This is an example of a single item visual analog scale (VAS) used to assess the level of craving based on response to the question “ In the past 24 hours, how strong is your craving for cigarettes?” on a scale from “no craving” to “strong craving” by measuring the number of millimeters (0–100 mm) from the “no craving” dot to the point at which the drawn line intersected the scale.
The Findings About Events or Interventions (FA) domain was used tp represent the assessment of craving. Sponsors may represent findings data in a single FA dataset or split the FA domain into separate datasets, following the guidance in the section Use of Relative Timing Variables (Copy). In this example, a FACE dataset was used. The craving itself is considered a clinical event, whereas the evaluation of craving at specific time points are considered findings about the clinical event. A parent record in the CE domain is not required.
Row 1:
Shows the craving VAS for subject 001 at baseline
Row 2:
Shows the craving VAS for subject 001 atVisist 12.
fa.xpt
face.xpt
Row
STUDYID
DOMAIN
USUBJID
FASEQ
FATESTCD
FATEST
FAOBJ
FACAT
FAORRES
FAORRESU
FASTRESC
FASTRESU
FAMETHOD
FALOBXFL
FAEVAL
VISITNUM
FADTC
FAEVLINT
FAANTXLO
FAANVLLO
FAANTXHI
FAANVLHI
1
TGI400
FA
001
1
SEV
SEVERITY/INTENSITY
CRAVING
SYMPTOM ASSESSMENT
98
mm
98
mm
VISUAL ANALOG SCALE (100 MM)
Y
PATIENT
1
2015-06-15
-P24H
NO CRAVING
0
STRONG CRAVING
100
2
TGI400
FA
001
2
SEV
SEVERITY/INTENSITY
CRAVING
SYMPTOM ASSESSMENT
43
mm
43
mm
VISUAL ANALOG SCALE (100 MM)
PATIENT
12
2016-07-15
-P24H
NO CRAVING
0
STRONG CRAVING
100
$warningHtml
FA NSV Metadata
Variable
Label
Type
Role
Origin
FAANTXLO
Anchor Text Low
text
Non-standard Variable Qualifier of --TEST/--TESTCD
CRF
FAANVLLO
Anchor Value Low
integer
Non-standard Variable Qualifier of --TEST/--TESTCD
CRF
FAANTXHI
Anchor Text High
text
Non-standard Variable Qualifier of --TEST/--TESTCD
CRF
FAANVLHI
Anchor Value High
integer
Non-standard Variable Qualifier of --TEST/--TESTCD
CRF
Dataset Wrapper Debug Message
Please add a row column to your dataset.
This example illustrates how information on the scale scoring may be represented as supplemental supplemental qualifier variables. A record in a SUPPFA dataset relates back to its parent record(s) via the key identified by the STUDYID, RDOMAIN, USUBJID, and IDVAR/IDVARVAL variables. Here the parent domain (RDOMAIN) is FA, and IDVAR is FASEQ. QNAM holds the name of the supplemental qualifier variable being defined.