{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T14:02:03Z","timestamp":1789826523490,"version":"4.0.1"},"reference-count":23,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2026,3,1]],"date-time":"2026-03-01T00:00:00Z","timestamp":1772323200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["NIHR131855"],"award-info":[{"award-number":["NIHR131855"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"\n Background<\/jats:title>\n Peripheral arterial disease is a major cause of the development of diabetic foot ulcers, lower limb amputation and mortality in patients with diabetes. Diagnosing peripheral arterial disease is of clinical importance but is difficult in this cohort of patients. Several diagnostic bedside tests exist, but there is uncertainty as to which is the most accurate.<\/jats:p>\n <\/jats:sec>\n \n Objective(s)<\/jats:title>\n To determine the diagnostic accuracy of five index tests (audible waveform assessment, visual waveform assessment, toe\u2013brachial pressure index, ankle\u2013brachial pressure index and exercise ankle\u2013brachial pressure index) for the diagnosis of peripheral arterial disease in patients with diabetes as determined by a reference test (computed tomography angiography or magnetic resonance angiography). In selected sites, to evaluate the performance of a sixth test, the Podiatry Ankle Duplex scan, a new point-of-care duplex ultrasound scan.<\/jats:p>\n <\/jats:sec>\n \n Design and methods<\/jats:title>\n Prospective multicentre diagnostic accuracy study.<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n Primary (general practice and community clinics) and secondary care National Health Service hospitals (inpatient and outpatient) in the United Kingdom.<\/jats:p>\n <\/jats:sec>\n \n Participants<\/jats:title>\n Patients were eligible for inclusion if they were aged\u2005\u2265\u200518 years and had a known history of diabetes. Exclusion criteria included contraindications to computed tomography angiography or magnetic resonance angiography, if their peripheral arterial disease status was known on imaging, or they had a known history of peripheral arterial disease intervention.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Participants underwent all bedside tests (Podiatry Ankle Duplex scan performed in three centres only), which were performed in a logical sequence to reduce the risk of bias. The reference scan was to be performed within 6 weeks of the index tests.<\/jats:p>\n <\/jats:sec>\n \n Main outcome measures<\/jats:title>\n The primary outcome measure of diagnostic performance is test sensitivity. Secondary outcomes included specificity, likelihood ratios, predictive values and diagnostic odds ratio, as well as patient acceptability of tests, technical success and health economic outcomes.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Based on the 573 reference tests performed, 222 (39%) participants had evidence of peripheral arterial disease. All routinely used index tests showed relatively low sensitivities: audible waveform 36%, 99% confidence interval 27% to 45%; visual waveform 42%, confidence interval 33% to 51%; toe\u2013brachial pressure index 55%, confidence interval 46% to 64%; ankle\u2013brachial pressure index 41%, confidence interval 32% to 50%; and exercise ankle\u2013brachial pressure index 41%, confidence interval 31% to 51%. The Podiatry Ankle Duplex scan had a higher sensitivity 89%, confidence interval 74% to 100%, as compared to all other index tests.<\/jats:p>\n <\/jats:sec>\n \n Limitations<\/jats:title>\n A large proportion of reference scans were performed outside the 6-week time window (45%), although peripheral arterial disease is a chronic condition and is unlikely to have developed\/progressed in the time frame. Additionally, the peripheral arterial disease prevalence was lower than anticipated during study design (39% vs. 50%). Lastly, despite efforts to standardise assessment and minimise bias, there is the possibility that one test may have influenced the interpretation of others.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Index tests used routinely in clinical practice for diagnosing peripheral arterial disease in patients with diabetes showed poor diagnostic accuracy for peripheral arterial disease and should not be recommended for diagnosing peripheral arterial disease in this population.<\/jats:p>\n <\/jats:sec>\n \n Future work<\/jats:title>\n A review of peripheral arterial disease diagnostic testing in patients with diabetes should be undertaken. It may be necessary to perform more reliable imaging, such as full lower limb duplex ultrasound as a first-line diagnostic test.<\/jats:p>\n <\/jats:sec>\n \n Funding<\/jats:title>\n This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number NIHR131855.<\/jats:p>\n <\/jats:sec>","DOI":"10.3310\/gjuj2819","type":"journal-article","created":{"date-parts":[[2025,8,19]],"date-time":"2025-08-19T12:21:21Z","timestamp":1755606081000},"page":"1-22","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Diagnostic tools to establish the presence and severity of peripheral arterial disease in people with diabetes: a synopsis of the DM PAD prospective multicentre diagnostic accuracy study"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7491-7557","authenticated-orcid":true,"given":"Laura","family":"Burgess","sequence":"first","affiliation":[{"name":"Department of Surgery and Cancer, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6362-7535","authenticated-orcid":true,"given":"Pasha","family":"Normahani","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9823-9252","authenticated-orcid":true,"given":"John","family":"Norrie","sequence":"additional","affiliation":[{"name":"Usher Institute, Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6186-6794","authenticated-orcid":true,"given":"Sharon","family":"Tuck","sequence":"additional","affiliation":[{"name":"Usher Institute, Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1889-712X","authenticated-orcid":true,"given":"Catriona","family":"Graham","sequence":"additional","affiliation":[{"name":"Edinburgh Clinical Research Facility, University of Edinburgh, Edinburgh, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2275-0916","authenticated-orcid":true,"given":"David","family":"Mark Epstein","sequence":"additional","affiliation":[{"name":"Faculty of Economics and Business Sciences, University of Granada, Granada, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-7373-8959","authenticated-orcid":true,"given":"Neghal","family":"Kandiyil","sequence":"additional","affiliation":[{"name":"Department of Radiology, University Hospitals of Leicester NHS Trust, Leicester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3399-094X","authenticated-orcid":true,"given":"Athanasios","family":"Saratzis","sequence":"additional","affiliation":[{"name":"The Leicester Vascular Institute, University of Leicester, Leicester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5184-0259","authenticated-orcid":true,"given":"Francine","family":"Heatley","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9843-5368","authenticated-orcid":true,"given":"Sasha","family":"Smith","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2343-7099","authenticated-orcid":true,"given":"Kamlesh","family":"Khunti","sequence":"additional","affiliation":[{"name":"Diabetes Research Centre, University of Leicester, Leicester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5331-0684","authenticated-orcid":true,"given":"David","family":"Wingfield","sequence":"additional","affiliation":[{"name":"Public Health and Primary Care, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Trusha","family":"Coward","sequence":"additional","affiliation":[{"name":"Podiatry Services, Central London Community Healthcare Trust, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-6469-8720","authenticated-orcid":true,"given":"Tim","family":"Hartshorne","sequence":"additional","affiliation":[{"name":"Vascular Studies Unit, University Hospitals of Leicester NHS Trust, Leicester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-7387-6444","authenticated-orcid":true,"given":"Simon","family":"Ashwell","sequence":"additional","affiliation":[{"name":"Diabetes Care Centre, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1011-7440","authenticated-orcid":true,"given":"Joseph","family":"Shalhoub","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-5387-4661","authenticated-orcid":true,"given":"Elizabeth","family":"Pigott","sequence":"additional","affiliation":[{"name":"Patient co-investigator, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5261-6913","authenticated-orcid":true,"given":"Alun H","family":"Davies","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2368-7496","authenticated-orcid":true,"given":"Usman","family":"Jaffer","sequence":"additional","affiliation":[{"name":"Department of Surgery and Cancer, Imperial College London, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2026,3]]},"reference":[{"key":"key2026090807025700_ref1-bib1","doi-asserted-by":"crossref","first-page":"964","DOI":"10.2337\/dc07-2367","article-title":"Use of the SINBAD classification system and score in comparing outcome of foot ulcer management on three continents","volume":"31","author":"Ince","year":"2008","journal-title":"Diabetes Care"},{"key":"key2026090807025700_ref2-bib2","doi-asserted-by":"crossref","first-page":"323","DOI":"10.1024\/0301-1526\/a000925","article-title":"The interrelationship between diabetes mellitus and peripheral arterial disease","volume":"50","author":"Stoberock","year":"2020","journal-title":"Vasa"},{"key":"key2026090807025700_ref3-bib3","doi-asserted-by":"crossref","first-page":"18","DOI":"10.1007\/s00125-006-0491-1","article-title":"High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study","volume":"50","author":"Prompers","year":"2007","journal-title":"Diabetologia"},{"key":"key2026090807025700_ref4-bib4","volume-title":"National Diabetes Foot Care Report","author":"The Information Centre for Health and Social Care","year":"2022"},{"key":"key2026090807025700_ref6-bib6","doi-asserted-by":"crossref","first-page":"e3277","DOI":"10.1002\/dmrr.3277","article-title":"Effectiveness of bedside investigations to diagnose peripheral artery disease among people with diabetes mellitus: a systematic review","volume":"36","author":"Forsythe","year":"2020","journal-title":"Diabetes Metab Res Rev"},{"key":"key2026090807025700_ref7-bib7","doi-asserted-by":"crossref","first-page":"1811","DOI":"10.1016\/j.jvs.2020.11.030","article-title":"A systematic review and meta-analysis of the diagnostic accuracy of point-of-care tests used to establish the presence of peripheral arterial disease in people with diabetes","volume":"73","author":"Normahani","year":"2021","journal-title":"J Vasc Surg"},{"key":"key2026090807025700_ref8-bib8","doi-asserted-by":"crossref","first-page":"e033753","DOI":"10.1136\/bmjopen-2019-033753","article-title":"Study protocol for a comparative diagnostic accuracy study of bedside tests used to detect arterial disease in diabetes: TEsting for Arterial disease in Diabetes (TrEAD) study","volume":"10","author":"Normahani","year":"2020","journal-title":"BMJ Open"},{"key":"key2026090807025700_ref9-bib9","doi-asserted-by":"crossref","first-page":"e605","DOI":"10.1097\/SLA.0000000000004545","article-title":"Diagnostic accuracy of point-of-care tests used to detect arterial disease in diabetes: testing for arterial disease in diabetes (TrEAD) study","volume":"276","author":"Normahani","year":"2022","journal-title":"Ann Surg"},{"key":"key2026090807025700_ref10-bib10","doi-asserted-by":"crossref","first-page":"e066950","DOI":"10.1136\/bmjopen-2022-066950","article-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","volume":"12","author":"Normahani","year":"2022","journal-title":"BMJ Open"},{"key":"key2026090807025700_ref11-bib11","doi-asserted-by":"crossref","first-page":"1317","DOI":"10.1001\/jama.286.11.1317","article-title":"Peripheral arterial disease detection, awareness, and treatment in primary care","volume":"286","author":"Hirsch","year":"2001","journal-title":"JAMA"},{"key":"key2026090807025700_ref12-bib12","doi-asserted-by":"crossref","first-page":"220","DOI":"10.1016\/j.jvs.2013.08.003","article-title":"The society for vascular surgery lower extremity threatened limb classification system: risk stratification based on wound, ischemia, and foot infection (WIfI)","volume":"59","author":"Mills","year":"2014","journal-title":"J Vasc Surg"},{"key":"key2026090807025700_ref13-bib13","doi-asserted-by":"crossref","first-page":"1381","DOI":"10.1016\/S0735-1097(01)01120-2","article-title":"Intermittent claudication: an objective office-based assessment","volume":"37","author":"McPhail","year":"2001","journal-title":"J Am Coll Cardiol"},{"key":"key2026090807025700_ref14-bib14","doi-asserted-by":"crossref","first-page":"507","DOI":"10.1016\/j.ejvs.2010.06.002","article-title":"Duplex ultrasound scanning of peripheral arterial disease of the lower limb","volume":"40","author":"Eiberg","year":"2010","journal-title":"Eur J Vasc Endovasc Surg"},{"key":"key2026090807025700_ref15-bib15","doi-asserted-by":"crossref","first-page":"59","DOI":"10.1016\/j.ejvs.2005.09.006","article-title":"Association of cardiovascular risk factors with pattern of lower limb atherosclerosis in 2659 patients undergoing angioplasty","volume":"31","author":"Diehm","year":"2006","journal-title":"Eur J Vasc Endovasc Surg"},{"key":"key2026090807025700_ref16-bib16","doi-asserted-by":"crossref","first-page":"325","DOI":"10.7326\/0003-4819-153-5-201009070-00007","article-title":"Meta-analysis: accuracy of contrast-enhanced magnetic resonance angiography for assessing steno-occlusions in peripheral arterial disease","volume":"153","author":"Menke","year":"2010","journal-title":"Ann Intern Med"},{"key":"key2026090807025700_ref17-bib17","doi-asserted-by":"crossref","first-page":"415","DOI":"10.1001\/jama.301.4.415","article-title":"Diagnostic performance of computed tomography angiography in peripheral arterial disease: a systematic review and meta-analysis","volume":"301","author":"Met","year":"2009","journal-title":"JAMA"},{"key":"key2026090807025700_ref18-bib18","doi-asserted-by":"crossref","first-page":"544","DOI":"10.1002\/bjs.10460","article-title":"Assessment and validation of a novel angiographic scoring system for peripheral artery disease","volume":"104","author":"Morris","year":"2017","journal-title":"J Br Surg"},{"key":"key2026090807025700_ref19-bib19","doi-asserted-by":"crossref","first-page":"173","DOI":"10.1111\/j.1369-7625.2007.00436.x","article-title":"User involvement in the development of a research bid: barriers, enablers and impacts 1","volume":"10","author":"Staniszewska","year":"2007","journal-title":"Health Expect"},{"key":"key2026090807025700_ref20-bib20","volume-title":"Briefing Notes for Researchers: Public Involvement in NHS, Public Health and Social Care Research","author":"Roberts","year":"2020"},{"key":"key2026090807025700_ref21-bib21","doi-asserted-by":"crossref","first-page":"j3453","DOI":"10.1136\/bmj.j3453","article-title":"GRIPP2 reporting checklists: tools to improve reporting of patient and public involvement in research","volume":"358","author":"Staniszewska","year":"2017","journal-title":"BMJ"},{"key":"key2026090807025700_ref22-bib22","doi-asserted-by":"crossref","first-page":"301","DOI":"10.1016\/S1078-5884(97)80102-5","article-title":"A comparative study of treadmill tests and heel raising exercise for peripheral arterial disease","volume":"13","author":"Amirhamzeh","year":"1997","journal-title":"Eur J Vasc Endovasc Surg"},{"key":"key2026090807025700_ref23-bib23","doi-asserted-by":"crossref","first-page":"2890","DOI":"10.1161\/CIR.0b013e318276fbcb","article-title":"Measurement and interpretation of the ankle-brachial index: a scientific statement from the American Heart Association","volume":"126","author":"Aboyans","year":"2012","journal-title":"Circulation"},{"key":"key2026090807025700_ref24-bib24","volume-title":"NIHR BAME Participation Toolkit"}],"container-title":["Health Technology Assessment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2050578","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/sites\/journalslibrary\/files\/journal_data\/GJUJ2819\/GJUJ2819.xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/njl-admin.nihr.ac.uk\/document\/download\/2050578","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T07:01:16Z","timestamp":1788850876000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.journalslibrary.nihr.ac.uk\/hta\/published-articles\/GJUJ2819"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3]]},"references-count":23,"alternative-id":["10.3310\/GJUJ2819"],"URL":"https:\/\/doi.org\/10.3310\/gjuj2819","relation":{},"ISSN":["2046-4924"],"issn-type":[{"value":"2046-4924","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3]]},"assertion":[{"value":"This content has been made freely available to all.","name":"free","label":"Free to read"},{"value":"09-2021","name":"contractual_start_date","label":"contractual_start_date","group":{"name":"article_history","label":"Article History"}},{"value":"01-2025","name":"editorial_review_begun","label":"editorial review begun","group":{"name":"article_history","label":"Article History"}},{"value":"09-2025","name":"accepted_for_publication","label":"Accepted for publication","group":{"name":"article_history","label":"Article History"}}]}}