Definitions and Outcome Measures in Pediatric Functional Upper Gastrointestinal Tract Disorders: A Systematic Review.
Functional disorders of the upper gastrointestinal tract are frequently diagnosed in children. Four different clinical entities are addressed by the Rome III committee: functional dyspepsia (FD), cyclic vomiting syndrome (CVS), adolescent rumination syndrome (ARS), and aerophagia. Management of these disorders is often difficult leading to a wide variety in therapeutic interventions. We hypothesize that definitions and outcome measures in these studies are heterogeneous as well. Our aim is to systematically assess how these disorders and outcomes are defined in therapeutic randomized controlled trials (RCTs).



CENTRAL, Embase, and MEDLINE/PubMed were searched from inception to February 25, 2015. Search terms were FD, CVS, ARS, and aerophagia. Therapeutic RCTs, or systematic reviews of RCTs, in English language including subjects ages 4 to 18 years (0-18 years for CVS) were evaluated. Quality was assessed using the Delphi list.



A total of 1398 articles were found of which 8 articles were included. Seven concerned FD and 1 concerned CVS. In all of the studies, Rome criteria or similar definitions were used; all the studies however used different outcome measures. Seventy-five percent of the trials were of good methodological quality. Only 57% used validated pain scales.



Different outcome measures are used in therapeutic trials on functional disorders of the upper gastrointestinal tract. There is a clear paucity of trials evaluating different treatment regimens regarding CVS, ARS, and aerophagia. Uniform definitions, outcome measures, and validated instruments are needed to make a comparison between intervention studies possible.
Emma Children's Hospital/Academic Medical Center, Amsterdam, The Netherlands.
Amara
A
Nassar-Sheikh Rashid
Jan A
JA
Taminiau
Marc A
MA
Benninga
Miguel
M
Saps
Merit M
MM
Tabbers
D000293:Adolescent; D000334:Aerophagy / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy; D002648:Child; D004415:Dyspepsia / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy; D019317:Evidence-Based Medicine; D019959:Feeding and Eating Disorders of Childhood / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy; D006801:Humans; D007223:Infant; D017063:Outcome Assessment, Health Care / Q000639:trends; D010372:Pediatrics / Q000379:methods* / Q000639:trends; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D041742:Upper Gastrointestinal Tract / Q000503:physiopathology*; D014839:Vomiting / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy