Example from Crohn's WP1 Disease Classification Module, which is still under discussion. Below is an abbreviated example showing the direction in which we seem to be heading, with the "Using Location Variables" section added as an afterthought.
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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).
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| Dataset wrap |
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| Rowcaps |
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| 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. |
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| Dataset2 |
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| 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 gangrenosumSKIN OF THE KNEE | SKIN OF THE KNEE |
| SKIN OF THE KNEE |
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| 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 |
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| Dataset wrap |
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| Rowcaps |
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| 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. |
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| Dataset2 |
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| hi1style | #ffebe5 |
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| hi2 | 3 |
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| hi1 | 2 |
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| hi2style | #fffae5 |
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| tableid | famh2 |
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| 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 |
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| Nsvmeta |
|---|
| Name | Label | Type | Codelist |
|---|
| FARESLOC | Result Location | text | (LOC) |
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But what do you do if you need the location and longest diameter is not collected...?