Osteoporotic vertebral fractures Musculoskeletal Diseases
Conditions
Interventions
Stage 1: Qualitative in-depth interviews
To understand and further characterise pain symptoms and experiences of men with OVF, and to evaluate the wording of the current Vfrac tool from men’s perspect
and the linear predictors for men with and without osteoporotic vertebral fractures falls within the 95% CI of the original Vfrac work in women, then these results will provide support for use of Vfra
Sponsors
University of Bristol
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Stage 1 1. Patient is willing and able to give informed consent for participation in the study. 2. Male aged over 65 years 3. Spinal radiograph in the previous three months that shows an osteoporotic vertebral fracture 4. Aware that they have an osteoporotic vertebral fracture Stage 3 1. Patient is willing and able to give informed consent for participation in the study. 2. Male aged over 65 years 3. Spinal radiograph in the previous three months
Exclusion criteria
Exclusion criteria: Stage 1 1. Female 2. Aged under 65 years 3. Potential participant is not aware they have a vertebral fracture 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 members 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 3: 1. Female 2. Aged under 65 years 3. Spinal malignancy (cancer) mentioned in the radiology report 4. 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 members 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/). 5. Participants who are unwilling to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measures taken once in each stage: Stage 1: 1. Qualitative outcomes of characterisation of pain symptoms and experiences of men with osteoporotic vertebral fractures based on a Topic Guide previously developed with women, and collected during one-to-one interview 2. A list of problematic words, phrases or questions for men within the current Vfrac tool collected through think-aloud during one-to-one interview Stage 3: 1. Risk of having an osteoporotic vertebral fracture ('High risk' or 'Low risk') based on the binary output of the modified Vfrac questionnaire using the pre-determined cut-off developed with women, collected through self-completion of the Vfrac questionnaire 2. The linear predictor based on the Vfrac regression equation, collected through self-completion of the Vfrac questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed