Anti-depressive effectiveness of olanzapine, quetiapine, risperidone and ziprasidone: a pragmatic, randomized trial

<p>Abstract</p> <p>Background</p> <p>Efficacy studies indicate anti-depressive effects of at least some second generation antipsychotics (SGAs). The Bergen Psychosis Project (BPP) is a 24-month, pragmatic, industry-independent, randomized, head-to-head comparison of olanzapine, quetiapine, risperidone and ziprasidone in patients acutely admitted with psychosis. The aim of the study is to investigate whether differential anti-depressive effectiveness exists among SGAs in a clinically relevant sample of patients acutely admitted with psychosis.</p> <p>Methods</p> <p>Adult patients acutely admitted to an emergency ward for psychosis were randomized to olanzapine, quetiapine, risperidone or ziprasidone and followed for up to 2 years. Participants were assessed repeatedly using the Positive and Negative Syndrome Scale - Depression factor (PANSS-D) and the Calgary Depression Scale for Schizophrenia (CDSS).</p> <p>Results</p> <p>A total of 226 patients were included. A significant time-effect showing a steady decline in depressive symptoms in all medication groups was demonstrated. There were no substantial differences among the SGAs in reducing the PANSS-D score or the CDSS sum score. Separate analyses of groups with CDSS sum scores > 6 or ≤6, respectively, reflecting degree of depressive morbidity, revealed essentially identical results to the primary analyses. There was a high correlation between the PANSS-D and the CDSS sum score (r = 0.77; p < 0.01).</p> <p>Conclusions</p> <p>There was no substantial difference in anti-depressive effectiveness among olanzapine, quetiapine, risperidone or ziprasidone in this clinically relevant sample of patients acutely admitted to hospital for symptoms of psychosis. Based on our findings we can make no recommendations concerning choice of any particular SGA for targeting symptoms of depression in a patient acutely admitted with psychosis.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov ID; URL: <url>http://www.clinicaltrials.gov/</url>: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00932529">NCT00932529</a></p

Randomised controlled trial of a new palliative care service: Compliance, recruitment and completeness of follow-up

<p>Abstract</p> <p>Background</p> <p>Palliative care has been proposed for progressive non-cancer conditions but there have been few evaluations of service developments. We analysed recruitment, compliance and follow-up data of a fast track (or wait list control) randomised controlled trial of a new palliative care service – a design not previously used to assess palliative care.</p> <p>Methods/Design</p> <p>An innovative palliative care service (comprising a consultant in palliative medicine, a clinical nurse specialist, an administrator and a psychosocial worker) was delivered to people severely affected by multiple sclerosis (MS), and their carers, in southeast London. Our design followed the MRC Framework for the Evaluation of Complex Interventions. In phase II we conducted randomised controlled trial, of immediate referral to the service (fast-track) versus a 12-week wait (standard best practice). Main outcome measures were: compliance (the extent the trial protocol was adhered to), recruitment (target 50 patients), attrition and missing data rates; trial outcomes were Palliative Care Outcome Scale and MS Impact Scale.</p> <p>Results</p> <p>69 patients were referred, 52 entered the trial (26 randomised to each arm), 5 refused consent and 12 were excluded from the trial for other reasons, usually illness or urgent needs, achieving our target numbers. 25/26 fast track and 21/26 standard best practice patients completed the trial, resulting in 217/225 (96%) of possible interviews completed, 87% of which took place in the patient's home. Main reasons for failure to interview and/or attrition were death or illness. There were three deaths in the standard best practice group and one in the fast-track group during the trial. At baseline there were no differences between groups. Missing data for individual questionnaire items were small (median 0, mean 1–5 items out of 56+ items per interview), not associated with any patient or carer characteristics or with individual questionnaires, but were associated with interviewer.</p> <p>Conclusion</p> <p>This is the first time a fast track (or wait list) randomised trial has been reported in palliative care. We found it achieved good recruitment and is a feasible method to evaluate palliative care services when patients are expected to live longer than 3–6 months. Home interviews are needed for a trial of this kind; interviewers need careful recruitment, training and supervision; and there should be careful separation from the clinical service of the control patients to prevent accidental contamination.</p> <p>Trial Registration</p> <p>Clinical Trials.Gov NCT00364963</p

Barriers and enablers in the management of tuberculosis treatment in Addis Ababa, Ethiopia: a qualitative study

Tuberculosis (TB) is an infectious disease which causes about two million deaths each year. In 1993, the World Health Organization (WHO) declared TB to be a “Global Emergency” due to an increasing number of TB cases and a rise in multidrug resistant cases in the developed world. Treatment interruption was considered one of the major challenges. WHO introduced the current TB control program DOTS (directly observed treatment, short course) as the tool to control the disease. To prevent further development of resistance against anti-TB drugs it was decided to observe each patient taking their daily dose of medication. The overall aim of this thesis is to explore how patients and health workers perceive and manage TB symptoms and treatment in a high-endemic and a low-endemic setting in the era of DOT(S). The data is based on fieldwork, including in-depth interviews and focus groups with TB patients and health workers, in Addis Ababa, Ethiopia (2001-2002) and in Oslo/Akershus, Norway (2007-2008). We found that people’s interpretation and management of TB symptoms is influenced by cultural, social and economic factors. TB was, in both contexts, associated with poverty, and subsequently with a disease that affects certain countries or certain segments of a population. TB was viewed as a severe disease in both contexts, but there was variation between individuals to what extent one considered oneself as a likely victim. In the absence of circumstantial causes, such as poverty, patients in a lowendemic setting like Norway, found it difficult to understand why they had developed the disease. There was scarce knowledge about the fact that the disease could be latent. Awareness of early symptoms, such as persistent cough, was low in both contexts. Perceptions of vulnerability, together with the presence or absence of socio-economic barriers or enablers influenced at what time patients would seek help. The study suggests that health personnel lacked awareness or misinterpreted early symptoms of TB. In Ethiopia, lay categorizations of early TB symptoms converged with diagnostic practices in parts of the professional health sector. The diagnostic process could endure for many months after patients’ first contact with the health services. Similarly, in Norway, we found that patients’ interpretations of early symptoms often were confirmed in the meeting with health personnel. The consequences were prolonged diagnostic processes. The study shows that patients’ ability to manage TB treatment is a product of dynamic processes, in which social and economic costs and other burdens interplay over time. A decision to interrupt treatment can be shaped by past struggles and accrued costs; in which seems financially, socially or emotionally unbearable at the moment of treatment interruption. The burdens related to DOT could also be significant, in patients who did not interrupt treatment. Patients in both Ethiopia and Norway experienced an authoritarian and rigid practice of DOT, which made it difficult to simultaneously attend to demands related to treatment and demands related to other areas of life. The most vulnerable patients, such as those without permanent jobs, suffered from high economic, social and emotional costs. In conclusion, health personal need more knowledge about typical and atypical symptoms of TB. In low-endemic settings doctors need to be trained to adjust their level of suspicion to the migration history of the patient. In high-endemic settings one should be aware that health personnel may understand and manage TB within a traditional perspective. Patients in both high- and low-endemic contexts need concrete information about the cause of TB, how it is transmitted, how symptoms can be manifested, how the disease can progress and how it can be cured. The study indicates that inequalities that predispose for TB may be reinforced in the patient’s interaction with the health services due to a rigid, disempowering practice of DOT. Subsequently, DOT per se may add to the chain of structural barriers that patients have to overcome to access and complete treatment. To ensure that TB patients complete treatment one must address the coexisting and interacting crises that follow a TB diagnosis. This could require TB programs to adopt a more holistic approach. Measures that secure early diagnosis may reduce some of the physical, psycho-social and economic costs patients face while undergoing treatment. Measures that empower patients to participate in their own health care may avoid disempowering and humiliating practices

The 'lived experience' of palliative care patients in one acute hospital setting - a qualitative study

Background There is limited understanding of the ‘lived experience’ of palliative care patient within the acute care setting. Failing to engage with and understand the views of patients and those close to them, has fundamental consequences for future health delivery. Understanding ‘patient experience’ can enable care providers to ensure services are responsive and adaptive to individual patient need. Methods The aim of this study was to explore the ‘lived experience’ of a group of patients with palliative care needs who had recently been in-patients in one acute hospital trust in the north-west of England. Qualitative research using narrative interviews was undertaken, and data was analysed using thematic analysis. A sample of 20 consecutive patients complying with the inclusion/exclusion criteria were recruited and interviewed. Results Patient Sample: Of the 20 patients recruited, there was a fairly equal gender split; all had a cancer diagnosis and the majority were white British, with an age range of 43–87 years. Findings from Interviews: Overall inpatient experience was viewed positively. Individual narratives illustrated compassionate and responsive care, with the patient at the centre. Acts of compassion appeared to be expressed through the ‘little things’ staff could do for patients, i.e., time to talk, time to care, humanity and comfort measures. AHSPCT involvement resulted in perceived improvements in pain control and holistic wellbeing. However, challenges were evident, particularly regarding over-stretched staff and resources, and modes of communication, which seemed to impact on patient experience. Conclusions Listening to patients’ experiences of care across the organisation provided a unique opportunity to impact upon delivery of care. Further research should focus on exploring issues such as: why some patients within the same organisation have a positive experience of care, while others may not; how do staff attitudes and behaviours impact on the experience of care; transitions of care from hospital to home, and the role of social networks

Binding the Smart City Human-Digital System with Communicative Processes

This chapter will explore the dynamics of power underpinning ethical issues within smart cities via a new paradigm derived from Systems Theory. The smart city is an expression of technology as a socio-technical system. The vision of the smart city contains a deep fusion of many different technical systems into a single integrated “ambient intelligence”. ETICA Project, 2010, p. 102). Citizens of the smart city will not experience a succession of different technologies, but a single intelligent and responsive environment through which they move. Analysis of such an environment requires a framework which transcends traditional ontologically-based models in order to accommodate this deep fusion. This chapter will outline a framework based on Latour’s Actor-Network Theory and Luhmann’s treatment of society as an autopoetic system. We shall use this framework to map the influence of relevant factors on ethical issues, irrespective of their composition or type. For example, under this treatment, both human praxis and technical design can be viewed as comparable tools of domination. This chapter will provide a framework for the analysis of relations between any elements of the smart city, ranging from top-level urban management processes down to individual device operations. While we will illustrate the use of this schema through examination of ethical issues arising from power dynamics within the smart city, it is intended that this example will demonstrate the wider utility of the model in general

Integration of oncology and palliative care : a Lancet Oncology Commission

Full integration of oncology and palliative care relies on the specific knowledge and skills of two modes of care: the tumour-directed approach, the main focus of which is on treating the disease; and the host-directed approach, which focuses on the patient with the disease. This Commission addresses how to combine these two paradigms to achieve the best outcome of patient care. Randomised clinical trials on integration of oncology and palliative care point to health gains: improved survival and symptom control, less anxiety and depression, reduced use of futile chemotherapy at the end of life, improved family satisfaction and quality of life, and improved use of health-care resources. Early delivery of patient-directed care by specialist palliative care teams alongside tumour-directed treatment promotes patient-centred care. Systematic assessment and use of patient-reported outcomes and active patient involvement in the decisions about cancer care result in better symptom control, improved physical and mental health, and better use of health-care resources. The absence of international agreements on the content and standards of the organisation, education, and research of palliative care in oncology are major barriers to successful integration. Other barriers include the common misconception that palliative care is end-of-life care only, stigmatisation of death and dying, and insufficient infrastructure and funding. The absence of established priorities might also hinder integration more widely. This Commission proposes the use of standardised care pathways and multidisciplinary teams to promote integration of oncology and palliative care, and calls for changes at the system level to coordinate the activities of professionals, and for the development and implementation of new and improved education programmes, with the overall goal of improving patient care. Integration raises new research questions, all of which contribute to improved clinical care. When and how should palliative care be delivered? What is the optimal model for integrated care? What is the biological and clinical effect of living with advanced cancer for years after diagnosis? Successful integration must challenge the dualistic perspective of either the tumour or the host, and instead focus on a merged approach that places the patient's perspective at the centre. To succeed, integration must be anchored by management and policy makers at all levels of health care, followed by adequate resource allocation, a willingness to prioritise goals and needs, and sustained enthusiasm to help generate support for better integration. This integrated model must be reflected in international and national cancer plans, and be followed by developments of new care models, education and research programmes, all of which should be adapted to the specific cultural contexts within which they are situated. Patient-centred care should be an integrated part of oncology care independent of patient prognosis and treatment intention. To achieve this goal it must be based on changes in professional cultures and priorities in health care