Lead Investigator: You-Shan Feng, Universitätsklinikum Tübingen
Title of Proposal Research: Psychometric properties and scoring approaches for the EuroQol-5 dimension-5 level (EQ-5D-5L) Psoriasis-specific questions
Vivli Data Request: 10391
Funding Source: This project is funded by the EuroQol Foundation (project code: 1901-RA)
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Psoriasis is a long-lasting skin condition where the immune system mistakenly attacks the skin, causing red, scaly patches. This affects about 2% of people in Europe and is common in Australasia, Europe, and wealthier parts of the Americas. Beyond just the visible skin changes, psoriasis can also lead to joint pain and significantly impact a person’s daily life.
To measure how psoriasis affects people’s lives, researchers often use a tool called the EQ-5D-5L. This questionnaire asks about five areas: mobility (how well you move around), self-care (how easily you can take care of yourself), usual activities (how much you can do your everyday tasks), pain/discomfort (how much pain or discomfort you feel), and anxiety/depression (how anxious or depressed you feel). Each area has five levels of response, ranging from no problems to severe problems.
While the EQ-5D-5L is widely used, it might not cover all the important aspects of living with psoriasis. To address this, two new questions have been added to the questionnaire: one about self-confidence and another about skin irritation. These questions were created based on past research using existing scientific evidence, interviews with patients, and consultation with medical experts. The aim of our project is to see if these new questions improve how well the EQ-5D-5L measures the impact of psoriasis treatments on a person’s quality of life.
We will evaluate this by analyzing data from three clinical trials where patients with psoriasis answered the EQ-5D-5L with the new questions. We will look at the responses before and after treatment to see if the new questions provide useful information about changes in patients’ quality of life. Additionally, we will test different methods for scoring the EQ-5D-5L with the new questions to ensure they accurately reflect the patients’ experiences and improvements from the treatment.
If our findings show that the added questions improve the quality of life measurements, they could be recommended for future studies. This would help ensure that new treatments for psoriasis are assessed more thoroughly and accurately, ultimately leading to better care for patients.
Requested Studies:
A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis
Data Contributor: Lilly
Study ID: NCT02561806
Sponsor ID: 16012
A 24-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Fumaric Acid Esters and Methotrexate in Patients With Moderate-to-Severe Plaque Psoriasis Who Are Naive to Systemic Treatment With an Extension Period
Data Contributor: Lilly
Study ID: NCT02634801
Sponsor ID: 16190
A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period
Data Contributor: Lilly
Study ID: NCT01646177
Sponsor ID: 13685