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Reclassification of risk of death with the knowledge of D-dimer in a cohort of treated HIV-infected individuals.


ABSTRACT: To evaluate the change in categories of risk of death by adding D-dimer to conventional mortality risk factors.Cohort study.Data on HIV-infected participants receiving standard combination antiretroviral therapy in two clinical trials (Evaluation of Subcutaneous Proleukin in a Randomized International Trial and Strategic Management of antiretroviral therapy), who had baseline D-dimer measured, were randomly split into two equal training and a validation datasets. A multivariable survival model was built using the training dataset and included only conventional mortality risk factors measured at baseline. D-dimer was added to create the comparison model. The level of reclassification of mortality risk, for those with at least 5-years of follow-up, was then assessed by tabulating mortality risk defined as low (?2% predicted rate), moderate (2-5%) or high (>5%). Reclassification analyses were then repeated on the validation dataset.The analysis population at baseline had a mean age of 43 years, median CD4(+) cell count of 535 cells/?l (IQR: 420-712), and 83% had HIV RNA of at least 500 copies/ml. In the training dataset (n=1946, 8939 person-years), there were 83 deaths at a rate of 0.93 per 100 person-years. Addition of D-dimer to the reference model resulted in 6% or fewer (P>0.05) being correctly reassigned, either up or down, to a new risk category, in both, training and validation datasets. The integrated discrimination improvement in training and validation datasets was 0.60% (P=0.084) and 0.45% (P=0.168), respectively.In this relatively well population, at the given risk cutoffs, D-dimer appeared to only modestly improve the discernment of risk. Risk reclassification provides a method for assessing the clinical utility of biomarkers in HIV cohort studies.

SUBMITTER: Achhra AC 

PROVIDER: S-EPMC5516536 | biostudies-other | 2012 Aug

REPOSITORIES: biostudies-other

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Reclassification of risk of death with the knowledge of D-dimer in a cohort of treated HIV-infected individuals.

Achhra Amit C AC   Amin Janaki J   Sabin Caroline C   Chu Haitao H   Dunn David D   Kuller Lewis H LH   Kovacs Joseph A JA   Cooper David A DA   Emery Sean S   Law Matthew G MG  

AIDS (London, England) 20120801 13


<h4>Objective</h4>To evaluate the change in categories of risk of death by adding D-dimer to conventional mortality risk factors.<h4>Design</h4>Cohort study.<h4>Methods</h4>Data on HIV-infected participants receiving standard combination antiretroviral therapy in two clinical trials (Evaluation of Subcutaneous Proleukin in a Randomized International Trial and Strategic Management of antiretroviral therapy), who had baseline D-dimer measured, were randomly split into two equal training and a vali  ...[more]

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