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

Well structured program equivalence is highly undecidable

We show that strict deterministic propositional dynamic logic with intersection is highly undecidable, solving a problem in the Stanford Encyclopedia of Philosophy. In fact we show something quite a bit stronger. We introduce the construction of program equivalence, which returns the value $\mathsf{T}$ precisely when two given programs are equivalent on halting computations. We show that virtually any variant of propositional dynamic logic has $\Pi_1^1$-hard validity problem if it can express even just the equivalence of well-structured programs with the empty program \texttt{skip}. We also show, in these cases, that the set of propositional statements valid over finite models is not recursively enumerable, so there is not even an axiomatisation for finitely valid propositions.Comment: 8 page

Towards developing an industry led educational framework using LEAN approach

The poor performance and inefficient manner in which the construction industry operates has been recognised through a variety of combined government and industry initiatives over the years. A major challenge towards improvement is recognised as lying with education and industry stakeholders actively creating closer and more effective relationships to facilitate a greater mutual understanding. The application of Information Technology (IT) systems can well enhance ‘Lean’ initiatives through improving process flow, reduction of the non-added value activities, better meet customers’ requirements and adding value which will increase the performance of the industry. This paper presents a project that is focused on developing an industry led framework for educational training programmes. The outcomes of two workshops organised with the industry that have resulted in a Continued Professional Development (CPD) training framework comprising of three distinct levels in terms of strategic, operational and technology aspects of that particular key area are discussed. The essence of this work is based on adopting the ‘Lean’ approach and adding value by identifying the IT skills gaps recognised ‘by the industry’ ‘for the industry’ and addressing them in developing training programmes

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

EAGLEView: A surface and grid generation program and its data management

An old and proven grid generation code, the EAGLE grid generation package, is given an added dimension of a graphical interface and a real time data base manager. The Numerical Aerodynamic Simulation (NAS) Panel Library is used for the graphical user interface. Through the panels, EAGLEView constructs the EAGLE script command and sends it to EAGLE to be processed. After the object is created, the script is saved in a mini-buffer which can be edited and/or saved and reinterpreted. The graphical objects are set-up in a linked-list and can be selected or queried by pointing and clicking the mouse. The added graphical enhancement to the EAGLE system emphasizes the unique capability to construct field points around complex geometry and visualize the construction every step of the way