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Pediatrics. 2017 Aug;140(2). pii: e20164166. doi: 10.1542/peds.2016-4166.

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

Author information

1
Department of Pediatric Gastro Gastroenterology and Nutrition, Emma Children's Hospital, Academic Medical Center, Amsterdam, Netherlands; m.m.j.singendonk@amc.uva.nl.
2
Department of Pediatric Gastro Gastroenterology and Nutrition, Emma Children's Hospital, Academic Medical Center, Amsterdam, Netherlands.
3
Department of Clinical Epidemiology, Biostatistics and Bioinformatics, and.
4
Medical Library, Academic Medical Center, Amsterdam, Netherlands; and.
5
Department of Pediatric Gastroenterology and Nutrition, VU Medical Center, Amsterdam, Netherlands.

Abstract

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.

PMID:
28751614
DOI:
10.1542/peds.2016-4166
[Indexed for MEDLINE]
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