The principle of benefit from drug development for patients in clinical research

From an ethical perspective, clinical research involving humans is only acceptable if it involves the potential for benefit. Various characteristics can be applied to differentiate research benefit. Often benefit is categorized in direct or indirect benefit, whereby indirect benefit might be further differentiated in collective or benefit for the society, excluding or including the trial patient in the long term. Ethical guidelines, such as the Declaration of Helsinki in its latest version, do not precisely favor a particular type of benefit.

Exploring Forensic Nursing Ethics and Practice: Roles, Loyalties and Photodocumentation Practices

Thesis (Ph.D.)--University of Washington, 2016-08

Oncological patient anxiety in imaging studies: the PET/CT example

The purpose of this study was to investigate the subjective perception of anxiety pre- and post-procedure, and explore the relationship between demographic, clinical variables and cancer patients' anxiety during a positron emission tomography/computed tomography (PET/CT) scan. Two hundred and thirty-two oncological out patients, with clinical indication for performing an (18)F-2-fluoro-2-deoxy-D-glucose ((18)F-FDG) PET/CT scan and attending a nuclear medicine (NM) department, participated in the study. Patients' anxiety and subjective experience of PET/CT were examined using two self-report questionnaires. The pre-procedure questionnaire focused on demographic information, level of knowledge regarding the scan and subjective perception of anxiety before the procedure. The post-procedure questionnaire included the subjective perception anxiety after the procedure, information adequacy and satisfaction with the NM department. The self-reported data indicate that patients were anxious during PET/CT. Furthermore, our data revealed a significant difference between the anxiety pre-procedure and post-procedure (z = -3909, p < 0.05), in which the anxiety pre-procedure has significantly higher values. No significant correlation was found between anxiety and age of the patients, education levels, adequacy of information or satisfaction with the NM Department. Perception of anxiety post-procedure differs between gender (U = 5641, p = 0.033). In conclusion, PET/CT generated anxiety levels in oncological patients, especially before the procedure. Although patients seemed to be satisfied with information delivered by staff and with the NM Department, attention has to be focused on effective interventions strategies that help patients to reduce anxiety.

bepress Launches Beta of Expert Gallery to Promote Research Expertise

We at bepress are excited to announce the beta launch of the Expert Gallery, a new product for institutions eager to highlight the rich expertise of their faculty. The Expert Gallery facilitates the valuable work of connecting an institution’s researchers with opportunities that might otherwise be missed. Groups such as Marketing and Communications and the Office of Research can use the product to better land funding opportunities, speaking engagements, and professional collaborations for top faculty members. The Expert Gallery is designed to let stakeholders within and outside of the institution find researchers by interest, skill set, and research emphasis: simple searching and browsing, along with the flexibility to create and display custom galleries, helps facilitate targeted discovery for experts on campus. A built-in, rich toolset lets institutions organize, manage, and connect their researchers to the right opportunities and interested parties outside the institution. While most expert galleries contain just biographical information and a bibliography, integration of the bepress Expert Gallery with SelectedWorks profiles lets researchers prove their expertise with a full picture of their scholarly research, including published and unpublished works, datasets, teaching materials, and media appearances. Launching the Expert Gallery as a new product reflects an important expansion of bepress’s mission. For years we’ve helped libraries reclaim their central role through providing services across campus. We’ve especially focused on supporting the library in its important efforts to promote the institution through the scholarship it produces. With the Expert Gallery, the library can meet its campus’s needs to go beyond demonstrating the value of its scholarship. Now the library can offer a way to promote the institution through the rich skills of the people who make it unique. We plan to continue on this path of helping institutions maximize the impact of people as well as their people’s scholarship. In early 2017 we will launch a suite of services that includes SelectedWorks, the Expert Gallery, and a set of faculty reporting and analytics tools.

Perspective of nurses involved in an action-research study on the changes observed in care provision: results from a focus group

Background According to the Nursing Role Effectiveness Model, the structural components (nurses, patients, organizational variables) may directly BMC Health Services Research 2016, Volume 16 Suppl 3 Page 41 of 132 or indirectly influence the care outcomes through the process (actions developed by the nurses). Objectives: To identify the changes that, from the nurses' perspective, occurred during the provision of care to patients with peripheral venous catheters (PVCs) between the first and the second phase of the Action-Research (AR) study, and the components that influenced these changes. Methods During the second phase of the AR study (December, 2011), a focus group composed of six nurses was held at a medicine unit of a central hospital. A script was used with six open-ended questions. All ethical procedures were followed. Results Positive changes in nursing care provision to patients with PVCs were identified related to the type of dressing used, patient monitoring, aseptic care, and infusion rate. The nurses believed that some variables of the organizational component influenced those changes, such as the centralization of the material used for catheterization or the availability of materials, such as transparent dressings. The nurses also valued the following aspects: knowledge of the research findings of the first phase; training sessions on the topic; and, above all, the nurses' engagement throughout the process of change in care provision. Conclusions Considering the model of analysis used, we found that the changes identified in nursing care resulted from several factors, with the engagement of the professionals themselves in the change process being considered a key aspect.

Assessment of the quality of sample labelling for clinical research

Objective: To assess the quality of the labels for clinical trial samples through current regulations, and to analyze its potential correlation with the specific characteristics of each sample. Method: A transversal multicenter study where the clinical trial samples from two third level hospitals were analyzed. The eleven items from Directive 2003/94/EC, as well as the name of the clinical trial and the dose on the label cover, were considered variables for labelling quality. The influence of the characteristics of each sample on labelling quality was also analyzed. Outcome: The study included 503 samples from 220 clinical trials. The mean quality of labelling, understood as the proportion of items from Appendix 13, was of 91.9%. Out of these, 6.6% did not include the name of the sample in the outer face of the label, while in 9.7% the dose was missing. The samples with clinical trial-type samples presented a higher quality (p < 0.049), blinding reduced their quality (p = 0.017), and identification by kit number or by patient increased it (p < 0.01). The promoter was the variable which introduced the highest variability into the analysis. Conclusions: The mean quality of labelling is adequate in the majority of clinical trial samples. The lack of essential information in some samples, such as the clinical trial code and the period of validity, is alarming and might be the potential source for dispensing or administration errors.

Finnish Preclinical and Clinical Medical Students as Strategic L2 English Learners: Language Learning Strategies and Communicating with Patients

This thesis focused on medical students’ language learning strategies for patient encounters. The research questions concerned the types of learning strategies that medical students use and the differences between the preclinical students and the clinical students, two groups who have had varying amounts of experience with patients. Additionally, strategy use was examined through activity systems to gain information on the context of language learning strategy use in order to learn language for patient encounters. In total, 130 first-year medical students (preclinical) and 39 fifth-year medical students (clinical) participated in the study by filling in a questionnaire on language learning strategies. In addition, two students were interviewed in order to create activity systems for the medical students at different stages of their studies. The study utilised both quantitative and qualitative research methods; the analysis of the results relies on Oxford’s Strategic Self-Regulation Model in the quantitative part and on activity theory in the qualitative part. The theoretical sections of the study introduced earlier research and theories regarding English for specific purposes, language learning strategies and activity theory. The results indicated that the medical students use affective, sociocultural-interactive and metasociocultural-interactive strategies often and avoid using negative strategies, which hinder language learning or cease communication altogether. Slight differences between the preclinical and clinical students were found, as clinical students appear to use affective and metasociocultural-interactive strategies more frequently compared to the preclinical students. The activity systems of the two students interviewed were rather similar. The students were at different stages of their studies, but their opinions were very similar. Both reported the object of learning to be mutual understanding between the patient and the doctor, which in part explains the preference for strategies that support communication and interaction. The results indicate that the nature of patient encounters affects the strategy use of the medical students at least to some extent.

Tying it Together: Education-Focused Community Change Initiatives

Policymakers make many demands of our schools to produce academic success. At the same time, community organizations, government agencies, faith-based institutions, and other groups often are providing support to students and their families, especially those from high-poverty backgrounds, that are meant to impact education but are often insufficient, uncoordinated, or redundant. In many cases, these institutions lack access to schools and school leaders. What’s missing from the dominant education reform discourse is a coordinated education-focused approach that mobilizes community assets to effectively improve academic and developmental outcomes for students. This study explores how education-focused comprehensive community change initiatives (CCIs) that utilize a partnership approach are organized and sustained. In this study, I examine three research questions: 1. Why and how do school system-level community change initiative (CCI) partnerships form? 2. What are the organizational, financial, and political structures that support sustainable CCIs? What, in particular, are their connections to the school systems they seek to impact? 3. What are the leadership functions and structures found within CCIs? How are leadership functions distributed across schools and agencies within communities? To answer these questions, I used a cross-case study approach that employed a secondary data analysis of data that were collected as part of a larger research study sponsored by a national organization. The original study design included site visits and extended interviews with educators, community leaders and practitioners about community school initiatives, one type of CCI. This study demonstrates that characteristics of sustained education-focused CCIs include leaders that are critical to starting the CCIs and are willing to collaborate across institutions, a focus on community problems, building on previous efforts, strategies to improve service delivery, a focus on education and schools in particular, organizational arrangements that create shared leadership and ownership for the CCI, an intermediary to support the initial vision and collaborative leadership groups, diversified funding approaches, and political support. These findings add to the literature about the growing number of education-focused CCIs. The study’s primary recommendation—that institutions need to work across boundaries in order to sustain CCIs organizationally, financially, and politically—can help policymakers as they develop new collaborative approaches to achieving educational goals.

Practical challenges in moving to Open Access: a focus on research funders and universities

At the Berlin7 conference in Paris on 3 December 2009 Knowledge Exchange provided a workshop on the practical challenges to be addressed in moving to Open Access. Presentations where provided by John Houghton and Alma Swan discussing the outcomes of studies on the costs and benefits of Open Access for institutions and the society as a whole. These were followed by presentations by two funding agencies on the results of financing publication costs both at an institutional and national level in Germany. Also the results of the Springer deal in the Netherlands where presented. The third section was focused on the results of implementing mandates both by funding bodies and institutions.

Five-year review of an international clinical research-training program

The exponential increase in clinical research has profoundly changed medical sciences. Evidence that has accumulated in the past three decades from clinical trials has led to the proposal that clinical care should not be based solely on clinical expertise and patient values, and should integrate robust data from systematic research. As a consequence, clinical research has become more complex and methods have become more rigorous, and evidence is usually not easily translated into clinical practice. Therefore, the instruction of clinical research methods for scientists and clinicians must adapt to this new reality. To address this challenge, a global distance-learning clinical research-training program was developed, based on collaborative learning, the pedagogical goal of which was to develop critical thinking skills in clinical research. We describe and analyze the challenges and possible solutions of this course after 5 years of experience (2008-2012) with this program. Through evaluation by students and faculty, we identified and reviewed the following challenges of our program: 1) student engagement and motivation, 2) impact of heterogeneous audience on learning, 3) learning in large groups, 4) enhancing group learning, 5) enhancing social presence, 6) dropouts, 7) quality control, and 8) course management. We discuss these issues and potential alternatives with regard to our research and background.

Heart failure in young adults

Heart failure (HF) is a major health concern affecting 15 million people in Europe and around 900 000 people in the U.K. HF predominantly affects the elderly, with the mean age of patients with a diagnosis of HF between 70 and 80 years. Most previous HF studies have accordingly focused on older patients. Although HF is less common in younger adults (<65 years), 15% to 20% of patients hospitalised with HF are younger than 60 years of age. Very few studies have described the characteristics of younger adults with HF and its outcome. The aims of this thesis are to describe the clinical characteristics of younger adults with HF, explore the epidemiology of HF in younger adults and determine their short- and long-term outcomes. This was made possible by access multiple databases consisting of large patient cohorts with HF. The first chapter is a systematic literature review of younger adults with HF. Gaps in the current literature were identified and the thesis focused on some of these. The CHARM study allows detail characterisations of younger adults with HF. It recorded characteristics of patients with HF, including symptoms and signs of HF, electrocardiographic changes, chest radiographic findings, and also left ventricular ejection fraction. HF hospitalisations and its precipitating factors were also recorded systematically. Younger adults were more likely to have a third heart sound and hepatomegaly, but less likely to have pulmonary crackles and peripheral oedema. Similarly, radiological findings in younger adults were less likely to show interstitial pulmonary oedema or pleural effusion. Interestingly, younger adults aged <40 years not only have similar HF hospitalisation rate to older patients, however during their presentation with decompensated HF, they were less likely to have clinical pulmonary oedema and radiological signs of HF. Physicians managing younger adults with HF need to be aware of this. Younger adults were also less compliant with medications and lifestyle restriction resulting in hospitalisation with decompensated HF. Fortunately, despite these challenges, mortality rates in younger adults with HF were lower compared to older patients. To further substantiate the findings from the CHARM study, the MAGGIC study, a meta-analysis consists of over 40 000 patients with HF from large observational studies and randomised controlled trials, was examined. In both databases, the commonest aetiology of HF in younger adults was dilated cardiomyopathy. The ejection fraction was the lowest in younger adults. Similar to the CHARM study, mortality rates in younger adults were lower compared to older patients. However, in the MAGGIC study, by stratifying mortality into patients with preserved ejection fraction and with reduced ejection fraction, younger patients with preserved ejection fraction have a much lower mortality rate compared to patients with reduced ejection fraction. Findings from clinical trials are not always reflective of the real life clinical practice. The U.K. Clinical Practice Research Datalink (CPRD), a large and well-validated primary care database with 654 practices contributing information into the database representing approximated 8% of the U.K. population, is a rich dataset offering a unique opportunity to examine the characteristics, treatments, and outcomes of younger adults with HF in the community. In contrast to the CHARM and MAGGIC studies, younger adults aged <40 years were stratified into 20-29 and 30-39 years in the CPRD analysis. This is possible due to the larger number of younger adults with HF. Further stratifying the younger age groups demonstrated heterogeneity among younger adults with HF. In contrast to previous data showing younger adults have lower co-morbidities, the proportions of depression, chronic kidney disease, asthma, and any connective tissue disease were high among patients aged 20-29 years in the analysis from the CPRD. Surprisingly, the treatment rates for angiotensin converting enzyme (ACE) inhibitor, and aldosterone antagonist were the lowest in patients aged 20-29 years. With the exception of patients aged ≥80 years, treatment rate with beta-blocker was also the lowest in patients aged 20-29 years. With over two decades of follow up, long-term mortality rates in younger adults with HF can be determined. The mortality rates continued to decline from 1988 to 2011. Physicians managing younger adults with HF can now use this contemporary data to provide prognostic information to patients and their family. A hospital administrative database is the logical next platform to explore younger adults with HF. The Alberta Ministry of Health database links an outpatient database to a hospitalisation database providing ample data to examine the relationship between outpatient clinic visits and hospital admissions in younger adults with HF. Following a diagnosis of HF in the outpatient setting, younger adults were admitted to the hospital with decompensated HF much sooner than older patients. Younger adults also presented to emergency department more frequently following their first hospitalisation for HF. In conclusion, this thesis presented the characteristics and outcomes of younger adults with HF, and helped to extend our current understanding on this important topic. I hope the data presented here will benefit not only physicians looking after younger adults with HF, but also patients and their family.

Attachment Style, Therapeutic Alliance and Recovery in forensic mental health: the A-STAR study and clinical research portfolio

Background: Research suggests that forensic mental health services and staff can play an important role in the recognition and intervention with attachment-related behaviours to promote engagement and recovery. There is a lack of literature exploring whether the attachment needs of forensic service-users are recognised and, associations between attachment style and factors predictive of recovery. Aims: This study aimed to examine the extent to which service-users and keyworkers agree about service-users’ attachment and to identify whether attachment was associated with service attachment, working alliance, ward climate and recovery. Methods: Twenty-two service-users from low and medium secure forensic services, completed questionnaire measures of their attachment style, service attachment, working alliance, ward climate and experiences of recovery. Nineteen keyworkers completed measures of the service-users attachment style and working alliance. Results: There was strong agreement between service-users and staff for attachment anxiety (ICC=0.71) but poor agreement for attachment avoidance (ICC=0.39). Service attachment was associated with more positive perceptions of staff support (r=0.49) and avoidant attachment was associated with lower ratings of recovery (r=-0.51). Correlations between attachment style and service attachment, working alliance and ward climate were small and non-significant. Conclusions: A focus on staff training to support recognition of the nature and impact of avoidant attachment styles is indicated. The findings suggest that interventions to enhance staff - service-user relationships may be important for service attachment and indeed promotion of a recovery focused orientation amongst service-users high in avoidant attachment may improve wellbeing and outcomes.

Safety and complexity: the inter-departmental threats to patient safety in the operating department

Purpose: Current thinking about ‘patient safety’ emphasises the causal relationship between the work environment and the delivery of clinical care. This research draws on the theory of Normal Accidents to extend this analysis and better understand the ‘organisational factors’ that threaten safety. Methods: Ethnographic research methods were used, with observations of the operating department setting for 18 month and interviews with 80 members of hospital staff. The setting for the study was the Operating Department of a large teaching hospital in the North-West of England. Results: The work of the operating department is determined by inter-dependant, ‘tightly coupled’ organisational relationships between hospital departments based upon the timely exchange of information, services and resources required for the delivery of care. Failures within these processes, manifest as ‘breakdowns’ within inter-departmental relationships lead to situations of constraint, rapid change and uncertainty in the work of the operating department that require staff to break with established routines and work with increased time and emotional pressures. This means that staff focus on working quickly, as opposed to working safely. Conclusion: Analysis of safety needs to move beyond a focus on the immediate work environment and individual practice, to consider the more complex and deeply structured organisational systems of hospital activity. For departmental managers the scope for service planning to control for safety may be limited as the structured ‘real world’ situation of service delivery is shaped by inter-department and organisational factors that are perhaps beyond the scope of departmental management.

Caregivers' experiences and coping strategies relating to patient's subjective treatment-related cognitive impairment following Haematopoietic Stem Cell Transplant (HSCT)

The treatments involved in cancers of the blood and bone marrow can be physically and psychologically challenging and be associated with adverse secondary effects, including cognitive impairment. The incidence and severity of treatment-related cognitive impairment varies widely, however it can significantly impact quality of life by interfering with patients’ activities of daily living, relationships and future plans. It can also pose challenges for the patients’ caregivers, an area which has received comparatively less research attention. The aim of this study was to investigate caregivers’ experiences of treatment-related cognitive impairment in patients who have undergone Haematopoietic Stem Cell Transplant (HSCT); how they coped, both practically and emotionally, and what supports they believe could help them. Participants were caregivers to individuals who had undergone HSCT within the past 20 years and who had reported cognitive changes at the HSCT Late Effects Clinic, Beatson West of Scotland Cancer Centre. Five participants completed a single semi-structured interview. The data was then analysed using Interpretative Phenomenological Analysis (IPA). Results of this analysis illustrated four super-ordinate themes: noticing change; managing expectations, managing personal feelings and commitment. Findings from the current study highlighted the importance of caregiver education regarding post HSCT cognitive and behavioural changes and providing caregiver emotional support. Future research should explore the mutual needs of both care recipient and caregiver.

Formação e supervisão das práticas clínicas : uma abordagem ecológica

Nos últimos anos, um conjunto de mudanças de natureza tecnológica institucional, legal e cultural alteraram as funções, a responsabilidade social e a estrutura das organizações de saúde. Estas transformações estão na base do debate actual sobre supervisão clínica em enfermagem enquanto estratégia de promoção da satisfação profissional, segurança e qualidade dos cuidados. A emergência da supervisão clínica em enfermagem permitiu interrogar e dar visibilidade a novas modalidades de formação no contexto de trabalho. A supervisão clínica é um processo multidimensional que inclui encontros regulares entre supervisores e supervisados, com o objectivo de analisar experiências de trabalho e de formação. Dedica-se especial atenção às dimensões emocionais, qualidade de cuidados, relação terapêutica e desenvolvimento pessoal e profissional. A presente pesquisa assume a forma de um estudo de caso realizado num hospital psiquiátrico (Hospital Magalhães Lemos). O objectivo principal do estudo consistiu em compreender o processo amplo e complexo de aprendizagens desenvolvidas em contexto clínico e a forma como estas condicionam as estratégias supervisivas. Recorrendo ao modelo bioecológico de Bronfenbrenner, o estudo interroga de forma sistemática a origem e as relações entre formação e supervisão. Os participantes do estudo foram 18 enfermeiros do referido hospital. Contamos, igualmente, com a colaboração de três peritos com profundo conhecimento da cultura e realidade hospitalar. A informação foi colhida com base em questionários e entrevistas semiestruturadas. O questionário (Clinical Supervision Nursing Inventory – CSNI - V1) inclui três partes. A parte I e II foram relevantes para caracterizar os participantes e o contexto clínico. A parte III do instrumento inclui um inventário com 24 itens. O Alfa de Cronbach calculado pelo autor foi de 0,93 para os 24 itens da escala, indicando excelentes resultados psicométricos. A entrevista semi-estruturada foi usada para a recolha de dados junto dos três peritos. Os enfermeiros possuem uma atitude positiva perante a supervisão clínica. O desenvolvimento pessoal e profissional dos enfermeiros estava relacionado com as oportunidades de formação emergentes no contexto das práticas. Embora a expressão “supervisão clínica” seja por vezes utilizada de forma incorrecta nas organizações, concluímos que existiam no hospital boas práticas a nível da supervisão dos cuidados, relacionando desenvolvimento pessoal, qualidade de cuidados e competências profissionais. Tentámos problematizar as experiências supervisivas partindo de teorias sócio-culturais e bio-ecológicas. Os participantes do estudo referiram que há necessidade de formalizar o sistema de supervisão clínica em enfermagem, evitando relacionálo com o sistema de supervisão de gestão. São apresentados e discutidos diversos subsídios para o desenvolvimento do sistema de supervisão clínica em enfermagem, no hospital.