Development of the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scales

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.

Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): Determining Therapeutic Goals for Treat-to-Target

“…Several scales have been developed over the past 20 years to assess PROs but none were developed according to the FDA guidance for PRO development, and thus cannot lead to PRO labeling ( 17,88,127 ). Once a consensus aimed at developing validated PROs based on the FDA guidance has been created, PROs are likely to be required by regulatory agencies as primary or major secondary end points in registration drug trials in patients with IBD.…”

Evaluation of the Frequency of Gastroesophageal Reflux Disease in Hemodialysis Patients

“…Son bir haftada en az 1 gün retrosternal bölgede yanma semptomu olanlar retrosternal yanma pozitif, kusma olmadan yiyecek veya içeceğin boğaza veya ağza geri gelme semptomu olanlar ise regürjitasyon pozitif olarak tanımlandı. Çalış-mada haftada en az 1 gün retrosternal yanma ve regürji-tasyon semptomları olan olgular GÖRH olarak kabul edildi [8,9] .…”

Turkish reliability of National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS®) constipation scale

“…The points for each question were summed. According to the scoring system in the original questionnaire, 0 point refers to not symptomatic, 1-3 points to least symptomatic, 4-7 points to mild symptomatic, [8][9][10][11][12][13][14][15] points to moderately symptomatic and 16 and more points to most symptomatic. The questionnaire was administered prospectively to patients equal and above 18 years that presented to Family Medicine outpatient clinic of Eskisehir Osmangazi University Translation process: The Constipation scale was translated into Turkish by three researchers, and a consensus meeting was held after the translation process.…”

“…The PROMIS Constipation, one of the eight categories in the PROMIS GI item banks, is designed to measure the frequency, severity, impact of and discomfort caused by main Constipation symptoms, based on the assumption that the complaints continue for at least seven days (10). The physician can question the complaints of constipation, and assess its severity through this easy-to-apply questionnaire by taking a short amount of time.…”

“…Constipation related scales generally question symptoms' frequency, severity and, in some cases, effect on quality of life within the last 7 days. (10).…”