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Archives of Osteoporosis
Published in: Archives of Osteoporosis 1/2019

Open Access 01-12-2019 | Osteoporosis | Original Article

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

Authors: T. K. Khera, A. Burston, S. Davis, S. Drew, R. Gooberman-Hill, Z. Paskins, T. J. Peters, J. H. Tobias, E. M. Clark

Published in: Archives of Osteoporosis | Issue 1/2019

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Abstract

Summary

The aim of this study is to produce an easy to use checklist for general practitioners to complete whenever a woman aged over 65 years with back pain seeks healthcare. This checklist will produce a binary output to determine if the patient should have a radiograph to diagnose vertebral fracture.

Purpose

People with osteoporotic vertebral fractures are important to be identified as they are at relatively high risk of further fractures. Despite this, less than a third of people with osteoporotic vertebral fractures come to clinical attention due to various reasons including lack of clear triggers to identify who should have diagnostic spinal radiographs. This study aims to produce and evaluate a novel screening tool (Vfrac) for use in older women presenting with back pain in primary care based on clinical triggers and predictors identified previously. This tool will generate a binary output to determine if a radiograph is required.

Methods

The Vfrac study is a two-site, pragmatic, observational cohort study recruiting 1633 women aged over 65 years with self-reported back pain. Participants will be recruited from primary care in two sites. The Vfrac study will use data from two self-completed questionnaires, a simple physical examination, a lateral thoracic and lateral lumbar radiograph and information contained in medical records.

Results

The primary objective is to develop an easy-to-use clinical screening tool for identifying older women who are likely to have vertebral fractures.

Conclusions

This article describes the protocol of the Vfrac study; ISRCTN16550671.
Literature
1.
2.
National Osteoporosis Society The Osteoporosis Agenda, England. National Osteoporosis Society,
3.
Kanis JA, Oden A, Johnell O, De Laet C, Jonsson B (2004) Excess mortality after hospitalisation for vertebral fracture. Osteoporos Int 15:108–112CrossRefPubMed
4.
Holroyd C, Cooper C, Dennison E (2008) Epidemiology of osteoporosis. Best Pract Res Clin Endocrinol Metab 22:671–685CrossRefPubMed
5.
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
6.
Al-Sari UA, Tobias JH, Clark EM (2018) Self-reported everyday physical activities in older people with osteoporotic vertebral fractures: a systematic review and meta-analysis. Osteoporos Int 29:19–29CrossRefPubMed
7.
Gold DT (1996) The clinical impact of vertebral fractures: quality of life in women with osteoporosis. Bone 18:185S–189SCrossRefPubMed
8.
Klotzbuecher CM, Ross PD, Landsman PB, Abbott TA 3rd, Berger M (2000) Patients with prior fractures have an increased risk of future fractures: a summary of the literature and statistical synthesis. J Bone Miner Res 15:721–739CrossRefPubMed
9.
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
10.
Kanis JA, McCloskey EV, Johansson H, Cooper C, Rizzoli R, Reginster JY, Scientific Advisory Board of the European Society for, O. Economic Aspects of, Osteoarthritis and F. the Committee of Scientific Advisors of the International Osteoporosis (2013) European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int 24:23–57CrossRefPubMed
11.
N. B. Watts (2003) Efficacy of teriparatide and alendronate on nonvertebral fractures. J Clin Endocrinol Metab 88:1402–1403; author reply 1403
12.
O'Neill TW, Felsenberg D, Varlow J, Cooper C, Kanis JA, Silman AJ (1996) The prevalence of vertebral deformity in european men and women: the European Vertebral Osteoporosis Study. J Bone Miner Res 11:1010–1018CrossRefPubMed
13.
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
14.
Clark EM, Gould V, Morrison L, Ades AE, Dieppe P, Tobias JH (2012) Randomized controlled trial of a primary care-based screening program to identify older women with prevalent osteoporotic vertebral fractures: Cohort For Skeletal Health in Bristol and Avon (COSHIBA). J Bone Miner Res 27:664–671CrossRefPubMed
15.
N. O. Society (2014) Life with osteoporosis: the untold story
16.
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
17.
Clark EM, Cummings SR, Schousboe JT (2017) Spinal radiographs in those with back pain-when are they appropriate to diagnose vertebral fractures? Osteoporos Int 28:2293–2297CrossRefPubMed
18.
Melzack R (1975) The McGill Pain Questionnaire: major properties and scoring methods. Pain 1:277–299CrossRefPubMed
19.
N. I. o. C. Excellence (2012) Osteoporosis assession the risk of fragility fracture [CG146]
20.
ARUK (2016) Clinical studies group strategy
21.
Paskins Z, Jinks C, Mahmood W, Jayakumar P, Sangan CB, Belcher J, Gwilym S (2017) Public priorities for osteoporosis and fracture research: results from a general population survey. Arch Osteoporos 12(45)
22.
Ismail AA, Cockerill W, Cooper C, Finn JD, Abendroth K, Parisi G, Banzer D, Benevolenskaya LI, Bhalla AK, Bruges Armas J, Cannata JB, Delmas PD, Dequeker J, Dilsen G, Eastell R, Ershova O, Falch JA, Felsch B, Havelka S, Hoszowski K, Jajic I, Kragl U, Johnell O, Lopez Vaz A, Lorenc R, Lyritis G, Marchand F, Masaryk P, Matthis C, Miazgowski T, Pols HAP, Poor G, Rapado A, Raspe HH, Reid DM, Reisinger W, Janott J, Scheidt-Nave C, Stepan J, Todd C, Weber K, Woolf AD, Ambrecht G, Gowin W, Felsenberg D, Lunt M, Kanis JA, Reeve J, Silman AJ, O'Neill TW (2001) Prevalent vertebral deformity predicts incident hip though not distal forearm fracture: results from the European Prospective Osteoporosis Study. Osteoporos Int 12:85–90CrossRefPubMed
23.
Kaptoge S, Armbrecht G, Felsenberg D, Lunt M, O'Neill TW, Silman AJ, Reeve J, E. S. Group (2004) When should the doctor order a spine X-ray? Identifying vertebral fractures for osteoporosis care: results from the European Prospective Osteoporosis Study (EPOS). J Bone Miner Res 19:1982–1993CrossRefPubMed
24.
Maraka S, Kennel KA (2015) Bisphosphonates for the prevention and treatment of osteoporosis. BMJ 351:h3783CrossRefPubMed
25.
Margolis RB, Tait RC, Krause SJ (1986) A rating system for use with patient pain drawings. Pain 24:57–65CrossRefPubMed
26.
27.
Freynhagen R, Baron R, Gockel U, Tolle TR (2006) painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin 22:1911–1920CrossRefPubMed
28.
Kanis JA, McCloskey EV, Johansson H, Oden A, Strom O, Borgstrom F (2010) Development and use of FRAX in osteoporosis. Osteoporos Int 21(Suppl 2):S407–S413CrossRefPubMed
29.
Hippisley-Cox J, Coupland C (2012) Derivation and validation of updated QFracture algorithm to predict risk of osteoporotic fracture in primary care in the United Kingdom: prospective open cohort study. BMJ 344:e3427CrossRefPubMed
30.
Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, Swinburn P, Busschbach J (2013) Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res 22:1717–1727CrossRefPubMed
31.
Coast J, Flynn TN, Natarajan L, Sproston K, Lewis J, Louviere JJ, Peters TJ (2008) Valuing the ICECAP capability index for older people. Soc Sci Med 67:874–882CrossRefPubMed
32.
Jiang G, Eastell R, Barrington NA, Ferrar L (2004) Comparison of methods for the visual identification of prevalent vertebral fracture in osteoporosis. Osteoporos Int 15:887–896CrossRefPubMed
33.
Ferrar L, Jiang G, Armbrecht G, Reid DM, Roux C, Gluer CC, Felsenberg D, Eastell R (2007) Is short vertebral height always an osteoporotic fracture? The osteoporosis and ultrasound study (OPUS). Bone 41:5–12CrossRefPubMed
34.
Ferrar L, Jiang G, Schousboe JT, DeBold CR, Eastell R (2008) Algorithm-based qualitative and semiquantitative identification of prevalent vertebral fracture: agreement between different readers, imaging modalities, and diagnostic approaches. J Bone Miner Res 23:417–424CrossRefPubMed
35.
Genant HK, Wu CY, van Kuijk C, Nevitt MC (1993) Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res 8:1137–1148CrossRefPubMed
36.
Hamilton W, Peters TJ, Bankhead C, Sharp D (2009) Risk of ovarian cancer in women with symptoms in primary care: population based case-control study. BMJ 339:b2998CrossRefPubMedPubMedCentral
37.
Harrell FE Jr, Lee KL, Mark DB (1996) Multivariable prognostic models: issues in developing models, evaluating assumptions and adequacy, and measuring and reducing errors. Stat Med 15:361–387CrossRefPubMed
Metadata
Title
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
Authors
T. K. Khera
A. Burston
S. Davis
S. Drew
R. Gooberman-Hill
Z. Paskins
T. J. Peters
J. H. Tobias
E. M. Clark
Publication date
01-12-2019
Publisher
Springer London
Published in
Archives of Osteoporosis / Issue 1/2019
Print ISSN: 1862-3522
Electronic ISSN: 1862-3514
DOI
https://doi.org/10.1007/s11657-019-0558-5

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