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BMJ 2003;326:1212-1213 (31 May), doi:10.1136/bmj.326.7400.1212-a
| The first 150 words of the full text of this article appear below. |
EDITORSudlow and Counsell argue for a trial comparing disease modifying treatments with azathioprine, and placebo as an alternative to the risk sharing scheme, which they believe to be scientifically unsound.1 As independent scientific advisers to the scheme we would like to correct some inaccuracies.
Firstly, patients who have already been prescribed disease modifying treatments will not contribute to the main analyses of cost effectiveness.
Secondly, subjects will be followed up irrespective of compliance to allow intention to treat analyses.
Thirdly, there are no obviously better alternatives to the expanded disability status score. A quality assurance protocol is being developed, including further validation of the status score against cost utilities. Blinded assessments are unhelpful without a concurrent control group.
Fourthly, other series of patients with multiple sclerosis will be used to validate the Canadian historical control cohort.
Finally, the scheme has approval from the multicentre research ethics
committee and
David Chadwick, professor of neurology
Walton Centre for Neurology and Neurosurgery, University of Liverpool, Liverpool L9 7LJ dwc@liv.ac.uk
Richard Gray, professor of statistics
Birmingham Clinical Trials Unit, University of Birmingham, Birmingham B15 2TT
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