External validation of a clinical decision rule and neuroimaging rule-out strategy for exclusion of subarachnoid haemorrhage in the emergency department: A prospective observational cohort study

Background The investigation of suspected subarachnoid haemorrhage (SAH) presents a diagnostic dilemma. The limited sensitivity of a negative CT brain scan has historically mandated hospital admission and a lumbar puncture to look for evidence of blood in the cerebrospinal fluid. However, emerging evidence has suggested the sensitivity of clinical decision rules and modern CT imaging protocols within early onset of symptoms, may be sufficient to exclude the diagnosis. Methods A prospective, multi-centre, observational study of consecutive adult patients with acute severe non-traumatic headache presenting to emergency departments. We plan to recruit 9000 patients from over a hundred sites across the UK. The primary outcome is adjudicated SAH as defined by neuroimaging or cerebrospinal fluid findings consistent with the diagnosis. Data will be collected on clinical history, examination findings, phlebotomy and imaging results. All participants will be followed for 28-days to identify SAH and other clinically relevant outcomes using case note review, and later Hospital Episode Statistics. A proportionate opt-out model of consent will be used to maximise patient recruitment and study generalisability. Discussion Whilst there is increasing evidence that early neuroimaging strategies for the diagnosis of SAH are very sensitive, there have been no large studies to confirm this in the UK population. Furthermore, the test characteristics of CT brain beyond 6 hours from onset are not well understood and there is limited biological plausibility for this defined time cutpoint. Finally, the performance of the Ottawa clinical decision rule has shown promise in the Canadian population. However, its performance in the UK has not been studied and there are concerns that due to the low specificity it may result in increased, rather than decreased rate of investigations. This study will therefore aim to assess the test characteristics of both a CT brain up to 24h from presentation and the Ottawa SAH clinical decision rule.