[P05.128] A Randomized, Controlled Trial of an Educational Intervention for MS Patients Concerning CCSVI
Dalia Rotstein, Michael F. Evans, Marika Hohol, Paul O'Connor, Toronto, ON, Canada
OBJECTIVE: To assess opinions concerning CCSVI in a Canadian cohort of MS patients and to determine whether a physician-designed educational tool would change patient opinions. BACKGROUND: Chronic Cerebrospinal Venous Insufficiency (CCSVI) is the theory that extracranial venous occlusions may give rise to multiple sclerosis (MS). A treatment involving venous angioplasty has been developed based on this theory. Access to this treatment, which remains controversial, has been widely demanded by MS patients in Canada. DESIGN/METHODS: A literature search was conducted in September 2010. The results were incorporated into a narrated slideshow video describing CCSVI and research performed to date. 74 patients were randomized to watch either the physician-designed video or a recent Canadian television documentary video on the topic. All subjects were required to fill out the same questionnaire concerning their opinions about CCSVI before and after observing the videos. The primary outcome was defined as desire for CCSVI surgery. RESULTS: Overall 74 patients participated, mean age 44, median EDSS 3.5, with 36 randomized to the physician-designed video group and 38 to the documentary video group. Seventy per cent desired CCSVI surgery before watching the videos compared to 65% after. There was no significant difference between the groups, either before or after viewing the video (p=1.0 for “before” and “after”). Higher EDSS scores were associated with desire for surgery (r=0.6, p<0.05). CONCLUSIONS: A significant majority of MS patients in Canada desire CCSVI surgery. A review of the scientific evidence did not dissuade patients from their desire for surgery, despite the fact that Class 1 or 2 evidence for its efficacy does not exist. Desire for CCSVI surgery is correlated with greater disability presumably because of the lack of effective conventional agents for more advanced disease.
I thought the mention of Class 1 or 2 evidence worth looking up, especially if Class 2 sets a lower bar. But it turns out they're both randomized controlled trials.
Class I: Prospective, randomized, controlled
clinical trial with masked outcome
assessment, in a representative population.
The following are required:
Primary outcome(s) is/are clearly defined.
Exclusion/inclusion criteria are clearly
Adequate accounting for drop-outs and
cross-overs with numbers sufficiently low to
have minimal potential for bias.
Relevant baseline characteristics are
presented and substantially equivalent among
treatment groups or there is appropriate
statistical adjustment for differences.
Class II: Prospective matched group cohort
study in a representative population with
masked outcome assessment that meets a-d
above OR a RCT in a representative
population that lacks one criteria a-d.
Class III: All other controlled trials
(including well-defined natural history
controls or patients serving as own controls) in a representative population, where
outcome assessment is independent of
Class IV: Evidence from uncontrolled
studies, case series, case reports, or expert
Are we at the Class III stage? Will any of the small randomized trials underway qualify to bump us up to Class II? Will Brave Dreams be recognized as quality research? If we are at the Class III stage with 2 Class III trials completed for a rating C, that would put it at possibly effective for the given population, but that would be counting Dr. Zamboni's endovascular treatment trial and...Dr. Mandato's trial or Dr. Mehta's trial or any of Dr. Simka's work?
More than ever, reading this over makes me appreciate Dr. Dake's approach of testing the effects of CCSVI on CCSVI, measuring improvement in blood flow from before to after treatment, with a very short control group time period. We need to define the 'given population': are we MS patients or are we CCSVI patients? It is possible to be both, just as it is possible to have heart disease and MS, and to need separate treatment and research into both.