Breakout Group Instructions & Case Example on Atopic Dermatitis
Explore breakout group logistics for meaningful discussions on demonstrating the endpoint in atopic dermatitis research. Dive into a case example focusing on measuring scratching activity as a key outcome, highlighting the importance of assessing itchiness in clinical trials.
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July 28, 2021 Breakout Group Instructions: Day 2
Small Group Discussions: Demonstrating Meaningfulness of the Endpoint Objective: Share insights on what s needed to demonstrate the meaningfulness of the endpoint.
Breakout Group Logistics Breakout sessions will be 40 minutes long Each participant will quickly introduce themselves (state name, role, and organization- <1 minute) Facilitator will ask the discussion questions Groups will use the case example to help guide answers After 40 minutes, you will be prompted to reconvene to the plenary session for a recap (provided by each facilitator) Accept the prompt back to plenary and then take a 5 min break before the recap
Atopic Dermatitis Atopic dermatitis (also known as atopic eczema) is a disorder characterized by inflammation of the skin (dermatitis)1 Onset typically occurs in infancy/childhood but can continue into adulthood Clinical presentation: dry, itchy skin and red rashes that can occur on any part of the body, although the pattern tends to be different at different ages Itch can be evaluated via subjective patient-reported assessments or by objective measurement of scratching activity.2 Clinical trials now use scratching measurement as a primary outcome measure, and steps toward the standardization of itch assessment are being made to meet the growing need for reliably measuring itch and its impact on quality of life in the clinical research setting. 2 1. MedlinePlus. Atopic Dermatitis. https://medlineplus.gov/genetics/condition/atopic-dermatitis/ 2. Erickson, S. Research Techniques Made Simple: Itch Measurement in Clinical Trial. Jrn of Inves Derm. Feb 2019
Case Example: Atopic Dermatitis Outcome to be measured Meaningful Aspect of Health (MAH) Concept of Interest (COI) Atopic Dermatitis I want to be able to sit through my daughter s recital without itching scratching Outcome: minutes per day of total scratching Endpoint: Change in the level of scratching as measured by mins/day Image Source: derived from playbook.dimesociety.org
Case Example The specific novel endpoint for this example is: Change in level of scratching Measured in minutes/day of total scratching Using an accelerometer* In patients with moderate to severe atopic dermatitis * an instrument for measuring acceleration or for detecting and measuring vibrations
