title: Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) gastrointestinal symptom scales.
abstract: OBJECTIVE
  The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS(®)) is a standardized set of patient-reported outcomes (PROs) that cover physical, mental, and social health. The aim of this study was to develop the NIH PROMIS gastrointestinal (GI) symptom measures.
  
  
  METHODS
  We first conducted a systematic literature review to develop a broad conceptual model of GI symptoms. We complemented the review with 12 focus groups including 102 GI patients. We developed PROMIS items based on the literature and input from the focus groups followed by cognitive debriefing in 28 patients. We administered the items to diverse GI patients (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), systemic sclerosis (SSc), and other common GI disorders) and a census-based US general population (GP) control sample. We created scales based on confirmatory factor analyses and item response theory modeling, and evaluated the scales for reliability and validity.
  
  
  RESULTS
  A total of 102 items were developed and administered to 865 patients with GI conditions and 1,177 GP participants. Factor analyses provided support for eight scales: gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). The scales correlated significantly with both generic and disease-targeted legacy instruments, and demonstrate evidence of reliability.
  
  
  CONCLUSIONS
  Using the NIH PROMIS framework, we developed eight GI symptom scales that can now be used for clinical care and research across the full range of GI disorders.
authors.affiliation: 1] Department of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, California, USA [2] Cedars-Sinai Center for Outcomes Research and Education, Los Angeles, California, USA [3] Department of Gastroenterology, VA Greater Los Angeles Healthcare System, Los Angeles, California, USA [4] Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, California, USA.
authors.forename: Brennan M R
authors.initials: BM
authors.lastname: Spiegel
authors.affiliation: 1] Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, California, USA [2] Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
authors.forename: Ron D
authors.initials: RD
authors.lastname: Hays
authors.affiliation: Cedars-Sinai Center for Outcomes Research and Education, Los Angeles, California, USA.
authors.forename: Roger
authors.initials: R
authors.lastname: Bolus
authors.affiliation: Department of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
authors.forename: Gil Y
authors.initials: GY
authors.lastname: Melmed
authors.affiliation: 1] Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA [2] Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.
authors.forename: Lin
authors.initials: L
authors.lastname: Chang
authors.affiliation: Cedars-Sinai Center for Outcomes Research and Education, Los Angeles, California, USA.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Whitman
authors.affiliation: Division of Rheumatology, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Puja P
authors.initials: PP
authors.lastname: Khanna
authors.affiliation: Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, California, USA.
authors.forename: Sylvia H
authors.initials: SH
authors.lastname: Paz
authors.affiliation: Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, California, USA.
authors.forename: Tonya
authors.initials: T
authors.lastname: Hays
authors.affiliation: Department of Psychology, UCLA, Los Angeles, California, USA.
authors.forename: Steve
authors.initials: S
authors.lastname: Reise
authors.affiliation: Division of Rheumatology, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Dinesh
authors.initials: D
authors.lastname: Khanna
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D017144:Focus Groups; D005767:Gastrointestinal Diseases / Q000453:epidemiology*; D006801:Humans; D007256:Information Systems; D008297:Male; D008875:Middle Aged; D009316:National Institutes of Health (U.S.); D063868:Patient Outcome Assessment; D011594:Psychometrics; D014481:United States