ScolQol PROM Phase 4
Research type
Research Study
Full title
SCOL-QoL: a new patient reported outcome measure for assessing long-term psychosocial outcomes of adolescent idiopathic scoliosis following no intervention, bracing only, or any spinal fusion surgery
IRAS ID
353779
Contact name
Lesley Dibley
Contact email
Sponsor organisation
University of Greenwich
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
We are developing a new Patient Reported Outcome Measure (PROM) to assess long-term non-clinical outcomes following diagnosis and treatment completion (no treatment, bracing/exercise, spinal fusion surgery) for people with Adolescent Idiopathic Scoliosis (AIS). The condition is usually identified and diagnosed at puberty: it affects the muscles, ligaments and other anatomical attachments to the spine, causing twists and curves of the spinal column; the vertebrae themselves are not damaged. Depending on severity of the curves, consequences include respiratory compromise, digestion and mobility issues, and disrupted body image. Girls are three times more likely to develop the condition than boys. Our earlier scoping reviews demonstrate that whilst clinical outcomes are usually excellent, current outcome measures have been developed without input from people with AIS, and do not assess the psychosocial, economic or practical aspects that they report as importance. Lack of awareness amongst clinicians of the longer-term impacts of AIS affects pre-operative counselling, and post-operative long-term follow-up. This four-phase study is using modern PROM development methods to generate a new scoliosis quality of life measure that reflects patients' needs and concerns.
We completed Phase 1 (lived experience interviews) and used the data to develop a long list of important items that were then rated in the Phase 2 consensus study. From that, we developed the draft PROM and checked the structure, content, wording, layout and usability via cognitive interviews in Phase 3. We recruited from community/online platforms for these three phases. For Phase 4 (validation, checking internal validity, consistency, and reliability over time) we need many more participantswho we plan to recruit via an NHS Trust database.
We have reported our Phase 1 findings at conferences throughout 2024; completion of this PROM will enable people with AIS to accurately report their concerns which often develop years after being discharged from specialist spinal clinics.REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
25/NW/0113
Date of REC Opinion
9 May 2025
REC opinion
Further Information Favourable Opinion