What will happen if I agree to participate in this study?
Before we enroll anyone, we will ask for a molecular confirmation of vEDS. We will then ask that you sign a consent form and HIPAA authorization form, which will give the study permission to obtain your medical records. We will collect and record information from your medical records and radiology imaging necessary for the research, on an annual basis.
If we cannot find certain pieces of information from your medical records, we may need to ask you questions about your health history and your family health history. You may refuse to answer any question we ask you and can end the interview at any time.
You will not receive any medical treatment or genetic results by participating in this study.
How will the study team obtain my medical records?
We will work with you on how the study can best obtain your medical records. You have the choice to obtain them yourself from your provider and share them with us, or we can obtain your records on your behalf.
Provider offices are used to releasing medical records. We will work with your provider’s office to make it as easy as possible for them to release your records.
How can I share medical records that I have obtained myself?
If you will provide the study with the medical records yourself, we will ask that you upload your medical records to Backpack Health, or fax medical records and/or mail medical records and cd of imaging. To ensure the security of your medical records, please do not email any records.
What is Backpack Health and how do I use it?
Backpack Health is a free, health data management program that can be used by anyone worldwide. You can create profiles for each individual you care for (including yourself) and share access to those profiles as needed, all in one place. This data management tool makes it easy for individuals to manage, own, and share health information for themselves and their families.
What if I have an event? Should I let the study know?
We will plan on capturing any new medical records you have on an annual basis. However, you are welcome to send us new clinical information whenever you wish.
Will I receive any individual or research results or publications?
This study will not generate individual results that will benefit patients.
As we analyze the data and publish any findings, we will post them to the vEDS collaborative website. You can always contact us and let us know if you are interested in receiving results as they are available.
How is the vEDS Research Collaborative Study related to the overall vEDS Research Collaborative work?
The vEDS Research Collaborative work is dedicated to supporting the vEDS community in driving patient-centered scientific research. The vEDS Collaborative work is funded by the Patient Centered Outcomes Research Institute (PCORI) and is dedicated to establishing research priorities.
Aligning with the priorities of the vEDS Research Collaborative, this study also creates an opportunity to reach out directly to patients and invite them to participate in additional clinical trials and information gathering surveys.
How does one enroll?
If you are interested in taking part in the study or would like more information, please contact the study team at (206) 353-3076 or email@example.com.
You can also click on “I am interested in this research study” [here].
We are also collaborating with EDS.org, the Marfan Foundation, and Backpack. If you enroll into any of these registries then you can also tell them you want to enroll into vEDS Collaborative Study.
Who is eligible to enroll?
Anyone who has a molecular confirmation of the vEDS diagnosis (genetic testing results or skin biopsy results)
If you are interested in participating and are eligible, you can upload your confirmation here[Recap Link]
Can children be enrolled in the study?
Yes. Children with a molecular confirmation of the vEDS diagnosis are eligible. A parental signature is required. We will ask children who are initially enrolled before they are 18 to consent themselves once they turn 18.
What security does the research study have?
All study data are stored on secure, encrypted servers at the University of Washington. All of the information you provide will be confidential.
Will the research study data be sold?
No – the UW research study data will not be sold to any other entity.
Will the reserach data be shared with other researchers?
Yes – currently we are partnered with other registries (such as Montalcino Aortic Consortium or GenTAC Alliance) for sharing deidentified data only. This means that your name and contact information will not be shared with other researchers.
Can I change my mind?
Absolutely! Being part of the study is voluntary and you can change your mind at any time. Your medical care will not be affected if you decide not to participate in this study. You would not receive any medical treatment or genetic results by participating in this study.
How can I learn more about human subjects research review?
If you want to know more about human subjects research review process at the University of Washington, click here.
How can I learn more about the PI, Dr. Shalhub?
If you want to know more about Dr. Shalhub – click here