Feasibility and Construct Validity of PROMIS and “Legacy” Instruments in an Academic Scleroderma Clinic

Abstract

Background The NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Roadmap initiative is a cooperative group program of research designed to develop, evaluate, and standardize item banks to measure patient-reported outcomes relevant across medical conditions. For adults, 11 domains have been developed in physical, mental, and social health. Purpose The objective of the current study was to assess feasibility and construct validity of PROMIS item banks versus legacy measures in a observational study in systemic sclerosis (SSc). Methods Patients with SSc in a single academic center completed computerized adaptive technology (CAT) administered PROMIS item banks during the clinic visit and legacy domains (using paper-and-pencil). The construct validity of PROMIS items was evaluated by examining correlations with corresponding legacy measures using multitrait-multimethod analysis. Results Participants consisted of 143 SSc patients with an average age of 51.5 years; 71% were female and 68% were Caucasian. The average number of items completed for each CAT-administered item bank ranged from 5 to 8 (69 CAT items per patient), and the average time to complete each CAT-administered item bank ranged from 48 seconds to 1.9 minutes per patient (average time= 11.9 minutes/per patient for 11 banks). All correlations between PROMIS domains and respective legacy measures were large and in the hypothesized direction (ranged from .61 to .82). Conclusion Our study supports the construct validity of the CAT-administered PROMIS item banks and shows that they can be administered successfully in a clinic with support staff. Future studies should assess the feasibility of PROMIS item banks in a busy clinical practice

Quality of life in systemic sclerosis

“…is a generic health status measure consisting of 36 items assessing 8 scales [9,103] which are summarized into Physical and Mental Component Summary scores. It has a 4-week recall period.…”

“…The Health Assessment Questionnaire-Disability Index (HAQ-DI) [9,105] is a self-administered 20 question instrument in 8 domains (dressing, arising, eating, walking, hygiene, reach, grip and common daily activities) designed for arthritis that assesses a patient's level of functional ability/disability and includes questions that involve both upper and lower extremities. It ranges from 0 (no disability) to 3 (severe disability) and has a 7 day recall period.…”

“…The SDO has shown good internal consistency and construct validity for individuals with SSc [108]. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [9,34,44] is a 13-item questionnaire that assesses selfreported fatigue and its impact upon daily activities and function, with a range of possible scores of 0-52, with lower scores reflecting more fatigue. It uses a 5-point categorical response scale of 0 (not at all) to 4 (very much).…”

“…It has a 7 day recall period. The Center for Epidemiologic Studies Depression (CESD-10) Scale [9,44,106] is a 10-item instrument that measures depressive symptoms using a 4-point categorical response scale (range 0 to 30) with higher scores representing greater depressive symptoms (score ≥ 10). The items include depressed mood, feelings of guilt, worthlessness and helplessness, psychomotor retardation, loss of appetite and sleep difficulties.…”

“…There is no effective treatment or cure to SSc [8][9][10], so a primary goal of care is to reduce symptoms and disability and to improve health-related quality of life (HR-QoL), with both pharmacological and non-pharmacological interventions [8,11].…”