The Registry

The goal of the You + M.E. Registry is to register individuals with ME/CFS and non-ME/CFS control participants and compile demographic and health information into a data bank that will further our understanding of ME/CFS.

Patient registries are used extensively in health care (over 100 exist in the U.S.) to better understand why and how a disease occurs, to understand how a disease proceeds, to help identify subsets, to more efficiently facilitate research and clinical trials, and to identify more effective treatments and assess treatment outcomes.

The You + M.E. Registry – the first patient registry ever for ME/CFS – will provide the foundation for all of these.

What is involved in You + M.E. participation?

You + M.E. is a completely online study that allows you take part anywhere at any time.

After providing consent to participate in the registry and completing some onboarding questions, you will be taken to your You + M.E. user dashboard where you can complete surveys, record information about your health conditions, and log any treatments you are taking. The surveys can be completed in a single sitting or you can save your progress and return to them later. We will send email reminders to provide updated information every 6 months or when a new survey is available to complete.

People with ME/CFS can also download a mobile app to track symptoms, general well-being and other life events as often as daily. This ongoing tracking allows for a more complete picture of the disease and how it changes over time.

We will also periodically contact you about opportunities to participate in new research studies or to provide a biological sample (e.g. blood). All messaging about these study opportunities will be sent to your profile email and will describe the time commitment and any other steps you must take before you decide to take part. These study opportunities are all optional.

The Registry will soon be open to participants age 18+ who live in the United States. We will be able to accept enrollments from international participants and people between the ages of 13 – 17 in the months following the U.S. launch to people 18 years of age and older! Sign up for updates here.

It is easier to understand what causes a disease and how to treat it if we can look at health information from several thousands of people, and identify patterns. By sharing their health information, patients and their caregivers provide the data that is necessary for researchers to see these patterns. Big data sets like this Registry may allow us to identify subtypes and understand why some people respond to different treatment and why some do not.

Volunteers without ME/CFS are a critical part of the success of You + M.E.! To be able to understand what has gone wrong with someone who has ME/CFS, we need to be able to compare their biology to someone without the disease.

I don’t live in the United States. Can I join?

Currently, the Registry is beta tested with a group in the United States. It will be available to international participants soon!

I am a caregiver. Can I help someone with ME/CFS enter their data?

If you are a caregiver for someone with ME/CFS, you can work together to complete surveys in You + M.E. or enter tracking data into the mobile app. Just make sure that you only input information about that person in their profile.

The App

The You + M.E. app can be downloaded from the apple store here (if you use an iphone) or from the Google play store here (if you use an android phone). After downloading, simply use the same login information you created when you registered with You + M.E. in the user portal. If you haven’t signed up with You + M.E. yet, be sure to visit the user portal here so you can get tracking!

How often do I have to record my health information?

For the symptom tracking using the app, you can choose how often you’d like to enter your health information, anywhere from every day to once a week. The app allows you to customize push notifications based on your preferred schedule. We ask that you track every three days, if possible, so we can amass a large amount of symptom data tracked over time from many individuals.

I don’t have a smartphone. How can I participate?

If you don’t have a smartphone, you will be unable to use the ongoing symptom tracking available through the mobile app. However, you can still participate in the Registry by signing up and completing your health information on a computer. If you don’t have access to a computer, please contact us at research@solvecfs.org so we can help facilitate your participation.

The BioBank

After reading and agreeing to an informed consent for sample collection, a collection kit and instructions will be sent to your preferred address. The collection kit will contain barcoded specimen collection systems appropriate for the sample type (e.g. tubes, blood dot collection cards); written instructions for the collection, labeling, and shipping of the kits; and postage-paid return mailers. You can take the kit to a lab (e.g. a Quest Diagnostics facility) close to where you live. If you cannot travel to a collection site, we will arrange for someone to come to your home to collect the sample.

No, Solve M.E. will cover the costs for any biosample collection.

We will contact you to see if you would be interested in providing biosamples. There may be a wait between the time of your registration and being contacted to give a sample. Although there is no guarantee that any given Registry participant will be eligible to provide a biological sample, your enrollment in the Registry is a critical component to participating in the BioBank.

Your samples will be used by researchers for studies to help uncover the causes of ME/CFS. Your samples are extremely precious to us, and we will only release them to researchers with research proposals that are of the highest quality, as evaluated by the You + M.E. Innovation Council.

The Research

Any researcher who wishes to do a research project using data and biosamples from You + M.E. will submit an application to Solve M.E. outlining their credentials and ME/CFS research interest. The application will be reviewed by the You + M.E. Innovation Council. The application requirements and the approval process will be more rigorous for applications for biosamples vs. those requesting data alone. Researchers who use the data will be required to share their methods and findings with the community.

Can I choose which researchers can access my data?

No, you will not be able to choose who uses your data. However, you will soon be able to pose your own research questions! We plan to build a forum that will allow participants to propose research questions that community members can “upvote” and that researchers can respond to and use to build community-driven studies.

Will I know if my data leads to a discovery?

We’ll let you know! Our goal is to ensure that participants in You + M.E. know which research projects their data is being used for, and to be informed of any results once the study is complete.

Will my data be used to give me specific medical advice?

No, your data will not be used to give you specific medical advice. However, you will be able to share your data with your care team to show them how your health has been between visits to the office.

Privacy

The privacy and security of your data is of paramount importance. The You + M.E. registry takes reasonable measures to help protect information about you from loss, theft, misuse, and unauthorized access, disclosure, alteration, and destruction Before it was approved as a Registry, You + M.E. and the processes for data protection were reviewed and approved by an independent ethics committee (sometimes called an IRB).

Registry data is securely stored in an encrypted mongoDB Atlas cloud database (https://www.mongodb.com/cloud/trust/compliance/hipaa). Personally-identifiable information is handled using processes compliant with industry practice, including use of encryption-at-rest when being stored in the Registry database. Data is transmitted from the Registry to the backend database using industry standard TLS/SSL encryption protocols.. We regularly back up the Registry database to decrease the serverrisk of data loss. Our disaster recovery system also follows maintains our full suite of security measures to protect backup data. For additional information on security standards, please visit: https://docs.mongodb.com/manual/security/. You can find out more about how we process your data by reviewing our Privacy Policy: https://youandmeregistry.com/privacy-policy/

Researchers who are approved by the You + M.E. Innovation Council will be able to see your data, but it will be anonymous/de-identified (collectively, “anonymized”, “anonymous”), and no one will be able to tell that the data they are looking at belongs to you. The Registry Coordinators at Solve M.E. will also be able to see your data, and they will be the only ones who will have the ability to see data that is not anonymous.

Yes, you are able to view your past responses through the You + M.E. user portal. Please follow the below steps to view your survey responses:

  1. Log into your account here
  2. Click the “My Surveys” link
  3. Click into the survey you are interested in to view a summary of your responses

Can I change my mind and remove my data later?

You can withdraw from You + M.E. (revoke your consent) at any time. This means we will not collect any further information from you. Existing anonymized data that have already been collected might still be used, as it will not always be possible to separate it from other data once anonymized. However, we will destroy the key linking the anonymized data and personal information.