Developmental study of treatment fidelity, safety and acceptability of a Symptoms Clinic intervention delivered by General Practitioners to patients with multiple medically unexplained symptoms

Acknowledgements This study was funded by the Chief Scientist Office of the Scottish Government, grant CZH_4_495.

Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years : 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study

Acknowledgments The VIVIANE study was funded and coordinated by GlaxoSmithKline Biologicals SA, which also covered all costs associated with development and publication of this report. We thank all study participants and their families. We gratefully acknowledge the work of the central and local study coordinators, and staff members of the sites who participated in this study. Writing support services were provided by Mary Greenacre (An Sgriobhadair, Isle of Barra, UK), on behalf of GSK Vaccines; editing and publication coordination services were provided by Jérôme Leemans (Keyrus Biopharma, Lasne, Belgium), Stéphanie Delval (XPE Pharma and Science, Wavre, Belgium), and Matthieu Depuydt (Business Decision Life Sciences, Brussels, Belgium), on behalf of GSK Vaccines

NEIGHBORHOOD PERCEPTION OF SAFETY AND THE MOBILITY GAP BETWEEN MEN AND WOMEN IN OLD AGE

Background and Objectives: Mobility limitations are a prevalent issue in older adult populations, and an important determinant of disability and mortality. Neighborhood conditions are key determinants of mobility and perception of safety may be one such determinant. Women have more mobility limitations than men, a phenomenon known as the gender mobility gap. The objective of this work was to validate a measure of perception of safety, examine the relationship between neighborhood perception of safety and mobility limitations in seniors, and explore if these effects vary by gender. Methods: This study was cross-sectional, using questionnaire data collected from community-dwelling older adults from four sites in Canada, Colombia, and Brazil. The exposure variable was the neighborhood aggregated Perception of Safety (PoS) scale, derived from the Physical and Social Disorder (PSD) scale by Sampson and Raudenbush. Its construct validity was verified using factor analyses and correlation with similar measures. The Mobility Assessment Tool – short form (MAT-sf), a video-based measure validated cross-culturally in the studied populations, was used to assess mobility limitations. Based on theoretical models, covariates were included in the analysis, both at the neighborhood level (SES, social capital, and built environment) and the individual level (age, gender, education, income, chronic illnesses, depression, cognitive function, BMI, and social participation). Multilevel modeling was used in order to account for neighborhood clustering. Gender specific analyses were carried out. SAS and M-plus were used in this study. Results: PoS was validated across all sites. It loaded in a single factor, after excluding two items, with a Cronbach α value of approximately 0.86. Mobility limitations were present in 22.08% of the sample, 16.32% among men and 27.41% among women. Neighborhood perception of safety was significantly associated with mobility limitations when controlling for all covariates, with an OR of 0.84 (CI 95%: 0.73-0.96), indicating lower odds of having mobility limitations as neighborhood perception of safety improves. Gender did not affect this relationship despite women being more likely to have mobility limitations and live in neighborhoods with poor perception of safety. Conclusion: Neighborhood perception of safety affected the prevalence of mobility limitations in older adults in the studied population.

MODERN SPORT COACHING AND THE LAW: IMPLICATIONS FOR COACH EDUCATION

Introduction
The intersection between the law of negligence and sport coaching in the UK is a developing area (Partington, 2014; Kevan, 2005). Crucially, since the law of negligence may be regarded as generally similar everywhere (Magnus, 2006), with the predominance of volunteer coaches in the UK reflective of the majority of countries in the world (Duffy et al., 2011), a detailed scrutiny of this relationship from the perspective of the coach uncovers important implications for coach education beyond this jurisdiction.  
Argumentation
Fulfilment of the legal duty of discharging reasonable care may be regarded as consistent with the ethical obligation not to expose athletes to unreasonable risks of injury (Mitten, 2013). More specifically, any ‘profession’ requiring ‘special skill or competence’ (Bolam v Friern Hospital Management Committee [1957] 1 WLR 582), including the coaching of sport (e.g., Davenport v Farrow [2010] EWHC 550), requires a higher standard of care to be displayed than would be expected of the ordinary reasonable person (Lunney & Oliphant, 2013; Jones & Dugdale, 2010). For instance, volunteer coaches with no formal qualifications (e.g., Fowles v Bedfordshire County Council [1996] ELR 51) would be judged by this benchmark of professional liability (Powell & Stewart, 2012). Further, as the principles of coaching are constantly assessed and revised (Cassidy et al., 2009; Taylor & Garratt, 2010), so too is the legal standard of care required of coaches (Powell & Stewart, 2012). Problematically, ethical concerns may include coaches being unwilling to increase knowledge, abusive treatment of players and incompetence/inexperience (Haney et al., 1998). These factors accentuate coaches’ exposure to civil liability.
Implications
It is imperative that coaches have an awareness of this emerging intersection and develop a ‘proactive risk assessment lens’ (Hartley, 2010). In addition to supporting the professionalisation of sport coaching, coach education/CPD focused on the legal and ethical aspects of coaching (Duffy et al., 2011; Telfer, 2010; Haney et al., 1998) would enhance the safety and welfare of performers, safeguard coaches from litigation risk, and potentially improve all levels of coaching (Partington, 2014). Interestingly, there is evidence to suggest a demand from coaches for more training on health and safety issues, including risk management and (ir)responsible coaching (Stirling et al., 2012). Accordingly, critical examination of the issue of negligent coaching would inform coach education by: enabling the modelling and sharing of best practice; unpacking important ethical concerns; and, further informing the classification of coaching as a ‘profession’.

Nutritional guide for a modern woman: a strategy for health education

"In the present article, we introduce a Health Education instrument that stems from a refection on the lay knowledge, salutogenic habits and daily nutritional practices of modern women in our current society. We developed a guide aimed at modern women, where the different food groups and food hygiene and safety measures are addressed. The guide includes eleven original pictograms that help the reader to locate and look up specific issues. The guide employs the label reading and interpretation principles, following the nutrition traffic-light internationally instituted, for it renders scientific information on nutrition clear and accessible to the general population. We believe that using this guide as a central strategy in health promotion will lead its users to adopt essential changes in their eating patterns and, in so doing, contribute to prevent diseases associated to bad eating habits. We also emphasize the role of mass media in spreading the conveyed information."

NEIGHBORHOOD PERCEPTION OF SAFETY AND THE MOBILITY GAP BETWEEN MEN AND WOMEN IN OLD AGE

Thesis (Master, Community Health & Epidemiology) -- Queen's University, 2016-10-02 21:02:07.735

Predictive Value Of Phase I Trials For Safety In Later Trials And Final Approved Dose: Analysis Of 61 Approved Cancer Drugs.

Phase I trials use a small number of patients to define a maximum tolerated dose (MTD) and the safety of new agents. We compared data from phase I and registration trials to determine whether early trials predicted later safety and final dose. We searched the U.S. Food and Drug Administration (FDA) website for drugs approved in nonpediatric cancers (January 1990-October 2012). The recommended phase II dose (R2PD) and toxicities from phase I were compared with doses and safety in later trials. In 62 of 85 (73%) matched trials, the dose from the later trial was within 20% of the RP2D. In a multivariable analysis, phase I trials of targeted agents were less predictive of the final approved dose (OR, 0.2 for adopting ± 20% of the RP2D for targeted vs. other classes; P = 0.025). Of the 530 clinically relevant toxicities in later trials, 70% (n = 374) were described in phase I. A significant relationship (P = 0.0032) between increasing the number of patients in phase I (up to 60) and the ability to describe future clinically relevant toxicities was observed. Among 28,505 patients in later trials, the death rate that was related to drug was 1.41%. In conclusion, dosing based on phase I trials was associated with a low toxicity-related death rate in later trials. The ability to predict relevant toxicities correlates with the number of patients on the initial phase I trial. The final dose approved was within 20% of the RP2D in 73% of assessed trials.

Efficacy And Safety Of Intravitreal Bevacizumab In Eyes With Neovascular Glaucoma Undergoing Ahmed Glaucoma Valve Implantation: 2-year Follow-up.

To evaluate the efficacy and safety of intravitreal bevacizumab (IVB) in eyes with neovascular glaucoma (NVG) undergoing Ahmed glaucoma valve (AGV) implantation. This was a multicentre, prospective, randomized clinical trial that enrolled 40 patients with uncontrolled neovascular glaucoma that had undergone panretinal photocoagulation and required glaucoma drainage device implantation. Patients were randomized to receive IVB (1.25 mg) or not during Ahmed valve implant surgery. Injections were administered intra-operatively, and 4 and 8 weeks after surgery. After a mean follow-up of 2.25 ± 0.67 years (range 1.5-3 years), both groups showed a significant decrease in IOP (p < 0.05). There was no difference in IOP between groups except at the 18-month interval, when IOP in IVB group was significantly lower (14.57 ± 1.72 mmHg vs. 18.37 ± 1.06 mmHg - p = 0.0002). There was no difference in survival success rates between groups. At 24 months, there was a trend to patients treated with IVB using less antiglaucoma medications than the control group (p = 0.0648). Complete regression of rubeosis iridis was significantly more frequent in the IVB group (80%) than in the control group (25%) (p = 0.0015). Intravitreal bevacizumab may lead to regression of new vessels both in the iris and in the anterior chamber angle in patients with neovascular glaucoma undergoing Ahmed glaucoma valve implantation. There is a trend to slightly lower IOPs and number of medications with IVB use during AGV implantation for neovascular glaucoma.

Long-term Efficacy And Safety Of Tenofovir Disoproxil Fumarate In Hiv-1-infected Adolescents Failing Antiretroviral Therapy: The Final Results Of Study Gs-us-104-0321.

Reports of long-term tenofovir disoproxil fumarate (TDF) treatment in HIV-infected adolescents are limited. We present final results from the open-label (OL) TDF extension following the randomized, placebo (PBO)-controlled, double-blind phase of GS-US-104-0321 (Study 321). HIV-infected 12- to 17-year-olds treated with TDF 300 mg or PBO with an optimized background regimen (OBR) for 24-48 weeks subsequently received OL TDF plus OBR in a single arm study extension. HIV-1 RNA and safety, including bone mineral density (BMD), was assessed in all TDF recipients. Eighty-one subjects received TDF (median duration 96 weeks). No subject died or discontinued OL TDF for safety/tolerability. At week 144, proportions with HIV-1 RNA <50 copies/mL were 30.4% (7 of 23 subjects with baseline HIV-1 RNA >1000 c/mL initially randomized to TDF), 41.7% (5 of 12 subjects with HIV-1 RNA <1000 c/mL who switched PBO to TDF) and 0% (0 of 2 subjects failed randomized PBO plus OBR with HIV-1 RNA >1000 c/mL and switched PBO to TDF). Viral resistance to TDF occurred in 1 subject. At week 144, median decrease in estimated glomerular filtration rate was 38.1 mL/min/1.73 m (n = 25). Increases in median spine (+12.70%, n = 26) and total body less head BMD (+4.32%, n = 26) and height-age adjusted Z-scores (n = 21; +0.457 for spine, +0.152 for total body less head) were observed at week 144. Five of 81 subjects (6%) had persistent >4% BMD decreases from baseline. Some subjects had virologic responses to TDF plus OBR, and TDF resistance was rare. TDF was well tolerated and can be considered for treatment of HIV-infected adolescents.

Patient education in glaucoma: what do patients know about glaucoma?

PURPOSE: To evaluate the knowledge glaucoma patients have about their disease and its treatment. METHODS: One hundred and eighty-three patients were interviewed at the Glaucoma Service of Wills Eye Hospital (Philadelphia, USA, Group 1) and 100 at the Glaucoma Service of University of Campinas (Campinas, Brazil, Group 2). An informal, relaxed atmosphere was created by the interviewer before asking a list of 18 open-ended questions. RESULTS: In Group 1, 44% of the 183 patients did not have an acceptable idea about what glaucoma is, 30% did not know the purpose of the medications they were taking, 47% were not aware of what was an average intraocular pressure, and 45% did not understand why visual fields were examined. In Group 2, 54% gave unsatisfactory answers to the question What is glaucoma?, 54% did not know the purpose of the medications they were taking, 80% were not aware of what was an average intraocular pressure, and 94% did not understand why visual fields were examined (p<0.001). Linear regression analysis demonstrated that level of education was positively correlated to knowledge about glaucoma in both groups (r=0.65, p=0.001). CONCLUSION: This study showed that patients' knowledge about glaucoma varies greatly, and that in an urban, American setting, around one third of the patients have minimal understanding, whereas in an urban setting in Brazil around two thirds of patients were lacking basic information about glaucoma. Innovative and effective methods are needed to correct this situation.

Educação física e inclusão educacional : entender para atender = Physical education and educational inclusion : understanding to attend

Universidade Estadual de Campinas . Faculdade de Educação Física

Pedagogia do esporte : organização, sistematização, aplicação e avaliação de conteúdos esportivos na educação não formal = Sport pedagogy : organization, systematization and application of sports content in non-formal education

Universidade Estadual de Campinas . Faculdade de Educação Física

Segurança no circo : questão de prioridade = Circus safety: a priority issue

Universidade Estadual de Campinas . Faculdade de Educação Física

Cidadania e educação física : matrizes históricas e políticas, contradições e perspectivas = Citizenship and physical education : historical and political matrices, perspectives and contradictions

Universidade Estadual de Campinas . Faculdade de Educação Física

O esporte paralímpico na formação do profissional em educação física : percepção de professores e acadêmicos = The paralympic sport in physical education professional forming: perceptions of teachers and students

Universidade Estadual de Campinas . Faculdade de Educação Física