Abstract
Abstract
Introduction 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.
Introduction 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.
| Original language | English |
|---|---|
| Article number | e050343 |
| Number of pages | 11 |
| Journal | BMJ Open |
| Volume | 12 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 24 May 2022 |
Bibliographical note
Funding Information:Acknowledgements The PHOENIX study is dedicated to the memory of J. Keenan Brown, inventor of QCT Pro (9 February 1960 to 11 December 2021). Without Keenan, this study would not have been possible. The authors would like to acknowledge Karen Blesic for providing a valuable nursing perspective, for helping develop the idea and for her major contributions towards the NHS Research Innovation Fund pilot to PHOENIX (the clinical service called CORTEX). The authors acknowledge the contributions of Polly Barnes and Charlotte Tyson to CORTEX and also their contributions towards the practicalities of imaging data flow. The authors acknowledge Judith Brown’s contributions towards the practicalities of patient flow and analysis through the pathways and imaging services. The authors acknowledge Jeremy Dearling as our primary PPIE representative who gave valuable contributions to the design of the overall study, provided detailed feedback on the materials and protocol development. The authors also acknowledge the assistance of the Eastern region NIHR Research Design Service team, specifically Jonathan Scales, Andrew Sharpe, Analisa Casarin (improving and developing the research idea and application) and Doreen Tembo (PPI lead for the same). KESP acknowledges the Cambridge NIHR Biomedical Research Centre who support his work, and support DC. KESP also thanks the NIHR for funding his attendance at the Pragmatic Clinical Trials Course at Queen Mary University of London which helped him develop the idea. Finally, the authors acknowledge the major contribution of Dr Alan Lamont, chair of East of England (EE), Research Ethic Committee whose helpful suggestions and understanding of the relevant GCP issues and legislation rekindled our interest in adopting pragmatic patient consent without a researcher present.
Funding Information:
Funding This project is funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0816-20027) and by the Cambridge NIHR Biomedical Research Centre (BRC-1215-20014). Funding is in place to 31 March 2022.
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