Research & Publications
The agenda of the Global Patient Reported Outcomes for Multiple Sclerosis (PROMS) Initiative: Progresses and open questions
The agenda of the Global Patient Reported Outcomes for Multiple Sclerosis (PROMS) Initiative: Progresses and open questions
Paola Zaratin, Patrick Vermersch, Maria Pia Amato, Giampaolo Brichetto, Timothy Coetzee, Gary Cutter, Gilles Edan, Gavin Giovannoni, Emma Gray, Hans Peter Hartung, Jeremy Hobart, Anne Helme, Robert Hyde, Usman Khan, Letizia Leocani, Lorenzo Giovanni Mantovani, Robert McBurney, Xavier Montalban, Iris-Katharina Penner, Bernard M.J. Uitdehaag, Pamela Valentine, Helga Weiland, Deborah Bertorello, Mario Alberto Battaglia, Peer Baneke, Giancarlo Comi
Published: March 23, 2022
Abstract
On 12 September 2019, the global Patient Reported Outcome for Multiple Sclerosis (PROMS) Initiative was launched at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
Measuring outcomes that matter most to people with Multiple Sclerosis: the role of patient-reported outcomes
Measuring outcomes that matter most to
people with Multiple Sclerosis: the role
of patient-reported outcomes
Giampaolo Brichetto, Paola Zaratin
Published: June, 2020
Abstract
Purpose of review: Patient-reported outcome (PRO) represents a unique opportunity to measure the impact of health research, and care on outcomes that matter most to people with Multiple Sclerosis (PwMS).
Read MoreDraft Guidance Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
US Food and Drug Administration
Published: September, 2022
Abstract
The PROMS Initiative encourages the FDA and other agencies to enable global collaboration toward the path forward for validation and regulatory approval of a PROM selected as a case study.
Important aspects that would benefit from such a collaborative effort are
1. to ensure that sponsors are viewing patients as an integral group instrumental to the success of all phases of a clinical trial. Engaging with patients early and often in the clinical trial development process is essential to understanding what is most important to patients.
2. to increase the sensitivity of Patient Reported Outcomes4 in clinical trials by strengthening passive and remote measuring through e-Health. Ongoing PROMS initiatives include a catalogue of e-Health tools providing active and passive measures of functional domains and interdependences in MS (in line with the conceptual framework provided in Appendix A of this draft guidance).
ePoster at ECTRIMS ’22
ePoster at #ECTRIMS 2022
A. Helme, A. Piraino, A. van de Putte, L. Mantovani, U. Khan
Published: October, 2022
Abstract
Introduction: Patient-reported outcomes (PROs), integrated with other measures, will make breakthroughs in the holistic and comprehensive approach needed to provide effective MS care and management. The global PROMS Initiative is one of the first examples of participatory governance in MS research.
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