Scolaris Content Display Scolaris Content Display

Cochrane Database of Systematic Reviews

Pharmacological treatment of gastro‐oesophageal reflux in children

Información

DOI:
https://doi.org/10.1002/14651858.CD008550.pub3Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 22 agosto 2023see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:
  1. Grupo Cochrane de Salud digestiva

Copyright:
  1. Copyright © 2023 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Cifras del artículo

Altmetric:

Citado por:

Citado 0 veces por enlace Crossref Cited-by

Contraer

Autores

  • Mark P Tighe

    Correspondencia a: Department of Paediatrics, University Hospitals Dorset, Poole, UK

    [email protected]

  • Edward Andrews

    Department of Paediatrics, University Hospitals Dorset, Poole, UK

  • Iona Liddicoat

    Department of Paediatrics, University Hospitals Dorset, Poole, UK

  • Nadeem A Afzal

    Faculty of Science & Health, Portsmouth University, Portsmouth, UK

  • Andrew Hayen

    Australian Centre for Public and Population Health, Faculty of Health, University of Technology Sydney, Sydney, Australia

  • R Mark Beattie

    Child Health, University Hospital Southampton NHS Foundation Trust, Southampton, UK

Contributions of authors

Roles and responsibilities

Agree the protocol is still appropriate: Mark Tighe, Mark Beattie,
Confirm the search strategy: Mark Tighe, Mark Beattie
Search for new trials (2 people): Mark Tighe, Iona Liddicoat,
Obtain copies of new trials: Mark Tighe, Iona Liddicoat
Select which trials to include (2 + 1 arbiter) Mark Tighe, Iona Liddicoat +Mark Beattie.
Extract data from trials (2 people) Mark Tighe, Iona Liddicoat
Enter data into RevMan: Mark Tighe, Iona Liddicoat
Carry out the analysis: Mark Tighe, Iona Liddicoat, Edward Andrews, Mark Beattie.
Interpret the analysis Mark Tighe, Nadeem Afzal, Mark Beattie, Iona Liddicoat, Edward Andrews, Andrew Hayen
Update the review Mark Tighe, Iona Liddicoat, Edward Andrews, Nadeem Afzal, Mark Beattie, Andrew Hayen.

Sources of support

Internal sources

  • Library, University Hospitals Dorset NHS Foundation Trust, UK

    Obtaining manuscripts

External sources

  • Cochrane Gut Group, Canada

    We would also like to thank the following editors and peer referees who provided comments to improve the review: Sarah Rhodes (editor), Yvan Vandenplas and Kornilia Nikaki (peer reviewers), and Alfretta Vanderheyden (consumer reviewer), Yuhong Yuan (managing editor) and to Grigoris Leontiadis (co‐ordinating editor). The update search strategies of Cochrane, MEDLINE and Embase were designed by Yuhong (Cathy) Yuan (Information Specialist at the Cochrane Gut group).

Declarations of interest

There are no authors' conflicts of interest.

A previous review of the medical treatment of gastro‐oesophageal reflux was completed for 'Pediatric Drugs' (publishers: 'Adis') and published in early 2009. However that article is substantially different from the Cochrane review. The Pediatric Drugs article was not funded.

Acknowledgements

Current version:

We would like to thank the following editors and peer referees who provided comments to improve the review: Sarah Rhodes (Statistical Editor), Yvan Vandenplas and Kornilia Nikaki (Peer Reviewers), Alfretta Vanderheyden (Consumer Reviewer), Yuhong Yuan and Teo Quay (Managing Editors) and Grigoris Leontiadis (Co‐ordinating Editor). The updated search strategies for CENTRAL, MEDLINE and Embase were designed by Yuhong (Cathy) Yuan (Information Specialist, Cochrane Gut). We would like to acknowledge the very kind work of University Hospitals Dorset Library, in accessing articles.

Previous version: We would like to again acknowledge the work that Amanda Bevan, Andrew Hayen and Alasdair Munro provided in the first review, as well as Bernie Higgins for his initial work in drafting the data collection form and the protocol. We would like to acknowledge the very kind work of Poole Hospital Library, in accessing articles.

We would also like to acknowledge the support of the Cochrane Gut Group, particularly Yuhong Yuan in performing the search.

Cochrane Gut supported the authors in the development of this Review Update.

The following people conducted the editorial process for this article:

  • Sign‐off Editor (final editorial decision): Bob Boyle, Imperial College London, UK

  • Managing Editor (selected peer reviewers, collated peer‐reviewer comments, provided editorial guidance to authors, edited the article): Colleen Ovelman and Anne‐Marie Stephani, Cochrane Central Editorial Service

  • Editorial Assistant (conducted editorial policy checks and supported editorial team): Lisa Wydrzynski, Cochrane Central Editorial Service

  • Copy Editor (copy‐editing and production): Faith Armitage, Cochrane Central Production Service

  • Peer‐reviewers (provided comments and recommended an editorial decision): Yvan Vandenplas, Vrije Universiteit Brussel, UZ Brussel, KidZ Health Castle (clinical/content review), Kornilia Nikaki, Paediatric Gastroenterology Consultant, Great Ormond Street Hospital, UK (clinical/content review), Nuala Livingstone, Cochrane Evidence Production and Methods Directorate (methods review), Robin Featherstone, Cochrane Central Editorial Service (search review).

Version history

Published

Title

Stage

Authors

Version

2023 Aug 22

Pharmacological treatment of gastro‐oesophageal reflux in children

Review

Mark P Tighe, Edward Andrews, Iona Liddicoat, Nadeem A Afzal, Andrew Hayen, R Mark Beattie

https://doi.org/10.1002/14651858.CD008550.pub3

2014 Nov 24

Pharmacological treatment of children with gastro‐oesophageal reflux

Review

Mark Tighe, Nadeem A Afzal, Amanda Bevan, Andrew Hayen, Alasdair Munro, R Mark Beattie

https://doi.org/10.1002/14651858.CD008550.pub2

2010 Jun 16

Pharmacological treatment for gastro‐oesophageal reflux in children

Protocol

Mark Tighe, Nadeem Afzal, Amanda Bevan, Bernie Higgins, R Mark Beattie

https://doi.org/10.1002/14651858.CD008550

Differences between protocol and review

Differences between the protocol and the present update:

  • Data collection and analysis: we used Review Manager 5.4 and RevMan Web for data collection and analysis, updated from RevMan 5.1.

  • Selection of studies: we added reprints of articles to the reference lists of included studies but did not consider them separately if they contained no new data. In the 2014 review, we discarded article reprints. We listed studies that were available only in abstract form, or were only identified in the ISRCTN register, as studies 'awaiting classification'.

  • Outcomes: we redesignated the outcome of 'pH/impedance studies' to 'pH/impedance indices' to account for the range of pH measurements described in the available literature.

  • Data extraction and management: three review authors (MT, IL, EA) independently extracted study data using a robust data extraction form and checked and entered the data into RevMan 5.4/RevMan Web, with MT, EA, and IL analysing the data and highlighting any discrepancies. In the 2014 review, two review authors extracted and entered study data into RevMan 5.1.

  • Measures of treatment effect: we extracted continuous data (e.g. reflux index) for summary data: we used means and standard deviations to derive a standardised mean difference (SMD) with a 95% confidence interval using a fixed‐effect model. The latest NASPGHAN/ESPGHAN guidelines do not define normal values for pH‐metry and pH‐impedance (NASPGHAN‐ESPGHAN guidelines 2018). The values of reflux index mentioned in the 2014 review (> 10% in 24 hours in infants and > 4% in 24 hours in children > 12 months) have been modified here with a judgement regarding improvement/non‐improvement. Dichotomous data, such as improvement/non‐improvement in endoscopic appearance, produced outcome data we presented as risk ratios. In the 2014 review, we used reported data rather than extracting summary data.

  • Unit of analysis issues: we considered issues related to multiple observations for the same outcome (e.g. repeated pH‐impedance measurements), and consulted the Cochrane Gut group if clarification was required. If we included multi‐arm studies, we would analyse multiple intervention groups to prevent arbitrary omission of relevant groups or double‐counting of participants. In the 2014 review, there was some overlap in reported data (e.g. according to age criteria); this was corrected in this review.

  • Dealing with missing data: we contacted trial authors or sponsors of studies published from 2014 to 2022 to provide missing data, or to seek clarification when we were uncertain about the specifics of a trial pertinent to analysis. In the 2014 review, we contacted study authors of studies published within the previous 10 years (e.g. to 2004).

  • Data synthesis: were unable to combine studies meaningfully due to the heterogeneity of studies in terms of outcomes, comparisons, and populations. For continuous measurements, we had planned to use weighted mean differences to pool results from studies using a common measurement scale. Where studies used different measurement scales, we planned to pool standardised mean differences. Instead, we have presented difference in means and 95% confidence intervals for individual studies and summary effects, using the following order: Population > Comparison > Outcome, following updated guidance. Given the individual study differences and heterogeneity in study design, we provided guidance based on individual treatments to give better focus for decision‐makers. This differs from the 2014 review.

  • Sensitivity analysis: if meta‐analysis had been possible, we intended to undertake sensitivity analysis using RevMan Web, to ascertain whether any decisions regarding thresholds influenced result reporting (e.g. choosing age thresholds at 12 months influencing meta‐analytic robustness). We planned to integrate the findings into the results and conclusions. This was not considered in the 2014 review. However, a meta‐analysis was not possible and sensitivity analysis not required.

  • Summary of findings and assessment of the certainty of the evidence: working independently, two authors used the five GRADE considerations (risk of bias, consistency of effect, imprecision, indirectness, and publication bias) to assess the certainty of the body of evidence for each outcome, and to draw conclusions about evidence certainty within the text of the review. We resolved disagreements through discussion, and involved all review authors involved if the initial two authors could not reach agreement. All authors then reviewed the GRADE considerations in assessing the certainty of evidence and integrated this into the summary of findings tables. The summary of findings tables distinguish results by age (infants, and children aged one to 16 years), then comparison, and the evidence is presented by outcome (symptoms, adverse events, pH‐impedance indices, and endoscopic findings), with clear rationales given where evidence was downgraded or upgraded according to GRADE criteria, including if the risk of bias was so great the evidence needed downgrading by two steps.

  • Literature search in this update version: we did not search the Cochrane Review Group Specialised Register as it was not updated since the 2014 version and the included RCTs are included in Cochrane CENTRAL, which we did search. We did not search the Centralised Information Service for Complementary Medicine (CISCOM). This database did not yield additional eligible studies for our review in the 2014 version, and it was not available to us for this update. In the 2014 version, we handsearched published abstracts from conference proceedings. For this update, we did not handsearch proceedings from conferences that took place after 2014 because Embase now includes proceedings from these conferences (2000 onwards); these abstracts were searched electronically through our main electronic search. In the 2014 version, we searched the clinical trials register mRCT. In this updated version, we searched the World Health Organization's clinical trials register (ICTPR) and ClinicalTrials.gov (https://clinicaltrials.gov/). We also revisited the search strategies, and added some new terms to reflect the current practice of treatment in the updated search.

  • We have used the terms GOR and GORD throughout the review, following NASPGHAN‐ESPGHAN guidelines 2018 and NICE 2019 definitions, and we acknowledge that different groups may have used different definitions for these terms in their studies. We have included some narrative where relevant and encourage readers to review the original articles if they wish to ascertain in more detail how other authors distinguish between GOR and GORD.

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.