SPINE-COS-AYA
Research type
Research Study
Full title
FIRST PHASE OF THE DEVELOPMENT OF A PERSON-CENTRED CORE OUTCOME SET FOR ADOLESCENTS AND YOUNG ADULTS WITH SPINAL DEFORMITY UNDERGOING TREATMENT: CREATION OF A MEANINGFUL LONG LIST OF CANDIDATE OUTCOME DOMAINS (SPINE-COS-AYA)
IRAS ID
279243
Contact name
Lisa Graham-Wisener
Contact email
Sponsor organisation
Queen's University Belfast
Duration of Study in the UK
1 years, 3 months, 2 days
Research summary
"Research Summary"
A Core Outcome Set (COS) for treatment of spinal deformity in Adolescents and Young Adults (AYA) is essential to ensure that appropriate outcomes are evaluated consistently, facilitating high-quality trials of different treatment modalities and informing the routine collection of clinical data within international spine registries. It is important to include a diverse range of key stakeholders in COS development.This first phase of a project to develop the COS will use an inductive approach involving qualitative methods with a diverse range of key stakeholders (HCPs, patients and family members) to generate a comprehensive list of potential core outcome domains (COD), which are constructs used to classify broad aspects of the effects of intervention. This is a crucial process to ensure all potential domains are identified to inform the subsequent Delphi study.
Semi-structured interviews (n=30-45, until data saturation) will be undertaken with AYA with spinal deformity who live in the UK. The sampling frame will include AYA (10-25 years) who have received surgical intervention for spinal deformity or who have received conservative treatment (observation or bracing), providing that the deformity was not secondary to other disease/disorder/syndrome or the result of trauma. Maximum variation sampling will be applied to achieve an appropriately diverse sample. For participants under 16 years of age, informed consent will be sought from their parent/guardian and informed assent from the young person. Semi-structured interviews will also take place with family members (n=20-30) and HCPs (n=10-15). Content analysis will provide counts for outcomes endorsed, and preferred phraseology for descriptors. Thematic analysis will generate list and descriptor content from open-ended responses. Convergence/ divergence will be explored across samples.
"Summary of results"
Research is continually ongoing to develop better treatments for adolescent idiopathic scoliosis, whether this is less invasive surgery or more effective bracing. In order to help patients and healthcare professionals make decisions about treatment, it is important to have the best available research evidence on which treatments work best for young people with scoliosis.The effect that a treatment has on a patient is measured using an 'outcome'. An example of an outcome is spinal curvature, and another example of an outcome is psychological wellbeing. There are many different outcomes which can be used to test whether a treatment has been effective.
Often the effect of treatments for health conditions (e.g. scoliosis) are measured using different outcomes, which makes it difficult for researchers to compare their research findings to know which treatment is best. This limits the quality of the research evidence and so patients and healthcare professionals may be unsure which treatment is most effective.
If researchers were to agree to measure the same outcomes for Scoliosis for young people, the findings could be combined or compared which leads to the availability of better quality research evidence. Therefore, it is important to speak to young people with scoliosis, their families and healthcare professionals to ensure that the outcomes which are most important to them are measured.
This agreement on what outcomes at minimum are most important to measure the success of a treatment is called a core outcome set (COS).
We as researchers at Queen's University Belfast, collaborated with our colleagues in the Belfast Health and Social Care Trust to develop the first stage of development for a core outcome set for adolescent idiopathic scoliosis. We were supported by a Young Person Advisory Group, who provided valuable advice on the design and conduct of the research.
We interviewed 40 young people with scoliosis, their parents and healthcare professionals from across Northern Ireland, to identify which outcome domains were important to them and why.
We are very grateful to the participants who supported our research. The interviews helped us to identify a total of 91 important outcome domains. Of these, 53 outcome domains applied both to young people undergoing surgery and bracing. There were 15 additional outcome domains for bracing only, and 23 additional outcome domains for surgery only. The majority of outcome domains were identified by at least two participant groups, suggesting a level of agreement on what is important, between young people, parents and healthcare professionals. The majority of outcome domains which participants felt were important to measure fell under the domain of 'life impact', with a smaller proportion classified as physiological/clinical outcomes, resource use or adverse events.
We now have a long list of outcome domains which young people with adolescent idiopathic scoliosis, their parents, and healthcare professionals feel are important. We are planning to bring this long list into an international consensus exercise, if we obtain more research funding. This is the final step of developing a core outcome set, which can be used to ensure the treatment outcomes which are most important are evaluated in clinical trials.
REC name
Wales REC 7
REC reference
20/WA/0088
Date of REC Opinion
28 Feb 2020
REC opinion
Favourable Opinion