Leslie Gelling

Potential role of NovoSeven in the prevention of rebleeding following aneurysmal subarachnoid haemorrhage

&NA; Rebleeding following aneurysmal subarachnoid haemorrhage is a major factor contributing to unfavourable outcome. Antifibrinolytic agents reduce the rate of rebleeding but increase the risk of cerebral ischaemia and infarction and hence provide no overall benefit. To address the theoretical concern that recombinant activated factor VII (NovoSeven®, Novo Nordisk A/S, Bagsvaerd, Denmark) might increase the risk of cerebral ischaemia while stabilizing the clot at the site of aneurysmal rupture, an open‐label, dose‐escalation safety study has been developed in collaboration with the UK Spontaneous Intracranial Haemorrhage Group. The trial design includes the recruitment of 15 patients (aged 18 years or over) in good grade with subarachnoid haemorrhage verified by computerized tomography scan or lumbar puncture. Safety evaluation includes clinical observation, monitoring of laboratory variables, positron emission tomography (PET) scanning (rCBF, rOEF, rCMRO2) and transcranial Doppler ultrasound. To date, ten patients have been recruited [NovoSeven® 80 μg/kg single bolus (” = 2), NovoSeven® 80 μg/kg single bolus followed by continuous infusion at 3.5 μg/kg per h (” = 2) or 7 μg/kg per h (” = 1), or control (” = 5)]. Clinical observation, transcranial Doppler ultrasound and PET studies revealed no evidence of cerebral ischaemia in the first nine patients treated with NovoSeven®. The last patient developed middle cerebral artery branch thrombosis contralateral to the aneurysm. The study is currently suspended pending further investigation. Blood Coagul Fibrinolysis 11 (suppl 1):S117‐S120

Difficulties in diagnosing the vegetative state

As our understanding of the complex mechanisms of brain injury continues to develop, accompanied by advances in medical science and technology, the numbers of patients surviving severe brain injury is increasing. Whilst the majority who make it to critical care units emerge from coma and make a useful recovery, a small but significant number remain unresponsive either in coma, the Vegetative State (VS) or the Minimally Conscious State (MCS). Distinguishing between these states is not straightforward, but accurate diagnosis is essential not least because, legally, decisions regarding continued treatment, including artificial hydration and nutrition, can be made on the basis of this diagnosis. Furthermore, there is evidence that patients in the MCS have greater potential for improvement and response to rehabilitation. The best known definition of coma is that proposed by Jennett and Teasdale, which describes the patient as having ‘no verbal response, not obeying commands and not opening the eyes spontaneously or to stimulation’. The literature on coma also describes patients as having no arousal and no awareness, no eye opening, reflex movements only, no language comprehension and no ‘purposeful’ response. Coma is a short-term condition and usually in 2 – 4 weeks most patients either regain consciousness, become vegetative or enter the minimally conscious state. While patients are in coma, regular assessment using a reliable tool such as the Glasgow Coma Scale (GCS) is a routine part of care. However, it is not always easy to identify the point at which changes occur, and coma evolves into the VS or MCS. Lack of eye opening and sleep wake cycles are characteristic of coma and the return of these behaviours indicates a change. Diagnosis of the VS or MCS depends on the absence of behavioural responses. This is considered to equate to lack of consciousness. Yet, there are other reasons why a patient may be unable to respond. For example, patients who are ‘locked in’ may appear to respond in the same way as patients in the VS. Other patients may have no spontaneous motor function, may be apraxic or may not understand language, and will not, therefore, respond to stimuli or commands. The detection of signs of awareness in patients with major perceptual and motor incapacities may prove very difficult. As diagnosis may be made on the basis of a relatively brief and subjective assessment, it is not surprising that misdiagnosis appears to be common. In a study of vegetative patients misdiagnosis was found in 37% of cases, a finding which was replicated by Andrews and colleagues. The main features of the vegetative state are described as spontaneous eye opening, sleep wake cycles, spontaneous maintenance of blood pressure, regular respiratory pattern, no localization to pain, no vocalization, no response to commands and lack of sustained visual pursuit. In an attempt to standardize these complex diagnoses the Royal College of Physicians published diagnostic criteria in 1996, which described three criteria to be met if a patient considered to be in the VS: first, no evidence of awareness, no volitional response and no evidence of language comprehension; secondly, that a cycle of eye opening and closure is present and third that hypothalamic and brain stem function is intact. These criteria have recently been updated in the light of experience with their use before the High Court Family Division. Perceived inconsistencies have been corrected with the emphasis firmly placed on loss of awareness as the single cardinal feature of

Applying for ethical approval for research in the United Kingdom

This article offers practical advice on how to expedite the ethical review process.

Ethical Review of Action Research: The Challenges for Researchers and Research Ethics Committees

Action research has repeatedly demonstrated how it can facilitate problem solving and change in many settings through a process of collaboration which is driven by the community at the heart of the research. The ethical review of action research can be challenging for action researchers and research ethics committees. This paper explores how seven ethical principles can be used by action researchers and research ethics committees as the basis for ethical review. This paper concludes by offering some suggestions for a way forward for both action researchers and research ethics committees.

Monitoring emergence from coma following severe brain injury in an octogenarian using behavioural indicators, electrophysiological measures and metabolic studies: a demonstration of the potential for good recovery in older adults

This case study describes a multi-disciplinary investigation of the emergence from coma of an 80-year old female (KE) following severe traumatic brain injury. The relationship between cognitive/behavioural ability and the integrity of cerebral function was assessed using neuropsychological measures, positron emission tomography, electroencephalography, somatosensory evoked potentials and trans-cranial magnetic stimulation. These investigations were performed as KE was beginning to emerge from coma (4 weeks) and, again, ∼1 year following brain injury, when she was judged to have achieved her maximum level of recovery. Neuropsychological measures revealed improvement during the first year post-injury in KEs speed of information processing, memory and executive abilities. Electrophysiological and metabolic studies indicated a restoration of functional integrity that was consistent with the gradual recovery in higher brain function documented using behavioural procedures. This case study demonstrates the rehabilitation potential of pre-morbidly healthy older adults following severe traumatic brain injury.

When to use mixed methods.

IT WAS not that long ago that combining one methodological approach with another, most obviously qualitative and quantitative research designs, would have been considered fundamentally flawed. Indeed, there were many researchers who would have described themselves as either qualitative or quantitative researchers and, regardless of the research question or the objectives of the research, they would have adopted their favored methodological approach to seek to answer their research question.

Planning a research project

The planning stage of any research project is one of the most important stages in the research process. This article offers insight into the important issues a researcher needs to consider when planning his or her research, including how to develop a research protocol, obtaining research funding, seeking academic, peer and social support, gaining research ethics and governance approval and planning a research schedule. Careful planning ensures that the research project is achievable and can be completed on time, with the funding available.

Introduction to the research series.

THIS ARTICLE PROVIDES an introduction to a series of 26 articles on research in nursing, to be published weekly in forthcoming issues of Nursing Standard, starting this week with ‘Stages in the research process’. There is increasing recognition of the importance of nursing research in developing patient care and nursing practice, and this is reflected in increased numbers of nurses involved in research. Research in nursing has a pivotal role in ensuring clinical practice remains evidence-based, person-centred, and cost effective. The series describes the research process, quantitative and qualitative research methods, dissemination of research findings and implementation in clinical practice. It aims to demystify how research is conducted and the language used to describe research, enabling readers to engage with research and understand its relevance to their practice. Nurses engage with research in different ways and for different reasons. Some undertake research projects to develop clinical practice or as part of educational programmes. Others use research evidence to guide their practice in the clinical environment. Few nursing students have the opportunity to undertake practical placements in research environments or to undertake research projects. However, all nurses should understand the importance of research, how evidence is produced and how they might engage in research. It is important that nurses understand research and develop the knowledge and skills to evaluate it in their area of clinical practice. They can then better recognise research projects that are effectively planned, applicable to practice and conducted in a rigorous, scientific and ethical manner. It may seem daunting at first, but learning about research and applying that learning can make research less intimidating and more accessible. The series provides a useful resource for nurse researchers, especially those new to research, but also serves as a guide to nurses who wish to evaluate the quality of the research they encounter in clinical practice. The series offers an introduction to some of the key methodological issues in research. While it has not been possible to consider all methodologies, designs and tools available to researchers, the topics included are representative of current nursing research. Each article offers an insightful introduction to and overview of a different topic. Topics for articles in the series are listed in Box 1. It has been a pleasure to have been involved in co-ordinating this series of articles and to have received submissions for the series from leading nurse researchers around the world. I hope the articles prove to be a useful resource to all readers of Nursing Standard when planning, undertaking or reading research NS

Stages in the research process.

Research should be conducted in a systematic manner, allowing the researcher to progress from a general idea or clinical problem to scientifically rigorous research findings that enable new developments to improve clinical practice. Using a research process helps guide this process. This article is the first in a 26-part series on nursing research. It examines the process that is common to all research, and provides insights into ten different stages of this process: developing the research question, searching and evaluating the literature, selecting the research approach, selecting research methods, gaining access to the research site and data, pilot study, sampling and recruitment, data collection, data analysis, and dissemination of results and implementation of findings.

A feminist approach to research.

FEMINIST RESEARCH focuses on the experiences of women in natural social settings, where the aim is to ‘make women visible, raise their consciousness and empower them’ (Holloway and Wheeler 2013). Adopting a feminist approach influences what questions researchers ask and how they think about their data, but it does not usually influence how data is managed or analysed. This edition of Nurse Researcher includes two themed papers exploring issues around the collection and analysis of qualitative data in research projects that have adopted a feminist approach. The first paper considers methodological issues in a feminist-informed study and the second paper describes how taking account of feminist ideologies might enhance interpretive interactionism.