Abstract
HIV-associated sensory peripheral neuropathy (HIV-SN) afflicts approximately 50% of patients on antiretroviral therapy, and is associated with significant neuropathic pain. Simple accurate diagnostic instruments are required for clinical research and daily practice in both high- and low-resource setting. A 4-item clinical tool (CHANT: Clinical HIV-associated Neuropathy Tool) assessing symptoms (pain and numbness) and signs (ankle reflexes and vibration sense) was developed by selecting and combining the most accurate measurands from a deep phenotyping study of HIV positive people (Pain In Neuropathy Study–HIV-PINS). CHANT was alpha-tested in silico against the HIV-PINS dataset and then clinically validated and field-tested in HIV-positive cohorts in London, UK and Johannesburg, South Africa. The Utah Early Neuropathy Score (UENS) was used as the reference standard in both settings. In a second step, neuropathic pain in the presence of HIV-SN was assessed using the Douleur Neuropathique en 4 Questions (DN4)-interview and a body map. CHANT achieved high accuracy on alpha-testing with sensitivity and specificity of 82% and 90%, respectively. In 30 patients in London, CHANT diagnosed 43.3% (13/30) HIV-SN (66.7% with neuropathic pain); sensitivity = 100%, specificity = 85%, and likelihood ratio = 6.7 versus UENS, internal consistency = 0.88 (Cronbach alpha), average item-total correlation = 0.73 (Spearman’s Rho), and inter-tester concordance > 0.93 (Spearman’s Rho). In 50 patients in Johannesburg, CHANT diagnosed 66% (33/50) HIV-SN (78.8% neuropathic pain); sensitivity = 74.4%, specificity = 85.7%, and likelihood ratio = 5.29 versus UENS. A positive CHANT score markedly increased of pre- to post-test clinical certainty of HIV-SN from 43% to 83% in London, and from 66% to 92% in Johannesburg. In conclusion, a combination of four easily and quickly assessed clinical items can be used to accurately diagnose HIV-SN. DN4-interview used in the context of bilateral feet pain can be used to identify those with neuropathic pain.
Highlights
HIV-associated sensory peripheral neuropathy (HIV-SN) is a length-dependent distal symmetrical polyneuropathy that occurs in individuals with treated and untreated HIV infection
A second study investigator (ASCR) and physicians (HY, AJ, GJ) administered Clinical HIV-associated Neuropathy Tool (CHANT) to each participant to allow the assessment of inter-tester concordance
A prototype tool (CHANT— Clinical HIV-associated Neuropathy Tool; Fig 2A, S2 Panel) was created by combining and refining the clinical phenotypes that achieved the best compromise between sensitivity and specificity
Summary
HIV-associated sensory peripheral neuropathy (HIV-SN) is a length-dependent distal symmetrical polyneuropathy that occurs in individuals with treated and untreated HIV infection. Increasing age and greater height appear to be universal risk factors for the neuropathy[1], while modifiable risk factors include: advanced AIDS and lower CD4 count in untreated infection, and exposure to stavudine-based ART[2,3,4,5,6], and perhaps protease inhibitors[2,7,8] in individuals receiving antiretroviral treatment (ART). Studies from Africa report similar prevalence of HIV-SN, with 37% of treatment-naïve patients[13], and ~60% of treated patients having the neuropathy[13,14,15]. A study in South Africa reported over 70% of patients with HIV-SN had moderate-to-severe pain and paraesthesiae [14]. The pain from HIV-SN has a detrimental effect on quality of life[9,16,17,18,19,20,21] and adherence to ART[22]
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