The Evaluation Measure for BRACe Experience (EMBRACE): developing a patient-reported outcome measure for infants with hip dysplasia

Aims: To identify or develop a patient-reported outcome measure (PROM) aligned with the family-centred core outcome set (COS) for infants with developmental dysplasia of the hip (DDH) treated in a brace. Methods: This study was conducted in five phases: 1) identification of relevant PROMs through two systematic literature reviews; 2) assessment of identified PROMs for content validity and relevance to the COS; 3) a consensus meeting with key stakeholders, including parents and clinicians; 4) development of a novel PROM; and 5) pilot testing with parents of infants treated in a brace. PROMs were assessed according to COSMIN criteria, and development was guided by stakeholder feedback. Results: The systematic reviews identified two relevant PROMs: the Hip Worries Inventory (HWI) and the Infant and Toddler Quality of Life Questionnaire (ITQOL). Neither tool fully aligned with the COS, nor was considered suitable for comprehensive assessment in this population. The HWI was judged to lack domain coverage and negatively framed items, whereas the ITQOL was lengthy and burdensome. A consensus meeting supported the development of a new, concise PROM. The resulting Evaluation Measure for BRACe Experience (EMBRACE) includes eight items, scored using a Likert scale, across caregiver and infant domains. Pilot testing confirmed acceptability, clarity, and relevance. Conclusion: The EMBRACE is a concise, family-centred PROM developed to reflect the core domains that were prioritized by families and clinicians for children undergoing DDH brace treatment. It enables the impact of treatment to be captured on both infants and caregivers.