Systematic review: Disease-specific instruments to assess gastrointestinal symptoms in functional dyspepsia

Abstract

Background

Functional dyspepsia (FD) is a common functional gastrointestinal disorder with incompletely understood pathophysiology and heterogeneous symptom presentation. Assessment of treatment efficacy in FD is a methodological challenge as response to treatment must be assessed primarily by measuring subjective symptoms. Therefore, the use of patient-reported outcome measures (PROMs) is recommended by regulatory authorities to assess gastrointestinal symptoms in clinical trials for FD. In the last decades, a multitude of outcome measures has been developed. However, currently no PROM has been approved by the regulatory authorities, and no consensus has been reached with regard to the most relevant outcome measure in FD.

Purpose

This systematic review discusses the available disease-specific outcome measures for assessment of FD symptoms with psychometric validation properties, strengths, and limitations. Moreover, recommendations for use of current available outcome measures are provided, and potential areas of future research are discussed.

Multiple different questionnaires are currently used in clinical trials to assess gastrointestinal symptoms in patients with functional dyspepsia. Although current available questionnaires do not fulfill all criteria for psychometric validation, the Leuven Postprandial Distress Scale and Functional Dyspepsia Symptom Diary seem most promising.

from #ORL-AlexandrosSfakianakis via ola Kala on Inoreader http://ift.tt/2G8rlup