Abstract
AimsThe aim of this study is to develop a core set of outcome domains that should be considered and reported in all future trials of childhood limb fractures.MethodsA four-phase study was conducted to agree a set of core outcome domains. Identification of candidate outcome domains were identified through systematic review of trials, and outcome domains relevant to families were identified through semi-structured interviews with 20 families (parent-child pairing or group). Outcome domains were prioritized using an international three-round Delphi survey with 205 panellists and then condensed into a core outcome set through a consensus workshop with 30 stakeholders.ResultsThe systematic review and interviews identified 85 outcome domains as relevant to professionals or families. The Delphi survey prioritized 30 upper and 29 lower limb outcome domains at first round, an additional 17 upper and 18 lower limb outcomes at second round, and four additional outcomes for upper and lower limb at the third round as important domains. At the consensus workshop, the core outcome domains were agreed as: 1) pain and discomfort; 2) return to physical and recreational activities; 3) emotional and psychosocial wellbeing; 4) complications from the injury and treatment; 5) rturn to baseline activities daily living; 6) participation in learning; 7) appearance and deformity; and 8) time to union. In addition, 9a) recovery of mobility and 9b) recovery of manual dexterity was recommended as a core outcome for lower and upper limb fractures, respectively.ConclusionThis set of core outcome domains is recommended as a minimum set of outcomes to be reported in all trials. It is not an exhaustive set and further work is required to identify what outcome tools should be used to measure each of these outcomes. Adoption of this outcome set will improve the consistency of research for these children that can be combined for more meaningful meta-analyses and policy development.Cite this article: Bone Joint J 2021;103-B(12):1821–1830.
Highlights
There is a growing awareness regarding the need for careful outcome selection in clinical research
This set of core outcome domains is recommended as a minimum set of outcomes to be reported in all trials
The Core Outcome Measures in Effectiveness Trials (COMET) Initiative has developed guidelines and methodology for the generation of these standardized sets of outcomes in the form of core outcome sets.5-7 In a core outcome set, an agreed collection of outcomes is identified as the minimum reporting standard for THE BONE & JOINT JOURNAL
Summary
There is a growing awareness regarding the need for careful outcome selection in clinical research. The objective of designing a core set of outcome domains is to agree the outcome domains that need to be measured in every research study. These are the broad “what to measure” constructs, such as pain or function. The Core Outcome Measures in Effectiveness Trials (COMET) Initiative has developed guidelines and methodology for the generation of these standardized sets of outcomes in the form of core outcome sets.5-7 In a core outcome set, an agreed collection of outcomes is identified as the minimum reporting standard for THE BONE & JOINT JOURNAL
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