...

...

The EXACT is a multiple-choice questionnaire that clinicians may use to measure of patient-reported symptoms of Chronic Obstructive Pulmonary Disease (COPD) exacerbations. It consists of 14 items, each rated on a 5-point or 6-point scale depending on the question. These items together provide information on the frequency, severity and duration of symptom-defined exacerbations.  The E-RS: COPD uses 11 of these 14 items to evaluate respiratory symptoms of COPD. The copyright holder provides software to derive A total score between 0-84 is also captured. 

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.

     

   1.  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 CRF does not include subtotals or a total score on the CRF, but the copyright holder provides information in a user manual to calculate these items. The EXACT Total score is computed across the 14 items . 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 Total score is computed across the 14 items and has a theoretical range of 0 to 100. Subscores scores are also computed for: Breathlessness, Cough & Sputum, and Chest Symptoms. These subscores also range from 0 to 100. 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. 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. QSSTAT = "NOT DONE" and QSREASND = "NO RESPONSE COLLECTED" to note that these records did not capture any data.

6. Terminology

   1. QSCAT, QSTESTCD, and QSTEST values are included

   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.

...

The table represents the items from the EXACT form. Rows 15 - 28 represent a day in whihc no resoonses were collected, which is based on assumption 5 above.

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.

...