East Hanover, NJ, USA – The impact of chronic plaque psoriasis on health-related quality of life is substantial and often causes symptoms, such as pain, that are not directly observable by clinicians. Measures that assess symptoms and impact from the patient’s perspective can thus guide comprehensive health assessments for clinical decision making. A Psoriasis Symptom Diary© was developed to assess patients’ daily self-reports of their psoriasis symptoms and the functional impact related to the underlying pathophysiology of the disease. The article “Item-Level Psychometric Properties for a New Patient-Reported Psoriasis Symptom Diary,” published in Value in Health, describes a study that was conducted to evaluate psychometric properties of the Psoriasis Symptom Diary© and its value in clinical development. The study was led by researchers from Novartis Pharmaceutical Corporation, ERT and US Dermatologists.
The Psoriasis Symptom Diary©, a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance (FDA Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims, 2009), demonstrated favorable psychometric properties and usefulness for treatment efficacy evaluation alongside other measures of disease severity in clinical trials for chronic plaque psoriasis.
This research, which administered an electronic Psoriasis Symptom Diary© in a Phase 2 clinical trial of US adult outpatients (N=172) with physician-diagnosed moderate to severe chronic plaque-type psoriasis, evaluated the psychometric properties of the measure; identified diary responder definitions for use in determining if a patient has experienced clinically meaningful change; and refined diary item content for use in future clinical trials.
Results indicated that the Psoriasis Symptom Diary© items were reliable and valid, sensitive to changes in the clinical condition over time, and scores are interpretable. Further, the measure demonstrated high levels of compliance, with participants completing 94% of scheduled electronic diary assessments across 12 study weeks.
“The Psoriasis Symptom Diary© is a relevant advancement in psoriasis research as it offers a valid and responsive assessment of patient symptoms that may vary on a daily basis.” said study investigator Dr. Bruce E. Strober, Vice Chair of the Department of Dermatology and Director of Clinical Trials, University of Connecticut.
Value in Health (ISSN 1098-3015) publishes papers, concepts, and ideas that advance the field of pharmacoeconomics and outcomes research as well as policy papers to help health care leaders make evidence-based decisions. The journal is published bi-monthly and has over 8,000 subscribers (clinicians, decision-makers, and researchers worldwide).
International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a nonprofit, international, educational and scientific organization that strives to increase the efficiency, effectiveness, and fairness of health care resource use to improve health.
For more information: www.ispor.org