An observational cohort study to produce and evaluate an improved tool to screen older women with back pain for osteopor
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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 T. K. Khera 1 & A. Burston 1 & S. Davis 2 & S. Drew 1 & R. Gooberman-Hill 1 & Z. Paskins 3,4 & T. J. Peters 1 & J. H. Tobias 1 & E. M. Clark 1 Received: 6 August 2018 / Accepted: 3 January 2019 # The Author(s) 2019
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 selfreported 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. Keywords Vertebral fracture . Screening . Osteoporosis . Protocol
Background and rationale Osteoporosis is estimated to affect 200 million women worldwide [1]. Osteoporotic fractures are strongly associated with
* T. K. Khera [email protected] 1
Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK
2
Health Economics and Decision Science, University of Sheffield, Sheffield, UK
3
Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Staffordshire ST5 5BG, UK
4
Haywood Academic Rheumatology Centre, Midlands Partnership NHS Foundation Trust, Stoke-on-Trent ST6 7AG, UK
morbidity, especially in terms of pain and disability: out of the people who have had a fracture, 42% have chronic pain and 33% of these describe the pain as severe or unbearable [2]. People who are hospitalised after a vertebral fracture (VF) have a higher mortality rate following fracture than those hospitalised after a hip fracture [3]. Unlike mortality following a hip fra
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