Patient-Reported Outcome Measures in Functional Dyspepsia: A Systematic Review and COSMIN Analysis

Abstract

Background:Functional dyspepsia (FD) as a non-organic disease, patient self-reporting of its symptoms becomes an important component of clinical outcome assessment. We performed a systematic review using Consensus Based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines to identify the best available patient-reported outcome measure (PROM) of FD. Methods: The study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). We searched four databases with no date limit, looking for previously confirmed PROMs for evaluating FD symptoms. An overall rating was then assigned based upon COSMIN guidelines, and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to assess the level of evidence for psychometric properties of included PROMs. Results: Thirty-three articles covering outcome indicators of 24 patient reports were included. The Nepean Dyspepsia Index (NDI), Dyspepsia Symptom Severity Index (DSSI), Leuven Postprandial Distress Scale (LPDS), Functional Dyspepsia Symptom Diary (FDSD), and Experience Sampling Method-Patient Reported Outcome Measure (ESM‐PROM) showed sufficient content validity and internal consistency, resulting in a Class A recommendation. Conclusion:NDI, DSSI, LPDS, FDSD and ESM‐PROM are the best currently available PROM to assess FD. However, they failed to assess several important areas. Future research can be continuously improved on this basis.