Systems validation: application to statistical programs

BACKGROUND: In 2003, the United States Food and Drug Administration (FDA) released a guidance document on the scope of "Part 11" enforcement. In this guidance document, the FDA indicates an expectation of a risk-based approach to determining which systems should undergo validation. Since statistical programs manage and manipulate raw data, their implementation should be critically reviewed to determine whether or not they should undergo validation. However, the concepts of validation are not often discussed in biostatistics curriculum. DISCUSSION: This paper summarizes a "Plan, Do, Say" approach to validation that can be incorporated into statistical training so that biostatisticians can understand and implement validation principles in their research. SUMMARY: Validation is a process that requires dedicated attention. The process of validation can be easily understood in the context of the scientific method

Escherichia coli O157:H7 in Malta for the first time

The emergence of E coli O157:H7 in Malta is a sign of the times. It represents one of the newly emerging infections associated with food. The first two documented cases of E coli 0157:H7 infection in Malta occurred in July and August, 1996. Food types classically incriminated were surveyed by the Department of Public Health. Epidemiological investigation aimed to trace the environmental sources of infection.• Microbiology was performed jointly by diagnostic and public health laboratories. Facts about infection and control of the disease are highlighted with a view to alerting local practitioners to the condition.peer-reviewe

Multifactorial analysis of human blood cell responses to clinical total body irradiation

Multiple regression analysis techniques are used to study the effects of therapeutic radiation exposure, number of fractions, and time on such quantal responses as tumor control and skin injury. The potential of these methods for the analysis of human blood cell responses is demonstrated and estimates are given of the effects of total amount of exposure and time of protraction in determining the minimum white blood cell concentration observed after exposure of patients from four disease groups

Dosimetry for radiobiological studies of the human hematopoietic system

A system for estimating individual bone marrow doses in therapeutic radiation exposures of leukemia patients was studied. These measurements are used to make dose response correlations and to study the effect of dose protraction on peripheral blood cell levels. Three irradiators designed to produce a uniform field of high energy gamma radiation for total body exposures of large animals and man are also used for radiobiological studies

Rehabilitation interventions for foot drop in neuromuscular disease

"Foot drop" or "Floppy foot drop" is the term commonly used to describe weakness or contracture of the muscles around the ankle joint. It may arise from many neuromuscular diseases

Symmetry Analysis of Multiferroic Co_3TeO_6

A phenomenological explanation of the magnetoelectric behavior of Co_3TeO_6 is developed. We explain the second harmonic generation data and the magnetic field induced spontaneous polarization in the magnetically ordered phase below 20K.Comment: Phys rev B Rapids, to appea

Experiment definition phase shuttle laboratory (LDRL-10.6 experiment): Shuttle sortie to elliptical orbit satellite

The following topics were reviewed: (1) design options for shuttle terminal, (2) elliptical orbit satellite design options, (3) shuttle terminal details, (4) technology status and development requirements, (5) transmitter technology, and (6) carbon dioxide laser life studies

Successful retrieval of competing spatial environments in humans involves hippocampal pattern separation mechanisms.

The rodent hippocampus represents different spatial environments distinctly via changes in the pattern of "place cell" firing. It remains unclear, though, how spatial remapping in rodents relates more generally to human memory. Here participants retrieved four virtual reality environments with repeating or novel landmarks and configurations during high-resolution functional magnetic resonance imaging (fMRI). Both neural decoding performance and neural pattern similarity measures revealed environment-specific hippocampal neural codes. Conversely, an interfering spatial environment did not elicit neural codes specific to that environment, with neural activity patterns instead resembling those of competing environments, an effect linked to lower retrieval performance. We find that orthogonalized neural patterns accompany successful disambiguation of spatial environments while erroneous reinstatement of competing patterns characterized interference errors. These results provide the first evidence for environment-specific neural codes in the human hippocampus, suggesting that pattern separation/completion mechanisms play an important role in how we successfully retrieve memories