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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

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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
Authors: Normahani, P
Burgess, L
Norrie, J
Epstein, D
Kandiyil, N
Saratzis, A
Khunti, K
Edmonds, M
Ahluwalia, R
Coward, T
Hartshorne, T
Ashwell, S
Shalhoub, J
Pigott, J
Davies, A
Jaffer, U
Item Type: Journal Article
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 (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 presentations and papers.
Issue Date: 3-Nov-2022
Date of Acceptance: 8-Sep-2022
URI: http://hdl.handle.net/10044/1/99705
DOI: 10.1136/bmjopen-2022-066950
ISSN: 2044-6055
Publisher: BMJ Journals
Start Page: 1
End Page: 9
Journal / Book Title: BMJ Open
Volume: 12
Issue: 11
Copyright Statement: © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
Sponsor/Funder: National Institute for Health Research
Funder's Grant Number: NIHR131855
Keywords: diabetic foot
diabetic nephropathy & vascular disease
diagnostic radiology
vascular medicine
vascular surgery
Humans
Prospective Studies
Peripheral Arterial Disease
Ankle Brachial Index
Diabetes Mellitus
Ultrasonography, Doppler, Duplex
Multicenter Studies as Topic
DM PAD study investigators
Humans
Diabetes Mellitus
Ultrasonography, Doppler, Duplex
Prospective Studies
Multicenter Studies as Topic
Ankle Brachial Index
Peripheral Arterial Disease
1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
Publication Status: Published
Online Publication Date: 2022-11-03
Appears in Collections:Department of Surgery and Cancer
Faculty of Medicine



This item is licensed under a Creative Commons License Creative Commons