Search PubMed⌕ Search
Home/Archive/PubMed

PubMed · 8997545

A sequential procedure to test the progressive decrease of rare adverse events.

P Y Boëlle·P Garnerin·A J Valleron
View original source ↗Export metadata ↓

Abstract

A program to construct the Rapid Sequential Test (R-ST), a sequential procedure to test the decrease of the rate of rare adverse events, is described. This sequential procedure is constructed with the Sequential Probability Ratio method. It relies on a model for the progressive decrease in the rate of adverse events from a given initial rate to a target rate, during a transition period. The program allows one to calculate the bounds of rejection of the R-ST, and to study its power under various types of decrease. It is shown that the R-ST gives a conclusion faster than standard sequential procedures for the same type I and II error, saving at least one quarter of the trials completed during the transition period. The use of the software to construct R-STs is discussed with respect to the specification of the model.

Explore related subjects

Blood TransfusionComputer GraphicsHistocompatibilityHumansMathematicsMedical ErrorsMonte Carlo MethodProbabilitySoftwareTransfusion ReactionJournal Article

Keep this discovery

Explore connections, maps & timelines

BibTeXRIS

P Y Boëlle, P Garnerin, A J Valleron. 1996. A sequential procedure to test the progressive decrease of rare adverse events.. https://doi.org/10.1016/s0010-4825(96)00032-7

Cite the original work for its findings. Save a collection to share your selection of sources.

KEEP EXPLORING

Related citations

PubMed1999

Neutralization of HIV type 1 by alloimmune sera derived from polytransfused patients.

Antibodies (Abs) against HLA and other cell surface molecules, which HIV-1 acquires during the budding process at the host cell surface, neutralize HIV-1 in vitro. Macaques were protected against infection by SIV grown in human cells after xenoimmunization with human MHC molecules. Besides the immune responses arising against xenogeneic antigens, the highly polymorphic character of the HLA antigens enables the induction of alloresponses after exposure to allogeneic HLA molecules. Since polytransfused (PT) patients develop alloresponses, including humoral anti-HLA responses, we assumed that sera derived from PT patients may neutralize HIV-1. In a model system two PT sera out of a panel of 12 PT and 6 normal control sera neutralized HIV IIIB in vitro. Neutralizing activity of the PT sera was comparable to the efficacy of anti-HIV sera. The neutralizing capacity coincided with strong IgG reactivity against (HIV-infected) cell lines, which were used for virus production, and recognition of cell-free viral particles. Active human complement enhanced HIV neutralization mediated by the sera. Our results suggest an IgG-mediated neutralization based on recognition of allogeneic HLA molecules expressed on the viral surface. A vaccination strategy based on alloimmunization appears conceivable and requires further investigation.

Blood Transfusion↗