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

F. G. M. Smeets*, A. A. M. Masclee, J. M. Conchillo, D. Keszthelyi

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

5 Citations (Web of Science)
16 Downloads (Pure)

Abstract

BackgroundFunctional 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.

PurposeThis 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.

Original languageEnglish
Article number13327
Number of pages10
JournalNeurogastroenterology and Motility
Volume30
Issue number8
DOIs
Publication statusPublished - Aug 2018

Keywords

  • functional dyspepsia
  • functional gastrointestinal disorder
  • patient-reported outcome measures
  • questionnaires
  • symptom assessment
  • QUALITY-OF-LIFE
  • REPORTED OUTCOME MEASURES
  • HEALTH-STATUS INSTRUMENT
  • NEPEAN DYSPEPSIA
  • POSTPRANDIAL DISTRESS
  • CONTROLLED-TRIAL
  • PRIMARY-CARE
  • VALIDATION
  • SEVERITY
  • INDEX

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