Research & Publications

The agenda of the Global Patient Reported Outcomes for Multiple Sclerosis Initiative: Progresses and open questions

The global patient-reported outcomes for Multiple Sclerosis Initiative: Bridging the gap between clinical research and care – updates at the 2023 Plenary Event

Paola Zaratin, Sara Samadzadeh, Meral Seferoğlu, Vito Ricigliano, Jonadab dos Santos Silva, Abdulkadir Tunc, Giampaolo Brichetto, Timothy Coetzee, Anne Helme, Usman Khan, Robert McBurney, Guy Peryer, Helga Weiland, Peer Baneke, Mario Alberto Battaglia, Valerie Block, Luca Capezzuto, Loïc Carment, Paolo Angelo Cortesi, Gary Cutter, Letizia Leocani, Hans-Peter Hartung, Jan Hillert, Jeremy Hobart, Kaisa Immonen, Paul Kamudoni, Rod Middleton, Patricia Moghames, Xavier Montalban, Liesbet Peeters, Maria Pia Sormani, Susanna van Tonder, Angela White, Giancarlo Comi and Patrick Vermersch on behalf of the PROMS Initiative Scientific Committee and Working Groups 

Published: 20 June 2024

Abstract

Significant advancements have been achieved in delineating the progress of the Global PROMS (PROMS) Initiative. The PROMS Initiative, a collaborative endeavor by the European Charcot Foundation and the Multiple Sclerosis International Federation, strives to amplify the influence of patient input on MS care and establish a cohesive perspective on Patient-Reported Outcomes (PROs) for diverse stakeholders. This initiative has established an expansive, participatory governance framework launching four dedicated working groups that have made substantive contributions to research, clinical management, eHealth, and healthcare system reform. 

Read More

Measuring outcomes that matter most to people with Multiple Sclerosis: the role of patient-reported outcomes

The global patient-reported outcomes for Multiple Sclerosis Initiative: Bridging the gap between clinical research and care – updates at the 2023 Plenary Event

Paola Zaratin, Sara Samadzadeh, Meral Seferoğlu, Vito Ricigliano, Jonadab dos Santos Silva, Abdulkadir Tunc, Giampaolo Brichetto, Timothy Coetzee, Anne Helme, Usman Khan, Robert McBurney, Guy Peryer, Helga Weiland, Peer Baneke, Mario Alberto Battaglia, Valerie Block, Luca Capezzuto, Loïc Carment, Paolo Angelo Cortesi, Gary Cutter, Letizia Leocani, Hans-Peter Hartung, Jan Hillert, Jeremy Hobart, Kaisa Immonen, Paul Kamudoni, Rod Middleton, Patricia Moghames, Xavier Montalban, Liesbet Peeters, Maria Pia Sormani, Susanna van Tonder, Angela White, Giancarlo Comi and Patrick Vermersch on behalf of the PROMS Initiative Scientific Committee and Working Groups 

Published: 20 June 2024

Abstract

Significant advancements have been achieved in delineating the progress of the Global PROMS (PROMS) Initiative. The PROMS Initiative, a collaborative endeavor by the European Charcot Foundation and the Multiple Sclerosis International Federation, strives to amplify the influence of patient input on MS care and establish a cohesive perspective on Patient-Reported Outcomes (PROs) for diverse stakeholders. This initiative has established an expansive, participatory governance framework launching four dedicated working groups that have made substantive contributions to research, clinical management, eHealth, and healthcare system reform. 

Read More

Men arguing

Comment on “Reflections on patient engagement by patient partners: How it can go wrong”

Paola Zaratin, Usman Khan and Guendalina Graffigna

Published: December 22, 2023

Abstract

As patient-advocacy, public policy and clinical researchers with special knowledge on Responsible Research Innovation (RRI) governance and the public health and psychology underlying patient engagement, we read with interest the comment contribution by Richards et al., “Reflections on patient engagement by patient partners: How it can go wrong” (Richards et al. in Res Involv Engagem 9:41, 2023. https://doi.org/10.1186/s40900-023-00454-13)

Read More

Measuring outcomes that matter most to people with Multiple Sclerosis: the role of patient-reported outcomes

Men arguing

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).

Read More

Measuring outcomes that matter most to people with Multiple Sclerosis: the role of patient-reported outcomes

Men arguing

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 More
doctor talking with elder patient

Draft 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). 

FDA Front building and logo

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.

Read More

ECTRIMS The Global Patient Reported Outcomes for Multiple Sclerosis Initiative