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© 2019 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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This document describes the CDISC implementation of the Exacerbations of Chronic Pulmonary Disease Tool (EXACT^®) - Patient-Reported Outcome  questionnaireOutcome (EXACT) instrument.

The EXACT questionnaire/daily diary that is used in clinical trials to provide a measure of patient-reported symptoms of Chronic Obstructive Pulmonary Disease (COPD) exacerbations.

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The representation of data collected for this questionnaire is instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Questionnaires (QS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

These specific implementation details for this questionnaire are instrument are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

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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 questionnaire. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument consists 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 (https://wiki.cdisc.org/download/attachments/92796580/EXACT%20Annotated%20CRF.pdf?api=v2). . 

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges principal author Nancy K. Leidy, EXACT-PRO Initiative, Evidera, for the approval to include the EXACT in the CDISC data standards.

Reference for the Exacerbations of Chronic Pulmonary Disease Tool (EXACT^®) - Patient-Reported Outcome:

Nancy K. Leidy, EXACT-PRO Initiative, Evidera, 7101 Wisconsin Avenue, Suite 1400, Bethesda, MD; EXACT copyright 2013, Evidera, Inc. All rights reserved). This also includes the subset EXACT-Respiratory Symptoms (E-RS) questions. http://www.exactproinitiative.com 

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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 CRF does not include 3 raw  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. The E, 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 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 itemsitemss. 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. 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).

   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. 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.

   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 --STAT=“NOT DONE” and --REASND=reason provided (e.g., “PREFER NOT TO ANSWER”).
      3. If the reason for the not done record is unknown, then the reason is that the response was not collected (--STAT=“NOT DONE” and --REASND=“NO RESPONSE COLLECTED”).

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 EXACT example below shows the terminology used to implement the instrument in the QS domain. This example shows the data for 1 subject collected at for at 1 evening of diary data capture and an additional evening in which no responses were captured on the EXACT instrument. The example uses CDISC Controlled Terminology for QSTESTCD, QSTEST, and QSCAT. All original results are represented with preferred terminology in QSORRES QSORRES. This result is also represented as the standard character representation in QSSTRESC.

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

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