Solitaire™ with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) trial: protocol for a randomized, controlled, multicenter study comparing the Solitaire revascularization device with IV tPA with IV tPA alone in acute ischemic stroke.

RATIONALE Early reperfusion in patients experiencing acute ischemic stroke is critical, especially for patients with large vessel occlusion who have poor prognosis without revascularization. Solitaire™ stent retriever devices have been shown to immediately restore vascular perfusion safely, rapidly, and effectively in acute ischemic stroke patients with large vessel occlusions. AIM The aim of the study was to demonstrate that, among patients with large vessel, anterior circulation occlusion who have received intravenous tissue plasminogen activator, treatment with Solitaire revascularization devices reduces degree of disability 3 months post stroke. DESIGN The study is a global multicenter, two-arm, prospective, randomized, open, blinded end-point trial comparing functional outcomes in acute ischemic stroke patients who are treated with either intravenous tissue plasminogen activator alone or intravenous tissue plasminogen activator in combination with the Solitaire device. Up to 833 patients will be enrolled. PROCEDURES Patients who have received intravenous tissue plasminogen activator are randomized to either continue with intravenous tissue plasminogen activator alone or additionally proceed to neurothrombectomy using the Solitaire device within six-hours of symptom onset. STUDY OUTCOMES The primary end-point is 90-day global disability, assessed with the modified Rankin Scale (mRS). Secondary outcomes include mortality at 90 days, functional independence (mRS ≤ 2) at 90 days, change in National Institutes of Health Stroke Scale at 27 h, reperfusion at 27 h, and thrombolysis in cerebral infarction 2b/3 flow at the end of the procedure. ANALYSIS Statistical analysis will be conducted using simultaneous success criteria on the overall distribution of modified Rankin Scale (Rankin shift) and proportions of subjects achieving functional independence (mRS 0-2).

Predicting psychotherapy outcome based on therapist interpersonal skills: A five-year longitudinal study of a therapist assessment protocol

Objective: In the past decade, variation in outcomes between therapists (i.e., therapist effects) have become increasingly recognized as an important factor in psychotherapy. Less is known, however, about what accounts for differences between therapists. The present study investigates the possibility that therapists' basic therapy-related interpersonal skills may impact outcomes. Method: To examine this, psychotherapy postgraduate trainees completed both an observer- and an expert-rated behavioral assessment: the Therapy-Related Interpersonal Behaviors (TRIB). TRIB scores were used to predict trainees' outcomes over the course of the subsequent five years. Results: Results indicate that trainees' with more positively rated interpersonal behaviors assessed in the observer-rated group format but not in a single expert-rated format showed superior outcomes over the five-year period. This effect remained controlling for therapist characteristics (therapist gender, theoretical orientation [cognitive behavioral or psychodynamic], amount of supervision, patient's order within therapist's caseload), and patient characteristics (patient age, gender, number of comorbid diagnoses, global severity, and personality disorder diagnosis). Conclusions: These findings underscore the importance of therapists' interpersonal skills as a predictor of outcome and source of therapist effects. The potential utility of assessing therapists' and therapists-in-training interpersonal skills are discussed.

Study of OLSR protocol with Network Simulator 2 over Linux

Until a few years ago, most of the network communications were based in the wire as the physical media, but due to the advances and the maturity of the wireless communications, this is changing. Nowadays wireless communications offers fast, secure, efficient and reliable connections. Mobile communications are in expansion, clearly driven by the use of smart phones and other mobile devices, the use of laptops, etc… Besides that point, the inversion in the installation and maintenance of the physical medium is much lower than in wired communications, not only because the air has no cost, but because the installation and maintenance of the wire require a high economic cost. Besides the economic cost we find that wire is a more vulnerable medium to external threats such as noise, sabotages, etc… There are two different types of wireless networks: those which the structure is part of the network itself and those which have a lack of structure or any centralization, in a way that the devices that form part of the network can connect themselves in a dynamic and random way, handling also the routing of every control and information messages, this kind of networks is known as Ad-hoc. In the present work we will proceed to study one of the multiple wireless protocols that allows mobile communications, it is Optimized Link State Routing, from now on, OLSR, it is an pro-active routing, standard mechanism that works in a distributed in order to stablish the connections among the different nodes that belong to a wireless network. Thanks to this protocol it is possible to get all the routing tables in all the devices correctly updated every moment through the periodical transmission of control messages and on this way allow a complete connectivity among the devices that are part of the network and also, allow access to other external networks such as virtual private networks o Internet. This protocol could be perfectly used in environments such as airports, malls, etc… The update of the routing tables in all the devices is got thanks to the periodical transmission of control messages and finally it will offer connectivity among all the devices and the corresponding external networks. For the study of OLSR protocol we will have the help of the network simulator “Network Simulator 2”, a freeware network simulator programmed in C++ based in discrete events. This simulator is used mainly in educational and research environments and allows a very extensive range of protocols, both, wired networks protocols and wireless network protocols, what is going to be really useful to proceed to the simulation of different configurations of networks and protocols. In the present work we will also study different simulations with Network Simulator 2, in different scenarios with different configurations, wired networks, and Ad-hoc networks, where we will study OLSR Protocol. RESUMEN. Hasta hace pocos años, la mayoría de las comunicaciones de red estaban basadas en el cable como medio físico pero debido al avance y madurez alcanzados en el campo de las comunicaciones inalámbricas esto está cambiando. Hoy día las comunicaciones inalámbricas nos ofrecen conexiones veloces, seguras, eficientes y fiables. Las comunicaciones móviles se encuentran en su momento de máxima expansión, claramente impulsadas por el uso de teléfonos y demás dispositivos móviles, el uso de portátiles, etc… Además la inversión a realizar en la instalación y el mantenimiento del medio físico en las comunicaciones móviles es muchísimo menor que en comunicaciones por cable, ya no sólo porque el aire no tenga coste alguno, sino porque la instalación y mantenimiento del cable precisan de un elevado coste económico por norma. Además del coste económico nos encontramos con que es un medio más vulnerable a amenazas externas tales como el ruido, escuchas no autorizadas, sabotajes, etc… Existen dos tipos de redes inalámbricas: las constituidas por una infraestructura que forma parte más o menos de la misma y las que carecen de estructura o centralización alguna, de modo que los dispositivos que forman parte de ella pueden conectarse de manera dinámica y arbitraria entre ellos, encargándose además del encaminamiento de todos los mensajes de control e información, a este tipo de redes se las conoce como redes Ad-hoc. En el presente Proyecto de Fin de Carrera se procederá al estudio de uno de los múltiples protocolos inalámbricos que permiten comunicaciones móviles, se trata del protocolo inalámbrico Optimized Link State Routing, de ahora en adelante OLSR, un mecanismo estándar de enrutamiento pro-activo, que trabaja de manera distribuida para establecer las conexiones entre los nodos que formen parte de las redes inalámbricas Ad-hoc, las cuales carecen de un nodo central y de una infraestructura pre-existente. Gracias a este protocolo es posible conseguir que todos los equipos mantengan en todo momento las tablas de ruta actualizadas correctamente mediante la transmisión periódica de mensajes de control y así permitir una completa conectividad entre todos los equipos que formen parte de la red y, a su vez, también permitir el acceso a otras redes externas tales como redes privadas virtuales o Internet. Este protocolo sería usado en entornos tales como aeropuertos La actualización de las tablas de enrutamiento de todos los equipos se conseguirá mediante la transmisión periódica de mensajes de control y así finalmente se podrá permitir conectividad entre todos los equipos y con las correspondientes redes externas. Para el estudio del protocolo OLSR contaremos con el simulador de redes Network Simulator 2, un simulador de redes freeware programado en C++ basado en eventos discretos. Este simulador es usado principalmente en ambientes educativos y de investigación y permite la simulación tanto de protocolos unicast como multicast. El campo donde más se utiliza es precisamente en el de la investigación de redes móviles Ad-hoc. El simulador Network Simulator 2 no sólo implementa el protocolo OLSR, sino que éste implementa una amplia gama de protocolos, tanto de redes cableadas como de redes inalámbricas, lo cual va a sernos de gran utilidad para proceder a la simulación de distintas configuraciones de redes y protocolos. En el presente Proyecto de Fin de Carrera se estudiarán también diversas simulaciones con el simulador NS2 en diferentes escenarios con diversas configuraciones; redes cableadas, redes inalámbricas Ad-hoc, donde se estudiará el protocolo antes mencionado: OLSR. Este Proyecto de Fin de Carrera consta de cuatro apartados distintos: Primeramente se realizará el estudio completo del protocolo OLSR, se verán los beneficios y contrapartidas que ofrece este protocolo inalámbrico. También se verán los distintos tipos de mensajes existentes en este protocolo y unos pequeños ejemplos del funcionamiento del protocolo OLSR. Seguidamente se hará una pequeña introducción al simulador de redes Network Simulator 2, veremos la historia de este simulador, y también se hará referencia a la herramienta extra NAM, la cual nos permitirá visualizar el intercambio de paquetes que se produce entre los diferentes dispositivos de nuestras simulaciones de forma intuitiva y amigable. Se hará mención a la plataforma MASIMUM, encargada de facilitar en un entorno académico software y documentación a sus alumnos con el fin de facilitarles la investigación y la simulación de redes y sensores Ad-hoc. Finalmente se verán dos ejemplos, uno en el que se realizará una simulación entre dos PCs en un entorno Ethernet y otro ejemplo en el que se realizará una simulación inalámbrica entre cinco dispositivos móviles mediante el protocolo a estudiar, OLSR.

Are pharmacological randomised controlled clinical trials relevant to real-life asthma populations? : A protocol for an UNLOCK study from the IPCRG

Funding The IPCRG provided funding for this research project as an UNLOCK Group study for which the funding was obtained through an unrestricted grant by Novartis AG, Basel, Switzerland. Novartis has no role in study design, data collection and analysis, decision to publish or preparation of the manuscript. This study will include data from the Optimum Patient Care Research Database and is undertaken in collaboration with Optimum Patient Care and the Respiratory Effectiveness Group.

Application of the Putting Women First protocol in a study on violence against immigrant women in Spain

In this paper, we describe our experience of using the Putting Women First protocol in the design and implementation of a cross-sectional study on violence against women (VAW) among 1607 immigrant women from Morocco, Ecuador and Romania living in Spain in 2011. The Putting Women First protocol is an ethical guideline for VAW research, which includes recommendations to ensure the safety of the women involved in studies on this subject. The response rate in this study was 59.3%. The prevalence of VAW cases last year was 11.7%, of which 15.6% corresponded to Ecuadorian women, 10.9% to Moroccan women and 8.6% to Romanian women. We consider that the most important goal for future research is the use of VAW scales validated in different languages, which would help to overcome the language barriers encountered in this study.

Improving the management of behaviour that challenges associated with dementia in care homes:protocol for pharmacy-health psychology intervention feasibility study

INTRODUCTION: The inappropriate use of antipsychotics in people with dementia for behaviour that challenges is associated with an estimated 1800 deaths annually. However, solely focusing on antipsychotics may transfer prescribing to other equally dangerous psychotropics. Little is known about the role of pharmacists in the management of psychotropics used to treat behaviours that challenge. This research aims to determine whether it is feasible to implement and measure the effectiveness of a combined pharmacy-health psychology intervention incorporating a medication review and staff training package to limit the prescription of psychotropics to manage behaviour that challenges in care home residents with dementia. METHODS/ANALYSIS: 6 care homes within the West Midlands will be recruited. People with dementia receiving medication for behaviour that challenges, or their personal consultee, will be approached regarding participation. Medication used to treat behaviour that challenges will be reviewed by the pharmacist, in collaboration with the general practitioner (GP), person with dementia and carer. The behavioural intervention consists of a training package for care home staff and GPs promoting person-centred care and treating behaviours that challenge as an expression of unmet need. The primary outcome measure is the Neuropsychiatric Inventory-Nursing Home version (NPI-NH). Other outcomes include quality of life (EQ-5D and DEMQoL), cognition (sMMSE), health economic (CSRI) and prescribed medication including whether recommendations were implemented. Outcome data will be collected at 6 weeks, and 3 and 6 months. Pretraining and post-training interviews will explore stakeholders' expectations and experiences of the intervention. Data will be used to estimate the sample size for a definitive study. ETHICS/DISSEMINATION: The project has received a favourable opinion from the East Midlands REC (15/EM/3014). If potential participants lack capacity, a personal consultee will be consulted regarding participation in line with the Mental Capacity Act. Results will be published in peer-reviewed journals and presented at conferences.

Graded Exercise Therapy Guided Self-Help Trial for Patients with Chronic Fatigue Syndrome (GETSET): Protocol for a Randomized Controlled Trial and Interview Study

Background: Chronic fatigue syndrome, also known as myalgic encephalomyelitis (CFS/ME), is characterized by chronic disabling fatigue and other symptoms, which are not explained by an alternative diagnosis. Previous trials have suggested that graded exercise therapy (GET) is an effective and safe treatment. GET itself is therapist-intensive with limited availability. Objective: While guided self-help based on cognitive behavior therapy appears helpful to patients, Guided graded Exercise Self-help (GES) is yet to be tested. Methods: This pragmatic randomized controlled trial is set within 2 specialist CFS/ME services in the South of England. Adults attending secondary care clinics with National Institute for Health and Clinical Excellence (NICE)-defined CFS/ME (N=218) will be randomly allocated to specialist medical care (SMC) or SMC plus GES while on a waiting list for therapist-delivered rehabilitation. GES will consist of a structured booklet describing a 6-step graded exercise program, supported by up to 4 face-to-face/telephone/Skype™ consultations with a GES-trained physiotherapist (no more than 90 minutes in total) over 8 weeks. The primary outcomes at 12-weeks after randomization will be physical function (SF-36 physical functioning subscale) and fatigue (Chalder Fatigue Questionnaire). Secondary outcomes will include healthcare costs, adverse outcomes, and self-rated global impression change scores. We will follow up all participants until 1 year after randomization. We will also undertake qualitative interviews of a sample of participants who received GES, looking at perceptions and experiences of those who improved and worsened. Results: The project was funded in 2011 and enrolment was completed in December 2014, with follow-up completed in March 2016. Data analysis is currently underway and the first results are expected to be submitted soon. Conclusions: This study will indicate whether adding GES to SMC will benefit patients who often spend many months waiting for rehabilitative therapy with little or no improvement being made during that time. The study will indicate whether this type of guided self-management is cost-effective and safe. If this trial shows GES to be acceptable, safe, and comparatively effective, the GES booklet could be made available on the Internet as a practitioner and therapist resource for clinics to recommend, with the caveat that patients also be supported with guidance from a trained physiotherapist. The pragmatic approach in this trial means that GES findings will be generalizable to usual National Health Service (NHS) practice.

Protocol: Quality of Life, Decision Making, Costs and Impact on Carers in People Managed without Dialysis - The PACKS Study

Collaboration in 3D virtual worlds : a protocol for case study research

Three-dimensional virtual worlds have been growing fast in number of users, and are used for the most diverse purposes. In collaboration, they are used with good results due to features such as immersion, interaction capabilities, use of avatar embodiment, and physical space. In the particular cases of avatar embodiment and physical space, these features support nonverbal communication, but its impact on collaboration is not well known. In this work we present a protocol for case study research and its creation process, which aims to assert itself as a tool to collect data on how nonverbal communication influences collaboration in three-dimensional virtual worlds. We define the propositions and units of analysis, and a pilot case to validate them. Then, two cases are analysed under the created protocol. Most of the propositions found chains of evidences supporting them.

Open Specification for BIM : Sydney Opera House Case Study

Executive Summary The objective of this report was to use the Sydney Opera House as a case study of the application of Building Information Modelling (BIM). The Sydney opera House is a complex, large building with very irregular building configuration, that makes it a challenging test. A number of key concerns are evident at SOH: • the building structure is complex, and building service systems - already the major cost of ongoing maintenance - are undergoing technology change, with new computer based services becoming increasingly important. • the current “documentation” of the facility is comprised of several independent systems, some overlapping and is inadequate to service current and future services required • the building has reached a milestone age in terms of the condition and maintainability of key public areas and service systems, functionality of spaces and longer term strategic management. • many business functions such as space or event management require up-to-date information of the facility that are currently inadequately delivered, expensive and time consuming to update and deliver to customers. • major building upgrades are being planned that will put considerable strain on existing Facilities Portfolio services, and their capacity to manage them effectively While some of these concerns are unique to the House, many will be common to larger commercial and institutional portfolios. The work described here supported a complementary task which sought to identify if a building information model – an integrated building database – could be created, that would support asset & facility management functions (see Sydney Opera House – FM Exemplar Project, Report Number: 2005-001-C-4 Building Information Modelling for FM at Sydney Opera House), a business strategy that has been well demonstrated. The development of the BIMSS - Open Specification for BIM has been surprisingly straightforward. The lack of technical difficulties in converting the House’s existing conventions and standards to the new model based environment can be related to three key factors: • SOH Facilities Portfolio – the internal group responsible for asset and facility management - have already well established building and documentation policies in place. The setting and adherence to well thought out operational standards has been based on the need to create an environment that is understood by all users and that addresses the major business needs of the House. • The second factor is the nature of the IFC Model Specification used to define the BIM protocol. The IFC standard is based on building practice and nomenclature, widely used in the construction industries across the globe. For example the nomenclature of building parts – eg ifcWall, corresponds to our normal terminology, but extends the traditional drawing environment currently used for design and documentation. This demonstrates that the international IFC model accurately represents local practice for building data representation and management. • a BIM environment sets up opportunities for innovative processes that can exploit the rich data in the model and improve services and functions for the House: for example several high-level processes have been identified that could benefit from standardized Building Information Models such as maintenance processes using engineering data, business processes using scheduling, venue access, security data and benchmarking processes using building performance data. The new technology matches business needs for current and new services. The adoption of IFC compliant applications opens the way forward for shared building model collaboration and new processes, a significant new focus of the BIM standards. In summary, SOH current building standards have been successfully drafted for a BIM environment and are confidently expected to be fully developed when BIM is adopted operationally by SOH. These BIM standards and their application to the Opera House are intended as a template for other organisations to adopt for the own procurement and facility management activities. Appendices provide an overview of the IFC Integrated Object Model and an understanding IFC Model Data.

Driver behaviour and decision making at railway level crossings : An exploratory on-road case study

Crashes at rail level crossings represent a significant problem, both in Australia and worldwide. Advances in driving assessment methods, such as the provision of on-road instrumented test vehicles, now provide researchers with the opportunity to further understand driver behaviour at rail level crossings in ways not previously possible. This paper gives an overview of a recent on-road pilot study of driver behaviour at rail level crossings in which 25 participants drove a pre-determined route, incorporating 4 rail level crossings, using MUARC's instrumented On-Road Test Vehicle (ORTeV). Drivers provided verbal commentary whilst driving the route, and a range of other data were collected, including eye fixations, forward, cockpit and driver video, and vehicle data (speed, braking, steering wheel angle, lane tracking etc). Participants also completed a post trial cognitive task analysis interview. Extracts from the wider analyses are used to examine in depth driver behaviour at one of the rail level crossings encountered during the study. The analysis presented, along with the overall analysis undertaken, gives insight into the driver and wider systems factors that shape behaviour at rail level crossings, and highlights the utility of using a multi-method, instrumented vehicle approach for gathering data regarding driver behaviour in different contexts.

An empirical study of data collection protocols for wireless sensor networks

In the past few years, numerous data collection protocols have been developed for wireless sensor networks (WSNs). However, there has been no comparison of their relative performance in realistic environments. Here we report the results of an empirical study using a Fleck3 sensor network testbed for four different data collection protocols: One phase pull Directed Diffusion (DD), Expected Number of Transmissions (ETX), ETX with explicit acknowledgment (ETX-eAck), and ETX with implicit acknowledgment (ETX-iAck). Our empirical study provides useful insights for future sensor network deployments. When the required application end-to-end reliability is not strict (e.g., 70%) and link quality is good, DD and ETX are the best options because of their simplicity and low routing overhead. Both ETX-eAck and ETX-iAck achieve more than 90% end-to-end reliability when the link quality is reasonable (less than 25% packet loss). When the link quality is good, ETX-iAck introduces significantly less routing overhead (up to 50%) than ETX-eAck. However, if the radio transceiver supports variable packet length, ETX-eAck can outperform ETX-iAck when the link quality is poor. The important message from this paper is that choice of data collection protocol should come after the operating environment is understood. This understanding must include the characteristics of the radio transceiver, and link loss statistics from a long-term (across seasons and weather variation) radio survey of the site.

To err (on the road) is human? An on-road study of driver errors

Human error, its causes and consequences, and the ways in which it can be prevented, remain of great interest to road safety practitioners. This paper presents the findings derived from an on-road study of driver errors in which 25 participants drove a pre-determined route using MUARC's On-Road Test Vehicle (ORTeV). In-vehicle observers recorded the different errors made, and a range of other data was collected, including driver verbal protocols, forward, cockpit and driver video, and vehicle data (speed, braking, steering wheel angle, lane tracking etc). Participants also completed a post trial cognitive task analysis interview. The drivers tested made a range of different errors, with speeding violations, both intentional and unintentional, being the most common. Further more detailed analysis of a sub-set of specific error types indicates that driver errors have various causes, including failures in the wider road 'system' such as poor roadway design, infrastructure failures and unclear road rules. In closing, a range of potential error prevention strategies, including intelligent speed adaptation and road infrastructure design, are discussed.