Screening women with back pain for vertebral fractures:Vfrac study_v1
Research type
Research Study
Full title
Production and evaluation of an improved tool to screen older women with back pain for vertebral fractures (Vfrac)
IRAS ID
239418
Contact name
Emma Clark
Contact email
Duration of Study in the UK
3 years, 5 months, 30 days
Research summary
Summary of Research
The aim of this study is to produce and evaluate the improved tool (Vfrac) to screen older women with back pain for vertebral fractures. The specific objectives of this research are. The aims of this study are split into two stages:Stage 1 focuses on generating the Vfrac tool. The aims of this stage are to recruit a de novo cohort of older women from the community with self-reported back pain in the last four months and collect data (self-report and physical examination) based on previous work (COSHIBA screening tool plus quality of back pain qualitative work); to perform spinal radiographs on all; to generate a final tool (Vfrac) to identify which older women with back pain are likely to have a vertebral fracture and therefore need a radiograph and then to generate a web-based version of Vfrac for online use.
Stage 2 focuses on work that will inform a future feasibility trial. The aims of this stage are to follow up participants recruited in Stage 1 to identify patient pathways after performing spinal radiographs; and to statistically model cost-effectiveness to identify likely cost-per QALY of Vfrac and to identify stopping rules for a future trial.
Summary of Results
An osteoporotic vertebral fracture (broken bone in the back due to weak bones) increases the chance of more fractures, but only one in three patients are diagnosed. One reason for this is because medical staff find it difficult to know who should have a spinal X-ray.
This study has developed a clinical checklist to help medical staff decide when an older woman with back pain should have a spinal X-ray.
To develop the checklist, 1635 women aged 65 and older answered questions, had a simple physical examination and has a spinal X-ray. The questions and components of the physical examination had been chosen from previous studies looking at pain symptoms and experiences of older women with vertebral fractures. Statistical analyses were then carried out to find a combination of questions and physical measurements which could be used to predict who actually had an osteoporotic vertebral fracture.
The final checklist is called Vfrac and consists of 12 questions and 3 measurements. It works reasonably well, and can identify over 90% of those women with more than one vertebral fracture and two-thirds of those with one. Additional statistical analyses suggest that it may be a cost-effective tool for the NHS, but further research is needed.REC name
West of Scotland REC 3
REC reference
18/WS/0061
Date of REC Opinion
18 Apr 2018
REC opinion
Further Information Favourable Opinion