To break down geographical barriers in research participation and to adapt to limitations on travel, The Ehlers-Danlos Society is delighted to announce a new screening and enrollment process for the Hypermobile Ehlers-Danlos Genetic Evaluation (HEDGE).
The exciting newly-established process will make it possible for individuals with hypermobile Ehlers-Danlos syndrome (hEDS) to enroll in the groundbreaking study, without traveling to an in-person event. The Ehlers-Danlos Society will now work from medical records uploaded to its EDS and HSD Global Registry, to enable more members of the hEDS community to take part than ever before.
Twelve in-person screening events have taken place around the world to date, and enrolled 413 individuals with hEDS into the study [July 2020]: each participant has given a blood sample towards the 1000-participant goal. Under the new enrolment system, invitees can now have blood drawn at home or at other locations.
Steps to take part in HEDGE:
- Sign up for Global Registry and complete all surveys.
To be considered for enrollment in HEDGE, you must first create an account in the EDS and HSD Global Registry. You must then complete the surveys you will find on your registry dashboard.
Your dashboard will also provide an activity to upload documents. If you are already in the registry please go back and check that you have completed all the surveys and uploaded any relevant documentation needed. You must be at least 16 years old to join the study. A family member can sign up on your behalf.
- Upload confirmation that you meet study criteria
You must upload a document from your healthcare provider that establishes you meet the criteria for hypermobile Ehlers-Danlos syndrome under the 2017 guidelines and itemizes those clinical findings.
Typically, this will be the record from the initial visit where your provider made the diagnosis. A document or record simply stating you meet the requirements will not be sufficient; the specific elements required by the 2017 guidelines must be included. Some examples of documents would be; a letter confirming the diagnosis, or a hEDS 2017 diagnostic checklist completed by your healthcare providor.
If you do not have the full record from the visit when your doctor first established the diagnosis, you should request it from your doctor. However, if that visit was before 2017, it is unlikely the record will contain the required itemized information. After you obtain the record establishing your diagnosis under the 2017 criteria, you should upload it to the EDS and HSD Global Registry.
- If your documentation meets the criteria, we will invite you to enroll
HEDGE staff are currently reviewing these uploaded records to identify individuals who are interested in the study and meet the enrollment criteria; we will then invite those individuals to participate. This process will start at the end of the summer 2020, and continue through the start of 2021, so please do not worry if you are not contacted for some time.
If you choose to participate in HEDGE, we will provide instructions to watch an explanatory video and obtain your signed consent. We will then arrange for your blood to be drawn at your home or nearby location. We expect to begin inviting participants under this new program by early 2021.