Corrigendum: development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) gastrointestinal symptom scales.

Abstract

ORIGINAL CONTRIBUTIONS nature publishing group FUNCTIONAL GI DISORDERS see related editorial on page x Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales Brennan M.R. Spiegel , MD, MSHS, RFF, FACG, AGAF 1 , 2 , 3 , 4 , Ron D. Hays , PhD 4 , 5 , Roger Bolus , PhD 2 , Gil Y. Melmed , MD, MS 1 , Lin Chang , MD 5 , 6 , Cynthia Whitman , MPH 2 , Puja P. Khanna , MD, MPH 7 , Sylvia H. Paz , PhD 4 , Tonya Hays , MS 4 , Steve Reise , PhD 8 and Dinesh Khanna , MD, MSc 7 OBJECTIVES: 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 fi rst conducted a systematic literature review to develop a broad conceptual model of GI symp- toms. 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 de- briefi ng in 28 patients. We administered the items to diverse GI patients (irritable bowel syndrome (IBS), infl ammatory 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 con- fi rmatory 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 refl ux (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 / fl atulence (12 items). The scales correlated signifi cantly with both generic and disease-targeted legacy instru- ments, 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. SUPPLEMENTARY MATERIAL is linked to the online version of the paper at http://www.nature.com/ajg Am J Gastroenterol 2014; 109:1804–1814; doi: 10.1038/ajg.2014.237; published online 9 September 2014 INTRODUCTION Patients typically seek health care because they experience symp- toms. Th is is especially true in gastroenterology where most digestive disorders initially present with symptoms rather than biochemical abnormalities alone. To fully describe the illness experience of gastrointestinal (GI) patients, providers must elicit, measure, and interpret patient symptoms as part of their clinical evaluation ( 1,2 ). 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 ; 5 Department of Medicine, David Geffen School of Medicine at UCLA , Los Angeles , California , USA ; 6 Gail and Gerald Oppenheimer Family Center for Neurobiology of Stress, David Geffen School of Medicine at UCLA , Los Angeles , California , USA ; 7 Division of Rheumatology, University of Michigan , Ann Arbor , Michigan , USA ; 8 Department of Psychology, UCLA , Los Angeles , California , USA . Correspondence: Brennan M.R. Spiegel, MD, MSHS, RFF, FACG, AGAF , Department of Gastroenterology and Health Services, Cedars-Sinai Medical Center, Pacifi c Theatre Building, 116 N. Robertson Blvd, 4th Floor , Los Angeles , California 90048 , USA or Dinesh Khanna, MD, MSc, University of Michigan Scleroderma Program, Division of Rheumatology / Department of Internal Medicine, 300 North Ingalls Street, Suite 7C27, Ann Arbor, Michigan 48109, USA. E-mail: bspiegel@ucla.edu or khannad@med.umich.edu Received 24 December 2013; accepted 24 June 2014 The American Journal of GASTROENTEROLOGY VOLUME 109 | NOVEMBER 2014 www.amjgastro.com