A global core outcome set for orthopaedic interventions in children with spinal dysraphism : aiming to enhance research quality and patient outcomes.

Aims: Orthopaedic interventions in spinal dysraphism (SD) are frequently required to address a wide spectrum of musculoskeletal deformities. The outcomes used to assess treatment, however, are heterogeneous and most fail to incorporate patient/family perceptions. The aim of this study was to identify the minimum set of outcomes to be collected in clinical practice and research settings following orthopaedic intervention in ambulatory and non-ambulatory children with SD. Methods: The study was based on Core Outcome Measures in Effectiveness trials (COMET) initiative. A list of individual clinical outcomes (ICOs) and outcome measurement tools (OMTs) were obtained from a systematic literature review (SR) and from patients and families through an interview and questionnaire. Core outcomes were rated for importance in a two-round Delphi process that included international orthopaedic surgeons, physiotherapists, orthotists, patients, and families. Outcomes that did not reach consensus during the Delphi process were resolved with a final consensus meeting. Results: In total, 88 statements, including ICOs and OMTs, were scored during the Delphi process for ambulatory and non-ambulatory children. A total of 35 items were resolved in the final consensus meeting. The final core outcome set (COS) is goal-based and includes 28 outcome parameters to be collected a minimum of one year after any orthopaedic intervention and at subsequent set points during childhood. The COS incorporates clinical examination, mobility and functional assessment, patient-reported outcome measures, and investigations with the Goal Attainment Score recommended for goal setting. Conclusion: A minimum set of outcomes to evaluate the orthopaedic treatment of SD was created thereby enabling consistency in reporting among centres and studies.