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Published in: Archives of Osteoporosis 1/2024

Open Access 01-12-2024 | Back Pain | Original Article

An online clinical decision tool to screen for vertebral fragility fractures (Vfrac) in older women presenting with back pain in general practice: protocol for a feasibility study in preparation for a future cluster randomised controlled trial

Authors: Tanzeela Y. Khalid, Tim J. Peters, Lucy V. Pocock, Sarah Drew, Sarah A. Hardcastle, Zoe Paskins, Sarah Davis, Eleni P. Kariki, Emma M. Clark

Published in: Archives of Osteoporosis | Issue 1/2024

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Abstract

Summary

This feasibility study for a future definitive randomized trial assesses the use and acceptability of a new clinical decision tool to identify risk of a vertebral fracture and those who should be referred for spinal radiography in women aged 65 or over presenting to primary care with back pain.

Purpose

Approximately 12% of older adults have vertebral fragility fractures, but currently fewer than one-third are diagnosed, potentially limiting access to bone protection treatment. Vfrac is a vertebral fracture screening tool which classifies individuals into high or low risk of having a vertebral fracture, allowing targeting of spinal radiographs to high-risk individuals. The objective of this study was to investigate the feasibility of conducting a cluster randomized controlled trial to evaluate the use of an online version of Vfrac in primary care.

Methods

The study will run in six general practices, with three given the Vfrac tool for use on older women (> 65 years) consulting with back pain and three using standard clinical processes for managing such back pain. Anonymised data covering a 12-month period will be collected from all sites on consultations by older women with back pain. Focus groups will be undertaken with healthcare professionals and patients on whom the tool was used to understand the acceptability of Vfrac and identify factors that impact its use. These patients will be sent a paper version of the Vfrac questionnaire to self-complete at home. Outputs of the self-completion Vfrac (high versus low risk) will be compared with the face-to-face Vfrac (high versus low risk), and agreement assessed using Cohen’s kappa.

Results

This study will evaluate the use and acceptability of Vfrac within primary care and determine if data on resource use can be collected accurately and comprehensively.

Conclusions

This article describes the protocol of the Vfrac feasibility study.

Trial registration

ISRCTN18000119 (registered 01/03/2022) and ISRCTN12150779 (registered 10/01/2022).
Appendix
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Literature
1.
go back to reference Svedbom A, Hernlund E, Ivergard M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jonsson B, Kanis JA, IOF EURPo, (2013) Osteoporosis in the European Union: a compendium of country-specific reports. Arch Osteoporos 8:137CrossRefPubMedPubMedCentral Svedbom A, Hernlund E, Ivergard M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jonsson B, Kanis JA, IOF EURPo, (2013) Osteoporosis in the European Union: a compendium of country-specific reports. Arch Osteoporos 8:137CrossRefPubMedPubMedCentral
2.
go back to reference van Staa TP, Dennison EM, Leufkens HG, Cooper C (2001) Epidemiology of fractures in England and Wales. Bone 29:517–522CrossRefPubMed van Staa TP, Dennison EM, Leufkens HG, Cooper C (2001) Epidemiology of fractures in England and Wales. Bone 29:517–522CrossRefPubMed
3.
go back to reference Al-Sari UA, Tobias J, Clark E (2016) Health-related quality of life in older people with osteoporotic vertebral fractures: a systematic review and meta-analysis. Osteoporos Int 27:2891–2900CrossRefPubMed Al-Sari UA, Tobias J, Clark E (2016) Health-related quality of life in older people with osteoporotic vertebral fractures: a systematic review and meta-analysis. Osteoporos Int 27:2891–2900CrossRefPubMed
4.
go back to reference Gold DT (1996) The clinical impact of vertebral fractures: quality of life in women with osteoporosis. Bone 18:S185–S189CrossRef Gold DT (1996) The clinical impact of vertebral fractures: quality of life in women with osteoporosis. Bone 18:S185–S189CrossRef
5.
go back to reference Boonen S, Laan RF, Barton IP, Watts NB (2005) Effect of osteoporosis treatments on risk of non-vertebral fractures: review and meta-analysis of intention-to-treat studies. Osteoporos Int 16:1291–1298CrossRefPubMed Boonen S, Laan RF, Barton IP, Watts NB (2005) Effect of osteoporosis treatments on risk of non-vertebral fractures: review and meta-analysis of intention-to-treat studies. Osteoporos Int 16:1291–1298CrossRefPubMed
6.
go back to reference Watts NB, Josse RG, Hamdy RC, Hughes RA, Manhart MD, Barton I, Calligeros D, Felsenberg D (2003) Risedronate prevents new vertebral fractures in postmenopausal women at high risk. J Clin Endocrinol Metab 88:542–549CrossRefPubMed Watts NB, Josse RG, Hamdy RC, Hughes RA, Manhart MD, Barton I, Calligeros D, Felsenberg D (2003) Risedronate prevents new vertebral fractures in postmenopausal women at high risk. J Clin Endocrinol Metab 88:542–549CrossRefPubMed
7.
go back to reference Li Y, Yan L, Cai S, Wang P, Zhuang H, Yu H (2018) The prevalence and under-diagnosis of vertebral fractures on chest radiograph. BMC Musculoskelet Disord 19:235CrossRefPubMedPubMedCentral Li Y, Yan L, Cai S, Wang P, Zhuang H, Yu H (2018) The prevalence and under-diagnosis of vertebral fractures on chest radiograph. BMC Musculoskelet Disord 19:235CrossRefPubMedPubMedCentral
8.
go back to reference Drew S, Clark E, Al-Sari U, Moore A, Gooberman-Hill R (2020) Neglected bodily senses in women living with vertebral fracture: a focus group study. Rheumatology (Oxford) 59:379–385CrossRefPubMed Drew S, Clark E, Al-Sari U, Moore A, Gooberman-Hill R (2020) Neglected bodily senses in women living with vertebral fracture: a focus group study. Rheumatology (Oxford) 59:379–385CrossRefPubMed
9.
go back to reference Clark EM, Hutchinson AP, McCloskey EV, Stone MD, Martin JC, Bhalla AK, Tobias JH (2010) Lateral back pain identifies prevalent vertebral fractures in post-menopausal women: cross-sectional analysis of a primary care-based cohort. Rheumatology (Oxford) 49:505–512CrossRefPubMed Clark EM, Hutchinson AP, McCloskey EV, Stone MD, Martin JC, Bhalla AK, Tobias JH (2010) Lateral back pain identifies prevalent vertebral fractures in post-menopausal women: cross-sectional analysis of a primary care-based cohort. Rheumatology (Oxford) 49:505–512CrossRefPubMed
10.
go back to reference Morrison LS, Tobias JH (2005) Effect of a case-finding strategy for osteoporosis on bisphosphonate prescribing in primary care. Osteoporos Int 16:71–77CrossRefPubMed Morrison LS, Tobias JH (2005) Effect of a case-finding strategy for osteoporosis on bisphosphonate prescribing in primary care. Osteoporos Int 16:71–77CrossRefPubMed
11.
go back to reference Tobias JH, Hutchinson AP, Hunt LP, McCloskey EV, Stone MD, Martin JC, Thompson PW, Palferman TG, Bhalla AK (2007) Use of clinical risk factors to identify postmenopausal women with vertebral fractures. Osteoporos Int 18:35–43CrossRefPubMed Tobias JH, Hutchinson AP, Hunt LP, McCloskey EV, Stone MD, Martin JC, Thompson PW, Palferman TG, Bhalla AK (2007) Use of clinical risk factors to identify postmenopausal women with vertebral fractures. Osteoporos Int 18:35–43CrossRefPubMed
12.
go back to reference Clark EM, Gooberman-Hill R, Peters TJ (2016) Using self-reports of pain and other variables to distinguish between older women with back pain due to vertebral fractures and those with back pain due to degenerative changes. Osteoporos Int 27:1459–1467CrossRefPubMed Clark EM, Gooberman-Hill R, Peters TJ (2016) Using self-reports of pain and other variables to distinguish between older women with back pain due to vertebral fractures and those with back pain due to degenerative changes. Osteoporos Int 27:1459–1467CrossRefPubMed
13.
go back to reference Khera TK, Burston A, Davis S, Drew S, Gooberman-Hill R, Paskins Z, Peters TJ, Tobias JH, Clark EM (2019) An observational cohort study to produce and evaluate an improved tool to screen older women with back pain for osteoporotic vertebral fractures (Vfrac): study protocol. Arch Osteoporos 14:11CrossRefPubMedPubMedCentral Khera TK, Burston A, Davis S, Drew S, Gooberman-Hill R, Paskins Z, Peters TJ, Tobias JH, Clark EM (2019) An observational cohort study to produce and evaluate an improved tool to screen older women with back pain for osteoporotic vertebral fractures (Vfrac): study protocol. Arch Osteoporos 14:11CrossRefPubMedPubMedCentral
14.
go back to reference Khera TK, Hunt LP, Davis S, Gooberman-Hill R, Thom H, Xu Y, Paskins Z, Peters TJ, Tobias JH, Clark EM (2022) A clinical tool to identify older women with back pain at high risk of osteoporotic vertebral fractures (Vfrac): a population-based cohort study with exploratory economic evaluation. Age Ageing 51(3):1–8. https://doi.org/10.1093/ageing/afac031 Khera TK, Hunt LP, Davis S, Gooberman-Hill R, Thom H, Xu Y, Paskins Z, Peters TJ, Tobias JH, Clark EM (2022) A clinical tool to identify older women with back pain at high risk of osteoporotic vertebral fractures (Vfrac): a population-based cohort study with exploratory economic evaluation. Age Ageing 51(3):1–8. https://​doi.​org/​10.​1093/​ageing/​afac031
15.
go back to reference Nix HP, Weijer C, Brehaut JC, Forster D, Goldstein CE, Taljaard M (2021) Informed consent in cluster randomised trials: a guide for the perplexed. BMJ Open 11:e054213CrossRefPubMedPubMedCentral Nix HP, Weijer C, Brehaut JC, Forster D, Goldstein CE, Taljaard M (2021) Informed consent in cluster randomised trials: a guide for the perplexed. BMJ Open 11:e054213CrossRefPubMedPubMedCentral
16.
go back to reference Bauer MW, Gaskell G (2000) Qualitative researching with text, image and sound: a practical handbook for social research. Sage Publications Bauer MW, Gaskell G (2000) Qualitative researching with text, image and sound: a practical handbook for social research. Sage Publications
17.
go back to reference Tavory I, Timmermans S (2014) Abductive analysis. The University of Chicago Press, Chicago, Theorizing qualitative researchCrossRef Tavory I, Timmermans S (2014) Abductive analysis. The University of Chicago Press, Chicago, Theorizing qualitative researchCrossRef
18.
go back to reference May C, Finch T, Mair F et al (2007) Understanding the implementation of complex interventions in health care: the normalization process model. BMC Health Serv Res 7:148CrossRefPubMedPubMedCentral May C, Finch T, Mair F et al (2007) Understanding the implementation of complex interventions in health care: the normalization process model. BMC Health Serv Res 7:148CrossRefPubMedPubMedCentral
19.
go back to reference Coyne IT (2008) Sampling in qualitative research. Purposeful and theoretical sampling; merging or clear boundaries. J Adv Nurs 26:623–630CrossRef Coyne IT (2008) Sampling in qualitative research. Purposeful and theoretical sampling; merging or clear boundaries. J Adv Nurs 26:623–630CrossRef
20.
go back to reference Guest G, Bunce A, Johnson L (2006) How many interviews are enough?: an experiment with data saturation and variability. Field Methods 18:59–82CrossRef Guest G, Bunce A, Johnson L (2006) How many interviews are enough?: an experiment with data saturation and variability. Field Methods 18:59–82CrossRef
21.
go back to reference Coyne IT (1997) Sampling in qualitative research. Purposeful and theoretical sampling; merging or clear boundaries? J Adv Nurs 26:623–630CrossRefPubMed Coyne IT (1997) Sampling in qualitative research. Purposeful and theoretical sampling; merging or clear boundaries? J Adv Nurs 26:623–630CrossRefPubMed
22.
go back to reference Braun V, V. C, (2006) Using thematic analysis in psychology. Qual Res Psychol 3:77–110CrossRef Braun V, V. C, (2006) Using thematic analysis in psychology. Qual Res Psychol 3:77–110CrossRef
23.
go back to reference Sekhon M, Cartwright M, Francis JJ (2017) Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res 17:88CrossRefPubMedPubMedCentral Sekhon M, Cartwright M, Francis JJ (2017) Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res 17:88CrossRefPubMedPubMedCentral
24.
go back to reference Ritchie J, Lewis J, McNaughton Nicholls C, Ormston R (2013) Qualitative research practice. SAGE Publications Ltd, A guide for social science students and researchers Ritchie J, Lewis J, McNaughton Nicholls C, Ormston R (2013) Qualitative research practice. SAGE Publications Ltd, A guide for social science students and researchers
25.
26.
go back to reference Mekhjian H, Turner JW, Gailiun M, McCain TA (1999) Patient satisfaction with telemedicine in a prison environment. J Telemed Telecare 5:55–61CrossRefPubMed Mekhjian H, Turner JW, Gailiun M, McCain TA (1999) Patient satisfaction with telemedicine in a prison environment. J Telemed Telecare 5:55–61CrossRefPubMed
27.
go back to reference Truter P, Russell T, Fary R (2014) The validity of physical therapy assessment of low back pain via telerehabilitation in a clinical setting. Telemed J E Health 20:161–167CrossRefPubMed Truter P, Russell T, Fary R (2014) The validity of physical therapy assessment of low back pain via telerehabilitation in a clinical setting. Telemed J E Health 20:161–167CrossRefPubMed
29.
go back to reference Guest G, Bunce A, Johnson L (2006) How many interviews are enough? An experiment with data saturation and variability. Field Methods 18:59–82CrossRef Guest G, Bunce A, Johnson L (2006) How many interviews are enough? An experiment with data saturation and variability. Field Methods 18:59–82CrossRef
30.
go back to reference Donaldson MG, Palermo L, Schousboe JT, Ensrud KE, Hochberg MC, Cummings SR (2009) FRAX and risk of vertebral fractures: the fracture intervention trial. J Bone Miner Res 24:1793–1799CrossRefPubMed Donaldson MG, Palermo L, Schousboe JT, Ensrud KE, Hochberg MC, Cummings SR (2009) FRAX and risk of vertebral fractures: the fracture intervention trial. J Bone Miner Res 24:1793–1799CrossRefPubMed
31.
go back to reference Schousboe JT, Rosen HR, Vokes TJ, Cauley JA, Cummings SR, Nevitt M, Black DM, Orwoll ES, Kado DM, Ensrud KE (2014) Prediction models of prevalent radiographic vertebral fractures among older women. J Clin Densitom 17:378–385CrossRefPubMedPubMedCentral Schousboe JT, Rosen HR, Vokes TJ, Cauley JA, Cummings SR, Nevitt M, Black DM, Orwoll ES, Kado DM, Ensrud KE (2014) Prediction models of prevalent radiographic vertebral fractures among older women. J Clin Densitom 17:378–385CrossRefPubMedPubMedCentral
32.
go back to reference Watson SJ, Jones AL, Oatway WB, Hughes JS (2005) Ionising radiaton exposure of the UK population: 2005 Review. Health Protection Agency, Radiation Protection Division, HPA-RPD-001 Watson SJ, Jones AL, Oatway WB, Hughes JS (2005) Ionising radiaton exposure of the UK population: 2005 Review. Health Protection Agency, Radiation Protection Division, HPA-RPD-001
Metadata
Title
An online clinical decision tool to screen for vertebral fragility fractures (Vfrac) in older women presenting with back pain in general practice: protocol for a feasibility study in preparation for a future cluster randomised controlled trial
Authors
Tanzeela Y. Khalid
Tim J. Peters
Lucy V. Pocock
Sarah Drew
Sarah A. Hardcastle
Zoe Paskins
Sarah Davis
Eleni P. Kariki
Emma M. Clark
Publication date
01-12-2024
Publisher
Springer London
Published in
Archives of Osteoporosis / Issue 1/2024
Print ISSN: 1862-3522
Electronic ISSN: 1862-3514
DOI
https://doi.org/10.1007/s11657-023-01364-1

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