Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: The National Institutes of Health PROMIS® roadmap initiative is a cooperative research program designed to develop, evaluate, and standardize item banks to measure patient-reported outcomes (PROs) across different medical conditions as well as the US population (www.nihpromis.org). PROMIS includes items banks that assess self-reported physical, mental, and social health. The aim of this study was to develop GI Symptoms measures applicable to patients with GI illness and the general population.
Methods: A systematic review was conducted to find relevant articles assessing PROs in GI diseases and a conceptual model was proposed for different GI symptoms scales (Spiegel et al Am J Gastroentrol 2011). The individual items from extant instruments were grouped based on different symptoms. This was complemented by 12 focus groups including 102 patients with GI conditions to evaluate their symptoms. New items were developed based on extant items and input from the focus group participants followed by cognitive debriefing in 28 patients with GI conditions. Preliminary items were administered to the patients (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), systemic sclerosis (SSc), and other common GI disorders) and the US General Population (GP, based on 2010 census data). Patients were recruited from academic, Veterans Affairs, and private practices and completed the survey predominantly on the web using SurveyMonkey® software and the US GP using the Cint®. Items were finalized based on psychometric analyses including categorical confirmatory factor analyses and item response theory modeling to estimate item thresholds and discrimination parameters.
Results: 102 items were developed after qualitative analysis (N=130 patients) and administered to 865 patients with GI conditions and 1177 participants from the US GP. Patients were older (mean age 48 vs. 45 years), more educated (86% vs. 62% with >=some college degree), and reported greater moderate to very-severe overall GI symptoms in the past 1 week (57% vs. 26%). Patients’ self-reported GI conditions included IBS (40%), GERD (33%), IBD (28%), chronic constipation (24%), SSc (16%), and other GI conditions. Confirmatory factor analyses provided support for 8 scales: Gastroesophageal reflux (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/flatulence (12 items). All scales are calibrated using the two-parameter IRT graded response model and scored on a T-score metric with a mean of 50 and SD of 10 in the U.S. general population.
Conclusion: Using NIH PROMIS framework, we have developed a 60-item GI Symptoms scale that can be used for clinical care and trials.
Disclosure:
D. Khanna,
NIH,
2,
Scleroderma Foundation,
2,
Actelion Pharmaceuticals US,
5,
Actelion Pharmaceuticals US,
8,
Gilead,
5,
United Therapeutics,
5,
United Therapeutics,
8,
Roche Pharmaceuticals,
5,
BMS,
5,
DIGNA,
5,
Merck Pharmaceuticals,
5;
L. Chang,
None;
G. Y. Melmed,
Janssen, given imagine, Abbvie,
5,
Abbott, prometheus labs ,
9,
Pfizer Inc,
2;
R. Bolus,
NIH,
5;
P. Khanna,
None;
R. Hays,
None;
B. Spiegel,
None.
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