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Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title


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


CDISC ReferenceQuestionnaire Supplement 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 Version1.1
StatusREVISION DRAFT
Date2019-12-02
NotesThis 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.


Revision History

DateVersionSummary of Changes
2019-12-021.1 Revision Draft
  • Converted the supplement to the current WIKI QRS supplement template.
  • Added the assumption 2 on using the QSEVINTX variable and added it to the example.
  • Added the assumption 3 on the inclusion of subtotal and total scores as Electronic Data Transfer (eDT).
  • Added assumption 5 regarding the need for a record of reach day of the study. The example was updated with a 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.
2016-03-241.0

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

© 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 (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. 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 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 enenibg of data capture 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.

We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.


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.

qs.xpt

qs.xpt

RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNQSSTATQSREASNDVISITNUMQSDTCQSEVINTX
1STUDYXQSP00011EXACT101EXACT1-Chest Feel CongestedEXACTSlightlySlightly    2012-11-16EVERY EVENING BEFORE BEDTIME
2STUDYXQSP00012EXACT102EXACT1-How Often CoughEXACTFrequentlyFrequently    2012-11-16EVERY EVENING BEFORE BEDTIME
3STUDYXQSP00013EXACT103EXACT1-Bring Up Mucus When CoughingEXACTA littleA little    2012-11-16EVERY EVENING BEFORE BEDTIME
4STUDYXQSP00014EXACT104EXACT1-Difficult to Bring Up MucusEXACTModeratelyModerately    2012-11-16EVERY EVENING BEFORE BEDTIME
5STUDYXQSP00015EXACT105EXACT1-Chest DiscomfortEXACTModerateModerate    2012-11-16EVERY EVENING BEFORE BEDTIME
6STUDYXQSP00016EXACT106EXACT1-Chest Feel TightEXACTSlightlySlightly    2012-11-16EVERY EVENING BEFORE BEDTIME
7STUDYXQSP00017EXACT107EXACT1-BreathlessEXACTSlightlySlightly    2012-11-16EVERY EVENING BEFORE BEDTIME
8STUDYXQSP00018EXACT108EXACT1-Describe How BreathlessEXACTBreathless during light activityBreathless during light activity    2012-11-16EVERY EVENING BEFORE BEDTIME
9STUDYXQSP00019EXACT109EXACT1-Short Breath Personal CareEXACTSeverelySeverely    2012-11-16EVERY EVENING BEFORE BEDTIME
10STUDYXQSP000110EXACT110EXACT1-Short Breath Indoor ActivitiesEXACTModeratelyModerately    2012-11-16EVERY EVENING BEFORE BEDTIME
11STUDYXQSP000111EXACT111EXACT1-Short Breath Outside ActivitiesEXACTExtremelyExtremely    2012-11-16EVERY EVENING BEFORE BEDTIME
12STUDYXQSP000112EXACT112EXACT1-Tired or WeakEXACTSlightlySlightly    2012-11-16EVERY EVENING BEFORE BEDTIME
13STUDYXQSP000113EXACT113EXACT1-Night Sleep DisturbedEXACTNot at allNot at all    2012-11-16EVERY EVENING BEFORE BEDTIME
14STUDYXQSP000114EXACT114EXACT1-Worried About Lung ProblemsEXACTSlightlySlightly    2012-11-16EVERY EVENING BEFORE BEDTIME
15STUDYXQSP000115EXACT101EXACT1-Chest Feel CongestedEXACTSlightlySlightly NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
16STUDYXQSP000116EXACT102EXACT1-How Often CoughEXACTFrequentlyFrequently NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
17STUDYXQSP000117EXACT103EXACT1-Bring Up Mucus When CoughingEXACTA littleA little NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
18STUDYXQSP000118EXACT104EXACT1-Difficult to Bring Up MucusEXACTModeratelyModerately NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
19STUDYXQSP000119EXACT105EXACT1-Chest DiscomfortEXACTModerateModerate NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
20STUDYXQSP000120EXACT106EXACT1-Chest Feel TightEXACTSlightlySlightly NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
21STUDYXQSP000121EXACT107EXACT1-BreathlessEXACTSlightlySlightly NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
22STUDYXQSP000122EXACT108EXACT1-Describe How BreathlessEXACTBreathless during light activityBreathless during light activity NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
23STUDYXQSP000123EXACT109EXACT1-Short Breath Personal CareEXACTSeverelySeverely NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
24STUDYXQSP000124EXACT110EXACT1-Short Breath Indoor ActivitiesEXACTModeratelyModerately NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
25STUDYXQSP000125EXACT111EXACT1-Short Breath Outside ActivitiesEXACTExtremelyExtremely NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
26STUDYXQSP000126EXACT112EXACT1-Tired or WeakEXACTSlightlySlightly NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
27STUDYXQSP000127EXACT113EXACT1-Night Sleep DisturbedEXACTNot at allNot at all NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
28STUDYXQSP000128EXACT114EXACT1-Worried About Lung ProblemsEXACTSlightlySlightly NOT DONENO RESPONSE COLLECTED 2012-11-17EVERY EVENING BEFORE BEDTIME
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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"

QSORRES

QSSTRESC

QSSTRESN

Not at allNot at all
SlightlySlightly
ModeratelyModerately
SeverelySeverely
ExtremelyExtremely

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

QSORRES

QSSTRESC

QSSTRESN

Not at allNot at all
RarelyRarely
OccasionallyOccasionally
FrequentlyFrequently
Almost constantlyAlmost constantly

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

QSORRES

QSSTRESC

QSSTRESN

None at allNone at all
A littleA little
SomeSome
A great dealA great deal
A very great dealA very great deal

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

QSORRES

QSSTRESC

QSSTRESN

Not at allNot at all
SlightlySlightly
ModeratelyModerately
Quite a bitQuite a bit
ExtremelyExtremely

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

QSORRES

QSSTRESC

QSSTRESN

Not at allNot at all
SlightSlight
ModerateModerate
SevereSevere
ExtremeExtreme

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

QSORRES

QSSTRESC

QSSTRESN

Unaware of breathlessnessUnaware of breathlessness
Breathless during strenuous activityBreathless during strenuous activity
Breathless during light activityBreathless during light activity
Breathless when washing or dressingBreathless when washing or dressing
Present when restingPresent when resting

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

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

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

QSORRES

QSSTRESC

QSSTRESN

Not at allNot at all
SlightlySlightly
ModeratelyModerately
SeverelySeverely
ExtremelyExtremely
Too breathless to do theseToo breathless to do these

End of Document

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