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.
Hajar Almoajil,Sally Hopewell,Helen Dawes,Francine Toye,Tim Theologis
Disease Category: Child health
Disease Name: Cerebral palsy
Age Range: 0 - 18
Sex: Either
Nature of Intervention: Surgery
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Systematic review
1) Qualitative Evidence Synthesis: to explore the stakeholders’ perspective of the provided treatment addressing musculoskeletal deformity and to understand their experiences of living with the condition.
2) Scope review: to determine available primary outcome measures used and the health aspects they address in the literature on orthopaedic surgery of the lower limb in ambulant CP.
3) Qualitative study: to understand the stakeholders' priorities of health aspects to be covered and factors which affect their perspective.
4) Delphi process: to achieve consensus on the primary outcome domains from all stakeholders' perspective.
5) Consensus meeting: to present and discuss the findings from the Delphi survey and to identify the primary outcome measures for the identified domains of key health aspects (COS).