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Session 33
Oral Abstract Presentations Clinical Trials in Resource-Limited Settings Session Day and Time: Thursday 4 - 6:15 pm Presentation Time: 4:00 Room: Ballroom C |
Background: Obtaining CD4+ cell counts are expensive
and not practical for routine monitoring in many resource-limited settings. Total
lymphocyte count (TLC) has been used as a surrogate CD4 marker but with varying
sensitivities and specificities.
Methods: Patients were drawn from an ongoing, observational
database cohort study at the UAB HIV clinic. Patients were included if they had
CD4+ cell count and Complete Blood Count (CBC) (TLC, hemoglobin, and
platelet count) drawn on the same day. Only one randomly selected set of
laboratory data was used per patient. The remaining data were used to validate
the models generated. Models predicting CD4+ cell count £ 200/μL were developed by 1) decision tree
analysis, and 2 )multivariable logistic regression analysis. The variables
included in the analyses were TLC, hemoglobin, platelet count, gender, and any
antiretroviral therapy (ART) in the previous 30 days (yes/no).
Results: We studied 1,189 patients (pts). Median age was 38 yrs,
55% were Caucasian, 77% male, median CD4+ cell count was 333/μL,
65% were on ART. Overall sensitivity, specificity, and positive predictive
value (PPV) of the decision tree to predict CD4+ cell count £ 200/μL were 89%, 77%, and 89%, respectively. Gender
and ART were not significant in the decision tree analysis. Multivariable
logistic regression analysis achieved similar results. The final multivariable
model for predicting CD4+ cell count £ 200/μL included TLC, hemoglobin, platelet
count, gender, gender*hemoglobin, and gender*platelet count, with sensitivity =
91%, specificity = 73%, and PPV = 88%.
Conclusion: Using inexpensive laboratory values of the CBC, the
decision tree analysis provides an effective model that is much simpler to use
than a logistic regression equation to predict whether the CD4+ cell count is £ or > 200/μL. This decision tree has
immediate relevance and applicability to resource-limited settings.
