An opportunity to improve the quality of care for patients with chronic spontaneous urticaria: A reimagined 3-step real-world study protocol.

Background: Chronic spontaneous urticaria (CSU) is a debilitating condition of the skin that leads to significant negative impacts on patient quality of life and psychological well-being. Given the complexities of the disease, care of patients with CSU is not always optimal, which presents the medical community with an opportunity to improve. Objectives: We sought to develop a greater understanding and better management of CSU using insights from real-world clinical practice. Methods: The study protocol for this 3-step mixed-methods approach is described. Results: Step 1 (patient factors): Patient electronic medical records using longitudinal data (December 31, 2012, to December 31, 2022) from Endeavor Health System will be analyzed to understand characteristics of CSU. Step 2 (physician perspectives from 5 allergists/immunologists and 5 dermatologists treating >50 patients with CSU/y and 5 internists, 5 pediatricians, and 5 family medicine doctors treating >10 patients with CSU/y): Physician demographics; electronic medical records, including use of patient-reported outcomes and adherence to guidelines; and 1:1 physician interviews on knowledge of CSU guideline-based care will be used to understand gaps in evaluation, diagnosis, and treatment of patients with CSU. Step 3 (quality improvement): Recommendations to improve quality of care for patients with CSU will be developed, pilot tested, and published. Conclusions: Greater understanding of patient factors, physician perspectives, and avenues to improve quality of care will assist physicians in providing better care, improving quality of life for patients with CSU. This study is an opportunity to provide patients with CSU with better understanding, support, and treatment.