Exploring Symptoms, Impacts, and Patient-Reported Outcome (PRO) Measures in Prurigo Nodularis: A Review of the Literature
Author(s)
Chanis R1, Dias Barbosa C2, Wilson R3, Jabbar-Lopez Z4, Puelles J4, Gabriel S4
1Evidera, Bethesda, MD, USA, 2Evidera, London , LON, UK, 3Evidera, Seattle, WA, USA, 4Galderma, La Tour-de-Peilz, Switzerland
OBJECTIVES Prurigo nodularis (PN) is a skin disease characterized by the presence of multiple nodules and papules that cause intense itch. This review aimed to identify the most bothersome symptoms in individuals living with PN, impacts of PN on health-related quality of life (HRQL), and patient-reported outcomes (PROs) used to collect patient experience data. METHODS Searches for published articles and conference abstracts were conducted in MEDLINE and EMBASE from January 2011 to March 2020. Selected studies included adults diagnosed with PN, and reported patients’ experiences of PN symptoms, impacts, and treatment. RESULTS Of the 134 identified articles, 27 studies of varied designs were included. These were observational (n=14), randomized controlled trials (n=5), quasi-experimental (n=5), and reviews (n=2). No qualitative studies were identified. Overall, studies showed itch was an important concept to measure among patients with PN. PN impacted HRQL, including sleep, emotional functioning, relationships, and daily activities. A total of 41 PROs assessing symptoms or impacts were identified. The most frequently used PRO for itch intensity is the Visual Analogue Scale (n=10). Other measures included the Worst Itch Numerical Rating Scale (n=5) and the Itch Verbal Rating Scale (n=5). Eight PROs assessing sleep were identified, using either multi-item (n=5) or single-item scales (n=3). Eight studies reported using the Dermatological Life Quality Index (DLQI), and three studies reported using ItchyQOL to assess HRQL. Psychological distress was measured using the Beck Depression Inventory (BDI) and Hospital Anxiety and Depression Scale (HADS). CONCLUSIONS Chronic itch is the most bothersome symptom in PN, interfering significantly with sleep and HRQL and causing high levels of anxiety and depression. Several different PROs have been used to assess symptoms and impacts; however, validation evidence through qualitative and psychometric evaluations is needed to support PRO use as key endpoints in future PN clinical trials.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
PMU90
Topic
Clinical Outcomes, Patient-Centered Research
Topic Subcategory
Clinical Outcomes Assessment, Patient-reported Outcomes & Quality of Life Outcomes
Disease
Rare and Orphan Diseases, Sensory System Disorders