amily-centred core outcome set for infants with developmental dysplasia of the hip undergoing brace treatment.

AIMS: The aim of this study was to identify a minimum set of family-centred outcomes that should be collected in research involving infants with developmental dysplasia of the hip (DDH) undergoing brace treatment. METHODS: A comprehensive list of potential outcomes was developed through a literature review and survey of key stakeholders including caregivers, clinicians, and researchers. Potential outcomes were evaluated in a two-round Delphi consensus process, which included a UK-led group with international involvement comprising orthopaedic surgeons, physiotherapists, nurse practitioners, researchers, parents, and charity representatives. Outcomes that did not reach consensus were discussed during a final consensus meeting, where a broad group of stakeholders voted on the inclusion or exclusion of these outcomes. RESULTS: A total of 14 family-centred outcomes were identified for inclusion in the Delphi process. Of these, 12 were derived from the comprehensive literature review and two additional outcomes were added following the initial stakeholder survey. No additional outcomes were identified during the Delphi process. Of the 14 outcomes, eight achieved 'consensus in' during the Delphi rounds and none were excluded. Six outcomes were further discussed at the final consensus meeting, resulting in one being added to the final core outcome set (COS). The final COS includes nine outcomes: infant cleanliness, sleep, comfort, development, skin irritation, and feeding; along with parental wellbeing, bonding, and the availability of information and resources. CONCLUSION: This family-centred COS is recommended as the minimum set of outcomes that should be collected in trials involving infants undergoing brace treatment for DDH. Further work is required to identify or develop an appropriate tool for collecting data on these outcomes.