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Systematic review: Disease‐specific instruments to assess gastrointestinal symptoms in functional dyspepsia
Author(s) -
Smeets F. G. M.,
Masclee A. A. M.,
Conchillo J. M.,
Keszthelyi D.
Publication year - 2018
Publication title -
neurogastroenterology and motility
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.489
H-Index - 105
eISSN - 1365-2982
pISSN - 1350-1925
DOI - 10.1111/nmo.13327
Subject(s) - prom , medicine , disease , outcome (game theory) , clinical trial , intensive care medicine , functional gastrointestinal disorder , patient reported outcome , medline , systematic review , physical therapy , irritable bowel syndrome , quality of life (healthcare) , mathematics , nursing , mathematical economics , obstetrics , political science , law
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 ( PROM s) 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.