Harmonization of real-world studies in multiple sclerosis: Retrospective analysis from the rirems group
| Autor: | Federica Pinardi, Simona Mallucchi, Paolo Ragonese, Eleonora Cocco, Valentina Tomassini, Alice Laroni, Lorena Lorefice, Claudio Solaro, Alberto Gajofatto, Cinzia Cordioli, Viviana Nociti, Maria Chiara Buscarinu, Claudio Gasperini, Marta Radaelli, Antonio Gallo, Luca Prosperini, Massimiliano Di Filippo, Massimiliano Calabrese, Damiano Paolicelli, Paola Cavalla, Diana Ferraro, Pietro Annovazzi, Roberta Lanzillo, Marcello Moccia, Carla Tortorella |
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| Přispěvatelé: | Moccia, M., Annovazzi, P., Buscarinu, M. C., Calabrese, M., Cavalla, P., Cordioli, C., Di Filippo, M., Ferraro, D., Gajofatto, A., Gallo, A., Lanzillo, R., Laroni, A., Lorefice, L., Mallucchi, S., Nociti, V., Paolicelli, D., Pinardi, F., Prosperini, L., Radaelli, M., Ragonese, P., Tomassini, V., Tortorella, C., Cocco, E., Gasperini, C., Solaro, C., Moccia M., Annovazzi P., Buscarinu M.C., Calabrese M., Cavalla P., Cordioli C., Di Filippo M., Ferraro D., Gajofatto A., Gallo A., Lanzillo R., Laroni A., Lorefice L., Mallucchi S., Nociti V., Paolicelli D., Pinardi F., Prosperini L., Radaelli M., Ragonese P., Tomassini V., Tortorella C., Cocco E., Gasperini C., Solaro C. |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Longitudinal study medicine.medical_specialty Harmonization Outcome measures Multiple sclerosis Outcome measure 03 medical and health sciences 0302 clinical medicine Real world medicine Humans Multiple sclerosi 030212 general & internal medicine Age of Onset Aged Retrospective Studies Expanded Disability Status Scale business.industry Retrospective cohort study General Medicine Variance (accounting) medicine.disease Neurology Italy Family medicine Observational study Female Neurology (clinical) business 030217 neurology & neurosurgery Multiple Sclerosis |
| Popis: | 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; p41.4 years (ES=4.37; 95%CI=3.40, 5.35; p2 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. |
| Databáze: | OpenAIRE |
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