{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,12]],"date-time":"2026-04-12T06:23:22Z","timestamp":1775975002684,"version":"3.50.1"},"reference-count":78,"publisher":"American Academy of Pediatrics (AAP)","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017,8,1]]},"abstract":"<jats:sec><jats:title>CONTEXT:<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>OBJECTIVES:<\/jats:title><jats:p>Systematically assess definitions and outcome measures in RCTs in this population.<\/jats:p><\/jats:sec><jats:sec><jats:title>DATA SOURCES:<\/jats:title><jats:p>Data were obtained through Cochrane, Embase, Medline, and Pubmed databases.<\/jats:p><\/jats:sec><jats:sec><jats:title>STUDY SELECTION:<\/jats:title><jats:p>We selected English-written therapeutic RCTs concerning GERD in children 0 to 18 years old.<\/jats:p><\/jats:sec><jats:sec><jats:title>DATA EXTRACTION:<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS:<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>LIMITATIONS:<\/jats:title><jats:p>Only English-written studies were included.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS:<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec>","DOI":"10.1542\/peds.2016-4166","type":"journal-article","created":{"date-parts":[[2017,7,27]],"date-time":"2017-07-27T09:58:26Z","timestamp":1501149506000},"source":"Crossref","is-referenced-by-count":17,"title":["Variations in Definitions and Outcome Measures in Gastroesophageal Reflux Disease: A Systematic Review"],"prefix":"10.1542","volume":"140","author":[{"given":"Maartje M.J.","family":"Singendonk","sequence":"first","affiliation":[{"name":"Department of Pediatric Gastro Gastroenterology and Nutrition, Emma Children\u2019s Hospital, Academic Medical Center, Amsterdam, Netherlands;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna J.","family":"Brink","sequence":"additional","affiliation":[{"name":"Department of Pediatric Gastro Gastroenterology and Nutrition, Emma Children\u2019s Hospital, Academic Medical Center, Amsterdam, Netherlands;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nina F.","family":"Steutel","sequence":"additional","affiliation":[{"name":"Department of Pediatric Gastro Gastroenterology and Nutrition, Emma Children\u2019s Hospital, Academic Medical Center, Amsterdam, Netherlands;"},{"name":"Department of Clinical Epidemiology, Biostatistics and Bioinformatics, and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Faridi S.","family":"van Etten-Jamaludin","sequence":"additional","affiliation":[{"name":"Medical Library, Academic Medical Center, Amsterdam, Netherlands; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michiel P.","family":"van Wijk","sequence":"additional","affiliation":[{"name":"Department of Pediatric Gastro Gastroenterology and Nutrition, Emma Children\u2019s Hospital, Academic Medical Center, Amsterdam, Netherlands;"},{"name":"Department of Pediatric Gastroenterology and Nutrition, VU Medical Center, Amsterdam, Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc A.","family":"Benninga","sequence":"additional","affiliation":[{"name":"Department of Pediatric Gastro Gastroenterology and Nutrition, Emma Children\u2019s Hospital, Academic Medical Center, Amsterdam, Netherlands;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Merit M.","family":"Tabbers","sequence":"additional","affiliation":[{"name":"Department of Pediatric Gastro Gastroenterology and Nutrition, Emma Children\u2019s Hospital, Academic Medical Center, Amsterdam, 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