title: Patient-Reported Outcomes Measurement Information System in Children with Crohn's Disease.
abstract: To assess the criterion validity and responsiveness of Patient-Reported Outcomes Measurement Information System (PROMIS) in a web-based cohort of children with Crohn's disease.
  
  
  
  We recruited children with Crohn's disease (ages 9-17 years) and their parents from the web-based Crohn's and Colitis Foundation of America Kids and Teens Study cohort. Upon entry into the cohort and 6 months later, children self-reported Crohn's disease activity, health-related quality of life, and PROMIS domains of pain interference, anxiety, depression, fatigue, and peer relationships.
  
  
  
  Mean PROMIS scores for the 276 participating patients were worse among those with worse self-reported Crohn's disease activity (per Short Crohn's Disease Activity Index, P < .005 for all), Crohn's disease activity in the prior 6 months (per Manitoba Index, P < .01 for all), and health-related quality of life (per IMPACT-35, P < .001 for all). One hundred forty-three patients and their parents completed follow-up questionnaires, 75% of whom reported stable disease activity. Those with improved Crohn's disease activity reported improved PROMIS scores, and those with worsened Crohn's disease activity reported worse PROMIS scores for all domains except anxiety. All participants reported improved anxiety from baseline, but those with stable or worsened Crohn's disease activity reported less improvement (P = .07).
  
  
  
  PROMIS scores were significantly associated with Crohn's disease activity in a linear and clinically meaningful manner, and responded to change in Crohn's disease activity over a 6-month period. This supports the criterion validity and responsiveness of pediatric PROMIS.
authors.affiliation: University of North Carolina at Chapel Hill, Chapel Hill, NC. Electronic address: marina_arvanitis@med.unc.edu.
authors.forename: Marina
authors.initials: M
authors.lastname: Arvanitis
authors.affiliation: University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Darren A
authors.initials: DA
authors.lastname: DeWalt
authors.affiliation: University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Christopher F
authors.initials: CF
authors.lastname: Martin
authors.affiliation: University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Millie D
authors.initials: MD
authors.lastname: Long
authors.affiliation: University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Wenli
authors.initials: W
authors.lastname: Chen
authors.affiliation: University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Beth
authors.initials: B
authors.lastname: Jaeger
authors.affiliation: University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Sandler
authors.affiliation: University of North Carolina at Chapel Hill, Chapel Hill, NC.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Kappelman
mesh_terms: D000293:Adolescent; D002648:Child; D015331:Cohort Studies; D003424:Crohn Disease / Q000150:complications* / Q000523:psychology*; D005260:Female; D063005:Health Information Systems; D006801:Humans; D007398:Interpersonal Relations; D008297:Male; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life; D015203:Reproducibility of Results; D057566:Self Report
keywords: Crohn's disease; PROMIS; anxiety; depression; fatigue; patient-reported outcomes; peer relationships; quality of life