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Quality of Life in Patients with Brainstem Cavernous Malformations

From Drs. Kelly Flemming and Giuseppe Lanzino at Mayo Clinic Rochester

Why is the study being done?

Many scientific studies use a general scoring system called the modified Rankin score to determine outcome in patients with cavernous malformations.  This score is a 5-point scale generally measuring physical defects. However, it does not take into account the emotional and social effects, nor your opinion on how you are feeling about the physical disability. To be able to give other patients better information to decide on the management of their brainstem cavernous malformation, we want to hear from you.

Who can participate?

  • You have a cavernous malformation of the brainstem (even if it has been removed)
  • You are 18 years old or older
  • You are able to read English
  • You have access to a computer

What is involved in the study?

  • The study involves answering a number of questions about your health and feelings about your health.
  • There are several questionnaires.  Some questions repeat themselves and this is intentional.  We are trying to determine which questionnaire provides the most helpful information.
  • The questionnaires may take up to 1 hour to fill out.  If you cannot fill out information in one sitting, you can save the information and return. 

What are the risks of this study?

There are no known risks to you from taking part in this research study.

What are the benefits of this study?

The benefits from this research study are to better understand the quality of life in persons with brainstem cavernous malformations in order for physicians to provide better information when explaining outcomes with and without surgery.

Please understand your participation is voluntary and you have the right to withdraw your consent or discontinue participation at any time without penalty. Specifically, your current or future medical care at Mayo Clinic will not be jeopardized if you choose not to participate.

How to participate?

Am I paid for this study?

  • No.

When can I fill out the survey?

  • We are accepting surveys between June 2018 and January 2019.

Optional Information

  • If you have a copy of your MRI or CT scan report, please forward to us so we may verify the part of the brainstem your cavernous malformation is in.  If you choose to do so, you must also send or email a copy of a HIPAA form (you will receive this from Mayo). Please see contact information and link below. You do NOT need to fill this out if not sending MRI reports.

What if I have questions?     

Contact if you have any questions about the Study or Withdrawing from the research study:

 

Kelly D. Flemming, MD

Mayo Clinic, Mayo Building W8

200 First Street SW

Rochester, MN 55905

RSTBrainstemQofL@mayo.edu  (This email is monitored intermittently for research purposes only; this email is not for clinical questions or appointments).  

Contact the Mayo Institutional Review Board (IRB) to speak to someone independent of the research team at 507-266-4000 or toll-free at 866-273-4681 if you have questions about:  Rights of a research participant, Use of your Protected Health Information, Stopping your authorization to use your Protected Health Information.

Research-related questions not listed above or any research-related complaints may also be addressed to Dr. Kelly Flemming. If you prefer to speak with someone independent of the research team, you may contact the Mayo Institutional Review Board (IRB).

 

Sincerely,

Kelly Flemming, MD  and Giuseppe Lanzino, MD

 

 

Updated 6/14/18