How sensitive and specific is continuous-wave Doppler for detecting peripheral arterial disease in people with and without diabetes? A cross-sectional study
Abstract:Background: Continuous-wave Doppler is frequently used for detecting peripheral arterial disease in patients with diabetes; however, there is limited evidence investigating diagnostic accuracy. This study aimed to determine sensitivity and specificity of continuous-wave Doppler for detecting peripheral arterial disease in populations with, and without, diabetes and to investigate the influence of disease severity on sensitivity of continuous-wave Doppler for detecting peripheral arterial disease. Results: Data… Show more
“…Among the studies identified, the most commonly evaluated bedside test was the ABI, which was reported in 13 of the studies. Two studies that did not use ABI were written by authors who previously reported on the use of ABI in a smaller cohort of patients and a further study reported ankle pressure without correcting for brachial pressure . The threshold value for diagnosis of PAD was defined as <0.9 or ≤0.9 in most studies; however, three studies used both a lower and upper threshold for diagnosis (<0.9 or >1.3 and ≤0.9 or ≥1.4 .…”
Section: Resultsmentioning
confidence: 99%
“…Systolic toe pressure was reported by two studies (using <97 mm Hg or <50 mm Hg as thresholds). Other tests used included TcPO 2 altered waveforms on colour wave Doppler audible Doppler waveforms, pulse reappearance time (PRT), change in pulse oximetry and pole test . One study looked at a wide variety of subjective clinical examination tests …”
Section: Resultsmentioning
confidence: 99%
“…Four studies used Doppler waveform analysis, recording abnormal waveform at the tibial arteries or ankles as suggestive of PAD . In all studies, waveform analysis performed very well with respect to NLR (0.09‐0.28), although the PLR were less consistent and varied between 3 and 13.…”
Section: Summary Of the Literaturementioning
confidence: 99%
“…Only four studies reported on the F I G U R E 1 PRISMA Flow Diagram presence of neuropathy [25][26][27][28] with a mean prevalence of 72%. The median prevalence of foot ulcers was 7% among those studies reporting it [26][27][28][29][30][31][32][33] -two of these studies included a population of patients of which all had a foot ulcer. 28,29 The mean duration of diabetes was 13.6 years among those studies in which it was reported.…”
The accurate identification of peripheral artery disease (PAD) in patients with diabetes and foot ulceration is important, in order to inform timely management and to plan intervention including revascularisation. A variety of non‐invasive tests are available to diagnose PAD at the bedside, but there is no consensus as to the most useful test, or the accuracy of these bedside investigations when compared to reference imaging tests such as magnetic resonance angiography, computed tomography angiography, digital subtraction angiography or colour duplex ultrasound. Members of the International Working Group of the Diabetic Foot updated our previous systematic review, to include all eligible studies published between 1980 and 2018. Some 15 380 titles were screened, resulting in 15 eligible studies (comprising 1563 patients, of which >80% in each study had diabetes) that evaluated an index bedside test for PAD against a reference imaging test. The primary endpoints were positive likelihood ratio (PLR) and negative likelihood ratio (NLR). We found that the most commonly evaluated test parameter was ankle brachial index (ABI) <0.9, which may be useful to suggest the presence of PAD (PLR 6.5) but an ABI value between 0.9 and 1.3 does not rule out PAD (NLR 0.31). A toe brachial index >0.75 makes the diagnosis of PAD less likely (NLR 0.14‐0.24), whereas pulse oximetry may be used to suggest the presence of PAD (if toe saturation < 2% lower than finger saturation; PLR 17.23‐30) or render PAD less likely (NLR 0.2‐0.27). We found that the presence of triphasic tibial waveforms has the best performance value for excluding a diagnosis of PAD (NLR 0.09‐0.28), but was evaluated in only two studies. In addition, we found that beside clinical examination (including palpation of foot pulses) cannot reliably exclude PAD (NLR 0.75), as evaluated in one study. Overall, the quality of data is generally poor and there is insufficient evidence to recommend one bedside test over another. While there have been six additional publications in the last 4 years that met our inclusion criteria, more robust evidence is required to achieve consensus on the most useful non‐invasive bedside test to diagnose PAD.
“…Among the studies identified, the most commonly evaluated bedside test was the ABI, which was reported in 13 of the studies. Two studies that did not use ABI were written by authors who previously reported on the use of ABI in a smaller cohort of patients and a further study reported ankle pressure without correcting for brachial pressure . The threshold value for diagnosis of PAD was defined as <0.9 or ≤0.9 in most studies; however, three studies used both a lower and upper threshold for diagnosis (<0.9 or >1.3 and ≤0.9 or ≥1.4 .…”
Section: Resultsmentioning
confidence: 99%
“…Systolic toe pressure was reported by two studies (using <97 mm Hg or <50 mm Hg as thresholds). Other tests used included TcPO 2 altered waveforms on colour wave Doppler audible Doppler waveforms, pulse reappearance time (PRT), change in pulse oximetry and pole test . One study looked at a wide variety of subjective clinical examination tests …”
Section: Resultsmentioning
confidence: 99%
“…Four studies used Doppler waveform analysis, recording abnormal waveform at the tibial arteries or ankles as suggestive of PAD . In all studies, waveform analysis performed very well with respect to NLR (0.09‐0.28), although the PLR were less consistent and varied between 3 and 13.…”
Section: Summary Of the Literaturementioning
confidence: 99%
“…Only four studies reported on the F I G U R E 1 PRISMA Flow Diagram presence of neuropathy [25][26][27][28] with a mean prevalence of 72%. The median prevalence of foot ulcers was 7% among those studies reporting it [26][27][28][29][30][31][32][33] -two of these studies included a population of patients of which all had a foot ulcer. 28,29 The mean duration of diabetes was 13.6 years among those studies in which it was reported.…”
The accurate identification of peripheral artery disease (PAD) in patients with diabetes and foot ulceration is important, in order to inform timely management and to plan intervention including revascularisation. A variety of non‐invasive tests are available to diagnose PAD at the bedside, but there is no consensus as to the most useful test, or the accuracy of these bedside investigations when compared to reference imaging tests such as magnetic resonance angiography, computed tomography angiography, digital subtraction angiography or colour duplex ultrasound. Members of the International Working Group of the Diabetic Foot updated our previous systematic review, to include all eligible studies published between 1980 and 2018. Some 15 380 titles were screened, resulting in 15 eligible studies (comprising 1563 patients, of which >80% in each study had diabetes) that evaluated an index bedside test for PAD against a reference imaging test. The primary endpoints were positive likelihood ratio (PLR) and negative likelihood ratio (NLR). We found that the most commonly evaluated test parameter was ankle brachial index (ABI) <0.9, which may be useful to suggest the presence of PAD (PLR 6.5) but an ABI value between 0.9 and 1.3 does not rule out PAD (NLR 0.31). A toe brachial index >0.75 makes the diagnosis of PAD less likely (NLR 0.14‐0.24), whereas pulse oximetry may be used to suggest the presence of PAD (if toe saturation < 2% lower than finger saturation; PLR 17.23‐30) or render PAD less likely (NLR 0.2‐0.27). We found that the presence of triphasic tibial waveforms has the best performance value for excluding a diagnosis of PAD (NLR 0.09‐0.28), but was evaluated in only two studies. In addition, we found that beside clinical examination (including palpation of foot pulses) cannot reliably exclude PAD (NLR 0.75), as evaluated in one study. Overall, the quality of data is generally poor and there is insufficient evidence to recommend one bedside test over another. While there have been six additional publications in the last 4 years that met our inclusion criteria, more robust evidence is required to achieve consensus on the most useful non‐invasive bedside test to diagnose PAD.
“…Diagnostic thresholds for ABI were in accordance with current international guidelines, with an ABI < 0.9 considered abnormal . TBI values of <0.6 were considered abnormal, and monophasic CWD were considered abnormal . However, due to the small number of participants with abnormal ABI values (n = 3 in each group), the association between the continuous measure of ABI and gait velocity was assessed using Pearson's r correlation.…”
Objectives: Rheumatoid arthritis (RA) is associated with higher risk of atherosclerotic vascular disease, including peripheral arterial disease (PAD). The aim of this study was to measure lower limb vascular characteristics (indicative of PAD), using non-invasive chairside testing methods, in people with RA compared to matched controls, and to determine the association between vascular characteristics and gait velocity as a measure of functional capacity in people with RA.Methods: This was a cross-sectional pilot study which measured lower limb vascular characteristics (bilateral continuous wave Doppler, toe brachial index [TBI] and ankle brachial index [ABI]) and gait velocity (6-m walk test) in people with RA and controls.Differences in vascular characteristics between groups were determined using linear regression models, and associations between vascular characteristics and gait were determined using logistic regression models.Results: Seventy-two participants were included: 34 participants with RA mean disease duration 26.2 (SD 12.1) and 38 age-and sex-matched controls. The control group contained 30 females (79%), and the RA group had 28 females (82%). There were no significant differences between the RA and control groups for lower limb vascular characteristics. People with RA walked significantly slower compared to controls (1.10 m/s vs 0.91 m/s, P < .001). People with RA who had abnormal TBI, or abnormal qualitative Doppler walked significantly slower compared to those with normal TBI (0.86 m/s vs 0.95 m/s, P = .043 and 0.81 m/s, vs 0.93 m/s, P = .028). There was no significant association between ABI and gait velocity.Conclusion: This study did not identify different lower limb vascular characteristics in people with RA compared to matched controls. However, in people with RA, abnormal Doppler and TBI results are associated with slower walking velocity.
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.
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