Validity of self-reported Peripheral Neuropathy (PN) as a surrogate marker for clinically-determined PN in HIV/AIDS patients initiating ART in Masaka, Uganda 2004-2008

Abstract

Background Globally, the prevalence of HIV/AIDS is about 37.9 million with Sub-Saharan Africa being the epicenter of the pandemic with 25.6 million people living with HIV/AIDS as of June 2019 (1). While opportunistic HIV-related infections have declined steadily in recent years, peripheral sensory neuropathies related to HIV and ART continue to be high and recurrent (2). Peripheral neuropathy (PN) is a neurological disorder regularly found in People Living with HIV (PLHIV), individuals with dysproteinemic disorders, and those on chemotherapy (3,4). Brief Peripheral Neuropathy Screen (BPNS), a screening tool used for symptom reporting and clinical assessment of PN, is not widely used in resource-limited settings due to cost constraints (3). For resource-limited settings, it would be beneficial to have a surrogate marker for determining PN in PLHIV. A surrogate marker is a physical measurement that can be used as a substitute or be considered a valid predictor of the true recognized outcome measure (clinical assessment) (5). For validation of a surrogate marker, Ross Prentice came up with two conditions; if both of these are satisfied then the surrogate can be considered to be valid (6). The Prentice criteria firstly indicate that a surrogate marker needs to be correlated with the true endpoint and secondly it should capture the entire effect of treatment upon the true endpoint (6).