title: Development of an online library of patient-reported outcome measures in gastroenterology: the GI-PRO database.
abstract: OBJECTIVE
  Because gastrointestinal (GI) illnesses can cause physical, emotional, and social distress, patient-reported outcomes (PROs) are used to guide clinical decision making, conduct research, and seek drug approval. It is important to develop a mechanism for identifying, categorizing, and evaluating the over 100 GI PROs that exist. Here we describe a new, National Institutes of Health (NIH)-supported, online PRO clearinghouse-the GI-PRO database.
  
  
  METHODS
  Using a protocol developed by the NIH Patient-Reported Outcome Measurement Information System (PROMIS(®)), we performed a systematic review to identify English-language GI PROs. We abstracted PRO items and developed an online searchable item database. We categorized symptoms into content "bins" to evaluate a framework for GI symptom reporting. Finally, we assigned a score for the methodological quality of each PRO represented in the published literature (0-20 range; higher indicates better).
  
  
  RESULTS
  We reviewed 15,697 titles (κ>0.6 for title and abstract selection), from which we identified 126 PROs. Review of the PROs revealed eight GI symptom "bins": (i) abdominal pain, (ii) bloat/gas, (iii) diarrhea, (iv) constipation, (v) bowel incontinence/soilage, (vi) heartburn/reflux, (vii) swallowing, and (viii) nausea/vomiting. In addition to these symptoms, the PROs covered four psychosocial domains: (i) behaviors, (ii) cognitions, (iii) emotions, and (iv) psychosocial impact. The quality scores were generally low (mean 8.88 ± 4.19; 0 (min)-20 (max). In addition, 51% did not include patient input in developing the PRO, and 41% provided no information on score interpretation.
  
  
  CONCLUSIONS
  GI PROs cover a wide range of biopsychosocial symptoms. Although plentiful, GI PROs are limited by low methodological quality. Our online PRO library (www.researchcore.org/gipro/) can help in selecting PROs for clinical and research purposes.
authors.affiliation: Division of Rheumatology, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Puja
authors.initials: P
authors.lastname: Khanna
authors.affiliation: 1] Department of Gastroenterology, VA Greater Los Angeles Healthcare System, Los Angeles, California, USA [2] Department of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
authors.forename: Nikhil
authors.initials: N
authors.lastname: Agarwal
authors.affiliation: Division of Rheumatology, University of Michigan, Ann Arbor, Michigan, USA.
authors.forename: Dinesh
authors.initials: D
authors.lastname: Khanna
authors.affiliation: Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, and Department of Health Services, UCLA School of Public Health, Los Angeles, California, USA.
authors.forename: Ron D
authors.initials: RD
authors.lastname: Hays
authors.affiliation: 1] Division of Digestive Diseases, David Geffen School of Medicine at UCLA, Los Angeles, California, USA [2] 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: 1] Division of Digestive Diseases, David Geffen School of Medicine at UCLA, Los Angeles, California, USA [2] UCLA/VA 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
authors.initials: G
authors.lastname: Melmed
authors.affiliation: UCLA/VA Center for Outcomes Research and Education, Los Angeles, California, USA.
authors.forename: Cynthia B
authors.initials: CB
authors.lastname: Whitman
authors.affiliation: Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, and Department of Health Services, UCLA School of Public Health, Los Angeles, California, USA.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Kaplan
authors.affiliation: Biomedical Library of the Health Sciences, University of California at Los Angeles, California, USA.
authors.forename: Rikke
authors.initials: R
authors.lastname: Ogawa
authors.affiliation: UCLA/VA Center for Outcomes Research and Education, Los Angeles, California, USA.
authors.forename: Bradley
authors.initials: B
authors.lastname: Snyder
authors.affiliation: 1] Department of Gastroenterology, VA Greater Los Angeles Healthcare System, Los Angeles, California, USA [2] Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, and Department of Health Services, UCLA School of Public Health, Los Angeles, California, USA [3] Division of Digestive Diseases, David Geffen School of Medicine at UCLA, Los Angeles, California, USA [4] UCLA/VA Center for Outcomes Research and Education, Los Angeles, California, USA.
authors.forename: Brennan Mr
authors.initials: BM
authors.lastname: Spiegel
mesh_terms: D019992:Databases as Topic; D005260:Female; D005762:Gastroenterology; D005767:Gastrointestinal Diseases / Q000175:diagnosis / Q000628:therapy*; D006801:Humans; D007256:Information Systems; D020407:Internet; D008297:Male; D008490:Medical Informatics / Q000379:methods*; D009316:National Institutes of Health (U.S.); D017063:Outcome Assessment, Health Care; D011788:Quality of Life; D012650:Self Disclosure; D014481:United States