Evidence map›Paper›PMID 38097238›Full record

ArticleBMJ open2023

Development of an international core outcome set for treatment trials in paediatric inguinal hernia: protocol for a three-phase study including a systematic review and Delphi survey.

Sanne C Maat, Ramon R Gorter, Ernest L W van Heurn, Hester Rippen, Nancy J Butcher, Martin Offringa, Joep P M Derikx

Abstract read
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Sanne C MaatDepartment of Pediatric Surgery, Amsterdam Reproduction and Development Research Institute, Emma Childrens' Hospital UMC, Amsterdam, The Netherlands s.c.maat@amsterdamumc.nl.ORCID 0000-0001-5957-7056
Ramon R GorterDepartment of Pediatric Surgery, Emma Childrens' Hospital UMC, Amsterdam, The Netherlands.
Ernest L W van HeurnDepartment of Pediatric Surgery, Amsterdam Reproduction and Development Research Institute, Emma Childrens' Hospital UMC, Amsterdam, The Netherlands.
Hester RippenChild and Hospital Foundation (Stichting Kind en Ziekenhuis), Utrecht, The Netherlands.
Nancy J ButcherChild Health Evaluative Sciences, Sick Kids, Toronto, Ontario, Canada.ORCID 0000-0002-5152-0108
Martin OffringaChild Health Evaluation Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.ORCID 0000-0002-4402-5299
Joep P M DerikxDepartment of Pediatric Surgery, Amsterdam Reproduction and Development Research Institute, Emma Childrens' Hospital UMC, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn children, open inguinal hernia repair has been the gold standard for treatment, but with recent technical advancements in laparoscopy, laparoscopic hernia repair is gaining popularity. Despite available results from comparative studies, there is still no consensus regarding the superiority of open versus laparoscopic treatment strategy. An important reason for lack of consensus is the large heterogeneity in the trials' reported outcomes and outcome definitions, which limits comparisons between studies and precludes conclusions regarding the superiority of treatment strategies. The development and implementation of a core outcome set (COS) is a solution for this heterogeneity in the selection, measurement and reporting of trial outcome measures across studies. Currently, there is no COS for the treatment of paediatric inguinal hernia. METHODS AND ANALYSIS: The aim of this project is to reach international consensus on a minimal set of outcomes that should be measured and reported in all future clinical trials investigating inguinal hernia repair in children. The development process comprises three phases. First, we identify outcome domains associated with paediatric inguinal hernia repair from a patient perspective and through a systematic review of the literature using EMBASE, MEDLINE and the Cochrane Library databases. Second, we conduct a three-step Delphi study to identify and prioritise 'core' outcomes for the eventual minimal set. In the third phase, an expert meeting is held to establish the final COS and develop implementation strategies with participants from all stakeholder groups: healthcare professionals, parents and patients' representatives. The final COS will be reported in accordance with the COS-Standards for Reporting statement. ETHICS AND DISSEMINATION: The medical research ethics committee of the Amsterdam UMC confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study and that full approval by the committee is not required. Electronic informed consent will be obtained from all participants. Results will be presented in peer-reviewed academic journals and at relevant conferences. PROSPERO REGISTRATION NUMBER: CRD42021281422.

Indexed as

Biomedical ResearchHernia, InguinalChildDelphi TechniqueHumansOutcome Assessment, Health CareResearch DesignSystematic Reviews as TopicTreatment OutcomePAEDIATRIC SURGERYSURGERYSurveys and Questionnaires

Identifiers

PMID38097238
PMCPMC10728975

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.