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dc.contributor.authorPoole, Kenneth ES
dc.contributor.authorChappell, Daniel DG
dc.contributor.authorClark, Emma
dc.contributor.authorFleming, Jane
dc.contributor.authorShepstone, Lee
dc.contributor.authorTurmezei, Thomas D
dc.contributor.authorWagner, Adam P
dc.contributor.authorWilloughby, Karen
dc.contributor.authorKaptoge, Stephen K
dc.date.accessioned2022-05-26T08:00:40Z
dc.date.available2022-05-26T08:00:40Z
dc.date.issued2022-05-24
dc.date.submitted2021-05-10
dc.identifier.issn2044-6055
dc.identifier.otherbmjopen-2021-050343
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/337500
dc.description.abstractINTRODUCTION: Two million out of the UK's 5 million routine diagnostic CT scans performed each year incorporate the thoracolumbar spine or pelvic region. Up to one-third reveal undiagnosed osteoporosis or vertebral fractures. We developed an intervention, Picking up Hidden Osteoporosis Effectively during Normal CT Imaging without additional X-rays ('PHOENIX'), to facilitate early detection and management of osteoporosis in people attending hospitals for CT scans. METHODS AND ANALYSIS: A multicentre, randomised, pragmatic feasibility study. From the general CT-attending population, women aged ≥65 years and men aged ≥75 years attending for CT scans are invited to participate, via a novel consent form incorporating Fracture Risk Assessment (FRAX) questions. Those at increased 10-year risk (within the amber or red zones of the UK FRAX graphical outputs for further action) are block randomised (1:1:1) to (1) PHOENIX intervention, (2) active control or (3) usual care. The PHOENIX intervention comprises (i) retrieving the CT scans using the NHS Image Exchange Portal, (ii) Mindways QCT Pro software analysis of CT hip and spine none density with CT vertebral fracture assessment, (iii) sending the participants' general practitioner (GP) a clinical report including diagnosis, necessary investigations and recommended treatment. Baseline CT scans from groups 2 and 3 are assessed with the PHOENIX intervention only at study end. Assuming 25% attrition, the study is powered to find a predicted superior osteoporosis treatment rate with PHOENIX (20%) vs 16% among patients whose GPs were sent the FRAX questionnaire only (active control) and 5% in the usual care group. Five hospitals are participating to determine feasibility. The co-primary feasibility outcome measures are (a) ability to randomise 375 patients within 10 months and (b) retention of 75% of survivors, completing their 1-year bone health outcome questionnaire. Secondary 1-year outcomes include osteoporosis/vertebral fracture identification rates and osteoporosis treatment rates. Stakeholder acceptability and economic aspects are evaluated. ETHICS AND DISSEMINATION: Approved by committee (National Research Ethics Service) East of England (EE) as REF/19/EE/0176. Dissemination will be through the Royal Osteoporosis Society (to patients and public) as well as to clinician peers via national and international bone/rheumatology scientific and clinical meetings. TRIAL REGISTRATION NUMBER: ISRCTN14722819.
dc.description.sponsorshipNIHR Research for Patient Benefit grant
dc.languageen
dc.publisherBMJ
dc.subjectRadiology and imaging
dc.subject1506
dc.subject1726
dc.subjectbone diseases
dc.subjectspine
dc.subjectcomputed tomography
dc.subjectdiagnostic radiology
dc.subjectrheumatology
dc.subjectback pain
dc.titlePHOENIX (Picking up Hidden Osteoporosis Effectively during Normal CT Imaging without additional X-rays): protocol for a randomised, multicentre feasibility study.
dc.typeArticle
dc.date.updated2022-05-26T08:00:39Z
prism.issueIdentifier5
prism.publicationNameBMJ Open
prism.volume12
dc.identifier.doi10.17863/CAM.84914
dcterms.dateAccepted2022-04-14
rioxxterms.versionofrecord10.1136/bmjopen-2021-050343
rioxxterms.versionVoR
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0/
rioxxterms.licenseref.startdate2022-05-20
dc.contributor.orcidPoole, Kenneth ES [0000-0003-4546-7352]
dc.contributor.orcidChappell, Daniel DG [0000-0002-1958-6246]
dc.contributor.orcidFleming, Jane [0000-0002-8127-2061]
dc.contributor.orcidWagner, Adam P [0000-0002-9101-3477]
dc.contributor.orcidWilloughby, Karen [0000-0002-2039-1155]
dc.identifier.eissn2044-6055
pubs.funder-project-idCambridge University Hospitals NHS Foundation Trust (CUH) (146281)
pubs.funder-project-idCambridge University Hospitals NHS Foundation Trust (CUH) (A095016 NIHR RfPB)
pubs.funder-project-idCambridge University Hospitals NHS Foundation Trust (CUH) (146281)
pubs.funder-project-idNational Institute for Health Research (IS-BRC-1215-20014)
cam.issuedOnline2022-05-24
rioxxterms.freetoread.startdate2022-05-20
rioxxterms.freetoread.startdate2022-05-20


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