ArticleJMIR research protocols2016
Multiple Sclerosis Therapy With Disease-Modifying Treatments in Germany: The PEARL (ProspEctive phArmacoeconomic cohoRt evaluation) Noninterventional Study Protocol.
Article in JMIR research protocols, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Real-World Evidence on the Societal Economic Relapse Costs in Patients with Multiple Sclerosis.PharmacoEconomics · 2020Observational
- Differentiating societal costs of disability worsening in multiple sclerosis.Journal of neurology · 2020Article
- The Multiple Sclerosis Health Resource Utilization Survey (MS-HRS): Development and Validation Study.Journal of medical Internet research · 2020Article
- Gender disparities in health resource utilization in patients with relapsing-remitting multiple sclerosis: a prospective longitudinal real-world study with more than 2000 patients.Therapeutic advances in neurological disorders · 2020Article
- Article
- The importance of collecting structured clinical information on multiple sclerosis.BMC medicine · 2016Article
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Abstract
backgroundPatients with multiple sclerosis (MS) require long-term therapy and have a wide variety of needs for health-related support. The efficacy and safety of MS therapy, as assessed by both clinicians and patients, are important parameters that need to be considered. However, few studies combine data on efficacy and safety outcomes with pharmacoeconomic data.
objectiveHere, we present the study design of the ProspEctive phArmacoeconomic cohoRt evaluation (PEARL), a prospective, multicenter, noninterventional cohort study on patients with relapsing-remitting MS (RRMS) treated with disease-modifying treatments (DMTs).
methodsDuring a prospective observational phase of 24 months per patient, PEARL evaluated clinical and patient-perceived efficacy and safety measures, as well as pharmacoeconomic data on RRMS patients treated with DMTs-interferon beta and glatiramer acetate. Measurements of the patients' perceptions included the assessment of patient-reported quality of life, treatment satisfaction, and compliance. The study was planned to include 1800 outpatients from 180 German neurological practices who had continuously been treated with an approved DMT for at least 30 days. The primary statistical analyses of the PEARL study will be descriptive. Particular focus will be on specific subgroups, such as patients who switched DMTs during therapy and patients with disease worsening or disease activity. Subgroups will be compared using stratified analyses.
resultsData collection for PEARL started in September 2010 and ended in July 2013. As of July 2015, the study is completed and is currently being analyzed and written up.
conclusionsPEARL is evaluating both the health status and resource utilization of RRMS patients treated with DMTs in Germany. The combination of pharmacoeconomic data with clinical and patients' self-perceived efficacy and safety outcomes will add useful information to the currently incomplete picture of the overall RRMS burden in Germany.
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