Project: SHAERPA (Members)

ACARE Project SHAERPA

 

Dear ACARE members,

We kindly invite you to join the ACARE project called SHAERPA (Stopping androgen treatment in patients with HAE – Characterization of rationale, protocols and development of advice for patients and physicians).

This international, multi-center, prospective cross-sectional academic study aims to determine why, how and with what consequences androgen therapy is discontinued in patients with hereditary angioedema (HAE).

SHAERPA consists of 2 questionnaires to be fill in the Redcap system. The first one is for patients and contains 55 questions that assess the type of androgens, the used dose, adverse effects, duration of androgen treatment, reason to suspend treatment and how androgens were discontinued. The second questionnaire is for physicians who treat patients with HAE. It has 23 questions and assesses the reasons to discontinue androgen treatment, the protocol used, and what medications were used after stopping androgens.

These questionnaires can be filled out directly in the Redcap system using a cell phone, tablet or computer, or they can be downloaded as a pdf and filled out by hand and after the physician enters the information into the system.

At the moment the questionnaire is available in 5 different languages (English, German, Spanish, French and Hungarian).

The ethical approval is available from Charité Universitätsmedizin Berlin (EA2/061/21), March 23th 2021). You will find all project documents in the SHAERPA file list.

Do you have patients with hereditary angioedema and would you like to participate?
Please follow these steps:

  1. Obtain your local ethics committee approval (document SHAERPA Application ethics committee SHAERPA final (feb2021) can be used for translation).
  2. Translate documents 1-4 (patient consent, patient information, patient questionnaire and physician questionnaire).
    Translations are already available (see file list). If there are more ACAREs in your country, the same translated documents can be used by all centers. We encourage you to send translated documents to the ACARE Office or to carolina.vera@charite.de . They are going to be made safely available in the password-protected area of the ACARE webpage and the translated questionnaire in the RedCap system.
  3. Ask at ACARE office or via carolina.vera@charite.de to send over the QR-code or link to enter the questionnaires for your patients and physicians.

We intend to present study results at an international congress (preferably EADV or EAACI) and publish them in peer-reviewed scientific journals. We want to include a total of 500 patients and 250 physicians questionnaires.

 

Do you want to become a co-author:

1) 20 patients included = one authorship

2) Additional 40 patients included = second authorship

3) Additional 80 patients included = third authorship

4) All Steering Committee members are authors (independent of number of patients included)

5) We can further specify the completeness of data required for patients to count towards authorship

6) All co-authors should contribute to interpretation of study results and manuscript development.

The study is going to be open until October 2023. Please do not hesitate to contact us (carolina.vera@charite.de) in case of any questions.

We are looking forward to working with you and are thanking you in advance.

With the kindest regards from the SHAERPA steering committee:

Carolina Vera and Marcus Maurer (project leaders) Markus Magerl Sebastien Sanges

Shimalee Andarawewa

Zsuzanna Balla

Lorena Lorenzo

Emel Aygören

Isabelle Boccon-Gibod

Sorena Kiani

David Launay

Henriette Farkas