Background: In nonexperimental comparative effectiveness research using health care databases, outcome measurements must be validated to evaluate and potentially adjust for misclassification bias. We aimed to validate claims-based myocardial infarction (MI) algorithms in a Medicaid population using an HIV clinical cohort as the gold standard.
Methods: Medicaid administrative data were obtained for the years 2002-2008 and linked to the UNC CFAR HIV Clinical Cohort based on social security number, first name, and last name and MI were adjudicated. Sensitivity, specificity, positive predictive value, and negative predictive value were calculated.
Results: There were 1063 individuals included in the study. Over a median observed time of 2.5 years, 17 had an MI. Specificity ranged from 0.979 to 0.993 with the highest specificity obtained using the ICD-9 code 410.xx in the primary or secondary position and a length of stay >3 days. Sensitivity of MI ascertainment varied from 0.588 to 0.824 depending on algorithm.
Conclusions: Specificities of varying claims-based MI ascertainment criteria are high but small changes impact positive predictive value in a cohort with low incidence. Sensitivities vary based on ascertainment criteria. Type of algorithm used should be prioritized based on study question and maximization of specific validation parameters that will minimize bias while also considering precision.
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http://dx.doi.org/10.1097/MLR.0b013e318287d6fd | DOI Listing |
Mol Ther
January 2025
Department of Biological Engineering, Massachusetts Institute of Technology; Cambridge, MA, USA, 02139; Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology; Cambridge, MA, USA, 02139; Department of Chemical Engineering, Massachusetts Institute of Technology; Cambridge, MA, USA, 02139; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University; Cambridge, MA, USA, 02139; Howard Hughes Medical Institute; Chevy Chase, MD, USA, 20815; Department of Materials Science of Engineering; Massachusetts Institute of Technology; Cambridge, MA, USA, 02139. Electronic address:
mRNA delivered using lipid nanoparticles (LNPs) has become an important subunit vaccine modality, but mechanisms of action for mRNA vaccines remain incompletely understood. Here, we synthesized a metal chelator-lipid conjugate enabling positron emission tomography (PET) tracer labeling of LNP/mRNA vaccines for quantitative visualization of vaccine trafficking in live mice and non-human primates (NHPs). Following i.
View Article and Find Full Text PDFBMC Public Health
January 2025
MAP Centre for Urban Health Solutions, Unity Health Toronto, Toronto, ON, Canada.
Background: Blood and oral fluid-based HIV self-tests are important for reaching the undiagnosed living with HIV. The study objectives were to evaluate the oral fluid-based OraQuick® HIV Self-Test (HIV-ST) performance in comparison to laboratory reference testing; determine if laypersons can correctly perform the HIV-ST; document if intended users can successfully interpret pre-made contrived positive, negative, and invalid results; and document if intended users can understand the key messages in the product labeling.
Methods: This prospective study enrolled consenting adult intended users of HIV self-testing from six community health centres in four Canadian provinces between June 2022 and January 2024.
J Infect Chemother
January 2025
Department of Respiratory Medicine, Hamamatsu Medical Center, Hamamatsu, Japan.
We describe a rare case of spontaneous remission of Pneumocystis jirovecii pneumonia (PCP) in a 42-year-old patient with human immunodeficiency virus (HIV) infection, followed by severe pulmonary nocardiosis. To our knowledge, this is the first report of spontaneous remission of PCP in a completely untreated patient with HIV infection. The patient, a bisexual Japanese man, presented with fever and anorexia and had a history of non-compliance with antiretroviral therapy (ART) for 13 years.
View Article and Find Full Text PDFJ Hepatol
January 2025
Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy; CRC "A. M. and A. Migliavacca" Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy; D-SOLVE consortium, an EU Horizon Europe funded project (No 101057917). Electronic address:
Background And Aims: Bulevirtide (BLV) 2 mg/day is EMA approved for treatment of compensated chronic hepatitis due to Delta virus (HDV) infection, however real-life data in large cohorts of patients with cirrhosis are lacking.
Methods: Consecutive HDV-infected patients with cirrhosis starting BLV 2 mg/day since September 2019 were included in a European retrospective multicenter real-life study (SAVE-D). Patient characteristics before and during BLV treatment were collected.
Lancet Microbe
December 2024
Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital, LMU Munich, Germany; German Center for Infection Research, Munich Partner Site, Munich, Germany; Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology, Infection, and Pandemic Research, Munich, Germany; Unit Global Health, Helmholtz Zentrum München, German Research Center for Environmental Health, Neuherberg, Germany. Electronic address:
Background: The broad use of bedaquiline and pretomanid as the mainstay of new regimens to combat tuberculosis is a risk due to increasing bedaquiline resistance. We aimed to assess the safety, bactericidal activity, and pharmacokinetics of BTZ-043, a first-in-class DprE1 inhibitor with strong bactericidal activity in murine models.
Methods: This open-label, dose-expansion, randomised, controlled, phase 1b/2a trial was conducted in two specialised tuberculosis sites in Cape Town, South Africa.
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