In this example, the physician evaluated the subject at each visit using the sPGA. The data for the sPGA were represented in the Questionnaires (QS) domain following the QRS Supplement: Clinical Global Impression (CGI; see https://www.cdisc.org/foundational/qrs). This supplement provides guidelines on the representation of CGI instruments, which include the Clinical Global Impression of Severity (CGI-S), the Clinical Global Impression of Change (CGI-C), and the Clinical Global Impression of Improvement (CGI-I). Assessments based on a specific point of time are typically called static assessments. However, when representing these data using the QS domain, the generic test name and codes are CGI02-Severity and CGI0201, respectively, as this static assessment is essentially a severity rating.
The sPGA shown in the following QS dataset is based on descriptions provided by the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) indicated for the treatment of psoriasis. Various sPGAs with different descriptions and scores have been used in clinical trials; most are similar to the example below. This assessment was based on a 6-point scale:
- Severe (5): Very marked plaque elevation, scaling, and/or erythema
- Moderate to severe (4): Marked plaque elevation, scaling, and/or erythema
- Moderate (3): Moderate plaque elevation, scaling, and/or erythema
- Mild (2): Slight plaque elevation, scaling, and/or erythema
- Almost clear (1): Intermediate between mild and clear
- Clear (0): No signs of psoriasis (post-inflammatory hyperpigmentation may be present)
Note that original result was standardized to the numeric value in QSSTRESC.
NUMERICAL RATING SCALE 6-POINT
|2||PS003||QS||001||2||CGI0201||CGI02-Severity||CGI||PSORIASIS||MILD||2||2||NUMERICAL RATING SCALE 6-POINT||2||2015-07-15|
|3||PS003||QS||001||3||CGI0201||CGI02-Severity||CGI||PSORIASIS||MILD||2||2||NUMERICAL RATING SCALE 6-POINT||3||2015-08-22|
|4||PS003||QS||001||4||CGI0201||CGI02-Severity||CGI||PSORIASIS||CLEAR||0||0||NUMERICAL RATING SCALE 6-POINT||4||2015-12-18|