Chuter V, Schaper N, Mills J, Hinchliffe R, Russell D, Azuma N, Behrendt CA, Boyko EJ, Conte MS, Humphries M, Kirksey L, McGinigle KC, Nikol S, Nordanstig J, Rowe V, van den Berg JC, Venermo M, Fitridge R, et al.
Diabetes/metabolism research and reviews. Date of publication 2024 Mar 1;volume 40(3):e3683.
1. Diabetes Metab Res Rev. 2024 Mar;40(3):e3683. doi: 10.1002/dmrr.3683. Epub
2023 Jul 21.
Effectiveness of bedside investigations to diagnose peripheral artery disease
among people with diabetes mellitus: A systematic review.
Chuter V(1), Schaper N(2), Mills J(3), Hinchliffe R(4), Russell D(5), Azuma
N(6), Behrendt CA(7), Boyko EJ(8), Conte MS(9), Humphries M(10), Kirksey L(11),
McGinigle KC(12), Nikol S(13), Nordanstig J(14), Rowe V(15), van den Berg
JC(16), Venermo M(17), Fitridge R(18)(19).
Author information:
(1)School of Health Sciences, Western Sydney University, Campbelltown, Sydney,
Australia.
(2)Division of Endocrinology, Department of Internal Medicine, MUMC+,
Maastricht, The Netherlands.
(3)Baylor College of Medicine, Houston, Texas, USA.
(4)Bristol Centre for Surgical Research, University of Bristol, Bristol, UK.
(5)Leeds Teaching Hospitals NHS Trust, Leeds, UK.
(6)Asahikawa Medical University, Asahikawa, Hokkaido, Japan.
(7)Department of Vascular and Endovascular Surgery, Asklepios Clinic Wandsbek,
Asklepios Medical School, Hamburg, Germany.
(8)University of Washington, Seattle, Washington, USA.
(9)University of California, San Francisco (UCSF) Medical Centre, San Francisco,
California, USA.
(10)UC Davis Medical Centre, Sacramento, California, USA.
(11)The Cleveland Clinic, Cleveland, Ohio, USA.
(12)University of North-Carolina, Chapel Hill, North Carolina, USA.
(13)Clinical and Interventional Angiology, Asklepios Klinik, St Georg, Hamburg,
Germany.
(14)Sahlgrenska University Hospital, Gothenburg, Sweden.
(15)David Geffen School of Medicine, UCLA, Los Angeles, California, USA.
(16)CENTRO VASCOLARE TICINO Ospedale Regionale di Lugano, sede Civico and
Universitätsinstitut für Diagnostische, Interventionelle und Pädiatrische
Radiologie Inselspital, Universitätsspital Bern Switzerland, Bern, Switzerland.
(17)Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
(18)Faculty of Health and Medical Sciences, University of Adelaide, Adelaide,
South Australia, Australia.
(19)Vascular and Endovascular Service, Royal Adelaide Hospital, Adelaide, South
Australia, Australia.
As a progressive disease process, early diagnosis and ongoing monitoring and
treatment of lower limb peripheral artery disease (PAD) is critical to reduce
the risk of diabetes-related foot ulcer (DFU) development, non-healing of
wounds, infection and amputation, in addition to cardiovascular complications.
There are a variety of non-invasive tests available to diagnose PAD at the
bedside, but there is no consensus as to the most diagnostically accurate of
these bedside investigations or their reliability for use as a method of ongoing
monitoring. Therefore, the aim of this systematic review was to first determine
the diagnostic accuracy of non-invasive bedside tests for identifying PAD
compared to an imaging reference test and second to determine the intra- and
inter-rater reliability of non-invasive bedside tests in adults with diabetes. A
database search of Medline and Embase was conducted from 1980 to 30 November
2022. Prospective and retrospective investigations of the diagnostic accuracy of
bedside testing in people with diabetes using an imaging reference standard and
reliability studies of bedside testing techniques conducted in people with
diabetes were eligible. Included studies of diagnostic accuracy were required to
report adequate data to calculate the positive likelihood ratio (PLR) and
negative likelihood ratio (NLR) which were the primary endpoints. The quality
appraisal was conducted using the Quality Assessment of Diagnostic Accuracy
Studies and Quality Appraisal of Reliability quality appraisal tools. From a
total of 8517 abstracts retrieved, 40 studies met the inclusion criteria for the
diagnostic accuracy component of the review and seven studies met the inclusion
criteria for the reliability component of the review. Most studies investigated
the diagnostic accuracy of ankle -brachial index (ABI) (N = 38). In people with
and without DFU, PLRs ranged from 1.69 to 19.9 and NLRs from 0.29 to 0.84
indicating an ABI <0.9 increases the likelihood of disease (but the extent of
the increase ranges from a small to large amount) and an ABI within the normal
range (≥0.90 and <1.3) does not exclude PAD. For toe-brachial index (TBI), a
threshold of <0.70 has a moderate ability to rule PAD in and out; however, this
is based on limited evidence. Similarly, a small number of studies indicate that
one or more monophasic Doppler waveforms in the pedal arteries is associated
with the presence of PAD, whereas tri- or biphasic waveform suggests that PAD is
less likely. Several forms of bedside testing may also be useful as adjunct
tests and 7 studies were identified that investigated the reliability of bedside
tests including ABI, toe pressure, TBI, transcutaneous oxygen pressure (TcPO2 )
and pulse palpation. Inter-rater reliability was poor for pulse palpation and
moderate for TcPO2. The ABI, toe pressure and TBI may have good inter- and
intra-rater reliability, but margins of error are wide, requiring a large change
in the measurement for it to be considered a true change rather than error.
There is currently no single bedside test or a combination of bedside tests that
has been shown to have superior diagnostic accuracy for PAD in people with
diabetes with or without DFU. However, an ABI <0.9 or >1.3, TBI of <0.70, and
absent or monophasic pedal Doppler waveforms are useful to identify the presence
of disease. The ability of the tests to exclude disease is variable and although
reliability may be acceptable, evidence of error in the measurements means test
results that are within normal limits should be considered with caution and in
the context of other vascular assessment findings (e.g., pedal pulse palpation
and clinical signs) and progress of DFU healing.
© 2023 The Authors. Diabetes/Metabolism Research and Reviews published by John
Wiley & Sons Ltd.
DOI: 10.1002/dmrr.3683
PMID: 37477087 [Indexed for MEDLINE]