Explaining temporal trends in annualised relapse rates in placebo groups of randomised controlled trials in relapsing multiple sclerosis: systematic review and meta-regression
2013 | journal article. A publication with affiliation to the University of Göttingen.
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Explaining temporal trends in annualised relapse rates in placebo groups of randomised controlled trials in relapsing multiple sclerosis: systematic review and meta-regression
Steinvorth, S. M.; Roever, C. ; Schneider, S.; Nicholas, R.; Straube, S. & Friede, T. (2013)
Multiple Sclerosis Journal, 19(12) pp. 1580-1586. DOI: https://doi.org/10.1177/1352458513481009
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Details
- Authors
- Steinvorth, Simon M.; Roever, Christian ; Schneider, Simon; Nicholas, Richard; Straube, Sebastian; Friede, Tim
- Abstract
- Background: Recent studies have shown a decrease in annualised relapse rates (ARRs) in placebo groups of randomised controlled trials (RCTs) in relapsing multiple sclerosis (RMS). Methods: We conducted a systematic literature search of RCTs in RMS. Data on eligibility criteria and baseline characteristics were extracted and tested for significant trends over time. A meta-regression was conducted to estimate their contribution to the decrease of trial ARRs over time. Results: We identified 56 studies. Patient age at baseline (p < 0.001), mean duration of multiple sclerosis (MS) at baseline (p = 0.048), size of treatment groups (p = 0.003), Oxford Quality Scale scores (p = 0.021), and the number of eligibility criteria (p<0.001) increased significantly, whereas pre-trial ARR (p = 0.001), the time span over which pre-trial ARR was calculated (p < 0.001), and the duration of placebo-controlled follow-up (p = 0.006) decreased significantly over time. In meta-regression of trial placebo ARR, the temporal trend was found to be insignificant, with major factors explaining the variation: pre-trial ARR, the number of years used to calculate pre-trial ARR and study duration. Conclusion: The observed decline in trial ARRs may result from decreasing pre-trial ARRs and a shorter time period over which pre-trial ARRs were calculated. Increasing patient age and duration of illness may also contribute.
- Issue Date
- 2013
- Status
- published
- Publisher
- Sage Publications Ltd
- Journal
- Multiple Sclerosis Journal
- ISSN
- 1477-0970; 1352-4585
- Sponsor
- National Institute of Health Research (NIHR) Biomedical Research Centre