The SPHERE Study: Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411]

Background: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland.CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines.

Methods: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to optimal secondary prevention identified in preliminary qualitative research with practitioners and patients. General practitioners and practice nurses attend training sessions in facilitating behaviour change and medication prescribing guidelines for secondary prevention of CHD. Patients are invited to attend regular four-monthly consultations over two years, during which targets and goals for secondary prevention are set and reviewed. The analysis will be strengthened by economic, policy and qualitative components.

Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial

Objective: To test the effectiveness of a complex intervention designed, within a theoretical framework, to improve outcomes for patients with coronary heart disease. Design: Cluster randomised controlled multicentre trial. Setting: General practices in Northern Ireland and the Republic of Ireland, regions with different healthcare systems. Participants: 903 patients with established coronary heart disease registered with one of 48 practices. Intervention: Tailored care plans for practices (practice based training in prescribing and behaviour change, administrative support, quarterly newsletter), and tailored care plans for patients (motivational interviewing, goal identification, and target setting for lifestyle change) with reviews every four months at the practices. Control practices provided usual care. Main outcome measures: The proportion of patients at 18 month follow-up above target levels for blood pressure and total cholesterol concentration, and those admitted to hospital, and changes in physical and mental health status (SF-12). Results: At baseline the numbers (proportions) of patients above the recommended limits were: systolic blood pressure greater than 140 mm Hg (305/899; 33.9%, 95% confidence interval 30.8% to 33.9%), diastolic blood pressure greater than 90 mm Hg (111/901; 12.3%, 10.2% to 14.5%), and total cholesterol concentration greater than 5 mmol/l (188/860; 20.8%, 19.1% to 24.6%). At the 18 month follow-up there were no significant differences between intervention and control groups in the numbers (proportions) of patients above the recommended limits: systolic blood pressure, intervention 98/360 (27.2%) v control, 133/405 (32.8%), odds ratio 1.51 (95% confidence interval 0.99 to 2.30; P=0.06); diastolic blood pressure, intervention 32/360 (8.9%) v control, 40/405 (9.9%), 1.40 (0.75 to 2.64; P=0.29); and total cholesterol concentration, intervention 52/342 (15.2%) v control, 64/391 (16.4%), 1.13 (0.63 to 2.03; P=0.65). The number of patients admitted to hospital over the 18 month study period significantly decreased in the intervention group compared with the control group: 107/415 (25.8%) v 148/435 (34.0%), 1.56 (1.53 to 2.60; P=0.03). Conclusions: Admissions to hospital were significantly reduced after an intensive 18 month intervention to improve outcomes for patients with coronary heart disease, but no other clinical benefits were shown, possibly because of a ceiling effect related to improved management of the disease. Trial registration: Current Controlled Trials ISRCTN24081411.

A dosimetric retrospective planning study comparing volumetric arc therapy (VMAT) and stereotactic body radiotherapy (SBRT) treatment plans for non-small cell lung cancer (NSCLC)

Purpose A retrospective planning study comparing volumetric arc therapy (VMAT) and stereotactic body radiotherapy (SBRT) treatment plans for non-small cell lung cancer (NSCLC). Methods and materials Five randomly selected early stage lung cancer patients were included in the study. For each patient, four plans were created: the SBRT plan and three VMAT plans using different optimisation methodologies. A total of 20 different plans were evaluated. The dose parameters of dose conformity results and the target dose constraints results were compared for these plans. Results The mean planning target volume (PTV) for all the plans (SBRT and VMAT) was 18·3 cm3, with a range from 15·6 to 20·1 cm3. The maximum dose tolerance to 1 cc of all the plans was within 140% (84 Gy) of the prescribed dose, and 95% of the PTV of all the plans received 100% of the prescribed dose (60 Gy). In all the plans, 99% of the PTV received a dose >90% of the prescribed dose, and the mean dose in all the plans ranged from 67 to 72 Gy. The planning target dose conformity for the SBRT and the VMAT (0°, 15° collimator single arc plans and dual arc) plans showed the tightness of the prescription isodose conformity to the target. Conclusions SBRT and VMAT are radiotherapy approaches that increase doses to small tumour targets without increasing doses to the organs at risk. Although VMAT offers an alternative to SBRT for NSCLC and the potential advantage of VMAT is the reduced treatment times over SBRT, the statistical results show that there was no significant difference between the SBRT and VMAT optimised plans in terms of dose conformity and organ-at-risk sparing.

The cost-effectiveness of the SPHERE intervention for the secondary prevention of coronary heart disease

Objectives: The Secondary Prevention of Heart disEase in geneRal practicE (SPHERE) trial has recently reported. This study examines the cost-effectiveness of the SPHERE intervention in both healthcare systems on the island of Ireland. Methods: Incremental cost-effectiveness analysis. A probabilistic model was developed to combine within-trial and beyond-trial impacts of treatment to estimate the lifetime costs and benefits of two secondary prevention strategies: Intervention - tailored practice and patient care plans; and Control - standardized usual care. Results: The intervention strategy resulted in mean cost savings per patient of 512.77 (95 percent confidence interval [CI], 1086.46-91.98) and an increase in mean quality-adjusted life-years (QALYs) per patient of 0.0051 (95 percent CI, 0.0101-0.0200), when compared with the control strategy. The probability of the intervention being cost-effective was 94 percent if decision makers are willing to pay €45,000 per additional QALY. Conclusions: Decision makers in both settings must determine whether the level of evidence presented is sufficient to justify the adoption of the SPHERE intervention in clinical practice. Copyright © Cambridge University Press 2010.

End-of-life decision making in Europe and Australia - A physician survey

Background: The frequencies with which physicians make different medical end-of-life decisions (ELDs) may differ between countries, but comparison between countries has been difficult owing to the use of dissimilar research methods. Methods: A written questionnaire was sent to a random sample of physicians from 9 specialties in 6 European countries and Australia to investigate possible differences in the frequencies of physicians' willingness to perform ELDs and to identify predicting factors. Response rates ranged from 39% to 68% (N= 10 139). Using hypothetical cases, physicians were asked whether they would ( probably) make each of 4 ELDs. Results: In all the countries, 75% to 99% of physicians would withhold chemotherapy or intensify symptom treatment at the request of a patient with terminal cancer. In most cases, more than half of all physicians would also be willing to deeply sedate such a patient until death. However, there was generally less willingness to administer drugs with the explicit intention of hastening death at the request of the patient. The most important predictor of ELDs was a request from a patient with decisional capacity (odds ratio, 2.1-140.0). Shorter patient life expectancy and uncontrollable pain were weaker predictors but were more stable across countries and across the various ELDs (odds ratios, 1.1-2.4 and 0.9-2.4, respectively). Conclusion: Cultural and legal factors seem to influence the frequencies of different ELDs and the strength of their determinants across countries, but they do not change the essence of decision making.

A VIVÊNCIA DO ONCOLOGISTA NA INFORMAÇÃO DO DIAGNÓSTICO DE CÂNCER À PACIENTE

O presente estudo teve como objetivo, por meio de uma pesquisa qualitativa segundo a abordagem fenomenológica existencial, investigar os pensamentos, sentimentos e atitudes do oncologista na informação do diagnóstico de câncer à paciente. Foram realizadas 5 entrevistas semi-dirigidas com oncologistas que atendem em consultório particular, e foi delimitada a análise compreensiva fenomenológica do conteúdo. Os resultados obtidos mostraram que: A informação do diagnóstico de câncer de mama para pacientes jovens em idade reprodutiva foi considerada a mais marcante para os médicos, lhes causando maior preocupação, medo e tristeza, devido às limitações impostas pela doença aos planos de vida da paciente e às questões da maternidade. Os entrevistados referiram que em qualquer caso, o momento da notícia lhes repercute emocionalmente, pela vivência do sentimento de tristeza, ou por fantasias relacionadas à responsabilidade pela doença. Eles apontaram como mais difícil nesse processo, o confronto com as reações emocionais da paciente e falar sobre o câncer utilizando palavras para amenizar o impacto dessa informação. Diante dessas dificuldades, a evolução da medicina, a possibilidade de cirurgia conservadora e a reconstrução mamária foram consideradas atenuantes. Os médicos afirmaram que informam a paciente de maneira clara, objetiva e gradativa, mas nem todos eles utilizam sempre a palavra câncer . Procuram encorajar a paciente com otimismo e solidariedade, engajando-a no tratamento como participante ativa. Além disso, sentem-se responsáveis por motivar aquela que demonstra desânimo ou que reluta em seguir o tratamento. Eles percebem que a partir da informação do diagnóstico a paciente estabelece um vínculo de confiança e dependência, e identificam que em alguns casos eles também se vinculam à paciente. Entretanto, reconhecem que desse vínculo deriva um desgaste emocional que os leva ao questionamento sobre a escolha de sua especialidade. Constatou-se que alguns oncologistas podem emitir sua opinião sobre determinado diagnóstico, às vezes, a pedido da paciente, mas que ao errarem nesse pré-julgamento, evidenciam sentimentos de impotência, ou fracasso, ou culpa, por não se prepararem, nem à paciente, para o momento da informação. Os casos em que a família interfere com questionamentos ou com o pedido de ocultação da informação não foram vistos por eles de modo negativo, contudo, o pedido de ocultação nem sempre é acatado. Os entrevistados referiram algum tipo de aprendizado através do contato com a paciente oncológica, ou por meio da reavaliação de seus valores morais, ou da reflexão sobre sua própria finitude. Particularmente nos casos de câncer avançado ou terminal, esse aprendizado abrangeu o apoio nos momentos que precedem a morte, ou o reconhecimento da própria impotência. Conclusão: A análise dos resultados revelou os conflitos e as dúvidas do médico como ser ético , que assume os riscos ao escolher quanto, quando e como informar o diagnóstico à paciente, sua consciência de culpabilidade, a ansiedade existencial desencadeada pelas reações emocionais da paciente, a manifestação de sua maneira preocupada de existir no mundo, a busca pelo encontro autêntico e criativo, a subjetividade utilizada como caminho para a compreensão do ser doente e a possibilidade do fracasso de um projeto resultar em frustração e num rebaixamento temporário da confiança em sua própria capacidade. Desse modo, esse trabalho demonstra a inevitável influência dos fatores subjetivos na atitude do médico que informa o diagnóstico de câncer para sua paciente e que esse processo está muito além de qualquer pretensa objetividade.

The trajectory of minor stroke recovery for men and their female spousal caregivers: Literature review

Title The trajectory of minor stroke recovery for men and their female spousal caregivers: literature review Aim This paper is a report of a narrative review to examine the current state of knowledge regarding the impact of minor stroke on male patients and their female spousal caregivers’ recovery trajectory and quality of life. Background Minor stroke survivors are often discharged early in the recovery process. The perception of the healthcare community that these patients and their female spousal caregivers will experience an uneventful recovery may lead to inadequate preparation for the postdischarge period. Methods A range of databases was searched to identify papers addressing ‘minor stroke’, ‘transitions’, ‘quality of life’, ‘chronic disease’, ‘caregivers’ and ‘spouse caregivers’, including AARP Ageline, AMED, CINAHL, Evidence Based Medicine Reviews, MEDLINE and PsychInfo. Papers published in English from 1990 to December 2006 were included. Thirty-four papers were in the final data set. Results Minor stroke survivors and their female spousal caregivers may experience major challenges in adaptations postdischarge. The trajectory of minor stroke recovery may necessitate a re-evaluation of life plans, rethinking of priorities and integration of resulting disabilities into current and emerging life situations for both stroke survivors and their female spousal caregivers. In many cases these adaptations are compounded by transitions associated with the normal ageing process. Conclusion While there is extensive literature on stroke recovery and the role of caregivers in general, there is little available describing the recovery of minor stroke survivors in relation to the normal ageing process. Further research is needed examining recovery from a transitional perspective, to support nurses and other health professionals discharge planning.

A comparison of conformal and intensity-modulated techniques for oesophageal radiotherapy.

Background and purpose: To investigate the potential of intensity-modulated radiotherapy (IMRT) to reduce lung irradiation in the treatment of oesophageal carcinoma with radical radiotherapy.Materials and methods: A treatment planning study was performed to compare two-phase conformal radiotherapy (CFRT) with IMRT in five patients. The CFRT plans consisted of anterior, posterior and bilateral posterior oblique fields, while the IMRT plans consisted of either nine equispaced fields (9F), or four fields (4F) with orientations equal to the CFRT plans. IMRT plans with seven, five or three equispaced fields were also investigated in one patient. Treatment plans were compared using dose-volume histograms and normal tissue complication probabilities.Results: The 9F IMRT plan was unable to improve on the homogeneity of dose to the planning target volume (PTV), compared with the CFRT plan (dose range, 16.9+/-4.5 (1 SD) vs. 12.4+/-3.9%; P=0.06). Similarly, the 9F IMRT plan was unable to reduce the mean lung dose (11.7+/-3.2 vs. 11.0+/-2.9 Gy; P=0.2). Similar results were obtained for seven, five and three equispaced fields in the single patient studied. The 4F IMRT plan provided comparable PTV dose homogeneity with the CFRT plan (11.8+/-3.3 vs. 12.4+/-3.9%; P=0.6), with reduced mean lung dose (9.5+/-2.3 vs 11.0+/-2.9 Gy; P=0.001).Conclusions: IMRT using nine equispaced fields provided no improvement over CFRT. This was because the larger number of fields in the IMRT plan distributed a low dose over the entire lung. In contrast, IMRT using four fields equal to the CFRT fields offered an improvement in lung sparing. Thus, IMRT with a few carefully chosen field directions may lead to a modest reduction in pneumonitis, or allow tumour dose escalation within the currently accepted lung toxicity.

Monitoring treatment fidelity in a randomised controlled trial of a complex intervention.

Aim. This paper is a report of a study to describe how treatment fidelity is being enhanced and monitored, using a model from the National Institutes of Health Behavior Change Consortium. Background. The objective of treatment fidelity is to minimize errors in interpreting research trial outcomes, and to ascribe those outcomes directly to the intervention at hand. Treatment fidelity procedures are included in trials of complex interventions to account for inferences made from study outcomes. Monitoring treatment fidelity can help improve study design, maximize reliability of results, increase statistical power, determine whether theory-based interventions are responsible for observed changes, and inform the research dissemination process. Methods. Treatment fidelity recommendations from the Behavior Change Consortium were applied to the SPHERE study (Secondary Prevention of Heart DiseasE in GeneRal PracticE), a randomized controlled trial of a complex intervention. Procedures to enhance and monitor intervention implementation included standardizing training sessions, observing intervention consultations, structuring patient recall systems, and using written practice and patient care plans. The research nurse plays an important role in monitoring intervention implementation. Findings. Several methods of applying treatment fidelity procedures to monitoring interventions are possible. The procedure used may be determined by availability of appropriate personnel, fiscal constraints, or time limits. Complex interventions are not straightforward and necessitate a monitoring process at trial stage. Conclusion. The Behavior Change Consortium’s model of treatment fidelity is useful for structuring a system to monitor the implementation of a complex intervention, and helps to increase the reliability and validity of evaluation findings.

The role of PET/CT scanning in radiotherapy planning

The introduction of functional data into the radiotherapy treatment planning process is currently the focus of significant commercial, technical, scientific and clinical development. The potential of such data from positron emission tomography (PET) was recognized at an early stage and was integrated into the radiotherapy treatment planning process through the use of image fusion software. The combination of PET and CT in a single system (PET/CT) to form an inherently fused anatomical and functional dataset has provided an imaging modality which could be used as the prime tool in the delineation of tumour volumes and the preparation of patient treatment plans, especially when integrated with virtual simulation. PET imaging typically using F-Fluorodeoxyglucose (F-FDG) can provide data on metabolically active tumour volumes. These functional data have the potential to modify treatment volumes and to guide treatment delivery to cells with particular metabolic characteristics. This paper reviews the current status of the integration of PET and PET/CT data into the radiotherapy treatment process. Consideration is given to the requirements of PET/CT data acquisition with reference to patient positioning aids and the limitations imposed by the PET/CT system. It also reviews the approaches being taken to the definition of functional/ tumour volumes and the mechanisms available to measure and include physiological motion into the imaging process. The use of PET data must be based upon a clear understanding of the interpretation and limitations of the functional signal. Protocols for the implementation of this development remain to be defined, and outcomes data based upon clinical trials are still awaited. © 2006 The British Institute of Radiology.

Children's lives, children's futures: A study of children starting secondary school

This title presents a fascinating analysis of how children in their first year of high school feel about their schools, its place in their lives and its role in their futures. This highly topical monograph focuses on how children in their first year of high school feel about school, its place in their lives and its role in their futures. The theoretical context of the study is the focus in educational studies on children's voice and children's active role in education, together with the focus in the sociology of childhood on children as active constructors of their lives and childhood as a subject of serious study. The importance of young people's life plans and the alignment between education and ambitions was recognized in the Sloan Foundation study of American teenagers. In many Western societies there is concern that children from less advantaged social backgrounds have limited aspirations, and are disproportionately unlikely to go to university. This book is highly relevant to understanding the nature of children's engagement with education, the choices and constraints they experience and the reasons some young people fail to take advantage of educational opportunities. "Continuum Studies in Educational Research" (CSER) is a major new series in the field of educational research. Written by experts and scholars for experts and scholars, this ground-breaking series focuses on research in the areas of comparative education, history, lifelong learning, philosophy, policy, post-compulsory education, psychology and sociology. Based on cutting edge research and written with lucidity and passion, the CSER series showcases only those books that really matter in education - studies that are major, that will be remembered for having made a difference.

Konsten att välja rätt spårvagn : en studie av segregation, skolval och unga människors studieplaner

The art of choosing the right tram – A study of urban segregation, choice of school and young people’s life plans When discussing barriers to integration and young people’s choice of school, research often focuses on language skills, cultural capital, supportive environments and other more obvious, distinct and material aspects that have an impact on educational achievement. In the present study, we have instead chosen to look at how young immigrants construct their inner career landscapes and life-plans, and how this relates to their perception of ethnicity, neighbourhood and identity. The sample used here consists of altogether twenty individuals. The interviews were used to explore certain designated dimensions and processes. All interviews were conducted in the school environment, in classrooms and other locations. The students attended two different inner-city schools. A narrative-sociological approach is used in the analysis. The young people’s perceptions and narratives are analysed in relation to concepts such as: territorial stigmatization, identity, self-perception and modifications of life plans. The findings show that the feelings of otherness which originates in housing conditions, experiences of exclusion and the everyday life of many immigrants, are transposed into the school area and transformed into strategies and life plans.

Plano de carreira versus crescimento do indivíduo e eficácia das organizações - o caso Instituto Batista de Educação de Vitória (ES)

A temática aqui proposta tem por objetivo analisar até que ponto a implementação de um plano de carreira pode vir a ser um fator de crescimento do indivíduo e de maior eficácia no Instituto Batista de Educação de Vitória (ffiEV). Assim, no presente Estudo de Caso foram realizadas pesquisas bibliográficas e pesquisa de campo mediante aplicação de questionário (entrevistas focalizadas, semi-estruturadas) de forma a embasar conceitualmente a temática e com informações relevantes caracterizar a Instituição, para estabelecer a relação entre plano de carreira, plano de vida e a utilização do capital humano como um fator de crescimento do indivíduo e de maior eficácia organizacional. Os elementos que compõem o quadro de recursos humanos do ffiEV serão apresentados e interpretados sob um enfoque dialético compatível com as proposições de plano de carreira e plano de vida, dos autores elencados na bibliografia No transcorrer dessa dissertação serão contracenados os conceitos de plano de carreira e plano de vida que por um longo período de tempo e talvez ainda hoje, são pensados como não correlacionados. Isto acontece porque, para conseguirmos correlacionar estes conceitos e sistemas, necessitamos aprender a analisá-los de uma perspectiva macro. Neste ponto, pode-se juntar estes conceitos e entender as suas correlações. É claro que estes relacionamentos são complexos, o que é uma das razões pelas quais eles não são enxergados. Olhando para este quadro geral através do conceito plano de carreira/plano de vida, é fácil concluir que o ffiEV é um sistema complexo com subsistemas ativos (humano e técnico) e uma estrutura geral (estrutura). Esta estrutura irá prover meios com os quais os subsistemas irão interagir, e conseqüentemente prover diferentes possibilidades de interação. As interações entre os atores do sistema terão conseqüências que poderão ser medidas através de investigações quantitativas e qualitativas. Estas conseqüências são, por exemplo, qualidade, eficiência organizacional, lucro, satisfação com o trabalho, comprometimento com a organização, ou pode-se dizer de maneira mais geral que estas conseqüências são referentes à saúde do indivíduo e à saúde da organização. Este sistema complexo chamado ffiEV existe e interage em um sistema maior, chamado mercado, que por sua vez é parte de outro sistema, que é a sociedade. O ser humano é também um componente destes dois outros sistemas. Este, então, age e interage em ambientes distintos e correlacionados, que são a instituição (como funcionário), o mercado (como consumidor) e a sociedade (como membro). Por se constatar que o sistema humano em questão interage uma certa quantidade de horas exclusivamente ou quase exclusivamente com a instituição, e uma mesma ou maior quantidade de horas com a sociedade, então não podem ser excluídas realidades da vida de alguém, do seu trabalho na organização ou do seu convívio com família e amigos.