Development of an online library of patient-reported outcome measures in gastroenterology: the GI-PRO database

Abstract

Objectives: Because gastrointestinal (GI) illnesses can cause physical, emotional, and social distress, patient-reported outcomes (PROs) are used to guide clinical decision making, conduct research, and seek drug approval. It is important to develop a mechanism for identifying, categorizing, and evaluating the over 100 GI PROs that exist. Here we describe a new, National Institutes of Health (NIH)-supported, online PRO clearinghouse-the GI-PRO database.

Methods: Using a protocol developed by the NIH Patient-Reported Outcome Measurement Information System (PROMIS(®)), we performed a systematic review to identify English-language GI PROs. We abstracted PRO items and developed an online searchable item database. We categorized symptoms into content "bins" to evaluate a framework for GI symptom reporting. Finally, we assigned a score for the methodological quality of each PRO represented in the published literature (0-20 range; higher indicates better).

Results: We reviewed 15,697 titles (κ>0.6 for title and abstract selection), from which we identified 126 PROs. Review of the PROs revealed eight GI symptom "bins": (i) abdominal pain, (ii) bloat/gas, (iii) diarrhea, (iv) constipation, (v) bowel incontinence/soilage, (vi) heartburn/reflux, (vii) swallowing, and (viii) nausea/vomiting. In addition to these symptoms, the PROs covered four psychosocial domains: (i) behaviors, (ii) cognitions, (iii) emotions, and (iv) psychosocial impact. The quality scores were generally low (mean 8.88 ± 4.19; 0 (min)-20 (max). In addition, 51% did not include patient input in developing the PRO, and 41% provided no information on score interpretation.

Conclusions: GI PROs cover a wide range of biopsychosocial symptoms. Although plentiful, GI PROs are limited by low methodological quality. Our online PRO library (www.researchcore.org/gipro/) can help in selecting PROs for clinical and research purposes.

Figure 1

Conceptual framework of gastrointestinal (GI) symptom bins from items in published GI patient-reported outcome (PRO) instruments.

Figure 2

Screenshot of GI PRO online library. Users initially view a text box in which any term can be entered that is relevant for a search of gastrointestinal (GI) patient-reported outcome (PRO) instruments. Examples include names of known instruments (e.g., IBS-QOL, PAGI-QOL, IBDQ), names of diseases (e.g., gastroesophageal reflux disease (GERD), dyspepsia, Crohn’s, Celiac), symptoms (e.g., bloating, diarrhea, constipation, nausea, pain), or health-related quality-of-life domains (e.g., sleep, fatigue, impact, embarrassment, depression). The example below shows the result of searching for “GERD”. Users can select individual instruments to obtain detailed information about them (e.g., inset shows details of ReQuest instrument).