Read about the involvement of the patient experts below to find out how they are working together to improve our understanding of severe asthma.
Lina Buzermaniene: Patient involvement
Role: Patient Representative on the UBIOPRED Ethics Board
What is your involvement in U-BIOPRED as a patient representative?
I have been a patient member of the ethics board for U-BIOPRED since 2009. I am the mother of an asthmatic child and a volunteer with the European Federation of Allergy and Airway Diseases Patients Association, (EFA) and the Lithuanian Council of Asthma Clubs, to represent patients. EFA told me that the UBIOPRED project was looking for patient representatives and so I joined as an independent patient representative.
As a patient member I make sure that the U-BIOPRED project considers the patients participating in the project, for example their right to confidentiality and the process of testing and giving samples. Myself and the other patient representatives try to make it as easy as possible for patients to participate, and help the scientific members to consider factors that they may not have thought of from a patient perspective.
What is the ethics board?
The ethics board monitors the processes and practices of the project according to ethical principles. Ethical principles used in research include preventing harm, providing accurate information, maintaining research quality, confidentiality, and consent.
The ethics board has 11 members. Of these four are patient representatives. The other members include clinical researchers, a lawyer, an animal research expert, a safety advisor, a paediatrician, and a methodology expert who specialises in how research projects are designed to get the best quality clinical and ethical results.
Why is it important for patients to be involved in developing research projects?
I believe it is very important for patients to be involved in matters important to their health. One of the other patients in the project used the phrase, ‘nothing about us, without us’. This sums it up: patients should be involved in research because it directly affects the diagnosis and treatment of them and other patients in the future.
Being involved in research projects gives patients the chance to learn about clinical trials and pass this information on to other patients. It was daunting to begin the project with no knowledge of clinical trials and how medical research works, but over time I gained in knowledge and confidence.
Patient involvement is essential for transparency, dissemination and more fruitful discussions on how to use the outcomes of projects.
How have patients on the ethics board influenced U-BIOPRED?
The patients on the ethics board have helped develop the informed consent forms, and review the study protocols, asthma control questionnaires and quality-of-life questionnaires. We also provide advice on any specific work package issues that arise during the project.
We were involved a lot at the beginning of the project when the protocols and patient participation were being developed but we have less involvement now that the project has reached the recruitment and testing stage.
We are contacted by email if any issues arise that need to be discussed, and are invited to the yearly annual general meeting to meet face-to-face and review the project so far.
How could patient involvement in research projects be improved?
I think that there needs to be better communication between the scientists and the patient representatives in the project. The biggest problem faced by patient representatives is having no training or ability to interact with researchers. It’s difficult for them to take part in projects when they haven’t been involved before. Patients need to develop the skills to communicate about research and to express their ideas so that the researchers understand and listen to them.
It is very important for patients to be involved and influence research but they need the skills to be effective in this environment, which is something that should be taken into account in all research projects. It would be good to give patients a basic training or introduction to research and patient involvement to help them develop these skills.
As a representative of patients, what are your hopes for the project?
I believe in the research being done by the project, and what it is trying to achieve. I believe that it will help to find better treatment options, save money and increase patients’ trust in medicine.
I hope that we can learn lessons from the project, such as what was successful, what wasn’t so successful, and how we can better use patients’ opinions and advice in the future.
What are the benefits of being involved in the project?
Through being involved in the project I have learnt new skills. Patient representatives are not involved in clinical trials in Lithuania and this experience has provided me with the opportunity and confidence to promote patient involvement and talk about research at a national level and in my work with the Lithuanian Council of Asthma Clubs and EFA.
What advice would you give to patients thinking about getting involved in research?
You may feel ignorant when you start, but over time it gets easier and your opinion as a patient and by providing the patient perspective is very valuable. It is not just the professional input that is important in clinical trials. Simple advice from an alternative perspective is valuable. Scientists do not always think of things from a patient perspective so it is important for patients to be involved and make them consider patient perspectives.
Asthma UK: How patient organisations are involved in U-BIOPRED
Role: Asthma UK and several other patient organisations are involved in raising public awareness of U-BIOPRED, helping recruit patients to the advisory boards and as participants in the study.
Asthma UK has invested over £50 million into research into finding better treatments for asthma and trying to find a cure, but we cannot do this alone. This is why collaborations such as the U-BIOPRED project are so important.
Asthma UK is a charity dedicated to improving the health and well-being of the 5.4 million people in the UK whose lives are affected by asthma.As a patient organisation, we hear from parents fighting to overcome life-limiting asthma and give their children the same chances that others take for granted. We also hear from people who have to stay in hospital, sometimes for weeks, because of their asthma, and are afraid their asthma will never improve enough for them to have a permanent job.
Very few people realise how much asthma can affect people’s lives. In the UK around a quarter of a million people have asthma symptoms so severe that they have difficulty breathing almost all the time.In the UK it gets very little attention from policy makers who assume that nothing more needs to be done or that asthma has less impact than other ‘more serious’ long term conditions.
U-BIOPRED involves academic scientists, pharmaceutical companies, patient organisations and people affected by asthma working together to ensure that different voices are heard and skills shared. Asthma UK has recruited patient representatives to sit on the project's advisory boards. We also participate in working groups to help tell people outside UBIOPRED about the project, and to oversee any ethical issues, particularly around patient involvement. Co-ordinating the various views and experiences of the public and project members can take a lot of time and effort, but it is worth it as it focuses the project on its main goal, bringing us closer to discovering new and improved treatments - sooner.
Other patient organisations involved in UBIOPRED are:
- European Lung Foundation (ELF)
- European Federation of Allergy and Airways Diseases Patients Associations (EFA)
- Long Fonds, Netherlands
- Lega Italiano Anti Fumo, Catania, Italy (LIAF)
For more information on Asthma UK visit their website.
For more information on the involvement of patient organisations in UBIOPRED and other EU projects, contact us.
Pim de Boer: Ethics, safety monitoring and the patient platform
Role: Co-creator of the Patient Input Platform and ordinary member of U-BIOPRED
What is the Patient Input Platform (PIP)?
The patient input platform is an advisory board consisting of patients. Its task is to advise the members of the U-BIOPRED project and respond to questions of members and boards from the patient’s perspective. It provides advice on the patient information forms, the clinical studies and the patient consent forms. The PIP also provides advice on the content of the website. The advisory board is also meant to comment on the project and results at a national level, via national organisations, as well as the project level. For example, if patients from the UK are participating in the project they can represent U-BIOPRED at a local level to tell people about the project and get patients involved. We currently have 12 patients in PIP, 8 of whom are very active contributors. One of them, David Supple, is chairing the PIP.
We also have three patients in the ethics board and one patient in the safety monitoring board, in order to have more input from the patient’s perspective.
How were the patients recruited to PIP?
Most of these patients have been recruited through patient organisations, through Astma Fonds, Asthma UK, EFA and LIAF. However, some others have been recruited through clinical leads in U-BIOPRED.
What has the PIP achieved so far?
Before the submission of the proposal, the patients led focus-group discussions on the proposal itself to provide, from their perspective, their views. Based upon their feedback the proposal was adapted.
One example of this feedback came from a focus group in the Netherlands on severe asthma and rhinovirus exposure. One patient asked if they had any evidence that exposing patients with severe asthma to a virus would not be harmful and the lead researcher, Peter Sterk, had to admit that they hadn’t. However, they did have evidence for exposure of patients with mild and moderate asthma. So the proposal was adapted to only expose patients with mild or moderate asthma. This change will hopefully ensure that patients with severe asthma will not become unwell and require time off work or from having the upsetting experience of exacerbations.
Another achievement was the participation of patients in the ethics and safety monitoring boards. They participated in the tasks required for these advisory boards and advised on questions of evaluation and input on the development of patient information forms as well as clinical study protocols and monitoring of the ongoing studies. Patients have also advised on the website development: what content appeals to patients, what would they like to feature on the site.
There was quite a lively discussion during the 2011 Assembly Meeting between PIP members and the whole U-BIOPRED group which led to the revision of more realistic expectations of patients by the scientists. In 2012, the PIP expressed concerns about the rate of recruitment of patients into the study. As a result the PIP are now included in that clinical Work Package and are in the best position to advise from their own experience and perspective about what barriers to recruitment may be.
What benefits do patients bring to U-BIOPRED?
I think the input of patient experiences will result in a better adaptation of the studies in U-BIOPRED to the wishes, needs and concerns of patients, which we have already shown during this proposal submission procedure.
The patients can also communicate about the project and potentially also tell others about the results from the projects, to give people insight into the disease. This would also advertise the project, which is a good way to get more traffic onto the website but also to get more people into the clinical centres, if the centres are encountering difficulties in recruiting.
The patients can also evaluate the results from their perspective. They can see whether the results or part of the results do reflect their own experiences of the disease. This could then result in better discussion with doctors, although this is of course some way in the future. The patients will fill in forms which ask them what they feel, think, and experience from living with severe asthma. These data will be combined with the biomarkers but also in itself it will be a specific result from U-BIOPRED.
So the patient involvement will influence the project. It will adapt the project better towards the wishes, needs, and concerns of patients, especially those with severe asthma.
The benefit to the patients is to gain the knowledge, and guide the direction of the project. We need to address the researchers’ mind-set to reinforce how central the patients are to this project. The patients are both the subject to be investigated but can also provide valuable information to guide the development and ensure the success of the project.
What role will the PIP play during the remainder of the project?
The PIP will help with the evaluation of the results of the study. PIP members will look at whether they are useful for patients or how they may help patients coping with their disease in terms of diagnostics, care and monitoring the disease. The PIP will also help the U-BIOPRED project leads to raise the profile of the disease amongst patients, physicians, the public or even politicians. The PIP will also be involved in communicating and disseminating the results. Perhaps even more importantly, this project provides the evidence that patients really can make a difference. The work of the PIP provides a model for how to do this; by building an online discussion forum via which patients from all over Europe can have open discussion and share their ideas, knowledge, needs, experiences and expectations, not only with other patients but also with researchers and caregivers in the project.