Implementing a centralised pharmacovigilance service in a non-commercial setting in the United Kingdom

The implementation of a pharmacovigilance service compliant with the legal and regulatory responsibilities of clinical trial sponsors presents particular challenges for sponsors in a non-commercial setting. In this paper we examine these challenges in detail. We identify and discuss the key steps in the development of a pharmacovigilance service within a public health service and university setting in the United Kingdom. We describe how we have established a central Pharmacovigilance Office with dedicated staff and resources within our organisation. This office is supported by an electronic pharmacovigilance reporting infrastructure developed to facilitate the receipt and processing of safety information, the onward reporting in compliance with legislation and the provision of sponsor institution oversight of clinical trial participant safety. An education and training programme has also been set up to ensure that all relevant staff in the organisation are fully aware of the pharmacovigilance service and are appropriately trained in its use. We discuss possible alternatives to this approach and why we consider our solution to be the most appropriate to ensure that a non-commercial sponsor organisation and investigators are operating in a fully compliant way

Surface disinfection challenges for Candida auris: an in-vitro study

The emerging pathogenic multidrug-resistant yeast Candida auris is an important source of healthcare-associated infections and of growing global clinical concern. The ability of this organism to survive on surfaces and withstand environmental stressors creates a challenge for eradicating it from hospitals. A panel of C. auris clinical isolates was evaluated on different surface environments against the standard disinfectant sodium hypochlorite and high-level disinfectant peracetic acid. C. auris was shown to selectively tolerate clinically relevant concentrations of sodium hypochlorite and peracetic acid in a surface-dependent manner, which may explain its ability to successfully persist within the hospital environment

Synthesis and characterization of nickel ferrite magnetic nanoparticles by co-precipitation method

Magnetic nickel ferrite (NiFe2O4) nanoparticles have been synthesized via co-precipitation method by varying the metal precursors ratio. Four different precursors ratio (Fe:Ni) are varied at 40:60, 50:50, 60:40 and 80:20. The size of the nanoparticles is found to increase with increasing iron (Fe) content. In addition, the morphology of the particles are observed to change from spherical to a shape similar to a nanooctahedral particle when the Fe content in the initial precursors ratio increases. The X-ray Diffraction (XRD) patterns have proved the presence of nickel ferrite nanoparticles. The magnetic properties characterized by Vibrating Sample Magnetometer (VSM) at room temperature proved that the assynthesized nickel ferrite nanoparticles are ferromagnetic and the saturation magnetization (Ms) increases with the content of Fe in the sample

General duality for abelian-group-valued statistical-mechanics models

We introduce a general class of statistical-mechanics models, taking values in an abelian group, which includes examples of both spin and gauge models, both ordered and disordered. The model is described by a set of ``variables'' and a set of ``interactions''. A Gibbs factor is associated to each variable and to each interaction. We introduce a duality transformation for systems in this class. The duality exchanges the abelian group with its dual, the Gibbs factors with their Fourier transforms, and the interactions with the variables. High (low) couplings in the interaction terms are mapped into low (high) couplings in the one-body terms. The idea is that our class of systems extends the one for which the classical procedure 'a la Kramers and Wannier holds, up to include randomness into the pattern of interaction. We introduce and study some physical examples: a random Gaussian Model, a random Potts-like model, and a random variant of discrete scalar QED. We shortly describe the consequence of duality for each example.Comment: 26 pages, 2 Postscript figure

Candida albicans biofilm heterogeneity does not influence denture stomatitis but strongly influences denture cleansing capacity

Approximately 20  % of the UK population wear some form of denture prosthesis, resulting in denture stomatitis in half of these individuals. Candida albicans is primarily attributed as the causative agent, due to its biofilm -forming ability. Recently, there has been increasing evidence of C. albicans biofilm heterogeneity and the negative impact it can have clinically; however, this phenomenon has yet to be studied in relation to denture isolates. The aims of this study were to evaluate C. albicans biofilm formation of clinical denture isolates in a denture environment and to assess antimicrobial activity of common denture cleansers against these tenacious communities. C. albicans isolated from dentures of healthy and diseased individuals was quantified using real-time PCR and biofilm biomass assessed using crystal violet. Biofilm development on the denture substratum poly(methyl methacrylate), Molloplast B and Ufi-gel was determined. Biofilm formation was assessed using metabolic and biomass stains, following treatment with denture hygiene products. Although C. albicans was detected in greater quantities in diseased individuals, it was not associated with increased biofilm biomass. Denture substrata were shown to influence biofilm biomass, with poly(methyl methacrylate) providing the most suitable environment for C. albicans to reside. Of all denture hygiene products tested, Milton had the most effective antimicrobial activity, reducing biofilm biomass and viability the greatest. Overall, our results highlight the complex nature of denture- related disease, and disease development cannot always be attributed to a sole cause. It is the distinct combination of various factors that ultimately determines the pathogenic outcome

Periodic and discrete Zak bases

Weyl's displacement operators for position and momentum commute if the product of the elementary displacements equals Planck's constant. Then, their common eigenstates constitute the Zak basis, each state specified by two phase parameters. Upon enforcing a periodic dependence on the phases, one gets a one-to-one mapping of the Hilbert space on the line onto the Hilbert space on the torus. The Fourier coefficients of the periodic Zak bases make up the discrete Zak bases. The two bases are mutually unbiased. We study these bases in detail, including a brief discussion of their relation to Aharonov's modular operators, and mention how they can be used to associate with the single degree of freedom of the line a pair of genuine qubits.Comment: 15 pages, 3 figures; displayed abstract is shortened, see the paper for the complete abstrac

Are routinely collected NHS administrative records suitable for endpoint identification in clinical trials? Evidence from the West of Scotland coronary prevention study

Background: Routinely collected electronic patient records are already widely used in epidemiological research. In this work we investigated the potential for using them to identify endpoints in clinical trials.<p></p> Methods: The events recorded in the West of Scotland Coronary Prevention Study (WOSCOPS), a large clinical trial of pravastatin in middle-aged hypercholesterolaemic men in the 1990s, were compared with those in the record-linked deaths and hospitalisations records routinely collected in Scotland.<p></p> Results: We matched 99% of fatal study events by date. We showed excellent matching (97%) of the causes of fatal endpoint events and good matching (.80% for first events) of the causes of nonfatal endpoint events with a slightly lower rate of mismatching of record linkage than study events (19% of first study myocardial infarctions (MI) and 4% of first record linkage MIs not matched as MI). We also investigated the matching of non-endpoint events and showed a good level of matching, with .78% of first stroke/TIA events being matched as stroke/TIA. The primary reasons for mismatches were record linkage data recording readmissions for procedures or previous events, differences between the diagnoses in the routinely collected data and the conclusions of the clinical trial expert adjudication committee, events occurring outside Scotland and therefore being missed by record linkage data, miscoding of cardiac events in hospitalisations data as ‘unspecified chest pain’, some general miscoding in the record linkage data and some record linkage errors.<p></p> Conclusions: We conclude that routinely collected data could be used for recording cardiovascular endpoints in clinical trials and would give very similar results to rigorously collected clinical trial data, in countries with unified health systems such as Scotland. The endpoint types would need to be carefully thought through and an expert endpoint adjudication committee should be involved.<p></p&gt