Patient experience in systemic lupus erythematosus: development of novel patient-reported symptom and patient-reported impact measures

Journal of Patient-reported Outcomes
Susan D MathiasAnca D Askanase

Abstract

Comprehensive assessment of systemic lupus erythematosus (SLE) and its treatment requires patient-reported outcome (PRO) measures to capture impacts and fluctuating symptoms. The objective of this study was to develop PROs, in accordance with the Food and Drug Administration (FDA) PRO Guidance, to assess fluctuations in SLE symptoms and its impact. Following independent review board approval, six US rheumatology practices recruited patients with SLE to participate in concept elicitation (CE) interviews, in order to identify important SLE symptoms and their impacts. The SLE Symptom Severity Diary (SSD) and SLE Impact Questionnaire (SIQ) were drafted based on CE interview results and clinician input. The PROs were revised based on patient feedback from cognitive debriefing (CD) interviews, clinician feedback, and a translatability assessment. Forty-one patients completed CE interviews. Commonly-reported symptoms included fatigue (98%), joint pain (93%), and rash (88%). The most frequently reported impact was difficulty with chores/housework (61%). Eighteen patients completed CD interviews. The PROs were considered comprehensive, clear, and relevant.The SSD contains 17 items assessing energy/vitality, joint and muscle pain/stiffne...Continue Reading

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Citations

Nov 21, 2018·International Journal of Nursing Practice·HyunSoo OhWhaSook Seo
Jul 4, 2019·American Journal of Medical Genetics. Part C, Seminars in Medical Genetics·Scott OishiTerri Beckwith
Jul 4, 2021·Rheumatic Diseases Clinics of North America·Narender Annapureddy, Meenakshi Jolly

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Software Mentioned

MAXQDA
PRO Evidence Dossier

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