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. 2014 Nov;109(11):1804-14.
doi: 10.1038/ajg.2014.237. Epub 2014 Sep 9.

Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) gastrointestinal symptom scales

Brennan M R Spiegel  1 , Ron D Hays  2 , Roger Bolus  3 , Gil Y Melmed  4 , Lin Chang  5 , Cynthia Whitman  3 , Puja P Khanna  6 , Sylvia H Paz  7 , Tonya Hays  7 , Steve Reise  8 , Dinesh Khanna  6
Affiliations

Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) gastrointestinal symptom scales

Brennan M R Spiegel et al. Am J Gastroenterol. 2014 Nov.

Erratum in

Abstract

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 first conducted a systematic literature review to develop a broad conceptual model of GI symptoms. 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 debriefing in 28 patients. We administered the items to diverse GI patients (irritable bowel syndrome (IBS), inflammatory 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 confirmatory 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 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). The scales correlated significantly with both generic and disease-targeted legacy instruments, 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.

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Conflict of interest statement

Potential competing interests: Brennan M.R. Spiegel has received grant support from Ironwood, Amgen, Shire Pharmaceuticals, and Theravance Pharmaceuticals, and served as a consultant to Ironwood, Forest, and Takeda North America. Dinesh Khanna has served as consultant and/or received grant support from Actelion, Astra-Zeneca, Bayer, BMS, DIGNA, Genentech, Gilead, InterMune, Merck, Roche, Takeda, Savient, and United Therapeutics. Ron D. Hays has served as a consultant to Amgen, Allergan, Pfizer, and the Critical Path Institute. Gil Y. Melmed has served as a consultant for Abbvie, Given Imaging, and Jannsen, is on the speaker’ s bureau for Prometheus and Abbott, and has received research support from Pfizer. Lin Chang has served as a consultant to Ironwood, Forest, Salix, Takeda North America, Purdue Pharma, and Entera Health, and has received grant support from Ironwood.

Figures

Figure 1
Figure 1
Patient-Reported Outcomes Measurement Information System (PROMIS) gastrointestinal (GI) Symptom Network.
Figure 2
Figure 2
Sample “heat map” patient report of gastrointestinal (GI) Patient-Reported Outcomes Measurement Information System (PROMIS) scores. Patient scores are compared with the general US population benchmarks to add interpretability to the scores, similar to a lab test. For this use case, a provider can immediately detect that the patient reported many GI symptoms, but that constipation was the most severe and bothersome, falling within the top quartile of severity compared with the general population (GP). Gas and bloating were also elevated in this patient, falling in the third quartile of severity. In contrast, although the patient reported abdominal pain and heartburn/reflux symptoms, those scores were only in the first and second quartiles compared with people in the GP with similar symptoms. For instructions on how to convert PROMIS scores to percentile, see Supplementary Appendix D. *Patients “most bothersome symptoms.
See this image and copyright information in PMC

References

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