Example from Crohn's WP1 Disease Classification, which is still under discussion. Below is the direction in which we seem to be heading, with the "Using Location Variables" section added as an afterthought.
As part of the screening visit, this study collected the patient's history of CD. Some information was provided directly by the patient, and other information was obtained from the subject's medical records. MHCAT was used to delineate between more general CD questions and those that pertain to extra-intestinal manifestations (EIM). MHTERM was assigned by the sponsor using the appropriate MedDRA Lowest Level Term (LLT), when available. MHDECOD was reported as the MedDRA Preferred Term. Note: Upper gastrointestinal CD is currently not as MedDRA LLT. If required, sponsors may request new terms be added to MedDRA (see https://www.meddra.org/how-to-use/change-requests).
Rows 1-7:
Not shown.
Row 8:
Shows that subject CR001-001 had pyoderma gangrenosum as an EIM.
mh.xpt
mh.xpt
Row
STUDYID
DOMAIN
USUBJID
MHSEQ
MHLNKID
MHTERM
MHDECOD
MHLLT
MHCAT
MHPRESP
MHOCCUR
MHLOC
VISITNUM
VISIT
MHDTC
8
CR001
MH
CR001-001
8
4
Pyoderma gangrenosum
Pyoderma gangrenosum
Pyoderma gangrenosum
EXTRA-INTESTINAL MANIFESTATION
Y
Y
1
SCREEN
2010-01-01
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The sponsor collected details findings about specific events or diagnoses. These findings were represented in the Findings About (FA) domain and were linked to the MH record via --LNKID. FAOBJ was assigned using MHDECOD.
Row 5:
Shows the number of pyoderma gangrenosum lesions.
Row 6:
Shows the location of the primary lesion of pyoderma gangrenosum.
Row 7:
Shows the longest diameter of the primary lesion of pyoderma gangrenosum.
fa.xpt
famh.xpt
Row
STUDYID
DOMAIN
USUBJID
FASEQ
FALNKID
FATESTCD
FATEST
FAOBJ
FAORRES
FAORRESU
FASTRESC
FASTRESN
FASTRESU
FALOBXFL
VISITNUM
VISIT
FADTC
FADY
5
CR001
FA
CR001-001
5
4
LESNUM
Number of Lesions
Pyoderma gangrenosum
2
2
2
Y
1
SCREEN
2010-01-01
-3
6
CR001
FA
CR001-001
6
4
PLLOC
Location of Primary Lesion
Pyoderma gangrenosum
SKIN OF THE KNEE
SKIN OF THE KNEE
SKIN OF THE KNEE
Y
1
SCREEN
2010-01-01
-3
7
CR001
FA
CR001-001
6
4
PLLDIAM
Longest Diameter of Primary Lesion
Pyoderma gangrenosum
30
mm
30
30
mm
Y
1
SCREEN
2010-01-01
-3
$warningHtml
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The RELREC dataset shows that some details of what is in MH are shown in the FAMH dataset and are linked via --LNKID.
$titleHtml
relrec.xpt
Row
STUDYID
RDOMAIN
USUBJID
IDVAR
IDVARVAL
RELTYPE
RELID
1
CR001
MH
MHLNKID
ONE
1
2
CR001
FAMH
FALNKID
MANY
1
$warningHtml
Using Location Variables
Row 5:
Shows the number of pyoderma gangrenosum lesions.
Row 7:
(Option 1: red, AMBIGUOUS) I examined the skin of the knee and found that the longest diameter of the primary lesion was 30mm. This could be interpreted to mean that other locations might also have primary lesions.
Row 7:
(Option 2: yellow) The longest diameter of the primary lesion of pyoderma gangrenosum was 30mm and this result was obtained from the skin of the knee.
fa.xpt
famh.xpt
Row
STUDYID
DOMAIN
USUBJID
FASEQ
FALNKID
FATESTCD
FATEST
FAOBJ
FAORRES
FAORRESU
FASTRESC
FASTRESN
FASTRESU
FALOC
FALOBXFL
VISITNUM
VISIT
FADTC
FADY
FARESLOC
5
CR001
FA
CR001-001
5
4
LESNUM
Number of Lesions
Pyoderma gangrenosum
2
2
2
Y
1
SCREEN
2010-01-01
-3
7
CR001
FA
CR001-001
6
4
PLLDIAM
Longest Diameter of Primary Lesion
Pyoderma gangrenosum
30
mm
30
30
mm
SKIN OF THE KNEE
Y
1
SCREEN
2010-01-01
-3
7
CR001
FA
CR001-001
6
4
PLLDIAM
Longest Diameter of Primary Lesion
Pyoderma gangrenosum
30
mm
30
30
mm
Y
1
SCREEN
2010-01-01
-3
SKIN OF THE KNEE
$warningHtml
XX NSV Metadata
Name
Label
Type
Codelist
FARESLOC
Result Location
text
(LOC)
Dataset Wrapper Debug Message
Please add a row column to your dataset.
But what do you do if you need the location and longest diameter is not collected...?