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The Evaluation Measure for BRACe Experience (EMBRACE): developing a patient-reported outcome measure for infants with
Joanna Craven1,2, Wesley W E S Theunissen3, Oliver Lane4
1University of Liverpool, Liverpool, UK.
Insights
A new patient-reported outcome measure (PROM), the Evaluation Measure for BRACe Experience (EMBRACE), was developed for infants with developmental dysplasia of the hip (DDH) undergoing brace treatment. EMBRACE captures outcomes for both infants and caregivers.
Area of Science:
- Orthopedics
- Patient-Reported Outcomes
- Pediatric Health
Background:
- Developmental dysplasia of the hip (DDH) is a common condition in infants requiring brace treatment.
- Existing patient-reported outcome measures (PROMs) lack alignment with family-centered core outcome sets (COS) for DDH.
- There is a need for a concise and relevant PROM for infants with DDH undergoing brace treatment.
Purpose of the Study:
- To identify or develop a PROM aligned with the family-centered COS for infants with DDH treated in a brace.
- To ensure the PROM captures key domains prioritized by families and clinicians.
- To evaluate the acceptability, clarity, and relevance of the developed PROM.
Main Methods:
- Systematic literature reviews identified existing PROMs.
- PROMs were assessed for content validity and relevance to the COS using COSMIN criteria.
- A consensus meeting with stakeholders informed the development of a novel PROM, followed by pilot testing.
Main Results:
- Two existing PROMs, HWI and ITQOL, were identified but deemed unsuitable.
- A new, concise PROM, the Evaluation Measure for BRACe Experience (EMBRACE), was developed.
- EMBRACE includes eight items across caregiver and infant domains and demonstrated acceptability, clarity, and relevance in pilot testing.
Conclusions:
- The EMBRACE is a family-centered PROM specifically designed for infants with DDH undergoing brace treatment.
- It effectively captures the impact of treatment on both infants and their caregivers.
- EMBRACE addresses the need for a concise and relevant outcome measure in this population.
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.
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