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.
Revision History
| Date | Version | Summary of Changes |
|---|---|---|
| 2019-11-27 | 1.1 Revision Draft |
|
| 2016-03-24 | 1.0 | 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.
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 ADaM QRS Supplements explaining the scoring and total of the results based on the user manual.
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. The copyright holder provides software to derive A total score between 0-84 is also captured.
The scale points include a text rating (e.g., "Not at all", "Slightly", etc.). 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.
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") as represented on the CRF.
The EXACT instrument includes CRF does not include subtotals or a totl score on th CRF, but the copyright holder provides software to calculate these derived items. They may be provides as part of 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.
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).
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.
- 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.
- The QSDTC variable contains the date/time the EXACT was completed by the subject and is used for the timing of this measure.
Terminology
QSCAT, QSTESTCD, and QSTEST (and other variables such as QSORRESU as needed) values are included in CDISC Controlled Terminology.
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 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.
Note: There are several optional space-saving options that can be included in the paragraph as appropriate or needed. Historically, we needed these to save space in Word/PDF documents. As we move to all wiki/html, these are likely not needed, but we are waiting to remove these options until we're sure:
- "This example is based on a questionnaire with an evaluation interval of xxx." allows the QSEVLINT (or QSEVINTX) column to be removed from the example. Note that it was not used for the IDS-SR instrument used in the example below as it is not the same for all items.
- "This example is based on a questionnaire with an evaluation interval of the past week. QSLOBXFL is NULL based on VISITNUM = 2." saves space if there are a large number of columns. If this statement is used, leave off the QSEVLINT, QSLOBXFL and VISITNUM columns in the example.
- "QSSTRESN is null as there are no standardized numeric results for this instrument." This statement is used when there are no standardized numeric values. The QSSTRESN column is then removed from the below example.
Update the data in the table below to the current instrument. Include row descriptions as needed to highlight idiosyncrasies or items otherwise of note in this particular instrument. If there are only a few row descriptions, information should be included in the text prior to the example instead of in separate row headers.
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.
Dataset Wrapper Debug Message
Row captions have been provided, but there doesn't seem to be a dataset to which the row captions would apply.
| Rows 13-14: | Questions 11 and 12 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Question 12 would not appear in the actual dataset and has result values of "XXX". |
|---|---|
| Rows 15-16: | Questions 13 and 14 are presented for illustrative purposes only. When the instrument is conducted, only one will be represented based on the CRF instructions. In this example, Question 14 would not appear in the actual dataset and has result values of "XXX". |
| Row 33: | The total score does not have an evaluation interval value represented, since there is a mixture of evaluation interval values with questions 13 and 14 that differ from the remaining questions on the CRF. |
Unable to render dataset table
The table contains merged cells. Please unmerge them.
| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSLOBXFL | VISITNUM | QSDTC | QSEVLINT |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STUDYX | QS | 2324-P0001 | 1 | IDSR101 | IDSR1-Falling Asleep | IDS-SR | I never take longer than 30 minutes to fall asleep | 0 | 0 | Y | 1 | 2015-05-15 | -P7D |
| 2 | STUDYX | QS | 2324-P0001 | 2 | IDSR102 | IDSR1-Sleep During the Night | IDS-SR | I do not wake up at night | 0 | 0 | Y | 1 | 2015-05-15 | -P7D |
| 3 | STUDYX | QS | 2324-P0001 | 3 | IDSR103 | IDSR1-Waking Up Too Early | IDS-SR | Most of the time, I awaken no more than 30 minutes before I need to get up | 0 | 0 | Y | 1 | 2015-05-15 | -P7D |
| 4 | STUDYX | QS | 2324-P0001 | 4 | IDSR104 | IDSR1-Sleeping Too Much | IDS-SR | I sleep no longer than 7-8 hours/night, without napping during the day | 0 | 0 | Y | 1 | 2015-05-15 | -P7D |
| 5 | STUDYX | QS | 2324-P0001 | 5 | IDSR105 | IDSR1-Feeling Sad | IDS-SR | I feel sad less than half the time | 1 | 1 | Y | 1 | 2015-05-15 | -P7D |
| 6 | STUDYX | QS | 2324-P0001 | 6 | IDSR106 | IDSR1- Feeling Irritable | IDS-SR | I feel irritable less than half the time | 1 | 1 | Y | 1 | 2015-05-15 | -P7D |
| 7 | STUDYX | QS | 2324-P0001 | 7 | IDSR107 | IDSR1-Feeling Anxious or Tense | IDS-SR | I feel anxious (tense) less than half the time | 1 | 1 | Y | 1 | 2015-05-15 | -P7D |
| 8 | STUDYX | QS | 2324-P0001 | 8 | IDSR108 | IDSR1-Your Mood to Good/Desired Events | IDS-SR | My mood brightens but I do not feel like my normal self when good events occur | 1 | 1 | Y | 1 | 2015-05-15 | -P7D |
| 9 | STUDYX | QS | 2324-P0001 | 9 | IDSR109 | IDSR1-Mood in Relation to Time of Day | IDS-SR | My mood often relates to the time of day because of environmental events (e.g., being alone, working) | 1 | 1 | Y | 1 | 2015-05-15 | -P7D |
| 10 | STUDYX | QS | 2324-P0001 | 10 | IDSR109A | IDSR1-Mood Worse Morn/Afternoon/Night | IDS-SR | Afternoon | Afternoon | Y | 1 | 2015-05-15 | -P7D | |
| Rows 11-32 removed for ease of use of template. (fyi, this row has merged cells so don't try to overwrite it when using the template; just delete it.) | ||||||||||||||
| 33 | STUDYX | QS | 2324-P0001 | 33 | IDSR131 | IDSR1-Score | IDS-SR | 18 | 18 | 18 | Y | 1 | 2015-05-15 | |
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.
| STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG |
|---|---|---|---|---|---|---|---|---|
| STUDYX | QS | P0001 | QSSEQ | Sequence number corresponding to row of qs.xpt that supplemental qualifier is needed for (e.g., 8) | Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT). | Label for QNAM (e.g., Contact Type) | Value of QNAM variable ( e.g., SUBJECT VISIT) | CRF |
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.
Include mappings for all sets of result values. For ease of use of this template, the complete set of response values for the example in Section 3.2 is not included.
If the instrument has been entered into QRS Maker (all instruments should be), then the complete set of response values can be copied from QRS Maker and pasted into this supplement.
Some example mappings are below.
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.
| QSSCAT | QSTESTCD |
|---|---|
| EMOTIONAL/INFORMATIONAL SUPPORT | QSSS0101 - QSSS0108 |
| TANGIBLE SUPPORT | QSSS0109 - QSSS0112 |
| AFFECTIONATE SUPPORT | QSSS0113 - QSSS0115 |
| POSITIVE SOCIAL INTERACTION | QSSS0116 - QSSS0118 |
| ADDITIONAL ITEM | QSSS0119 |
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"
| QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| Original result 1 | 0 | 0 |
| Original result 2 | 1 | 1 |
| Original result 3 | 2 | 2 |
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 | QSSTRESC | QSSTRESN |
|---|---|---|
| I never take longer than 30 minutes to fall asleep | 0 | 0 |
| I take at least 30 minutes to fall asleep, less than half the time | 1 | 1 |
| I take at least 30 minutes to fall asleep, more than half the time | 2 | 2 |
| I take more than 60 minutes to fall asleep, more than half the time | 3 | 3 |
Omit the QSSTRESN column when it is not applicable to the dataset.
QSTESTCD = "test code" QSTEST = "test name"
| QSORRES | QSSTRESC |
|---|---|
| yes | Y |
| no | N |
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"
| QSORRES | QSSTRESC | QSSTRESN |
|---|---|---|
| I have not experienced the physical sensation of feeling weighted down and without physical energy | 0 | 0 |
| I have occasionally experienced periods of feeling physically weighted down and without physical energy, but without a negative effect on work, school, or activity level | 1 | 1 |
| I feel physically weighted down (without physical energy) more than half the time | 2 | 2 |
| I feel physically weighted down (without physical energy) most of the time, several hours per day, several days per week | 3 | 3 |
5 Supplemental Qualifier Name Codes
The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black.
Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed.
Remove Section 5 if it does not apply to the new instrument.
The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.
| QNAM | QLABEL | QVAL |
|---|---|---|
| Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT). | Label for QNAM (e.g., Contact Type) | Value of QNAM ( e.g., SUBJECT VISIT) |
End of Document
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