Driving Adoption of Nocturnal Scratch as a Digital Endpoint & Improving Patients’ Lives
Atopic dermatitis affects up to 2.4% of the world’s population, with nighttime scratching being a predominant and burdensome symptom for patients.
Today’s digital technologies can help us better understand these patients’ actions by examining their conditions in their home environment. Using digital tools and sensor-generated data, clinical researchers and drug developers can collect essential information about patients’ nighttime scratching, measuring, and quantifying this behavior in real-time.
Access the tools that will help you move from “what should I measure?” to “this is what I will measure and here’s how I’m going to be successful.”
Patient Research: Measures that Matter
We conducted a mixed methods study, interviewing 49 adult and pediatric patients as well as their caregivers, partners, and spouses. Following the qualitative interview, we performed a quantitative study surveying 758 adult patients and 591 caregivers for child patients.
DOWNLOAD QUANTITATIVE DATASET
This publication reports the research study as part of DiMe’s Nocturnal Scratch project and dives into the everyday experience of a patient with atopic dermatitis. Patients with atopic dermatitis were surveyed and interviewed, and the team explored signs, symptoms, and effects on daily life and looked into nocturnal scratching as a concept that has not been historically sufficiently explored.
Measures Terminology and Ontology
A shared terminology and measure ontology enables you to assess nocturnal scratch consistently across studies and in different patient populations.
What is ontology? It is a set of measurement concepts that also shows their properties and the relationships between them. The unified terminology for “nocturnal” and “scratch” is based in systematic literature review and conversations with regulators.
When we all measure the same thing the same way, we can all benefit from the scientific findings. We hope to see adoption of these measurement ontologies and properties among technology developers, regulators, payers, patients, and the industry to enable the standardization of measuring nocturnal scratch.
Deployment to Clinical Trials
Are you planning a study with digitally measured nocturnal scratch as an outcome measure? This toolkit of resources, created by patients, clinicians, technologists, academics, and industry experts, will guide you every step of the way.
Use the tools below to articulate value, select the right technology for the right patients, and optimize your study for the best patient and site experience. Additionally, there are recommendations for subject privacy, data collection, or study monitoring.
Digitally measured nocturnal scratch can provide additional value to the development of drug-based products, evidence generation, and reimbursement decisions.
You can use these resources to hold internal discussions and plan for payer involvement and reimbursement strategies. You can also help payers understand the field of digital evidence generating tools.
We’ve worked with leading organizations who are developing and deploying digitally measured nocturnal scratch as a digital drug development tool. Together, we are driving the adoption and acceptance of this novel digital measure.