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            <funder>OFSEP was supported by a grant provided by the French State and handled by the "Agence Nationale de la Recherche", within the framework of the "Investments for the Future" program, under the reference ANR-10-COHO-002, by the Eugène Devic EDMUS Foundation against multiple sclerosis and by the ARSEP Foundation. ML has recieved travel grant from ARSEP foundation for this project. The Clinical Outcomes Research unit at the University of Melbourne received funding from NHMRC (grant number 1140766, 1129789, and 1157717) to support this study. The MSBase Foundation is a not-for-profit organization that receives support from Biogen, Novartis, Merck, Roche, Teva Pharmaeutical Industries and Sanofi Genzyme. The Danish Multiple Sclerosis Registry did not receive any funding to collaborate in this study.</funder>
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                <idno type="issn">1471-2288</idno>
                <title level="j">BMC Medical Research Methodology</title>
                <imprint>
                  <publisher>BioMed Central</publisher>
                  <biblScope unit="volume">22</biblScope>
                  <biblScope unit="issue">1</biblScope>
                  <biblScope unit="pp">155</biblScope>
                  <date type="datePub">2022-05-30</date>
                  <date type="dateEpub">2022-05-30</date>
                </imprint>
              </monogr>
              <idno type="doi">10.1186/s12874-022-01623-8</idno>
              <idno type="pubmed">35637426</idno>
              <idno type="pubmedcentral">PMC9150358</idno>
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            <langUsage>
              <language ident="en">English</language>
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            <textClass>
              <keywords scheme="author">
                <term xml:lang="en">Causal contrasts</term>
                <term xml:lang="en">Censoring</term>
                <term xml:lang="en">Effectiveness</term>
                <term xml:lang="en">Indication bias</term>
                <term xml:lang="en">Multiple sclerosis</term>
                <term xml:lang="en">Positivity assumption</term>
                <term xml:lang="en">Propensity score</term>
              </keywords>
              <classCode scheme="mesh">Fingolimod Hydrochloride</classCode>
              <classCode scheme="mesh">Humans</classCode>
              <classCode scheme="mesh">Multiple Sclerosis</classCode>
              <classCode scheme="mesh">Multiple Sclerosis, Relapsing-Remitting</classCode>
              <classCode scheme="mesh">Natalizumab</classCode>
              <classCode scheme="mesh">Treatment Outcome</classCode>
              <classCode scheme="halDomain" n="sdv">Life Sciences [q-bio]</classCode>
              <classCode scheme="halTypology" n="ART">Journal articles</classCode>
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              <p>Background: Natalizumab and fingolimod are used as high-efficacy treatments in relapsing-remitting multiple sclerosis. Several observational studies comparing these two drugs have shown variable results, using different methods to control treatment indication bias and manage censoring. The objective of this empirical study was to elucidate the impact of methods of causal inference on the results of comparative effectiveness studies.Methods: Data from three observational multiple sclerosis registries (MSBase, the Danish MS Registry and French OFSEP registry) were combined. Four clinical outcomes were studied. Propensity scores were used to match or weigh the compared groups, allowing for estimating average treatment effect for treated or average treatment effect for the entire population. Analyses were conducted both in intention-to-treat and per-protocol frameworks. The impact of the positivity assumption was also assessed.Results: Overall, 5,148 relapsing-remitting multiple sclerosis patients were included. In this well-powered sample, the 95% confidence intervals of the estimates overlapped widely. Propensity scores weighting and propensity scores matching procedures led to consistent results. Some differences were observed between average treatment effect for the entire population and average treatment effect for treated estimates. Intention-to-treat analyses were more conservative than per-protocol analyses. The most pronounced irregularities in outcomes and propensity scores were introduced by violation of the positivity assumption.Conclusions: This applied study elucidates the influence of methodological decisions on the results of comparative effectiveness studies of treatments for multiple sclerosis. According to our results, there are no material differences between conclusions obtained with propensity scores matching or propensity scores weighting given that a study is sufficiently powered, models are correctly specified and positivity assumption is fulfilled.</p>
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