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© 2021 2022 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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Instructions for scoring the EXACT and E-RS: COPD, done during analysis of a clinical trial, can be found in the user manuals provided from the copyright holder when copyright use permission is obtained. Both measures will have ADaM QRS Supplements explaining the scoring and total of the results based on the user manual.

CDISC does did not modify this questionnaires, ratings, and scales (QRS) instruments instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

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The EXACT is a multiple-choice self-administered daily diary completed by respondents 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. Instructions for electornic electronic data capture are described in the user manual.

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 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 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 dataset for that collection date. Each day a patient is followed in the study must have a record for the day. For these missing diary days, a record is created for each item with QSORRES, QSSTRESC and QSSTRESN represented with missing values and QSSTAT = "NOT DONE". If a reason for not collecting an item is collected, it is represented in the QSREASND variable. Collecting this reason would be a good practice, but is not specfically specifically 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 collected, then QSSTAT=“NOT DONE” and QSREASND=reason provided (e.g., “PREFER NOT TO ANSWER”). If a reason for the not done record is not collected, 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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