Nurse-led trials of medical devices: General principles and good practice

Aim To provide an overview of key governance matters relating to medical device trials and practical advice for nurses wishing to initiate or lead them. Background Medical device trials, which are formal research studies that examine the benefits and risks of therapeutic, non-drug treatment medical devices, have traditionally been the purview of physicians and scientists. The role of nurses in medical device trials historically has been as data collectors or co-ordinators rather than as principal investigators. Nurses more recently play an increasing role in initiating and leading medical device trials. Review Methods A review article of nurse-led trials of medical devices. Discussion Central to the quality and safety of all clinical trials is adherence to the International Conference on Harmonization Guidelines for Good Clinical Practice, which is the internationally-agreed standard for the ethically- and scientifically-sound design, conduct and monitoring of a medical device trial, as well as the analysis, reporting and verification of the data derived from that trial. Key considerations include the class of the medical device, type of medical device trial, regulatory status of the device, implementation of standard operating procedures, obligations of the trial sponsor, indemnity of relevant parties, scrutiny of the trial conduct, trial registration, and reporting and publication of the results. Conclusion Nurse-led trials of medical devices are demanding but rewarding research enterprises. As nursing practice and research increasingly embrace technical interventions, it is vital that nurse researchers contemplating such trials understand and implement the principles of Good Clinical Practice to protect both study participants and the research team.

Transition Pedagogy Handbook : A Good Practice Guide for Policy and Practice in the First Year Experience at QUT

This Handbook has been specifically designed for academic and professional staff responsible for managing first year students and curriculum and co-curricular programs at QUT. As well as presenting examples of good practice, the handbook provides a brief overview of QUT’s First Year Experience Program, a summary of QUT’s First Year Experience and Retention Policy and the Transition Pedagogy that frames both curricular and co-curricular activities. We hope you find this resource both useful and informative.

Structural, mechanical and biocompatibility studies of hydroxyapatite-derived composites toughened by zirconia addition

Hydroxyapatite(OHAp)-based ceramic composites with added ZrO2 have been prepared both by sintering at 1400 °C and by hot isostatic pressing (HIP) at 1450 °C and 140 MPa pressure (argon atmosphere). The development of the crystalline phases and the microstructure of the composites have been examined using X-ray diffraction, electron microscopy, infrared and magic-angle spinning nuclear magnetic resonance (MASNMR) spectroscopic techniques. The fracture toughness and biocompatibility of the composites have also been studied. The effect of the addition of CeO2- and Y2O3-stabilized ZrO2 and of simple monoclinic ZrO2 to the initial physical mixture, on the structure and properties of the resulting composites has been investigated. In most of the sintered or HIP samples, the OHAp decomposes into tricalcium phosphate (β-TCP). CaO, which forms as a product of decomposition, dissolves completely in ZrO2 and stabilizes the latter in its cubic/tetragonal phase. Presence of the β-TCP phase in the product seems to be the result of a structural synergistic effect of hexagonal OHAp. Two structurally distinct orthophosphate groups have been identified in the composites by MASNMR of 31P and attributed to decomposition products of OHAp at higher temperatures. The composites possess high KIC values (2–3 times higher than that of pure OHAp). Decomposition of hydroxyapatite gives rise to differences in microstructure between HIP and simply sintered composites although fracture toughness values are similar in magnitude indicating the presence of several toughening mechanisms. The in vitro SP2-O cell test suggests that these composites possess good biocompatibility. The combination of good biocompatibility, desirable microstructure and easy availability of initial reactants indicates that the simply sintered composite of OHAp and monoclinic ZrO2(ZAP-30) appears to be the most suitable for prosthetic applications.

Microwave-assisted selective deoxygenation of layer- and chain-containing oxides

Very rapid (within 5 min), selective, single-step deoxygenation of layer- and chain-containing oxides, MoO3, CrO3, V2O5, alpha-VOPO4 . 2H(2)O and Ag6Mo10O33 has been accomplished using graphitic carbon in a microwave-assisted reaction. The products were found to be MoO2, Cr2O3, VO2, VPO4 and a mixture of (Ag + MoO2), respectively. Products were characterised by X-ray diffraction (XRD), differential scanning calorimetry (DSC), IR and electron paramagnetic resonance (EPR) spectroscopies. Although conventional methods of preparing these materials are tedious, the present method is simple, fast and yields very homogeneous products of good crystallinity. Our results reveal that while layer- and chain-containing oxides undergo rapid microwave-assisted carbothermal reduction, the non-layered materials do not. The high structural selectivity of these reactions is suggestive of the topochemical nature of the fast reduction process.

Ecological condition of coastal ocean and estuarine waters of the U.S. South Atlantic Bight: 2000-2004

In March-April 2004, the National Oceanic and Atmospheric Administration (NOAA), U.S. Environmental Protection Agency (EPA), and State of Florida (FL) conducted a study to assess the status of ecological condition and stressor impacts throughout the South Atlantic Bight (SAB) portion of the U.S. continental shelf and to provide this information as a baseline for evaluating future changes due to natural or human-induced disturbances. The boundaries of the study region extended from Cape Hatteras, North Carolina to West Palm Beach, Florida and from navigable depths along the shoreline seaward to the shelf break (~100m). The study incorporated standard methods and indicators applied in previous national coastal monitoring programs — Environmental Monitoring and Assessment Program (EMAP) and National Coastal Assessment (NCA) — including multiple measures of water quality, sediment quality, and biological condition. Synoptic sampling of the various indicators provided an integrative weight-of-evidence approach to assessing condition at each station and a basis for examining potential associations between presence of stressors and biological responses. A probabilistic sampling design, which included 50 stations distributed randomly throughout the region, was used to provide a basis for estimating the spatial extent of condition relative to the various measured indicators and corresponding assessment endpoints (where available). Conditions of these offshore waters are compared to those of southeastern estuaries, based on data from similar EMAP/NCA surveys conducted in 2000-2004 by EPA, NOAA, and partnering southeastern states (Florida, Georgia, South Carolina, North Carolina, Virginia) (NCA database for estuaries, EPA Gulf Ecology Division, Gulf Breeze FL). Data from a total of 747 estuarine stations are included in this database. As for the offshore sites, the estuarine samples were collected using standard methods and indicators applied in previous coastal EMAP/NCA surveys including the probabilistic sampling design and multiple indicators of water quality, sediment quality, and biological condition (benthos and fish). The majority of the SAB had high levels of DO in near-bottom water (> 5 mg L-1) indicative of "good" water quality. DO levels in bottom waters exceeded this upper threshold at all sites throughout the coastal-ocean survey area and in 76% of estuarine waters. Twenty-one percent of estuarine bottom waters had moderate levels of DO between 2 and 5 mg L-1 and 3% had DO levels below 2 mg L-1. The majority of sites with DO in the low range considered to be hypoxic (< 2 mg L-1) occurred in North Carolina estuaries. There also was a notable concentration of stations with moderate DO levels (2 – 5 mg L-1) in Georgia and South Carolina estuaries. Approximately 58% of the estuarine area had moderate levels of chlorophyll a (5-10 μg L-1) and about 8% of the area had higher levels, in excess of 10 μg L-1, indicative of eutrophication. The elevated chlorophyll a levels appeared to be widespread throughout the estuaries of the region. In contrast, offshore waters throughout the region had relatively low levels of chlorophyll a with 100% of the offshore survey area having values < 5 μg L-1.

Ecological Condition of Coastal Ocean Waters within Stellwagen Bank National Marine Sanctuary: 2008

In June 2008, the NOAA National Ocean Service (NOS), in conjunction with the EPA National Health and Environmental Effects Laboratory (NHEERL), conducted an assessment of the status of ecological condition of soft-bottom habitat and overlying waters within the boundaries of Stellwagen Bank National Marine Sanctuary (SBNMS). The sanctuary lies approximately 20 nautical miles east of Boston, MA in the southwest Gulf of Maine between Cape Ann and Cape Cod and encompassing 638 square nautical miles (2,181 km2). A total of 30 stations were targeted for sampling using standard methods and indicators applied in prior NOAA coastal studies and EPA’s Environmental Monitoring and Assessment Program (EMAP) and National Coastal Assessment (NCA). A key feature adopted from these studies was the incorporation of a random probabilistic sampling design. Such a design provides a basis for making unbiased statistical estimates of the spatial extent of ecological condition relative to various measured indicators and corresponding thresholds of concern. Indicators included multiple measures of water quality, sediment quality, and biological condition (benthic fauna, fish tissue contaminant levels). Depths ranged from 31 – 137 m throughout the study area. About 76 % of the area had sediments composed of sands (< 20 % silt-clay), 17 % of the area was composed of intermediate muddy sands (20 – 80 % silt-clay), and 7 % of the sampled area consisted of mud (> 80 % siltclay). About 70 % of the area (represented by 21 sites) had sediment total organic carbon (TOC) concentrations < 5 mg/g and all but one site (located in Stellwagen Basin) had levels of TOC < 20 mg/g, which is well below the range potentially harmful to benthic fauna (> 50 mg/g). Surface salinities ranged from 30.6 – 31.5 psu, with the majority of the study region (approximately 80 % of the area) having surface salinities between 30.8 and 31.4 psu. Bottom salinities varied between 32.1 and 32.5 psu, with bottom salinities at all sites having values above the range of surface salinities. Surface-water temperatures varied between 12.1 and 16.8 ºC, while near-bottom waters ranged in temperature from 4.4 – 6.2 ºC. An index of density stratification (Δσt) indicated that the waters of SBNMS were stratified at the time of sampling. Values of Δσt at 29 of the 30 sites sampled in this study (96.7 % of the study area) varied from 2.1 – 3.2, which is within the range considered to be indicative of strong vertical stratification (Δσt > 2) and typical of the western Gulf of Maine in summer. Levels of dissolved oxygen (DO) were confined to a fairly narrow range in surface (8.8 – 10.4 mg/L) and bottom (8.5 – 9.6 mg/L) waters throughout the survey area. These levels are within the range considered indicative of good water quality (> 5 mg/L) with respect to DO. None of these waters had DO at low levels (< 2 mg/L) potentially harmful to benthic fauna and fish.

Synthesis, electrochemistry, fluorescence and ECL of Ru (phen)(2) (dcbpy) (PF6)(2)

A new ECL-active species, Ru (phen)(2) (dcbpy) (PF6)(2), has been designed and synthesized. Its structure was confirmed by means of IR, ESI-MS and 2D NMR. Also, its properties of electrochemistry, fluorescence and ECL are reported, which have suggested a good hope of being used in electrochemiluminescent immunoassay and nucleic acid hybridization.

Rotation periods of exoplanet host stars

The stellar rotation periods of 10 exoplanet host stars have been determined using newly analysed CaII H&K flux records from the Mount Wilson Observatory and Strömgren b, y photometric measurements from Tennessee State University's automatic photometric telescopes at the Fairborn Observatory. Five of the rotation periods have not previously been reported, with that of HD 130322 very strongly detected at Prot = 26.1 +/- 3.5 d. The rotation periods of five other stars have been updated using new data. We use the rotation periods to derive the line-of-sight inclinations of the stellar rotation axes, which may be used to probe theories of planet formation and evolution when combined with the planetary orbital inclination found from other methods. Finally, we estimate the masses of 14 exoplanets under the assumption that the stellar rotation axis is aligned with the orbital axis. We calculate the mass of HD 92788 b (28 MJ) to be within the low-mass brown dwarf regime and suggest that this object warrants further investigation to confirm its true nature.

Structure and dynamics of dextran in binary mixtures of a good and a bad solvent

The structure and dynamics of the common polysaccharide dextran have been investigated in mixed solvents at two different temperatures using small-angle X-ray scattering (SAXS) and viscosity measurements. More specifically, binary mixtures of a good solvent (water, formamide, dimethylsulfoxide, ethanolamine) and the bad solvent ethanol as the minority component have been considered. The experimentally observed effects on the polymer conformation (intrinsic viscosity, coil radius, and radius of gyration) of the bad solvent addition are discussed in terms of hydrogen bonding density and are correlated with the Hansen solubility parameters and the surface tension of the solvent mixtures. Hydrogen bonding appears to be an important contributor to the solubility of dextran but is not sufficient to capture the dextran coil contraction in the mixtures of good+bad solvents.

General practitioners’ perceptions of the barriers and solutions to good quality palliative care in dementia

The general practitioner (GP) is in a pivotal position to initiate and adapt care for their patients living with dementia. This study aimed to elicit GPs' perceptions of the potential barriers and solutions to the provision of good-quality palliative care in dementia in their practices. A postal survey of GPs across Northern Ireland was conducted with open-ended items soliciting for barriers in their practices and possible solutions; 40.6% (138/340) were returned completed. Barriers to palliative care in dementia were perceived to be a dementia knowledge deficit for healthcare staff and the public, a resource shortfall within the GP practice and community, poor team coordination alongside inappropriate dementia care provision, and disagreements from and within families. These findings have significant implications for educators and clinicians as enhanced dementia education and training were highlighted as a strong agenda for GPs with the suggestions of dementia awareness programmes for the public.

Molecular Characterization and Gene Expression Profiling of Antimicrobial Peptides in Penaeid Shrimps

The constitutive production of AMPs in shrimps ensures that animals are able to protect themselves from low-level assaults by pathogens present in the environment. As these molecules play important roles in the shrimp immune defense system, the expression level of these AMPs are possible indicators of the immune state of shrimps. The present study also indicates the antiviral property of AMPs, especially ALF, stressing the importance of their up-regulation through the application of immunostimulants/probiotics as a prophylactic strategy in aquaculture. The present study shows that shrimp defense system is equipped enough to evade WSSV infection to a certain extent, when the animals were maintained on marine yeast and probiotic diet, whereas the control diet fed group succumbed to WSSV infection. This study reveals that marine yeast and probiotic supplemented diet can delay the process of WSSV infection and confer greater protection to the animals. Particularly, the protection conferred by marine yeast, C. haemulonii S27 and Bacillus MCCB101 were highly promising imparting greater hope to the aquaculture community to overcome the prevailing disease problems in aquaculture. It may be inferred from the present study that up-regulation of AMP genes could be effected by the application of immunostimulants and probiotics. Also, AMP expression profile could be used as an effective tool for screening immunostimulants and probiotics for application in shrimp culture. Ultimately, it is likely that no single compound or strategy will provide a solution to the problem of disease within aquaculture and that, in reality, a suite of techniques will be required including the manipulation of the rearing environment, addition of probionts as a matter of routine during culture, and the use of immunostimulants and other supplements during vulnerable growth phases. Finally, the development of good management practices, the control of environmental variables, genetic improvement in the penaeid species, understanding of host-virus interaction, modulation of the shrimp immune system, supported by functional genomics and proteomics of this crustacean, as a whole suggests that the control of WSSV is not far.

Analysis of the electronic structure, hyperfine structure, and volume isotope shifts in the low lying states of BA I and BA II

Relativistic multi-configuration Dirac Fock (MCDF) wavefunctions coupled to good angular momentum J have been calculated for low lying states of Ba I and Ba II. These wavefunctions are compared with semiempirical ones derived from experimental atomic energy levels. It is found that significantly better agreement is obtained when close configurations are included in the MCDF wavefunctions. Calculations of the electronic part of the field isotope shift lead to very good agreement with electronic factors derived from experimental data. Furthermore, the slopes of the lines in a King plot analysis of many of the optical lines are predicted accurately by these calculations. However, the MCDF wavefunctions seem not to be of sufficient accuracy to give agreement with the experimental magnetic dipole and electric quadrupole hyperfine structure constants.