Variations in Definitions and Outcome Measures in Gastroesophageal Reflux Disease: A Systematic Review

Autor: Nina F Steutel, Faridi S. van Etten-Jamaludin, Marc A. Benninga, Anna J Brink, Maartje Singendonk, Michiel P. van Wijk, Merit M. Tabbers
Rok vydání: 2017
Předmět:
Zdroj: Singendonk, M M J, Brink, A J, Steutel, N F, Van Etten-Jamaludin, F S, Van Wijk, M P, Benninga, M A & Tabbers, M M 2017, ' Variations in definitions and outcome measures in gastroesophageal reflux disease : A systematic review ', Pediatrics, vol. 140, no. 2, e20164166 . https://doi.org/10.1542/peds.2016-4166
ISSN: 1098-4275
0031-4005
DOI: 10.1542/peds.2016-4166
Popis: 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.
Databáze: OpenAIRE