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.

Cryotherapy for docetaxel-induced hand and nail toxicity: Randomised control trial

Purpose This study investigated the efficacy and safety of cryotherapy, in the form of frozen gel gloves, in relation to docetaxel-induced hand and fingernail toxicities. Patients and methods After piloting with 21 patients, a consecutive series sample of patients (n=53) prescribed docetaxel every three weeks, for a minimum of three cycles, was enrolled in this randomised control trial. Participants acted as their own control, with the frozen gel glove worn on one randomised hand for 15 minutes prior to infusion, for the duration of the infusion, and for 15 minutes of after completion of treatment. Hand and nail toxicities were evaluated by two blinded assessors according to CTCAE.v4 criteria. To assess the potential for cross-infection of multi-use gloves, microbial culture and sensitivity swabs were taken of each glove at every tenth use. Results Of the 53 participants enrolled in the main study, 21 provided evaluable data. There was a 60% withdrawal rate due to patient discomfort with the intervention. The mean incidence and severity of toxicities in all evaluable cycles in control and intervention hands respectively were erythroderma Grade 1 (5%/5%); nail discolouration Grade 1 (81%/67%); nail loss Grade 1 (19%/19%) and nail ridging Grade 1 (57%/57%). No significant differences were determined between hand conditions in terms of time to event, nor in terms of toxicity in gloved and non-gloved hands. Conclusion While cryotherapy in the form of frozen gloves for the cutaneous toxicities associated with docetaxel is safe, its limited efficacy, patient discomfort and some logistical issues preclude its use in our clinical setting.

Cross-sectional survey of the health behaviour of southeast Queensland women with cancer-treatment induced menopause : Implications for cancer and primary care nurses

Purpose Women who experience cancer treatment-induced menopause are at risk of long-term chronic morbidity. This risk can be prevented or offset with adherence to health promotion and risk reduction guidelines. The purpose of this study was to explore health behaviours in younger female survivors of cancer and the variables (quality of life and psychological distress) believed to moderate health behaviours. Design Cross-sectional survey of a convenience sample of women (n = 85) in southeast Queensland. Methods Health behaviour and health status were elicited with items from the Australian Health Survey and the Behavioural Risk Factor Surveillance System. The WHO Quality of Life (Brief) measured participants’ self-reported quality of life and their satisfaction with their health. The Brief Symptom Inventory-18 measured psychological distress. Findings Higher self-reported health status was associated with regular exercise and better quality of life. However, a substantial proportion of participants did not engage in the physical activity, dietary or cervical screening practices recommended by Australian guidelines. Conclusions The participants require education regarding the benefits of diet, exercise, weight loss and decreased alcohol intake, as well as information on future health risks and possible comorbidities. These education sessions could be addressed by a nurse-led health promotion model of care at the time of discharge or in the community.

Caribbean copyright showdown

The tiny Caribbean island of Antigua doesn’t make the news very often. Located 1800 kilometres east of Miami, just north of Montserrat, it is best known as a holiday destination for well-heeled Europeans and celebrities with private yachts. Now it is in the headlines for an unexpected reason...

Amateur Media : Social, Cultural and Legal Perspectives

The rise of Web 2.0 has pushed the amateur to the forefront of public discourse, public policy and media scholarship. Typically non-salaried, non-specialist and untrained in media production, amateur producers are now seen as key drivers of the creative economy. But how do the activities of citizen journalists, fan fiction writers and bedroom musicians connect with longer traditions of extra-institutional media production? This edited collection provides a much-needed interdisciplinary contextualisation of amateur media before and after Web 2.0. Surveying the institutional, economic and legal construction of the amateur media producer via a series of case studies, it features contributions from experts in the fields of law, economics and media studies based in the UK, Europe and Singapore. Each section of the book contains a detailed case study on a selected topic, followed by two further pieces providing additional analysis and commentary. Using an extraordinary array of case studies and examples, from YouTube to online games, from subtitling communities to reality TV, the book is neither a celebration of amateur production nor a denunciation of the demise of professional media industries. Rather, this book presents a critical dialogue across law and the humanities, exploring the dynamic tensions and interdependencies between amateur and professional creative production. This book will appeal to both academics and students of intellectual property and media law, as well as to scholars and students of economics, media, cultural and internet studies.

Histories of user-generated content : between formal and informal media economies

Debates about user-generated content (UGC) often depend on a contrast with its normative opposite, the professionally produced content that is supported and sustained by commercial media businesses or public organisations. UGC is seen to appear within or in opposition to professional media, often as a disruptive, creative, change-making force. Our suggestion is to position UGC not in opposition to professional or "producer media", or in hybridised forms of subjective combination with it (the so-called "pro-sumer" or "pro-am" system), but in relation to different criteria, namely the formal and informal elements in media industries. In this article, we set out a framework for the comparative and historical analysis of UGC systems and their relations with other formal and informal media activity, illustrated with examples ranging from games to talkback radio. We also consider the policy implications that emerge from a historicised reading of UGC as a recurring dynamic within media industries, rather than a manifestation of consumer agency specific to digital cultures.

Nanomorphology influence on the light conversion mechanisms in highly efficient diketopyrrolopyrrole based organic solar cells

In this work, diketopyrrolopyrrole-based polymer bulk heterojunction solar cells with inverted and regular architecture have been investigated. The influence of the polymer:fullerene ratio on the photoactive film nanomorphology has been studied in detail. Transmission Electron Microscopy and Atomic Force Microscopy reveal that the resulting film morphology strongly depends on the fullerene ratio. This fact determines the photocurrent generation and governs the transport of free charge carriers. Slight variations on the PCBM ratio respect to the polymer show great differences on the electrical behavior of the solar cell. Once the polymer:fullerene ratio is accurately adjusted, power conversion efficiencies of 4.7% and 4.9% are obtained for inverted and regular architectures respectively. Furthermore, by correlating the optical and morphological characterization of the polymer:fullerene films and the electrical behavior of solar cells, an ad hoc interpretation is proposed to explain the photovoltaic performance as a function of this polymer:blend composition.

Abundance and prevalence of Aedes aegypti immatures and relationships with household water storage in rural areas in southern Viet Nam

Since 2000, the Government of Viet Nam has committed to provide rural communities with increased access to safe water through a variety of household water supply schemes (wells, ferrocement tanks and jars) and piped water schemes. One possible, unintended consequence of these schemes is the concomitant increase in water containers that may serve as habitats for dengue mosquito immatures, principally Aedes aegypti. To assess these possible impacts we undertook detailed household surveys of Ae. aegypti immatures, water storage containers and various socioeconomic factors in three rural communes in southern Viet Nam. Positive relationships between the numbers of household water storage containers and the prevalence and abundance of Ae. aegypti immatures were found. Overall, water storage containers accounted for 92–97% and 93–96% of the standing crops of III/IV instars and pupae, respectively. Interestingly, households with higher socioeconomic levels had significantly higher numbers of water storage containers and therefore greater risk of Ae. aegypti infestation. Even after provision of piped water to houses, householders continued to store water in containers and there was no observed decrease in water storage container abundance in these houses, compared to those that relied entirely on stored water. These findings highlight the householders’ concerns about the limited availability of water and their strong behavoural patterns associated with storage of water. We conclude that household water storage container availability is a major risk factor for infestation with Ae. aegypti immatures, and that recent investment in rural water supply infrastructure are unlikely to mitigate this risk, at least in the short term.

Cultures of sharing in 3D printing: What can we learn from the licence choices of Thingiverse users?

This article contributes to the discussion by analysing how users of the leading online 3D printing design repository Thingiverse manage their intellectual property (IP). 3D printing represents a fruitful case study for exploring the relationship between IP norms and practitioner culture. Although additive manufacturing technology has existed for decades, 3D printing is on the cusp of a breakout into the technological mainstream – hardware prices are falling; designs are circulating widely; consumer-friendly platforms are multiplying; and technological literacy is rising. Analysing metadata from more than 68,000 Thingiverse design files collected from the site, we examine the licensing choices made by users and explore the way this shapes the sharing practices of the site’s users. We also consider how these choices and practices connect with wider attitudes towards sharing and intellectual property in 3D printing communities. A particular focus of the article is how Thingiverse structures its regulatory framework to avoid IP liability, and the extent to which this may have a bearing on users’ conduct. The paper has three sections. First, we will offer a description of Thingiverse and how it operates in the 3D printing ecosystem, noting the legal issues that have arisen regarding Thingiverse’s Terms of Use and its allocation of intellectual property rights. Different types of Thingiverse licences will be detailed and explained. Second, the empirical metadata we have collected from Thingiverse will be presented, including the methods used to obtain this information. Third, we will present findings from this data on licence choice and the public availability of user designs. Fourth, we will look at the implications of these findings and our conclusions regarding the particular kind of sharing ethic that is present in Thingiverse; we also consider the “closed” aspects of this community and what this means for current debates about “open” innovation.

Hybrid approaches for clustering

Applications in various domains often lead to very large and frequently high-dimensional data. Successful algorithms must avoid the curse of dimensionality but at the same time should be computationally efficient. Finding useful patterns in large datasets has attracted considerable interest recently. The primary goal of the paper is to implement an efficient Hybrid Tree based clustering method based on CF-Tree and KD-Tree, and combine the clustering methods with KNN-Classification. The implementation of the algorithm involves many issues like good accuracy, less space and less time. We will evaluate the time and space efficiency, data input order sensitivity, and clustering quality through several experiments.

Caracterización y evaluación preliminar de diecinueve accesiones de frijol tepari (Phaseolus acutifolius gray)

El presente trabajo se realizó en el período de postrera (Octubre, 1991) en el Centro Experimental La Compañía, localizado en San Marcos, Carazo. Trata sobre la caracterización y evaluación preliminar de 19 accesiones de frijol tepari (Phaseolus acutifolius Gray). El germoplasma utilizado fue colectado por el Programa de Recursos Genéticos Nicaragüenses (REGEN). en diferentes localidades de Chinandega, León, Masaya y Rivas. El diseño utilizado consistió en un arreglo típico de ensayos preliminares sin réplicas en el que se incluyó una parcela del testigo cada 3 accesiones. El análisis de los caracteres cuantitativos se utilizó el valor máximo, promedio, mínimo coeficiente de variación y la desviación estándar y para los cualitativos se incluyó la variante predominante dentro del carácter. Para los diferentes caracteres en estudio presentaron variación entre y dentro de las accesiones, esto puede atribuirse a las condiciones ambientales, genotipo y la interacción de ambos. En las condiciones ecológicas en que se efectuó el experimento, las accesiones. 2261, 1796 y 1652 superaron al testigo (Revolución 79A) en rendimiento. La accesiones 2281, 245, 1798, 1852, 1991, 1996 y 2105 mostraron los menores grados de severidad para la enfermedad Mancha angular (lsariopsis griseola Sacc). Se presenta un catálogo de 19 accesiones estudiados conteniendo el valor máximo, promedio, mínimo, desviación estándar y coeficiente de variación para los caracteres cuantitativos y la moda para caracteres cualitativos

Propuesta de estimadores para el estudio epidemiológico de las enfermedades foliares en café (Coffea arabica L.)

Se realizó un estudio en tres agroecosistemas de café con los objetivos de comparar tres métodos de cuantificación de enfermedades foliares del café, determinar el parámetro a estimar en la medición de la intensidad de la enfermedad (incidencia y/o severidad) considerando las característica físicas y biológicas de cada agroecosistema y proponer un tamaño de muestra que teniendo un costo menor principalmente en cuanto al tiempo, permita estimar la cantidad de enfermedad con una precisión determinada. Se seleccionaron 7 personas para que hicieran lecturas de dos enfermedades foliares en un cafetal, utilizando tres métodos de cuantificación de enfermedades y luego se compararon los métodos, usando para ello el coeficiente de variabilidad de la interacción métodos-personas. Se seleccionaron fincas con regímenes climáticos diferentes y en cada una se seleccionó un lote, en el cual se seleccionaron al azar cinco conglomerados de cinco plantas cada uno y en cada planta se marcaron al azar 6 bandolas para dar un total de 150 bandolas en el lote de observación. En cada bandola se hicieron lecturas semanales de incidencia y severidad1 también se recolectó información concerniente al nivel tecnológico, el manejo agronómico y las características físicas del lote observado. Con los datos obtenidos se hizo un estudio de la correlación incidencia-severidad y con base en una propuesta para el tamaño y arreglo de la muestra, también se hizo un estudio del tamaño y arreglo de la muestra y se calculó la eficiencia relativa del muestreo por conglomerados. El método de estimación visual fue el que presentó la menor variabilidad y el mayor ahorro de tiempo y esfuerzo físico en relación a los métodos basados en escala. No se puede generalizar un modelo de regresión único para la relación, incidencia-severidad ya que ésta cambia de acuerdo a un sin número de factores del agroecosistema, entre los cuales el patosistema, el microambiente y el mesoambiente parecen ser los más importantes. De las enfermedades foliares en café como roya, mancha de hierro y antracnosis es suficiente medir la incidencia. El tamaño de muestra aquí propuesto para evaluar porcentajes (bajos) de incidencia para las tres enfermedades en estudio es de 15 plantas distribuidas en 5 conglomerados de 3 plantas cada uno. Se pudo comprobar que las tres enfermedades en estudio se comportan de forma agregada consistentemente: la varianza es mayor que la media (o2 >m), al aplicar a los datos la ley ponderada de Taylor estos cumplen con la regla de que el coeficiente de regresión es mayor que uno (b > l) y, para cada enfermedad la varianza entre plantas es mayor que la varianza entre conglomerados (sitios).

Influencia de períodos de enmalezamiento sobre el crecimiento y rendimiento del frijol común (Phaseolus vulgaris L.) var dor 364

El presente trabajo se realizó en época de postrera de 1995 (septiembre-diciembre) en la estación experimental La Compañía, ubicada en el municipio de San Marcos, Carazo. En un suelo de origen volcánico de la serie Masatepe (MS), con el propósito de determinar la influencia de periodos de enmalezamiento sobre la dinámica de las malezas y el crecimiento y rendimiento del cultivo de frijol común (Phaseolus vulgaris L.). Para el estudio se utilizó un Diseño de Bloques completos al Azar (BCA) con cuatro réplicas y siete tratamientos, siendo estos: períodos de enmalezamiento por periodos de 15, 21, 28, 35, 42 y 49 días después de la siembra. Un tratamiento permaneció enmalezado durante todo el ciclo del cultivo. Las variables evaluadas fueron diversidad, abundancia y biomasa de malezas, altura de plantas, componentes del rendimiento y el rendimiento como tal. Los resultados pueden resumirse de la siguiente forma: se encontraron trece especies de malezas en el ensayo compitiendo con el cultivo, cinco pertenecen a las monocotiledóneas y ocho a las dicotiledóneas. La altura de planta en el cultivo de frijol se incrementa a medida que aumenta el período de competencia con las malezas. Existió efecto significativo de los períodos de enmalezamiento sobre el número de vainas por planta. El cultivo de frijol reduce su rendimiento un 50.6 por ciento cuando compile con las malezas durante todo el ciclo y las labores iniciales de control de malezas afectan el rendimiento un 11.3 por ciemo. El rendimiento de frijol se reduce significativamente cuando el cultivo compite con las malezas durante el periodo de 28 a 35 días después de la siembra, en el intervalo de dicho periodo de tiempo existe una reducción de rendimiento de 515.1 por ciento. Las 1abores de control de malezas en el frijol común deben realizarse en el periodo anterior a la prefloración del cultivo ( 18 y 30 días después de La siembra) y no llevarse más allá de la floracion del mismo

Don Ramón Vega, enigmático rebelde de la ópera mexicana

Resumen: Un fortuito hallazgo del libreto manuscrito de la ópera El grito de Dolores, de Ramón Vega, compositor mexicano del siglo XIX, protagonizado por esta autora, desencadenó una serie de preguntas que hasta el presente no han sido respondidas a cabalidad por los estudios dedicados a la historia de la música en México. La investigación desarrollada con el propósito de situar el manuscrito encontrado en el contexto social y cultural del siglo de la Independencia y la exhaustiva pesquisa realizada en diferentes archivos históricos fructificaron en el descubrimiento de un vasto corpus de fuentes documentales actualmente desconocidas. La información que arrojó el análisis de estos documentos completó el conocimiento existente sobre la vida de Ramón Vega, permitió enderezar algunas ideas falibles en torno a su producción operística, así como construir y sustentar la hipótesis de que El grito de Dolores puede calificarse como el primer intento de creación de una ópera mexicana “enteramente nacional”.