Abstract
BackgroundMedial humeral epicondyle fractures of the elbow are one of the most common injuries in childhood and often require 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 humeral epicondyle fractures in children.Methods/designThis study will include a systematic review of the academic 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 two rounds will then be used to define the most important outcomes to all stakeholders forming the COS.DiscussionCore outcomes represent the minimum expected data reported for a specific condition and will improve the quality of future studies reducing bias, allowing easier comparison and enhancing opportunities for larger meta-analysis. It is anticipated that this COS will form part of the feasibility to a National Institute for Health Research (NIHR) Health Technology Assessment (HTA)-funded trial concerning the management of elbow fractures in children.Trial registrationCore Outcome Measures in Effectiveness Trials Initiative (COMET), registration number:949. Registered on 17 January 2017.Prospero International prospective register of systematic reviews, registration number: CRD 42017057912. Registered on 16 April 2017.
Highlights
Medial humeral epicondyle fractures of the elbow are one of the most common injuries in childhood and often require surgery
Core outcomes represent the minimum expected data reported for a specific condition and will improve the quality of future studies reducing bias, allowing easier comparison and enhancing opportunities for larger meta-analysis
It is anticipated that this core outcome set (COS) will form part of the feasibility to a National Institute for Health Research (NIHR) Health Technology Assessment (HTA)-funded trial concerning the management of elbow fractures in children
Summary
Medial humeral epicondyle fractures of the elbow are one of the most common injuries in childhood and often require surgery. Wide variation in currently reported outcomes makes comparison of treatment difficult. Medial humeral epicondyle fractures are one of the most common injuries in childhood and often require surgery [1, 2]. There are currently no standardised outcome measures to assess progress after an elbow injury in a child. Wide variation in currently reported outcomes (radiographic-, surgeon- and patientreported) makes comparison of the treatment of elbow fractures in children difficult. National Institute for Health Research (NIHR) Health Technology Assessment (HTA) have made children’s orthopaedic surgery a priority area and are considering a clinical trial in the management of medial epicondyle fractures in children [4]. A major barrier to these trials is the lack of a clear outcome, i.e. pain, function, fracture union, cosmesis, quality of life
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