Harmonization of real-world studies in multiple sclerosis: Retrospective analysis from the rirems group.

Adult Age of Onset Aged Female Humans Italy / epidemiology Multiple Sclerosis / epidemiology Retrospective Studies

Harmonization Multiple sclerosis Outcome measures Real world

Journal

Multiple sclerosis and related disorders

ISSN: 2211-0356

Titre abrégé: Mult Scler Relat Disord

Pays: Netherlands

ID NLM: 101580247

Informations de publication

Date de publication:
Oct 2020

Historique:

received: 05 05 2020

revised: 25 06 2020

accepted: 11 07 2020

pubmed: 20 7 2020

medline: 15 5 2021

entrez: 20 7 2020

Statut: ppublish

Résumé

Worldwide multiple sclerosis (MS) centers have coordinated their efforts to use data acquired in clinical practice for real-world observational studies. In this retrospective study, we aim to harmonize outcome measures, and to evaluate their heterogeneity within the Rising Italian Researchers in MS (RIReMS) study group. RIReMS members filled in a structured questionnaire evaluating the use of different outcome measures in clinical practice. Thereafter, thirty-four already-published papers from RIReMS centers were used for heterogeneity analyses, using the DerSimonian and Laird random-effects method to compute the between-study variance (τ Based on questionnaire results, we defined basic modules for diagnosis and follow-up, consisting of outcome measures recorded by all participating centers at the time of diagnosis, and, then, at least annually; we also defined more detailed/optional modules, with outcome measures recorded less frequently and/or in the presence of specific clinical indications. Looking at heterogeneity, we found 5-year variance in age at onset (ES=27.34; 95%CI=26.18, 28.49; p<0.01; τ We suggest common sets of biomarkers to be acquired in clinical practice, that can be used for research purposes. Also, we provide researchers with specific indications for improving inclusion criteria and data analysis, ultimately allowing data harmonization and high-quality collaborative studies.

Sections du résumé

BACKGROUND BACKGROUND

METHODS METHODS

RIReMS members filled in a structured questionnaire evaluating the use of different outcome measures in clinical practice. Thereafter, thirty-four already-published papers from RIReMS centers were used for heterogeneity analyses, using the DerSimonian and Laird random-effects method to compute the between-study variance (τ

RESULTS RESULTS

Based on questionnaire results, we defined basic modules for diagnosis and follow-up, consisting of outcome measures recorded by all participating centers at the time of diagnosis, and, then, at least annually; we also defined more detailed/optional modules, with outcome measures recorded less frequently and/or in the presence of specific clinical indications. Looking at heterogeneity, we found 5-year variance in age at onset (ES=27.34; 95%CI=26.18, 28.49; p<0.01; τ

DISCUSSION CONCLUSIONS

We suggest common sets of biomarkers to be acquired in clinical practice, that can be used for research purposes. Also, we provide researchers with specific indications for improving inclusion criteria and data analysis, ultimately allowing data harmonization and high-quality collaborative studies.

Identifiants

DOI: 10.1016/j.msard.2020.102394 PMID: 32683308

pubmed: 32683308

pii: S2211-0348(20)30469-7

doi: 10.1016/j.msard.2020.102394

pii:

doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

102394

Informations de copyright

Déclaration de conflit d'intérêts

Declaration of competing interest Marcello Moccia has received research grants from ECTRIMS-MAGNIMS, UK MS Society, and Merck; honoraria from Biogen, Merck, Novartis, and Roche; and consulting fees from Veterans Evaluation Services. Maria Chiara Buscarinu has received honoraria from Allmiral, Teva, Biogen, Meck, Roche, Sanofi-Genzyme and Novartis. Paola Cavalla has received honoraria from Biogen, Merck, Teva, Roche, Novartis and Sanofi-Genzyme; travel support for conferences from Biogen, Merck, Teva, Roche, Novartis and Sanofi-Genzyme. Cinzia Cordioli has received honoraria from Novartis, Merck Serono, Almirall, and Biogen. Massimiliano Di Filippo has received honoraria and travel support for conferences from Bayer, Biogen, Sanofi-Genzyme, Merck, Mylan, Novartis, Roche and Teva. Alberto Gajofatto has received honoraria from Biogen and Merck; and travel support for conferences from Merck. Antonio Gallo has received honoraria from Merck, Teva, Roche, and Sanofi-Genzyme; and travel support for conferences from Merck, Teva, Roche, and Sanofi-Genzyme. Alice Laroni has received research grants from Fondazione Italiana Sclerosi Multipla, Italian Ministry of Health and Italian Ministry of University; and honoraria from Merck, Biogen, Sanofi, Roche, and Novartis. Viviana Nociti has received honoraria from Teva, Bayer, Novartis, Roche, Mylan, Biogen, Merk and Sanofi-Genzyme; and travel support for conferences from Teva, Biogen, Sanofi-Genzyme, Roche and Novartis. Damiano Paolicelli has received honoraria from Biogen, Merck, Bayer, Sanofi-Aventis, Teva, Novartis, and Genzyme. Luca Prosperini has received honoraria from Biogen, Celgene, Genzyme, Merck, Mylan, Novartis, Roche, and Teva; and research grants from Genzyme and Fondazione Italiana Sclerosi Multipla. Marta Radaelli has received honoraria from Merck, Roche, Sanofi-Genzyme, and Novartis; and travel support for conferences from Merck, Roche, Sanofi-Genzyme, and Novartis. Paolo Ragonese has received honoraria from Biogen, Merck, Novartis, Roche, Teva, Sanofi-Genzyme; travel support for conferences from Biogen-Idec, Merck-Serono, Roche and Sanofi-Genzyme; and research grants from Almyral and Roche. Carla Tortorella has received honoraria from Merck, Teva, Roche, Sanofi-Genzyme, Novartis, and Biogen; and travel support for conferences from Merck, Teva, Roche, Sanofi-Genzyme, Novartis, and Biogen. Claudio Gasperini has received honoraria from Almirall, Bayer, Biogen, Teva, Bayer, Sanofi-Genzyme, Merck, Roche, Novartis and Sanofi-Genzyme. Other authors have nothing to disclose.