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LFR Frequently Asked Questions

General

1. What is a patient registry?

2. What is the purpose of a “research study”?

Most Frequently Asked

3. What is the best way to tell others about the registry?

4. What if I have questions?

5. What should I do if I don’t understand a survey question?

6. What should I do if none of the given response options match me exactly?

Who Can Join

7. Who can join the LFR?

8.  Can men join the registry?

9.  Can children join the registry?

10.  If I live outside of the United States, can I join the registry?

11.  If I don’t have lipedema, can I still participate in the LFR?

Purpose & Goals

12. What are the goals of the LFR?

13. What specific questions do we hope to answer by using the data in the LFR?

14. Why is this called an Initial Survey? What surveys are next?

What Do I Have to Do if I Decide to Participate?

15. What do I have to do if I decide to participate in LFR?

16. Can I use a mobile phone, iPad, or other smaller-screen device to access the Registry?

17. Does it cost anything to join the registry?

18. Will I get paid to participate?

What Happens to the Data in LFR?

19. What happens to the data in the LFR?

20. Who will be able to access my data?

21. With which groups have Data Sharing Agreements been signed?

22. Will the data that I provide to the LFR identify who I am? Will researchers who have been authorized to access data from the LFR be able to identify me?

23. Who decides how LFR data can be used?

What are the Risks of Participation?

24.  What are the emotional risks of participating in the LFR?

25. What are the security risks of participating in online registries?

26. Can I do anything to further reduce security risks?

What are the Benefits of Participation?

27.  What are the benefits of joining the LFR?

28.  Will joining the registry improve my symptoms of lipedema?

29.  By participating in the registry, will I receive medical advice or treatment?

30.  By participating in the registry, will I receive any mental health care?

31. By participating in the registry, will I be eligible to receive any funding from the foundation to pay for my healthcare, surgery, compression or anything else?

Miscellaneous

32. The LFR webpage mentions other surveys. Where can I learn more about those?

33.  Does joining the LFR guarantee a spot in a research study or clinical trial?

34. One question asks for clinicians’ names. Why?

35.  What if I have an idea for a new registry question? How can I submit this question for consideration?

36.   I am a physician, surgeon or therapist. How can I support my lipedema patients better?

37.  I am a researcher. How may I conduct research with the LFR data?

38.  I am interested in joining the board that will manage the LFR. How do I learn more?

39.  Are you in any way associated with the Lipedema Project, Lipedema Simplified, the Friedman Center, or Lipedema Products in any way?

REDCap Cloud Questions

40. If I step away from my computer in the middle of the survey, will my data be lost?

41. What does a 503/504 error on my screen mean?

Compliance

42. Is the LFR HIPAA compliant?

43. Is the LFR GDPR compliant?

Contact Us

 

 

LFR Frequently Asked Questions

General

1. What is a patient registry? 

A patient registry is a place to store detailed information about individuals with a condition as well as people who do not have the condition.

2. What is the purpose of a “research study”?

The purpose of a research study is to learn more about a condition in a controlled way. One way to understand a condition is to study people who have the condition and compare their experiences with those of people who do not have the condition. It is important to study as many people as possible. Scientists study people with lipedema to understand its cause, to learn about its symptoms, and to test management approaches and treatments.

Most Frequently Asked

3. What is the best way to tell others about the registry?

Please ask them to visit www.lipedema.org/registry, or print the LFR flier www.lipedema.org/lfr-flier and give it to them.

Thank you for referring others to the registry. We especially need people without lipedema to respond.

4. What if I have questions?

If you have any questions about the Informed Consent, the Signup Instructions, the platform, these FAQs, the webpages etc, please feel free to:

(1)    Visit our webpages

(2)    Email registry@lipedema.org

(3)    Leave a voicemail message at +1-800-407-5241 or +1-203-489-2989

5. What should I do if I don’t understand a survey question?

You should skip the question. We are not allowed to clarify question wording or tell you how to answer questions (according to survey best practices). We welcome any comments about survey questions, which can be provided via this feedback survey www.surveymonkey.com/r/5JDVHQJ if you wish. 

6. What should I do if none of the given response options match me exactly?

If the question says “answer to the best of your ability” or “select the closest answer”, then select the closest answer. If the question does not say that then skip the question and report the issue to LF via the feedback survey www.surveymonkey.com/r/5JDVHQJ.

Who Can Join

7. Who can join the LFR?

Anyone! The LFR collects information about three types of people:

●        People with lipedema

●        People who think they might have lipedema

●        People who do not have lipedema (to use as comparison groups)

In addition to individuals who have, or believe they may have lipedema, the LFR is looking for participation from the following comparison groups:

●        Healthy people

●        People with obesity

●        People without obesity

●        People with Dercum disease

●        People with Familial Multiple Lipomatosis and other fat disorders

●        People with Primary or Secondary Lymphedema

●        People with Lipo-lymphedema

●        People with Lipodystrophy

●        People with Lipohypertrophy (a term used in Europe described as similar to lipedema but without pain or swelling)

8.  Can men join the registry?

Yes.

9.  Can children join the registry?

Yes.

Participants under 18 must be enrolled in the registry by an adult. The adult must:

●        Be 18 years of age or older

●        Be the parent, legal guardian, or other legally authorized representative of the participant

●        Be willing and able to provide consent for the child under 18

●        Obtain assent (agreement) from the minor participant if they are between 13–17 years of age and are able to assent. Children under 13 are able to participate, although assent is not required

Once the participant turns 18, we will contact the family and request that the participant provide his/her own consent to stay in the LFR.

10.  If I live outside of the United States, can I join the registry?

Yes. Participants from any country are welcome to participate. Currently, the LFR materials are only available in English and participants must be able to read and understand the consent and surveys in English and provide responses in English. We will share translations of LFR materials as they become available.

Note, however, that due to GDPR we may not offer goods or services to individuals in any of the member countries of the European Union (such as), see Compliance – GDPR section of this FAQ.

11.  If I don’t have lipedema, can I still participate in the LFR?

Absolutely! In fact, your participation as a control or comparison group member is critical to helping us better understand what makes lipedema unique.

Purpose & Goals

12. What are the goals of the LFR?

The goals of the LFR are to:

●        Help the lipedema community

●        Learn more about lipedema

●        Understand the barriers to diagnosis

●        Better manage symptoms

●        Assess the quality of life impact

●        Develop new treatment approaches

The information that we collect will be used for research, especially to identify research topics that might be funded by the Lipedema Foundation or other groups. Your participation will help promote lipedema research and discovery by helping to speed research in lipedema by sharing your data.

13. What specific questions do we hope to answer by using the data in the LFR?

We hope to understand:

●        What causes lipedema?

●        Is lipedema more than one condition?

●        What factors might increase the risk for lipedema?

●        Which diseases or conditions commonly appear with lipedema?

●        Which treatments would be safe and effective for people with lipedema?

●        How helpful lifestyle modifications, such as exercise, are in reducing the effects of lipedema?

●        What research should the Lipedema Foundation fund in the future?

14. Why is this called an Initial Survey? What surveys are next?

The Initial Survey asks basic questions about the lipedema community and is a starting point for future research. In the future, additional surveys will be added that ask questions about:

●        Symptoms

●        Treatments

●        Family History

●        Path to Diagnosis

●        Co-morbidities

●        Quality of Life

●        Specific Research Topics and Questions

What Do I Have to Do if I Decide to Participate?

15. What do I have to do if I decide to participate in the LFR?

1.       Review and understand the Informed Consent and other documents such as this one (click all links from the landing page www.lipedema.org/registry)

2.       Create an Account on REDCap Cloud’s MyHealth platform.

3.       Sign the Informed Consent in REDCap Cloud MyHealth including making selections for:

●        whether LF can share your information with researchers

●        whether we can share with for-profits and/or non-profits

●        whether we should share your identifiable or de-identified data with those groups.

4.       Open the Initial Survey in REDCap Cloud MyHealth

5.       Provide answers to the questions in the Initial Survey that you wish to answer, to the best of your ability. Questions include topics such as:

●        important measurements, like your upper leg circumference

●        medications you’re currently taking

●        what other medical conditions you have

●        upload a photo with your head cropped out.

6.       Submit feedback and ideas for future surveys if you wish www.surveymonkey.com/r/5JDVHQJ

7.       In the future, receive email from the LF team to ask you to update your information and to answer new surveys or survey questions.

8.       In the future, we will also send you information about other types of research studies.

16. Can I use a mobile phone, iPad, or other smaller-screen device to access the Registry?

The registry platform works best on a laptop or computer with larger screen (see also Security Risks questions).

17. Does it cost anything to join the registry?

No.

18. Will I get paid to participate?  

No.

What Happens to the Data in LFR?

19. What happens to the data in the LFR?

Many things can happen with the data:

●        LF staff can analyze LFR data

LF staff and/or hired bio-statisticians will analyze the data submitted. We will use the information to help us prioritize which research projects to fund. For example, if half of people diagnosed with lipedema have also meet their Beighton criteria for hypermobility, we might prioritize a research project that involves hypermobility over other research projects.

LF staff could also publicize interesting aggregate findings via social media, or publish papers on the data. For example, we may get similar (or different) responses to survey results published by Lipoedema UK here, and we could discuss these similarities (or differences) on Facebook. Another potential interesting finding would be if we had data that supported something believed to be true by many patients, such as most physician–diagnosed lipedema patients say their lipedema ‘started’ during puberty.

●        External researchers can analyze LFR data

Some participants will choose to share their data with researchers outside of LF.

Researchers can apply to LF for permission to study the LFR data that participants are willing to share. If the researchers meet our criteria and LF and their institution sign data sharing agreements, the researchers will be given access to relevant data. For example, they may want to know how many people diagnosed with lipedema also have CVI (Chronic Venous Insufficiency) and then look at characteristics in that group.

●        External researchers can get LF’s help finding potential participants for their studies

The LFR will provide participants with notifications of opportunities to participate in research. Choosing to participate is still the participant’s choice. LFR will simply notify participants of possible research opportunities for which they qualify.

For example, if a researcher wants to do a study on people with both lipedema and Chronic Venous Insufficiency (CVI), they could determine if participants in the LFR have both lipedema and CVI. Furthermore, researchers could design a study and inform LF of it. LF would then send the information about that study to the LFR participants who have both lipedema and CVI. Those people could decide if they want to participate in that study or not.

Note, however, that due to GDPR we may not offer goods or services to individuals in any of the member countries of the European Union (such as), see Compliance – GDPR section of this FAQ.

20. Who will be able to access my data?

All data you submit can be accessed by the Lipedema Foundation’s registry staff, the REDCap Cloud technical team, and partner organizations who analyze LFR data for LF (such as hired biostatisticians). In the Informed Consent, you can choose to allow LF to share your data with non-profit and/or for-profit groups, and you can choose to share either your identifiable data, or your de-identified data (meaning your data with identifiable information removed).

Check back here for a current list as agreements are signed.

21. With which groups have Data Sharing Agreements been signed?

As of February 15, 2019, LF has not signed any data sharing agreements with other institutions, therefore no one else can access any LF data.

Check back here for a current list as agreements are signed.

22. Will the data that I provide to the LFR identify who I am? Will researchers who have been authorized to access data from the LFR be able to identify me?

It depends on what you choices you make in the Informed Consent

●     If you choose to share only de-identified data, no. De-identified data is information that cannot be used to identify you. For example, a researcher may know that LFR participant ID number 100 has stage 2 lipedema, is 45 years old and lives in Arizona. The researcher would not, however, know the participant’s name or any other elements of that participant’s ID Information. Choosing to allow LF to share your de-identified data with other institutions maximizes both your security and lipedema research potential.

●     If you choose to share your identifiable data, yes, researchers may be able to identify you. However, they should not contact you about the LFR or participating in research directly unless you have also enrolled in their studies separately. Sharing identifiable data may help researchers determine if there are enough participants physically close to their workplace.

●     If you change your decision on sharing or not sharing your identifiable/de-identified data after you have completed the consent form, please contact LF at registry@lipedema.org.

23. Who decides how LFR data can be used?

The LFR is operated and governed by the Lipedema Foundation. Informed by consultants from RTI, patients, other non-profits, lipedema survey authors, physicians, therapists, researchers, a technology services and consultant firm, and employees of REDCap Cloud, among others, to determine best practices in governing the registry. The Lipedema Foundation will establish a board to govern the registry and data sharing policies in the near future.

What are the Risks of Participation?

24.  What are the emotional risks of participating in the LFR?

There is a chance that answering questions about your experience with lipedema might make you upset, angry, or worried. You are not required to answer these questions.

25. What are the security risks of participating in online registries?

Participating in a registry and registry research comes with a small risk that information about you will be discovered by someone who is not authorized to see or have it. The LFR team has taken steps to reduce this risk and protect your information. LF has hired a technology support, systems management, and consulting services firm to create and enforce best security practices within LF.

The personal information you share with us, including information about your identity, your health, and your experiences will be stored securely in a registry powered by REDCap Cloud’s products REDCap Cloud MyHealth and REDCap Cloud EDC. According to REDCap Cloud, these information management systems are ISO 27001 certified and are hosted on a secure cloud environment used in many clinical trials. To learn more visit www.redcapcloud.com. See also REDCap Cloud’s Privacy Policy www.redcapcloud.com/privacy-policy and Privacy Shield Policy www.redcapcloud.com/privacy-shield-policy .

But of course, no data transmission or storage system is 100 percent secure.

26. Can I do anything to further reduce security risks?

To reduce security risks, you may wish to:

●        Sit at home or another place with only trusted people around when you are logged into REDCap Cloud products

●        Use a secure network / connection (e.g. do not use public wireless connections at coffee shops or hotels)

●        Use a newer laptop/computer with the most recent Operating System and all patches installed

●        Have hardware encryption enabled on your device

●        Use strong passwords

●        Use the Chrome internet browser to access REDCap Cloud products (available for download at www.google.com/chrome )

●        Use an Incognito tab within Chrome browser and/or disable cookies (search for these steps or try www.wikihow.com/Disable-Cookies )

●        Use a Gmail email address when you create your REDCap Cloud account.

What are the Benefits of Participation?

27.  What are the benefits of joining the LFR?

The benefits of participating in the LFR include helping lipedema research. You can help advance lipedema research by sharing your data and electing to join research studies. You will help us meet the goals of the registry (question 12), answer key questions about lipedema (question 13), help us design future studies (question 14) and help the overall research effort (question 19)!

28.  Will joining the registry improve my symptoms of lipedema? 

No. Participating in the LFR will not improve your lipedema symptoms, but the information we learn from all registry participants may help researchers and clinicians understand symptoms that are commonly experienced by lipedema patients.

29.  By participating in the registry, will I receive medical advice or treatment?

No. You will not receive medical advice or treatment through your participation in the LFR. However, the information we learn from all registry participants may help researchers and clinicians identify better treatments.

30.  By participating in the registry, will I receive any mental health care?

No. You will not receive any mental health care through your participation in the LFR. However, the information we learn from all registry participants may help researchers and clinicians understand the mental health status of lipedema patients and identify better ways to address the mental health concerns of lipedema patients.

31. By participating in the registry, will I be eligible to receive any funding from the foundation to pay for my healthcare, surgery, compression or anything else?

No. The Lipedema Foundation does not provide any funds for personal use or healthcare. Our primary focus is on lipedema research to ultimately benefit the entire lipedema population.

Miscellaneous

32. The LFR webpage mentions other surveys. Where can I learn more about those? What other groups support the lipedema community?

This Initial Survey was based on and benefited from our excellent colleagues across the entire Lipedema Community. 

In particular, we wish to acknowledge: Karen Herbst and the entire TREAT Program* at The University of Arizona; Rachelle CrescenziPaula Donahue, and the entire INFORM team* at Vanderbilt University Medical Center; Joanna Dudek* and Tilly Smidt*; Polly Armour and Cheyenne Brinson and the entire Fat Disorders Resource Society team; Sharie Fetzer, contributors to the 2014 Lipoedema UK’s Big Survey* and the entire Lipoedema UK team; FasterCures Patients Count program; REDCap Cloud team; and RTI International.

We are also indebted to the following organizations and that working groups that have duly informed key aspects of the survey, including: Stefanie Reich-Schupke, Stefan Rapprich* and the fellow authors of the German S1 Lipoedema Guidelines; Anne Williams and fellow authors of the Wounds UK Lipoedema Best Practice Guidelines; Anne Halk, Robert Damstra and fellow authors of the Dutch Guidelines; Carl Caspersen and fellow authors for the Definitions of Exercise; Robin Bjork and Suzie Ehmann of the ILWTI, Christine Blome and fellow authors of Patient-relevant Outcomes* for lymphedema and lipedema.

And of course, our LF community members – from patients, researchers, caregivers, family, and friends – that have helped us test and continuously improve this effort.

33.  Does joining the LFR guarantee a spot in a research study or clinical trial?

No. Not everyone can participate in every study. Most studies have specific eligibility criteria for participation, such as age, gender, family history, genetic background or other factors. Joining the registry does increase the chance that you will learn about new studies that might be of interest to you.

34. One question asks for clinicians’ names. Why?

LF hopes to learn about more clinicians who treat lipedema. Answering these questions is entirely your choice; you can skip the questions.

35.  What if I have an idea for a new registry question? How can I submit this question for consideration?

Great! Please submit potential questions or response options to https://www.surveymonkey.com/r/5JDVHQJ.

36.   I am a physician, surgeon or therapist. How can I support my lipedema patients better?

Please direct your patients to our Resources webpage www.lipedema.org/resources.

37.  I am a researcher. How may I conduct research with the LFR data?

Email the Lipedema Foundation staff at info@lipedema.org to learn more about our application and approval process.

38.  I am interested in joining the board that will manage the LFR. How do I learn more?

Email the Lipedema Foundation staff at info@lipedema.org.

39.  Are you in any way associated with the Lipedema Project, Lipedema Simplified, the Friedman Center, or Lipedema Products in any way?

No. 

REDCap Cloud Questions

40. If I step away from my computer in the middle of the survey, will my data be lost?

No. The registry is set to time out after 20 minutes of no activity. If you time out, you will have to log back in through the link provided and enter your username and password and launch the Initial Survey.

41. What does a 503/504 error on my screen mean?

This error occurs when the website's server is unavailable, usually because the server is too busy, the connection is bad or because maintenance is being performed on it. You may have to refresh your screen or exit the web page and log back into the survey.

Compliance

42. Is the LFR HIPAA compliant?

According to REDCap Cloud, the platforms the LFR runs on are HIPAA compliant as of February 16th 2019. LF has no control over REDCap Cloud, so it is out of our control if they make changes to their systems that make them no longer HIPAA compliant.

As of February 16, 2019, LF itself does not have to be HIPAA compliant because we are a research institution and not a medical institution. However, LF is prepared to become HIPAA compliant if and when our business needs change; we have already taken a number of steps toward HIPAA compliance.

43. Is the LFR GDPR compliant?

As of February 16, 2019, the Lipedema Foundation does not fall under GDPR because we are not “offering goods or services” to individuals in any of the member countries of the European Union. If we were to fall under GDPR, however, we would fall under the carveouts related to research institutions. Nonetheless, we have already taken a number of steps toward GDPR compliance. GDPR went into effect in May 2018 and while the laws have been written, how exactly they apply to LF/LFR is not entirely clear. We believe we meet the spirit of the law except, perhaps, with one point: duration of data retention. Under GDPR, data is not to be retained for an unjustifiably long time. However, because the first patient registry in a medical condition that needs genetic, longitudinal and prevalence studies, we intend to retain LFR data across many generations. While we believe that to be justifiable, the GDPR governing bodies may not.

According to REDCap Cloud, the platforms the LFR runs on are GDPR compliant as of February 16th 2019. LF has no control over REDCap Cloud, so it is out of our control if they make changes to their systems that make them no longer GDPR compliant.

The GDPR language follows. Their use of ‘Personal Information’ is similar to our use of ‘Identifiable Information’. Their use of ‘Non-Personal Information’ is similar to, but slightly different from, our use of ‘De-identified Information’; ours indicates the potential anonymization of data.

Your Rights Regarding Your Personal Information

You may have certain rights regarding the manner of collection, processing and usage of your personal information pursuant to applicable privacy laws such as the EU General Data Protection Regulations (“GDPR”). Under the GDPR (to the extent it applies to you) you may be eligible for the following rights:

o   The right to have your personal Information deleted.

This right is subject to any requirement we may be subject to in connection with our compliance with a legal obligation / our exercise of a legal defense.

o   The right to access the Personal Information collected and processed.

In order for us to accommodate such right, please contact us in accordance with the details found at the “Contact us” section below.

o   The right to rectify untrue or incorrect Personal Information.

In order for us to accommodate such right, please contact us in accordance with the details found at the “Contact us” section below.

o   The right to object to us processing your Personal Information.

You may be entitled to object to certain processing functions, made for example, in connection with profiling activities. In order for us to accommodate such right (to the extent applicable), please contact us in accordance with the details found at the “Contact us” section below.

o   The right to have your Personal Information exported at your request.

We will make efforts to comply with within a reasonable time, and provide you with such compiled data in an electronic medium of our choice.

Please note that the above list contains a summary of the main rights you may have under the GDPR. Under no circumstances shall the above be deemed as an exhaustive list, nor should you rely on it in terms of fully understanding all of your rights under the GDPR.






Contact Us

If you have any questions about the Informed Consent, please feel free to:

(1)    Visit our webpages

●        Registry www.lipedema.org/registry

●        Signup Instructions www.lipedema.org/lfr-signup-instructions

●        FAQ (Frequently Asked Questions) www.lipedema.org/faqs

(2)    Join our Facebook group “Lipedema Foundation” www.facebook.com/Lipedema

(3)    Email registry@lipedema.org

(4)    Leave a voicemail message at +1-800-407-5241 or +1-203-489-2989

Or, contact the Data Protection Officer Felicitie Daftuar at felicitie@lipedema.org.

LFR products, including associated webpages and questionnaire are copyright © 2019

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