Title: Organic disease masquerading as IBS: an RCT in primary care: The Lincolnshire Poacher Study(Promoting Optimal Assessment to Change Health and Engineer an Economic Revolution)
Funder: Department of Health and Social Care

Abstract: Background: Irritable Bowel Syndrome (IBS), a chronic relapsing disorder, is diagnosed by symptom-based criteria in the absence of detectable organic causes. IBS frequently leads to severely impaired health related quality of life. IBS-like symptoms, affecting up to 20% of the population, carry significant costs for sufferers, society and healthcare. The National Institute for Health and Care Excellence (NICE) directs that a limited number of tests are performed when someone presents with IBS-like symptoms. If these tests are normal, lifestyle modifications or specified medication should be prescribed. However, more than 50% of patients diagnosed with IBS do not improve with this approach. This may be because alternative conditions are missed particularly when people have IBS-like symptoms characterised by diarrhoea. Evidence suggests that more than 75% of these patients have other diagnoses, particularly pancreatic insufficiency, microscopic colitis, small bowel bacterial overgrowth, carbohydrate malabsorption or bile acid diarrhoea. Clinical history taking is inaccurate at identifying the cause for symptoms, whereas targeted investigations diagnose these conditions precisely. In patients with IBS-like symptoms characterised by diarrhoea, no studies have examined the cost-effectiveness and health benefits of early, more comprehensive investigations. Data show that nurses using checklists, can assess patients accurately, arrange appropriate investigations and apply treatments effectively achieving improvement in symptoms comparable to gastroenterologists even when patients have complex underlying gastrointestinal disorders. Methodology: This randomised trial proposal was developed collaboratively by patients with IBS, GPs, a multidisciplinary group of primary and secondary care clinicians, academic researchers and the chair of the local Clinical Commissioning Group. We will assess whether patients with IBS-like symptoms fulfilling Rome IV criteria for diagnosis of mixed constipation/diarrhoea or diarrhoea predominant IBS, presenting to primary care benefit from nurse-delivered care, which includes investigations and management denied by NICE, compared with standard care delivered by a GP following NICE recommendations. We will additionally undertake an economic analysis examining the costs for patients and healthcare in each arm of the study and a qualitative process evaluation, including semi-structured interviews with the nurses, GPs and and a selection of patients, to understand the contextual factors which will facilitate wider application of our approach. Research plan:, After providing informed consent to participate, eligible patients will be stratified by IBS severity and gender, then randomised to care by a GP following NICE guidance or to care provided by a primary care nurse, specially trained to use structured investigations to identify organic pathology and equipped with treatment protocols targeting abnormal investigation results. Recruitment of 134 patients will give the study 85% power to detect clinically significant improvement in the primary endpoint, IBS severity scoring system (IBSSSS) score at one year. We have allowed for 10% patients loss to follow up and 5% GP deviation from NICE guidance. Recruitment will be completed within 16 months. We will report our results within 3 years. Conclusion: If our hypothesis is correct, that missed organic disease frequently causes IBS-like symptoms, we will bring health benefits to a population where there is substantial unmet need while reducing long-term costs.

Lay abstract: Irritable bowel syndrome (IBS) affects up to 1 in 5 people in Britain. IBS can have a huge impact on a sufferer s daily activities, general wellbeing and overall health. IBS often carries major financial implications because of time lost from work, the cost of attending GP appointments and prescriptions. Sufferers also often report substantial extra ongoing costs for things like over-the-counter medicines, incontinence pads, deodorants, extra lavatory paper and laundry. And IBS does not just affect sufferers, their work, family and friendships. Treating IBS costs the NHS much more than &pound;100 million annually. The National Institute for Health and Care Excellence (NICE) guides how tests and treatments for diseases should be used. For IBS they recommend that the diagnosis can be made if someone has typical symptoms and normal results from four blood tests. More detailed tests used by specialists, NICE says, are not needed. Once IBS is diagnosed, NICE recommends lifestyle and dietary changes and/or medicines although they admit that the evidence that these things help is weak. Indeed, NICE acknowledges that when their recommended treatments are used, at least half of sufferers continue with long term troublesome symptoms. The problem is that &ldquo;typical IBS symptoms&rdquo; and four blood tests are an unreliable way to distinguish patients with true IBS from those with other conditions which cause symptoms similar to IBS. Evidence suggests that most people with constant or intermittent diarrhoea diagnosed as IBS in fact have a different diagnosis which the NICE recommended tests do not pick up. Examples of very treatable, often missed diagnoses and the number of affected people include: Sensitivity to fat in diet 1 in 4 patients Abnormal digestion of sugars 1 in 4 Germs living in parts of the bowel where there should be no germs 1 in 4 Microscopic bowel inflammation 1 in 10 Pancreas gland working inadequately 1 in 20 We will carry out a scientific study, known as randomised controlled trial, in 134 patients recruited from more than 20 GP surgeries across Lincolnshire. They will have intermittent or constant diarrhoea coming to see a GP who makes a new diagnosis of likely IBS. We will measure the benefit for the patient of care delivered by a GP following NICE recommendations compared to care given by a specially trained nurse. The nurse will arrange a simple series of tests focusing on identifying the whether the treatable conditions listed above are present and offering specific treatments based on the test results. During our study, we will measure which group improves the most and the cost for the patients and the NHS of this approach. We will follow the patients for a year to see whether any improvement achieved continues long term.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: ORAL AND GASTROINTESTINAL