title: Establishing clinical meaning and defining important differences for Patient-Reported Outcomes Measurement Information System (PROMIS®) measures in juvenile idiopathic arthritis using standard setting with patients, parents, and providers.
abstract: Patient-Reported Outcomes Measurement Information System (PROMIS) measures are used increasingly in clinical care. However, for juvenile idiopathic arthritis (JIA), scores lack a framework for interpretation of clinical severity, and minimally important differences (MID) have not been established, which are necessary to evaluate the importance of change.
  
  
  
  We identified clinical severity thresholds for pediatric PROMIS measures of mobility, upper extremity function (UE), fatigue, and pain interference working with adolescents with JIA, parents of JIA patients, and clinicians, using a standard setting methodology modified from educational testing. Item parameters were used to develop clinical vignettes across a range of symptom severity. Vignettes were ordered by severity, and panelists identified adjacent vignettes considered to represent upper and lower boundaries separating category cut-points (i.e., from none/mild problems to moderate/severe). To define MIDs, panelists reviewed a full score report for the vignettes and indicated which items would need to change and by how much to represent "just enough improvement to make a difference."
  
  
  
  For fatigue and UE, cut-points among panels were within 0.5 SD of each other. For mobility and pain interference, cut-scores among panels were more divergent, with parents setting the lowest cut-scores for increasing severity. The size of MIDs varied by stakeholders (parents estimated largest, followed by patients, then clinicians). MIDs also varied by severity classification of the symptom.
  
  
  
  We estimated clinically relevant severity cut-points and MIDs for PROMIS measures for JIA from the perspectives of multiple stakeholders and found notable differences in perspectives.
authors.affiliation: Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA. esi.morgan_dewitt@cchmc.org.|Division of Rheumatology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, MLC 4010, Cincinnati, OH, 45229, USA. esi.morgan_dewitt@cchmc.org.|James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA. esi.morgan_dewitt@cchmc.org.
authors.forename: Esi M
authors.initials: EM
authors.lastname: Morgan
authors.affiliation: Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.|Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Constance A
authors.initials: CA
authors.lastname: Mara
authors.affiliation: Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.|Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors.forename: Bin
authors.initials: B
authors.lastname: Huang
authors.affiliation: Division of Rheumatology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, MLC 4010, Cincinnati, OH, 45229, USA.
authors.forename: Kimberly
authors.initials: K
authors.lastname: Barnett
authors.affiliation: Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.|Department of Psychology, University of Cincinnati College of Arts and Sciences, Cincinnati, OH, USA.
authors.forename: Adam C
authors.initials: AC
authors.lastname: Carle
authors.affiliation: Division of Rheumatology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, MLC 4010, Cincinnati, OH, 45229, USA.
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Farrell
authors.affiliation: Department of Medical Social Sciences, Northwestern University, Chicago, IL, USA.
authors.forename: Karon F
authors.initials: KF
authors.lastname: Cook
mesh_terms: D000293:Adolescent; D000328:Adult; D001171:Arthritis, Juvenile / Q000523:psychology*; D005260:Female; D006282:Health Personnel; D006801:Humans; D008297:Male; D010290:Parents; D000071066:Patient Reported Outcome Measures; D010361:Patients; D011594:Psychometrics / Q000379:methods*; D018434:Sickness Impact Profile; D055815:Young Adult
keywords: Item response theory (IRT); Juvenile idiopathic arthritis; PROMIS; Patient-reported outcomes; Psychometric methods