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Factors Associated with Treatment Escalation for Psoriasis: an Electronic Health Record Platform for Retrospective and Prospective Real-world Studies

Year: 2022
Type: preprint
Study design: Observational Study
Abstract: Background Electronic health records (EHRs) offer the possibility of using data entry templates to simultaneously perform routine documentation during clinical care and to capture disease-specific measures as discrete data elements that can be used for health services research (HSR). The objective of this study was to determine factors associated with meaningful treatment escalation of psoriasis as a pilot study for future real-world retrospective and prospective comparative effectiveness studies, including pragmatic clinical trials. Methods We conducted a retrospective, observational cohort study of patients with psoriasis by using data collected in the course of routine clinical care from an EHR using EpiCare® SmartForms customized for psoriasis. The Psoriasis SmartForm records body surface area (BSA) affected, plaque and overall Physician Global Assessments (pPGA and oPGA), and a patient-reported severity rating scale as well as descriptive findings (e.g., lesion locations, symptoms such as itch or pain) to generate visit notes. These clinical data were extracted and analyzed to identify factors associated with meaningful treatment escalation (MTE), defined as changing or adding phototherapy or systemic oral or biologic therapy. Results We identified 473 patients with psoriasis who had at least three consecutive visits between October 2015 and October 2018; 239 patients underwent MTE between their first (Visit 1) and third (Visit 3) observed visits, while 234 patients did not. Patients who experienced MTE had more severe disease at Visit 1 as assessed by BSA, pPGA, oPGA, and the patient-reported measure than patients who did not experience MTE. Other factors associated with MTE included use of topical medications only or no active treatment at Visit 1, palmoplantar disease phenotype and involvement of other difficult-to-treat body areas. After adjusting for potential confounding factors, we found that patients who underwent MTE experienced larger improvements in disease severity than those who did not. Conclusions This study highlights how data collected during routine clinical practice can be readily used for real-world retrospective HSR studies when disease measures are captured discretely. This approach could provide a cost-effective platform to conduct retrospective and prospective real-world studies, pragmatic trials, and comparative effectiveness research.
DOI: 10.21203/rs.3.rs-1732814/v1
Language: English
Subfield: Immunology
Open Access status: green
OpenAlex ID: W4284668974
Cites: 12
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Related to: 10