Invitation
Dear colleagues,
The BELSPEED Scientific Committee would like to invite you to take part in our study entitled BELCOME@GHD: BELux Children OutcoME during A(@)dulthood with GHD.
Our group has enrolled, in the BELGROW registry, most children and adolescents that have or are being treated with rhGH in Belgium over the past 30+ years. This database is a unique opportunity to perform a follow-up study of the status of rhGH therapy in adults with childhood-onset GHD (CO-GHD) in Belgium and Luxembourg.
The BELCOME@GHD study aims to assess the follow-up of adult CO-GHD patients via a customized questionnaire. The primary objective is to evaluate the proportion of adult CO-GHD patients still under medical follow-up and still treated with rhGH. The secondary objectives are to assess their compliance with treatments and their metabolic profile/comorbidities (through BMI, blood pressure, glycemic & lipid profile, IGF-1 levels, other pituitary deficiencies, DXA if available).
BELSPEED physicians will be responsible for contacting their former patients. If they agree and after signing ICF, patients will fill in the questionnaire to assess their follow-up, regularity of consultations, use of GH treatment, and compliance. Patients who have continued regular medical follow-ups in one of your adult endocrinology departments will be asked, at the end of the questionnaire, whether they consent that we (BELSPEED) contact their current endocrinologist to collect their most recent clinical and biological data. In practice, we will need your help and collaboration mainly to obtain their most recent biology and consultation report (< 12 months).
Patients lost to follow-up will be proposed a new clinical examination and a standard-of-care blood test at the clinical center of their choice (or at their general practitioner), for data to be retrieved.
We will ask each participating physician to send us their patient data via a digital or hard-copy CRF, but participating physicians will not need to take care of data encoding. The data will be encoded in the secure REDCAP database directly by the research team. The research team will also carry out statistical analyses.
A working group has already been set up for this study with BELSPEED members. You are more than welcome to join this working group if you wish to participate in the construction of the project and be involved in future publications (at BELSPEED, any member of the working group is always co-author of the article concerned by the project).
We thank you in advance for your help and future collaboration in this nationwide project.
If you have any questions don’t hesitate to contact us:
Prof Philippe Lysy, philippe.lysy@saintluc.uclouvain.be
Dr Marianne Becker, becker.marianne@chl.lu
Dr Laure Boutsen, laure.boutsen@saintluc.uclouvain.be
In collaboration with BELSPEED/BELCOME-working group and IREC laboratory (UCL)
Brief outline of the project
BELCOME@GHD study: BELux Children OutcoME during A(@)dulthood with GHD.
Inclusion criteria: patient ³ 18 years old registered in BELGROW for childhood-onset GHD and diagnosed with persistent GHD during transition / early adulthood
Primary objective: to assess the follow-up of adult CO-GHD patients via a customized questionnaire to evaluate the proportion of adult CO-GHD patients still under medical follow-up and still treated with rhGH
Secondary objectives: to evaluate the compliance to rhGH treatment and the metabolic profile of adult CO-GHD patients (BMI, blood pressure, glycemic & lipid profile, IGF-1 levels, other pituitary deficiencies, DXA if available)
Design: prospective multicentric study
Expected number of patients: 200 patients
Principal investigator: Prof Philippe Lysy, philippe.lysy@saintluc.uclouvain.be Sub-investigator: Dr Laure Boutsen, laure.boutsen@saintluc.uclouvain.be
In collaboration with BELSPEED/BELCOME-working group and IREC laboratory (UCL)
Authorship rules for BELSPEED projects based on a BELSPEED database:
Creation of a working group and invitation to participate to all members.
Authorship for these projects is organized as such: 1 person of each participating clinical center as co-author, all members of working group as co-authors, all members of the Society concerned by the patient data cited as collaborators (i.e. “on behalf of the Society”, which develops the name of all concerned members).
