Search

Your search keyword '"Tim Hartshorne"' showing total 2 results
Start Over Author "Tim Hartshorne" Publication Year Range Last 10 years
2 results on '"Tim Hartshorne"'

1. Study protocol for a multicentre comparative diagnostic accuracy study of tools to establish the presence and severity of peripheral arterial disease in people with diabetes mellitus: the DM PAD study

Author

Kamlesh Khunti, Athanasios Saratzis, John Norrie, David Mark Epstein, Joseph Shalhoub, Pasha Normahani, Usman Jaffer, M Edmonds, Alun H Davies, Elizabeth Pigott, Laura Burgess, Raju Ahluwalia, Neghal Kandiyil, Sasha Smith, Trusha Coward, Tim Hartshorne, and Simon Ashwell

Subjects
Medicine
Abstract

Introduction Peripheral arterial disease (PAD) is a key risk factor for cardiovascular disease, foot ulceration and lower limb amputation in people with diabetes. Early diagnosis of PAD can enable optimisation of therapies to manage these risks. Its diagnosis is fundamental, though challenging in the context of diabetes. Although a variety of diagnostic bedside tests are available, there is no agreement as to which is the most accurate in routine clinical practice.The aim of this study is to determine the diagnostic performance of a variety of tests (audible waveform assessment, visual waveform assessment, ankle brachial pressure index (ABPI), exercise ABPI and toe brachial pressure index (TBPI)) for the diagnosis of PAD in people with diabetes as determined by a reference test (CT angiography (CTA) or magnetic resonance angiography (MRA)). In selected centres, we also aim to evaluate the performance of a new point-of-care duplex ultrasound scan (PAD-scan).Methods and analysis A prospective multicentre diagnostic accuracy study (ClinicalTrials.gov Identifier NCT05009602). We aim to recruit 730 people with diabetes from 18 centres across the UK, covering primary and secondary healthcare. Consenting participants will undergo the tests under investigation. Reference tests (CTA or MRA) will be performed within 6 weeks of the index tests. Imaging will be reported by blinded consultant radiologists at a core imaging lab, using a validated scoring system, which will also be used to categorise PAD severity. The presence of one or more arterial lesions of ≥50% stenosis, or tandem lesions with a combined value of ≥50%, will be used as the threshold for the diagnosis of PAD. The primary outcome measure of diagnostic performance will be test sensitivity.Ethics and dissemination The study has received approval from the National Research Ethics Service (NRES) (REC reference 21/PR/1221). Results will be disseminated through research presentations and papers.Trial registration number NCT05009602.

Published
2022
Full Text
View/download PDF

2. Study protocol for a multicentre comparative diagnostic accuracy study of tools to establish the presence and severity of peripheral arterial disease in people with diabetes mellitus: the DM PAD study

Author

Pasha Normahani, Laura Burgess, John Norrie, David Mark Epstein, Neghal Kandiyil, Athanasios Saratzis, Sasha Smith, Kamlesh Khunti, M Edmonds, Raju Ahluwalia, Trusha Coward, Tim Hartshorne, Simon Ashwell, Joseph Shalhoub, Elizabeth Pigott, Alun H Davies, Usman Jaffer, and National Institute for Health Research

Subjects
Ultrasonography, Doppler, Duplex, 1103 Clinical Sciences, General Medicine, vascular medicine, DM PAD study investigators, vascular surgery, 1117 Public Health and Health Services, diabetic nephropathy & vascular disease, Peripheral Arterial Disease, Peripheral Arterial Disease/diagnosis, Diabetes Mellitus, diagnostic radiology, Humans, Multicenter Studies as Topic, Ankle Brachial Index, Prospective Studies, diabetic foot, Ankle Brachial Index/adverse effects, 1199 Other Medical and Health Sciences
Abstract

Introduction Peripheral arterial disease (PAD) is a key risk factor for cardiovascular disease, foot ulceration and lower limb amputation in people with diabetes. Early diagnosis of PAD can enable optimisation of therapies to manage these risks. Its diagnosis is fundamental, though challenging in the context of diabetes. Although a variety of diagnostic bedside tests are available, there is no agreement as to which is the most accurate in routine clinical practice. The aim of this study is to determine the diagnostic performance of a variety of tests (audible waveform assessment, visual waveform assessment, ankle brachial pressure index (ABPI), exercise ABPI and toe brachial pressure index (TBPI)) for the diagnosis of PAD in people with diabetes as determined by a reference test (CT angiography (CTA) or magnetic resonance angiography (MRA)). In selected centres, we also aim to evaluate the performance of a new point-of- care duplex ultrasound scan (PAD-scan). Methods and analysis A prospective multicentre diagnostic accuracy study ( ClinicalTrials. gov Identifier NCT05009602). We aim to recruit 730 people with diabetes from 18 centres across the UK, covering primary and secondary healthcare. Consenting participants will undergo the tests under investigation. Reference tests (CTA or MRA) will be performed within 6 weeks of the index tests. Imaging will be reported by blinded consultant radiologists at a core imaging lab, using a validated scoring system, which will also be used to categorise PAD severity. The presence of one or more arterial lesions of ≥50% stenosis, or tandem lesions with a combined value of ≥50%, will be used as the threshold for the diagnosis of PAD. The primary outcome measure of diagnostic performance will be test sensitivity. Ethics and dissemination The study has received approval from the National Research Ethics Service (NRES) (REC reference 21/PR/1221). Results will be disseminated through research presentations and papers., National Institute for Health Research (NIHR) NIHR131855, NIHR Clinical Lectureship NIHR Imperial Biomedical Research Centre (BRC)

Published
2022

Catalog

Books, media, physical & digital resources
See catalog results