Core Outcome Measures in Effectiveness Trials

Development of a core outcomes set for orthopaedic interventions in ambulant children and young people with cerebral palsy

General Information

Summary:
Background: Cerebral Palsy (CP) is the most common cause of physical disability in childhood. Although CP is considered as a non-progressive condition, the musculoskeletal manifestations are often progressive, with musculoskeletal deformities and gait abnormalities progressing during growth and development. Orthopaedic surgery can reduce or prevent long-term decline of function. The literature on orthopaedic interventions includes multiple outcome measures used to evaluate a diverse range of treatment outcomes. These outcomes do not necessary represent the patients’ views of treatment outcome. Evidence suggests that there is often an unmet or different expectation of CP patients and their caregivers regarding the treatment provided. Outcomes are most valuable if they are standardised, comparable between studies and include outcome domains that are relevant to the patient population of interest. In addition, the CP orthopaedic literature is affected by heterogeneity in outcome measures used in different trials. Paediatric orthopaedic surgery trials in this area of clinical practice can be improved in quality by improving selection, measurement and reporting of outcomes. This could be achieved through the development of a core outcomes set (COS).


Aim: to develop a core outcomes set relevant to clinical and research practice in the orthopaedic treatment of cerebral palsy

Contributors:
The study is being undertaken by Hajar Almoajil for a DPhil at the Nuffield Department of Orthopaedic, Rheumatology and Musculoskeletal Science (NDORMS), University of Oxford.

The principal investigator/primary supervisor: Mr Tim Theologis MSc, PhD, FRCS, Consultant Orthopaedic Surgeon at Nuffield Orthopaedic Centre, Oxford.

Co-investigator/supervisor: Professor Helen Dawes, Director Centre for Movement, Occupational and Rehabilitation Sciences, Faculty of Health and Life, Oxford Brookes University, Oxford.

Co-investigator/supervisor: Dr Francine Toye, Oxford University Hospitals NHS Trust, Oxford.


Further Study Information

Current Stage:
Ongoing
Date:
October 2017 - September 2020
Funding source(s):
The Royal Embassy of Saudi Arabian Cultural Bureau in the UK

Health Area

Disease Category
Child health

Disease Name
Cerebral palsy

Target Population

Age Range
0 - 18

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

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).


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)

Study Type

COS for clinical trials or clinical research
COS for practice

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.