title: Development of the Systemic Lupus Erythematosus Steroid Questionnaire (SSQ): a novel patient-reported outcome tool to assess the impact of oral steroid treatment.
abstract: BACKGROUND
  Oral glucocorticoids (steroids) are the mainstay of treatment for systemic lupus erythematosus (SLE), but their use is often associated with short- and long-term side effects. Following a literature review and discussions with patients with SLE, clinicians, and payers, a need was identified for a comprehensive SLE-specific tool that can be used to evaluate the side effects and benefits of steroids over time from a patient perspective. The objective of this study was to develop a patient-reported outcome (PRO) measure to assess general impact (baseline burden), benefits, side effects, and impacts associated with the use of oral steroids in patients with SLE.
  
  
  METHODS
  A qualitative research protocol was developed in which adults with SLE currently receiving or who had received steroids in the past year were recruited from six US rheumatology practices to participate in concept elicitation (CE) interviews. The SLE Steroid Questionnaire (SSQ) was developed based on CE interview results and clinical input. Cognitive debriefing interviews with a second group of patients with SLE evaluated the content, clarity, and relevance of the items. The SSQ was refined using patient feedback, clinician review, and a translatability assessment. The protocol received central independent review board approval.
  
  
  RESULTS
  Thirty-three patients (52% moderate disease severity; 58% currently receiving steroids, mean dose 8.7 mg/day) completed CE interviews. Patients reported benefits, side effects, and impacts from steroids. The refined SSQ contains 50 items assessing steroid dose/duration (4 items), general impact (baseline burden; 19 items), benefits (7 items), work/productivity (3 items), side effects (10 items), emotions (6 items), and overall satisfaction (1 item).
  
  
  CONCLUSIONS
  The SSQ is a unique PRO, developed using robust scientific methodology in accordance with the Food and Drug Administration PRO Guidance. It was designed to comprehensively assess the patient experience with steroid therapy and better understand the benefits and burden of steroids for patients with SLE.
authors.affiliation: Health Outcomes Solutions, PO Box 2343, Winter Park, FL, 32790, USA. smathias@healthoutcomessolutions.com.
authors.forename: Susan D
authors.initials: SD
authors.lastname: Mathias
authors.affiliation: GSK, King of Prussia, PA, USA.
authors.forename: Pamela
authors.initials: P
authors.lastname: Berry
authors.affiliation: GSK, London, UK.
authors.forename: Jane
authors.initials: J
authors.lastname: De Vries
authors.affiliation: Columbia University Medical Center, New York, NY, USA.
authors.forename: Anca
authors.initials: A
authors.lastname: Askanase
authors.affiliation: GSK, London, UK.
authors.forename: Katie
authors.initials: K
authors.lastname: Pascoe
authors.affiliation: Health Outcomes Solutions, PO Box 2343, Winter Park, FL, 32790, USA.
authors.forename: Hilary H
authors.initials: HH
authors.lastname: Colwell
authors.affiliation: GSK, Philadelphia, PA, USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Chang
mesh_terms: D000328:Adult; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006305:Health Status Indicators; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000150:complications / Q000188:drug therapy* / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011594:Psychometrics; D036301:Qualitative Research; D011788:Quality of Life / Q000523:psychology; D011795:Surveys and Questionnaires / Q000592:standards*
chemical_list: D005938:Glucocorticoids
keywords: Impact; Oral steroids; Patient-reported outcomes; Steroid burden; Systemic lupus erythematosus