WP01 - Preparation


WP1 will ensure proper preparation of the study.

To answer the research questions of dsd-LIFE and announcement of the study.

  • To bundle complementarity and to share and amplify expertise of the partners in working groups for the study protocol (Task 1)
  • To develop the study protocol to answer the main questions of dsd-LIFE (Task 2)
  • To advertise the study to all the potential audiences, in particular, patient organizations and physicians to optimize recruitement of patients (Task 2)
  • To translate the study protocol (Task 4)
  • To obtain ethical approval in the different national study centres (Task 3)

Work Package Description

The major aim of WP1 is constitution of the study protocol. WP1 is closely linked to WP3 data analysis. Decisions on adequate tools for evaluation of the main outcome measures psychosocial adaption, HQOL and psychological well-being, various off label treatment/interventions such as (1) choice of sex of rearing, (2) surgery, (3) hormone therapies, (4) psychological support and interrelating factors as, metabolism, psychosexual development, cultural influences and patients’ views will be made. The consortium will start work in small working groups to bundle and amplify the expertises of the study centres for development of the study protocol. The working groups will consist of experts covering the main issues of dsd-LIFE. All study centres have close contact to national patient organizations. We will implement collaboration with patient organizations for patients’ view, participation and dissemination of general knowledge on DSD and the study results. Advertisement of the study to enhance recruitment of patients will start in WP1.

Task 1: Constitution of a study protocol
We will constitute a study protocol in English until month 06 to give the basis for evaluation of the patients. Constitution of the study protocol includes (1) a medical questionnaire, (2) a clinical examination protocol, (3) questionnaires on socioeconomic background, (4) psychosocial adaption, HQOL and psychological well-being, (5) psychosexual development and (6) patients’ view and cultural background. The study protocol will be reviewed by the steering committee of the study and the external advisor group including a patient organization.

Task 2: Design of a flyer for recruitment
We will develop and translate a flyer in the national languages to advertise the study.

Task 3: Application for ethical approval in the national study centres
Ethical approval of the English study protocol in each study centre will be requested from the national local ethic committees before translation.

Task 4: Translation of the study protocol in the national languages
The study protocol will be translated in the national languages.

WP Leader

Dr. Birgit Köhler