Innovation Prize for Haemophilia Project
In early November, the project group of the Centers for Haemostaseology in Münster, Frankfurt, and Berlin was presented with the Innovation Prize 2007 for its HaemoassistTM. With this award, the German Society for Telemedicine (DGTelemed) honored the innovative approach of using an electronic substitution diary in haemophilia therapy which had been developed together with hemostaseologists and the Clinische Studien Gesellschaft mbH (CSG), Wyeth Pharma AG, and Condat AG.
Dr.Berthold Siegmund (Institut für Thrombophilie und Hämostaseologie, Münster), Barbara Weise (CSG), Dr.Annette Galler (Wyeth Pharma AG), Dr. Robert Klamroth (Hämophiliezentrum, Vivantes Klinikum im Friedrichshain, Berlin), Dr. Wolfgang Mondorf (Haemostas-Frankfurt), Dr. Martina Westfeld (Wyeth Pharma AG), Dr. Hartmut Pollmann (Institut für Thrombophilie und Hämostaseologie, Münster), Herr Jo van Nouhuys (Condat AG)
Haemophilia is a recessively inherited X chromosomal dysfunction which is characterized by a coagulation defect and a related disposition to spontaneous bleeding. Bleeding to the joints, skin, and muscles are typical symptoms. However, bleeding may also occur in the brain and other organs and may partially result in life-threatening situations. That is why haemophilia patients have to rely on a lifelong substitution of the absent coagulation factor. In the 1970s, the first tests were conducted in self-treatment at home under the supervision of a physician which greatly improved the quality of life of the afflicted individuals. This type of therapy has become widely accepted in haemophilia today. Instructed by physicians, patients carry out the intravenous injection of the factors by themselves at home. In return for this freedom, patients, however, must document the factor substitution in accordance with § 14 of the German Transfusion Act. So far, injection-related data have been recorded in a haptic substitution diary which is submitted to the physician during routine visits approximately every three to four months. Even though this documentation is an important source of information for the physicians, problems may arise because unusual substitution or bleeding patterns were often not recognized early enough and were, thus, treated insufficiently.
Perfect Therapy Monitoring
The solution is provided by HaemoassistTM. It is an electronic substitution diary that works on the basis of a PDA (Personal Digital Assistant). The program provides simple navigation through the menu which permits haemophilia patients to document all compulsory injection-related data within two or three minutes. Data are recorded pseudonymized and then transmitted SSL encrypted via mobile phones to a secured data bank. Physicians can log into the online data bank via the HaemoassistTM Online-Application by entering an encoded password and, thus, get up-to-date information on their patients’ therapy. An essential element of HaemoassistTM are the so-called reminders. If potentially critical bleeding, which has been predefined in the system, occurs in the patient, then this patient gets an information to contact the physician. Additionally, the physician is informed of the event by email which allows the physician to adjust the therapy in a timely manner.
Perfect Patient Management
In addition to injection-related data, the quality of life can also be recorded by patients – with their consent – in the system via the SF 12 questionnaire on a semiannual basis. This additional information is of great significance to the physician in assessing the patient’s overall general condition. Furthermore, the physicians are not only able to view the current injection-related data of their patients in a timely manner, they can also access the history page. They can, thus, compare the prescription volume with the actual consumption of the factor. The system will also provide the physicians with a semiannual, standardized report which, in addition to patient-specific analyses, also permits the evaluation of all patients at the center as well as comparisons of the overall values of the participating centers. HaemoassistTM makes, therefore, a vital contribution towards improving the transparency and assuring the quality of haemophilia therapy.
Clinische Studien Gesellschaft mbH (CSG)
On behalf of the Wyeth Pharma corporation, CSG developed the idea for the system together with haemostaseologists and the Condat AG. In the current project, CSG is responsible for server hosting, data maintenance and processing, support, the organization of PDAs, reporting as well as integrating additional physicians and new patients into the project.
