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Development of an international core outcome set for treatment trials in paediatric inguinal hernia: protocol for a
Sanne C Maat1,2,3, Ramon R Gorter2, Ernest L W van Heurn4,3
1Department of Pediatric Surgery, Amsterdam Reproduction and Development Research Institute, Emma Childrens' Hospital UMC, Amsterdam, The Netherlands s.c.maat@amsterdamumc.nl.
Insights
This study aims to establish a core outcome set for pediatric inguinal hernia repair to standardize reporting and improve treatment comparisons. Developing this consensus will address heterogeneity in current research, leading to clearer evidence on surgical approaches.
Area of Science:
- Pediatric surgery
- Clinical trial methodology
Background:
- Open inguinal hernia repair is standard in children, but laparoscopic techniques are emerging.
- Lack of consensus on surgical superiority stems from inconsistent outcome reporting in trials.
- A core outcome set (COS) is needed to standardize outcome measurement and reporting in pediatric inguinal hernia repair.
Purpose of the Study:
- To achieve international consensus on a minimal set of outcomes for pediatric inguinal hernia repair trials.
- To reduce heterogeneity in outcome selection, measurement, and reporting across studies.
- To facilitate evidence-based decision-making for surgical treatment strategies.
Main Methods:
- Systematic literature review to identify outcome domains from patient and literature perspectives.
- Three-round Delphi study involving stakeholders to prioritize core outcomes.
- Expert consensus meeting to finalize the COS and develop implementation strategies.
Main Results:
- The project is in its development phase, aiming to establish a COS.
- The methodology involves systematic reviews, Delphi studies, and expert consensus.
- The final COS will be reported following COS-Standards for Reporting.
Conclusions:
- A standardized core outcome set is crucial for advancing research in pediatric inguinal hernia repair.
- This initiative will improve the quality and comparability of clinical trials.
- The developed COS will guide future research and clinical practice, ultimately benefiting patient outcomes.
Introduction:
In 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.
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