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

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.

European guidelines on chronic mesenteric ischaemia – joint United European Gastroenterology, European Association for Gastroenterology, Endoscopy and Nutrition, European Society of Gastrointestinal and Abdominal Radiology, Netherlands Association of Hepatogastroenterologists, Hellenic Society of Gastroenterology, Cardiovascular and Interventional Radiological Society of Europe, and Dutch Mesenteric Ischemia Study group clinical guidelines on the diagnosis and treatment of patients with chronic mesenteric

“…Consensus was reached when 70% scored 7-9 and 15% scored 1-3. 9 A recommendation was excluded when 70% scored 1-3 and 15% scored 7-9 or when consensus was not reached after the third voting round. A detailed description of the methods used to develop this guideline and an overview of the results of the voting process can be found in Supplementary Material Document A.…”

“…Experts voted by rating their agreement with a recommendation on a nine‐point Likert scale, where ‘1’ meant complete disagreement and ‘9’ meant complete agreement. Consensus was reached when ≥70% scored 7–9 and ≤15% scored 1–3 9 . A recommendation was excluded when ≥70% scored 1–3 and ≤15% scored 7–9 or when consensus was not reached after the third voting round.…”

A systematic review of reported outcomes following Ponseti correction of idiopathic club foot

“…Measuring and comparing clubfoot treatment success as well as indications for further intervention is currently hindered by the lack of agreed outcomes by the treating community. Core Outcome Sets (COS), defined as the minimum standardized collection of outcomes to be measured and reported in all research for a specific clinical area, 34 have been developed for several musculoskeletal conditions 35 , 36 but not for clubfoot management. In the absence of a COS we have used the COMET (Core Outcome Measures in Effectiveness Trials) initiative principles 37 to identify the outcome tools reported following Ponseti correction of idiopathic clubfoot and analyze them according to domains and acceptance.…”

Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol

“…Distribution of scores will be computed for each outcome and stakeholder group. Determination of consensus for each outcome, by stakeholder group, will be based on definitions used in other COS studies [21–24]. Specifically, it will be defined as ≥ 70% participants scoring 7–9 and < 15% scoring the outcome as 1–3.…”