Conducting randomised controlled trials in an acute stroke unit

Abstract

Stroke 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.