Survey of Non-Traditional Treatment in ITPDear Patient with ITP: The attached is a survey for you to complete if you are willing to participate in this study of treatments of ITP being carried out by Dr James Bussel of Cornell University in New York City and Joan Young of the Platelet Disorders Support Association. The study is entitled “Survey of Non-Traditional Treatment in ITP”. All patients with ITP, and parents of children with ITP may participate if you choose to do so. The goal of the study is to discover which nontraditional treatments have been used for ITP, which ones appear to be effective for increasing platelet counts or alleviating symptoms, and which ones had side effects, even if the side effects were tolerable. There is no treatment involved in this survey study; we are only requesting retrospective (past) information about treatments that you/your child may have used in the past. If you or your child have ITP and have tried non-traditional treatments of ITP, then you can elect to participate in this study by completing the survey; the survey has a list of some of the non-traditional treatments of ITP. We estimate that completing could take between 10 and 30 minutes of your time. The “risk” of participating in this survey study is that you are providing personal information. Your information will however be kept confidential in that only the investigators (Dr Bussel, Joan Young, and their co-investigators) would have access to the information. In case there are questions, we would like to be able to get back to you but you are not required to list a personal identifier that would allow us to do so (by email). We have chosen this survey as a first study because it is not clear which non-traditional treatments of ITP (if any) are effective enough to warrant being studied prospectively (in the future). Therefore, we thought we would ask patients and parents of patients in general what they were using and how well it worked. We think that it is very important that responders who complete the survey give us truthful answers. This will make it more likely that we can use the cumulative results to inform patients of the findings of this study with confidence and learn if one or more medications would benefit from a prospective study to confirm its efficacy. There is no guarantee that we will do this prospective study and we could not think of an alternative way of obtaining this information because of the wide variety of treatments and the heterogeneity of patients with ITP. You do not have to participate and there will be no penalty if you choose not to participate in this study. For example, not participating in the survey study discussed here would not prevent you from later participating in a prospective study if there were to be one. If you have specific questions about the study you can contact Dr. James Bussel at, Weill Medical College of Cornell University, 525 E. 68th Street, P-695, New York, NY 10021, (212) 746-3474; Fax (212) 746-5121. If you have concerns about the entire study or issues connected with the safeguards of the study or ethics of the research you can contact the Committee on Human Rights in Research Office of Cornell University at 212-746-6026. Sincerely yours, James B. Bussel, M.D. |