Variations in definitions and outcome measures in gastroesophageal reflux disease: A systematic review

Maartje M.J. Singendonk, Anna J. Brink, Nina F. Steutel, Faridi S. Van Etten-Jamaludin, Michiel P. Van Wijk, Marc A. Benninga, Merit M. Tabbers

Research output: Contribution to journalReview articleAcademicpeer-review

12 Citations (Scopus)


CONTEXT: Gastroesophageal reflux (GER) is defined as GER disease (GERD) when it leads to troublesome symptoms and/or complications. We hypothesized that definitions and outcome measures in randomized controlled trials (RCTs) on pediatric GERD would be heterogeneous. OBJECTIVES: Systematically assess definitions and outcome measures in RCTs in this population. DATA SOURCES: Data were obtained through Cochrane, Embase, Medline, and Pubmed databases. STUDY SELECTION: We selected English-written therapeutic RCTs concerning GERD in children 0 to 18 years old. DATA EXTRACTION: Data were tabulated and presented descriptively. Each individual parameter or set of parameters with unique criteria for interpretation was considered a single definition for GER(D). Quality was assessed by using the Delphi score. RESULTS: A total of 2410 unique articles were found; 46 articles were included. Twenty-six (57%) studies defined GER by using 25 different definitions and investigated 25 different interventions. GERD was defined in 21 (46%) studies, all using a unique definition and investigating a total of 23 interventions. Respectively 87 and 61 different primary outcome measures were reported by the studies in GER and GERD. Eight (17%) studies did not report on side effects. Of the remaining 38 (83%) studies that did report on side effects, 18 (47%) included this as predefined outcome measure of which 4 (22%) as a primary outcome measure. Sixteen studies (35%) were of good methodological quality. LIMITATIONS: Only English-written studies were included. CONCLUSIONS: Inconsistency and heterogeneity exist in definitions and outcome measures used in RCTs on pediatric GER and GERD; therefore, we recommend the development of a core outcome set.

Original languageEnglish
Article numbere20164166
Pages (from-to)e20164166
Issue number2
Early online date2017
Publication statusPublished - 1 Aug 2017

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