This research study is open to those who have been diagnosed with a hypermobility spectrum disorder (which includes Ehlers-Danlos Syndrome (EDS). The purpose of this research study is to understand the gynecological impacts of hypermobility.

The questionnaire will assess gynecological concerns and their impact on individuals with hypermobility regarding avoidance, fear, relationships, sexual dysfunction, and quality of life. Quality of life will be assessed using the World Health Organization Quality of Life brief scale (WHOQOL-BREF). Sexual dysfunction will be assessed using the Female Sexual Functioning Index (FSFI).

Original questions are follow-up questions to the two included measures, such as sexual functioning’s impact on various relationships.

The study aims to assess the psychological and day-to-day impact of gynecological concerns in hypermobile individuals. Additionally, it will provide guidance as to the gynecologically-informed treatments utilized/recommended in the hypermobile population.

We’re inviting you to participate in a research study. This study consists of an online survey. You will be asked to complete a series of questions about your sexual health and gynecological functioning. This survey may be completed on any computer with internet access. You are free to skip any questions that you would prefer not to answer.

Participation is completely voluntary. If you agree to participate, you can always change your mind and withdraw. There are no negative consequences, whatever you decide.

• If you have any questions about or do not understand something on this form, you should ask the research team for more information.
• You can and should discuss your participation with anyone you choose, such as family or friends.
• Do not agree to participate in this study unless the research team has answered your questions and you decide that you want to be part of this study.

Some questions may be very personal or upsetting. You can skip any questions you don’t want to answer or stop the survey entirely.

• Online data being hacked or intercepted: This is a risk you experience any time you provide information online. We’re using a secure system to collect this data and are not collecting identifiable information, but we can’t completely eliminate this risk.
• Breach of confidentiality: There is a chance your data could be seen by someone who shouldn’t have access to it. We’re minimizing this risk in the following ways:
  • Data is anonymous.
  • We’ll store all electronic data on REDCAP, a secure online survey server, or on a password-protected, encrypted computer when statistical analyses are conducted.

In the unlikely event that you suffer an injury or illness directly related to your participation in this research project, upon your request, Midwestern University will arrange for the provision of treatment for such injury or illness at the closest medical facility. Payment for such treatment will be your responsibility, although your commercial insurance carrier if any, may pay all or part of the medical expenses that you might incur. Midwestern University will not pay any monetary compensation for research related injury or illness or pay for treatment outside any MWU-affiliated Hospitals or Medical Centers. You are not waiving any of your legal rights by volunteering to participate in this study.

Although you will not benefit directly from participating in this study, you will make a major contribution to the information known about gynecologically related concerns impact in hypermobility. In future, others may benefit because doctors will learn about how hypermobility affects gynecological functioning.

You will not be compensated for participation.

This questionnaire should take no more than 15 minutes to complete.

We will not collect any identifying information for the research.

Where will data be stored?
On the servers for the online survey software, REDCAP.

How long will it be kept?
For the duration of the research project (estimated < 1 year).

Who can see my data?

• We (the researchers) will have access to de-identified (no names, birthdate, address, etc.) information. This is so we can analyze the data and conduct the study.
• We may share our findings in publications or presentations. If we do, the results will be de-identified.

This study has been reviewed and approved by the Midwestern University Institutional Review Board (AZ #5070). If you have questions about this research project and the research subjects’ rights please contact the principal investigator, Tom B. Virden III, Ph.D., at (623) 572-3868 or email at tvirde@midwestern.edu.

If you have any questions regarding the rights of being a research subject, please call the Office of Research and Sponsored Programs at 623-806-7670 or via email: AZORSP@midwestern.edu.

You can also contact Brona Hagins, MA, at bhagins67@midwestern.edu.