The Lincolnshire Poacher Study
Research type
Research Study
Full 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
IRAS ID
276667
Contact name
Jervoise Andreyev
Contact email
Sponsor organisation
Lincolnshire Community Health Services NHS Trust
ISRCTN Number
ISRCTN87945798
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Summary of Research
This study proposal was put together after detailed discussions between patients with Irritable bowel syndrome
(IBS), GPs across Lincolnshire, a multidisciplinary group of clinicians from primary and secondary care, academic
researchers from the University of Lincoln and the chair of the local Clinical Commissioning Group.We aim in a randomised trial to assess whether specially trained nurses can improve outcomes for patients
presenting for the first time with IBS-like symptoms compared to standard care delivered by a GP. In our study,
GPs will follow NICE management guidance for patients with a diagnosis of IBS. The nurses will be trained to
follow detailed checklists and a management algorithm which will include additional, mostly non-invasive, well
tested investigations which are not included in NICE recommendations but have the ability to identify organic
diagnoses which mimic IBS and which would otherwise be missed. The cost of both approaches for patients and
healthcare will be measured and trial participants will be followed for one year to assess whether any symptom
improvements are maintained. We hypothesise that the nurse managed arm will benefit more than patients
managed by GPs.We have previously developed a teaching programme to teach nurses the skills to manage patients with complex
gastrointestinal (GI disorders). However, as part of this study we will also conduct a Process Evaluation, which
without doubt will help us improve the way we teach these skills to so that our methodology can be applied widely
elsewhere.Summary of Results
: Irritable Bowel Syndrome (IBS) is common and impairs quality of life. IBS is usually diagnosed based on symptoms. Treatment leads to disappearance of symptoms in <50%. Poor response to treatment may be because alternative diagnoses are missed.We performed a randomised controlled trial recruiting people attending GP surgeries who had not been previously treated for IBS who had typical symptoms and intermittent or constant diarrhoea. Participants were allocated at random to receive usual care management by general practitioners (GPs) following UK National Institute of Health Care Excellence IBS Guidelines or structured investigation and treatment of newly diagnosed gastrointestinal conditions by trained nurses.
113 participants were randomised; 81 were women and 32 men their average age was 33 years old and 62 (70%) had severe symptoms. There was a highly clinically and statistically significant reduction in participant IBS score in the arm randomised to care by the nurses compared to those randomised to the GP arm. We also saw significant improvement in quality of life in the patients allocated to nurse care.
Causes for symptoms where intervention led to sustained improvement included the following conditions - bile acid diarrhoea (35%), small intestinal bacterial overgrowth (35%), lifestyle issues (23%), fructose intolerance (12%), exocrine pancreatic insufficiency (5%), lactose intolerance (5%) and coeliac disease (2%).
We feel that this trial defines a new standard of care for the very large patient group with IBS-like symptoms characterised by diarrhoea.
REC name
West of Scotland REC 4
REC reference
20/WS/0029
Date of REC Opinion
20 Mar 2020
REC opinion
Further Information Favourable Opinion