Patient Reported Outcomes for MS (PROMS) brings together the global MS community, people with and affected by MS, healthcare workers and researchers, healthcare industry and many more, to enable science with and of patient input in research, clinical trials of new therapies, and the design of healthcare systems.
The PROMS initiative aims to ensure an informed and quality participation of people with MS in the decision-making processes of research and healthcare regarding their treatments and performances.
The initiative focuses on the symptoms and aspects of living with MS that matter most to patients.
Patient Reported Outcomes (PROs) reflect the experiences that patients have in relation to their treatment or condition. This could include how they feel, their symptoms or what they are able to do.
People with MS are the first experts on what it means to live with this disease, on the impact that a treatment has, on the decisive aspects of their life to which a new drug or rehabilitation intervention must respond. In order for their voice on these issues to have a full meaning that can be shared by all the actors in the field, they have to be scientifically qualified (science of patients input).
Efforts to enable the uptake of existing PRO into clinical practice and regulatory agencies decision-making processes will be greatly enhanced and informed by a commonly held strategic PRO research agenda and roadmap, shared by all relevant stakeholders.
The PROMS initiative will take a global approach to tackling this challenge. It will advocate for a set of standardised PROs to be used in therapies development and health care and promote research to develop new PROs to meet the needs of all relevant stakeholders.
The programme of work is led and coordinated jointly by the European Charcot Foundation and the MS International Federation. It is building on the experience and expertise of the Italian MS Society, who acts as the lead agency on behalf of the global MSIF movement.
Strategic priorities of the PROMS agenda
Research, validation and development
- Identify the most important functional domains for people with MS that will lead to the prioritisation of functional domains. This is particularly important to ensure the validity of the content
- Fill critical gaps in the knowledge base that hinder progress towards the development of a clear roadmap for research needs and progress.
- Research, validate and develop relevant PROMs
- Identify current PROs and PROMs for use in clinical care and collected in regulatory and clinical records and advice.
- Satisfy the position of regulatory agencies on PROs and PROMs (e.g. MSOAC EMA document).
- Promote, coordinate, implement and support initiatives to validate and harmonize ODPs across cultures.
- Establish the current return on e-Health investments for all stakeholders involved.
- Enable patients, doctors and other stakeholders to benefit from the long-term benefits of e-Health.
- Translate standardized data into a performance measure (PRO-PM) that captures the most important results to improve long-term well-being.
- Enable PRO-PMs in innovative reimbursement models, regulatory frameworks and their algorithms to support clinical decisions.
Launch of the PROMS Initiative
PROMS was presented on Thursday 12 September at ECTRIMS Congress by:
- Peer Baneke CEO, Multiple Sclerosis International Federation, UK
- Prof Mario Alberto Battaglia President, Italian Multiple Sclerosis Society, IT
- Prof Giancarlo Comi President, European Charcot Foundation, IT
- Pamela Valentine CEO & President, Multiple Sclerosis Society of Canada, CA
- Prof Patrick Vermersch Board Member, European Charcot Foundation, FR
The initiative is jointly led and coordinated by the European Charcot Foundation and the Multiple Sclerosis International Federation, with the Italian MS Society acting as the lead agency for and on behalf of the Global MSIF Movement.
The PROMS initiative will hold a meeting in Baveno on November 21, 2019, adjacent to the ECF’s annual meeting.
Relevant stakeholders, invited to attend the meeting, will work in setting the agenda of the PROMS Initiative in line with its strategic priorities.
This will lead to the development of the PROMS Initiative white paper, a first publication to set the scene for the Initiative and help engage the global community.