VAS for Itching and Quality of Life

This is an example of the representation of a patient VAS for evaluating the severity of itching and the impact of psoriasis symptoms on daily life. These are only examples and sponsors may use other assessments.

The Findings About Events or Interventions (FA) domain was used for the assessment of signs and symptoms. Sponsors may represent findings data in a single FA dataset or split the FA domain into separate datasets, following the guidance in the SDTMIG. In this example, an FACE dataset was used. The psoriasis condition (including symptoms) is considered a clinical event, whereas the evaluation of signs and symptoms at specific time points are considered findings about the clinical event. A parent record in the CE domain is not required.

• The severity of itching is rated using an 11-point numerical scale of 0-10, with 0 = "No Itching" and 10 = "Worst Itch Imaginable." No descriptions were provided for the other numbers. Subjects circled the number which best described their itching in the last 24 hours. 
• The impact of psoriasis symptoms on quality of life (QOL) is assessed using a VAS scale of 50 mm, where the subject rates the impact from "No Influence" to "A Lot of Influence."