In an events or interventions domain, the variable --PRESP = "Y" can be used to indicate that the value in the topic variable (--TERM or --TRT) was pre-specified. However, --PRESP is not a variable that is allowed in findings domains.
Suppose a study collected the following data about findings from a chest x-ray:
- Is effusion present? Yes/No
- Are infiltrates present? Yes/No
- Other findings, specify ____________
In a findings domain, the first two questions are treated as specific indicator tests with results of "Yes" or "No", while the "Other findings, specify" question is represented as an open-ended question with a free-form text response, as illustrated in this example. (Note that this abbreviated example table does not include all required and expected variables for the Respiratory System Findings [RE] domain)
re.xpt
| Row | Description |
|---|---|
| 1-2: | These records for pre-specified findings use indicator tests for specific findings. These two tests are in CDISC Controlled Terminology (CT); if data was collected for a finding not in CT, the implementer would create an appropriate test name and test code. |
| 3: | This record uses the open-ended test for the respiratory domain from CDISC Controlled Terminology. This example includes only one "other" finding, but if multiple "other" findings were recorded, each would be represented by a record with this same test. |
| Row | STUDYID | DOMAIN | USUBJID | RETESTCD | RETEST | REORRES |
|---|---|---|---|---|---|---|
| 1 | ABC23 | RE | 101 | EFFIND | Effusion Indicator | N |
| 2 | ABC123 | RE | 101 | INFLTIND | Infiltrates Indicator | Y |
| 3 | ABC123 | RE | 101 | REEXAM | Respiratory System Examination | Calcifications |
All three records in the example can be thought of as results of an open-ended examination of the chest x-ray in which all abnormalities are recorded. Some findings were collected in response to questions about pre-specified findings while others are collected as free text results in a representation of the data with certain drawbacks.
- There is no one field where all findings are represented.
- For any pre-specified findings, an "indicator" test for that particular finding must be used.