Patient Involvement in Research – How and Why those with Brain, Mind and Pain Disorders must be involved

Patient Involvement in Research – How and Why those with Brain, Mind and Pain Disorders must be involved

22 June 2016, 8.30 -10.00h
Members’ Salon, European Parliament, Brussels

This meeting was hosted by Marian Harkin MEP, who opened by saying that many life-threatening diseases have been eradicated thanks to years of effort by physicians, scientists, and medical professionals investigating the causes of and potential treatments for disease.

However, she said: “The brain does not give up its secrets easily and, as we know, the brain is the origin of many disabling diseases including chronic pain, depression and neurodegenerative diseases such as multiple sclerosis. And all have a huge impact on the lives of people affected by them, as well as the healthcare systems that support them.”

She stressed how crucial it is that the huge challenges posed by brain and pain disorders are addressed through integrated, coordinated and co-operative efforts, both at the European and national level.

The first speaker was EFNA Executive Director, Donna Walsh, who said that research was a central focus of the Interest Group. This, she attributed to the huge unmet needs of patients affected by brain, mind and pain disorders. For many of these disorders there is no cure. In fact, in most cases, we are still unaware of the exact cause. More research is needed – from basic to clinical to translational. However, due to the complexity of this research, the high failure rates and the lengthy development times (compared to other disease areas), many companies are downsizing or closing their operations in this area. She called for the EU to ensure that public funding through H2020 and the IMI ensured that they bridged this gap.

She also called for the EU to ensure that meaningful patient involvement was a feature of successful funding proposals. This is particularly important in brain, mind and pain disorders where:

  • The most impactful symptoms and disease progress often cannot be directly measured and must be assessed using questionnaires or interviews with patients
  • Clinical scales against which outcomes can be measured are, therefore, limited
  • External markers of disease progress are often absent
  • Secondary symptoms often more burdensome than primary/Multi-Morbidity

You can access the full presentation here


The next speaker – Isabelle Abbey-Vital of Parkinson’s UK – spoke about the UK system of patient and public involvement [PPI] as an example of best practice.

Evidence of PPI is a compulsory requirement for National Institute of Health Research (NIHR) funding streams, and is increasingly being recognized as important by other major funders. In fact, research collated by NIHR has suggested that PPI, done well, can:

  • Improve the quality and relevance of research
  • Offer a unique insight and perspective from people with personal knowledge and lived experience of a condition/service/treatment
  • Ensure accountability for public or charity funding
  • Empower patients and carers, providing a route to influencing change and improvement in issues which concern people most

However, she said, that while many researchers are open to patient involvement, they are not always sure where to start. This led to the development of Parkinson’s UK ‘Resource for Researchers’ which outlines how and why they should engage in PPI.

In summing up, she called for:

  • More emphasis on patient involvement in funding calls for research proposals
  • Increased availability of guidelines and training on patient involvement from the EU to researchers applying for grants
  • Improved support for patient organizations to facilitate involvement

You can access the full presentation here


Prof. Judith Rosmalen

Prof. Judith Rosmalen

The next speaker was Prof. Judith Rosmalen of the University of Gronigen. She began by stating that medical research is traditionally focused on diseases, but how we feel is determined by symptoms. Most symptoms remain medically unexplained, and many EU citizens have to live with their symptoms every day.

She has worked with her team to develop an eHealth system called Master your Symptoms, which will provide patients with personalized self-help guidance in order to manage their symptoms.

In the context of this project, the researchers asked professionals what interventions they considered most useful for patients. They also asked patients what interventions they preferred. It was then discovered that the ideas of the professionals did not meet the patients needs. One aspect which was particularly emphasised from the patients was the need for better communication with health care professionals.

Now, with the help of a grant from EIT Health, the researchers are developing an online course to train professionals in communication with patients with medically unexplained symptoms. To ensure the patient perspective is heard throughout this project, Pain Alliance Europe will be actively involved.

Based on her experiences, Prof. Rosmalen had the following recommendations for implementation at the EU level.

  • Provide funding for topics that are considered relevant by patients. Medicine is not about diseases, it is about patients. Ask in grant proposals for information on how patients were and will be involved in the project.
  • Expand the EU focus on eHealth initiatives, also to somatic symptoms. eHealth programs are able to support patients in their self-management of diseases and enable patients to actively participate in their care.
  • Empower patients and caregivers by increasing their general knowledge about health problems. Massive Open Online Courses (MOOCs) may be a very efficient method to share knowledge with patients and citizens across Europe.


The next speaker was Rachel Schindler MD, Vice-President, Neuroscience at Pfizer. She began by stating that there are many opportunities for bilateral exchange of information between patients and drug developers throughout the drug development process.

She called on EU policy-makers to ensure that barriers are overcome to ensure that we:

  • Involve patients early from product concept through clinical development, regulatory approval, and the product lifecycle
  • Enhance the patient experience in clinical development
  • Ensure medicines that are developed meet patient needs

This involvement has multiple potential benefits, including:

  • Drugs developed are more closely aligned with patient needs
  • Treatments are developed more quickly and efficiently
  • By being more involved, patients may have a greater awareness and interest in managing their health and well being



Michael Boni MEP

The meeting finished with a fascinating, keynote presentation from Michal Boni MEP on the opportunities for greater patient involvement in research via e- and m-Health applications.

“This is – the new opportunity due to new technologies, due to digital game changer – to make the healthcare systems much more preventive, cost effective, patient centric, with high quality results of the therapies due to personalization of treatment. And with the new possibility: to collect more data, to process them in the direction to have more knowledge on specificities of some diseases,” he said.

He particurlarly called for:

  • Better and stronger cooperation between all stakeholders
  • A focus on increasing digital health literacy
  • Reasonable and flexible policies at all levels, particularly in the area of data

He finished by pleding his support for the MEP Interest Group on Brain, Mind and Pain – saying: We need the leadership – common leadership and shared responsibilities. So, let’s do this – together!

You can access the full speech here.
You can also read his position paper on mHealth.

The meeting finished with a short discussion session with contributions from the floor. These included input from Magda Chlebus of EFPIA who spoke about three upcoming IMI projects which will explore chronic pain, but also – in October – the launch of a project on patient engagement (Why? Who? When?). She encouraged the patient partners of the Interest Group to get involved.

Catherine Berens of DG Research, Neuroscience, also participated on the day and spoke about how the Commission increasingly recognises the central role of patients. She encouraged patient advocates/organisations to contribute to their wide consultations around their proposed work programmes. She also said that there is now more scope for patient participation in Horizon 2020. This includes patient representatives in the Advisory Group but also within individual projects, where their costs to participate are fully covered.

Marian Harkin thanked all speakers, participants and organisers and closed the meeting.


The next meeting is scheduled to take place on November 29th 2016 in Brussels and will be entitled (provisionally): Retain, Rehabilitate and Reintegrate


Note: During the meeting both MEP Harkin and Ann Little, EFNA President, updated participants on the Interest Group’s upcoming Written Declaration on Access to Employment. This will be open for signing from September 12th – with a launch event in Strasbourg on September 13th, hosted by MEP Heinz Becker. All present were encouraged to get involved in asking any MEP contacts, particularly nationally, to sign. The Interest Group will provide promotional materials and templates to equip those willing to support to get involved. Contact: for any further information.

Neurological and Chronic Pain Disorders at Work – Meeting report

February 24, 2016 from 08.30 – 10.00
Members’ Salon, European Parliament, Brussels, Belgium


An initiative of the European Federation of Neurological Associations [EFNA] & Pain Alliance Europe [PAE]

This meeting was hosted by Jeroen Lenaers MEP, who opened the event by saying that those affected by neurological and chronic pain disorders were at a ‘double disadvantage’ in terms of access to employment and education. He mentioned how the debilitating symptoms and side-effects of treatment can mean that for these patients it can be difficult to find and then remain in employment. Additionally, those who are succesful then need to, not only contend with their condition, but also the stigma and social biases that it can create.

He said that even minor adjustments to the working environment can help to combat the issues raised above. He drew the audience’s attention to an amendement which he – and his fellow co-chair Marian Harkin – supported, which was put forward by the Interest Group to the Strategic Framework on Health and Safety at Work. This had been incorporated in the final draft:

It ‘draws the attention of the Commission to the increased number of workers affected by chronic illness in the workforce; takes the view that accessible and safe jobs should be available for people affected by terminal illnesses, chronic and long-term conditions and disability; urges the Member States to focus on retention and integration of people affected by chronic diseases as well as to support reasonable adaptation of workplaces, which will ensure a timely return to work; calls on the Commission to promote integration and rehabilitation measures for people with disabilities and to support Member States’ efforts by raising awareness and identifying and sharing good practices on accommodations and adjustments in the workplace; urges Eurofound to further examine and analyse the employment opportunities and the degree of employability of people with chronic diseases.’

stigma-presentationThe first speaker was Dr. Chiara Scaratti of the Besta Neurological Institute, Italy. She presented the results of a survey conducted by the European Federation of Neurological Associations [EFNA], which had almost 5000 responses from across Europe, covering a wide spectrum of brain disorders.

The analysis of these results showed that stigma in the workplace was a common problem encountered by those living with neurological disorders. It was reported that:

  • Women perceive stigma more than men
  • Young people experience stigma more than older workers
  • The lower the educational level, the higher the stigma
  • Workplace stigma increases after 1 year of illness
  • Workplace stigma is higher for those who experience pain and increases with pain intensity

She summed up by saying that urgent attention was needed to address levels of stigma at work felt by the vulnerable groups mentioned above. She said: ‘Work impacts on social cohesion and on people’s quality of life. Thus, identifying first and then caring about workers with neurological disorders could benefit employers, thanks to tailored interventions. A healthier work environment can be a facilitator, and not a barrier, in helping to prevent increases in the levels of disability experienced by people affected by neurological disorders’.

24.2The next speaker – Prof. Dr. Michiel Reneman of the University of Groningen – supported the point that work can have a therapeutic affect on patients – supporting overall physical and mental wellbeing.

He called for the European Institutions to promote Vocational Rehabilitation [VR], which he described as ‘whatever helps people to return to work or stay at work’, and said that VR:

  • Is proven effective and efficient; rehab works!
  • Could be supported by a very good business case
  • Should be made available, alongside modified work where required, for all EU citizens with health related work participation challenges
  • Public education was needed to promote this concept
  • New technology should be used to assist Healthy Aging @ Work

In conclusion, he made a plea for health and employment departments at local, regional, national and European level to work together – rather that in silos.

The next two presentations were real-life experiences from the employer and employee focussing on the benefits and challenges of people affected by neurological disorders participating in the workforce.

Karin Hellsvik presented a case-study from Biogen Italy who had hired a person affected by multiple scerlosis [MS] as part of an internship programme – Believe and Achieve – coordinated by the European MS Platform. She said their biggest learning was that internal HR policies can inadvertently lead to a person being ‘labelled’, and over-compensating for stigma can actually exacerbate the problem. She said it was important for the employer and employee to work together in creating a ‘safe and comfortable’ environment.

Jane Whelan, a person affected by severe migraine, spoke about the impact that her disorder had on her career progression but outlined minor workplace modifications e.g. felxible working hours, regular breaks, extra time for travel, etc. which helped to ensure she could better prevent attacks and manage them when they occured (as outlined in the amendment above). However, she said that disclosure to her boss and colleagues was necessary to ensure these adjustments were put in place and that the ‘invisible’ nature of the condition often led to scepticism, even amongst those who were aware of her diagnosis.

The final presentation was from Matthijs Groenveld, attache to the Dutch EU Presidency. He said that employment issues were at the heart of the European political agenda, and emphasised that a socially inclusive labour market was needed if we are to have a pan-European, job-rich economic recovery. He said that the employment guidelines as part of the European Semester process could be a vehicle through which the issues raised during the meeting could be pursued. However, he said there were also many other pieces of EU legislation which would be drawn upon to ensure access to employment and education for thos affected by neurological disorders and chornic pain conditions. The Dutch Presidency is currently awaiting a review of 24 Directives on Occupational Health and Safety, which will be accompanied by proposals on how this legilsation can be consolidated and improved. He advsied the Interest Group to follow the outcomes closely and to contribute if appropriate.

Marian Harkin, MEP co-chair, then presented a draft Written Declaration produced by the Interest Group which she said she hoped would be passed. If so, this would give patients/patient organisations across Europe another tool with which to advocate for their employment/educational rights at a national level. She said that this would be tweaked further based on the feedback from the meeting and encouraged those present to contact their national MEPs, once approved/opened, to to ask them to sign. Donna Walsh, EFNA Executive Director, said that attendees would be sent some templates to allow them to reach out effectively and confirmed that if the Declaration was passed, the Interest Group would work on a toolkit to enable its implementation.

The meeting finished with a discussion – the result of which was used to reshape the Written Declaration, which will be launched in autumn 2016. The final text will be published on once approved and open for signing.


Tackling the Stigma of Brain, Mind and Pain Disorders

Meeting of the Interest Group on Brain, Mind and Pain

– In partnership with the Interest Group on Mental Health, Wellbeing and Brain Disorders

14 October 2015, European Parliament, Brussels

Meeting report



(Left: MEP Nessa Childers, Right: Ann Little, President EFNA)

Ann Little (President, EFNA) opened the meeting welcoming participants and underlining that stigma is at the top of the list of important issues for all those affected by brain, pain and mental health disorders. Stigma stems from ignorance and fear and has pervasive consequences in all areas of life. Stigma not only results in negative behaviour; it has many other consequences, for instance in the area of funding. Brain, pain and mental health conditions occur twice as much as cancer-related conditions, yet research on cancer and cancer organisations receive twice as much funding. There is a need for more awareness of these conditions, which will also help those affected to seek help earlier.

Ann Little then gave the floor to Marian Harkin MEP, who paid respect to GAMIAN-Europe President Pedro Montellano, who sadly passed away on 2 October. A one minute silences was observed.

Marian Harkin welcomed the two Interest Groups working together on this issue, and emphasized the grave influence of stigma persons affected by brain, pain and mental health conditions and their carers. There is a growing need for more awareness and clear information. Listening to those who suffer stigma and how it impacts on their lives is crucial in this respect, and the meeting provided the opportunity to do just that. Nessa Childers MEP agreed, and stated that it is hugely important to get stakeholders and the general public interested in these conditions, as more and better information will help reduce stigma. She considers it part of her duty as an MEP to host meetings of this kind.


Session 1:             Our personal experience of stigma

During this session, Liisa Mikonen (person affected by chronic pain), Andrea Bilbow OBE (parent of children affected by ADHD) and Emily Benson (daughter of dystonia patient) shared their personal experiences of stigma.

Liisa Mikonen

Liisa Mikonen

Liisa Mikonen talked about the prejudice, disbelief and negative attitudes her condition triggers in society, working life and social and family life. She also wondered why patients are viewed so differently from non-patients and why their opinions and knowledge often do not seem to count.

Andrea Bilbow talked about society, the media and teachers blaming her (parents in general) for the problems and condition of children affected by ADHD. She also underlined the stigma surrounding existing medication for ADHD and expressed the hope that ADHD would be recognized as a mainstream and treatable condition.

Emily Benson told her story as a daughter of a cervical dystonia patient, which was diagnosed when Emily was seven. She has become a real expert on the disease and while her mother, Emily herself and her family have found a way to live with the impact of dystonia, stigma is a negative factor. Emily would wish for much greater awareness of the condition, which would help overcome stigma.

Lisa Mokenen

Closing the session, Nessa Childers MEP underlined the importance of learning from these testimonials and the need for more awareness, education and training.


Session 2               The evidence of stigma

The first speaker in this session was neurologist Prof. Matilde Leonardi (Besta Neurological Institute) who informed the audience of the outcomes of a Patient Experience Survey carried out by EFNA between November 2014 and February 2015. This was a cross-sectional study involving organisations involved with advocacy and support for patients with neurological conditions in 27 European countries. The data analysis was carried out by Professor Leonardi and her team.

The survey consisted of a questionnaire created by EFNA, collecting information on socio-demographic variables, clinical variables, impact on various life domains, social support, psychological symptoms, somatic symptoms, and stigma. Almost 5.000 patients replied.

One of the main finding was that 57% of the sample feels stigmatised at least occasionally. To evaluate the stigma in all its components, 3 scales were developed, addressing workplace stigma, social stigma and overall well-being. In relation to workplace, it was found that 11% of the total sample (457 persons) perceive a relevant workplace stigma. The findings showed that 16% of the total sample (712 persons) perceive a relevant social stigma. And in terms of overall well-being, 17% of the total sample (710 persons) perceive an overall negative well-being. Another interesting finding was that persons who think that their condition should have been diagnosed earlier perceive a significant higher workplace and social stigma and a worse overall well-being compared to persons who think that their condition was diagnosed on time.

Matilde Leonardi further stated that according to the bio-psycho-social model disability is the result of an interaction of a health condition with the environment: any barrier in this environment increases disability. Stigma is such a barrier, as it increases disability of people with all psychiatric and brain disorders. This is a violation of human rights as well as a violation of dignity of the person; stigma stands in the way of equal opportunities. Delays in diagnosis or denying the patient the right to be prescribed the most efficacious drugs are examples of such ‘barrier’ behavior.

Therefore, stigma should not only be investigated in surveys, but also considered when planning policies and interventions for people with neurological disorders. A “fit for purpose” data collection with validated instruments could allow a better tailoring of possible interventions and services. Much remains to be done at different societal levels, to identify behaviors, laws, attitudes and practices that could be prevent stigma, but interventions ARE possible and are a political choice.

The second speaker, Paul Arteel (Executive Director, GAMIAN-Europe) informed the audience of the patient’s perspective on stigma and exclusion, as measured by a number of patient surveys carried out by his organisation. These assess the views of the “expert by experience” on specific themes (stigma, physical health, adherence to treatment, mental health and workplace). These are not intended as academic studies; rather, they serve to assess what lives amongst patients, to feed into advocacy activities, help inform policy makers and help clinicians to know the extent to which patients’ views can positively or adversely influence therapeutic outcomes.

The first GAMIAN-Europe survey (2006) addressed stigma and yielded 4500 responses from 20 countries. A second, identical survey on stigma was carried out 5 years later, in order to see if there were (positive or negative) changes. The surveys were designed to measure the levels of internalised stigma, the degree of perceived discrimination and the levels of self-esteem and empowerment).

It was found that a positive evolution on self-stigma and empowerment had taken place. However, there was a small increase in the level of perceived hold negative attitudes by the general public.

Stigma has been a major item in other GAMIAN-Europe surveys as well. For instance, the 2011 survey on Physical aspects of Mental Health showed that 20% of the patients that experienced barriers to contact a doctor to treat physical problems indicated stigma and fear of disclosing their mental health problem to their GP as the reason. The 2013 survey on Mental Health and Workplace (2013) revealed that 50% of the patients did not want to inform their employers on their mental health problems. In conclusion, Paul Arteel underlined that, for people confronted with mental illness stigma is not a theoretical concept; it affects daily life, physical health, treatment and social inclusion. He made a strong plea for access to and availability of psychotherapy, as human contact remains one of the most vital elements on the way to recovery.


The final speaker in the session was Joop van Griensven (President Pain Alliance Europe), who stated that stigma relates to a belief in false or inadequate information with a strong impact on the person and their families. The social impact is enormous Where does it come from? Who creates this? Is it the general public, regulators, health care professionals, patients?

It is the right of a patient to avoid unnecessary pain. However, the experience of patients is often not believed – because of stigma. This needs to be changed. A recent survey, The PAIN Patients Pathways Project, amongst health professionals has found that 77 % of those questioned state that they believe their patients. This is interpreted as a good result; however, it still leaves 1 in 4 health professionals that does not believe patients. So 25 million pain-patients in Europe have a doctor that does not believe them. The findings in governmental institutions are even more devastating.

These issues should be addressed at a higher policy level. The differences between countries in terms of access to services and treatment and basic patients’ rights are enormous and these differences should be addressed by a higher authority.

Stigma cannot be changed by pointing at others and expecting them to take action. It can only be solved if patients and other stakeholders work together. This is why a European awareness campaign will be developed by EFNA and the European Pain Alliance, in order to create an environment of trust between all stakeholders. This will help to achieve the basic right of each patient: the right to be believed.


Nessa Childers MEP then gave the floor to Michael Hübel (European Commission, DG SANTE) who shared some reflections.

Better jobs and improved growth are the key priority for the Commission. Economic, social and employment policies and healthy populations, enabling people to be part of society are all part of this priority.

Three quarters of EU health care cost are related to chronic disease and the proportion of brain disorders and mental health conditions within this is huge. This does not only relate to the direct costs of the conditions, but also to indirect costs, due to (for instance) long term absence and early retirement. If awareness of these facts does not increase and if policy makers and service providers cannot be convinced that this is a serious issue, a situation where people will not reach their full potential will be continued.

Stigma is a very important aspect in this respect. It often relates or leads to outright discrimination. There are several tools, such as the Convention of the Rights of People with a Disability, to which the EU has signed up. The Commission’s Mental Health Pact, the Joint Action on Mental Health and the work carried out to address mental health in the work place are all useful actions taken by the EU level.

How do people with mental disorders see themselves in this equation? While on the one hand side, we need the testimonials and experience of people affected by mental health conditions to raise awareness which could help combat stigma and address their needs appropriately, patients themselves are often reluctant or even fearful to reveal their situation.

The workplace would seem to be an ideal setting to promoting mental health and well-being, because so much time is spent there. In terms of the organisation of health services, the general trend towards community care based services should be seen as an opportunity to bring mental and physical health services together. However, the philosophy upon which these services are based will determine how they deal with and combat stigma.

Brain disorders can be prevented and we need more investment in policy and research. All these issues need to be looked at as the Joint Action on mental health is coming to a close.

Michael Hübel concluded by underlining that if we want to truly tackle the issues around chronic disease, we will need to look at mental as well as at physical health.


Heather Clarke, EU Affairs, EFNA

Heather Clarke, EU Affairs, EFNA

Marian Harkin MEP then gave the floor to Heather Clarke (EFNA), who briefly introduced the draft work plan for the Brain Mind and Pain Group in the area of stigma. The main activity will be the launch of a European awareness campaign addressing stigma, entitled ‘Under the umbrella’. This launch will take place during Brain Awareness Week and will take place in the European Parliament.

Heather Clarke also announced a meeting of the Brain Mind and Pain Group taking place on February 24 addressing issues around the workplace. Another meeting scheduled for June on the topic of patient involvement in research.

Paul Arteel (GAMIAN-Europe) outlined the plans of the Interest Group on Mental health, Well-being and Brain Disorders, stating that the overall aim for the coming period is to ensure an appropriate and more comprehensive follow-up to the EU Joint Action on Mental health. GAMIAN-Europe will be working with the co-chairs to table amendments to this effect for all relevant policy reports going through the European Parliament.

The next meeting will take place in December together with the Interest Group on Carers, which will address the needs of those caring for persons with mental health conditions.

For next year, joint meeting with the European Brain Council and the Brain, Mind and Pain Group are foreseen.


Discussion and Questions

During the discussion the following issues were raised:

  • The way doctors communicate with patients’ needs to be addressed. Often this is done in a patronising manner, and this helps to perpetuate stigma.
  • Several organisations of specialists informed the audience that they are in the process of working with patient organisations in various ways, for instance by setting up a patient liaison committee and organising joint sessions at relevant meetings. It is increasingly felt that working together with (neurological) patients is the only way to ensure better quality of life and better health.
  • The right to work, as enshrined in various Charters, is not the same as having the opportunity to work. Stigma very often gets in the way. While the principle is positive, it is void of content. The EU should take concrete action to tackle this. Information and awareness needs to be improved and increases.
  • When developing the stigma campaign a number of different dimensions and variables need to be taken into account such as the audiences (different messages may be required for different stakeholder groups) and whether it will be implemented top down or bottom up.
  • It is not only those affected by brain, pain and mental health conditions that suffer stigmatisation; those who treat them (psychiatrists, psychologists) are stigmatised as well.
  • Listening to patient testimonials is important; it educates health professionals and helps them deal with patients better.
  • Professional curricula taking better account of the patient experience and knowledge are being developed, and these should become the standard. The EU level could help the exchange of good practice and support wider dissemination of these curricula.
  • Events such as these provide the opportunity to talk directly to the policy makers. However, in these conversations we should not just present problems but also focus on possible solutions. It also needs to be borne in mind that health care remains a national competence and that it is unrealistic to ask for European legislation.


Christine Marking, 16 October 2015


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