Versions Compared

Old Version 6

changes.mady.by.user Steve Kopko

Saved on

compared with

New Version 7

changes.mady.by.user Steve Kopko

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...


The table represents the items from the EXACT form.

Dataset wrap
Nameqs


dataset2
Dataset2


RowSTUDYIDDOMAINUSUBJIDQSSEQQSTESTCDQSTESTQSCATQSORRESQSSTRESCQSSTRESNVISITNUMQSDTCQSEVINTX
1STUDYXQSP00011EXACT101EXACT1-Chest Feel CongestedEXACTSlightlySlightly  2012-11-16EVERY EVENING
2STUDYXQSP00012EXACT102EXACT1-How Often CoughEXACTFrequentlyFrequently  2012-11-16EVERY EVENING
3STUDYXQSP00013EXACT103EXACT1-Bring Up Mucus When CoughingEXACTA littleA little  2012-11-16EVERY EVENING
4STUDYXQSP00014EXACT104EXACT1-Difficult to Bring Up MucusEXACTModeratelyModerately  2012-11-16EVERY EVENING
5STUDYXQSP00015EXACT105EXACT1-Chest DiscomfortEXACTModerateModerate  2012-11-16EVERY EVENING
6STUDYXQSP00016EXACT106EXACT1-Chest Feel TightEXACTSlightlySlightly  2012-11-16EVERY EVENING
7STUDYXQSP00017EXACT107EXACT1-BreathlessEXACTSlightlySlightly  2012-11-16EVERY EVENING
8STUDYXQSP00018EXACT108EXACT1-Describe How BreathlessEXACTBreathless during light activityBreathless during light activity  2012-11-16EVERY EVENING
9STUDYXQSP00019EXACT109EXACT1-Short Breath Personal CareEXACTSeverelySeverely  2012-11-16EVERY EVENING
10STUDYXQSP000110EXACT110EXACT1-Short Breath Indoor ActivitiesEXACTModeratelyModerately  2012-11-16EVERY EVENING
11STUDYXQSP000111EXACT111EXACT1-Short Breath Outside ActivitiesEXACTExtremelyExtremely  2012-11-16EVERY EVENING
12STUDYXQSP000112EXACT112EXACT1-Tired or WeakEXACTSlightlySlightly  2012-11-16EVERY EVENING
13STUDYXQSP000113EXACT113EXACT1-Night Sleep DisturbedEXACTNot at allNot at all  2012-11-16EVERY EVENING
14STUDYXQSP000114EXACT114EXACT1-Worried About Lung ProblemsEXACTSlightlySlightly  2012-11-16EVERY EVENING
Rowcaps
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.




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 all0
SlightlySlightly1
ModeratelyModerately2
SeverelySeverely3
ExtremelyExtremely4

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

QSORRES

QSSTRESC

QSSTRESN

Not at allNot 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