Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC). A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats

BACKGROUND: Uncertainties surrounding the effectiveness and cost-effectiveness of childhood tonsillectomy for recurrent sore throat led the NHS Health Technology Assessment Programme to commission this research to evaluate the effectiveness and cost-effectiveness of tonsillectomy and adeno-tonsillectomy in comparison with standard non-surgical management in children aged under 16 with recurrent throat infections. The aim is to evaluate if tonsillectomy and adeno-tonsillectomy reduces the number of episodes of sore throats among children to a clinically significant extent. METHODS/DESIGN: A simple prospective pragmatic randomised controlled trial with economic analysis and prospective cohort study of non-trial participants comparing surgical intervention with conventional medical treatment. The treatment arm will receive tonsillectomy and adeno-tonsillectomy while in the control arm non-surgical conventional medical treatment only will be used. The primary outcome measure will be reported number of episodes of sore throat over two years with secondary outcomes measures of reported number of episodes of sore throat, otitis media and upper respiratory tract infection which invoke a GP consultation; reported number of symptom-free days; reported severity of sore throats and surgical and anaesthetic morbidity. The study will take place in five hospitals in the UK. The trial population will be 406 children aged 4–15 on their last birthday with recurrent sore throat referred by primary care to the 5 otolaryngology departments. The duration of the study is seven years (July 2001- July 2008). DISCUSSION: As with all pragmatic randomised controlled trials it is impossible to control the external environment in which the research is taking place. Since this trial began a number of factors have arisen which could affect the outcome including; a reduction in the incidence of respiratory tract infections, marked socio-economic differences in consultation rates, the results from the National Prospective Tonsillectomy Audit and the Government's waiting list initiatives

Describing the impact of health research: a Research Impact Framework

BACKGROUND: Researchers are increasingly required to describe the impact of their work, e.g. in grant proposals, project reports, press releases and research assessment exercises. Specialised impact assessment studies can be difficult to replicate and may require resources and skills not available to individual researchers. Researchers are often hard-pressed to identify and describe research impacts and ad hoc accounts do not facilitate comparison across time or projects. METHODS: The Research Impact Framework was developed by identifying potential areas of health research impact from the research impact assessment literature and based on research assessment criteria, for example, as set out by the UK Research Assessment Exercise panels. A prototype of the framework was used to guide an analysis of the impact of selected research projects at the London School of Hygiene and Tropical Medicine. Additional areas of impact were identified in the process and researchers also provided feedback on which descriptive categories they thought were useful and valid vis-à-vis the nature and impact of their work. RESULTS: We identified four broad areas of impact: I. Research-related impacts; II. Policy impacts; III. Service impacts: health and intersectoral and IV. Societal impacts. Within each of these areas, further descriptive categories were identified. For example, the nature of research impact on policy can be described using the following categorisation, put forward by Weiss: Instrumental use where research findings drive policy-making; Mobilisation of support where research provides support for policy proposals; Conceptual use where research influences the concepts and language of policy deliberations and Redefining/wider influence where research leads to rethinking and changing established practices and beliefs. CONCLUSION: Researchers, while initially sceptical, found that the Research Impact Framework provided prompts and descriptive categories that helped them systematically identify a range of specific and verifiable impacts related to their work (compared to ad hoc approaches they had previously used). The framework could also help researchers think through implementation strategies and identify unintended or harmful effects. The standardised structure of the framework facilitates comparison of research impacts across projects and time, which is useful from analytical, management and assessment perspectives