Core Outcome Measures in Effectiveness Trials

Management of medial epicondyle fractures of the elbow in children: A structured review protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

General Information

Summary:
Medial epicondyle fractures are one of the most common injuries in childhood often requiring surgery. There are currently no standardised outcome measures to assess progress after an elbow injury in a child. Wide variation in currently reported outcomes makes comparison of treatment difficult. This study aims to identify outcome measures that have previously been reported in studies evaluating the management of medial epicondyle fractures in children and to facilitate the development of a consensus core outcome set (COS) suitable for use in all future studies of medial epicondyle fractures in children.

This study will include a systematic review of the literature to identify a list of outcome measures that have previously been reported. The list of outcome measures will be used in a consensus setting exercise with focus groups of key stakeholders to identify key outcomes. A Delphi process to include three rounds will then be used to define the most important outcomes to all stakeholders forming the COS.

Link to protocol: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2472-3

Contributors:
Sara Dorman - principle investigator
James Shelton - investigator
Ken Lineman - University Librarian
Daniel Perry - Supervisor
Jamie Kirkham - University of Liverpool

Further Study Information

Current Stage:
Planning
Date:
January 2017 - March 2017
Funding source(s):
AO grant £5000 for facilitation of delphi survey

Health Area

Disease Category
Orthopaedics & trauma

Disease Name
Medial Epicondyle Fracture Distal Humerus

Target Population

Age Range
0 - 18

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Systematic review

This study will include a systematic review of the literature (meddling, emboss, pubmed) to identify a list of outcome measures that have previously been reported. The list of outcome measures will be used in a consensus setting exercise with focus groups of key stakeholders (children, parents, clinicians) to identify key outcomes. A Delphi process to include three rounds will then be used to define the most important outcomes to all stakeholders forming the COS.


Stakeholders Involved

Clinical experts
Families
Patient/ support group representatives

Study Type

COS for clinical trials or clinical research

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