Puja Khanna1, Nikhil Agarwal2, Dinesh Khanna1, Ron D Hays3, Lin Chang4, Roger Bolus5, Gil Melmed6, Cynthia B Whitman7, Robert M Kaplan3, Rikke Ogawa8, Bradley Snyder7, Brennan Mr Spiegel9. 1. Division of Rheumatology, University of Michigan, Ann Arbor, Michigan, USA. 2. 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. 3. 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. 4. 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. 5. 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. 6. Department of Gastroenterology, Cedars-Sinai Medical Center, Los Angeles, California, USA. 7. UCLA/VA Center for Outcomes Research and Education, Los Angeles, California, USA. 8. Biomedical Library of the Health Sciences, University of California at Los Angeles, California, USA. 9. 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.
Abstract
OBJECTIVES: 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.
OBJECTIVES: 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.
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