Page History

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Evidera, Inc. owns the copyright for the EXACT 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 questionnairethe 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. 

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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 must apply these numeric responses in their SDTMIG and ADaM datasets. For this EXACT supplement, QSORRES is populated with the text description while the numeric rating is represented as "xxx" in QSSTRESC and QSSTRESN.

2. The time period of evaluation for the EXACT is populated in the QSEVINTX field. The evaluation interval for the EXACT is in 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 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 items. 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. Timing of the EXACT Instrument Diary Collection

   1. The QRS EXACT instrument diary or manual describes that it is a self-administered daily diary, completed by respondents each evening before bedtime. There is no further information provided with the necessary timing information needed to align the timing to the CDISC QRS domain variables. Any additional information regarding the timing of the diary capture should be described in a protocol.
   2. The following CDISC timing variables represent the EXACT collection timing.
      1. VISITNUM variable is represented as a null value since sponsors have different methods operating procedures to assign visit information relative to diary collection.
         1. QSDTC variable represents the date/time the diary information was collected by the subject and is used for the timing of this measure.
         2. QSEVINTX variable represent the evaluation interval text timing described on the instrument relative to diary collection.
5. As described in the user manual, where no diary entry exists for a given day, create a record in the data file dataset for that daycollection date. Each day a patient is followed in the study must have a record for the day. For these missing diary days, a records record is created for each question item with QSORRES, QSSTRESC and QSSTRESN are QSSTRESN represented with missing values and QSSTAT = "NOT DONE". If a reason for not collecting an item is collected, it is represneted represented 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 knowncollected, then QSSTAT=“NOT DONE” and QSREASND=reason provided (e.g., “PREFER NOT TO ANSWER”). If a reason for the not done record is not providedcollected, 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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The table represents the items from the EXACT instrument. Rows . The timing of diary collection is explained in assumption 4. Rows 15 - 22 represent the bedtime day -7 raw08-Nov-2012 diary collected raw, domain, and EXACT total scores as described in assumption 3 above. These are also represented for each additonal diary daycollection date. The subject did not fill out the EXACT at bedtime day -6 dairy day and the observations on this day are represented as described in assumption 3 abovediary on 09-Nov-2012 and no reason for not collecting the diary was provided. Since the reason for not completing the assessments was not collected, no collection date is assumed for when the diary collection would have occurred. The remaining diary day information collection follows the same pattern of information thru the completion of the dairy.

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