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; PROMS Initiative Working Groups; Giancarlo Comi

doi:10.1016/j.msard.2022.103757

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. UitdehaagPamela Valentine, Helga Weiland, Deborah Bertorello, Mario Alberto Battaglia, Peer Baneke, PROMS Initiative Working Groups, Giancarlo Comi

^*Corresponding author for this work

Research output: Contribution to journal › Comment/Letter to the editor › Academic

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). The multi-stakeholder PROMS Initiative is jointly led by the European Charcot Foundation (ECF) and the Multiple Sclerosis International Federation (MSIF), with the Italian Multiple Sclerosis Society (AISM) acting as the lead agency for and on behalf of the global MSIF movement. The initiative has the ambitious mission to (i) maximize the impact of science with and of patient input on the life of people affected by MS, and (ii) to represent a unified view on Patient-Reported Outcomes for MS to people affected by MS, healthcare providers, regulatory agencies and Health Technologies Assessments agencies. Equipped with an innovative participatory governance of an international and interdisciplinary network of different stakeholders, PROMS has the potential to guide future breakthroughs in MS patient-focused research and care. In this paper we present the progresses of the global PROMS Initiative and discuss the open questions that we aim to address.

Original language	English
Article number	103757
Journal	Multiple Sclerosis and Related Disorders
Volume	61
DOIs	https://doi.org/10.1016/j.msard.2022.103757
Publication status	Published - 1 May 2022

Access to Document

10.1016/j.msard.2022.103757

Cite this

Zaratin, P., Vermersch, P., Amato, M. P., Brichetto, G., Coetzee, T., Cutter, G., Edan, G., Giovannoni, G., Gray, E., Hartung, H. P., Hobart, J., Helme, A., Hyde, R., Khan, U., Leocani, L., Mantovani, L. G., McBurney, R., Montalban, X., Penner, I-K., ... Comi, G. (2022). The agenda of the global patient reported outcomes for multiple sclerosis (PROMS) initiative: Progresses and open questions. Multiple Sclerosis and Related Disorders, 61, [103757]. https://doi.org/10.1016/j.msard.2022.103757

@article{abfa1d8351a341f6b5dcdc56086392bb,

title = "The agenda of the global patient reported outcomes for multiple sclerosis (PROMS) initiative: Progresses and open questions",

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). The multi-stakeholder PROMS Initiative is jointly led by the European Charcot Foundation (ECF) and the Multiple Sclerosis International Federation (MSIF), with the Italian Multiple Sclerosis Society (AISM) acting as the lead agency for and on behalf of the global MSIF movement. The initiative has the ambitious mission to (i) maximize the impact of science with and of patient input on the life of people affected by MS, and (ii) to represent a unified view on Patient-Reported Outcomes for MS to people affected by MS, healthcare providers, regulatory agencies and Health Technologies Assessments agencies. Equipped with an innovative participatory governance of an international and interdisciplinary network of different stakeholders, PROMS has the potential to guide future breakthroughs in MS patient-focused research and care. In this paper we present the progresses of the global PROMS Initiative and discuss the open questions that we aim to address.",

keywords = "Digital Health, Multiple Sclerosis progression, Patient Reported Outcomes (PRO), Patient engagement, Personalized care, Responsible Research Innovation (RRI)",

author = "Paola Zaratin and Patrick Vermersch and Amato, {Maria Pia} and Giampaolo Brichetto and Timothy Coetzee and Gary Cutter and Gilles Edan and Gavin Giovannoni and Emma Gray and Hartung, {Hans Peter} and Jeremy Hobart and Anne Helme and Robert Hyde and Usman Khan and Letizia Leocani and Mantovani, {Lorenzo Giovanni} and Robert McBurney and Xavier Montalban and Iris-Katharina Penner and Uitdehaag, {Bernard M. J.} and Pamela Valentine and Helga Weiland and Deborah Bertorello and Battaglia, {Mario Alberto} and Peer Baneke and {PROMS Initiative Working Groups} and Giancarlo Comi",

note = "Funding Information: The core of the PROMS participatory governance is an innovative framework used to engage patients. Within this framework, patient advocacy organizations play an important role, as boundary organizations between science and society, to define and implement the ?how to? of patient engagement. Hence, the Engagement Coordination Team (ECT), including people affected by MS, was established to support the PROMS Initiative, integrating the unique experience of living with MS to the initiative. For the PROMS Initiative, the term ?patient? (person with the disease) refers to any individual with lived experience of the disease. While ?People affected by the disease? refers to a broader stakeholder group that is also engaged as part of the PROMS Initiative, and includes family members, caregivers and similar individuals/groups in addition to patients. The concept of the ECT was developed within the EU-funded RRI MULTI- ACT project (MULTI-ACT Patient Engagement Guidelines, 2020) and is also utilized by other relevant multi-stakeholder research initiatives (Progressive MS Alliance, People Affected by MS ECT, 2021). Applying the MULTI-ACT/ECT governance approach is considered instrumental to engage the relevant people affected by MS community, to reflect the diversity and complexity of their experiential knowledge. The ECT is leading the design and implementation of a plan for the engagement of people affected by MS in the PROMS agenda, as the initiative develops over time, in the implementation, monitoring and evaluation phases. The ECT is co-chaired by an MS organization representative and a person with or affected by MS. ECT members are also embedded within the working groups to jointly identify how and where to engage the MS community in a meaningful way, as well as help the Scientific Steering Committee and working groups to identify which priorities of the PROMS agenda will benefit from patient engagement activities. Funding Information: This work was supported by the Italian Multiple Sclerosis Foundation, the International Multiple Sclerosis Federation and the European Charcot Foundation. Publisher Copyright: {\textcopyright} 2022 Elsevier B.V.",

year = "2022",

month = may,

day = "1",

doi = "10.1016/j.msard.2022.103757",

language = "English",

volume = "61",

journal = "Multiple Sclerosis and Related Disorders",

issn = "2211-0348",

publisher = "Elsevier",

}

Zaratin, P, Vermersch, P, Amato, MP, Brichetto, G, Coetzee, T, Cutter, G, Edan, G, Giovannoni, G, Gray, E, Hartung, HP, Hobart, J, Helme, A, Hyde, R, Khan, U, Leocani, L, Mantovani, LG, McBurney, R, Montalban, X, Penner, I-K, Uitdehaag, BMJ, Valentine, P, Weiland, H, Bertorello, D, Battaglia, MA, Baneke, P, PROMS Initiative Working Groups & Comi, G 2022, 'The agenda of the global patient reported outcomes for multiple sclerosis (PROMS) initiative: Progresses and open questions', Multiple Sclerosis and Related Disorders, vol. 61, 103757. https://doi.org/10.1016/j.msard.2022.103757

TY - JOUR

T1 - The agenda of the global patient reported outcomes for multiple sclerosis (PROMS) initiative

T2 - Progresses and open questions

AU - Zaratin, Paola

AU - Vermersch, Patrick

AU - Amato, Maria Pia

AU - Brichetto, Giampaolo

AU - Coetzee, Timothy

AU - Cutter, Gary

AU - Edan, Gilles

AU - Giovannoni, Gavin

AU - Gray, Emma

AU - Hartung, Hans Peter

AU - Hobart, Jeremy

AU - Helme, Anne

AU - Hyde, Robert

AU - Khan, Usman

AU - Leocani, Letizia

AU - Mantovani, Lorenzo Giovanni

AU - McBurney, Robert

AU - Montalban, Xavier

AU - Penner, Iris-Katharina

AU - Uitdehaag, Bernard M. J.

AU - Valentine, Pamela

AU - Weiland, Helga

AU - Bertorello, Deborah

AU - Battaglia, Mario Alberto

AU - Baneke, Peer

AU - PROMS Initiative Working Groups

AU - Comi, Giancarlo

N1 - Funding Information: The core of the PROMS participatory governance is an innovative framework used to engage patients. Within this framework, patient advocacy organizations play an important role, as boundary organizations between science and society, to define and implement the ?how to? of patient engagement. Hence, the Engagement Coordination Team (ECT), including people affected by MS, was established to support the PROMS Initiative, integrating the unique experience of living with MS to the initiative. For the PROMS Initiative, the term ?patient? (person with the disease) refers to any individual with lived experience of the disease. While ?People affected by the disease? refers to a broader stakeholder group that is also engaged as part of the PROMS Initiative, and includes family members, caregivers and similar individuals/groups in addition to patients. The concept of the ECT was developed within the EU-funded RRI MULTI- ACT project (MULTI-ACT Patient Engagement Guidelines, 2020) and is also utilized by other relevant multi-stakeholder research initiatives (Progressive MS Alliance, People Affected by MS ECT, 2021). Applying the MULTI-ACT/ECT governance approach is considered instrumental to engage the relevant people affected by MS community, to reflect the diversity and complexity of their experiential knowledge. The ECT is leading the design and implementation of a plan for the engagement of people affected by MS in the PROMS agenda, as the initiative develops over time, in the implementation, monitoring and evaluation phases. The ECT is co-chaired by an MS organization representative and a person with or affected by MS. ECT members are also embedded within the working groups to jointly identify how and where to engage the MS community in a meaningful way, as well as help the Scientific Steering Committee and working groups to identify which priorities of the PROMS agenda will benefit from patient engagement activities. Funding Information: This work was supported by the Italian Multiple Sclerosis Foundation, the International Multiple Sclerosis Federation and the European Charcot Foundation. Publisher Copyright: © 2022 Elsevier B.V.

PY - 2022/5/1

Y1 - 2022/5/1

N2 - 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). The multi-stakeholder PROMS Initiative is jointly led by the European Charcot Foundation (ECF) and the Multiple Sclerosis International Federation (MSIF), with the Italian Multiple Sclerosis Society (AISM) acting as the lead agency for and on behalf of the global MSIF movement. The initiative has the ambitious mission to (i) maximize the impact of science with and of patient input on the life of people affected by MS, and (ii) to represent a unified view on Patient-Reported Outcomes for MS to people affected by MS, healthcare providers, regulatory agencies and Health Technologies Assessments agencies. Equipped with an innovative participatory governance of an international and interdisciplinary network of different stakeholders, PROMS has the potential to guide future breakthroughs in MS patient-focused research and care. In this paper we present the progresses of the global PROMS Initiative and discuss the open questions that we aim to address.

AB - 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). The multi-stakeholder PROMS Initiative is jointly led by the European Charcot Foundation (ECF) and the Multiple Sclerosis International Federation (MSIF), with the Italian Multiple Sclerosis Society (AISM) acting as the lead agency for and on behalf of the global MSIF movement. The initiative has the ambitious mission to (i) maximize the impact of science with and of patient input on the life of people affected by MS, and (ii) to represent a unified view on Patient-Reported Outcomes for MS to people affected by MS, healthcare providers, regulatory agencies and Health Technologies Assessments agencies. Equipped with an innovative participatory governance of an international and interdisciplinary network of different stakeholders, PROMS has the potential to guide future breakthroughs in MS patient-focused research and care. In this paper we present the progresses of the global PROMS Initiative and discuss the open questions that we aim to address.

KW - Digital Health

KW - Multiple Sclerosis progression

KW - Patient Reported Outcomes (PRO)

KW - Patient engagement

KW - Personalized care

KW - Responsible Research Innovation (RRI)

UR - http://www.scopus.com/inward/record.url?scp=85127091503&partnerID=8YFLogxK

U2 - 10.1016/j.msard.2022.103757

DO - 10.1016/j.msard.2022.103757

M3 - Comment/Letter to the editor

C2 - 35367873

SN - 2211-0348

VL - 61

JO - Multiple Sclerosis and Related Disorders

JF - Multiple Sclerosis and Related Disorders

M1 - 103757

ER -

The agenda of the global patient reported outcomes for multiple sclerosis (PROMS) initiative: Progresses and open questions

Abstract

Access to Document

Other files and links

Cite this