Comparative incidence of adverse drug reaction during the first and subsequent year of antiretroviral therapy in a Nigerian HIV infected Cohort.

BACKGROUND: Despite close to two decades of antiretroviral therapy (ART) in Nigeria, data on late on-onset ART-associated adverse drug reactions (ADRs) are sparse. OBJECTIVES: To describe early and late-onset ADRs and compare their incidence in an outpatient HIV positive Cohort on ART. METHOD: We described the incidence of clinical ADRs identified and documented in an outpatient clinic cohort of HIV-positive patients treated between June 2004 and December 2015 at a tertiary health facility in Nigeria. Incidence rates of ADRs during the first and subsequent years of ART were compared. RESULTS: of the 13,983 patients' data analyzed, 9317 were females (66%), and those in the age bracket of 25 to 45 years made up 78% of the studied population. During 52,411 person-years (py) of ART, 1485 incident ADRs were recorded; Incidence rate (IR) 28.3 (95% confidence interval [CI] 26.9:29.8) ADRs per 1000 person-years (py) of ART. The IR of ADRs was about two times higher in the first year of ART compared to subsequent years of treatment; crude incidence rate ratio (IRR) 1.77 (95% CI 1.59:1.97). Anemia, hypersensitivity reactions, and nervous system disorders had 7, 23, and 5 times higher incidence, respectively, in the first year of therapy, compared to subsequent years. CONCLUSION: The first year of ART is the period of highest risk of ADRs. Individual and programmatic treatment success in resource-limited settings requires strategies for early identification and management of ADR during the period of greatest risk of ADRs.

Evaluation of Psychometric Quality of EQ-5D-5L Scale for Assessing Health-Related Quality of Life of Malaria Patients.

OBJECTIVES: To evaluate the validity and reliability of the 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L) through classical test theory and the Rasch measurement model. METHODS: Three hundred patients treated for uncomplicated malaria in selected primary healthcare facilities of Plateau state, Nigeria, completed the EQ-5D-5L scale. Classical test theory was used to establish validity and Cronbach's alpha reliability of the scale. Rasch analysis was used to confirm the unidimensionality, item fitness, item and person separations and reliabilities, and targeting of item difficulty to patient ability levels and presentation on Wright map (item-person map). RESULTS: The outcome of classical test theory revealed unidimensional scale with average variance extracted values > 0.5, and the square root of the average variance extracted for construct was greater than the correlation coefficients, indicating convergent and discriminant validities of the scale whose Cronbach's alpha coefficient (α) was 0.87. Rasch analysis indicated variance explained values of 88.3% and the eigenvalues of the first contrast was 1.3, further confirming the unidimensionality of the scale, whose fit index values were within accepted ranges. The high item and person separation and reliability values indicated the instrument's strength in detecting and evenly spreading items and persons on the Wright map based on item difficulty and the respondents' ability levels, respectively. CONCLUSION: The EQ-5D-5L scale performed well in uncomplicated malaria, hence, it is recommended for use in the assessment of health-related quality of life in this patient population.