title: Disease-specific patient reported outcome tools for systemic lupus erythematosus.
abstract: OBJECTIVE
  Systemic lupus erythematosus (SLE) can significantly affect both health and non-health-related quality of life (HRQOL and non-HRQOL). However, of the existent published patient-reported outcome (PRO) tools, none were developed from US patients, an ethnically diverse population. Furthermore, these tools do not address men with SLE or assess non-HRQOL issues. Herein, we present the development and validation of the Lupus Patient-Reported Outcome tool (LupusPRO) and discuss its clinical utility and research value compared with other PRO tools currently available for SLE.
  
  
  METHODS
  Beginning with a conceptual framework, items for LupusPRO were generated using feedback from women and men with SLE. The tool underwent iterations based on patient feedback and clinimetric and psychometric analyses. Validity (content, construct, and criterion) and reliability (internal consistency and test-retest) for the 44-item LupusPRO tool are presented.
  
  
  RESULTS
  Consistent with the conceptual framework, items were identified that were related to HRQOL and non-HRQOL constructs. HRQOL domains included (1) lupus symptoms; (2) physical health (physical function, role physical); (3) pain-vitality; (4) emotional health (emotional function and role emotional); (5) body image; (6) cognition; (7) procreation; and (8) lupus medications. Non-HRQOL domains were (1) available social support and coping; (2) desires-goals; and (3) satisfaction with medical care. Internal consistency reliability (0.68-0.94), test-retest reliability (0.55-0.92), content, construct (r > 0.50 with SF-36), and criterion (r > -0.35 with disease activity) validity were fair to good.
  
  
  CONCLUSIONS
  LupusPRO is a valid and reliable disease-targeted patient-reported health outcome tool that is generalizable to SLE patients in the United States of varied ethnic backgrounds and either gender.
authors.affiliation: Rush University, Chicago, IL, USA. Meenakshi_Jolly@rush.edu
authors.forename: Meenakshi
authors.initials: M
authors.lastname: Jolly
authors.forename: A Simon
authors.initials: AS
authors.lastname: Pickard
authors.forename: Joel A
authors.initials: JA
authors.lastname: Block
authors.forename: Rajan B
authors.initials: RB
authors.lastname: Kumar
authors.forename: Rachel A
authors.initials: RA
authors.lastname: Mikolaitis
authors.forename: Caitlyn T
authors.initials: CT
authors.lastname: Wilke
authors.forename: Roger A
authors.initials: RA
authors.lastname: Rodby
authors.forename: Louis
authors.initials: L
authors.lastname: Fogg
authors.forename: Winston
authors.initials: W
authors.lastname: Sequeira
authors.forename: Tammy O
authors.initials: TO
authors.lastname: Utset
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Cash
authors.forename: Iona
authors.initials: I
authors.lastname: Moldovan
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Katsaros
authors.forename: Perry
authors.initials: P
authors.lastname: Nicassio
authors.forename: Mariko L
authors.initials: ML
authors.lastname: Ishimori
authors.forename: Mark
authors.initials: M
authors.lastname: Kosinsky
authors.forename: Joan T
authors.initials: JT
authors.lastname: Merrill
authors.forename: Michael H
authors.initials: MH
authors.lastname: Weisman
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Wallace
mesh_terms: D000203:Activities of Daily Living; D005246:Feedback; D005260:Female; D006304:Health Status; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy; D008297:Male; D017063:Outcome Assessment, Health Care; D010146:Pain; D011788:Quality of Life; D015203:Reproducibility of Results; D057566:Self Report; D016896:Treatment Outcome; D014481:United States