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(PROMIS) Gastrointestinal Symptom Scales nature publishing group ORIGINAL CONTRIBUTIONS 1 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 , MD5 , 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 FUNCTIONAL GI DISORDERS 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 advance online publication, 9 September 2014; doi: 10.1038/ajg.2014.237 INTRODUCTION biochemical abnormalities alone. To fully describe the illness Patients typically seek health care because they experience symp- experience of gastrointestinal (GI) patients, providers must elicit, toms. Th is is especially true in gastroenterology where most measure, and interpret patient symptoms as part of their clinical digestive disorders initially present with symptoms rather than evaluation (1,2 ). 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 ; 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: [email protected] or [email protected] Received 24 December 2013; accepted 24 June 2014 © 2014 by the American College of Gastroenterology The American Journal of GASTROENTEROLOGY 2 Spiegel et al. Patient-generated reports, also known as patient-reported Phase 1: item development outcomes (PROs), capture the patients ’ illness experience in a Systematic literature review . We performed a structured search structured format and may help providers understand symptoms to identify English-language PROs across all luminal diseases and from the patients ’ perspective ( 1 ). PROs measure any aspect of other illnesses that directly aff ect the GI tract (e.g., systemic scle- health directly reported by the patient (e.g., physical, emotional, rosis — a “ non-GI ” condition that aff ects GI function). Next, we or social symptoms) and can help to direct care and improve developed a search strategy that targeted studies of English-lan- clinical outcomes ( 3 – 9 ). When clinicians systematically collect guage PROs that measure GI symptoms and abstracted individu- patient-reported data in the right place at the right time, PRO al items from each PRO to develop a comprehensive item library. measurement can eff ectively aid in detection and management of Th en, we developed “ bins ” to categorize items describing GI conditions ( 3,4 ), improve satisfaction with care ( 5 ), and enhance symptoms, and used this to assess a framework for GI symptom the patient – provider relationship ( 5 – 9 ). reporting, similar to one developed previously for irritable bowel Th e National Institutes of Health (NIH) launched the syndrome (IBS) ( 15 ) and in line with the process supported by Patient-Reported Outcomes Measurement Information System the NIH PROMIS network ( 14 ). Aft er binning items into defi ned (PROMIS ® ) in 2004 with the goal of developing, evaluating, and categories, we “ winnowed ” items that were similar, leaving only disseminating a toolbox of publicly available item banks capable items that covered unique symptom attributes. We presented our of measuring PROs across the breadth and depth of the human results to an expert panel consisting of three gastroenterologists illness experience ( www.nihpromis.gov ) ( 10 ). Moreover, PROMIS with PRO expertise that provided feedback and identifi ed addi- measures are designed for either traditional paper-and-pencil or tional PROs and candidate items (William Chey (University of electronic modes of data collection. Th e NIH PROMIS vision is to Michigan), Douglas Drossman (University of North Carolina), create highly effi cient and short questionnaires that are feasible to and Jan Irvine (University of Toronto)). We previously reported FUNCTIONAL GI DISORDERS FUNCTIONAL GI DISORDERS implement in busy clinical systems while preserving reliability and the extended methods and results of this search that culminated validity. PROMIS is a system that off ers the potential for establish- in the “ GI-PRO database ” — a publicly available search engine to ing common-language benchmarks for symptoms across condi- identify extant GI PROs ( http://www.researchcore.org/gipro/ ) tions and identifying clinical thresholds for action and meaningful ( 12 ). improvement or decline. In the fi eld of gastroenterology, patients, providers, investigators, Focus groups . In order to gain insights from patients about and regulators are interested in using PROs to guide clinical deci- their GI-related symptoms, we conducted 12 disease-specifi c sion making ( 1 ), conduct clinical research (1 ), and achieve drug focus groups. We conducted the groups at the University of approval ( 11 ). Over the past two decades, investigators have devel- California Los Angeles (UCLA) and the West Los Angeles oped over 100 disease-targeted PROs that measure a range of GI Veteran Administration (WLAVA) campuses between 13 symptoms ( 12 ). However, the fi eld remains in need of a standard- November 2010 and 12 February 2011. Subjects were eligible if ized, rigorously developed, electronically administered set of PROs they were diagnosed by a physician with gastroesophageal re- that span the breadth and depth of GI symptoms, and can be used fl ux disease, infl ammatory bowel disease (IBD), IBS, or systemic across all GI disorders for clinical and research purposes. sclerosis (SSc); these conditions span the breadth and depth of GI Th is paper describes content and cross-sectional construct vali- symptoms. We next recruited participants across gender, ethnic- dation of the NIH PROMIS GI symptom scales using data from ity, and education levels and identifi ed patients through recruit- diverse GI patients and members of the general population (GP). ment from the GI clinics at UCLA, WLAVA, and Cedars-Sinai Medical Center. Additional participants were recruited through fl yers distributed around UCLA clinics and through online METHODS advertisements using Craigslist. Before the focus groups, Study overview and objectives we developed a guide with patient instructions, open-ended We sought to develop and evaluate a new set of PROMIS GI symp- think-aloud exercises, and scripted probes. An experienced tom scales that capture the breadth and depth of physical symp- moderator led each group with assistance from a co-facilitator toms associated with the GI system. We designed the scales to be (refer to Supplementary Appendix A online for the moderator ’
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