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Prespecified Threshold (prespecified + threshold)

Distribution by Scientific Domains

Medical Sciences	50%

Selected Abstracts

Sample Size Determination for Categorical Responses

JOURNAL OF FORENSIC SCIENCES, Issue 1 2009
Dimitris Mavridis Ph.D.
Abstract:, Procedures are reviewed and recommendations made for the choice of the size of a sample to estimate the characteristics (sometimes known as parameters) of a population consisting of discrete items which may belong to one and only one of a number of categories with examples drawn from forensic science. Four sampling procedures are described for binary responses, where the number of possible categories is only two, e.g., licit or illicit pills. One is based on priors informed from historical data. The other three are sequential. The first of these is a sequential probability ratio test with a stopping rule derived by controlling the probabilities of type 1 and type 2 errors. The second is a sequential variation of a procedure based on the predictive distribution of the data yet to be inspected and the distribution of the data that have been inspected, with a stopping rule determined by a prespecified threshold on the probability of a wrong decision. The third is a two-sided sequential criterion which stops sampling when one of two competitive hypotheses has a probability of being accepted which is larger than another prespecified threshold. The fifth procedure extends the ideas developed for binary responses to multinomial responses where the number of possible categories (e.g., types of drug or types of glass) may be more than two. The procedure is sequential and recommends stopping when the joint probability interval or ellipsoid for the estimates of the proportions is less than a given threshold in size. For trinomial data this last procedure is illustrated with a ternary diagram with an ellipse formed around the sample proportions. There is a straightforward generalization of this approach to multinomial populations with more than three categories. A conclusion provides recommendations for sampling procedures in various contexts. [source]

Dynamics of Ventricular Repolarization in Patients with Dilated Cardiomyopathy Versus Healthy Subjects

ANNALS OF NONINVASIVE ELECTROCARDIOLOGY, Issue 2 2005
Jose Luis Alonso M.D.
Background: Patients with impaired left ventricular function have a high risk of developing ventricular arrhythmias and sudden death. Among different markers of risk, the prolongation and regional heterogeneity of repolarization are of increasing interest. However, there are limited data regarding feasibility of analyzing repolarization parameters and their dynamics in 24-hour Holter ECG recordings. Methods: Dynamic behavior of repolarization parameters was studied with a new automatic algorithm in digital 24-hour Holter recordings of 60 healthy subjects and 55 patients with idiopathic dilated cardiomyopathy (IDC). Repolarization parameters included the mean value of QT and QTc durations, QT dispersion, and peaks of QT duration and QT dispersion above prespecified thresholds. Results: In comparison to healthy subjects, patients with IDC had lower heart rate variability, longer mean QT and QTc durations, higher content of QTc peaks >500 ms, longer QT dispersion and its standard deviation, and a higher content of peaks >100 ms of QT dispersion (P < 0.01 for all comparisons). These repolarization parameters were significantly higher in IDC patients after adjustment for age, sex, and heart rate variability. The parameters of repolarization dynamics correlated with SDNN in healthy subjects but not in dilated cardiomyopathy patients. Conclusions: The automatic assessment of repolarization parameters in 24-hour digital ECG recordings is feasible and differentiates dilated cardiomyopathy patients from healthy subjects. Patients with dilated cardiomyopathy have increased QT duration, QT dispersion, and increased variability of QT dispersion reflecting variations in T-wave morphology, the factors which might predispose them to the development of arrhythmic events. [source]

Residual serum monoclonal protein predicts progression-free survival in patients with previously untreated multiple myeloma

CANCER, Issue 3 2010
Eric W. Schaefer MS
Abstract BACKGROUND: Currently used treatment response criteria in multiple myeloma (MM) are based in part on serum monoclonal protein (M-protein) measurements. A drawback of these criteria is that response is determined solely by the best level of M-protein reduction, without considering the serial trend. The authors hypothesized that metrics incorporating the serial trend of M-protein would be better predictors of progression-free survival (PFS). METHODS: Fifty-five patients with measurable disease at baseline (M-protein ,1 g/dL) who received ,4 cycles of treatment from 2 clinical trials in previously untreated MM were included. Three metrics based on the percentage of M-protein remaining relative to baseline (residual M-protein) were considered: metrics based on the number of times residual M-protein fell within prespecified thresholds, metrics based on area under the residual M-protein curve, and metrics based on the average residual M-protein reduction between Cycles 1 and 4. The predictive value of these metrics was assessed in Cox models using landmark analysis. RESULTS: The average residual M-protein reduction was found to be significantly predictive of PFS (P = .02; hazard ratio, 0.37), in which a patient with a 10% lower average residual M-protein reduction from Cycle 1 to 4 was estimated to be at least 2.7× more likely to develop disease progression or die early. None of the other metrics was predictive of PFS. The concordance index for the average residual M-protein reduction was 0.63, compared with 0.56 for best response. CONCLUSIONS: The average residual M-protein reduction metric is promising and needs further validation. This exploratory analysis is the first step in the search for treatment-based trend metrics predictive of outcomes in MM. Cancer 2010. © 2009 American Cancer Society. [source]