Versions Compared

Old Version 9

changes.mady.by.user Steve Kopko

Saved on

compared with

New Version 10

changes.mady.by.user Steve Kopko

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Page properties


Title


Exacerbations of Chronic Pulmonary Disease Tool (EXACT®) - Patient-Reported Outcome


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

EXACT

QRS Permission StatusApproved
TeamCOPD Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version1.1
StatusREVISION DRAFT
Date2019-1112-2702
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.


...

DateVersionSummary of Changes
2019-1112-27021.1 Revision Draft
  • Converted the supplement to the current WIKI QRS supplement template.
  • Added the assumption on using the QSEVINTX variable and added it to the example.
  • Added the assumption on the inclusion of subtotal and total scores as Electronic Data Transfer (eDT). Need to review with Dana to potentially add these a new tests.
  • The QSEVAL assumption and variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.
2016-03-241.0

Final - Updated per Evidera instructions.  They have Trademarked trademarked the EXACT® and updated the name of the E-RS™: COPD.

...

  1. The scale points include a text rating (e.g., "Not at all", "Slightly", etc.). The E-RS (EXACT-Respiratory Symptoms)* USER MANUAL (Version 4.0) May 2015 that is provided upon user's receiving copyright permission provides the numeric scoring of the responses for the questions. Based on this being copyrighted, the numeric scores cannot be provided in this supplement. Upon receiving permission, sponsors may apply these numeric responses in their SDTM and ADaM datasets.  For this EXACT supplement, QSORRES and QSSTRESC is populated with the text description while the numeric rating is represented as missing in QSSTRESN.

  2. The time period of evaluation for the EXACT is populated in the QSEVINTX field. The evaluation interval for the EXACT is the past 7 days (QSEVLINT = "EVERY EVENING BEFORE BEDTIME") as represented on the CRF.

  3. The EXACT instrument includes instrument CRF does not include subtotals or a total score on the CRF, but the copyright holder provides software  information in a user manual to calculate these derived items. These items may be provided as part of Electronic Data Transfer (eDT) that are considered as captured data and not considered as derived in the example below.

    1. 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 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).

  4. VISITNUM is null at the time of publication of this document until CDISC develops guidance on how to consistently model timing information for daily diary instruments.
    1. The QSDTC variable contains the date/time the EXACT was completed by the subject and is used for the timing of this measure.

  5. Terminology

    1. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the result fields is provided in Section 4, SDTM Mapping Strategy.

...

Dataset wrap
Nameqs


Dataset2


RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNVISITNUMQSDTCQSEVINTX
1STUDYXQSP00011EXACT101EXACT1-Chest Feel CongestedEXACTSlightlySlightly  2012-11-16EVERY EVENING BEFORE BEDTIME
2STUDYXQSP00012EXACT102EXACT1-How Often CoughEXACTFrequentlyFrequently  2012-11-16EVERY EVENING BEFORE BEDTIME
3STUDYXQSP00013EXACT103EXACT1-Bring Up Mucus When CoughingEXACTA littleA little  2012-11-16EVERY EVENING BEFORE BEDTIME
4STUDYXQSP00014EXACT104EXACT1-Difficult to Bring Up MucusEXACTModeratelyModerately  2012-11-16EVERY EVENING BEFORE BEDTIME
5STUDYXQSP00015EXACT105EXACT1-Chest DiscomfortEXACTModerateModerate  2012-11-16EVERY EVENING BEFORE BEDTIME
6STUDYXQSP00016EXACT106EXACT1-Chest Feel TightEXACTSlightlySlightly  2012-11-16EVERY EVENING BEFORE BEDTIME
7STUDYXQSP00017EXACT107EXACT1-BreathlessEXACTSlightlySlightly  2012-11-16EVERY EVENING BEFORE BEDTIME
8STUDYXQSP00018EXACT108EXACT1-Describe How BreathlessEXACTBreathless during light activityBreathless during light activity  2012-11-16EVERY EVENING BEFORE BEDTIME
9STUDYXQSP00019EXACT109EXACT1-Short Breath Personal CareEXACTSeverelySeverely  2012-11-16EVERY EVENING BEFORE BEDTIME
10STUDYXQSP000110EXACT110EXACT1-Short Breath Indoor ActivitiesEXACTModeratelyModerately  2012-11-16EVERY EVENING BEFORE BEDTIME
11STUDYXQSP000111EXACT111EXACT1-Short Breath Outside ActivitiesEXACTExtremelyExtremely  2012-11-16EVERY EVENING BEFORE BEDTIME
12STUDYXQSP000112EXACT112EXACT1-Tired or WeakEXACTSlightlySlightly  2012-11-16EVERY EVENING BEFORE BEDTIME
13STUDYXQSP000113EXACT113EXACT1-Night Sleep DisturbedEXACTNot at allNot at all  2012-11-16EVERY EVENING BEFORE BEDTIME
14STUDYXQSP000114EXACT114EXACT1-Worried About Lung ProblemsEXACTSlightlySlightly  2012-11-16EVERY EVENING BEFORE BEDTIME




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.

...