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

1 Introduction

This document describes the CDISC implementation of the 

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

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.

The Evaluating Respiratory Symptoms (E-RS^™) in COPD (E-RS^™: COPD) scale is part of the EXACT instrument.  It is comprised of 11 items (of the 14-item EXACT) which provide information specific to respiratory symptoms in stable COPD. The E-RS: COPD is not administered separately from the EXACT.  For this reason, a separate SDTM questionnaire supplement for the E-RS: COPD will not be developed. 

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

The representation of data collected for this questionnaire 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 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/foundational/qrs.

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

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

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 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.

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 

3 The QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS domain are applicable to this supplement. Additional assumptions specific to the EXACT are listed below.

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. 

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 subtotals or a total score on the CRF. 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. Subtotal 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.

   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.

3.2 Example for the EXACT QS Domain Model

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 1 evening of 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. This result is also represented as the standard character representation in QSSTRESC.

The table represents the items from the EXACT form. Rows 15 - 28 represent a day in which no responses 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.

QSTESTCD = "EXACT101" QSTEST = "EXACT1-Chest Feel Congested"

QSTESTCD = "EXACT106" QSTEST = "EXACT1-Chest Feel Tight"

QSTESTCD = "EXACT107" QSTEST = "EXACT1-Breathless"

QSTESTCD = "EXACT112" QSTEST = "EXACT1-Tired or Weak"

QSTESTCD = "EXACT113" QSTEST = "EXACT1-Night Sleep Disturbed"

QSTESTCD = "EXACT114" QSTEST = "EXACT1-Worried About Lung Problems"

QSTESTCD = "EXACT102" QSTEST = "EXACT1-How Often Cough"

QSTESTCD = "EXACT103" QSTEST = "EXACT1-Bring Up Mucus When Coughing"

QSTESTCD = "EXACT104" QSTEST = "EXACT1-Difficult to Bring Up Mucus"

QSTESTCD = "EXACT105" QSTEST = "EXACT1-Chest Discomfort"

QSTESTCD = "EXACT108" QSTEST = "EXACT1-Describe How Breathless"

QSTESTCD = "EXACT109" QSTEST = "EXACT1-Short Breath Personal Care"

QSTESTCD = "EXACT110" QSTEST = "EXACT1-Short Breath Indoor Activities"

QSTESTCD = "EXACT111" QSTEST = "EXACT1-Short Breath Outside Activities"

End of Document