Imperial College London
Alternate

Professor Alun H Davies, MA,DM,DSc,FRCS,FHEA,FEBVS,FACPh

Faculty of Medicine, Department of Surgery & Cancer

Professor of Vascular Surgery
 
 
 
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Contact

 

+44 (0)20 3311 7309a.h.davies

 
 
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Location

 

4E04 EastEast WingCharing Cross Campus

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Summary

 

Publications

Citation

BibTex format

@article{Normahani:2022:10.1136/bmjopen-2022-066950,
author = {Normahani, P and Burgess, L and Norrie, J and Epstein, D and Kandiyil, N and Saratzis, A and Khunti, K and Edmonds, M and Ahluwalia, R and Coward, T and Hartshorne, T and Ashwell, S and Shalhoub, J and Pigott, J and Davies, A and Jaffer, U},
doi = {10.1136/bmjopen-2022-066950},
journal = {BMJ Open},
pages = {1--9},
title = {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},
url = {http://dx.doi.org/10.1136/bmjopen-2022-066950},
volume = {12},
year = {2022}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - 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 (computed tomography 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 United Kingdom (UK), covering primary and secondary healthcare. Consenting participants will undergo the tests under investigation. Reference tests (CTA or MRA) will be performed within six 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 presentatio
AU  - Normahani,P
AU  - Burgess,L
AU  - Norrie,J
AU  - Epstein,D
AU  - Kandiyil,N
AU  - Saratzis,A
AU  - Khunti,K
AU  - Edmonds,M
AU  - Ahluwalia,R
AU  - Coward,T
AU  - Hartshorne,T
AU  - Ashwell,S
AU  - Shalhoub,J
AU  - Pigott,J
AU  - Davies,A
AU  - Jaffer,U
DO  - 10.1136/bmjopen-2022-066950
EP  - 9
PY  - 2022///
SN  - 2044-6055
SP  - 1
TI  - 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
T2  - BMJ Open
UR  - http://dx.doi.org/10.1136/bmjopen-2022-066950
UR  - https://bmjopen.bmj.com/content/12/11/e066950
UR  - http://hdl.handle.net/10044/1/99705
VL  - 12
ER  -
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