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1. The scale points include a text rating (e.g., "Not at all", "Slightly", etc.). 

   1. 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 (QSEVINTX = "EVERY EVENING BEFORE BEDTIME") as represented on the CRF.

3. The EXACT instrument includes 3 raw and domain respiratory symptom scores, a raw total score, and an EXACT total score that are not represented on the CRF, but described in the user manual, that are considered as captured data and is not considered as derived in the example below. These scores may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from the usewr user manual. The E-RS (EXACT-Respiratory Symptoms)* USER MANUAL (Version 4.0) May 2015 that is provided upon user's receiving copyright permission provides information to calculate these itemssitems. The EXACT raw total score is computed across the 14 items and then transformed via a table lookup to obtain the EXACT total score that has a theoretical range of 0 to 100. Three raw respiratory symptom scores are also computed for: Breathlessness, Cough & Sputum, and Chest Symptoms. These raw respiratory scores are transformed via a table lookup to obtain the respiratory symptom domain scores that have a theoretical range of 0 to 100.  

   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 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).

   2. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.
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. As described in the user manual, where no diary entry exists for a given day, create a record in the data file for that day. Each day a patient is followed in the study must have a record for the day. For these missing diary days, a records is created for each question with QSORRES, QSSTRESC and QSSTRESN are represented with missing values and QSSTAT = "NOT DONE". If a reason for not collecting an item is collected, it is represneted in the QSREASND variable. Collecting this reason would be a good practice, but is not specfically described in the manual.

   1. “Presence of Data” items missing data rule:

      1. A record is created in qs.xpt for all items.
      2. If the reason for the not done record is known, then QSSTAT=“NOT DONE” and QSREASND=reason provided (e.g., “PREFER NOT TO ANSWER”). If a reason for the not done record is not provided, the QSREASND variable is not populated,

6. 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.

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Example with numeric scores as described in the manual if the subteam thinbks this can be included based on the best practice of incuding numeric scores defined in a manual

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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QSTESTCD = "EXACT113" QSTEST = "EXACT1-Night Sleep Disturbed"

QSTESTCD = "EXACT102" QSTEST = "EXACT1-How Often Cough"

QSTESTCD = "EXACT103" QSTEST = "EXACT1-Bring Up Mucus When Coughing"

QSTESTCD = "EXACT104" QSTEST = "EXACT1-Difficult to Bring Up Mucus"

QSTESTCD = "EXACT105" QSTEST = "EXACT1-Chest Discomfort"

QSTESTCD = "EXACT108" QSTEST = "EXACT1-Describe How Breathless"

QSTESTCD = "EXACT109" QSTEST = "EXACT1-Short Breath Personal Care"

QSTESTCD = "EXACT110" QSTEST = "EXACT1-Short Breath Indoor Activities"

QSTESTCD = "EXACT111" QSTEST = "EXACT1-Short Breath Outside Activities"

QSTESTCD = "EXACT114" QSTEST = "EXACT1-Worried About Lung Problems"

End of Document