Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study

BACKGROUND: Radium-223 dichloride (radium-223), a first-in-class α-emitting radiopharmaceutical, is recommended in both pre- and post-docetaxel settings in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases based on overall survival benefit demonstrated in the phase III ALSYMPCA study. ALSYMPCA included prospective measurements of health-related quality of life (QOL) using two validated instruments: the general EuroQoL 5D (EQ-5D) and the disease-specific Functional Assessment of Cancer Therapy-Prostate (FACT-P).

PATIENTS AND METHODS: Analyses were conducted to determine treatment effects of radium-223 plus standard of care (SOC) versus placebo plus SOC on QOL using FACT-P and EQ-5D. Outcomes assessed were percentage of patients experiencing improvement, percentage of patients experiencing worsening, and mean QOL scores during the study.

RESULTS: Analyses were carried out on the intent-to-treat population of patients randomized to receive radium-223 (n = 614) or placebo (n = 307). The mean baseline EQ-5D utility and FACT-P total scores were similar between treatment groups. A significantly higher percentage of patients receiving radium-223 experienced meaningful improvement in EQ-5D utility score on treatment versus placebo {29.2% versus 18.5%, respectively; P = 0.004; odds ratio (OR) = 1.82 [95% confidence interval (CI) 1.21-2.74]}. Findings were similar for FACT-P total score [24.6% versus 16.1%, respectively; P = 0.020; OR = 1.70 (95% CI 1.08-2.65)]. A lower percentage of patients receiving radium-223 experienced meaningful worsening versus placebo measured by EQ-5D utility score and FACT-P total score. Prior docetaxel use and current bisphosphonate use did not affect these findings. Treatment was a significant predictor of EQ-5D utility score, with radium-223 associated with higher scores versus placebo (0.56 versus 0.50, respectively; P = 0.002). Findings were similar for FACT-P total score (99.08 versus 95.22, respectively; P = 0.004).

CONCLUSIONS: QOL data from ALSYMPCA demonstrated that improved survival with radium-223 is accompanied by significant QOL benefits, including a higher percentage of patients with meaningful QOL improvement and a slower decline in QOL over time in patients with CRPC.

Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points.

Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion.

Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer-reviewed journals and social media including the CPROR twitter account and UOB departmental website (http://www.birmingham.ac.uk/cpro0r).

Anti-VEGF treatment of patients with diabetic macular edema : Studies of visual acuity, macular edema and patient-reported outcomes

The aim of this thesis was to describe and evaluate visual acuity, macular edema and patientreported outcomes (PRO) following anti-VEGF treatment of diabetic macular edema (DME) patients in a real-world setting. Using a longitudinal study design, a cohort of DME patients was followed from baseline to 1 year after treatment start. Data were collected from two eye clinics at two county hospitals. Social background characteristics, medical data and PRO were measured before treatment initiation, at four month and after 1 year. A total of 57 patients completed the study. Mean age was 69 years and the sample was equally distributed regarding sex. At baseline, the patients described their general health as low. One year after treatment initiation, 30 patients had improved visual acuity and 27 patients had no improvement in visual acuity. The patients whose visual acuity improved reported an improvement in several subscales in patient-reported outcome measures (PROM), which was in contrast to the group that experienced a decline in visual acuity, where there was no improvement in PROM. Outcomes from the study can be useful for developing and providing relevant information and support to patients undergoing this treatment.

Self-reported fatigue and associated factors six years after stroke

Several studies have found that fatigue is one of the most commonly reported symptoms after stroke and the most difficult to cope with. The present study aimed to investigate the presence and severity of self-reported fatigue six years after stroke onset and associated factors. The cohort "Life After Stroke Phase I" (n = 349 persons) was invited at six years to report fatigue (Fatigue Severity Scale 7-item version), perceived impact of stroke and global recovery after stroke (Stroke Impact Scale), anxiety and depression (Hospital Anxiety and Depression Scale), life satisfaction (Life Satisfaction Checklist) and participation in everyday social activities (Frenchay Activities Index). At six years 37% of the 102 participants in this cross-sectional study reported fatigue. The results showed that in nearly all SIS domains the odds for post-stroke fatigue were higher in persons with a higher perceived impact. Furthermore, the odds for post-stroke fatigue were higher in those who had experienced a moderate/severe stroke and had signs of depression and anxiety. Fatigue is still present in one-third of persons as long as six years after stroke onset and is perceived to hinder many aspects of functioning in everyday life. There is an urgent need to develop and evaluate interventions to reduce fatigue.

Patient-reported outcomes and visual acuity after 12 months of anti-VEGF-treatment for sight-threatening diabetic macular edema in a real world setting

Aims To examine objective visual acuity measured with ETDRS, retinal thickness (OCT), patient reported outcome and describe levels of glycated hemoglobin and its association with the effects on visual acuity in patients treated with anti-VEGF for visual impairment due to diabetic macular edema (DME) during 12 months in a real world setting. Methods In this cross-sectional study, 58 patients (29 females and 29 males; mean age, 68 years) with type 1 and type 2 diabetes diagnosed with DME were included. Medical data and two questionnaires were collected; an eye-specific (NEI VFQ-25) and a generic health-related quality of life questionnaire (SF-36) were used. Results The total patient group had significantly improved visual acuity and reduced retinal thickness at 4 months and remains at 12 months follow up. Thirty patients had significantly improved visual acuity, and 27 patients had no improved visual acuity at 12 months. The patients with improved visual acuity had significantly improved scores for NEI VFQ-25 subscales including general health, general vision, near activities, distance activities, and composite score, but no significant changes in scores were found in the group without improvements in visual acuity. Conclusions Our study revealed that anti-VEGF treatment improved visual acuity and central retinal thickness as well as patient-reported outcome in real world 12 months after treatment start.

& she was like "O_O" : Animation of reported speech on Twitter

This study relates discourse-pragmatic aspects of the use of the quotatives say, be like, be all, and go to the question of the supposed or actual spoken-likeness of written computer-mediated communication (CMC). 1,800 tokens of reported speech, collected from Twitter, were analyzed in a “constructed dialogue” framework (Tannen, 2007). The results show that users of Twitter employ various CMC devices to animate and modally enrich reported speech, especially in speech reports with be like, be all, and go. They perform a style of communication that is reminiscent of conversational speech, even while having qualities that seem to belong uniquely to CMC.

Systemizers are better code-breakers: self-reported systemizing predicts code-breaking performance in expert hackers and naïve participants

Studies on hacking have typically focused on motivational aspects and general personality traits of the individuals who engage in hacking; little systematic research has been conducted on predispositions that may be associated not only with the choice to pursue a hacking career but also with performance in either naïve or expert populations. Here, we test the hypotheses that two traits that are typically enhanced in autism spectrum disorders—attention to detail and systemizing—may be positively related to both the choice of pursuing a career in information security and skilled performance in a prototypical hacking task (i.e., crypto-analysis or code-breaking). A group of naïve participants and of ethical hackers completed the Autism Spectrum Quotient, including an attention to detail scale, and the Systemizing Quotient (Baron-Cohen et al., 2001, 2003). They were also tested with behavioral tasks involving code-breaking and a control task involving security X-ray image interpretation. Hackers reported significantly higher systemizing and attention to detail than non-hackers. We found a positive relation between self-reported systemizing (but not attention to detail) and code-breaking skills in both hackers and non-hackers, whereas attention to detail (but not systemizing) was related with performance in the X-ray screening task in both groups, as previously reported with naïve participants (Rusconi et al., 2015). We discuss the theoretical and translational implications of our findings.

A educação intercultural na aula de português no 3º Ciclo do Ensino Básico

Esta investigação foi realizada no âmbito do Doutoramento em Educação, na vertente de Educação e Interculturalidade, tendo como título “A educação intercultural na aula de Português no 3º Ciclo do Ensino Básico”. O principal objetivo foi não só o de conhecer as representações e práticas docentes relativamente à diversidade cultural nas turmas de 3º ciclo do Ensino Básico dos Agrupamentos de Escolas e das Escola Não Agrupadas da freguesia de Arrentela, - concelho do Seixal, península de Setúbal -, como também propor uma “matriz sociocultural” para a disciplina de Português no 3º Ciclo do Ensino Básico e aplicá-la a turmas alvo, permitindo verificar se a mesma propicia uma maior e efetiva participação de todos os alunos, contribuindo para o seu sucesso educativo. Esta investigação alicerçou-se no quadro teórico da educação para a cidadania intercultural, nomeadamente na educação intercultural e no modelo coorientacional de Byram. Este trabalho tomou a forma de estudo de caso, tendo-se recorrido ao paradigma quantitativo e qualitativo, tornando-os complementares na recolha de dados. No decorrer desta investigação, efetuou-se um processo de investigação exploratória, tendo-se realizado pesquisa documental para uma breve caracterização da Península de Setúbal, do concelho do Seixal, da freguesia de Arrentela. Fez-se um levantamento de dados sobre a diversidade cultural das escolas com 3º ciclo do Ensino Básico desta freguesia e sobre o insucesso dos alunos no exame de Português de 9º ano. Utilizou-se, ainda, um inquérito por questionário a vinte e um docentes do grupo 300 que lecionaram Português no 3º ciclo do Ensino Básico das escolas supra mencionadas, nos anos letivos 2011/2012, 2012/2013/ 2013-2014 (alguns dos quais ainda lecionam), para conhecer as representações docentes e práticas letivas recorrentes em escolas pluriculturais. A análise dos primeiros dados recolhidos por inquérito por questionário demonstrou que, para os docentes inquiridos, o objetivo primordial da educação intercultural é a abertura e aproximação ao Outro. No que concerne as práticas letivas, há uma preocupação dos professores em aproveitar uma parte do manancial e da riqueza da diversidade cultural das turmas heterogéneas, nomeadamente na prática da leitura/escuta, (re)escrita, na divulgação de textos enriquecedores entre cultura(s), na comparação entre culturas, na promoção de atividades colaborativas, nas atividades integrando a cultura de origem ou de herança. Verificou-se ainda que os materiais privilegiados na sala de aula são maioritariamente os manuais escolares e a compilação de textos emanados pelas editoras de livros escolares. Uma vez que os manuais escolares não contemplam muitas culturas, os docentes utilizam, em menor percentagem, textos de todo o género que permitem a comparação entre culturas, uma atitude crítica e a descentração. Relativamente à colaboração entre alunos, esta é essencialmente realizada através do trabalho de pares, enquanto a cooperação entre escola/comunidade é desenvolvida sobretudo por exposição e eventos escolares abertos à população e por atividades que podem ser corealizadas por alunos e Encarregados de Educação e/ou seus familiares. Como causas para a não implementação da educação intercultural nas aulas de Português, os inquiridos denunciaram fatores fulcrais como a ausência de formação adequada e de materiais didáticos e pedagógicos adequados ou o comportamento dos alunos, entre outros. Posteriormente, foi produzido e aplicado um inquérito por questionário a três turmas heterogéneas escolhidas (7.°, 8.° e 9.° anos) para sua posterior caracterização. Após esta etapa, foram recolhidos e selecionados materiais e atividades pedagógicos que foram integrados numa proposta de “matriz sociocultural” (Costa Afonso, 2002) aberta a modificações, transversal a outras disciplinas, baseada nas diversas identidades socioculturais dos alunos presentes em sala de aula, alicerçada, por um lado, essencialmente, no domínio da educação literária, por outro, na ponte que deve ser, continuamente, estabelecida entre escola/ comunidade local/ comunidade global. Nesta proposta é visível a preocupação na procura de textos literários canónicos, cujos conteúdos culturais permitam o contacto com a alteridade, com outras cosmovisões capazes de promover, por um lado, a desconstrução de preconceitos, estereótipos, do racismo e/ou suas manifestações, por outro, proporcionar a compreensão, a valorização crítica de culturas, a consciencialização da necessidade de liberdade, criatividade e reflexão crítica na criação de um mundo mais justo e na sustentação de um estado democrático. Aquando da aplicação experimental da “matriz”, envolvido nas interações comunicacionais interculturais propiciadas pelos materiais e atividades/projetos subsequentes, o discente assumiu o papel de sujeito sociocultural crítico, cidadão ativo e responsável. Da aplicação experimental foi efetuado um registo dos acontecimentos mais pertinentes. Outras sugestões de atividades/projetos foram veiculadas.

Myths and legends: the reality of rape offences reported to a UK police force

Rape myths affect many aspects of the investigative and criminal justice systems. One such myth, the 'real rape' myth, states that most rapes involve a stranger using a weapon attacking a woman violently at night in an isolated, outdoor area, and that women sustain serious injuries from these attacks. The present study examined how often actual offences reported to a central UK police force over a two year period matched the 'real rape' myth. Out of 400 cases of rape reported, not a single incident was found with all the characteristics of the 'real rape' myth. The few stranger rapes that occurred had a strong link to night-time economy activities, such as the victim and offender both having visited pubs, bars, and clubs. By contrast, the majority of reported rape offences (280 cases, 70.7%) were committed by people known to the victim (e.g., domestic and acquaintance rapes), occurred inside a residence, with most victims sustaining no physical injuries from the attack. The benefits of these naturalistic findings from the field for educating people about the inaccuracy of rape myths are discussed.

RACISM IN DIGITAL ERA: DEVELOPMENT AND INITIAL VALIDATION OF THE PERCEIVED ONLINE RACISM SCALE (PORS V1.0)

Racism continues to thrive on the Internet. Yet, little is known about racism in online settings and the potential consequences. The purpose of this study was to develop the Perceived Online Racism Scale (PORS), the first measure to assess people’s perceived online racism experiences as they interact with others and consume information on the Internet. Items were developed through a multi-stage process based on literature review, focus-groups, and qualitative data collection. Based on a racially diverse large-scale sample (N = 1023), exploratory and confirmatory factor analyses provided support for a 30-item bifactor model with the following three factors: (a) 14-item PORS-IP (personal experiences of racism in online interactions), (b) 5-item PORS-V (observations of other racial/ethnic minorities being offended), and (c) 11-item PORS-I (consumption of online contents and information denigrating racial/ethnic minorities and highlighting racial injustice in society). Initial construct validity examinations suggest that PORS is significantly linked to psychological distress.

First case reported of Bouveret's syndrome associated to duodenal and biliary perforation to retroperitoneum

We present the case of a 69 year old woman with a history of cholecystitis, who consulted for severe abdominal pain, nausea and vomiting. Abdominal CT showed duodenal obstruction caused by a gallstone, cholecystoduodenal fistula and pneumobilia, what is known as Bouveret's syndrome, a rare form of gallstone ileus. Additionally, she presented free duodenal and vesicular perforation to retroperitoneum at the same level of the cholecystoduodenal transit point. The patient underwent a difficult cholecystectomy, enterolithotomy, repair of the duodenal defect, extensive washing and drainage of the retroperitoneum. The postoperative course was uneventful except for a laparotomy infection.

Self-reported vaccination in the elderly : SABE Bogotá study, Colombia

Objectives: To determine the frequency of vaccination in older adults within the city of Bogotá and to estimate the association with sociodemographic and health factors. Methods: This is a secondary data analysis from the SABE-Bogotá Study, a cross-sectional population-based study that included a total of 2,000 persons aged 60 years. Weighted percentages for self-reported vaccination [influenza, pneumococcal, tetanus] were determined. The association between vaccination and covariates was evaluate by logistic regression models. Results: A total of 73.0% of respondents received influenza, 57.8% pneumococcal and 47.6% tetanus vaccine. Factors independently associated with vaccination included: 1- age (65-74 years had higher odds of receiving vaccinations, compared to 60-64 years; 2- socioeconomic status (SES) (higher SES had lower odds of having influenza and pneumococcal vaccines, compared to those with lower SES); 3- health insurance (those with contributive or subsidized health insurance had higher odds (between 3 and 5 times higher) of having vaccinations, compared to those with no insurance); 4- older adults with better functional status (greater Lawton scores) had increased odds for all vaccinations; 5- older adults with higher comorbidity had increased odds for influenza and pneumococcal vaccinations. Conclusion: Vaccination campaigns should be strengthened to increase vaccination coverage, especially in the group more reticent to vaccination or vulnerable to reach it such as the disable elder.