DOI: 10.5061/dryad.fh2nt
title: Data from: Quantitative benefit-risk assessment of methylprednisolone in multiple sclerosis relapses

description: Background: High-dose short-term methylprednisolone is the recommended
 treatment in the management of multiple sclerosis relapses, although it
 has been suggested that lower doses may be equally effective. Also,
 glucocorticoids are associated with multiple and often dose-dependent
 adverse effects. This quantitative benefit-risk assessment compares high-
 and low-dose methylprednisolone (at least 2000 mg and less than 1000 mg,
 respectively, during at most 31 days) and a no treatment alternative, with
 the aim of determining which regimen, if any, is preferable in multiple
 sclerosis relapses. Methods: An overall framework of probabilistic
 decision analysis was applied, combining data from different sources.
 Effectiveness as well as risk of non-serious adverse effects were
 estimated from published clinical trials. However, as these trials
 recorded very few serious adverse effects, risk intervals for the latter
 were derived from individual case reports together with a range of
 plausible distributions. Probabilistic modelling driven by logically
 implied or clinically well motivated qualitative relations was used to
 derive utility distributions. Results: Low-dose methylprednisolone was not
 a supported option in this assessment; there was, however, only limited
 data available for this treatment alternative. High-dose
 methylprednisolone and the no treatment alternative interchanged as most
 preferred, contingent on the risk distributions applied for serious
 adverse effects, the assumed level of risk aversiveness in the patient
 population, and the relapse severity. Conclusions: The data presently
 available do not support a change of current treatment recommendations.
 There are strong incentives for further clinical research to reduce the
 uncertainty surrounding the effectiveness and the risks associated with
 methylprednisolone in multiple sclerosis relapses; this would enable
 better informed and more precise treatment recommendations in the future.
description: Sampled values for all
 probability variables of the benefit-risk assessmentThe sampled values are
 based on probabilistic modelling of data from published clinical trials
 and from individual case safety reports contained in VigiBase, the WHO
 international database of suspected adverse drug reactions. The first two
 columns are used to determine what scenario of the assessment that is
 considered: the first column indicates the type of distribution over the
 derived risk intervals for the serious adverse effects, and the second
 column indicates the proportion of the sampled risk values that is
 attributed to the background. Each of the following columns belongs to one
 of the probability variables for one of the three considered treatment
 alternatives. Variables are listed in the order obtained when traversing
 the decision tree in Figure 3 top to bottom, starting from the leftmost
 level. There are 10,000 rows for each scenario. Abbreviations:
 HDMP=high-dose methylprednisolone, LDMP=low-dose methylprednisolone, NT=no
 treatment.probabilities.csvSampled values for all utility variables of the benefit-risk assessmentThese data have been generated by probabilistic modelling driven by qualitative relations specified between the considered clinical outcomes of the benefit-risk assessment. The first two columns are used to determine what scenario of the assessment that is considered: the first column indicates the severity of the relapse as measured by the patient's starting EDSS value, and the second column indicates the so called minimum utility difference between lethal and non-lethal outcomes. Each of the following columns belongs to the utility variable corresponding to one of the considered clinical outcomes. Variables are listed in the order obtained when viewing all branches of the decision tree in Figure 3 top to bottom. There are 10,000 rows for each scenario.utilities.csvResulting samples for the expected utility of the three alternativesThe data displayed in this file are the resulting samples for the expected utility of the three considered treatment alternatives in all considered scenarios. They have been obtained by combining the data displayed in the two files 'Sampled values for all probability variables of the benefit-risk assessment' and 'Sampled values for all utility variables of the benefit-risk assessment', using the decision tree depicted in Figure 3 and the formulae given in Figure 1. The first four columns are used to determine what scenario of the assessment that is considered: the first column indicates the type of distribution over the derived risk intervals for the serious adverse effects; the second column indicates the proportion of the sampled risk values that is attributed to the background; the third column indicates the severity of the relapse as measured by the patient's starting EDSS value; and the fourth column indicates the so called minimum utility difference between lethal and non-lethal outcomes. The fifth, sixth, and seventh columns then show the computed expected utility values for high-dose methylprednisolone (HDMP), low-dose methylprednisolone (LDMP), and no treatment (NT), respectively. There are 10,000 rows for each scenario.expected_utilities.csvResulting preference rates for the three alternativesThe data in this file has been computed directly from the raw data in the file 'Resulting samples for the expected utility of the three alternatives'. This file contains the same scenarios as that file, discernible from the the first four columns, but shows only a single value for each treatment alternative in each scenario. This value, the preference rate, is the fraction of all 10,000 sampling iterations for a given scenario in which the indicated alternative was the preferred one, i.e. had the highest expected utility. Preference rates for high-dose methylprednisolone (HDMP), low-dose methylprednisolone (LDMP), and no treatment (NT) are shown in columns 5-7, respectively. Figures 10 and 11 have been generated based on precisely this data.preference_rates.csv