The donation of post-mortem brain tissue for research is of fundamental importance to further understanding of the causes of these disorders and to develop more effective diagnostic tools and treatments for these conditions.
What does Gut Reaction do?
For many patients, these records cover their whole IBD journey, from diagnosis to treatment, including different medications and surgeries.
Over time, these data create a detailed picture of how their IBD has developed and progressed, and this information is used to help them make treatment decisions with their doctors.
These health records form a very important source of health data. However, different kinds of this data are stored in different locations – for example, GP surgeries, pathology or radiology clinics, or pharmacies.
Another key source is the data that is collected when IBD patients take part in research. People who participate in research through the NIHR IBD BioResource (part of the NIHR BioResource) provide a biological sample (usually blood) that can be used to read their genetic information (DNA) and provide other information about them, such as their blood type and information about how their immune system is functioning.
NIHR BioResource participants also complete a health questionnaire and allow access to their health records. The biological samples and data are safely and securely stored in the sample repository in Milton Keynes, and the data at University of Cambridge.
Gut Reaction aims to develop tools to make it possible to bring these sources of data (real-world health data and research data from the BioResource) together on thousands of people with IBD, so that clinicians and scientists can access these data for research purposes without compromising privacy of individuals or the security of the data.
Tinnitus study revises protocol and patient-facing documents as result of PPI feedback
Dr Marina Salorio-Corbetto, who is studying how tinnitus affects adults who use cochlear implants and the effectiveness of sound therapy in improving tinnitus symptoms, initially asked the panel to review the participant information sheet (PIS), consent form and questionnaire for her project.
This review was carried out by panel members via email and the volunteers’ feedback on their readability, coherence and phrasing helped Dr Salorio-Corbetto – who does not suffer from hearing loss – gain more understanding of what it’s like to live with this condition.
But their feedback also showed the range of difficulties experienced by those with hearing loss – and that while doctors can scientifically predict its effects, this may not accurately reflect the day-to-day reality for people living with the condition.
Dr Salorio-Corbetto took on board many of the PPI panel members’ recommendations but it also became clear to her that her research would benefit from a tinnitus-specific PPI group, including people with varying degrees of hearing loss and with symptoms of tinnitus. Dr Salorio-Corbetto now plans to set this up to help improve the sound therapy intervention and feedback on the research as it evolves.
Feedback from the panel also led to a research-protocol amendment, which Dr Salorio-Corbetto agrees has helped make her research more attractive to potential participants.
The testing sound therapy on participants was originally set to last for one day but panel members felt that this was too long – especially if those taking part did not live locally or had other things to do.
This was accepted and the protocol amended from 7 hours for the testing sound therapy to 4 hours.
Patients input into study design and protocol for ‘pill on a string’ cancer diagnostic tool
What? Professor Rebecca Fitzgerald and team have developed a new diagnostic tool for Barrett’s Oesophagus called the cytosponge. Barrett’s oesophagus is linked with the occurrence of oesophageal cancer. The cytosponge has been extensively tested in studies with patients and healthy volunteers at the Cambridge Clinical Research Facility. The team now want to find out if the tool can be used effectively in GP surgeries, and prove if it can be used to diagnose Barrett’s oesophagus early and therefore detect patients who might be at risk of developing this cancer.
The CUH PPI Panel volunteers were involved in reviewing the study design and protocol, patient information sheets and summaries, and have received feedback and updates on trial progress.
How? They met as a focus group to hear a presentation from the study data coordinator and research nurse and to provide feedback on study documents. There have been subsequent meetings to update the group on progress. The panel asked many questions including how GP surgeries were chosen and why not all GP surgeries. The team explained that GP surgeries close to endoscopy units were chosen in case of any emergencies, for example, swallowing of the capsule and string. They also need to have some GP surgeries as control groups to assess the normal level of diagnosis in the community.
Why? As a result of the focus group, patient information sheets were simplified and the ethical considerations and selection choices explained. The public group are now informed of progress and hope to retain a role in oversight for further research. The research team were hugely appreciative of the support they received and are now advocates for the early involvement of patients and the public in the research process.
Medicine Adherence for Patients Support (MAPS)
The researchers had devised a series of text and voice messages to remind patients to take their medication. This intervention was created to help those who forget or needed support to adhere to a routine to take their medication.
The research team were not sure if the messages were of the right tone or if the nature of delivery would be acceptable or viewed as intrusive. Their research aimed to gather views of patients on long term medication asking them to trial the system and then attend a focus group to collect their views. Ultimately they wanted to provide evidence to support this intervention for patients who forget to take their medication.
The CUH PPI Panel were involved in reviewing the Patient Information Sheets (PIS) and Consent Forms and two individuals who already take medications long term volunteered to test run the intervention and focus group discussion.
This feedback and early testing allowed the research team to make changes to the PIS and consent forms. The feedback drew out some issues around patient confidentiality and recruitment of patients through their GP. The trial of the messaging and the test run of the focus groups helped the team to modify the intervention and provide them with valuable insights as to how they might facilitate the focus group discussion.
The aim of this input was not necessarily to change the primary outcome of the research but to ensure that their approach would optimise input and feedback from the patients taking part.
The panel were very supportive of the study, having learned that non-adherence to medication potentially costs the NHS £millions in wasted prescriptions and also compromises the health of patients often leading to other more intensive treatment.
Dr Katerina Kassavou who is leading the study was very grateful of the support and feedback she received. She also presented her work at a CUH PPI panel meeting and to the PPI oversight committee gaining exposure for the research and support from patient and public representatives.
The time allowed to gather and test the intervention happened over a 4-6 week period. The research team now have an improved Patient Information Sheet; an improved intervention with modifications to the messaging service; valuable insight to improve the focus group discussions; and were open to friendly but challenging questions which have given them the opportunity to prepare for the types of question you might receive from a funding committee or ethics board.
How can we prevent frail elderly patients from losing strength following a hospital admission?
As a result, many frail people require admission to hospital because they are unable to look after themselves at home. One of the reasons frail people struggle to recover from illness might be because they lose muscle and become weaker when in hospital due to lack of activity.
The aim of this study was to investigate changes in muscle strength in frail elderly patients following a hospital admission. Peter Hartley, a physiotherapist who is leading the study, asked for support from the CUH PPI panel to help design the intervention.
With the support of PPI Coordinator they coordinated a focus group of 10 individuals from the panel. The aim of the meeting was to discuss and gain views on the overall approach of the study; how to measure changes in strength and physical ability; and the panel’s views on patients having an exercise programme in hospital.
The focus group discussion raised a number of issues around the acceptability of this type of intervention in elderly patients (over 80). Practical suggestions were made which changed the outcome measures from counting 10 repeats of a standing/sitting exercise to however many the patient could manage.
The discussion and subsequent document review allowed Peter to modify the study design and give consideration as to how to sensitively recruit patients. Again the panel could clearly see the need for this research and the support for activities to help elderly patients retain muscle strength and mobility.
Peter’s grant application was successful, and he was awarded a highly competitive Dunhill Medical Trust Research Training Fellowship award which will allow him to carry out this research over the next three years.
HOPE – ART (Health Observation & Patient Effect modelling for Abrogation of Radiotherapy Toxicity)
Amy wanted to know in particular if the panel thought there was significant patient benefit – and if the approach was acceptable. She was keen to seek the panel’s views as early as possible in the proposal process to ensure that changes and modifications could be incorporated in her study.
The term prostate cancer describes a group of cancers that arise within the male prostate gland. Around 47,000 men each year are diagnosed with prostate cancer. Both surgery and radiotherapy are considered the gold standard treatment for prostate cancer dependent the stage of the cancer. Almost 90% of those diagnosed with prostate will survive 5 years or more, while 84% will survive 10 years or more. It is therefore vital that we consider the implications of not only the short-term side effects of treatment and prognosis but also the management of long-term side effects (morbidities) and impaired quality of life, both from the patients’ perspective and health economically.
The aim of the study was to develop a predictive modelling tool that combines health observations, severity of acute radiation (during treatment) toxicity and overall dosage of radiation received to predict which men are more likely to have late radiation (6 months after treatment) toxicity side effects.
Around 7% of patients experience the late radiation side effects, some of which are as a result of damage to the organs around the prostate during the radiation treatment; and can include diarrhoea, urgency, and erectile dysfunction.
This can cause significant problems for patients and lead to further treatment in the NHS. The study hopes to be able to identify men most at risk and then be able to support them more appropriately during their treatment. Knowing who those patients are will also significantly reduce the financial burden to the NHS as treatment plans can be adjusted.
The panel provided a great deal of feedback to Amy to help her explain her study rationale, also in how she might approach patients around some of the more sensitive questions, particularly concerning erectile dysfunction. Amy attended a panel meeting and gave a very clear and informative presentation followed by a Q&A. This has also helped her to prepare for presenting her work in future to funders and other lay audiences.
If you are a member of the public…
The link below will take you to our Patient and Public Involvement pages, with information on:
- Taking part in research
- Patient Led Research Hub
- Training Opportunities
- Case studies
We hope to see you soon!
FAQs for researchers
Don’t forget – it’s not just the PPI team who can help you; we can also draw on the skills and expertise of the CUH PPI panel, a group of more than 70 members of the public who are interested in getting involved in local research and who can get involved in PPI activities directly with your team. We can also provide advice to help you involve specific communities or patient groups and connect you with groups we know through our network.
Can the PPI team help me design a PPI strategy for my research project?
Yes, please! We are very happy to help researchers at all career stages to involve people in their research. We can provide advice on creating a PPI strategy for your project, as well as how you can describe this strategy for your research proposal. Please get in touch with Amanda or Georgina and we can discuss how to involve people in your research.
I’m working on a research proposal (or planning to)/not yet funded and need some free or low cost ways to involve the public to inform my application. Can you help?
Yes. Our PPI Team can provide advice on ways to involve people in your research that are free or very low cost. We also have a large panel of people (the CUH PPI panel) who are interested in getting involved in research and there are several ways that we can involve them that will cost you no more than a packet of biscuits.
Can the PPI team help me calculate PPI costings for my grant?
Absolutely. Please get in touch and we can discuss what your project needs and how much you should request to cover it.
Can you and/or the panel write the PPI section of my grant for me?
No. However, a member of the PPI Team will be very happy to review what you have written and it is possible to send PPI sections (or even whole applications) to be reviewed by the panel.
My funding application form asks what training I will provide my PPI members. Is this something you can help me with?
The PPI team have been working on creating training support for members of the public involved in research projects on campus. Please get in touch with us and we can discuss what we are able to offer further.
I would like to include a PPI post in my research proposal, can you advise on this?
Absolutely! The PPI team can help you write the role description for such a position, advertise the post through our networks, assist with interviewing and provide training and support to your recruited team member.
I don’t know anything about PPI! Where can I find out more?
The PPI team run several, free ‘Introduction to PPI for Researchers’ training courses on campus each year. (Coming soon: link to online training dates.) We also run courses on more specific topics, including how to run a PPI panel. You are welcome to get in touch with the PPI Team to discuss your training needs.
Can the PPI team organise/run my patient event for me?
We can provide advice on style and format of patient events, connect you with patient groups we know, help you to publicise your event through our public networks and assist with incorporation of feedback into your research project. If your event is local and held during business hours, and we have capacity, we may be able to help you facilitate your event. However, we are a very small team and do not have the capacity to organise, fund or run events on your behalf. If you are planning a large patient engagement event as part of your research proposal, we recommend that you cost a PPI post into your project. The PPI team can help you write the role description for such a position, advertise the post through our networks, assist with interviewing and provide training and support to your recruited team member to help them to arrange such an event.
Involving the CUH PPI Panel in my research
I need my response in less than 2 weeks. Can I still ask the panel for feedback?
Meaningful PPI takes time – both because your contributors need adequate time to reflect on the project in order to provide their feedback, but also because we value our contributors’ time and we can’t expect them to instantly provide feedback with no notice. You also need time to be able to reflect on their feedback and adjust your research in response. As such, we will not send research proposals out to the whole panel with a less than two-week deadline. However, if you need to get some feedback quickly, we will work with you where we can. If you have a short deadline, please get in touch with Georgina or Amanda who will discuss your requirements with you and see what we can organise.
Why do I need to submit background information and a lay summary if my research proposal doesn’t require one?
It is much easier for our PPI contributors to provide quality feedback to a project when they understand the context that the research is happening in – remember that all contributors (including the PPI team!) can only provide feedback about the research based on the information you have provided us. Sometimes understanding why you have chosen a particular subject and the research that has preceded it can be really helpful in better understanding the project overall. Likewise, a lay summary is essential to help the panel understand your research and helps you to practice your ability to discuss it with a lay audience.
What if the panel hates my project?
Members of the panel aim to be your ‘critical friends’ and very much want to see your research succeed. Sometimes comments might feel challenging or questioning, and the intent behind this is always to help you think about how to make your research stronger and more appropriate to the end users. If you feel that you have received lots of negative comments, please get in touch with Amanda or Georgina and we will help you work through the feedback and discuss how you can use it to improve your research.
How much does it cost to use the panel?
If your research is funded or supported by the NIHR Cambridge Biomedical Research Centre (most researchers whose research involves patients on campus), there is no cost for you to involve the panel in your research. We cover the reimbursements for panel members to attend focus groups organised by the PPI team using PPI meeting rooms. The only cost to research teams is for refreshments for panel members attending focus groups. If you wish to involve panel members in other activities as part of your research (for example, as a representative on a steering committee) then it would be up to you to discuss and cover any payments or reimbursements for those activities.
Can I use my own facilities for the focus group?
Yes, you are welcome to use your own meeting rooms for a focus group. However, if the facility you wish to use is not on campus, you will need to cover the travel reimbursements for the attendees through your research funds. Similarly, you will need to help us provide directions to the panel in our invitation.
I didn’t get my funding/ethics approval. Do I still need to feedback to the panel?
We are sorry to hear that. Yes, we would still like to be able to feedback this news to the panel and hear what you plan to do next. Grant/ethics rejections are an unfortunate reality of the research process and the panel want to hear about the outcomes of the research they support – both good and bad. Amanda and Georgina are also very happy to discuss the PPI feedback from your application and where it could be improved, if this area was mentioned in the feedback.
Can I put panel members as co-researchers on my grant application?
Under a minority of circumstances, it may be possible to invite a panel member to be a co-researcher/co-applicant to your project. However, we will only invite panel members to do this where we feel that your project could truly benefit from a public co-applicant and where you can demonstrate that you plan to involve them to an extent that reflects that of a true co-applicant. We cannot give you the name of a panel member to add to your application for this purpose (yes, we have been asked this before!).
Is my project confidential?
Yes. In order to become a member of the CUH PPI panel, panel members must sign an agreement not to discuss or share any of the projects that they are involved in. The PPI Team discuss this requirement with all new members and explain why privacy and confidentiality are important. Similarly, the PPI team will not discuss the specifics of your project with anyone without your consent. Occasionally we meet other researchers or research support staff that we think could benefit from talking with you – however, we will not introduce them without first gaining your permission.
General questions about PPI
My project doesn’t use human participants. Do I still need PPI?
Need? Maybe not, if your funding body doesn’t require it. Could it still benefit from involvement? Almost certainly! If your research will ultimately influence the treatment of patients (as we hope it will!) or has used samples or data that came from patients (even in another study) then you should be involving patients and the public in the research. All research can benefit from involving the public, even if just to write a lay summary and assist with the dissemination plan. The PPI team are happy to help you find ways to involve people in your research, however obscure, and you will be surprised at the valuable perspectives you gain from the process.
Some of the suggestions made by contributors are contradictory/impossible to implement. What should I do?
It is true that asking lots of people for their opinions will give rise to… lots of opinions – the classic one being a combination of too long/too short/just right replies! Ultimately, you are the final decision-maker and can choose to implement the suggestions and feedback that are right for your project. Where this happens, it can help to explain to contributors why you took the decision that you did (for example, you couldn’t make your document longer, because there is a word limit). You can also take a lot of the information on board in other ways – for example the feedback may make you aware of useful information that you can include in your patient documents that answers a particular question or refutes a common misconception. The PPI team are very happy to help you review your feedback and help you use it to improve your research.
COVID-19 studies currently recruiting at CUH
Alongside the excellent care our staff are delivering, we are using our tremendous research capabilities to better understand COVID-19 and its successful management, including development of innovative approaches to testing and treatment.
National studies that we are supporting in Cambridge Hospitals include: PRIEST (Pandemic Respiratory Infection Emergency System Triage) to optimise the triage of people using the emergency care system; RECOVERY (Randomised Evaluation of COvid-19 thERapY), a trial of potential therapies that can be adapted to introduce new treatment arms as potential therapies emerge; and REMAP-CAP (Randomised, Embedded, Multifactorial, Adaptive Platform trial), a trial designed to evaluate a number of treatment options simultaneously and efficiently in critically ill patients.
We have also developed a new research resource in the NIHR COVID-19 BioResource, which will allow all patients admitted to Cambridge hospitals to participate in research studies by providing biological samples and health information. We have recruited over 100 BioResource participants, and the first samples have already been processed for analysis. The NIHR COVID-19 BioResource will be instrumental in understanding why the virus affects people in such different ways and identifying new treatments.
Our SAMBA (simple amplification-based assay) point of care test is already helping us rapidly find out whether patients have COVID-19 and ensure that they receive the right treatment in the right ward of the hospital.
We would like to thank all of the clinical and research staff who have made these remarkable achievements possible in such a short period of time, as well as all of the patients who have participated in our studies and made such a valuable contribution to improving care and treatment for COVID-19.
What is the purpose of the trial?
Currently, there are no specific licensed or approved drugs for the disease; and with the number of confirmed cases of COVID-19 infection arising from the SARS-CoV-2 coronavirus expected to rise substantially and rapidly, this has the potential to overwhelm the ability of the National Health Service (NHS) to cope with the increased demand.
What is the drug being tested?
Hydroxychloroquine is commonly used to treat malaria and rheumatological conditions and its side effects are well-known. The doses used in this trial are at the lower end of the range of normal treatment doses prescribed for the conditions they are licensed for, so side effects may be less likely to occur.
This is a double-blind trial meaning neither you nor the trial doctor will know which treatment you have been assigned to.