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Care4PAIS: Healthcare for patients with post-acute infection syndromes (PAIS) and diseases, including ME/CFS


Information and Data Privacy Form


What do we want to achieve with this study?

This study, sponsored by the WE&ME Foundation, is being conducted by the Department of Primary Care Medicine at the Center for Public Health of the Medical University of Vienna, by the Department of Mathematics of the University of Vienna and by the Austrian Society for ME/CFS (ÖG ME/CFS). In our scientific research study, we would like to learn directly from you and your experiences and identify factors, which may be of importance to improving the current healthcare situation. Please help us with your expertise!

Post Acute Infection Syndromes (PAIS) include all chronic conditions that arise after an infection or exposure to certain triggers. This survey is an extensive, detailed questionnaire, encompassing the entire spectrum of PAIS patients. In our study, we are particularly interested in:

1)      Whether you have experienced certain conditions or symptom complexes often associated with PAIS, such as pain, dysfunctions of the autonomic nervous system, fatigue, etc.

2)      Your experiences navigating through the healthcare system with regard to care, diagnostics (performed tests and examinations) as well as accessibility and affordability of these.

3)      Which treatments have you already tried and which of these have brought you relief, which have not changed your condition, and which have made it even worse.

We will also be analysing how many patients with PAIS fulfil the Canadian diagnostic criteria for ME/CFS (Myalgic Encephalomyelitis – Chronic Fatigue Syndrome).

Who do we want to reach with this study?

We are interested in the experiences of all patients, who are currently suffering OR have suffered (and have since recovered) from Post Acute Infection Syndrome (PAIS). These infections may be caused by many different viruses or bacteria, such as SARS-CoV-2 (Covid-19), Influenza virus, Epstein-Barr virus, Borrelia bacteria (Lyme disease), or other pathogens (e.g. mold or parasites). For the purpose of this study, we have decided to use a broad definition of PAIS to include other triggers as well, such as toxins, severe trauma, or surgeries etc. Some people may refer to your condition/symptoms as Long-Covid, Post-Covid, Long-Lyme, Chronic-Lyme, Long-EBV, ME/CFS, etc. In this questionnaire we will be using the term PAIS to refer to all of these illnesses.

You can participate in this study, even if you do not know which pathogen triggered your disease or if you are not even sure if your PAIS was onset by an infection. You also do not require an official diagnosis from a doctor (you may also be self-diagnosed). You must, however, have or have had symptoms for at least 3 months, that were caused by an infection or other triggers, such as toxins, trauma or surgery.

What are the inclusion criteria?

·       For legal reasons, you must be at least 18 years old.

·       You are only permitted to participate once.

·       You must speak English or German.

·       In the case of severely affected adult patients, caregivers or confidants may entirely fill out the questionnaire for you. However, they must have an in-depth knowledge of your health situation and receive your oral consent.

·       You or your confidant must agree to the data protection statement and online consent declaration form via click.

·       You must be experiencing symptoms for longer than 12 weeks, which have been preceded by an infection or another trigger (e.g. toxin or surgery).

·       Recovered patients, fulfilling the above-mentioned criteria, may also participate.

 

How does the questionnaire work?

After reading this information sheet and filling out the online informed consent declaration form, you will be able to participate in this study. Before the questionnaire is initiated, you must select a language (English or German) of your preference.

The online questionnaire is expected to take about 1.5-3 hours to fill out, depending on how many symptoms you have and how many treatments you have already tried. You may always take a break and complete this questionnaire in stages, as your responses will automatically be saved. You may continue with the questionnaire whenever you have more time or energy. You can also terminate or interrupt the study prematurely at any time without providing a reason. Not wanting to participate or premature termination will have no negative consequences for you.

This questionnaire is divided into 4 parts:

·       Part 1: Demographic and General Healthcare Data

·       Part 2: Symptoms and Medical History

·       Part 3: Diagnostic Examinations

·       Part 4: Treatment Attempts and Medications

In parts 3 and 4 you may need to gather some of your medical documents and prescribed medications in order to fill out the questionnaire properly. While filling out the questionnaire, we ask you to select the answers carefully, to the best of your knowledge and belief.

The Ethics Committee of the Medical University of Vienna has issued a positive vote on this study and on the data privacy and consent declaration forms and all its amendments (EK No.: 1515/2023).

Should you have any questions in connection to the study and concerning your rights as a participant, you are always more than welcome to contact our study coordinator, Dr. Golda Schlaff, under pais@meduniwien.ac.at. Please note that if you decide to directly contact the study team with questions about your data, complete anonymity can no longer be fully guaranteed.

Option to participate in Follow-Up Surveys:

There is the possibility for you to enrol in the longitudinal continuation of our current study as well. This means, that in the next 5 years, every 12 months, you will be asked to participate in a short follow-up survey (duration about 10 minutes) – allowing us to observe how your condition is changing over time.

You do not have to agree to the longitudinal follow-up surveys. Your participation is completely optional. If you decide that you would also like to participate in the follow-up surveys, you must make sure to separately agree to it, by checking specified boxes in the consent declaration form, after which you will be asked to provide your email-address. By agreeing to participate in the longitudinal, follow-up surveys, your data will no longer be completely anonymous, but rather pseudonymized (please read the Data Protection Statement below for further details). Please be assured, your person or name will in no case ever appear in any publication of the data.


Data Protection Statement: How will my data be processed? (Please open for more information)↓

As part of this study, data about you will be collected and processed. A basic distinction must be made between:

1) personal data that can be used to directly identify a person (e.g. name, date of birth, address, social security number, photographs, etc.)

2) pseudonymized personal data, meaning, data in which all information that allows to identify a specific person is either removed, replaced by a code (e.g. a number) or made unrecognizable (e.g. in the case of images). However, despite compliance with these measures, it cannot be completely ruled out that re-identification may occur inadmissibly.

3) anonymized data, where it is not possible to trace the data back to a specific person.

Depending on the type of participation you choose (single participation in the current study or also participating in the optional follow-up surveys) your data will be handled differently. The current, single participation study involves anonymous data. If you participate in the follow up surveys, pseudonymized data as well.

In any case, only the project team will have access to the data by which you can be directly identified. In addition, authorized representatives of the Medical University of Vienna, who are bound to confidentiality, as well as representatives of domestic and/or foreign health authorities and the relevant ethics committees may inspect this data to the extent necessary to verify the proper conduct of the study. All persons who have access to this data are subject to the applicable national data protection regulations and/or the EU General Data Protection Regulation (GDPR). The Medical University of Vienna has also concluded a GDPR-compliant contract with SoSci-Survey.

The code that makes it possible to assign the pseudonymized data to your person is stored securely in the SoSci Survey system and, if necessary, at the test center. Only the pseudonymized or anonymized data will be used for any publications. In the context of this study, no transfer of data to countries outside or within the EU (third country) is planned.

Your consent forms the legal basis for the processing of your personal data. You can withdraw your consent to the collection and processing of your data at any time without giving reasons. No further data about you will be collected after you withdraw your consent. However, the data collected up to the point of withdrawal may continue to be processed in the context of this study.

Under the GDPR, you have the rights to information, rectification, erasure, restriction of processing, data portability and objection, provided that this does not render impossible or seriously impair the objectives of the study and provided that this does not conflict with other statutory provisions.

The duration of the storage of your data beyond the end or discontinuation of the study is regulated by legal provisions. If you have any questions about the handling of your data in this study, please contact study coordinator first at pais@meduniwien.ac.at. If necessary, they can forward your request to the persons responsible for data protection.

Contact details of the data protection officers of the institutions involved in this study: Data protection officer of MedUni Vienna: datenschutz@meduniwien.ac.at 

You have the right to lodge a complaint with the Austrian Data Protection Authority about the handling of your data (www.dsb.gv.at; e-mail: dsb@dsb.gv.at).


Department of Primary Care Medicine – 2024