Traditional, open-ended provider questions regarding patient symptoms are insensitive.
Better methods are needed to measure symptoms for clinical management, patient-oriented
research, and adverse drug-event reporting. Our objective was to develop and initially
validate a brief, self-reported HIV symptom index tailored to patients exposed to
multidrug antiretroviral therapies and protease inhibitors, and to compare the new
index to existing symptom measures. The research design was a multistage design including
quantitative review of existing literature, qualitative and quantitative analyses
of pilot data, and quantitative analyses of a prospective sample. Statistical analyses
include frequencies, chi-square tests for significance, linear and logistic regression.
The subjects were from a multisite convenience sample (n = 73) within the AIDS Clinical
Trials Group and a prospective sample from the Cleveland Veterans Affairs Medical
Center (n = 115). Measures were patient-reported symptoms and health-related quality
of life, physician-assessed disease severity, CD4 cell count, and HIV-1 RNA viral
quantification. A 20-item, self-completed HIV symptom index was developed based upon
prior reports of symptom frequency and bother and expert opinion. When compared with
prior measures the index included more frequent and bothersome symptoms, yet was easier
to use (self-report rather than provider interview). The index required less than
5 minutes to complete, achieved excellent completion rates, and was thought comprehensive
and comprehensible in a convenience sample. It was further tested in a prospective
sample of patients and demonstrated strong associations with physical and mental health
summary scores and with disease severity. These associations were independent of CD4
cell count and HIV-1 RNA viral quantification. This 20-item HIV symptom index has
demonstrated construct validity, and offers a simple and rational approach to measuring
HIV symptoms for clinical management, patient-oriented research, and adverse drug
reporting.