@article{36ad7042637146cd821d990d40c046da,
title = "Harmonization of real-world studies in multiple sclerosis: Retrospective analysis from the rirems group: Multiple Sclerosis and Related Disorders",
abstract = "Background: 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. 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 (τ2). 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; τ2=4.76), and 7% in female percent (ES=66.42; 95%CI=63.08, 69.76; p<0.01; τ2=7.15). EDSS variance was 0.2 in studies including patients with average age <36.1 years (ES=1.96; 95%CI=1.69, 2.24; p<0.01; τ2=0.19), or from 36.8 to 41.1 years (ES=2.70; 95%CI=2.39, 3.01; p<0.01; τ2=0.18), but increased to 3 in studies including patients aged >41.4 years (ES=4.37; 95%CI=3.40, 5.35; p<0.01; τ2=2.96). The lowest variance of relapse rate was found in studies with follow-up duration ≤2 years (ES=9.07; 95%CI=5.21, 12.93; p = 0.02; τ2=5.53), whilst the lowest variance in EDSS progression was found in studies with follow-up duration >2 years (ES=5.41; 95%CI=3.22, 7.60; p = 0.02; τ2=1.00). Discussion: 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. {\textcopyright} 2020 Elsevier B.V.",
keywords = "Harmonization, Multiple sclerosis, Outcome measures, Real world, biological marker, adult, age, Article, clinical article, clinical assessment, cognition assessment, data analysis, diagnostic procedure, disease exacerbation, evaluation study, Expanded Disability Status Scale, female, follow up, gender, human, laboratory test, longitudinal study, male, multiple sclerosis, neuroimaging, neurophysiology, onset age, outcome assessment, publication, recurrence risk, retrospective study, structured questionnaire, study design",
author = "M. Moccia and P. Annovazzi and M.C. Buscarinu and M. Calabrese and P. Cavalla and C. Cordioli and {Di Filippo}, M. and D. Ferraro and A. Gajofatto and A. Gallo and R. Lanzillo and A. Laroni and L. Lorefice and S. Mallucchi and V. Nociti and D. Paolicelli and F. Pinardi and L. Prosperini and M. Radaelli and P. Ragonese and V. Tomassini and C. Tortorella and E. Cocco and C. Gasperini and C. Solaro",
note = "Export Date: 11 March 2021 Correspondence Address: Moccia, M.; Multiple Sclerosis Clinical Care and Research Centre, Via Sergio Pansini 5, Italy; email: marcello.moccia@unina.it Funding details: Merck Funding details: Novartis Funding details: Biogen Funding details: Teva Pharmaceutical Industries Funding details: Sanofi Funding details: Roche Italia Funding text 1: RIReMS meetings during the planning and the conduction of the project were supported by an unrestricted contribution from Merck . The sponsor contributed to the logistics of the meetings, but had no role in the planning, study design, or conduction of the project. Funding text 2: 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.",
year = "2020",
doi = "10.1016/j.msard.2020.102394",
language = "English",
volume = "45",
journal = "Mult. Scler. Relat. Disord.",
issn = "2211-0348",
publisher = "Elsevier B.V.",
}