Title: Improving Outcomes in Necrotising Otitis Externa (IONOE)
Funder: Dunhill Medical Trust

Abstract: Necrotising otitis externa (NOE) is an invasive infection of the external auditory canal (EAC) typically seen in the elderly. It also occurs in diabetic or immunocompromised patients. Individuals present with severe otitis externa (SOE) and associated bone infection and are at risk of serious complications including cranial nerve palsies and skull-base osteomyelitis. The severe ear pain and hearing loss associated with NOE can have a profound effect on the quality-of-life of elderly patients. Treatment involves prolonged courses of broad-spectrum, intravenous antibiotics often necessitating considerable inpatient stays with risks of long-term venous access(Rubin Grandis et al., 2004). The disease is associated with notable mortality; one case-series reported overall survival of 38% at 5 years with disease-specific mortality of 14%(Stern Shavit et al., 2016). No established national or international diagnostic or treatment guidelines exist(Hasibi et al., 2017). Published data is extremely limited and consists of small, retrospective case-series and anecdotal experience(Mahdyoun et al., 2013). The optimal strategy for diagnosis and management therefore remains uncertain and a recent publication suggested wide variability across the UK(Chawdhary et al., 2017). There is critical need to perform high-quality clinical trials in order to inform the management of this neglected disease of the elderly. However, before such work can be contemplated it is essential high-quality, prospectively collected descriptive data regarding the clinical epidemiology, current management and outcomes of NOE patients be collected. Given the clinical difficulty distinguishing NOE from SOE and lack of understanding regarding risk factors for progression of SOE to NOE it is also important to understand the incidence, management and clinical course of SOE. This study seeks to do this by performing a UK multi-centre, prospective cohort study of clinically possible NOE cases that undergo CT imaging. The primary objective of this study will be to describe the demographics, clinical presentation, surgical and medical management and outcomes of these cases. Secondary objectives of this study will include; (i) identification of risk factors; (ii) assessment of the sensitivity and specificity of CT imaging for diagnosis (iii) understanding whether differences in antibiotic choice and duration impact on clinical outcome and resource utilisation and (iv) describing the role of local and deep surgical sampling and debridement. NOE is a long neglected disease of the elderly. This data will inform high-quality clinical trials to optimise the diagnosis and management of NOE and ultimately minimise the profound effect of this disease on the quality of life of elderly patients.

Lay abstract: Necrotising Otitis Externa (NOE for short) is a severe ear infection which causes bad ear pain and hearing loss. Older people are particularly likely to get NOE, but it can also affect those with diabetes or poor immune systems. In the worst cases, NOE leads to permanent paralysis of part of the face or long-term problems swallowing. The standard treatment offered is antibiotics, but this treatment itself can cause problems: older people might have to stay in a hospital to have the antibiotics delivered through a tube into their veins, and they are also at greater risk of antibiotic side-effects, especially if they have to take them for a long time (as is often the case with NOE). All of this means that, about 14% of people affected do not respond well to the treatment and die. Despite this, and despite the recent increase in the number of people with NOE, there are no national or international guidelines for how to diagnose or treat NOE. As our population ages, more people are likely to get NOE, and so we have set up a network of more than 80 doctors to help with our study on NOE. This is the first group of specialists to work on NOE together internationally. Specialists at a number of hospitals working in the UK working with us will keep detailed records of how they diagnose and treat NOE, and whether the treatment works. We will analyse this information to find out the risk factors for NOE, which scans and surgical samples are the best way to diagnose this disease, and which type and dose of antibiotics work best. Doctors currently do not know what is the best way to manage NOE, with different people trying different things – we hope that our analysis will formulate the optimal strategy for managing NOE. We will ask patients involved in this study to sign a consent form and complete a ‘quality of life questionnaire’ at the beginning and end of the study. Patients won’t need to attend any special clinics or have any special tests: most of the information will be collected from their medical notes and scans. We will publish our results in clinical and medical journals, to help with future clinical trials and guidelines on management of NOE with particular benefit for the elderly.

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