Something I had never really considered before was;
How much involvement do patients have with research within the scope of their conditions?
Turns out, lots.
Why is this important?
Patient & Public Involvement (PPI) is something that happens within all clinical research or clinical trial. And when you think about it, it makes sense – why would you research something, create and set up a trial for something new, if you didn’t think about the people you are doing it for? If you didn’t ask for their opinions? If you didn’t want their experience as patients; living with their condition, day in and day out.
It seems so logical but it is a MINDFEILD of questions and considerations.
Days like the IBD Patient Involvement in Research Day – set up and organised by Kapil Sahnan & Mark Samaan in conjunction with Crohn’s and Colitis UK and Bowel Disease Research Foundation (BDRF) – are set out to invite patients; who are considered experts within their own patient experience to hear about research projects from clinicians; who are experts in their own IBD medical related field.
The partnership of patients and clinicians; beyond the confines of the hospital setting – it was wonderful to see. Encouraged to speak without titles, just first names; that was a reassuring first step; a breaker of the ice.
How does PPI work?
The engagement for PPI is fundamental to trials and research in the UK. The NIHR, CRN and the Clinical Trial Gateway specify that PPI is part of every single piece of research done in the UK. And rightly so, PPI does the following things:
- Advances the care of patients
- Gets the right people involved
- The right, robust and rigorous research is carried out
- And it begins to unravel the RIGHT QUESTIONS.
Asking the right questions is key throughout research. From the inception of the research, through to delivery – where patients begin to become involved – and towards dissemination.
And when it comes to IBD, PPI can be used in all levels of research – from new treatment strategies, biomarker responses, dietary therapy, advancement in Perianal CD issues, pain, incontience and fatigue. Those are just a few of the highlights of current IBD research taking place in the UK currently.
CCUK as a charity has a strong connection to PPI and actively encourages patients to look into and get involved with research via their website – Take Part in Research page.
Along side them, is the BDRF – who are primarily focused on the advancing the cure and treatment of bowel disease. They have a dedicated section on their site for Medical Research, including their Ongoing Projects section.
Kapil and Mark invited over 40 researchers to attend and had a staggering 80 patients come along to participate in the projects presented. Eleven projects were presented from a range of hospital and departments. Split between Ulcerative Colitis and Crohn’s Disease focus, the day was packed full of involvement – from just feeling grateful to be involved to changing and shaping the responses to key research outcomes.
What was presented?
Prof Matt Brookes & Wladzia Czuber-Dochan (Royal Wolverhampton NHS Trust): The lived experience of family planning of females patients diagnosed with Inflammatory Bowel Disease (IBD) and their partners during key reproductive stages – a qualitative study.
Many women with IBD delay starting a family, or have fewer or no children. Women with inactive IBD usually have no more difficulty becoming pregnant than women without IBD, and can expect to have a normal pregnancy and a healthy baby. We want to examine why so many people with IBD choose to not have children, what concerns they have around becoming pregnant, and how they could benefit from pregnancy services specifically for people with IBD
Dr Gordan Moran (Nottingham University Hospital): Non-invasive approaches to identify the causes of fatigue in Inflammatory Bowel Disease patients.
This study aims to unravel the major causes of fatigue in IBD. Understanding what is happening in
the brain, heart, lungs and muscle of those experiencing fatigue could help to develop treatments that actually target the causes of fatigue in people with IBD. This would improve the quality of life of people with IBD, and increase the socioeconomic contribution that people with IBD provide to the UK
Prof Christine Norton (Kings College London): IBD BOOST Living well with Inflammatory Bowel Disease
This study aims to support people living with inflammatory bowel disease who have symptoms of fatigue, pain or difficulty getting to the toilet in time, by developing an online, nurse-supported self-management programme.
Ulcerative Colitis Projects:
Mr Omar Faiz (St Marks Hospital and Academic Instutute): Colectomy and Reconstruction in Ulcerative Colitis in Sweden and England – CRUISE
People with Ulcerative Colitis who need to have a colectomy (removal of the colon) can be offered restorative surgery in the form of an internal pouch or, less commonly, an ileorectal anastomosis (IRA). Both of these avoid the need for a permanent stoma. Recent data suggests that half of Swedish patients and one third of English patients who have a colectomy go on to have restorative surgery. This study will give patients considering restorative surgery the choice between an internal pouch or ileorectal anastomosis, and will follow them up post-surgery with quality of life and satisfaction surveys.
Dr Charlie Lees/Philip Jenkinson (University of Edinburgh): PREdiCCt
PREdiCCT looks to increase our understanding of how environmental factors, diet and gut micro- organisms influence Crohn’s Disease and Ulcerative Colitis flare. The study will recruit 1,500 people in remission from Crohn’s Disease or Ulcerative Colitis, and will follow how their IBD behaves for two years, while collecting information on what they eat, their lifestyle, and their gut bacteria. We hope that it might be possible to find a link between these factors and the severity of people’s IBD flares.
Prof Tariq Iqbal (University Hospital Birmingham): STOP-COLITIS
The human body contains vastly more bacteria (bugs) than human cells and it is becoming increasingly clear that these bacteria have important and previously unrecognised effects on the body. The majority of these bacteria reside in the colon and it is now known that the bacterial population (microbiome)
in patients with Ulcerative Colitis (UC) is different from that of healthy people. Over the past 10 years doctors and patients from many countries have attempted to change the microbiome in UC using FMT (faecal microbiota transplant – transfer of faeces from a healthy individual to a person with disease), and their attempts have suggested that this may be an effective treatment. However, there has never been a study with enough patients to truly assess the effectiveness of this treatment. STOP-COLITIS will be the largest trial of Faecal Microbiota Transplant once completed.
Prof Andrew Hart (Norwich Medical School, University of East Anglia) : Does excess dietary sulphur impair the response to drug treatments in patients with Ulcerative Colitis? A proof of concept study.
Our hope is that this research will ultimately lead to doctors, using evidence-based medicine, to advise patients which foods to avoid to ensure their IBD drugs are more effective to improve their symptoms and quality of life.
Crohn’s Disease Projects:
Prof Jack Satsangi (University of Oxford): SPARE
One of the most commonly used strategies in the medical management of Crohn’s Disease is combination therapy of the anti-TNF drug infliximab with an immunosuppressant drug (like azathioprine, or methotrexate). Although combination therapy is highly effective in inducing remission, doctors and patients are aware of uncertainties and controversies in terms of safety and effectiveness with long-term use. In particular, unanswered questions surround drug cessation. SPARE aims to find the safest and most effective way for patients to discontinue their combination therapy once they are in stable remission.
Dr Miranda Lomer (Kings College London And Guys & St Thomas’ NHS Foundation Trust) : Development of a nutritional assessment and dietary management algorithm for patients with Inflammatory Bowel Disease.
This study is developing a patient-centred algorithm to better recognise the patients with IBD who need dietary advice. It includes a self-assessment tool for patients to score their nutritional health. The algorithm will help identify the patients who would benefit from more support around their diet, and those at risk of malnutrition. This will help more people have quicker access to the right dietary treatment, improving their psychological, social and physical health.
Dr James Lindsay (Queen Marys University of London): ASTIClite
A previous trial, ASTIC, looked at whether stem cell therapy (HSCT) where a patient’s own stem cells are given back after their immune system has been destroyed by chemotherapy, is effective in curing Crohn’s Disease. The trial showed that high dose chemotherapy led to significant side effects, but half of those treated in the trial had complete disease remission, and the others appeared to respond to drug therapies that they previously been unresponsive to.
ASTIClite will test whether HSCT with much lower doses of chemotherapy will still be effective but also much safer. We also aim to assess the mechanism by which HSCT works and confirm whether anti TNF therapy (like Infliximab and Humira) is effective in patients with disease activity after trans- plant.
Mr Samuel Adegbola (St Marks Hospital and Academic Institute): Developing a quality of life score for Crohn’s Anal Fistula.
We aim to develop a new patient-centred quality of life assessment scale with the help of people living in the community with Crohn’s-related perianal fistulas. We will call this the Crohn’s Anal Fistula Quality of Life scale (CAF-QoL). It will help healthcare professionals understand how a perianal fistula affects their patient and help them in their treatment decisions.
It took getting seriously unwell with my IBD before I looked into trials. For a long while, I just went along with my treatments plans and expected my team to be the experts. It wasn’t until we reached a huge fork in the road and we had no treatment options left. We looked at clinical trials or surgery. And that is when I took interest into PPI, even though I didn’t know what it really entailed or how I would be suitable. It turns out being a proactive, vocal and passionate patient is what makes me most suitable.
The variety of how IBD – not only how it is treated but how and why it manifests itself, how it goes on to return and why it fades for some and not others – is so wide and deep; the need for more patients to become interested and involved in research will only do good. Pushing forward existing modern medicine, holding research in higher regard, but also making it also more accessible and without the overly off-putting medical lingo is what PPI comes down to.
PPI is a two way street: clinicians get to present their research and develop it with patients in mind as they sit right in front of them. But patients also get to access medicine in its basic form – research. The ideas that might push us towards a cure; but before then, better treatment, better care, more knowledge, more understand and more collaborations.
Egos – if you still think medical professionals have them – were put aside. Encouraged to use names not titles, to break down the barriers to create a wonderful partnership. It goes beyond just “you scratch my back, I’ll scratch yours” mentality; the connection between clinicians and patients – outside of an appointment, a surgery, a ward visit, a medication review – was extremely gratifying.
IBD is life long. It is a rollercoaster of emotional and phsyical pain and heartbreak. It comes with highs and lows and its a daily battle, sometimes a struggle. But knowing there are people out there delving into what makes something happen, what can be done to improve what we deal with; it is comforting. It brings me joy and happiness knowing that my battle is not one I have to fight alone. It is not one that noone else can empathise with. And its not just fellow patients I share this with, its the people driving our research forward.
How can you get involved?
Details of the invidivual research projects are available by looking through the CCUK page on “Our Research Projects“.
Information on patient participation in research is available from NHS Choices and National Institute of Health Research. Other ongoing trials can be found at IBD Clinical Trials, UK Clinical Trials Gateway and Clinical Research Networks.
There will be inclusion criteria for you to participate in research in specific areas. It is worth asking your consultant and / or your IBD nurse for which projects would be most suited to your particular circumstances. Do not be discourage is there is nothing for you at this present time, IBD research does not stop and there is always demand for looking into new and undiscovered parts of IBD. Or even just improvement in existing processes and treatments.
Disclaimer: I was invited to this IBDPRD as part of CCUK’s ongoing involvement with PPI in IBD research. The views reflected in this post are mine and information collected from the presentations by the researchers on the day.