Conducting randomised controlled trials in an acute stroke unit

PhD ThesisStroke is a major cause of death and disability in the UK. Few treatments exist and those that do, such as thrombolysis (‘clot-busting’ treatment) must be given urgently and are not risk-free. Large scale randomised controlled trials are crucial for the development of safe, effective, acute interventions, but progress has been limited, ostensibly due to ethical and regulatory difficulties. Theoretical work in this area has focussed primarily upon the requirement for prospective informed consent, but has also considered potential conflicts of interests inherent in the dual role of clinicianresearchers, and the notion that research and clinical practice are, can be, and should be conducted separately. Empirical evidence on this topic is lacking. By providing such evidence, this study examines claims made in the literature regarding the difficulties encountered or perceived in conducting emergency research. It also explores whether, how, and to what effect, the distinction between research and clinical activity advocated in the bioethical literature is maintained. Methods Ethnographic methods were employed, including participant observation, semistructured interviews, and audio-recording of research consent interactions in an acute stroke unit. Data were analysed drawing upon constant comparative and framework methods. Results and conclusion Whilst providing empirical evidence supporting some of the theoretical and conceptual literature, the data also furnish a detailed account of pragmatic issues encountered and managed daily by healthcare professionals in the acute stroke environment. Whilst attempts were made at the study site to separate, at least in part, clinical and research activity, it was observed that absolute separation of clinical activities is neither attainable, sustainable, nor desirable. Placement of research nurses within the clinical environment may promote transparency and greater understanding of their role, whilst simultaneously demystifying research concepts. Ultimately this may promote closer working relationships, contributing to enhanced recruitment, retention and management of research participants.personal Researcher Development Award, from the Department of Health National Coordinating Centre for Research Capacity Development (since superseded by the National Institute for Health Research

'I just keep thinking I haven't got it because I'm not yellow': a qualitative study of the factors that influence the uptake of Hepatitis C testing by prisoners

<p>Abstract</p> <p>Background</p> <p>Hepatitis C viral (HCV) infection is a significant public health problem. In the UK, an estimated 200,000 individuals have active HCV infection, most of whom are injecting drug users (IDUs). Many IDUs spend time within the prison system therefore screening for HCV infection in this setting is important. However, uptake of testing within prisons is very low.</p> <p>Methods</p> <p>Qualitative interview study. 30 interviews with 25 male and 5 female prisoners with a history of injecting drug use.</p> <p>Results</p> <p>Personal and institutional barriers to uptake of testing for HCV were identified. Personal barriers included: prisoners' fears and lack of knowledge about HCV, low motivation for testing, lack of awareness about the testing procedure, and concerns about confidentiality and stigma. Institutional barriers included: the prisons' applications procedure for testing, inadequate pre- and post-test discussion, lack of pro-active approaches to offering testing, and lack of continuity of care on discharge and transfer.</p> <p>Conclusion</p> <p>This study highlights potential areas of development in the management of HCV in prisons. Further research is needed to evaluate care pathways for HCV in the prison setting and to develop and assess interventions to improve the uptake of testing for HCV by prisoners.</p

Cognitive stimulation therapy in dementia care: exploring the views and experiences of service providers on the barriers and facilitators to implementation in practice using Normalization Process Theory

Background:&nbsp;Cognitive stimulation therapy (CST) is an evidence-based, cost-effective psychosocial intervention for people with dementia but is currently not a standard part of post-diagnostic care. This qualitative study explored the views and experiences of dementia care providers on the barriers and facilitators to its implementation in usual care.&nbsp; Method:&nbsp;Thirty four semi-structured interviews (24 participants) were conducted across four dementia care sites in the North of England; ten were follow-up interviews. Data were analyzed using thematic analysis and then mapped to the Normalization Process Theory framework.&nbsp; Results:&nbsp;Participants considered CST a &ldquo;good fit&rdquo; with their &ldquo;preferred&rdquo; ways of working and goals of dementia care namely the provision of person-centered services. For facilitators delivering the intervention, compared to other behavioral interventions, CST was seen to offer benefits to their work and was easy to understand as an intervention. Training in CST and seeing benefits for clients were important motivators. Time and resources were crucial for the successful implementation of CST. Participants were keen to objectively measure benefits to participants but unsure how to do this.&nbsp; Conclusions:&nbsp;CST is a cost-effective psychosocial intervention for people with dementia, recommended by national guidance. Despite our findings which show that, using the NPT framework, there are more facilitators than barriers to the implementation of CST, it is still not a standard part of post-diagnostic dementia care. Further research is needed to explore the reasons for this implementation gap in ensuring evidence-based care in translated into practice

Implementing Shared Decision Making in the NHS: Lessons from the MAGIC Programme

Contains fulltext : 174279.pdf (publisher's version ) (Open Access

Clinical research without consent in adults in the emergency setting: a review of patient and public views

<p>Abstract</p> <p>Background</p> <p>In emergency research, obtaining informed consent can be problematic. Research to develop and improve treatments for patients admitted to hospital with life-threatening and debilitating conditions is much needed yet the issue of research without consent (RWC) raises concerns about unethical practices and the loss of individual autonomy. Consistent with the policy and practice turn towards greater patient and public involvement in health care decisions, in the US, Canada and EU, guidelines and legislation implemented to protect patients and facilitate acute research with adults who are unable to give consent have been developed with little involvement of the lay public. This paper reviews research examining public opinion regarding RWC for research in emergency situations, and whether the rules and regulations permitting research of this kind are in accordance with the views of those who ultimately may be the most affected.</p> <p>Methods</p> <p>Seven electronic databases were searched: Medline, Embase, CINAHL, Cochrane Database of Systematic Reviews, Philosopher's Index, Age Info, PsychInfo, Sociological Abstracts and Web of Science. Only those articles pertaining to the views of the public in the US, Canada and EU member states were included. Opinion pieces and those not published in English were excluded.</p> <p>Results</p> <p>Considering the wealth of literature on the perspectives of professionals, there was relatively little information about public attitudes. Twelve studies employing a range of research methods were identified. In five of the six questionnaire surveys around half the sample did <it>not </it>agree generally with RWC, though paradoxically, a higher percentage would <it>personally </it>take part in such a study. Unfortunately most of the studies were not designed to investigate individuals' views in any depth. There also appears to be a level of mistrust of medical research and some patients were more likely to accept an experimental treatment 'outside' of a research protocol.</p> <p>Conclusion</p> <p>There are too few data to evaluate whether the rules and regulations permitting RWC protects – or is acceptable to – the public. However, any attempts to engage the public should take place in the context of findings from further basic research to attend to the apparently paradoxical findings of some of the current surveys.</p

A patient decision aid to support shared decision-making on anti-thrombotic treatment of patients with atrial fibrillation: randomised controlled trial

Objective: to determine the efficacy of a computerised decision aid in patients with atrial fibrillation making decisions on whether to take warfarin or aspirin therapy.Design: two-armed open exploratory randomised controlled trial.Setting: two research clinics deriving participants from general practices in Northeast England.Participants: 109 patients with atrial fibrillation aged over 60.Interventions: computerised decision aid applied in shared decision-making clinic compared to evidence-based paper guidelines applied as direct advice.Main outcome measures: primary outcome measure was the decision conflict scale. Secondary outcome measures included anxiety, knowledge, decision-making preference, treatment decision, use of primary and secondary care services and health outcomes.Results: decision conflict was lower in the computerised decision aid group immediately after the clinic; mean difference ?0.18 (95% CI ?0.34 to ?0.01). Participants in this group not already on warfarin were much less likely to start warfarin than those in the guidelines arm (4/16, 25% compared to the guidelines group 15/16, 93.8%, RR 0.27, 95% CI 0.11 to 0.63).Conclusions: decision conflict was lower immediately following the use of a computerised decision aid in a shared decision-making consultation than immediately following direct doctor-led advice based on paper guidelines. Furthermore, participants in the computerised decision aid group were significantly much less likely to start warfarin than those in the guidelines arm. The results show that such an approach has a positive impact on decision conflict comparable to other studies of decision aids, but also reduces the uptake of a clinically effective treatment that may have important implications for health outcome