...

Revision History

© 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.

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 (attach QRS instrument here). 

© 2022 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 (PRO) (EXACT) instrument.

The Evaluating Respiratory Symptoms (E-RS^™) in COPD (E-RS^™:COPD) scale is part of the EXACT instrument. It comprises 11 items (of the 14-item EXACT) which provide information specific to respiratory symptoms in stable chronic obstructive pulmonary disease (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. 

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 Analysis Data Model (ADaM) QRS supplements explaining the scoring and total of the results based on the user manual.

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

The representation of data collected for this 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: 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.

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

Rush, A.J., Carmody, T. and Reimitz, P.E. The Inventory of Depressive Symptomatology (IDS): Clinician (IDS-C) and self-report (IDS-SR) ratings of depressive symptoms. International Journal of Methods in Psychiatric Research, 9:45-59, 2000. 

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 assess the severity of depressive symptoms. It consists of 30 items, each rated on a 4-point scale. A total score between 0-84 is also captured.

foundational/sdtmig.

These specific implementation details for this 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.

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 instrument.

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. 

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.

Note that the EXACT and E-RS:COPD have been validated for electronic administration (ePRO); pen-and-paper CRF administration is not recommended by the copyright holders.

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, Inc., for the approval to include the EXACT in the CDISC data standards.

Reference for the EXACT:

• 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 E-RS:COPD questions. http://www.exactproinitiative.com

• The Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Patient-Reported Outcome (PRO) USER MANUAL (Version 7.0). October 2014, EXACT© 2013, Evidera, Inc. All rights reserved.

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.

EXACT is a multiple-choice self-administered daily diary completed by respondents that clinicians may use to measure of patient-reported symptoms of COPD exacerbations. It consists of 14 items, each rated on a 5- 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 electronic data capture are described in the user manual.

1. The scale points include a text rating (e.g., "Not at all", "Slightly"). 

   1. The Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Patient-Reported Outcome (PRO) USER MANUAL (Version 7.0, October 2014) that is provided upon receiving copyright permission provides the numeric scoring of the responses for the questions. Because EXACT is a copyrighted instrument, 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; 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 (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 ADaM per scoring instructions from the user manual. The Exacerbations of Chronic Pulmonary Disease Tool (EXACT) Patient-Reported Outcome (PRO) USER MANUAL (Version 7.0, October 2014) that is provided upon 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 and 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"

4. Include a description of scale score or other possible responses (You may need multiple numbered points for this, tho the IDS-SR did not.). For scale scores use the following language: The scale points include a numeric rating (0-3) and a definition of what is represented by the rating (e.g., 0 = "I never take longer than 30 minutes to fall asleep"). For the EXACT, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

5. Include a description of the evaluation interval if one exists. This may be numeric (QSEVLINT) or text (QSEVINTX). When the evaluation interval is provided in text and cannot be described in ISO 8601 format, use QSEVINTX instead of "QSEVLINT field in ISO 8601 format" and replace "the past 7 days" with the text (e.g., "DAYTIME'". Refer to SDTMIG Section 2.2.5 Timing Variables for All Classes. The evaluation interval needs to be clearly defined on the CRF. Remove this point if it does not apply.: The time period of evaluation for the EXACT is populated in the QSEVLINT field in ISO 8601 format (or QSEVINTX, as appropriate) when the evaluation interval can be precisely described as duration. The evaluation interval for the EXACT is the past 7 days (QSEVLINT = "-P7D").

6. If there are subcategories, include a note that subcategories will be represented in QSSCAT. Also provide a list of the subcategories unless one is already provided in the description preceding the assumptions. Remove this point if it does not apply.

7. If the instrument standards currently being developed includes logically skipped items, insert:  'Some items on the EXACT may be logically skipped per the instrument instructions. Language to be used for this assumption is currently under review.'

   This language is currently under review. Remove this point if it does not apply.:  Some items on the EXACT may be logically skipped per the instrument instructions.  Responses for logically skipped items should be (1) recorded and/or scored according to the instructions provided in the instrument’s user manual, scoring manual, or other documentation provided by the instrument developer and (2) included in the submission dataset. If such instructions are not available, then records for logically skipped items should be included in the submission dataset with:
   ·       QSSTAT = NOT DONE;
   ·       QSREASND = LOGICALLY SKIPPED ITEM; and
   ·       QSORRES, QSSTRESC, and QSSTRESN all set to null
   When submitting data to US FDA or some other regulatory authority to support regulatory review of a medical product, if the electronic data collection system is not capable of automatically populating records for logically skipped items, these records should be post-populated prior to submission and the sponsor will need to explain this in the corresponding reviewer's guide.

8. Include this point if score(s) are submitted to SDTM. Use the following language as stated if this point applies to the new instrument. Remove this point if it does not apply.: The EXACT instrument includes a total score (and other scores as needed.  If so, change "that is" to "that are") that is considered as captured data on the CRF and is 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).

9. This language is currently under review. Evaluator information is only to be included when the information is collected directly on the CRF. Questionnaires will no longer be using QSEVAL/QSEVALID; however RSEVAL/RSEVALID and FTEVAL/FTEVALID will continue to be used on Clinical Classifications and Functional Tests. Language for Clinical Classifications and Functional tests follows; language for questionnaires is currently under review. Remove this point if it does not apply.

   For Clinical Classifications and Functional Tests (only when collected on the CRF):  The evaluator is stored in RSEVAL (FTEVAL). For EXACT, the evaluator is defined as the (the appropriate term from controlled terminology). Alternatively, if only evaluator name or initials could be collected: For EXACT, sponsors should follow their internal data management procedures on representing the name or initials of the evaluator. CDISC Controlled Terminology is available for Evaluator (e.g., --EVAL = "HEALTH CARE PROFESSIONAL") and Medical Evaluator (e.g., --EVALID = "RATER 1"). To reiterate, only include this point if the evaluator/administrator is collected directly on the CRF.

10. Include this point if there are comments at the end of the instrument. Remove this point if it does not apply.: Comments located at the end of the EXACT will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.

11. 1. If scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.

12. 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. 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 because 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 represents the evaluation interval text timing described on the instrument relative to diary collection.
13. 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 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 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,
    Include this point if there are responses over 200 characters. Remove this point if it does not apply: Some responses to the EXACT questions exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which question responses were revised in order to fit the 200-character limit.

14. Terminology

    1. QSCAT, QSTESTCD, and QSTEST (and other variables such as QSORRESU as needed) values are included values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the qualifier, timing, result, and unit fields is provided in Section 4, SDTM Mapping Strategy. (Note: Only the result field is always used. Include qualifier, timing, and unit fields as needed and remove this note.)

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 the baseline visit for the7 evenings of diary data capture 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 then transformed into the standard numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC.

...

...

The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

Text that would remain unchanged has been left in black:

The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

...

...

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.

...

For QRS instruments with subcategories:

When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results.

QSSCAT alignment with QSTESTCD

As stated in Section 3.1 assumptions, items on the EXACT are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

...

If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:

"All QSTESTCDs"

...

Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.

...

If there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:

QSTESTCD = "test code 1" QSTEST = "test name 1"

QSTESTCD = "test code 4" QSTEST = "test name 4"

QSTESTCD = "test code 5" QSTEST = "test name 5"

QSTESTCD = "test code 6" QSTEST = "test name 6"

QSTESTCD = "test code 7" QSTEST = "test name 7"

QSTESTCD = "test code 8" QSTEST = "test name 8"

QSTESTCD = "test code 15" QSTEST = "test name 15"

QSTESTCD = "test code 22" QSTEST = "test name 22"

QSTESTCD = "test code 27" QSTEST = "test name 27"

QSTESTCD = "test code 29" QSTEST = "test name 29"

QSORRES. Based on assumption 1 above, the numeric values from the user manual are represented as "xxx" in QSSTRESC and QSSTRESN. There is no baseline observation flag represented because the user manual describes how to derive and potentially rederive the baseline EXACT domain and total scores as an analysis variable based on the subject disease status.

The table represents the items from the EXACT instrument. The timing of diary collection is explained in assumption 4. Rows 15-22 represent that the 08-Nov-2012 diary collected raw, domain, and EXACT total scores as described in assumption 3 above. These are also represented for each additional diary collection date. The subject did not fill out the EXACT diary on 09-Nov-2012 and no reason for not collecting the diary was provided. Although the reason for not completing the assessments was not collected, the protocol specified that evaluations occur nightly for 7 straight days, so the collection date is included for these missing evaluations. The remaining diary collection follows the same pattern through the completion of the dairy.

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.

Based on assumption 1 above, the numeric values from the user manual are represented as "xxx" in QSSTRESC and QSSTRESN.

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"

...

Omit the QSSTRESN column when it is not applicable to the dataset.

QSTESTCD = "test code" QSTEST = "test name"

...

For responses that are for 8 or more consecutive items, an override label should be used in QRS Maker to show the items that are included as follows:

QSTESTCD = "first test code in sequence" QSTEST = "first test name in sequence" through

QSTESTCD = "last test code in sequence" QSTEST = "last test name in sequence"

...

5 Supplemental Qualifier Name Codes

The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.

...

...

End of Document