Remote testing of Vfrac – men

• Research type

  Research Study

• Full title

  Testing self-completion vs face-to-face use of Vfrac in men: An osteoporotic vertebral fracture screening tool for use in older people with back pain

• IRAS ID

  309446

• Contact name

  Emma M Clark

• Contact email

  emma.clark@bristol.ac.uk

• Sponsor organisation

  University of Bristol

• Clinicaltrials.gov Identifier

  12150779, ISRCTN registration

• Duration of Study in the UK

  1 years, 1 months, 30 days

• Research summary

  Having a fracture in the spine due to osteoporosis (weak bones that break easily) considerably increases the chances of having another osteoporotic fracture, and is a marker of osteoporosis. Identifying people with osteoporotic vertebral fractures (OVFs) provides the opportunity to intervene with bone protection therapies, reducing the risk of further fractures by 30-65%. However, an estimated two-thirds of OVFs are undiagnosed. Potential reasons for this include a high prevalence of all-cause back pain in older people and a lack of understanding about which clinical features should be used to trigger referral for a diagnostic spinal radiograph.

  To address this we developed the Vfrac clinical tool. The intention of Vfrac is to help healthcare practitioners in primary care decide if an older person with back pain is at high risk of an OVF and therefore requires a spinal radiograph to confirm the diagnosis. However, Vfrac was developed to be delivered by a healthcare practitioner, and the model of consultation/service delivery has markedly changed in the pandemic. It is highly unlikely that there will be a full-scale return to face-to-face (F2F) consultations as the primary mode of clinical assessment in primary care. In addition, Vfrac was developed in women, and this study is one of three designed to make Vfrac available for men as well.

  This study has therefore been developed to identify if Vfrac could be used fully remotely, with men self-completing all questions and carrying out a self assessment of the physical characteristics themselves. Additional studies will be looking at remote use in women.

  The aims of this application are
  1. assessment of agreement between self-completion vs F2F use of Vfrac in men
  2. assessment of satisfaction and ease of use of completion of the remote Vfrac in men
  3. a decision as to whether Vfrac could be recommended for remote use in men

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  22/PR/0378

• Date of REC Opinion

  17 May 2022

• REC opinion

  Further Information Favourable Opinion