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Published on: December 14, 2020
Variations in Definitions and Outcome Measures in Gastroesophageal Reflux Disease: A Systematic Review
Maartje M J Singendonk1, Anna J Brink2, Nina F Steutel2,3
1Department of Pediatric Gastro Gastroenterology and Nutrition, Emma Children's Hospital, Academic Medical Center, Amsterdam, Netherlands; m.m.j.singendonk@amc.uva.nl.
Insights
Pediatric gastroesophageal reflux disease (GERD) trials lack consistent definitions and outcome measures. Developing a core outcome set is recommended to improve research consistency in pediatric GERD.
Area of Science:
- Pediatric Gastroenterology
- Clinical Trial Methodology
- Evidence-Based Medicine
Background:
- Gastroesophageal reflux (GER) is a common condition in children, often leading to gastroesophageal reflux disease (GERD) with troublesome symptoms or complications.
- Randomized controlled trials (RCTs) are crucial for evaluating GERD treatments, but their effectiveness depends on standardized methodologies.
Purpose of the Study:
- To systematically assess the heterogeneity in definitions and outcome measures used in randomized controlled trials (RCTs) for pediatric GERD.
- To identify inconsistencies in how GER and GERD are defined and measured in pediatric clinical trials.
Main Methods:
- A systematic literature search was conducted across major databases (Cochrane, Embase, Medline, Pubmed).
- English-written therapeutic RCTs involving children aged 0-18 years with GERD were selected.
- Data on definitions, interventions, and outcome measures were extracted and descriptively analyzed. Study quality was assessed using the Delphi score.
Main Results:
- A total of 46 RCTs were included, revealing significant heterogeneity.
- Twenty-six studies defined GER using 25 different definitions, while 21 studies defined GERD with unique definitions.
- A wide array of primary outcome measures were reported (87 for GER, 61 for GERD), with significant variation in reporting side effects.
Conclusions:
- Substantial inconsistency and heterogeneity exist in the definitions and outcome measures employed in pediatric GERD RCTs.
- This variability hinders the comparability and synthesis of research findings in pediatric GERD.
- The development and adoption of a core outcome set are recommended to standardize future research in pediatric GERD.
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.
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