0020 5 ANSD0105 ANSD01-Rate Chest Pain at Its Worst ANSD V1.0 NOT DONE 1 13 STUDYX QS 2324-P0020 6 ANSD0106 ANSD01-Rate Cough at Its Worst ANSD V1.0 NOT DONE 1 14 STUDYX QS 2324-P0020 7 ANSD0107 ANSD01-Total Score ANSD V1.0 NOT DONE 1

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