Title: A programme of high priority Cochrane systematic reviews to investigate the management of Inflammatory Bowel Disease during and after the COVID-19 pandemic: Optimal biologic and immunomodulator therapies, diet therapies, telehealth and education interventions
Funder: Department of Health and Social Care

Abstract: What is Inflammatory Bowel Disease (IBD)?_x000D_ IBD is a lifelong inflammatory disorder of the gut. IBD affects 1 in 125 people in the UK and most commonly presents as Crohn’s Disease and Ulcerative Colitis. When active, IBD causes debilitating symptoms such as diarrhoea, weight loss, an urgent need to use the toilet, pain and extreme tiredness. IBD is widely misunderstood – it can affect almost every part of the body and every aspect of life. When symptoms reduce people are in remission, but often face a lifetime of medication and for many, major surgery. There is no cure._x000D_ _x000D_ What type of research is this?_x000D_ We will take advantage of completed clinical trials to carry out systematic reviews. A systematic review is desk-based analysis of all existing trial data on a specific area, while also considering how well the trial was carried out. IBD affects everyone differently and responses to treatments or interventions vary from person to person – so important results can be missed if trials only have a small number of participants or are poorly designed. Combining existing data creates a larger population allowing us to find missing results, and analysing data together in this way gives us more confidence in the findings. Our reviews will give people with IBD and their healthcare team high quality evidence on care options, allowing informed decision making and patient choice._x000D_ _x000D_ What is being investigated?_x000D_ We will analyse data on four themes:_x000D_ 1. Patient education and the use of virtual/tele health to deliver care outside the clinic. This is topical as the COVID-19 pandemic has changed access to healthcare regardless of patient preference, causing patients to seek information elsewhere and take a more active role in managing their conditions._x000D_ 2. Biologic medicines – a comparison. Biologic medicines are commonly used to treat IBD, but there are many different types with varying side effects, and we don’t yet know which are best at getting and keeping people in remission._x000D_ 3. Dietary supplements. People with IBD often control their diet to help manage symptoms, unsupervised by healthcare professionals. Evidence to support this approach is greatly lacking, with patients looking to unreliable sources of information. We will look at two easily modifiable dietary supplements – vitamin D, known to affect the immune system, and prebiotics, a group of foods that support the growth of healthy bacteria in the body._x000D_ _x000D_ How will the project work?_x000D_ Our experienced research team will perform the 8 individual systematic reviews needed to address our three themes, supported by IBD clinical experts. We will use our established relationship with the charity Crohn’s & Colitis UK (CCUK) to involve people with IBD in each review. Our findings will be shared promptly with professionals and through CCUK to people with IBD._x000D_ _x000D_ How will the results impact patients?_x000D_ The themes were selected through patient workshops and professional’s views and are aligned with the highest areas of priority for both. As with previous reviews, we expect the findings will directly impact the UK IBD guidelines for care, as well as providing crucial evidence for or against changes sparked by the pandemic. These results will help IBD patients and their healthcare teams make informed, evidence-based decisions about their care.

Lay abstract: Background_x000D_ Inflammatory bowel disease (IBD) is a group of inflammatory conditions of the gut, most commonly presenting as Crohn’s Disease (CD) and Ulcerative Colitis (UC). Over the last 12 months, our team in Cochrane Gut has worked with the UK British Gastroenterology Society (BSG) and Crohn’s and colitis UK (CCUK) to examine key priority publications and then refine them into this programme to address only the most contemporaneous review gaps within the field._x000D_ _x000D_ The COVID-19 pandemic has switched clinical work to remote telehealth options, as well as increasing demand for patient education to support self-management, but no synthesis of these techniques exists. With an increasing range of biologic options for CD, up to date synthesis to compare the full range of options is needed. However, biologics have also been a key concern during their pandemic, as there is a recognised infection risk with their use. Finally, many patients are interested in dietary supplements to change their symptoms and this represents a gap in the current Cochrane portfolio. _x000D_ _x000D_ Aims and objectives_x000D_ The scope of the programme will address these aims:_x000D_ - What is the efficacy and safety of patient education and remote management of IBD care? _x000D_ - What is the efficacy and safety of biologic and immunosuppressant therapies for Crohn’s disease?_x000D_ - What is the efficacy and safety of supplements to normal diet for IBD?_x000D_ _x000D_ Methods_x000D_ This programme of 8 Cochrane reviews of varying size, scope and complexity will include three update reviews, five new titles including one network meta-analysis. A steering group will be established. The core team will consist of the Chief investigator, a full time experienced Cochrane reviewer, a senior researcher and a member of the CCUK patient information editorial board. All staff are in post and their time seconded, allowing timely project establishment. _x000D_ _x000D_ We will prioritise the reviews that will have direct impact during the COVID-19 pandemic. We will ensure the scope and outcome measures for every review are considered by the steering group. The Cochrane Gut group structure offers the support of our colleagues in the second Canadian base of the group for all editorial and review duties in an expedited fashion._x000D_ _x000D_ Timelines for delivery_x000D_ _x000D_ In the first 3 months of the project the team will complete all protocols. Two of the new protocols are already in the final stage of peer review at time of this proposal submission. The core review work will be completed over 12 months, with the reviews grouped in three blocks by theme. Whist the grant is not supporting core CRG activity, the wider group allows significant contingency to ensure successful delivery of the programme. _x000D_ _x000D_ Anticipated impact and dissemination_x000D_ _x000D_ As well as the 8 published reviews, findings will be fed-back to the key stakeholder organisations to support prompt uptake. In particular, continuing our close working relationship established with CCUK and BSG, we will support their Knowledge & Evidence team and IBD committees respectively in updating relevant patient information and guidance for UK users. Additionally, keynote sessions at major scientific meetings are in place offer another route to dissemination, with most already shifting to virtual formats to continue during the pandemic. Finally, we have shared publication agreements with key journals in the field.

Research activity codes: 6.1 PHARMACEUTICALS;6.7 PHYSICAL;7.1 INDIVIDUAL CARE NEEDS
Health categories: ORAL AND GASTROINTESTINAL