New Research – Evolution of Real-world Evidence Outcome Measures in Multiple Sclerosis Exemplified by Fingolimod

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European Neurological Review, a peer-reviewed, open access, bi-annual neurology journal publish cutting-edge article by Mefkure Eraksoy, Helmut Butzkueven, Tjalf Ziemssen, Robert Zivadinov.

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Real-world evidence provides important information concerning the long-term effectiveness and safety of disease-modifying treatments (DMTs) for multiple sclerosis (MS) in clinical practice in a large number of patients.

Physicians routinely collect data from multiple sclerosis (MS) patients as part of clinical practice. Much of these data are now in electronic formats. Minimum datasets for monitoring clinical outcomes are similar in many centres, and consensus is generally easily reached. When aggregated, these data potentially produce a powerful database. When paper records were ubiquitous, clinical research was largely separate from clinical practice with clinical research organisations and pharma companies populating databases via questionnaires.

The development of electronic health records is a major improvement, but an agreed minimum dataset and data-sharing arrangements are also required to monitor a long-term disease such as MS. The information in electronic medical records is ‘big data’ and typically describe overall global trends, but are not necessarily suitable to analyse individual patient outcomes. In common with a clinical trial, a disease registry (or long-term database) uses an agreed minimum dataset. Examples in MS include the European Database for Multiple Sclerosis (EDMUS) project, the Swedish National Registry, the Danish National Registry and the global MS Registry (MSBase). Once the language (i.e. the minimum dataset) has been agreed, typically including demographics, disease classification, relapse dates, Expanded Disability Status Scale (EDSS) scores, disease-modifying drug (DMD) start and stop dates, codified magnetic resonance imaging (MRI) and other diagnostic testing, it can be implemented as a physician-initiated registry. Ideally, the registry data collection effort is highly integrated with clinical practice, with little extra time taken. A common misconception among physicians is lack of time, but the large existing registries with over 150,000 MS records in aggregate illustrate that it is possible with proper motivation and, ideally, some dedicated resources. For example, the Danish registry was started in 1948 and now includes over 25,000 records.3 It demonstrates the motivation of the Danish neurologists with minimal additional resources to produce this valuable dataset.

Most of the successful approaches are hybrids – comprising both a registry function and an e-health record function. For example, 80 % of Swedish MS patients are monitored online using such a system that provides data to the clinician on treatment, relapses and EDSS scores, together with comparative information on the severity of disease compared with other patients (see Figure 1). Registries provide long-term information displayed graphically making it easy to relate the patients’ current situation to the past, thus helping their management.

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Barney Kent
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