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Ferrara, September 9, 2010
in your capacity as President of the Foundation sponsor the Center for Vascular Diseases me direct, I want to express yourself with scientific and organizational push me bitterly that, given these conditions, to resign from the Steering Committee of the Epidemiologic Study IMF.
Were lost several months in discussions with findings inconsistent with the stated goal: to confront linearly with the protocol clearly defined and published by me to assess its veracity. A simple task increasingly serious as time goes by too many compromises.
Scientifically, none of the instances that I put forward in the meeting and subsequent correspondence has gone unanswered, most of the time I have not even had the privilege of a discussion or a reply. In summary, are not strongly convinced of the feasibility study following the compromise of the protocol taught in different way than my other centers found suitable to teaching, the timing required for the preparation of the investigators and the subsequent data collection. Although I perceives that it was necessary to work much more in the training of operators, there has been no willingness to do so or to reduce a huge sample to allow reliable detection at least to the trained operators.
In addition to the failure, clear, detailed comparison with the protocol that you should investigate further motivation for a high risk of failure is the finding that the times of preparation of players is too short compared to their initial state that I have personally check. Now. It would be essential to a long process of meetings in small groups (recall in Ferrara), alternating with periods of self-learning with a tutor at a distance, to implement personal learning curve. The principle is that only one operator on duty is driven provider of an adequate epidemiological data. If it does not provide a reliable epidemiological data it is clear that the epidemiological study has no value.
Besides, with people who believe that the anomalies identified by me fall into the "normal" and have no idea of wanting to investigate more than just what is purpose to get the study, I can appreciate that attitude as an expression of scientific freedom sacrosanct until it becomes detrimental methodologically, eventually crossing the threshold of even ridicule, as evidenced by resignation had produced by the participants' instrumental exacerbation of this attitude.
Some colleagues, in fact, called me outraged because the teaching sessions in which I was not there, they were clearly put into question the students the principles of the protocol that they would have had to be trained to adequately compare potervicisi. You know well, dear Fabio that in such a context the value given the Education ended up being unfairly minimized; a dependent variable from a problem of timing and subjective evaluations negating the very foundations of the protocol that should be compared, but did not do that, a priori.
Alternatively then, to meet the time schedule imposed by the IMF, I suggested ridune the sample to 1000-1500 subjects in place of parting 2400, using only the best operators of record objectively. Although the independent statistical, Dr. Sormani, had clearly indicated that the number of 2400 subjects provided was totally arbitrary (political motivations within a territory?) Because one should not observe any preliminary assessment of power, the Steering Committee has, however, rejected this proposal. Clearly this has an enormous number of tests to be performed only by operators who pass the qualifying exams. In other words there is a risk that instead of 120 subjects they should inquire 250-300 individuals, with a timetable set arbitrarily at the end of the study in June 2011, and inevitable loss of quality. Which prodest?
In addition, planning should devote myself to this study, according to plans drawn up and is not shared by me, such a large number of hours to be hilarious. For education, however inadequate, 150 hours for proficiency testing in 1996, Reading 4500. Something like 5000 hours if you add the meetings of the Steering Committee, and other personnel required at least 500 hours of my property in anything that IMF has offered to implement. It 'obvious that I had made requests to Prof. Battle of minimum investment in terms of my staff at the facility should have, instead, be accepted for at least follow what his office would have taken the research capacity of the Centre. I have never had answers instead, beyond repeated requests for cooperation in order to provide our scientific expertise in the field of CCSVI, unique and valuable. In place of an implementation of personnel through research grants to young people prepared, as I asked in a letter last spring to the IMF, has instead been offered to me and two other investigators experienced a personal check for the readings of the tests peripherally . Something radically different than what I needed in terms of budget for a good organization of research, through a source of continuing education that could be visited by the investigators.
This assessment was shared by Fabrizio Salvi, who was part of the steering committee and also was able to verify that the imposition of the lame pre-established protocol, the incongruous numerosity of the sample related to the timing, with no one to take into account issues relating to 'suitable response methodology in dealing with the protocol which we propose to verify the veracity and importance of training and proper identification of the operators. No response, no chance to change anything to increase the scientific study even for the creator of the know-how and therefore well knows, no willingness to listen and to vary functionally useful as previously decided. Without asking.
With prayer to communicate my position institutionally valid as chairman of the Scientific Committee of the Foundation Hilarescere. I salute you dearly.