ORIGINAL PAPER

Peripheral artery questionnaire improves ankle brachial index screening in symptomatic patients with peripheral artery disease B.-H. Kim,1 K.-I. Cho,2 J. Spertus,3 Y.-H. Park,4 H.-G. Je,5 M.-S. Shin,6 J.-H. Lee,7 J.-S. Jang8

1

Department of Internal Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, Korea 2 Department of Internal Medicine, Kosin University School of Medicine, Busan, Korea 3 Saint Luke’s Mid America Heart Institute, University of Missouri–Kansas City, Kansas City, MO, USA 4 Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea 5 Department of Cardiovascular Surgery, Pusan National University Yangsan Hospital, Yangsan, Korea 6 Department of Internal Medicine, Gil Hospital, Gacheon University School of Medicine, Incheon, Korea 7 Department of Internal Medicine, Maryknoll Medical Center, Busan, Korea 8 Department of Internal Medicine, Busan Paik Hospital, University of Inje College of Medicine, Busan, Korea

SUMMARY

What’s known

Aim: The peripheral artery questionnaire (PAQ) is a disease-specific health status measure of patients with peripheral artery disease (PAD). Whether the PAQ scores are associated with a PAD diagnosis among patients with symptoms suspicious for PAD is unknown and could help increase the pretest probability of ankle brachial index (ABI) screening among patients with suspicious symptoms. Methods: The PAQ was completed by 567 patients evaluated for potential intermittent claudication at six tertiary centres. Demographics, medical history, physical examination findings and the PAQ domain scores were compared with ABI. A diagnostic threshold < 0.90 for a PAD diagnosis was assessed with a ROC of PAQ scores. The correlation between the PAQ Summary Score and ABI was also calculated. Results: The PAQ Summary Score was significantly lower in patients with low ABI as compared with those having a normal ABI (37.6  19.0 vs. 70.1  22.7, p < 0.001). The PAQ Summary Score and ABI were highly correlated (r = 0.56, p < 0.001) and the optimal PAQ Summary Score for predicting low ABI was 50.3 (AUC = 0.86, sensitivity 80.3%, specificity 78.3%). Conclusions: The PAQ Summary Score was associated with an increased likelihood of PAD in patients with suspected PAD symptoms, and a low summary score (≤ 50.3) was an optimal threshold for predicting PAD among patients referred for ABI.

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Introduction Peripheral artery disease (PAD) is a frequent manifestation of atherosclerosis in elderly people population and is two to four times more prevalent in diabetic patients (1). PAD is a significant predictor of diabetic foot problems and future cardiovascular (CV) events, such as myocardial infarction or stroke, but is often under-diagnosed particularly in diabetic

PAD is a frequent manifestation of atherosclerosis in the elderly population and is a strong prognostic marker for future CV events. However, because of the silent nature of this disease and the subtle findings on physical examination, PAD is considered to be the least effectively managed major atherosclerotic vascular disorder. ABI in patients with symptoms suggestive of intermittent claudication is a sensitive and costeffective screening tool for PAD, but better methods for identifying those who warrant such testing are needed to improve the recognition and treatment of PAD.

What’s new



Correspondence to: Kyoung-Im Cho, MD, Division of Cardiology, Department of Internal Medicine, Kosin University School of Medicine, 34 Amnam-Dong, Seo-Ku, Busan 602-702, Korea Tel.: + 82 51 990 6105 Fax: + 82 51 990 3005 Email: [email protected] Disclosures None of the authors of this study had any conflict of interest.



There was a strong association between PAQ scores and ABI results among those with confirmed PAD, further confirming the criterion validity of the PAQ. A lower PAQ summary score was strongly associated with an increased likelihood of PAD in patients with PAD-related symptoms, and the optimal threshold for discriminating those with and without ABI-confirmed PAD was 50. In multivariable analyses, PAQ scores below this threshold were the most strongly associated predictor of PAD, and this association was robust amongst those with and without type 2 diabetes. Given the importance of diagnosing and treating patients with PAD, these data suggest that patient-specific health status may serve a valuable role in the initial evaluation of patients with symptoms concerning for PAD.

patients (1–6). In fact, asymptomatic disease may be present in up to 50% of patients with PAD and the incidence of symptomatic PAD increases with age and the presence of CV risk factors (7,8). Although PAD is a strong prognostic marker for future CV events, previous research indicates that only a small fraction of patients with PAD are properly diagnosed (9,10). Because of the silent nature of this disease and the subtle findings on physical examination

ª 2014 John Wiley & Sons Ltd Int J Clin Pract, December 2014, 68, 12, 1488–1495. doi: 10.1111/ijcp.12494

Questionnaire for peripheral artery disease

(11,12), PAD is considered to be the least effectively managed major atherosclerotic vascular disorder (9,13), with only 25% of PAD patients being recognised and treated (9,10). The ankle brachial index (ABI) in patients with symptoms suggestive of intermittent claudication is a sensitive and cost-effective screening tool for PAD. The ABI reflects anatomical arterial narrowing of the lower extremities and is often reduced in patients with symptomatic PAD (14,15). Despite this association, few studies have examined the association between ABI and the impact of PAD on patients’ health status, including their symptoms, function and quality of life (16,17). Moreover, despite the simple and non-invasive nature of ABI screening, better methods for identifying those who warrant such testing are needed to improve the recognition and treatment of PAD. To reliably monitor PAD patients’ health status, sensitive, disease-specific instruments have been developed. The psychometrically sound peripheral artery questionnaire (PAQ), a disease-specific measure, was developed for this purpose in the USA population (18) and has recently been translated and validated into Korean (19). However, the clinical utility of the PAQ for identifying patients with potential PAD who have significant decreases in ABIs, or the association between ABIs and PAQ scores among those with PAD, is unknown. Since the PAQ is a systematic method for quantifying the severity of patients’ symptoms, and since the diagnosis of PAD is presumed to be more common among those with more severe symptoms, we hypothesised that the PAQ might be able to discriminate patients with potential PAD into those with confirmed disease and those without. The aim of this study was to establish the clinical validity of the PAQ by examining its association with ABI in patients presenting with symptoms suggestive of intermittent claudication. Furthermore, we investigated the diagnostic value of the PAQ by assessing whether it was more strongly associated with reduced ABI than the Edinburgh claudication questionnaire (ECQ), a validated questionnaire to diagnose intermittent claudication in epidemiological surveys of PAD (20). Finding a strong association of the PAQ with ABI-confirmed PAD and superior performance over the ECQ could support a new application of the PAQ in screening patients with claudication symptoms.

Methods Participants and selection criteria We conducted a six-tertiary centre, cross-sectional, observational study, between January 2012 and Octoª 2014 John Wiley & Sons Ltd Int J Clin Pract, December 2014, 68, 12, 1488–1495

ber 2012. The recruitment methods were consistent across centres, and the patients were randomly selected from those registered at the clinics with existing patients or patients consulting for the first time with a specialist. The study screening visit was a part of normal practice with patients being recruited as part of usual care. One principal researcher (CKI) was responsible for the recruitment at each centre, and these self-completed questionnaires were completed at the time of the visit. The main inclusion criteria were clinical symptoms suggestive of PAD, with established coronary artery disease/cerebrovascular disease or at least one major cardiovascular risk factor (smoking, type 2 diabetes mellitus (DM), hypertension or dyslipidaemia, as defined by the TASC II report) (8). The exclusion criteria were age younger than 18 years, refusal to participate, a prior history of diabetic peripheral neuropathy, thoracic or brain surgery, and conditions that required hospitalisation, such as cancer or a life-threatening illness. A diagnosis of diabetic peripheral neuropathy was made on the basis of symptoms and/or signs of peripheral nerve dysfunction by a 10-g Monofilament test, a 128-Hz tuning fork and Michigan neuropathy screening instrument in patients with type 2 DM. Patient demographics, a history of atherothrombotic events, smoking status, presence of hypertension, DM, dyslipidaemia (risk factors for PAD) and medications in the last 6 months (including antihypertensives, antidiabetics, lipid lowering drugs and antithrombotic agents) were recorded during the study screening visit (Table 1). Blood pressure, heart rate, body weight, height, body mass index (BMI), waist circumference and physical examination findings specific to PAD (absence of pedal pulses, arterial murmur, and trophic changes of the foot) were also recorded. For patients diagnosed with PAD, the recommended treatment strategy was also noted. The study protocol was approved by the Institutional Review Boards of all participating institutions, and all patients provided written informed consent.

Questionnaires administered The peripheral artery questionnaire (PAQ) The PAQ is a self-administered, 20-item, disease-specific health status measure for patients with PAD (18). Each question asks about symptoms attributable to PAD over the previous 4 weeks. Scores are available for six domains, including symptoms, symptom stability (recent change in symptoms), physical limitation, treatment satisfaction, social functioning and quality of life. A summary score is calculated as the average of the physical limitation, symptoms, quality of life and social functioning

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Questionnaire for peripheral artery disease

Table 1 Demographical and clinical characteristics of the patients with PAD-related symptoms according to the

presence of low-ankle brachial index (ABI < 0.9)

Age (years) Male, n (%) Education (years) Body mass index (kg/m2) Systolic blood pressure (mmHg) Diastolic blood pressure (mmHg) Total cholesterol (mg/dl) LDL(mg/dl) HDL (mg/dl) TG (mg/dl) Hs CRP (mg/L) FPG (mg/dl) Hb A1C (%) ABI Mean PWV(cm/s) Hypertension, n (%) Diabetes mellitus, n (%) Dyslipidaemia, n (%) Family history of CAD, n (%) Current smoking, n (%) Aspirin, n (%) Clopidogrel, n (%) ACEI/ARB, n (%) CCB, n (%) Cilostazol, n (%) Statin, n (%)

Low ABI (n = 246)

Normal ABI (n = 321)

65.9  13.0 144 (58.5%) 8.95  3.37 23.03  3.96 125.9  17.8 76.5  10.8 174.9  47.9 110.9  43.8 41.7  27.9 163.3  10.8 3.85  15.4 133.04  54.0 7.91  2.08 0.69  0.17 1764.4  481.3 190 (77.2%) 153 (62.1%) 153 (62.2%) 33 (13.4%) 89 (36.2%) 84 (34.2%) 25 (10.2%) 90 (36.6%) 54 (22.0%) 77 (31.3%) 103 (41.9%)

64.7  11.5 202 (62.9%) 9.03  3.37 23.03  3.51 124.1  16.2 76.7  10.5 165.1  47.0 103.9  47.4 48.4  13.0 143.9  78.2 0.96  2.65 117.1  36.4 7.21  2.08 1.07  0.10 1648.6  581.3 180 (56.1%) 154 (48.0%) 171 (53.3%) 34 (10.6%) 76 (23.7%) 121 (37.7%) 59 (18.4%) 40 (12.5%) 61 (19.0%) 35 (10.9%) 94 (29.3%)

p-value

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Peripheral artery questionnaire improves ankle brachial index screening in symptomatic patients with peripheral artery disease.

The peripheral artery questionnaire (PAQ) is a disease-specific health status measure of patients with peripheral artery disease (PAD). Whether the PA...
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