The Patient Reported Outcomes Initiative for MS (PROMS) will bring 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.
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.
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. 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 will be led and coordinated jointly by the European Charcot Foundation and the MS International Federation. It will build on the experience and expertise of the Italian MS Society, who will act as the lead agency on behalf of the global MSIF movement.
Strategic priorities of the PROMS agenda include:
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.
For more information please contact:
Paola Zaratin: firstname.lastname@example.org
Jan Samyn: email@example.com