38 Journal of The Association of Physicians of India ■ Vol.

64 ■ August 2016

Original Article

Sensitivity and Specificity of Pulse Oximetry
and Ankle-Brachial Index for Screening
Asymptomatic Peripheral Vascular Diseases in
Type 2 Diabetes Mellitus
M Satheesh Kumar1, Ayush Lohiya2, Viviktha Ramesh2, Priyamadhaba Behera2,
Sarika Palepu 2, SA Rizwan3

Abstract Editorial Viewpoint
Objectives: To compare pulse oximetry and Ankle-Brachial Index (ABI) • Diabetic patients tend to
with duplex ultrasonography as reference standard to determine the have a two to four fold
diagnostic accuracy for screening asymptomatic PVD in type 2 diabetes increase in the risk of
mellitus. PVD.
Methods: This cross-sectional study was conducted in 2012 at tertiary • Pulse oximetry is an easier
hospital in Madurai among diabetic patients attending the medicine way to access PVD.
outpatient department (OPD). Type 2 Diabetes Mellitus patients, • T h i s s t u d y s h o w s
asymptomatic with regards to symptoms and signs of PVD, aged above pulse oximetry to be as
40 years were included. good as ankle-brachial
index for screening of
Pulse Oximetry was performed using a pulse oximeter and ABI using
asymptomatic PVD.
sphygmomanometer cuffs and duplex ultrasonography of femoral,
popliteal, tibial, posterior tibial and dorsalis pedis arteries. A diagnosis of diabetic patients globally,
of PVD was based on: monophasic waveforms in any artery by duplex with a prevalence of about 8%
ultrasonography, toe saturation being less than finger saturation by among adults next only to China.
>2% or if foot saturation decreased by >2% in an elevated position and Currently about 35 million Indians
an ABI <0.9. are reported to suffer from
Results: Among 120 patients included in the study, prevalence of PVD diabetes, a significant proportion
was 22.5% (95% CI: 15.9, 30.8). The PVD group had a higher proportion of whom are either undiagnosed
of elderly, males, current smokers, long-standing diabetics and or diagnosed but under-treated
comorbidities. The sensitivity, specificity, positive predictive value (PPV) leading to poor glycemic
and negative predictive value (NPV) of pulse oximetry were 74.1% (95% control. 1 This leads to accelerated
CI: 55.3, 86.8), 95.7% (89.4, 98.3), 83.3% (64.1, 93.3) and 92.7% (85.7, 96.4) d e ve l o p m e n t o f c o m p l i c a t i o n s
respectively, while those of ABI were 70.3% (51.5, 84.2), 87.1 (78.8, 92.5), like Peripheral Vascular Disease
61.3% (43.8, 76.3) and 91.0% (83.3, 95.4) respectively. Parallel testing had (PVD). PVD, defined as a clinical
disorder in which there is stenosis
net sensitivity increased to 92.3% and net specificity decreased to 83.3%.
or occlusion in the arteries of the
Performances did not differ across the subgroups.
limbs, 2 is a common complication
Conclusion: Pulse oximetry was atleast as good as ABI for the screening of long standing diabetes mellitus.
for asymptomatic PVD among diabetics. Individuals with diabetes tend to
have a two to four fold increase

Introduction
1
Post-Graduate Trainee, Madurai Medical College, Madurai, Tamil Nadu; 2Post-Graduate Trainee, All India Institute

I ndia, dubbed to be the diabetic
capital of the world, has the
second largest absolute number
of Medical Sciences, New Delhi; 3Assistant Professor, Department of Community Medicine, Velammal Medical
College Hospital & Research Institute, Madurai, Tamil Nadu
Received: 25.06.2015; Revised: 21.07.2015; Accepted: 23.10.2015

Prevalence of PVD among diabetic patients was in the risk of PVD. more readily available Instruments bilateral. 9 PVD were required. reported that ABI had a sensitivity of only 28. Patients suffering from P V D 7 . 10. This process was such as pain. is a very accurate Material and Methods analysis to check for presence of me t h o d f o r d e t e c t i n g va s c u l a r comorbidities. Duplex ultrasonography.5 In diabetes. 90%. ABI.16 irrespective of Magnetic Resonance Angiography manner for eligibility according to control of blood sugar. Patients’ medical Patients and setting r e c o r d s we r e u s e d t o c o n f i r m lesions. Among the methods used for (Box 1) All eligible consenting 2.. Hence. valvular heart disease.4% among asymptomatic we calculated that 11 patients of 4. study was calculated as 122. about 80% and specificity of over diabetic patients required for the which make it more difficult 90%. pressure (BP) in the legs to that of Sr. countries like India. 64 ■ August 2016 39 Box 1: Eligibility criteria in colour and Doppler spectral November 2012 in the medicine Sr. reference standard and to compare using a semi-structured. patients are asymptomatic. 7. Patients who were unable to lie alpha of 5% and beta of 20%. which works considered to be about 10%. physical examination was done for diagnosis of PVD. 6 Stenosis in patients in India and hence the need Duplex ultrasonography of lower PVD usually develops gradually for this study. Journal of The Association of Physicians of India ■ Vol. along with medical record based technique. However. Systolic blood amputations among these patients perfusion. Extremely sick patients who required intensive care. duration of (MRA) are also accurate though predefined inclusion and exclusion diagnosis. sensitivity of over 90% in detecting Using the formula. It is the combination of real-time B mode scanning This cross-sectional study was the presence of Coronary Heart conducted between March and Disease (CHD). pulsating arterial oxygen saturation) of large proportion of lower extremity veins and poor peripheral fingers and toes. swelling. the final number of PVD has certain peculiar features. Not previously investigated for or screening.8 relative precision of 20%. United States of America (USA) 3. other complications. Ankle-Brachial Index patients were then subjected to diagnosed as PVD and asymptomatic with regard to symptoms of PVD (ABI) and pulse oximetry are all three tests. Applying a non-response in south Indians. for e. 8 b u t s o m e s t u d i e s we r e 4x[sensitivity×(1-sensitivity)] hypercoagulable states. 5 so the PVD among overt diabetic patients by combining spectrophotometry number of diabetic patients needed was estimated to be about 6 to 8% and optical plethysmography was 110. Diabetic mellitus.g . Other imaging modalities hospital in southern India. common. a st udy done in and assuming a sensitivity of vascular disease. to treat. Exclusion criteria in the arms was shown to have a Sample size No. Computerized patients who attended the OPD or based on blood sugar records as Tomography (CT) angiography and were screened in a consecutive per American Diabetic Association (ADA) criteria. it is multi-segmental. pre-tested the performance of these tests questionnaire. Madurai. 13 2. criteria using a screening checklist. Age less than 40 years. cheaper. 10 It is simple. A handheld pulse oximeter was leading to poorer prognosis as it performs poorly in cases of used to measure SpO2 (peripheral compared to non-diabetic PVD. 1. 11 Only a few studies pressures of the arms and legs were lead to significant disability and have assessed ABI and pulse measured with appropriate size economic burden to the individual oximeter as a screening tool for sphygmomanometer cuffs and a and the health system in developing asymptomatic PVD in diabetic handheld 8 MHz Doppler probe. hence not appropriate for screening Hospital. either physician diagnosed like arteriography.12 This study was extremity arteries was performed and is accompanied by formation of designed to assess the diagnostic using a Doppler ultrasonogram extensive collaterals so most of the accuracy of pulse oximetry and machine. treatment and presence of expensive in clinical practice. duration of diabetes mellitus can surely limit its duplex ultrasonography as the and smoking history was collected debilitating effects. 4. supine for the period of testing. and therefore liable to spectrum precision^2 suspected arteritis and collagen bias . Cerebrovascular . ulcers. size was achieved. an ultrasound. 3 Prevalence of The pulse oximeter. patients. A dyshemoglobinemia. congestive done in overtly symptomatic cases n= heart failure. extensive and involves and can be performed without predominantly distal vessels any special training. the ratio of blood continued till the requisite sample previous amputations etc. ABI as a screening tool to detect Procedures early detection and treatment of asymptomatic PVD in patients with Information on patient PVD in patients with diabetes type 2 diabetes mellitus against demographics. Inclusion criteria analysis. non-invasive. Adults pre-diagnosed type 2 diabetes purposes. but it is expensive and OPD of Government Rajaji No. has a reported sensitivity of rate of 10%. a tertiary care 1. A comprehensive Various methods are available across different subgroups.

who required treatment as per their vs.5) duration.10 ABI was Research ethics prevalence of PVD in the sample calculated by measuring systolic BP of the brachial artery at the Ethical clearance was obtained was 22. popliteal. elbows and that of posterior tibial from the Institutional Review Board Comparison of baseline parameters artery (or dorsalis pedis artery of the Government Rajaji Hospital. 1: Flow of participant of DM o f t e s t 2 ] .2) was measured in two positions.1% National Committee on Prevention. specificity. 14 Statistical analysis The sensitivity and specificity A hand-held pulse oximeter was Characteristics of the study of pulse oximetry were 74.3.3% (64.9%) and comorbidities Treatment of High Blood Pressure care.5% vs. 3 % waveforms in any one artery by measure was also calculated for (43. while those and both big toes. 9.1) 29 (31. 40.3) Definitions used for PVD diagnosis compared separately with the and 92.1) Fig. 95. 31.8.9 for (against a calculated sample size of arteries bilaterally. Intervals (CI).7) 37 (39. Diagnostic accuracy 98.3. Disease (CVD) and Hypertension. Patients (81. and diagnosis were given appropriate (81.4) respectively The presence of monophasic reference standard and a combined a n d t h o s e f o r A B I we r e 6 1 .9) 40 (43.2%). Main reason for refusal was lack used as the reference standard in leg had abnormal results. Cerebrovascular dis. Eighteen extremities was done at the level were calculated by dividing the patients (13%) refused to participate of femoral.5% (95% CI: 15. The many previous studies. 92. 30. diabetes After this initial assessment. Written informed consent compared to non-PVD patients. When Patients screened for according to selected socio.4. 10.5) 10 (10. 64 ■ August 2016 Table 1: Distribution of participants a parallel testing scenario. Coronary heart dis. 4 (14. Toe saturation of the index tests was calculated of ABI were 70. smokers (74. due to their performed ABI followed by pulse strong association with PVD were duplex ultrasonography was taken oximetry on the same day. considered negative. the saturation of both index fingers percentages. in supine and the other at 12-inch PPV. P V D wa s the study team) who was blind to considered present if toe saturation the results of index tests.5) 55 (59. 93. The parallel eligible = 138 n=27 n=93 testing formulae 17 used were: Age grp 41-50 7 (25.2) a few important covariates.40 Journal of The Association of Physicians of India ■ Vol.3% (51.8). positive by any Not eligible = 274 Variable Category Peripheral vascular one test was considered positive disease n (%) and negative by both tests was Patients found Present. ( JNC 7) for BP measurement. as in case posterior tibial had no Madurai. expert radiographer (not part of for subgroup analysis. 76. 72%).8) sex. (Table 1). cardiovascular disease one of the study investigators Hypertension 22 (81.4) .5% vs.0) of test 2)] and Net specificity = [specificity of test 1 x specificity Duration <10 years 5 (18. decreased by >2% in the elevated were screened and 138 were found Duplex ultrasonography of lower position.5) 55 (59.8.1) and hypertension.8) 6 (6. 15 ABI values for each leg eligible for inclusion. long-standing diabetics Detection. Each index test was oximetry were 83.1% (95% used to measure SpO 2 to measure p o p u l a t i o n we r e d e s c r i b e d i n CI: 55.8) and 95.5) 26 (28.7% (89.9. An considered as important covariates as confirmatory evidence for PVD.0) (sensitivity of test 1 × sensitivity included = 120 Females 5 (18.7. conducted was less than finger saturation Results duplex ultrasonography within by >2% or if the foot saturation A total of 412 diabetic patients one-week of the initial assessment.5) 67 (72. Absent. This test has any leg was considered positive for 122) with type 2 diabetes mellitus specificity of 97% when compared PVD.2) Net sensitivity = [sensitivity 61-70 5 (18. smoking status. and 87. males by the seventh report of the Joint was strictly maintained. tibial. Age.8%).3) and 91.5) respectively.5% vs.0) Refusal = 18 (years) 51-60 15 (55.1 (78. one in terms of sensitivity.3) respectively. of time to stay for the tests.5) 38 (40. and NPV with 95% Confidence The PPV and NPV for pulse elevation from the horizontal plane. B y p u l s e o x i m e t r y . showed that the PVD group. 18 (66.8) of test 1 + sensitivity of test 2 – Total patients Sex Males 22 (81. 84.9) selection process subgroup analysis according to Current smoker 20 (74.5. We a l s o p e r f o r m e d ≥10 years 22 (81. calculating the net sensitivity eligibility = 412 demographic variables and and net specificity for the parallel comorbidities testing scenario. 16 A patient was considered to were included in the study (Figure with arteriography and has been be positive for PVD even if any one 1). Evaluation. signal) at the ankles. 86.0% (83. 96.6) 43 (46.7% (85. ankle systolic BP by the elbow and finally a total of 120 patients posterior tibial and dorsalis pedis pressure and a value of < 0.1. following was obtained from all participants had a higher proportion of elderly the usual precautions prescribed and confidentiality of information patients (18.

(80.5.0) 91.6) 90.1 57.8) Table 4: Subgroup analysis of sensitivity.0 72. (86. (54. (81. (72.8) 98.9. (89. (45. (72.9.5 88.6.7.2 66.7. Journal of The Association of Physicians of India ■ Vol.1.9.5.2) 92.8. (24.8) respectively.9) 97.2.9. (11.7 94. specificity and predictive values of ABI by selected covariates Index Validity Age Sex Diabetes duration Current smoker CHD Hypertension test measure % (95% CI) % (95% CI) % (95% CI) % (95% CI) % (95% CI) % (95% CI) <55 years ≥55 years Male Female <10 years ≥10 years Yes No Present Absent Present Absent ABI Sensitivity 66. (29. 93. (84. (49.1) 99. as expected diabetes duration ≥10 years and ranging from about 6% to 8%.8) 83.7) 91.8.4) 96. duration. (29.3) 93.5) 95.5 96.3 (43. This could be due to the fact that There was no statistically The best performance of the parallel the study sample came from a testing strategy was seen in the .4) 94.1.7) 99.1 (55.0. specificity and predictive values of pulse oximetry by selected covariates Index Validity Age Sex Diabetes duration Current smoker CHD Hypertension test measure % (95% CI) % (95% CI) % (95% CI) % (95% CI) % (95% CI) % (95% CI) <55 years ≥55 years Male Female <10 years ≥10 years Yes No Present Absent Present Absent Pulse Sensitivity 66.4 93. (75.6) 97. sensitivity of 98% and specificity of for pulse oximetry as compared specificity. (17. patients of CHD and hypertension.8 92.6 91.3 (23.0 89. (17. (49.0) 85. (76.8) 95. (79.2) 95.2 94.5 65.3) 98.1) 99.5 80.0 36.9.9.9.4) 92. (90. 98.3 91.5 89.0 (35.6) 91.1.9 75. (51.6.7 96.9) 99. 92.1.3.1.1 96. (79.3 75.2.7) 99.6) 96.9.8) 98.3) 99.1 89.1.1 (39.2 70.8. current non-smokers group with a validity parameters were higher overlapping CIs) in sensitivity. indicating no subgroups of age.2.6) 99.5. (77.5 95. (68.7) 94.6.6 98. 76. (86.0 (83.6) 99.0 78.4) Positive 19 12 Negative 8 81 Combination 92.5. (29.6) 88.3) 95.4.9) 92. (78. (69.0.6) 99.3 (51. non-smokers. 86.0 94. (66.9 97. (29.1) NPV 93.1.8.6 93.7. prevalent among the diabetics in parallel testing mode showed 4).8.3) 99.0 60.7 (85. 84.9) Specificity 94.9) 96. (30. Therefore.2.3) 92.6) 90.68. (60.8 82.9) Specificity 84.3 (75. 96.8) 99. presence We found that PVD was fairly A combination of these two tests of CHD and hypertension (Tables 3.8.8) 98. specificity and predictive values of pulse oximetry and ABI with duplex ultrasonography as reference standard Index test PVD (by duplex USG) Sensitivity Specificity PPV NPV Present nos. (66.9) 97. 64 ■ August 2016 41 Table 2: Sensitivity.3) 97.1 80.4.8) 88.4. (48. (81. (20. (59. (40.7 78.1 96. (12.1 44.4. (56.0.4) Positive 20 4 Negative 7 89 ABI 70.1.0 77.3) 87.4 96.6) 99.2) 89. included in this study.3) 83. Absent nos.3 90.1 80.3 87. (42.3 68.3 66.0. (17.4 42.3. In the parallel testing scenario.3 85. (24.1 92.9) 99.9) 92.0) 99.9.8.3 71.6 94.0.9 81.5) 83.8. 92. (82.3 (64.8) 98. (56. (85.3) 98.2) 90.3. (78.4) 99. 96.5.8) 96.4.3) NPV 92.7 77. 4.6 90.2.0 54.1 (84. (83. 92. (30. PPV and NPV between 88% (Table 5).4 87. (29.6) PPV 47.0 72.2 (82.0. (86.4. 88.3.8.7 80. 88.2 80. (40.5 95.1. (46. (75.6 72. 88.8 98.8 (81. A few an increase in net sensitivity to sensitivity increased for all age community-based studies have 92% and a slight decline in net groups.5 (72.9.2) 98.7 80.9.3 (86.1 (78. (51. (44.0 oximetry (35.2) 87. smoking status.4.0 85.0.e.3) 83.6 65.3.5) 61. sex.3) 91.9.5) 94.0 95.3.0 91.7) 91.3.8 66.6.9) PPV 72.0 90.6.1 81.6) 98.0.6) 81. diabetes Discussion significant statistical difference.6 68. (30. (82. (15.1.3.4) .0.6 80.2) 98.2. (79.4 96.9.3 66.0 85.0 60.3) 79. (75. (84.0 54. (81. 98.0) 83. (79.9) 94.5.7 92.0.7) 99.7 72.7 65.0) 88.7) 83.0.5) 99.7 66. (64. (50.9) 85. to ABI but the limits of 95% CI pulse oximetry and ABI across the were overlapping. (75. (49. - (parallel testing) Positive 21 13 Negative 6 80 Total 27 93 Table 3: Subgroup analysis of sensitivity.9. male sex. (89.8. (40. (78.3 94.8) 99.6) 81.5 68. (45. (84.7) 98.7) 88.8.0 97.4. (45.6) 90. (66. (44.1.3) 92.9) 92.7 (89.8) 97.6.6 73. (83. (30. all the significant difference (i.0.5 75.4.8.3 97.5.9. (62. (42.9.6) 95. (62.5. (86.3.3 84.7) 98.7) 99.0. (45.6) 95. (65.2 83. (65. % (95% CI) % (95% CI) % (95% CI) % (95% CI) Pulse oximetry 74.1.6) 88.6) 99.7 92.0 60.5.2) 77.0. 97.5 (Table 2).9) 96. 95.8.6) 89. 97.7 96. reported a lower prevalence specificity to 83%.7.5.0.5.0) 99.2) 85.4.0.8.7 91. (64.8) 90.5.0) 88. (80.9) .3 98.

(82.6) Specificity 80.1. previously established in severe staff makes it a attractive option The idea behind subgroup cases. specificity and predictive values of combination of pulse oximetry and ABI by selected covariates Index test Validity Age Sex Diabetes duration Current smoker CHD Hypertension measure % (95% CI) % (95% CI) % (95% CI) % (95% CI) % (95% CI) % (95% CI) <55 years ≥55 years Male Female <10 years ≥10 years Yes No Present Absent Present Absent Combination Sensitivity 88.5 98. This selection criterion also for crowded OPD/physician office analysis was to check if the test tried to avoid to some extent. cheap.12 Since the factors care setting. 10.4 88. non.3) 91. for diabetes duration ≥10 between the various grades of studies.2. only in cases of severe disease.6) 90. (68.2 96.8 91.8 88.1.42 Journal of The Association of Physicians of India ■ Vol.3.8 94.3) 98. (90. (66. the settings. (84.1.5) 84. We f o u n d n o s i g n i f i c a n t the index tests. (66. sensitivity increased for only able to detect asymptomatic to avoid commonly encountered all age groups.0 (parallel (82. cases. 86. thereby avoiding spectrum is quick. although the study covariates such as age.1) 98.8 78. (82.2 75.5) 94. (90. (82.1. clustered within the individual and combination was reported to be Also. we avoided the clinics. Another study showing sensitivity control of PVD can serve as an We found that for asymptomatic and specificity of pulse oximetry important preventive strategy for patients. sex.1) 99.2 96.5 77.1.1) 95. (89.3.4.2. which because the reference standard tests of this group may be different are also known risk factors for were performed independently of from those attending primary care P V D .1) 95. This study predictive values of pulse oximetry all three tests. resulting in prevalence was higher than in the screening test for PVD have given large numbers of amputation general community. Secondly.9) 92. On combining been demonstrated in previous to reduce consequent disability.2.1) 82.7 73. 63% and 86% respectively.5.7) 97. we avoided the would be applicable to all such and ABI in the subgroups were verification bias. it has been shown that PVD PVD is a generalized process.7. inter-observer variability and its to perform reasonably well among Accuracy of these tests has been ease of use even by paramedical asymptomatic patients.2 87.1) 82.1) 97. among males.0. (84. 2 the two tests in parallel testing studies that pulse oximetry was not Our study was carefully designed scenario. (88. Relative Risk for PVD was more common among patients having moderate PVD. Firstly.2.6) 94.3. (81.5. hospital and the characteristics of CHD and hypertension. the reference standard test has very asymptomatic with regard to PVD. pulse oximetry performed to be 87% and 87% respectively reducing cardiovascular events atleast as good as ABI if not better concluded that pulse oximetry among diabetics. (88. (80. easily available.4) 91. In a study done in surgeries.1 89.7) 93. specificity and since all patients underwent be applicable to them. non. (76. (82. (64. In this sample mixed results.0 93. level analysis rather than extremity and 92% for their combination. Thirdly. testing) 94. diabetes varying performances with regard was conducted in a tertiary care duration.1. 1 4 alt houg h a few st udies asymptomatic patients with regard and hypertension. Our unit of analyses was r e p o r t e d t o b e o n l y 1 6 % .4) 80. males and sensitivity of pulse oximetry was patients with diabetes is 12 times smokers.8.1. (69.0 84. 64 ■ August 2016 Table 5: Subgroup analysis of sensitivity.3) 98.0 93. presence to disease duration. but could also differentiate biases in diagnostic accuracy smokers. Pulse oximetry reported that ABI performs better to PVD. International and the combination of both could could be used as a simple. 15 I n as compared with that of non- patient and not limb as done by another study done in primary diabetic patients. (78. 9 bias where test performances requires minimal training. 12 It has for PVD. smoking status. as a preventive measure among diabetics.6) 94. we included only years and among patients of CHD PVD.8 89. Patients with diabetes more high sensitivity and specificity 20 is Previous studies assessing the commonly develop symptomatic not perfect and there is a possibility . agencies such as the ADA have be used as a good screening tool for invasive screening device similar recommended regular screening the diagnosis of asymptomatic PVD to ABI in assessing PVD.1. there are no strong reasons change in the performance of tests diagnostic review bias.4) tertiary care hospital and hence the utility of pulse oximetry as a forms of PVD. ABI and their prevent this significant disability.7 91. (78.6 89.8) 85. In terms of external performances were different across bias that occurs when the tests have validity. although diabetic patients who are currently comparable.6) 94. has low whereas in our study it was found are based on only severe cases.2. it 77%.4. 10 is correlated with cardiovascular was considered better to do patient Specificity was 97% for both tests events such as MI and Stroke. the sensitivity of and appropriate treatment can that are associated with PVD are pulse oximetry.9.1 (71. Finally. 19 Early detection other studies.7 86. Therefore early detection and level analysis. (94. to believe that the results would not and also sensitivity. lower extremity amputation in those aged 51-60 years.4 85.3 74.

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