Can a vertebral fracture screening tool be used remotely as well as face-to-face?

Not Applicable

• Conditions: Osteoporotic vertebral fractures; Musculoskeletal Diseases; Osteoporosis with pathological fracture

• Registration Number: ISRCTN12150779
• Lead Sponsor: niversity of Bristol

Brief Summary

2024 Protocol article in https://doi.org/10.1007/s11657-023-01364-1 (added 07/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-10
• Last Update Posted: 19 February 2024
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Stage 1:
1. Patient is willing and able to give informed consent for participation in the study
2. Male aged 65+ years
3. Spinal radiograph in the previous 3 to 6 months

Stage 2:
1. Patient is willing and able to give informed consent for participation in the study
2. Patient had a previous F2F use of Vfrac when consulting in primary care with back pain

Exclusion Criteria

Stage 1:
1. Female
2. Aged under 65 years
3. Has not had a spinal radiograph in the previous 3 to 6 months
4. Spinal malignancy (cancer) mentioned in the radiology report
5. Patients who do not have the capacity to provide informed consent. Capacity to consent will be assessed by the researcher, in consultation with a clinical member of the study team (EC). This is in accordance with the Mental Capacity Act 2005 (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/mental-capacity-act/).
6. Participants who are unwilling to provide informed consent

Stage 2:
1. Not had a previous F2F use of Vfrac
2. Spinal malignancy
3. Patients who do not have the capacity to provide informed consent. Capacity to consent will be assessed by the researcher, in consultation with a clinical member of the study team (EC). This is in accordance with the Mental Capacity Act 2005 (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/mental-capacity-act/)
4. Participants who are unwilling to provide informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measures taken once in each stage:<br><br>Stages 1 and 2:<br>1. Risk of having an osteoporotic vertebral fracture (OVF) as calculated by the self-completed Vfrac tool<br>2. Risk of having an OVF as calculated by the face-to-face Vfrac tool<br><br>Stage 3:<br>Assessment of agreement between remote vs F2F use of the Vfrac tool using Cohen’s kappa. Standard classifications of Cohen’s kappa will be used with 0.6 indicating substantial agreement

Secondary Outcome Measures

Name	Time	Method
Satisfaction and ease of use of remote vs F2F Vfrac questionnaire collected during Stages 1 and 2. Questions based on the framework on Quality in Healthcare developed by Huycke et al. to cover process, interpersonal and technical attributes, plus relevant questions from the validated question on remote consultations by Mekhjian et al.