The treatment of relapsing-remitting multiple sclerosis (RRMS) has become more effective over the last decade with the advent of the currently available disease-modifying therapies (DMTs). Pivotal clinical studies differ in many characteristics, such that cross-comparisons of relative risk reductions are of limited value and can be misleading. Our objective was to compare the clinical efficacy of currently approved first-line DMTs in patients with RRMS, applying an evidence-based medicine approach. We reviewed all phase III pivotal trials of DMTs. Six clinical trials of Avonex, Betaseron, Copaxone, Rebif and Tysabri in patients with RRMS were identified for analysis. Only randomized, placebo-controlled, double-blind studies were included. The clinical efficacy endpoints compared were: proportion of relapse-free patients at 1 and 2 years; annualized relapse rate at 2 years; proportion of progression-free patients at 2 years, and proportion of patients free of gadolinium-enhancing lesions at 1 year or 9 months. Based on these analyses, Betaseron, Rebif, and Tysabri show comparable effects, whereas for several endpoints Avonex or Copaxone did not significantly differ from placebo. In the absence of head-to-head studies for all products used to treat RRMS, it still may be possible to compare treatment effects by applying evidence-based medicine principles.
"IFN-β or glatiramer acetate) (James et al., 2013; Pozuelo-Moyano et al., 2013). IFN-β treatment has proven effects on MRI activity in RRMS (Filippini et al., 2003; Freedman et al., 2008), thus our finding of a reduction of MRI activity upon IFN-β introduction was expected. The trend for a negative relationship between increasing 25(OH)D levels and MRI activity in the period without IFN-β was in line with our previous published data (Løken-Amsrud et al., 2012), as were the observed alterations of serum inflammation marker levels after initiation of therapy (Holmøy et al., 2013). "
"The simulation model enables three ways for treatment assessment. Firstly, pressing the " assess " button after selecting a treatment from the list, a new 30 years prediction is made by the system reflecting the treatment effect in terms of " Absolute Risk Reduction " on two variables in accordance to published data in the literature: relapse free and progression free at 2 years treatment (Filippini et al., 2003; Freedman et al., 2008; Jacobs et al., 1996; Johnson et al., 1995; Polman et al., 2006). Treatment effect is calculated through the impact of those two factors upon the time to reach the different EDSS states, and this will be reflected in the estimation of the EDSS distribution along the 30 years that will be displayed, together a prediction of the QALYs gain at 30 years, "
[Show abstract][Hide abstract] ABSTRACT: Shared decision making (SDM) is concerned with patient involvement into medical decisions and chronic conditions such as Multiple sclerosis (MS), with only partially effective treatments leading to potential severe side effects, conflicting evidence, and uncertain evidence on outcomes, constitute a typical condition for SDM. As treatment options increase and patients participate more intensively in decisions, the need for evidence-based information (EBI) becomes clear.
Natural history (NH) studies of MS represent the basic sources for required EBI and are especially useful to contribute to the practical exercise of prognosis formulation and to enable the evaluation of effectiveness in the context of treatment. Several of these identify early clinical factors predictive of the course of MS but there is no consensus method for determining the long term progression of disability and evolution of individual patients on the basis of observations on the early stages of the disease, which constitutes a major challenge for the practicing neurologist.
Aiming at delivering more reliable prognosis estimation, this study combines the distribution of patients reaching specific levels of disability within defined time periods as determined in NH studies, with disability curves and severity scores as a function of time, in terms of percentiles and deciles respectively, derived from longitudinal data analysis studies. A computer agent-based simulation model was implemented as a comprehensive and easy to utilize tool able to predict and monitor progression of disability in MS patients, and to support the neurologist discussing prognosis scenarios with the individual patient for effective SDM.
Multiple Sclerosis and Related Disorders 05/2013; DOI:10.1016/j.msard.2013.04.001 · 0.88 Impact Factor
"Neither further disease course nor chance of benefit can reliably be predicted in an individual case. Moreover, long-term effectiveness of immunotherapy is a matter of debate . Since patients have to weigh up uncertain benefits and considerable side effects, these decisions are highly appropriate for a shared decision making process . "
[Show abstract][Hide abstract] ABSTRACT: Shared decision making is based on the idea of cooperation and partnership between patients and doctors. In this concept both parties may initiate and perform specific decision-making steps. However, the common observation-based instruments focus solely on doctors' behaviour. Content and quality of information provided to involve patients in medical decisions are hardly considered in evaluation of SDM. This study investigates the advantages of a revised observer inventory taking into account these aspects.
Based on the OPTION scale, a more comprehensive observation-based inventory was developed, additionally considering both the patient-sided indicators for patient involvement and the criteria of evidence-based patient information. The inventory comprises three scales (doctor, patient, doctor-patient dyad) and 15 indicators each. Rater training and re-analyses of 76 consultations previously analysed using the OPTION scale were conducted. Convergent validities were calculated between the observer-based scales and the patients' ratings on the Shared Decision Making Questionnaire, the Decisional Conflict Scale and the Control Preference Scale.
Interrater reliabilities of the revised scales were high (r=.87 to .74) and even higher when only the dyadic perspective was coded (.86). The revised inventory provided additional information on the involvement taking place. No substantive correlations were found between observation-based and patients' subjective judgments.
The observers' perspective on patient involvement needs to consider patient activities. Inconsistencies of patients' and observers' judgements concerning patient participation need further investigation.
Zeitschrift für Evidenz Fortbildung und Qualität im Gesundheitswesen 07/2012; 106(4):275-83. DOI:10.1016/j.zefq.2012.04.005
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