H. Almoajil1,2, S. Hopewell3, H. Dawes4, F. Toye5, T. Theologis1
1University of Oxford, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, 2Imam Abdulrahman Bin Faisal University, Department of Physical Therapy, College of Applied Medical Science, AlKhobar, Saudi Arabia, 3University of Oxford, Centre of Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Oxford, United Kingdom, 4University of Exeter, College of Medicine and Health, Medicine, Nursing and Allied Health Professions, Exeter, United Kingdom, 5Oxford University Hospitals NHS Foundation Trust, Physiotherapy Research Unit, Nuffield Orthopaedic Centre, Oxford, United Kingdom
Background: The literature on lower limb orthopaedic surgery and post-surgical rehabilitation for ambulant children with cerebral palsy (CP) demonstrates significant heterogeneity of outcomes and evidence for selective outcome reporting. This limits evidence synthesis and undermines research findings through outcome reporting bias. Although several outcomes are commonly measured and reported, these outcomes do not always capture the needs and expectations of children and families into account.
Purpose: This study aims to develop a minimum set of important and relevant outcomes, a “Core Outcome Set”, for use in future clinical trials evaluating lower limb orthopaedic surgery and post-surgical rehabilitation for ambulant children with CP.
Methods: The study was designed in two parts. (A) potential outcomes were identified through: (1) Qualitative Evidence Synthesis, (2) Scoping Review; and (3) Qualitative study: interviews with stakeholders (healthcare professionals, researchers, children and families). (B) Prioritisation of outcome domains through: (4) International two-round e-Delphi consensus methodology was used to gain agreement between stakeholders as to which outcomes were “core”; and (4) Consensus meetings, where outcomes selected through the Delphi process were brought forward the panel to agree on the final core outcome set. Target stakeholders from relevant national and international networks were approached to contribute to this selection.
International multi-stakeholders’ groups including:
1. Healthcare professionals and researchers: who had experiences in managing or conducting a research focus on lower limb orthopaedic surgery and post-surgical rehabilitation for children with CP.
2. Individuals with CP and representative: children, young adults or adults with CP, have had experience with at least one surgery for any lower limb deformity or have the intention of undergoing that treatment in the future. Representative of a family member (parents) or carer of a child with the above criteria.
International multi-stakeholders’ groups including:
1. Healthcare professionals and researchers: who had experiences in managing or conducting a research focus on lower limb orthopaedic surgery and post-surgical rehabilitation for children with CP.
2. Individuals with CP and representative: children, young adults or adults with CP, have had experience with at least one surgery for any lower limb deformity or have the intention of undergoing that treatment in the future. Representative of a family member (parents) or carer of a child with the above criteria.
Results: The literature review and stakeholder interviews initially identified 99 outcome domains. These were grouped into 41 outcomes for prioritisation in the Delphi survey. A total of 197 participants were surveyed from 16 countries. The findings were brought forward to the consensus meetings with 21 international stakeholders. Consensus was achieved on eight outcome domains: (1) pain and fatigue; (2) lower limb structure; (3) motor function; (4) daily life activities; (5) gait-related outcomes; (6) physical activity; (7) independence; and (8) quality of life. An adverse event domain was suggested as an essential part of documentation.
Conclusions: This study has developed an evidence-based, internationally endorsed core outcome set for lower limb orthopaedic surgery and post-surgical rehabilitation for children with ambulant CP. The development of a core outcome sets would provide more robust evidence on this field. It is recommended that these outcomes be implemented into future clinical studies to enhance the relevance, efficiency, consistency and transparency of research outcomes, which in turn facilitate meta-analysis/ synthesis and ultimately inform clinical practice and improve in patient care.
Implications:
- Eight meaningful and relevant outcomes to all stakeholders should be considered.
- Inform more robust evidence on the field of lower limb orthopaedic interventions research.
- Underpin the development of a core outcome measurements set for use in the same field of research.
Funding acknowledgements: The project funded from Imam Abdulrahman Bin Faisal University, Saudi Arabia
Keywords:
Cerebral Palsy
Lower limb
Core outcome set
Cerebral Palsy
Lower limb
Core outcome set
Topics:
Paediatrics: cerebral palsy
Paediatrics
Orthopaedics
Paediatrics: cerebral palsy
Paediatrics
Orthopaedics
Did this work require ethics approval? Yes
Institution: Oxfordshire Research Ethics Committee B
Committee: Oxfordshire Research Ethics Committee B
Ethics number: (REC reference 19/SC/0357)
All authors, affiliations and abstracts have been published as submitted.
