Frequently Asked Questions
TSW Patient Registry
Frequently Asked Questions
Thank you for your interest in TSW Patient Registry. Please see below some frequently asked questions. If you have additional questions that are not listed, please contact us!
Who is ITSAN?
The International Topical Steroid Awareness Network (ITSAN) was formed in 2012 to raise awareness about Topical Steroid Withdrawal Syndrome (TSW). ITSAN is a diverse community of individuals, medical professionals, and caregivers united by our commitment to prevent TSW and to alleviate the suffering of anyone facing this painful experience.
ITSAN has grown into a thriving, world-wide online community where members comfort, share, and support one another.
What is the purpose of the Topical Steroid Withdrawal Syndrome Patient Registry?
The primary aim of the Topical Steroid Withdrawal Syndrome Patient Registry (TSW Patient Registry) is to gather information on prevalence to reflect the most accurate number of people that are affected by TSW. Just by taking the first step to register and providing consent to participate in the registry, this objective is reached.
Other priorities of the registry include gathering information on the disease itself: to better understand how to distinguish Topical Steroid Withdrawal Syndrome (TSW) from atopic dermatitis.
What is a Patient Registry?
A patient registry is a collection of standardized information about a group of patients who share a condition. The information may be used for a variety of purposes such as understanding prevalence, building a profile of the condition, conducting natural history studies, and supporting disease specific clinical trial recruitment.
Who can join the study?
Individuals of any age are eligible for inclusion if they have used topical steroids, and have subsequently stopped their use and fulfill one or both of the following:
- Individual was evaluated by a physician and identified as having TSW Syndrome and/or
- Self-assessed or Caregiver-assessed as having TSW Syndrome based on new or worsening symptoms (e.g., original skin condition escalated, burning skin, spreading rashes, skin flaking)
Why should I participate in the TSW Registry?
This is your chance to be part of the first ever TSW patient registry. This is also the research we’ve been asking for. We are relying on our community to report on their treatment history and journey through TSW. By participating in the TSW Registry, you are helping fuel the research process. We can share what we have learned with investigators and doctors researching TSW.
Can I sign up on behalf of my child (who is a minor)?
Yes, we encourage you to sign up for your child if they are a minor. You will be prompted at the beginning of enrollment to indicate if you are the parent/guardian. Please note that a new registry questionnaire must be completed for each child individually. You cannot combine the information for multiple children at one time.
OK. I joined the registry. Now, what’s the next step?
First, thank you for enrolling in the registry! The next step is to consent to participate in the registry and begin answering surveys. Then, we ask that you help us in getting the word out about the registry. If there are members in your family with TSW, we hope you’ll encourage them to participate. You can also post about participating in the registry and the enrollment process in the TSW Facebook groups, Instagram, and TikTok. Together as a community, we need to encourage all with TSW to participate. The more patients who participate, the larger the pool of information is available for researchers to work with.
How long will it take me?
The amount of time it takes to complete the surveys varies for each person who joins the study. There are several topics covered in the surveys. You can complete the sections at different times and in multiple sittings, if needed. Don’t feel the need to complete all sections in one sitting. Some sections are shorter than others. It is important for you to complete sections to help researchers have the most comprehensive set of data.
The first time you enter the study to complete surveys will be longer than when you return to provide updates. This is so we can capture your full experience with TSW from its beginning.
When you return to the registry, you will answer a variety of questions based on the time since you last reported. If you are currently in TSW, you will be asked to provide updates on your symptoms experienced every month. If you are in the later stages of TSW, you will be asked to provide updates on your symptoms every 6 months. Some questions will only appear once a year no matter where you are in your journey. These reminders will be sent via email to the email address provided at registration.
We encourage you to participate in these surveys so we can learn about how TSW symptoms change over time.
Why are there non-medical terms used to describe symptoms?
The doctors are not using common language to describe common things they’re seeing, if the doctors don’t have common language, we have to find a way to see if our understanding is the same. Patients are describing what they see and feel. One of the goals is to find common language that can be used by doctors and their patients.
Other Questions
Where is the data stored?
The registry is hosted on the National Organization for Rare Disorder’s (NORD®) IAMRARE® platform. Sponsor and Participant Registry Data is stored on NORD’s encrypted servers and/or encrypted servers of third-party vendors hosted in Canada. Regular back-up at commercially acceptable intervals is provided. These servers meet industry standards and are compliant with US and international regulations, including GDPR.
Is the data safe?
The registry follows strict government guidelines to ensure patient information is protected. The platform is served over HTTPS, which means that the data is encrypted when being sent from the user’s browser to the NORD servers. The data is also kept encrypted in the NORD database. Communications between the registry platform application server and the database are also encrypted. As with any information you provide electronically, there is a very rare chance that your privacy could be compromised. However, the registry and the security measures minimize the chance of this occurring.
Who owns the data?
The study data are owned by the study sponsor, ITSAN. ITSAN decides how and with whom to share the data. NORD staff will have access to the data for activities related to support and maintenance of the Platform and will collect Platform-wide participation statistics. The specifics will be outlined in your informed consent.
Who will have access to Protected Health Information (PHI)?
All data, including those with PHI, will be stored in a password protected secure server. Access to PHI will be limited to:
- Approved members of the Topical Steroid Withdrawal Syndrome Patient Registry research team
- NORD staff, in cases where technical support is needed and with the permission of registry staff
- With agreement from the Sponsor, NORD may conduct IRB-approved, cross-disease research using registry data.
In all cases, your privacy will be protected. The Registry Advisory Board will evaluate all requests for data from researchers. Researchers will only be provided with the minimum data necessary to accomplish their research study goals. Data containing PHI will only be shared if the research cannot be done without it. The researchers will be required to sign a Confidentiality Agreement in which they promise to keep your information safe.
Who is NORD – the National Organization for Rare Disorders, Inc.?
NORD, an independent nonprofit, is leading the fight to improve the lives of rare disease patients and families. We do this by supporting the rare community, its people, and organizations. We work together to accelerate research, raise awareness, provide valuable information, and drive public policy that benefits the estimated 25-30 million Americans impacted by rare diseases.
Learn more about NORD at https://rarediseases.org/.