title: Responsiveness to Change and Minimally Important Differences of the Patient-Reported Outcomes Measurement Information System Gastrointestinal Symptoms Scales.
abstract: The NIH-sponsored Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal (GI) Symptoms scales were developed to assess patients' GI symptoms in clinical settings.
  
  
  
  To assess responsiveness to change and provide minimally important difference (MID) estimates for the PROMIS GI Symptoms scales.
  
  
  
  A sample of 256 GI outpatients self-administered the eight PROMIS GI Symptoms scales (gastroesophageal reflux, disrupted swallowing, diarrhea, bowel incontinence/soilage, nausea and vomiting, constipation, belly pain, and gas/bloating/flatulence) at two visits. Patient self-reported and physician-reported assessments of the subjects' overall GI condition were employed as change anchors. In addition, we prospectively assessed change at both visits using a GI-symptom anchor, the Gastrointestinal Symptom Rating Scale (GSRS). Responsiveness to change was assessed using F-statistics. The minimally changed group was those somewhat better or somewhat worse on the retrospective anchors and changing by one category on the modified GSRS (e.g., from slight to mild discomfort to moderate to moderately severe discomfort).
  
  
  
  Responsiveness to change was statistically significant for 6 of 8 PROMIS scales using the self-report GI anchor, 3 of 8 scales using the physician-reported anchor, and 5 of 5 scales using the corresponding GSRS scales as anchors. The MID estimates for scales for improvement and worsening were about 0.5-0.6 SD using the GSRS anchor and generally larger in magnitude than the change for the "about the same" group.
  
  
  
  The responsiveness and MID estimates provided here for the PROMIS GI Symptoms scales can aid in scale score interpretation in clinical trials and observational studies.
authors.affiliation: Division of Rheumatology, University of Michigan, 1500 E. Medical Center Dr., SPC 5370, Ann Arbor, MI, 48109, USA. khannad@med.umich.edu.|Division of Rheumatology/Department of Internal Medicine, University of Michigan Scleroderma Program, 300 North Ingalls Street, Suite 7C27, Ann Arbor, MI, 48109, USA. khannad@med.umich.edu.
authors.forename: Dinesh
authors.initials: D
authors.lastname: Khanna
authors.affiliation: Division of General Internal Medicine & Health Services Research, David Geffen School of Medicine at UCLA, 911 Broxton Avenue, Los Angeles, CA, 90024, USA.|Department of Health Policy and Management, UCLA Fielding School of Public Health, 911 Broxton Avenue, Los Angeles, CA, 90024, USA.
authors.forename: Ron D
authors.initials: RD
authors.lastname: Hays
authors.affiliation: Division of Gastroenterology, University of Michigan, 1500 E. Medical Center Dr., SPC 5362, Ann Arbor, MI, 48109-5362, USA.
authors.forename: Andrew B
authors.initials: AB
authors.lastname: Shreiner
authors.affiliation: Department of Gastroenterology, Cedars-Sinai Medical Center, 8730 Alden Dr., Los Angeles, CA, 90048, USA.
authors.forename: Gil Y
authors.initials: GY
authors.lastname: Melmed
authors.affiliation: Vatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.|G. Oppenheimer Family Center for Neurobiology of Stress and Resilience, David Geffen School of Medicine at UCLA, 100 UCLA Medical Plaza, Los Angeles, CA, 90095, USA.
authors.forename: Lin
authors.initials: L
authors.lastname: Chang
authors.affiliation: Division of Rheumatology, University of Michigan, 1500 E. Medical Center Dr., SPC 5370, Ann Arbor, MI, 48109, USA.
authors.forename: Puja P
authors.initials: PP
authors.lastname: Khanna
authors.affiliation: Department of Gastroenterology, VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd., Los Angeles, CA, 90073, USA.|UCLA/VA Center for Outcomes Research and Education (CORE), 11301 Wilshire Blvd., Los Angeles, CA, 90073, USA.
authors.forename: Roger
authors.initials: R
authors.lastname: Bolus
authors.affiliation: UCLA/VA Center for Outcomes Research and Education (CORE), 11301 Wilshire Blvd., Los Angeles, CA, 90073, USA.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Whitman
authors.affiliation: Division of General Internal Medicine & Health Services Research, David Geffen School of Medicine at UCLA, 911 Broxton Avenue, Los Angeles, CA, 90024, USA.|Department of Health Policy and Management, UCLA Fielding School of Public Health, 911 Broxton Avenue, Los Angeles, CA, 90024, USA.
authors.forename: Sylvia H
authors.initials: SH
authors.lastname: Paz
authors.affiliation: Division of General Internal Medicine & Health Services Research, David Geffen School of Medicine at UCLA, 911 Broxton Avenue, Los Angeles, CA, 90024, USA.|Department of Health Policy and Management, UCLA Fielding School of Public Health, 911 Broxton Avenue, Los Angeles, CA, 90024, USA.
authors.forename: Tonya
authors.initials: T
authors.lastname: Hays
authors.affiliation: UCLA Department of Psychology, 3857 Franz Hall, Los Angeles, CA, 90095, USA.
authors.forename: Steven P
authors.initials: SP
authors.lastname: Reise
authors.affiliation: Division of General Internal Medicine & Health Services Research, David Geffen School of Medicine at UCLA, 911 Broxton Avenue, Los Angeles, CA, 90024, USA. Brennan.Spiegel@cshs.org.|Department of Health Policy and Management, UCLA Fielding School of Public Health, 911 Broxton Avenue, Los Angeles, CA, 90024, USA. Brennan.Spiegel@cshs.org.|Department of Gastroenterology, VA Greater Los Angeles Healthcare System, 11301 Wilshire Blvd., Los Angeles, CA, 90073, USA. Brennan.Spiegel@cshs.org.|UCLA/VA Center for Outcomes Research and Education (CORE), 11301 Wilshire Blvd., Los Angeles, CA, 90073, USA. Brennan.Spiegel@cshs.org.|Medicine and Public Health, Division of Health Services Research, Cedars-Sinai Health System, Cedars-Sinai and UCLA, 8723 W. Alden Drive, Steven Spielberg Building, Los Angeles, CA, 90048, USA. Brennan.Spiegel@cshs.org.
authors.forename: Brennan
authors.initials: B
authors.lastname: Spiegel
mesh_terms: D000328:Adult; D000368:Aged; D003936:Diagnosis, Computer-Assisted; D005260:Female; D005767:Gastrointestinal Diseases / Q000175:diagnosis* / Q000473:pathology / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D011446:Prospective Studies; D011788:Quality of Life; D057566:Self Report; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: Gastroenterology; Gastrointestinal disorders; PROMIS®; Patient-reported outcomes