Details of the CHESS data collection and reporting system

 

CHESS is structured as a prospective web-based adverse reporting system with the minimum possible impact on the routine of hemophilia centres. It allows participating centre to record events on a single page form immediately after the event happens or at the end of a three-month period. Only information routinely recorded for patient management is reported; no extra examination or data collection is required.

 

Patients included in the surveillance

 

Haemophilia A
Haemophilia B
von Willebrand’s disease:       type 1 severe (<15% VWF:RiCo), type 2 , type 3
Factor I deficiency:                Afibrinogenemia (<10mg/dl), Hypofibrinogenemia (10-50 mg/dl), Dysfibrinogenemia (50-150 mg/dl)
Factor II deficiency
Factor V deficiency
Factor VII deficiency
Factor X deficiency
Factor XI deficiency
Factor XIII deficiency
Alpha 2 antiplasmin deficiency
Combined Factor V+VIII deficiency
Combined Factor II, VII, IX, X deficiency

 

Patients excluded from surveillance

 

Patients with acquired clotting factor deficiencies.

 

Events to be reported during surveillance

 

Allergic or other acute event
Transfusion transmitted infections
Inhibitors (antibodies against the coagulation factor)
Thromboses
New cardiovascular events
New malignancy diagnoses
Deaths

 

Population data

 

At the end of each complete year of surveillance, population data (i.e. data on the number of patients registered with participating centres and the clotting factor concentrates used to treat them) will be imported from the CHR/CHARMS after approval and review by the Hemophilia Clinic Director. Centres may report usage of unlicensed clinical trial products (no product name is reported) as well as licensed named products.

 

 

 

IT Development and Support by MDSAS (2013)