At the end of '80 years, a computerized clinical record named Computhal was realized for italian centres specialized in the treatment of thalassemia. New progress in the field of thalassemia on one side, informatic tecnology and problems connected with the year 2000 on the other side, imposed to develop a new instrument.
In a discussion of these issues during two medical conferences held in spring '99, several participants, who deal with thalassemia and hemoglobinopathies, discovered to have in common needs and goals, as:
having a computerized clinical record for the daily management of patients with thalassemia and hemoglobinopathies, but open to be improved
simplifying the exchange of clinical and research informations
standardizing data format to simplify cooperative studies and the elaboration of therapeutic and follow up protocols
having a network meeting point where healthcare workers involved with these diseases could exchange information and discusse issues.
The response to these needs is the Project WebTHAL.
It grow up a work group leaded by an Executive Board consisting of the Thalassemia Treatment Centres of Brindisi, Cagliari, Genoa, Milan, and Turin, with the technical support of the informatics firm Most srl of Turin and with the organizational support of the Novartis Italia.
Taking advantage of the experience and the basic structure of the previous computerized clinical record, in these first months it has been created a new clinical record usable on line.
The new program is based on an SQL relational database with a web interface (HTML+Javascript). It has been installed on a national server (SUN Enterprise 250 with an Oracle database), currently situated in the headquarters of Most s.r.l. and connected to a fast Internet link by means of a toll-free dedicated thelephone line (toll-free number 800-390563)
We disposed two different ways to use the clinical record:
Remote access: the Centre can directly connect to the server by means of a telephone line or Internet connection. Using a conventional web browser (Netscape 3.1 or higher, or Explorer 4.0 or higher), the operator can insert modify and print pages on the printer connected to his or her own personal computer. All administrative operations will be carried out on the central server.
Local access: the Centre has acces to a Web server set up as a "closed" device, which will provide access to the program of clinical record of thalassemia; the operator can work directly on the server or access the program using a conventional web browser from any personal computer included in a local network. The server will be connected to Internet to allow remote assistance and, if enabled , data exchange with the national server. Server maintenance and any program updating will be carried out through the remote server. The clinical record can be printed out on local server itself or at any PC workstation included in the local network.
Secure Socket Layer (SSL) encryption technology has been utilized to ensure the secure transmission of data over the pubblic-access network.
A dedicated Web site has been prepared:
Methods
Each Centre will be able to select the access mode most suitable to its individual requirements. Regardless of the access mode chosen the data of a given center will be accessible exclusively by the center, via verification of individual user login and password. Most s.r.l. guarantees that access to such data will not be granted for any reason, whatsoever to any other partecipating center, to any of its own employees, or to any employees of Novartis Italia. The patients number, age and sex as well as the date of the last update will , however, be registered by Most s.r.l. and rendered accessible at the Web site.
Participating centers agree to allow access to and sharing of these general statistical indices.
Results
or
On that site it's possible to see the new computerized clinical record, clicking on DEMO pointer.
The clinical record structure includes individual forms for the following data:
1.Basic Data
2.Family tree (Data at Diagnosis)
3-10. Day Hospital
3.Clinical Data
4.Transfusional Treatment
5.Iron Chelation
6.Reactions to Chelation Therapy Data
7.Other Drugs 1
8.Other Drugs 2
9-10. Blood Tests 1-2
11. Investigations and Consultations
12. Urinary Iron Excretion
13. Intensive Desferal Chelation
14. Annual Summary Chart
15. Complications
16-20. Heart Assessment
16. Heart Assessment Summary
17. Heart Assessment
18. Ecocardiography
19. Holter E.K.G.
20. Ergospirometry
21. Weekly Deferiprone Follow up
22. Personalization
Heading
Default values
Reference values
Blood request forms
23. Export and graph
Each of the other pointers belongs to the Centres that have adhered to the WebTHAL project in this initial stage of development and that are using the clinical record (current participation includes 29 centers, with data on a total of 1235 patients, aproximately 110.230 admissions for transfusion, 31.737 years/patient.).
The clinical record will be granted free of charge to all healthcare structures that request it for the management of their patients.
Upon request, the Executive Board will provide support for the realization of the study through all its phases, including an initial evaluation of feasibility.
Every Centre will have full autonomy in deciding whether or not to take part in proposed studies and in the editing and transmission of its data. The operations of data exportation and transmission will be carried out by the center. If, for tecnical reasons, the staff of the partecipating center is unable to complete data exportation operations,these operations can be carried out by the staff ohf the Most s.r.l., but only upon the specific request of the center.
Most s.r.l. guarantees that the technological support it furnishes will ensure:
the absolutely privacy and integrity of all data (access allowed exclusively by authentication with login/password, encryption of all data transmitted on public networks, control of accesses and data flow)
technical assistance in the clinical record use
technical assistance for network connection
updating of the following:
general statistical data
list of the centres that join the Webthal project
date of most recent update
age distribution data
gender distribution data
Each User/Center agrees to:
complete the Webthal registration form
assume full responsability for the medical content and quality of the data it inserts
reply freely and rapidly to all proposals for cooperative studies
The Executive Board agrees to:
support permanent collaboration among member Centers by all appropriate means, including meetings, teleconferences, collaborator sharing, mailing-list, discussion groups
assume full responsability for clinical record's medical and scientific content, the web site and all future WebTHAL initiatives
update the clinical record's structure to meet the changing needs of users
provide training for medical and nursing staff on use of clinical record)
Novartis agrees to support:
all training activities and meetings among members
project updating and development
e-mail BOARD Nica
Cappellini
GianLuca
Forni forni@galliera.it Renzo
Galanello renzo.galanello@mcweb.unica.it Antonio
Piga (coordinator) antonio.piga@unito.it Gianni
Quarta brinemat@tin.it MOST Emanuela
Mormile manu@most.it Lorenzo
Nazario lorenzo.nazario@most.it support@most.it NOVARTIS Daniele
Alberti daniele.alberti@pharma.novartis.com Luigi
Boano gino.boano@pharma.novartis.com SECRETARIAT Silvia
Facello facello@pediatria.unito.it Marta Di Cosmo segreteria.webthal@pediatria.unito.it Il
Board
Development
COOPERATIVE STUDIES
Proposals for cooperative studies may be advanced by the Executive Board, the WebTHAL work group or by external sources. Direct data exchange among the centres, without Board coordination will also be allowed.