Atopic dermatitis (AD, or eczema) is a common inflammatory skin disorder driven by a complex relationship between genetic predisposition and environmental exposures. It affects approximately 17% of children with moderate to severe disease severity in 37% of school-age children and greater severity in lower socioeconomic and minority populations. Nevertheless, there are significant knowledge gaps about the impact of the disease and its treatment on quality of life (QOL) for these many children. PROMIS aims to establish a national resource for precise and efficient measurement of self-reported symptoms, functioning, and QOL appropriate for patients with a wide variety of chronic disorders conditions. AD provides a high prevalence/high impact model of a chronic disorder with symptoms that can be exacerbated by personal and environmental stressors, further compromising psychosocial and family well-being. This project aims to evaluate the validity, reliability and responsiveness of the pediatric PROMIS measures in children with AD via collaboration with the Lurie Children?s Dermatology Research Registry at Northwestern. This registry is chosen due to the patient-centered nature of the Eczema Center, which has assembled and met several times with an Advisory Board to better understand and evaluate outcomes issues with children with AD. They found that current PROMIS measures do not address pruritus (itch), the most frequent and bothersome symptom associated with AD. AD-related Itch, and its effects upon sleep, mood and functioning, is associated with substantial psychological, financial, and social burden to patients and families. Itch is also a life-altering feature of several other pediatric inflammatory skin conditions, noncutaneous allergies, systemic disease, use of psychotropic medication, or even psychosomatic disease. We propose to develop an itch item bank to complement the currently available, more generic pediatric PROMIS tools, thus capturing the full spectrum of patient-reported outcomes (PROs) and their impact in children with chronic pruritic skin disorders. This 48-month project has 4 specific aims: 1) Using our PROMIS standards, develop and calibrate a pediatric itch item bank for children ages 5-17. We will use a mixed methods approach to ensure that final items are appropriate for use with children and adolescents. 2) Validate generic PROMIS measures of global health, pain, depressive symptoms, anxiety, physical function, fatigue, peer relationships, psychological stress experiences, and stigma, and the new itch-specific measures in our well-characterized children with AD who span a wide range of ages and disease severity. PROMIS measures will be examined in relationship to clinical and other PRO assessments. 3) Examine the sensitivity of PROMIS in detecting clinically significant change in disease status and estimate minimally important differences for PROMIS measures in children with AD. 4) Investigate the impact upon environmental stressors to domains measured by the PROMIS measures by evaluating differences between children with different races/ethnicities and family income status.
|Phipatanakul, Wanda; Koutrakis, Petros; Coull, Brent A et al. (2017) The School Inner-City Asthma Intervention Study: Design, rationale, methods, and lessons learned. Contemp Clin Trials 60:14-23|