How do we improve MS research and care? Let’s act on what people affected by MS are telling us

The ‘PROMS’ initiative stands for Patient Reported Outcomes (PROs) for MS. PROs allow an individual to share their lived experience about their health or quality of life. Examples include how they feel, what symptoms they are experiencing, or what they are able to do. Using PRO measures (PROMs) – for example questionnaires that allow people to report on their individual experiences – helps us understand the impact of research, treatment and care for people affected by MS.

The PROMS initiative brings together people affected by MS, researchers, clinicians, pharmaceutical companies, MSIF’s member organisations and funders from across the world. The initiative is led and coordinated jointly by MSIF and the European Charcot Foundation, with the Italian MS Society as the lead agency for MSIF.

The goals of this important global initiative are laid out in an article published this month in the journal Multiple Sclerosis and Related Disorders, by members of the PROMS Scientific Steering Committee. The questions the PROMS initiative intends to answer include:

• What outcomes matter most to patients?
• Which existing PROMs should be used to help assess treatment effects or compare different care options?
• How could the use of PROs be improved to inform health policy in MS?
• How could the use of PROs be improved in the development and approval of new treatments?

Peer Baneke, CEO of MSIF and co-Chair of the PROMS initiative’s Executive Committee, says:

“The PROMS initiative has the potential to guide future breakthroughs in MS research and care, ensuring people affected by MS are kept at the heart of everything we do. This significant publication is a call to everyone in the global MS community to recognise the importance of improving the use of PROs for MS across the whole research and care continuum.”

What steps are being taken to answer these questions?

What outcomes matter most to patients?

The PROMS initiative will reach out to people affected by MS across the world, to find out what aspects of living with MS have the biggest impact on their day to day lives. This will tell us whether current PROMs capture everything that is important, or if there are gaps that need addressing.

Existing PROMs are increasingly used as outcomes in clinical trials of disease-modifying therapies, symptomatic treatments and rehabilitation. However, many of these were not developed in partnership with MS patients, nor are they able to capture the full extent of MS activity and progression.

If new PROMs need to be created, then we will work with people affected by MS to create guidelines for how to develop PROMs using a truly participatory approach. This will ensure any new measures reliably capture information across MS disease stages, along an individual’s disease course, as well as in varied geographical, social and cultural settings.

Which existing PROMs should be used to help assess treatment effects or compare different care options?

Incorporating PROMs into clinical practice is not intended to be a substitute for a meaningful patient-clinician interaction; indeed, the use of PROMs should enhance this interaction. The PROMS initiative aims to identify a core set of existing PROs that can usefully define the symptoms, abilities and quality of life issues that people with MS often need to describe to their health care practitioners. Including a discussion of PROs in the conversation between the clinician and patient is not yet routine practice in many places. The PROMS initiative will also aim to demonstrate to healthcare practitioners the added value that PROs bring, in terms of more effective treatment and care decision-making, and how digital and eHealth technology could overcome barriers to capturing and sharing PROs more easily.

Ideally, this core set of PROs will not only be useful in the clinic, they could also be used routinely in clinical trials, and incorporated into MS registries. This will help ensure that research is focused on outcomes that are most meaningful to people affected by MS.

How could the use of PROs be improved to inform health policy in MS?

PROs are not only important in research and for individual healthcare decisions, they can also be used to guide decision-making at the health system level about the treatment and care of people with MS. For example, PROs could be used to make better decisions around access to rehabilitation, disease modifying treatment, or reimbursement. The PROMS initiative aims to understand how PROs are currently incorporated into health policy and practice in different parts of the world, in order to develop recommendations and raise awareness of the value of using PROs in this way.

How could the use of PROs be improved in the development and approval of new treatments?

It is important to consider the way in which PROs are collected and shared. This can help reduce the burden of measuring, reporting and sharing data for people with MS, healthcare practitioners and researchers. Capturing PROs through digital methods – such as wearable devices – can enable PROs to be included as outcomes in research and clinical trials more efficiently. PROs can be measured actively (e.g. a person directly reports about their experiences or feelings) or passively (e.g. a device captures the degree of sleep disturbance someone is experiencing). The PROMS initiative will conduct a survey of eHealth tools that currently capture PROs relevant to MS, with the eventual aim of identifying tools that would be most useful for research, care or self-management purposes.

Read the full details in the paper here, and you can also learn more about the role of people affected by MS in the PROMS initiative.