Screening rules for determining blood pressure status in clinical trials : application to the trials of hypertension prevention.
Multistage blood pressure screening rules are often used to select subjects for clinical trials.
Multiple blood pressure readings are taken over successive visits, and the subject must meet eligibility criteria at each visit.
In this paper, the authors present methods which depend on the distribution of the subject's underlying blood pressure values (the predictive value approach) or, alternatively, the subject's observed mean over all screening visits (the empirical predictive value approach) given the observed mean after one or more visits.
The authors apply these methods to data from Phase I of the Trials of Hypertension Prevention, which attempts to identify subjects with mean diastolic blood pressures in the range 80-89 mmHg over three screening visits.
Mots-clés Pascal : Pression sanguine, Essai clinique phase I, Modèle mathématique, Hémodynamique, Sélection, Homme, Prédiction, Hypertension artérielle, Appareil circulatoire pathologie, Méthodologie
Mots-clés Pascal anglais : Blood pressure, Phase I trial, Mathematical model, Hemodynamics, Selection, Human, Prediction, Hypertension, Cardiovascular disease, Methodology
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Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 93-0588246
Code Inist : 002B30A08. Création : 199406.