1. Patients research priorities in gastrointestinal disease Mark Welfare Gastroenterologist, Senior Lecturer at University of Newcastle

2. Acknowledgements Co-researchers: Sally Corbett, Linda Goulbourne, Jackie Colligan, Sam Molyneux Patients and NACC members for participating

3. Outline Where did we start How did it develop What have we found Relevance to JLA

4. Where did we start Background in colon cancer research- finding the cause. One tiny brick. Meat and gravy. Did I want to pursue further tiny bricks? What relevance has it got anyway? Will people change their diet sufficiently? Appointed to teaching academic job but expected to have some research. Working in DGH- hard to get funding for lab work Inspired by early work of Sandy and others Nothing in GI disease then or since Seemed like an interesting and important area to pursue

5. Ulcerative colitis- why? Embarrassing disease, life long Cancer risk and effects on quality of life Treatments partially effective, many side effects c. 90% of research is genetic No direct benefit yet to patients from genetic research We carried out pilot focus groups with patients with ulcerative colitis

6. Progress Proved very interesting. Lots of research ideas Not without problems- e.g. awareness of cancer risk Triangulated with interviews on a one to one basis Funding- none Medical student project, Masters project

7. Research priorities of UC patients finding the cause of colitis cure of colitis prevention of colitis living with colitis treatment and its side-effects (conventional, complementary and surgical) control of particular symptoms information about colitis communicating with health professionals service delivery.

8. Cause- patient quotes Before you have a cure you have got to find what causes it Diet- [if there was] one thing you could do in terms of research, I think diet would be it No evidence based advice at the time. Increasing evidence for sulphur as a factor. Other interests: genes, stress,

9. Treatment- general priorities. Paradox: Treatment currently is not highly effective but, more powerful treatment must have more side effects. How can this be balanced. The tablets are too big to swallow (true!) Complementary medicine interesting but we need more evidence that it works Would I benefit from surgery and if so when?

10. Treatment quotes I mean any drug that is going to work has to have some side-effects otherwise they wouldnt work [Interview 6] I would like it controlled in other ways, perhaps if the drugs could be reduced [Group 1, 3] Most of our concerns seem to be the fact that we are using steroids [Group 1, participant 3] I wouldnt take my medication because the tablets were too big…… They were like horse tablets [Interview 7]

11. Control of particular symptoms Participants identified a number of specific symptoms that they felt were incompletely understood and felt that more research into their control was required. These included faecal incontinence, abdominal and perineal pain, nausea, flatulence and lethargy or tiredness. Has changed my practice!

12. Living with colitis Big theme for any chronic disease/long term condition Unsure if this was an area they should expect help with Little published until recently

13. Living with colitis- quotes What about researching things like exercise and its role in relieving stress [Interview 12]. Its just something you learn to live with. Im not sure theres anything the doctor could do [Interview 4] I think if the research was towards helping patients coping with the complaint, that would be very helpful [Group 2, participant 2] You try to talk about your problems with your partner or family because they are the people who are closest to you but unless they can experience it they cannot really sympathise [Group 2, participant 3]

14. Lessons learnt Focus groups and interviews were complimentary. Abortion only discussed in interviews Need support for people adversely affected Some clinicians are very negative to this. Disparaging comments from one BMed Sci examiner. Need to explain and convert. Hard to publish- rejected by BMJ, Lancet, Gut, IBD journal. In press: The research priorities of patients with ulcerative colitis. Eur J G Hep. Welfare MR, Colligan J, Molyneux S, Pearson P, Barton JR.

15. Use of this information Developed a joint project with NACC for self-help groups for people with UC Called Colitis Education and Support Programme (CESP) Based on improving knowledge, sharing top tips and dealing with stress Process- 6 sessions, each with these three components.

16. Colitis Education and Support Programme RCT comparing CESP to written information only Supported by the National Lotteries Charity Board, Social Research fund £155,000 over 3 years Patients mostly loved it. Did not affect overall quality of life! We used the wrong end-point for the study! NACC are rolling this out In the process of publication See: Development of two educational resources for people with inflammatory bowel disease: Enabling health professionals to provide self-management support. Gastrointestinal Nursing 2006;4:27-33.

17. Next steps What about other patient groups? Develop some theories about patients research priorities based on type of illness. Eg difference between colon cancer and colitis No priority order- needed some numbers What about clinicians?

18. Next steps-Reflux disease Used same methods Similarities and differences with colitis Long term condition but very common and increasing Effective treatment in form of tablets with few side effects Invasive testing and can be hard to diagnose Cancer risk

19. Themes in reflux Causes of reflux including diet, genetic and stress Prevention of reflux and complications. Concerns about life-long medication, cost & dependency Effectiveness of treatment- getting it under control & reducing symptoms Timing & access to surgery & prosthetic non-surgical implants Effectiveness of tests and reducing discomfort Service delivery. Problems with identifying reflux early on and using time with specialist effectively Cure not mentioned!

20. Next steps- Prioritisation Method? Representativeness Sample size Agreement with clinicians The Q sort

21. Q sort A method to enable participants to give their opinion on the importance of different aspects of a scenario Rigorous, statistical, systematic Based on ranking statements about the scenario We would like you to imagine you are in charge of some money to share out to fund different research projects

22. Development of the statements Based on the interviews and focus groups done with patients Added in interviews with clinicians and researchers in the field. Broad range including health service researcher, biological researcher, GP, academic GP, NHS consultants and nurse specialists Lot of work to standardise statements, reduce redundancy, cognitive testing

23. Statements and analysis 64 statements 9 original themes and 1 extra from researchers about improving methodologies Participants are asked to sort them into statements they agree, disagree or feel neutral about. They then put them on a grid in rank order. Analysis is based on finding groups of individuals who have a shared opinion- factor analysis. Specific software to do this. Free text comments invited on the statements

24. Results Sent to 100 members of the BSG, purposive sample based on personal knowledge and description of expertise in BSG handbook. 100 patients locally. We found five factors or groups of individuals. Some were patient or professional dominant, some shared Accounted for >50% of the variance in views

25. Factor 1 Academic views – interest in developing new frontier of knowledge 6 health professionals and 3 patients mapped to this factor. Priorities were cure, cause & prevention which involved modifying genes and understanding the role of genes. Unimportant was research into service delivery such as understanding access to care and what factors influence this and lifestyle factors such as diet.

26. Factor 2 – Patient empowerment views Only health professionals mapped to this. Characterised by belief in patient empowerment and an interest in general clinical care. Disagree with genetic research, animal studies and research by large private companies Strongly agree with getting patients actively involved in decision making, exploring the feelings which stop them seeking help and minimising the impact of colitis on lifestyle.

27. Factor 3 – Medical Model Group 14 patients loaded on this and only one health professional. They express trust in Drs, want to improve medical care. They value research into cure, prevention and cause but want the results available in near future and put into practice quickly. Want research into improving symptoms, effective medication and medical care. Negative statements were about research into self help, improving social problems, raising awareness and research which took ten years or more. Free text comments showed that one individual felt that money spent on genetic research had not shown any benefit so far.

28. Factor 5 Care not Cure, service delivery 2 patients and 1 professional loaded on this factor – but important to include their views. This group strongly disagreed with research into cause, cure and prevention. Felt it was important to spend money on research into the organisation of health service for colitis patients. Wanted to help get patients more actively involved in decision making and give a higher priority to improving the information patients are given re their condition and treatment.

29. Conclusions Q sort was a very interesting way to sample opinion Needed a lot of work to derive statements Enabled ranking of priorities Five types of view were identified, some with few representatives Views of professionals and patients are both overlapping and different

30. Relevance for JLA Our focus was overall research priorities not just treatment uncertainties No GI partnership yet. NACC would be a good organisation to work with. Also Long- term Medical Conditions Alliance and the Inflammatory bowel disease group of BSG Important to influence National and Local research networks. Only for cancer so far in GI.

31. Relevance for JLA Methods for sampling opinion and creating priorities are varied. No best one. Focus groups and interviews are useful for identifying themes Q sort begins to address some questions about sample size and representation. Small groups hold important views. There may be groups with very polarised views eg genetics versus self care. Q sort can be done postally. Sample size need not be large. Could be used for DUETS Similar methods could be used by funding bodies including charities to help find patients priorities

32. The end Thank you for the invite. Questions if time allows Contact: Mark.Welfare@northumbria- healthcare.nhs.ukMark.Welfare@northumbria- healthcare.nhs.uk Or doctormarkw@aol.com