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Title

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

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 Version2.0
StatusREVISION DRAFT
Date2021-08-1718
Notes
  • This 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.
  • This instrument is a US FDA Qualified Clinical Outcome Assessment (COA) instrument. 


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DateVersionSummary of Changes
2021-08-17182.0 Revision Draft
  • Converted the supplement to the current WIKI QRS supplement template.
  • Updated the title by adding the QSCAT value at the end (e.g., (EXACT).
  • Annotated CRF updated to the MSG V2.0 annotation guidelines
  • Added assumption 2 on using the QSEVINTX variable and added it to the example.
  • Added assumption 3 on the inclusion of 4 respiratory symptom raw and domain scores, a raw EXACT total and an EXACT total scores as described in the user manual.
  • Added assumption 5 regarding the need for a record of each day of the study. The example was updated with a diary day having no responses.
  • 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.
  • Updated the example to represent all 7 diary days related to VISITNUM = 1 to indicate the dairy days are planned observations with the QSDTC dates represented.
    • Revised the QSSTRESC and QSSTRESN values in the example and section 4 to values of "xxx" to represent numeric values based on the user manual describes on how these numeric values are represented.
2016-03-241.0

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

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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 the 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. The EXACT instrument is conducted as a diary with planned assessments between visits in which the subject reports the diary data to the investigator. To align the timing of the diary data to visits in a study, the foloowing timing varibles are used.
    1. VISITNUM (Visit Number) variable represents the visit number in which the subject's diary data was reported to the investigator. 
    2. QSDTC (Date/Time of Assessment Collection) variable represents the date the diary day information was recorded by the subject.
    3. QSTPT (Planned Time Point) variable represents timing of the planned diary day.
    4. QSTPTREF (Planned Timepoint Reference) variable represents the visit name the subject attends to return the diary data.
    5. QSRFTDTC (Date/Time of the Reference Timepoint) variable represents the visit date the subject returned diary data.
    6. QSEVLINT QSEVINTX (Evaluation Interval Text) variable represents the evaluation interval timing for the diary information.
  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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