Standards Needed to Determine Critical Value Ranges for Neonates

Using Directional Distance Functions to Determine Ranking Ranges in Cross-efficiency Evaluations

Estimation of reference ranges: how many subjects are needed?

We measured Na, K, Cl, glucose, hemoglobin, erythrocytes, and hematocrit in the serum or blood from approximately 800 male and 200 female second-year medical students in an effort to define the size of an acceptable reference population. Using the data from the men and Monte Carlo simulations of 10-400 samples, each carried out 5000 times, we found that for most of the above tests, approximatel...

Commentary: Reporting standards are needed for evaluations of risk reclassification.

New approaches have been developed in recent years to quantify the improvement in prediction performance gained by adding a novel marker to a set of baseline predictors of risk. The paper by Tzoulaki et al. concerns risk reclassification techniques and focuses specifically on the net reclassification improvement (NRI) index. Their review shows that use of risk reclassification analysis is extre...

How to Improve Safety Critical Systems Standards

Abstract: An effective standard for safety critical software systems is one that should help both developers and assessors of such systems. For developers it should be clear what is required in order to conform to the standard, while for assessors it should be possible to determine objectively compliance to the standard. The existing set of standards do not pass this basic quality test. We prov...

A Multilaboratory, Multicountry Study To Determine Bedaquiline MIC Quality Control Ranges for Phenotypic Drug Susceptibility Testing.

The aim of this study was to establish standardized drug susceptibility testing (DST) methodologies and reference MIC quality control (QC) ranges for bedaquiline, a diarylquinoline antimycobacterial, used in the treatment of adults with multidrug-resistant tuberculosis. Two tier-2 QC reproducibility studies of bedaquiline DST were conducted in eight laboratories using Clinical Laboratory and St...