Vfrac feasibility study
Research type
Research Study
Full title
Vertebral fracture clinical decision tool for older women with back pain (Vfrac) – a feasibility study
IRAS ID
313632
Contact name
Emma Clark
Contact email
Sponsor organisation
University of Bristol
Clinicaltrials.gov Identifier
12150779, ISRCTN registry; 18000119, ISRCTN registry
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Background and study aims
Osteoporosis (weak bones) is one of the most common musculoskeletal conditions in older women. Osteoporotic vertebral fractures (broken bones in the back due to osteoporosis) are particularly important because they identify people at high risk of breaking more bones. However, less than a third of people with vertebral fractures are correctly diagnosed and treated. The main reason for this failure is difficulty understanding who should have spinal X-rays.The Vfrac tool is a simple questionnaire developed carefully by research involving women with and without osteoporotic vertebral fractures. Vfrac is for healthcare professionals in GP practices to complete for women aged over 65 with back pain. The output of Vfrac indicates whether or not they should have a spinal X-ray.
Vfrac has never been tested in a real-world situation to find out if it works and is likely to be cost effective for the NHS. This real-world testing will be a large study involving many GP practices, and will look at whether Vfrac improves the treatment of older people with osteoporosis. Before we can design this study, we need more information to help us plan a high quality study.
Therefore the aims of this Vfrac feasibility study are to help us plan
1. The size and process of the study, based on information including numbers of women who attend their GP with back pain, and the average time it takes for X-ray results to get back to the GP
2. IT requirements, based on what different IT systems GP practices use
3. How Vfrac is used, based on which healthcare professionals see older people with back pain in primary care
4. Whether we need to change the tool based on understanding patient and healthcare
professionals’ views and experiences of using Vfrac
5. Whether we can use Vfrac over the telephone (during a remote consultation)REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
22/YH/0135
Date of REC Opinion
28 Jun 2022
REC opinion
Favourable Opinion