Colchicine effectiveness in symptom and inflammation modification in knee osteoarthritis (COLKOA): study protocol for a randomized controlled trial.

BACKGROUND: Despite the high prevalence and global impact of knee osteoarthritis (KOA), current treatments are palliative. No disease modifying anti-osteoarthritic drug (DMOAD) has been approved. We recently demonstrated significant involvement of uric acid and activation of the innate immune response in osteoarthritis (OA) pathology and progression, suggesting that traditional gout therapy may be beneficial for OA. We therefore assess colchicine, an existing commercially available agent for gout, for a new therapeutic application in KOA. METHODS/DESIGN: COLKOA is a double-blind, placebo-controlled, randomized trial comparing a 16-week treatment with standard daily dose oral colchicine to placebo for KOA. A total of 120 participants with symptomatic KOA will be recruited from a single center in Singapore. The primary end point is 30% improvement in total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at week 16. Secondary end points include improvement in pain, physical function, and quality of life and change in serum, urine and synovial fluid biomarkers of cartilage metabolism and inflammation. A magnetic resonance imaging (MRI) substudy will be conducted in 20 participants to evaluate change in synovitis. Logistic regression will be used to compare changes between groups in an intention-to-treat analysis. DISCUSSION: The COLKOA trial is designed to evaluate whether commercially available colchicine is effective for improving signs and symptoms of KOA, and reducing synovial fluid, serum and urine inflammatory and biochemical joint degradation biomarkers. These biomarkers should provide insights into the underlying mechanism of therapeutic response. This trial will potentially provide data to support a new treatment option for KOA. TRIAL REGISTRATION: The trial has been registered at clinicaltrials.gov as NCT02176460 . Date of registration: 26 June 2014.

Effects of chronic mild traumatic brain injury on white matter integrity in iraq and afghanistan war veterans

Mild traumatic brain injury (TBI) is a common source of morbidity from the wars in Iraq and Afghanistan. With no overt lesions on structural MRI, diagnosis of chronic mild TBI in military veterans relies on obtaining an accurate history and assessment of behavioral symptoms that are also associated with frequent comorbid disorders, particularly posttraumatic stress disorder (PTSD) and depression. Military veterans from Iraq and Afghanistan with mild TBI (n = 30) with comorbid PTSD and depression and non-TBI participants from primary (n = 42) and confirmatory (n = 28) control groups were assessed with high angular resolution diffusion imaging (HARDI). White matter-specific registration followed by whole-brain voxelwise analysis of crossing fibers provided separate partial volume fractions reflecting the integrity of primary fibers and secondary (crossing) fibers. Loss of white matter integrity in primary fibers (P < 0.05; corrected) was associated with chronic mild TBI in a widely distributed pattern of major fiber bundles and smaller peripheral tracts including the corpus callosum (genu, body, and splenium), forceps minor, forceps major, superior and posterior corona radiata, internal capsule, superior longitudinal fasciculus, and others. Distributed loss of white matter integrity correlated with duration of loss of consciousness and most notably with "feeling dazed or confused," but not diagnosis of PTSD or depressive symptoms. This widespread spatial extent of white matter damage has typically been reported in moderate to severe TBI. The diffuse loss of white matter integrity appears consistent with systemic mechanisms of damage shared by blast- and impact-related mild TBI that involves a cascade of inflammatory and neurochemical events. © 2012 Wiley Periodicals, Inc.

Protocol for the "Implementation, adoption, and utility of family history in diverse care settings" study.

BACKGROUND: Risk assessment with a thorough family health history is recommended by numerous organizations and is now a required component of the annual physical for Medicare beneficiaries under the Affordable Care Act. However, there are several barriers to incorporating robust risk assessments into routine care. MeTree, a web-based patient-facing health risk assessment tool, was developed with the aim of overcoming these barriers. In order to better understand what factors will be instrumental for broader adoption of risk assessment programs like MeTree in clinical settings, we obtained funding to perform a type III hybrid implementation-effectiveness study in primary care clinics at five diverse healthcare systems. Here, we describe the study's protocol. METHODS/DESIGN: MeTree collects personal medical information and a three-generation family health history from patients on 98 conditions. Using algorithms built entirely from current clinical guidelines, it provides clinical decision support to providers and patients on 30 conditions. All adult patients with an upcoming well-visit appointment at one of the 20 intervention clinics are eligible to participate. Patient-oriented risk reports are provided in real time. Provider-oriented risk reports are uploaded to the electronic medical record for review at the time of the appointment. Implementation outcomes are enrollment rate of clinics, providers, and patients (enrolled vs approached) and their representativeness compared to the underlying population. Primary effectiveness outcomes are the percent of participants newly identified as being at increased risk for one of the clinical decision support conditions and the percent with appropriate risk-based screening. Secondary outcomes include percent change in those meeting goals for a healthy lifestyle (diet, exercise, and smoking). Outcomes are measured through electronic medical record data abstraction, patient surveys, and surveys/qualitative interviews of clinical staff. DISCUSSION: This study evaluates factors that are critical to successful implementation of a web-based risk assessment tool into routine clinical care in a variety of healthcare settings. The result will identify resource needs and potential barriers and solutions to implementation in each setting as well as an understanding potential effectiveness. TRIAL REGISTRATION: NCT01956773.

The reporting behaviours of student nurses who have experienced verbal abuse

Background: There is evidence that student nurses are vulnerable to experiencing verbal abuse from a variety of sources and under-reporting of verbal abuse is prevalent throughout the nursing profession. The objective of the study is to explore the reporting behaviours of student nurses who have experienced verbal abuse. Method: For this study a definition of verbal abuse was adopted from current Department of Health (England) guidelines. Questionnaires were distributed in 2005 to a convenience sample of 156 third year nursing students from one pre-registration nursing programme in England. A total of 114 questionnaires were returned, giving an overall response rate of 73.0%. Results: Fifty one students (44.7% of responses) reported verbal abuse; all of these completed the section exploring reporting behaviours. The incidents involved patients in thirty three cases (64.7%); eight cases (15.7%) involved visitors or relatives and ten cases (19.6%) involved other healthcare workers. Thirty two students (62.7%) stated that they did report the incident of verbal abuse they experienced and nineteen (37.3%) of respondents reported that they did not. Only four incidents developed from an oral report to being formally documented. There was a statistically significant association (P = 0.003) between the focus of verbal abuse (patient/visitor or colleague) and the respondents reporting practices with respondents experiencing verbal abuse from colleagues less likely to report incidents. Most frequent feelings following experiences of verbal abuse from colleagues were feelings of embarrassment and hurt/shock. Most frequent consequences of experiencing verbal abuse from patients or relatives were feeling embarrassed and feeling sorry for the abuser. When comparing non reporters with reporters, the most frequent feelings of non reporters were embarrassment and hurt and reporters, embarrassment and feeling sorry for the abuser. When considering levels of support after the incident the mean rating score of respondents who reported the incident was 5.40 (standard deviation 2.89) and of those that did not, 4.36 (standard deviation 2.87) which was not statistically significant (p = 0.220). Conclusions: 1. Not documenting experiences of verbal abuse formally in writing is a prevalent phenomenon within the sample studied and reporting practices are inconsistent. 2. Both Higher Education Institutions and health care providers should consider emphasising formal reporting and documenting of incidents of verbal abuse during student nurse training and access to formal supportive services should be promoted. 3. Effective incident reporting processes and analysis of these reports can lead to an increased awareness of how to avoid negative interactions in the workplace and how to deal with incidents effectively.

Verbal abuse experienced by student nurses

Aim: This paper is a report of a study to describe the nature, severity, frequency and sources of verbal abuse experienced by nursing students while gaining clinical experience. Background: Verbal abuse of healthcare workers is currently receiving considerable attention and nursing students have been identified as a group vulnerable to experiencing workplace verbal abuse. Method: Questionnaires were distributed in 2005 to a convenience sample of 156 third year nursing students from one pre-registration nursing programme in England. A total of 114 questionnaires were returned, giving a response rate of 73.0%. Findings: Experience of verbal abuse was reported by 45.1% of respondents, 34.5% had witnessed other students experiencing this and 65.5% reported that they were aware of other students experiencing verbal abuse. The incidents involved patients in 64.7% of cases, 15.7% involved visitors or relatives and 19.6% involved other healthcare workers. Students reported experiencing threats to kill them, racial abuse and sexually oriented verbal abuse, with the majority of incidents occurring in general medical, mental health and general surgical clinical areas. Conclusion: Education and healthcare providers should prepare students to manage negative verbal exchanges during nursing education, and policies and support networks relating to managing verbal abuse in clinical practice should be available to nursing students.

Reaching across organisational, sectoral and geographical boundaries: exploring the learning potential of an EU cross-border project

Research This paper outlines some of the key findings from an evaluation of the project and demonstrates that EC funded projects such as this, which seek to promote cross border collaboration and understanding (i.e. across organisational, sectoral and geographical boundaries) offer considerable learning potential – not least about variances in health politics across different communities. However, for this learning to be realised a comprehensive system of knowledge management needs to be an integral part of project planning alongside a system for sustaining embryonic professional networks. The concept of managing relationships was also a key part of the projects success. Executing a project funded by the EU demands the development of complex organisational skills to negotiate all the administrative challenges en route to successful completion and this project in particular relied for its success on the development of social relationships of trust and mutual respect across national, professional and social boundaries. Context A three–year European Commission funded project designed to exchange a wide range of staff (professional semiprofessional and voluntary staff in health and social care) project led by the University of Greenwich (UK) and the Université Catholique de Lille, France was completed this year (February 2008). The project was complex because it involved working in different national contexts, was multi-disciplinary, and demanded the negotiation of multiple boundaries. Theories A mixed method evaluation including written reports gathered immediately after each exchange visit and a post hoc series of individual interviews and focus groups was conducted in order to gain qualitative information (from the participants perspective) on their experiences and to identify any learning gained. Results Analysis of the data provided evidence of learning on a number of levels; personally, inter and intra professionally and organisationally as well as across sectors and also from a project management perspective. The learning crystallised around the extent of the differences noted by the participants between the UK and the French health and social care systems despite geographical proximity, common membership of the EU and many shared challenges in health and social care. The extent of these differences, noted at every level from policy to practice proved a rich source for reflection on organisational philosophies, ways of working, distribution of resources, professional roles and autonomy and professional registration and mobility - in short on health politics at ‘macro’ and ‘micro’ levels.

Interprofessional attitudes amongst undergraduate students in the health professions: a longitudinal questionnaire survey

Background: Interprofessional education (IPE) introduced at the beginning of pre-registration training for healthcare professionals attempts to prevent the formation of negative interprofessional attitudes which may hamper future interprofessional collaboration. However, the potential for IPE depends, to some extent, on the readiness of healthcare students to learn together. Objectives: To measure changes in readiness for interprofessional learning, professional identification, and amount of contact between students of different professional groups; and to examine the influence of professional group, student characteristics and an IPE course on these scores over time. Design: Annual longitudinal panel questionnaire survey at four time-points of pre-registration students (n = 1683) drawn from eight healthcare groups from three higher education institutions (HEIs) in the UK. Results: The strength of professional identity in all professional groups was high on entry to university but it declined significantly over time for some disciplines. Similarly students’ readiness for interprofessional learning was high at entry but declined significantly over time for all groups, with the exception of nursing students. A small but significant positive relationship between professional identity and readiness for interprofessional learning was maintained over time. There was very minimal contact between students from different disciplines during their professional education programme. Students who reported gaining the least from an IPE course suffered the most dramatic drop in their readiness for interprofessional learning in the following and subsequent years; however, these students also had the lowest expectations of an IPE course on entry to their programme of study. Conclusion: The findings provide support for introducing IPE at the start of the healthcare students’ professional education to capitalise on students’ readiness for interprofessional learning and professional identities, which appear to be well formed from the start. However, this study suggests that students who enter with negative attitudes towards interprofessional learning may gain the least from IPE courses and that an unrewarding experience of such courses may further reinforce their negative attitudes.

Drug calculations part 2: alternative strategies to the formula

Drug calculations are an essential skill for nurses. The clinical skill of performing a drug calculation has come under recent scrutiny,resulting in the development of essential skills clusters inwhich pre-registration nurses must be competent before qualifying (Nursing and Midwifery Council 2007). The focuson drug calculation skills places renewed emphasis on how these skills are taught in higher education institutions and how they are learned by students theoretically and in clinical practice.

Direct entry: equipped for competence?

The effectiveness of direct-entry midwifery education has been the subject of much debate. This paper describes a study comparing perceptions of competence among midwives educated on direct-entry and post-registration programmes.

A written assessment is an invalid test of numeracy skills

Nurses need good clinical numeracy skills to aid them in their clinical practice. There is some concern, however, that the calculation skills learned during pre-registration nurse education have little practical application to nurses. This article discusses the Fitness for Practice initiatives from the Nursing and Midwifery Council which aim to ensure new registrants are numerate. The article argues that written numeracy assessment tools are not a valid test of the numeracy skills candidates will require for clinical practice and that nurse education needs to focus on researching and examining how best to support, assess and develop the numeracy skills of nursing students within their clinical practice placements to ensure that at the point of registration they are fit for practice.

Is childhood type 1 diabetes a wealth-related disease? An ecological analysis of European incidence rates

Aims/Hypothesis: To describe the epidemiology of childhood-onset Type 1 (insulin-dependent) diabetes in Europe, the EURODIAB collaborative group has established prospective, geographically-defined registers of children diagnosed under 15 years. A total of 16,362 cases were registered by 44 centres during the period 1989-1994. The registers cover a population of approximately 28 million children with most European countries represented. Methods In most centres a primary and a secondary source of ascertainment were used so that the completeness of registration could be assessed by the capture-recapture method. Ecological correlation and regression analyses were used to study the relationship between incidence and various environmental, health and economic indicators. Findings: The standardised average annual incidence rate during the period 1989-94 ranged from 3.2 cases per 100,000 per annum in the Former Yugoslavian Republic of Macedonia to 40.2 cases per 100,000 per annum in Finland. Indicators of national prosperity such as infant mortality (r= -0.64) and gross domestic product (r= 0.58) were most strongly and significantly correlated with incidence rate, and previously-reported associations with coffee consumption (r= 0.51), milk consumption (r= 0.58) and latitude (r= 0.40) were also observed. Conclusion/Interpretation: The wide variation in childhood type 1 diabetes incidence rates within Europe could be partially explained by indicators of national prosperity. These indicators could reflect differences in environmental risk factors such as nutrition or lifestyle that are important in determining a country's incidence rate.

Toward Self-Assembled Ferroelectric Random Access Memories: Hard-Wired Switching Capacitor Arrays with Almost Tb/in.2 Densities

We report on the successful fabrication of arrays of switchable nanocapacitors made by harnessing the self-assembly of materials. The structures are composed of arrays of 20-40 nm diameter Pt nanowires, spaced 50-100 nm apart, electrodeposited through nanoporous alumina onto a thin film lower electrode on a silicon wafer. A thin film ferroelectric (both barium titanate (BTO) and lead zirconium titanate (PZT)) has been deposited on top of the nanowire array, followed by the deposition of thin film upper electrodes. The PZT nanocapacitors exhibit hysteresis loops with substantial remnant polarizations, while although the switching performance was inferior, the low-field characteristics of the BTO nanocapacitors show dielectric behavior comparable to conventional thin film heterostructures. While registration is not sufficient for commercial RAM production, this is nevertheless an embryonic form of the highest density hard-wired FRAM capacitor array reported to date and compares favorably with atomic force microscopy read-write densities.

Chronic child abuse: The characteristics and careers of children caught in the child protection system

The introduction of the Quality Protects initiative in England and the focus on performance management has challenged social services departments to examine the systems, processes and outcomes for children who have their name on a child protection register. Research indicates that approximately one-quarter of the situations in which children are registered could be described as chronic—that is, they remain on the child protection register for significant periods of time, experience more than one period of registration or suffer a further incident of significant harm whilst subject to a child protection plan. In this article, the findings from a research study conducted into this group of vulnerable children are reported, focusing on the characteristics of the children and their families, and their careers in the child protection system. The paper concludes with observations about the weak conceptualization of performance management and the need to recognize the complexity of the factors that influence children’s careers in the child protection system.

Optimising the use of virtual and conventional simulation: a clinical and economic analysis

Background and purpose: Currently, optimal use of virtual simulation for all treatment sites is not entirely clear. This study presents data to identify specific patient groups for whom conventional simulation may be completely eliminated and replaced by virtual simulation. Sampling and method: Two hundred and sixty patients were recruited from four treatment sites (head and neck, breast, pelvis, and thorax). Patients were randomly assigned to be treated using the usual treatment process involving conventional simulation, or a treatment process differing only in the replacement of conventional plan verification with virtual verification. Data were collected on set-up accuracy at verification, and the number of unsatisfactory verifications requiring a return to the conventional simulator. A micro-economic costing analysis was also undertaken, whereby data for each treatment process episode were also collected: number and grade of staff present, and the time for each treatment episode. Results: The study shows no statistically significant difference in the number of returns to the conventional simulator for each site and study arm. Image registration data show similar quality of verification for each study arm. The micro-costing data show no statistical difference between the virtual and conventional simulation processes. Conclusions: At our institution, virtual simulation including virtual verification for the sites investigated presents no disadvantage compared to conventional simulation.

A randomized controlled trial of tea tree oil (5%) body wash versus standard body wash to prevent colonization with methicillin-resistant Staphylococcus aureus (MRSA) in critically ill adults: research protocol

Background
Over the past ten years MRSA has become endemic in hospitals and is associated with increased healthcare costs. Critically ill patients are most at risk, in part because of the number of invasive therapies that they require in the intensive care unit (ICU). Washing with 5% tea tree oil (TTO) has been shown to be effective in removing MRSA on the skin. However, to date, no trials have evaluated the potential of TTO body wash to prevent MRSA colonization or infection. In addition, detecting MRSA by usual culture methods is slow. A faster method using a PCR assay has been developed in the laboratory, but requires evaluation in a large number of patients.

Methods/Design
This study protocol describes the design of a multicentre, phase II/III prospective open-label randomized controlled clinical trial to evaluate whether a concentration of 5% TTO is effective in preventing MRSA colonization in comparison with a standard body wash (Johnsons Baby Softwash) in the ICU. In addition we will evaluate the cost-effectiveness of TTO body wash and assess the effectiveness of the PCR assay in detecting MRSA in critically ill patients. On admission to intensive care, swabs from the nose and groin will be taken to screen for MRSA as per current practice. Patients will be randomly assigned to be washed with the standard body wash or TTO body wash. On discharge from the unit, swabs will be taken again to identify whether there is a difference in MRSA colonization between the two groups.

Discussion
If TTO body wash is found to be effective, widespread implementation of such a simple colonization prevention tool has the potential to impact on patient outcomes, healthcare resource use and patient confidence both nationally and internationally.

Trial Registration
[ISRCTN65190967]