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

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.

Original languageEnglish
Article numbere20164166
JournalPediatrics
Volume140
Issue number2
DOIs
Publication statusPublished - 1 Aug 2017

Cite this

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, 140(2), [e20164166]. https://doi.org/10.1542/peds.2016-4166
Singendonk, Maartje M.J. ; Brink, Anna J. ; Steutel, Nina F. ; Van Etten-Jamaludin, Faridi S. ; Van Wijk, Michiel P. ; Benninga, Marc A. ; Tabbers, Merit M. / Variations in definitions and outcome measures in gastroesophageal reflux disease : A systematic review. In: Pediatrics. 2017 ; Vol. 140, No. 2.
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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.",
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Variations in definitions and outcome measures in gastroesophageal reflux disease : A systematic review. / Singendonk, Maartje M.J.; Brink, Anna J.; Steutel, Nina F.; Van Etten-Jamaludin, Faridi S.; Van Wijk, Michiel P.; Benninga, Marc A.; Tabbers, Merit M.

In: Pediatrics, Vol. 140, No. 2, e20164166, 01.08.2017.

Research output: Contribution to journalReview articleAcademicpeer-review

TY - JOUR

T1 - Variations in definitions and outcome measures in gastroesophageal reflux disease

T2 - A systematic review

AU - Singendonk, Maartje M.J.

AU - Brink, Anna J.

AU - Steutel, Nina F.

AU - Van Etten-Jamaludin, Faridi S.

AU - Van Wijk, Michiel P.

AU - Benninga, Marc A.

AU - Tabbers, Merit M.

PY - 2017/8/1

Y1 - 2017/8/1

N2 - 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.

AB - 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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U2 - 10.1542/peds.2016-4166

DO - 10.1542/peds.2016-4166

M3 - Review article

VL - 140

JO - Pediatrics

JF - Pediatrics

SN - 0031-4005

IS - 2

M1 - e20164166

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Singendonk MMJ, Brink AJ, Steutel NF, Van Etten-Jamaludin FS, Van Wijk MP, Benninga MA et al. Variations in definitions and outcome measures in gastroesophageal reflux disease: A systematic review. Pediatrics. 2017 Aug 1;140(2). e20164166. https://doi.org/10.1542/peds.2016-4166