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Nucleic acid amplification testing using dried blood spots to confirm the diagnosis of HIV-1 in adults.
J Clin Virol
December 2024
Department of Medicine, Division of Infectious Diseases and Geographic Medicine, Stanford University School of Medicine, Stanford, CA, USA.
Background: The WHO HIV testing algorithm for high prevalence populations recommends the use of three different serologic assays, though this approach may lead to diagnostic misclassification. The study objective was to compare dried blood spot (DBS)-based HIV-1 nucleic acid detection methods to determine their suitability to confirm the diagnosis of HIV-1 in adults generally with suppressed or low-level plasma HIV-1 RNA.
Methods: Four methods were evaluated: Cepheid Xpert HIV-1 Qual Assay (Xpert), Hologic Aptima HIV-1 Quant Dx assay (Aptima), Roche Cobas Ampliprep/Cobas TaqMan HIV-1 test, v.
Bridged Treatment Comparisons: an Illustrative Application in HIV Treatment.
Am J Epidemiol
August 2024
Department of Biostatistics, UNC Gillings School of Global Public Health, Chapel Hill, NC.
Comparisons of treatments, interventions, or exposures are of central interest in epidemiology, but direct comparisons are not always possible due to practical or ethical reasons. Here, we detail a fusion approach to compare treatments across studies. The motivating example entails comparing the risk of the composite outcome of death, AIDS, or greater than a 50% CD4 cell count decline in people with HIV when assigned triple versus mono antiretroviral therapy, using data from the AIDS Clinical Trial Group (ACTG) 175 (mono versus dual therapy) and ACTG 320 (dual versus triple therapy).
View Article and Find Full Text PDFTransporting survival of an HIV clinical trial to the external target populations.
J Biopharm Stat
October 2024
Department of Statistics, North Carolina State University, Raleigh, North Carolina, USA.
Article Synopsis
- The treatment effects from the ACTG 175 HIV trial can't be directly applied to diverse target populations, like early-stage HIV patients in the US, Thailand, and southern Ethiopia, due to significant differences in patient characteristics.
- The paper reviews several transport methods for translating treatment effects, particularly focusing on survival outcomes, including outcome regression using Cox proportional hazard models, inverse probability weighting, and a doubly robust approach (augmented calibration weighting).
- Since the Cox model's assumption was incorrect for the ACTG 175 trial, the study introduces a new method using a linear spline-based hazard regression model to improve accuracy in transporting survival outcomes to external populations.
Adaptive selection of the optimal strategy to improve precision and power in randomized trials.
Biometrics
January 2024
Manning College of Information and Computer Sciences, University of Massachusetts Amherst, Amherst, MA 01003, United States.
Benkeser et al. demonstrate how adjustment for baseline covariates in randomized trials can meaningfully improve precision for a variety of outcome types. Their findings build on a long history, starting in 1932 with R.
View Article and Find Full Text PDFAnalysis of the Cox Model with Longitudinal Covariates with Measurement Errors and Partly Interval Censored Failure Times, with Application to an AIDS Clinical Trial.
Stat Biosci
May 2023
Vaccine and Infectious Disease and Public Health Sciences Divisions, Fred Hutchinson Cancer Center, Seattle, WA USA.
Unlabelled: Time-dependent covariates are often measured intermittently and with measurement errors. Motivated by the AIDS Clinical Trials Group (ACTG) 175 trial, this paper develops statistical inferences for the Cox model for partly interval censored failure times and longitudinal covariates with measurement errors. The conditional score methods developed for the Cox model with measurement errors and right censored data are no longer applicable to interval censored data.
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