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A core outcome set for lower limb orthopaedic surgery for children with cerebral palsy: An international
Hajar Almoajil1,2, Sally Hopewell1, Helen Dawes3,4
1Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Insights
A core outcome set was developed for children with cerebral palsy undergoing lower limb surgery. This standardized approach ensures consistent measurement of treatment impact, improving research comparability for pediatric orthopedic surgery outcomes.
Area of Science:
- Pediatric Orthopedics
- Rehabilitation Medicine
- Clinical Trial Methodology
Background:
- Children with cerebral palsy (CP) often require lower limb orthopaedic surgery.
- Standardized outcome measurement is crucial for evaluating surgical interventions in this population.
- Current research lacks a unified set of outcome domains, hindering comparative analysis.
Purpose of the Study:
- To establish a core outcome set (COS) for clinical studies on lower limb orthopaedic surgery in ambulant children with CP.
- To ensure the COS reflects the priorities of diverse stakeholders, including children, parents/carers, and health professionals.
- To facilitate consistent and meaningful evaluation of surgical outcomes in pediatric CP.
Main Methods:
- Literature review and qualitative interviews identified potential outcome domains.
- An international two-round Delphi survey with key stakeholders scored outcome importance.
- A consensus meeting finalized the core outcome domains and the COS.
Main Results:
- 161 health professionals and 36 individuals with CP and their families participated.
- The Delphi survey rated 21 of 41 outcomes as important.
- A final COS includes 19 outcomes across eight domains: pain/fatigue, lower limb structure, motor function, mobility, gait, physical activity, independence, and quality of life.
Conclusions:
- A comprehensive COS for lower limb orthopaedic surgery in children with CP has been developed.
- Implementing this COS will enable more holistic treatment impact assessment.
- This standardized approach will enhance the comparability and synthesis of future clinical study results.
Aim:
To develop a core set of outcome domains to be measured in clinical studies on lower limb orthopaedic surgery for ambulant children with cerebral palsy (CP) that represents the priorities of an international multi-stakeholder group (children, parent/carers, and health professionals).
Method:
Potential outcome domains were identified through literature review and qualitative interviews with key stakeholders. These were scored in an international two-round Delphi survey, using a 9-point Likert scale. A final consensus meeting with key stakeholders agreed on the most important outcome domains and refined the core outcome set (COS).
Results:
One hundred and sixty-one health professionals and 36 individuals with CP and their parents/carers rated 21 of 41 outcomes as important in the Delphi survey. The final consensus group agreed 19 outcomes within eight domains to be included in the final COS: pain and fatigue, lower limb structure, motor function, mobility (daily life activities), gait-related outcomes, physical activity, independence, and quality of life.
Interpretation:
A COS for lower limb orthopaedic surgery for children with CP was developed. Incorporating this in the design of future clinical studies will provide a more holistic assessment of the impact of treatment while allowing meaningful comparisons and future synthesis of results from primary studies.
What This Paper Adds:
Eight core outcome domains were identified as important to measure in future clinical research. Key stakeholders perceived pain, balance and fall, and independence as very important outcomes. Six contextual factors were identified as essential in surgical decision-making.
