Osteoporotic vertebral fractures Musculoskeletal Diseases Osteoporosis with pathological fracture
Conditions
Interventions
Stage 1: Testing agreement between remote vs face-to-face (F2F) Vfrac in men
Men aged over 65 years (65+) who have had a spinal radiograph will be invited to take part in this study. All those recruit
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measures taken once in each stage: Stages 1 and 2: 1. Risk of having an osteoporotic vertebral fracture (OVF) as calculated by the self-completed Vfrac tool 2. Risk of having an OVF as calculated by the face-to-face Vfrac tool Stage 3: 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom
Outcome results
None listed