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H. Almoajil1,2, S. Hopewell3, H. Dawes4, F. Toye5, R. Kamran1, 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: Recent recommendations, consensus-based study on core outcome set for lower limb orthopaedic surgery and post-surgical rehabilitation, informed this study, which provides suggestions on which outcome domains to evaluate in ambulant children with cerebral palsy. Eight domains are identified as highly relevant: (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. Choosing the most fit-for-purpose outcome measures for a pre-identified core domains is fundamental because using inappropriate measures can lead to detection bias.
In addition, the literature evaluating lower limb orthopaedic surgery and post-surgical rehabilitation for ambulant children with CP has substantial heterogeneity for outcome measures used. This limits the comparability and evidence synthesis in this field. A core outcome measures set (an agreed, minimum set of outcome measures) was needed to address the heterogeneous measurement of outcomes in in this field of research and to facilitate the production of transparent, meaningful and efficient outcome data.
In addition, the literature evaluating lower limb orthopaedic surgery and post-surgical rehabilitation for ambulant children with CP has substantial heterogeneity for outcome measures used. This limits the comparability and evidence synthesis in this field. A core outcome measures set (an agreed, minimum set of outcome measures) was needed to address the heterogeneous measurement of outcomes in in this field of research and to facilitate the production of transparent, meaningful and efficient outcome data.
Purpose: The aim of this study was to develop a core set of outcome measures in the field of lower limb orthoparedic surgery and post-surgical rehabilitation for ambulant children with cerebral palsy.
Methods: Outcome measures were identified through a scoping review of the literature. The measures’ constructs were identified and matched to a pre-defined core domains set. The psychometric properties of the outcome measures and feasibility criteria were assessed and summarised according to the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) guideline. A consensus meeting with seven health professionals was then held to reach agreement and confirm the core outcome measures set.
Results: The review identified 38 outcome measures, of which 20 measures had sufficient relevance for measuring the pre-defined core domains. The quality of the evidence ranged from “poor” to “strong” depending on the measure and the psychometric properties assessed. Few measures had evidence for responsiveness.
The consensus was achieved on eight outcome measures for use in assessing orthopaedic surgical interventions and post-surgical rehabilitation for ambulant children with CP. These were a combination of (A) clinician-driven objective measures, include: (1) Three-Dimensional Gait Analysis (3-DGA), (2) Edinburgh Visual Gait Score (EVGS), (3) 10-Meter Walk Test (10-MWT) and (4) Gross Motor Functional Measure (GMFM-66), and (B) Patient-Reported Outcome Measures (PROMs), include: (5) Gait Outcomes Assessment List (GOAL), (6) Gillette Functional Assessment Questionnaire (Gillette FAQ), (7) Patient-Reported Outcomes Instruments System (PROMIS) and (8) Cerebral Palsy - Quality of Life (CP- QoL).
The consensus was achieved on eight outcome measures for use in assessing orthopaedic surgical interventions and post-surgical rehabilitation for ambulant children with CP. These were a combination of (A) clinician-driven objective measures, include: (1) Three-Dimensional Gait Analysis (3-DGA), (2) Edinburgh Visual Gait Score (EVGS), (3) 10-Meter Walk Test (10-MWT) and (4) Gross Motor Functional Measure (GMFM-66), and (B) Patient-Reported Outcome Measures (PROMs), include: (5) Gait Outcomes Assessment List (GOAL), (6) Gillette Functional Assessment Questionnaire (Gillette FAQ), (7) Patient-Reported Outcomes Instruments System (PROMIS) and (8) Cerebral Palsy - Quality of Life (CP- QoL).
Conclusions: This comprehensive study demonstrated the strengths and weaknesses of research outcome measures that have been used in the field of lower limb orthopaedic surgery and post-surgical rehabilitation in CP. Eight core measures are recommended for use in future clinical research in this field. The use of this core set would enhance the consistency, validity and comparability of future research.
Implications:
- If the core outcome measures set implemented in all future studies, then studies results will be more readily incorporated into meta-analyses in systematic reviews.
- Clinical care will be informed by the best available evidence.
Funding acknowledgements: The project funded from Imam Abdulrahman Bin Faisal University, Saudi Arabia
Keywords:
Cerebral palsy
Lower limb
Outcome measures
Cerebral palsy
Lower limb
Outcome measures
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.
