Title: PRimary care Infection Management for Everyday practice (PRIME)
Funder: Department of Health (England)

Abstract: Aims This programme will address the public health need a) to provide evidence for more rationally targeting antibiotics to those most likely to benefit and b) to develop better antibiotic and non-antibiotic strategies. Background Acute infections are the commonest conditions managed in primary care, and most people still receive an antibiotic despite limited evidence for their effectiveness. The overuse of antibiotics creates a major threat to the public health - antibiotic resistance. To move patient care forward we need to a) understand which patients are likely to suffer adversely when antibiotics are not given b) assess the impact of infections and their treatment on quality of life c) assess the effectiveness of alternative antibiotic prescribing strategies and non antibiotic approaches, and d) develop easily accessible information for patients. Research plans We propose a series of efficiently overlapping and complementary workstreams/studies 1) Qualitative study. This study will explore issues for patients and doctors surrounding the quality of life for infections (RTIs) and their complications; analgesic use, other self help measures; and perceptions of delayed prescribing. 2) Complication study. This study will assess predictors of complications for the commonest respiratory infection, lower respiratory tract infection (LRTI). It will further develop simple recruiting methods for large prospective clinical cohorts. We will investigate all patient reported adverse events and assess predictors of adverse outcome. 3) Exploratory trial. This multi factorial trial will a) allow efficient estimation of several interventions (delayed prescribing;analgesia; steam) - prior to a larger definitive trial of promising individual components b) facilitate economic data collection from patients with a range of uncomplicated illness presentations, and c) allow methodological development. 4) Recurrent illness. Recurrent/chronic rhinosinusitis has very poor quality of life. Patients with chronic/recurrent rhinosinusitis will be invited from GP lists and randomised to: daily a) nasal irrigation b) steam inhalation c) neither d) both. Resources permitting we will extend trials of xylitol and probiotics for recurrent sore throat, and otitis media. 5) Trial of tailored self management website. We will develop and then perform a moderate sized trial of a robust, theoretically based, interactive and tailored website to alter antibiotic expectations and use. We will develop a website and perform a trial among a minimum of 2000 patients. (A definitive trial will require several thousand patients). A website has the potential for results to be available rapidly nationally and currently 60% of families have access rising by 5% each year. 6) Economic modelling study. The existing Cochrane review's of antibiotics for sore throat, otitis media, chest infections, and sinusitis will be used or updated if the last update was more than 2 years previously. The data from these reviews, the data from studies 2 to 5 (both quality of life and resource use data), and other data on the quality of life for complications (either from systematic reviews of the data or from denuovo data collection as necessary) will be used to populate economic models to estimate the cost effectiveness of different management strategies in acute RTI (analgesic advice; steam inhalation; delayed prescription; interactive website) and chronic relapsing RTI (steam inhalation; nasal irrigation). Research team. The Southampton and Oxford groups are international leaders in the field of the management of acute infections in both adults and children in primary care. The team is a multi-disciplinary one – encompassing qualitative and quantitative methodologists, health psychology, computing, statistics, and health economics. Research Environment. This Programme is supported by the primary care groups of both Universities, and also by the local primary care trusts - where our previous research has been performed and the results successfully implemented. Anticipated outputs. The output has the potential to affect millions of primary care consultations annually, and to significantly improve patient care in the area of most frequent contact with the health service. Public involvement. A key focus of this work is to address patients’ major concerns; the qualitative research aims to understand and incorporate fully patients’ perspectives; a patient has joined the team as a full collaborator, and a patient representative will also be invited to join the TSC. Ethical implications. There are no major ethical implications for any of these studies. Justification of resources. By using novel recruitment mechanisms, taking recruitment out of the consultation where possible and/or keeping the inclusion criteria broad and the data collection simple, we have kept the main research resources (3.5 FTE RAs) to the minimum in order to offer very good value for money


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: INFECTION