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| Date | Version | Summary of Changes |
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| 2021-08-12 | 2.0 Revision Draft | - Converted the supplement to the current WIKI QRS supplement template.
- Annotated CRF updated to the MSG V2.0 annotation guidelines
- Added assumption 2 on using the QSEVINTX variable and added it to the example.
- Added assumption 3 on the inclusion of 4 respiratory symptom raw and domain scores, a raw EXACT total raw and an EXACT total score scores as described in the user manual.
- 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.
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| 2016-03-24 | 1.0 | Final - Updated per Evidera instructions. They They have trademarked the EXACT® and updated the name of the E-RS™: COPD. |
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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.
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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 EXACT-Respiratory Symptoms (E-RS) 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
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The EXACT is a multiple-choice self-administered daily diary completed by respondents 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. Instructions for electornic data capture are described in the user manual.
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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 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. This result is also represented as the standard character representation in QSSTRESC. There is no baseline observation flags represented, since the manual describes how to drive and potentially re-derive the baseline EXACT domain and total scores as an analysis variable based on the subject disease status.
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We are unable to make the |
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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 instrument. Rows 15 - 28 represent a day in which no responses were collected, which is based on assumption 5 above.18 - 25 reprsent the raw, domain, and EXACT total scores at the first diary day as described in assumption 3 above. The subject did not fill out the EXACT at the second dairy day and the observations on this day are represented as described in assumption 3 above.
Example without numeric scores as described in the manual in accordance with assumption 1.a. and V1.0 published supplement with "xxx" indicating the derived score values
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| Dataset2 |
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| | Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | VISITNUM | QSDTC | QSTPT | QSTPTREF | QSRFTDTC | QSEVINTX | | 1 | STUDYX | QS | P0001 | 1 | EXACT101 | EXACT1-Chest Feel Congested | EXACT | Slightly | Slightly |
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| 1 | 2012-11- |
16EVERY EVENING BEFORE 2| DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 2 | STUDYX | QS | P0001 | 2 | EXACT102 | EXACT1-How Often Cough | EXACT | Frequently | Frequently |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11- |
16| 15 | EVERY EVENING BEFORE BEDTIME | | 3 | STUDYX | QS | P0001 | 3 | EXACT103 | EXACT1-Bring Up Mucus When Coughing | EXACT | A little | A little |
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| 1 | 2012-11- |
16| 08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 4 | STUDYX | QS | P0001 | 4 | EXACT104 | EXACT1-Difficult to Bring Up Mucus | EXACT | Moderately | Moderately |
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| 1 | 2012-11- |
16| 08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 5 | STUDYX | QS | P0001 | 5 | EXACT105 | EXACT1-Chest Discomfort | EXACT | Moderate | Moderate |
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| 1 | 2012-11- |
16| 08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 6 | STUDYX | QS | P0001 | 6 | EXACT106 | EXACT1-Chest Feel Tight | EXACT | Slightly | Slightly |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11- |
16| 15 | EVERY EVENING BEFORE BEDTIME | | 7 | STUDYX | QS | P0001 | 7 | EXACT107 | EXACT1-Breathless | EXACT | Slightly | Slightly |
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| 1 | 2012-11- |
16| 08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 8 | STUDYX | QS | P0001 | 8 | EXACT108 | EXACT1-Describe How Breathless | EXACT | Breathless during light activity | Breathless during light activity |
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| 1 | 2012-11- |
16| 08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 9 | STUDYX | QS | P0001 | 9 | EXACT109 | EXACT1-Short Breath Personal Care | EXACT | Severely | Severely |
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| 1 | 2012-11- |
16| 08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 10 | STUDYX | QS | P0001 | 10 | EXACT110 | EXACT1-Short Breath Indoor Activities | EXACT | Moderately | Moderately |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11- |
16| 15 | EVERY EVENING BEFORE BEDTIME | | 11 | STUDYX | QS | P0001 | 11 | EXACT111 | EXACT1-Short Breath Outside Activities | EXACT | Extremely | Extremely |
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| 1 | 2012-11- |
16| 08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 12 | STUDYX | QS | P0001 | 12 | EXACT112 | EXACT1-Tired or Weak | EXACT | Slightly | Slightly |
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| 1 | 2012-11- |
16| 08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 13 | STUDYX | QS | P0001 | 13 | EXACT113 | EXACT1-Night Sleep Disturbed | EXACT | Not at all | Not at all |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11- |
16| 15 | EVERY EVENING BEFORE BEDTIME | | 14 | STUDYX | QS | P0001 | 14 | EXACT114 | EXACT1-Worried About Lung Problems | EXACT | Slightly | Slightly |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11- |
16| 15 | EVERY EVENING BEFORE BEDTIME | | 15 | STUDYX | QS | P0001 | 15 |
EXACT101Chest Feel Congested| Breathlessness Raw Score | EXACT |
NOT DONE | NO RESPONSE COLLECTED | xxx | xxx | xxx |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11- |
17| 15 | EVERY EVENING BEFORE BEDTIME | | 16 | STUDYX | QS | P0001 | 16 |
EXACT102How Often CoughEXACT | NOT DONE | | Cough & Sputum Raw Score | EXACT | xxx | xxx | xxx |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE |
NO RESPONSE COLLECTED17| 15 | EVERY EVENING BEFORE BEDTIME | | 17 | STUDYX | QS | P0001 | 17 |
EXACT103Bring Up Mucus When CoughingEXACT | NOT DONE | | Chest Symptoms Raw Score | EXACT | xxx | xxx | xxx |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE |
NO RESPONSE COLLECTED17| 15 | EVERY EVENING BEFORE BEDTIME | | 18 | STUDYX | QS | P0001 | 18 |
EXACT104Difficult to Bring Up MucusEXACT | NOT DONE | | EXACT Total Raw Score | EXACT | xxx | xxx | xxx |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE |
NO RESPONSE COLLECTED17| 15 | EVERY EVENING BEFORE BEDTIME | | 19 | STUDYX | QS | P0001 | 19 |
EXACT105Chest DiscomfortEXACT | NOT DONE | | Breathlessness Domain Score | EXACT | xxx | xxx | xxx |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE |
NO RESPONSE COLLECTED17| 15 | EVERY EVENING BEFORE BEDTIME | | 20 | STUDYX | QS | P0001 | 20 |
EXACT106Chest Feel TightEXACT | NOT DONE | | Cough & Sputum Domain Score | EXACT | xxx | xxx | xxx |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE |
NO RESPONSE COLLECTED17| 15 | EVERY EVENING BEFORE BEDTIME | | 21 | STUDYX | QS | P0001 | 21 |
EXACT107Breathless| Chest Symptoms Domain Score | EXACT |
NOT DONE | | xxx | xxx | xxx |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE |
NO RESPONSE COLLECTED17| 15 | EVERY EVENING BEFORE BEDTIME | | 22 | STUDYX | QS | P0001 | 22 |
EXACT108Describe How BreathlessNOT DONE | | xxx | xxx | xxx |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE |
NO RESPONSE COLLECTED17| 15 | EVERY EVENING BEFORE BEDTIME | | 23 | STUDYX | QS | P0001 | 23 |
EXACT109Short Breath Personal Care| Chest Feel Congested | EXACT |
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| NOT DONE |
NO RESPONSE COLLECTED
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11- |
17| 15 | EVERY EVENING BEFORE BEDTIME | | 24 | STUDYX | QS | P0001 | 24 |
EXACT110Short Breath Indoor Activities| How Often Cough | EXACT |
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| NOT DONE |
NO RESPONSE COLLECTED17EVERY EVENING BEFORE | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 25 | STUDYX | QS | P0001 | 25 |
EXACT111Short Breath Outside Activities| Bring Up Mucus When Coughing | EXACT |
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| NOT DONE |
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| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE |
NO RESPONSE COLLECTED17| 15 | EVERY EVENING BEFORE BEDTIME | | 26 | STUDYX | QS | P0001 | 26 |
EXACT112Tired or Weak| Difficult to Bring Up Mucus | EXACT |
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| NOT DONE |
NO RESPONSE COLLECTED17EVERY EVENING BEFORE 27 | | DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 27 | STUDYX |
STUDYXEXACT113Night Sleep Disturbed| Chest Discomfort | EXACT |
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| NOT DONE |
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| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE |
NO RESPONSE COLLECTED17| 15 | EVERY EVENING BEFORE BEDTIME | | 28 | STUDYX | QS | P0001 | 28 |
EXACT114Worried About Lung Problems| Chest Feel Tight | EXACT |
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| NOT DONE |
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| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE |
NO RESPONSE COLLECTED17| 15 | EVERY 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"
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| 29 | STUDYX | QS | P0001 | 29 | EXACT107 | EXACT1-Breathless | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 30 | STUDYX | QS | P0001 | 30 | EXACT108 | EXACT1-Describe How Breathless | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 31 | STUDYX | QS | P0001 | 31 | EXACT109 | EXACT1-Short Breath Personal Care | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 32 | STUDYX | QS | P0001 | 32 | EXACT110 | EXACT1-Short Breath Indoor Activities | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 33 | STUDYX | QS | P0001 | 33 | EXACT111 | EXACT1-Short Breath Outside Activities | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 34 | STUDYX | QS | P0001 | 34 | EXACT112 | EXACT1-Tired or Weak | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 35 | STUDYX | QS | P0001 | 35 | EXACT113 | EXACT1-Night Sleep Disturbed | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 36 | STUDYX | QS | P0001 | 36 | EXACT114 | EXACT1-Worried About Lung Problems | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 37 | STUDYX | QS | P0001 | 37 | EXACT115 | EXACT1-Breathlessness Raw Score | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 38 | STUDYX | QS | P0001 | 38 | EXACT116 | EXACT1-Cough & Sputum Raw Score | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 39 | STUDYX | QS | P0001 | 39 | EXACT117 | EXACT1-Chest Symptoms Raw Score | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 40 | STUDYX | QS | P0001 | 40 | EXACT118 | EXACT1-EXACT Total Raw Score | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 41 | STUDYX | QS | P0001 | 41 | EXACT119 | EXACT1-Breathlessness Domain Score | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 42 | STUDYX | QS | P0001 | 42 | EXACT120 | EXACT1-Cough & Sputum Domain Score | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 43 | STUDYX | QS | P0001 | 43 | EXACT121 | EXACT1-Chest Symptoms Domain Score | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 44 | STUDYX | QS | P0001 | 44 | EXACT122 | EXACT1-EXACT Total Score | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME |
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Example with numeric scores as described in the manual if the subteam thinbks this can be included based on the best practice of incuding numeric scores defined in a manual
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| Row | STUDYID | DOMAIN | USUBJID | QSSEQ | QSTESTCD | QSTEST | QSCAT | QSORRES | QSSTRESC | QSSTRESN | QSSTAT | QSREASND | VISITNUM | QSDTC | QSTPT | QSTPTREF | QSRFTDTC | QSEVINTX | | 1 | STUDYX | QS | P0001 | 1 | EXACT101 | EXACT1-Chest Feel Congested | EXACT | Slightly | 1 | 1 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 2 | STUDYX | QS | P0001 | 2 | EXACT102 | EXACT1-How Often Cough | EXACT | Frequently | 3 | 3 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 3 | STUDYX | QS | P0001 | 3 | EXACT103 | EXACT1-Bring Up Mucus When Coughing | EXACT | A little | 1 | 1 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 4 | STUDYX | QS | P0001 | 4 | EXACT104 | EXACT1-Difficult to Bring Up Mucus | EXACT | Moderately | 2 | 2 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 5 | STUDYX | QS | P0001 | 5 | EXACT105 | EXACT1-Chest Discomfort | EXACT | Moderate | 2 | 2 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 6 | STUDYX | QS | P0001 | 6 | EXACT106 | EXACT1-Chest Feel Tight | EXACT | Slightly | 1 | 1 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 7 | STUDYX | QS | P0001 | 7 | EXACT107 | EXACT1-Breathless | EXACT | Slightly | 1 | 1 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 8 | STUDYX | QS | P0001 | 8 | EXACT108 | EXACT1-Describe How Breathless | EXACT | Breathless during light activity | 2 | 2 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 9 | STUDYX | QS | P0001 | 9 | EXACT109 | EXACT1-Short Breath Personal Care | EXACT | Severely | 3 | 3 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 10 | STUDYX | QS | P0001 | 10 | EXACT110 | EXACT1-Short Breath Indoor Activities | EXACT | Moderately | 2 | 2 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 11 | STUDYX | QS | P0001 | 11 | EXACT111 | EXACT1-Short Breath Outside Activities | EXACT | Extremely | 3 | 3 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 12 | STUDYX | QS | P0001 | 12 | EXACT112 | EXACT1-Tired or Weak | EXACT | Slightly | 1 | 1 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 13 | STUDYX | QS | P0001 | 13 | EXACT113 | EXACT1-Night Sleep Disturbed | EXACT | Not at all | 0 | 0 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 14 | STUDYX | QS | P0001 | 14 | EXACT114 | EXACT1-Worried About Lung Problems | EXACT | Slightly | 1 | 1 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 15 | STUDYX | QS | P0001 | 15 | EXACT115 | EXACT1-Breathlessness Raw Score | EXACT | 8 | 8 | 8 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 16 | STUDYX | QS | P0001 | 16 | EXACT116 | EXACT1-Cough & Sputum Raw Score | EXACT | 4 | 4 | 4 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 17 | STUDYX | QS | P0001 | 17 | EXACT117 | EXACT1-Chest Symptoms Raw Score | EXACT | 4 | 4 | 4 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 18 | STUDYX | QS | P0001 | 18 | EXACT118 | EXACT1-EXACT Total Raw Score | EXACT | 23 | 23 | 23 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 19 | STUDYX | QS | P0001 | 19 | EXACT119 | EXACT1-Breathlessness Domain Score | EXACT | 45 | 45 | 45 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 20 | STUDYX | QS | P0001 | 20 | EXACT120 | EXACT1-Cough & Sputum Domain Score | EXACT | 56 | 56 | 56 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 21 | STUDYX | QS | P0001 | 21 | EXACT121 | EXACT1-Chest Symptoms Domain Score | EXACT | 38 | 38 | 38 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 22 | STUDYX | QS | P0001 | 22 | EXACT122 | EXACT1-EXACT Total Score | EXACT | 47 | 47 | 47 |
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| 1 | 2012-11-08 | BEDTIME DAY -7 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 23 | STUDYX | QS | P0001 | 23 | EXACT101 | EXACT1-Chest Feel Congested | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 24 | STUDYX | QS | P0001 | 24 | EXACT102 | EXACT1-How Often Cough | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 25 | STUDYX | QS | P0001 | 25 | EXACT103 | EXACT1-Bring Up Mucus When Coughing | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 26 | STUDYX | QS | P0001 | 26 | EXACT104 | EXACT1-Difficult to Bring Up Mucus | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 27 | STUDYX | QS | P0001 | 27 | EXACT105 | EXACT1-Chest Discomfort | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 28 | STUDYX | QS | P0001 | 28 | EXACT106 | EXACT1-Chest Feel Tight | EXACT |
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| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 29 | STUDYX | QS | P0001 | 29 | EXACT107 | EXACT1-Breathless | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 30 | STUDYX | QS | P0001 | 30 | EXACT108 | EXACT1-Describe How Breathless | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 31 | STUDYX | QS | P0001 | 31 | EXACT109 | EXACT1-Short Breath Personal Care | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 32 | STUDYX | QS | P0001 | 32 | EXACT110 | EXACT1-Short Breath Indoor Activities | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 33 | STUDYX | QS | P0001 | 33 | EXACT111 | EXACT1-Short Breath Outside Activities | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 34 | STUDYX | QS | P0001 | 34 | EXACT112 | EXACT1-Tired or Weak | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 35 | STUDYX | QS | P0001 | 35 | EXACT113 | EXACT1-Night Sleep Disturbed | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 36 | STUDYX | QS | P0001 | 36 | EXACT114 | EXACT1-Worried About Lung Problems | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 37 | STUDYX | QS | P0001 | 37 | EXACT115 | EXACT1-Breathlessness Raw Score | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 38 | STUDYX | QS | P0001 | 38 | EXACT116 | EXACT1-Cough & Sputum Raw Score | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 39 | STUDYX | QS | P0001 | 39 | EXACT117 | EXACT1-Chest Symptoms Raw Score | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 40 | STUDYX | QS | P0001 | 40 | EXACT118 | EXACT1-EXACT Total Raw Score | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 41 | STUDYX | QS | P0001 | 41 | EXACT119 | EXACT1-Breathlessness Domain Score | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 42 | STUDYX | QS | P0001 | 42 | EXACT120 | EXACT1-Cough & Sputum Domain Score | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 43 | STUDYX | QS | P0001 | 43 | EXACT121 | EXACT1-Chest Symptoms Domain Score | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME | | 44 | STUDYX | QS | P0001 | 44 | EXACT122 | EXACT1-EXACT Total Score | EXACT |
|
|
| NOT DONE |
| 1 | 2012-11-09 | BEDTIME DAY -6 | NEXT CLINIC VISIT DATE | 2012-11-15 | EVERY EVENING BEFORE BEDTIME |
|
|
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 all | Not at all |
|
| Slightly | Slightly |
|
| Moderately | Moderately |
|
| Severely | Severely |
|
| Extremely | Extremely |
|
QSTESTCD = "EXACT102" QSTEST = "EXACT1-How Often Cough"
QSORRES | QSSTRESC | QSSTRESN |
|---|
| Not at all | Not at all |
|
| Rarely | Rarely |
|
| Occasionally | Occasionally |
|
| Frequently | Frequently |
|
| Almost constantly | Almost constantly |
|
QSTESTCD = "EXACT103" QSTEST = "EXACT1-Bring Up Mucus When Coughing"
QSORRES | QSSTRESC | QSSTRESN |
|---|
| None at all | None at all |
|
| A little | A little |
|
| Some | Some |
|
| A great deal | A great deal |
|
| A very great deal | A very great deal |
|
QSTESTCD = "EXACT104" QSTEST = "EXACT1-Difficult to Bring Up Mucus"
QSORRES | QSSTRESC | QSSTRESN |
|---|
| Not at all | Not at all |
|
| Slightly | Slightly |
|
| Moderately | Moderately |
|
| Quite a bit | Quite a bit |
|
| Extremely | Extremely |
|
QSTESTCD = "EXACT105" QSTEST = "EXACT1-Chest Discomfort"
QSORRES | QSSTRESC | QSSTRESN |
|---|
| Not at all | Not at all |
|
| Slight | Slight |
|
| Moderate | Moderate |
|
| Severe | Severe |
|
| Extreme | Extreme |
|
QSTESTCD = "EXACT108" QSTEST = "EXACT1-Describe How Breathless"
QSORRES | QSSTRESC | QSSTRESN |
|---|
| Unaware of breathlessness | Unaware of breathlessness |
|
| Breathless during strenuous activity | Breathless during strenuous activity |
|
| Breathless during light activity | Breathless during light activity |
|
| Breathless when washing or dressing | Breathless when washing or dressing |
|
| Present when resting | Present 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 all | Not at all |
|
| Slightly | Slightly |
|
| Moderately | Moderately |
|
| Severely | Severely |
|
| Extremely | Extremely |
|
| Too breathless to do these | Too breathless to do these |
|
Alternate section 4 with numeric scores includes in the responses
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"
QSORRES | QSSTRESC | QSSTRESN |
| Not at all | 0 | 0 |
| Slightly | 1 | 1 |
| Moderately | 2 | 2 |
| Severely | 3 | 3 |
| Extremely | 4 | 4 |
QSTESTCD = "EXACT102" QSTEST = "EXACT1-How Often Cough"
QSORRES | QSSTRESC | QSSTRESN |
| Almost constantly | 0 | 0 |
| Frequently | 1 | 1 |
| Not at all | 2 | 2 |
| Occasionally | 3 | 3 |
| Rarely | 4 | 4 |
QSTESTCD = "EXACT103" QSTEST = "EXACT1-Bring Up Mucus When Coughing"
QSORRES | QSSTRESC | QSSTRESN |
| None at all | 0 | 0 |
| A little | 1 | 1 |
| Some | 1 | 1 |
| A great deal | 2 | 2 |
| A very great deal | 3 | 3 |
QSTESTCD = "EXACT104" QSTEST = "EXACT1-Difficult to Bring Up Mucus"
QSORRES | QSSTRESC | QSSTRESN |
| Not at all |
Not at allSlightlyModerately | Severely | Severely | | 2 | 2 |
| Quite a bit | 3 | 3 |
| Extremely | 4 | 4 |
Extremely | ExtremelyQSTESTCD = "
...
EXACT105" QSTEST = "EXACT1-
...
Chest Discomfort"
QSORRES | QSSTRESC | QSSTRESN |
| Not at all |
Not at all | Rarely | Rarely | Occasionally | Occasionally | Frequently | Frequently | Almost constantly | Almost constantly | 0 | 0 |
| Slight | 1 | 1 |
| Moderate | 2 | 2 |
| Severe | 3 | 3 |
| Extreme | 4 | 4 |
QSTESTCD = "
...
EXACT108" QSTEST = "EXACT1-
...
Describe How Breathless"
| None at all | None at all | A little | A little | Some | Some | A great deal | A great deal | A very great deal | A very great deal | ...
|
| Unaware of breathlessness | 0 | 0 |
| Breathless during strenuous activity | 1 | 1 |
| Breathless during light activity | 2 | 2 |
| Breathless when washing or dressing | 3 | 3 |
| Present when resting | 3 | 3 |
QSTESTCD = "EXACT109" QSTEST = "EXACT1-
...
Short Breath Personal Care"
QSORRES | QSSTRESC | QSSTRESN |
| Not at all | 0 |
Not at allSlightlyModerately | Quite a bit | Quite a bit | | 2 |
| Severely | 3 | 3 |
| Extremely | 3 | 3 |
| Too breathless to do these | 4 | 4 |
Extremely | ExtremelyQSTESTCD = "EXACT105EXACT110" QSTEST = "EXACT1-Chest Discomfort"
...
QSORRES
...
QSSTRESC
...
QSSTRESN
Short Breath Indoor Activities"
...
QSTESTCD = "EXACT108EXACT111" QSTEST = "EXACT1-Describe How BreathlessShort Breath Outside Activities"
| Unaware of breathlessness | Unaware of breathlessness | Breathless during strenuous activity | Breathless during strenuous activity | Breathless during light activity | Breathless during light activity | Breathless when washing or dressing | Breathless when washing or dressing | Present when resting | Present when resting | QSTESTCD = "EXACT109" QSTEST = "EXACT1-Short Breath Personal Care"
...
|
| Not at all | 0 | 0 |
| Slightly | 1 | 1 |
| Moderately | 2 | 2 |
| Severely | 3 | 3 |
| Extremely | 3 | 3 |
| Too breathless to do these | 3 | 3 |
QSTESTCD = "EXACT114" QSTEST = "EXACT1-
...
Worried About Lung Problems"
...
QSTESTCD = "EXACT111" QSTEST = "EXACT1-Short Breath Outside Activities"
QSORRES | QSSTRESC | QSSTRESN |
| Not at all | 0 |
Not at allSlightlyModeratelySeverelyExtremelyToo breathless to do these | Too breathless to do these
End of Document