Wednesday, 10 November 2010

The importance of follow-up studies.

I know I have written about this before, but I cannot over-emphasise the importance of recording data on patients having the liberation procedure and what happens to them subsequently.

Kuwait is recording data, and the clinic I went to in Poland is doing 6-month and 12-month follow-up with their patients, but because so many MS patients are travelling long distances at considerable personal expense to have the treatment done, how many will attend their check-ups?

If we are to get a true picture of the effectiveness or otherwise of CCSVI treatment, then, in my view, longitudinal prospective studies (Studies in which individuals are followed up over time to assess who develops a certain outcome)are the way to go.

Double blind studies may be the gold standard for drugs, where it is important to separate benefits seen from the effects of the drug, and those seen from the effect of just being in a study. But I am not convinced that this is appropriate for a surgical procedure. Would you do this for a heart transplant to assess the long term result on the patient? I don't see that it is ethical.

But a longitudinal study of those on whom the procedure has been carried out, detailing change in symptoms over time, and over a large enough patient population, should give a true picture of the value and effectiveness. Although the progress of MS in an individual patient is erratic and virtually impossible to predict, there is sufficient data available to indicate the prognosis for a large patient population and to provide averages to compare predicted outcomes over time, and those actually experienced. (For example this paper)

Some other patient populations ,such as those on Tysabri, are being very carefully monitored, because of the known and very real risk of PML, an often fatal brain infection. As this is currently the most effective drug therapy in slowing progression and reducing relapses in MS, they could provide a useful comparison group.

In the meantime, what can we do? Pressure on our medical and MS societies, certainly. But please, if you are planning or have had the angioplasty, please record your information on CCSVI Tracking. Negative results are as important, if not more so than positive ones, to gain some understanding of this disease we live with.

By using the power of the web, we have the potential to carry out possibly the largest study ever. So take part.

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