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The database network taking it to the next level. . . Bodo Grimbacher, MD The database network taking it to the next level. . . Bodo Grimbacher, MD University of Freiburg, Germany Head of ESID patient registries

Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry The CVID Subregistry Requirements Time schedule Support for the documenting centers Summary Prospectives

President: Prof. L. D. Notarangelo, Brescia, Italy; Secretary: Prof. H. Wolf, Vienna, Austria Main President: Prof. L. D. Notarangelo, Brescia, Italy; Secretary: Prof. H. Wolf, Vienna, Austria Main patient registry 10, 717 recorded cases of Primary Immunodeficiencies in Europe a non-profit organization established in 1983, became a society in 1994 • to facilitate the exchange of ideas and information among doctors, nurses, biomedical studies, patients and their families, collaboration with IPOPI and INGID • to establish common diagnostic criteria (together with PAGID) (Clin. Immunol. 1999; 93: 190). • to promote research on causes, mechanisms and treatment - summer schools (education, pathogenesis, treatment of primary immunodeficiencies) - biennual scientific meetings (next: 21 -24 October, 2004 in Versailles, France) All ESID Countries Austria Belgium Croatia Czech. Republic Denmark Estonia Finland France Germany Greece Hungary Iceland Ireland Israel Italy Netherlands Norway Poland Portugal Russia Serbia. Montenegro Spain Sweden Switzerland Turkey United. Kingdom

Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry The CVID Subregistry Requirements Time schedule Support for the documenting centers Summary Prospectives

What features should a patient- and research database have? Longitudinal Analysis of a single What features should a patient- and research database have? Longitudinal Analysis of a single patient and a cohort of patients Cross-sectional Analysis of patient cohorts Multivariate Analysis and complex database queries Variable programming of queries Easy implementation of new databases via XML-programming Data-entry via electronic Import, Scanning-Function or manually Connecting medical centers world-wide Accessable any time from any place Patient-Report-Generation Recall-Function Security: Implementation of rules for patient‘s data protection Access: controlled by complex User-Role-Management

User-Role management Concept and architecture of an internet based ESID database network • User-Password: User-Role management Concept and architecture of an internet based ESID database network • User-Password: Handles access to the ESID-database system

Client Thin Client-Server Architecture XML Initialisierung Server View Client access via Standard Internet Browser Client Thin Client-Server Architecture XML Initialisierung Server View Client access via Standard Internet Browser XML Controller Java 2 Enterprise. Edition Server Operating. System: Unix Model DB

ESID Main Registry & Subregistries ESID Main Patient Registry CVID Subregistry DGS Subregistry NBS ESID Main Registry & Subregistries ESID Main Patient Registry CVID Subregistry DGS Subregistry NBS Subregistry XLA Subregistry HIGM Subregistry SCID Subregistry Neutropenia Subregistry. . . Additional Subregistries 1. ESID Main Registry 2. CVID Subregistry 3. Additional Subregistries on demand

Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry The CVID Subregistry Requirements Time schedule Support for the documenting centers Summary Prospectives

Core data-subset PATIENT: Sex, date of birth, region of residence (clustered in regions with Core data-subset PATIENT: Sex, date of birth, region of residence (clustered in regions with > 30 millions inhabitants) DIAGNOSIS: Date of diagnosis, onset of symptoms, disease/diagnosis THERAPY: Date, drug, dose per weight, dose interval, route (oral / SC / IV), from, until, side-effects, reason stopped, compliance PHARMACO-ECON: Days in hospital, days missed at school, days missed at work IMMUNIZATIONS: Date, vaccine, postvaccinal titres LABORATORY: Date, time, label, value (Ig. G, Ig. A, Ig. M, CD 3, CD 4, CD 8, CD 19 or CD 20, CD 56, Leukocytes, Thrombocytes, Erythrocytes, Lymphocytes, Granulocytes, Hb, Eosinophils, Basophils, Macrophages) in percent or/and in absolute values

The ESID Main Registry The ESID Main Registry

The ESID Main Registry The ESID Main Registry

The ESID Main Registry The ESID Main Registry

The ESID Main Registry The ESID Main Registry

Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry The CVID Subregistry Requirements Time schedule Support for the documenting centers Summary Prospectives

Datamodel: CVID database-system Datamodel: CVID database-system

The CVID Subregistry The CVID Subregistry

The CVID Subregistry The CVID Subregistry

The CVID Subregistry The CVID Subregistry

The CVID Subregistry The CVID Subregistry

The CVID Subregistry The CVID Subregistry

The CVID Subregistry The CVID Subregistry

The CVID Subregistry The CVID Subregistry

The CVID Subregistry The CVID Subregistry

The CVID Subregistry The CVID Subregistry

The CVID Subregistry The CVID Subregistry

The CVID Subregistry The CVID Subregistry

Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry The CVID Subregistry Requirements Time schedule Support for the documenting centers Summary Prospectives

Requirements Positive statement of data protection officer and/or ethics board Signed consent form from Requirements Positive statement of data protection officer and/or ethics board Signed consent form from patients Database models

Data protection approval: source document Data protection approval: source document

Ethics vote: source document Ethics vote: source document

Requirements Positive statement of data protection officer and/or ethics board Signed consent form from Requirements Positive statement of data protection officer and/or ethics board Signed consent form from patients Database models

Consent form for patients Consent form for patients

Requirements Positive statement of data protection officer and/or ethics board Signed consent form from Requirements Positive statement of data protection officer and/or ethics board Signed consent form from patients Database models

PID Classification & Steering committees PID Classification & Steering committees

Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry The CVID Subregistry Requirements Time schedule Support for the documenting centers Summary Prospectives

Time schedule Sept. 1 st 2003 Jan. 27 th, 2004 Jan. 29 th, 2004 Time schedule Sept. 1 st 2003 Jan. 27 th, 2004 Jan. 29 th, 2004 Feb. 2 nd, 2004 Feb. 19 th, 2004 March 8 th, 2004 May 15 th, 2004 Start of project CVID-datamodel submitted NBS-datamodel submitted DGS-datamodel submitted osteopetrosis-datamodel submitted The beta-version goes online End of test drive June 15 th, 2004 The ESID-registry will go online with the ESID-main-registry and the CVID subregistry additional 3 subregistries implemented additional 4 subregistries per year October 1 st, 2004 from there on:

Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry The CVID Subregistry Requirements Time schedule Support for the documenting centers Summary Prospectives

Letter to the ESID members The ESID registry working party has made major steps Letter to the ESID members The ESID registry working party has made major steps towards an ”ESID Online Patient- and Research-Registry”. Bonus system: We are about to develop a multi-centred data collection system in European and Non-European countries for patients with Primary Immunodeficiencies. The data collected in the participating centres shall be pseudonymized and thereafter be entered and made accessible in a central online registry. The registry will consist of multiple 'disease-specific subregistries'. In addition, there shall be an annual award for the five best publications of the five disciplines (Antibody deficiencies, T-cell or combined deficiencies, Phagozytic disorders, Complement disorders, Other PIDs) within PID using data of the ESID registry of about EUR 2. 000, 00 per publication and an extra award of EUR 5. 000, 00 for the best publication over all. Compensation for secretarial assistance (EUR 10 per Furthermore, a center which has reached a specific patient per year) number of documented patients shall be rewarded by travel grants to either the ESID summer school or the biannual ESID scientific meetings. Free registration to the meetings is also beeing discussed. Annual award for the best publications within PID using data of the ESID Registry Each center may install the database locally to be able to Data from e. g. national registries will be automatically transferrable to eliminate the need of a second registration. The system will enable the user to enter any data at any time for any visit. We are asking for yearly updates of the records. With PPTA (Plasma Protein Therapeutics Association), the major financial sponsor of this project, we are about to arrange a financial compensation for the use of secretarial help for the documentation. work with personalized data, since the application will be able to generate patient reports to be sent e. g. to the home By now -physician. In addition, the database will support features about 150 like 'recall functions' which will remember the physician if a patient has not shown up for his/her regular follow-up visit. confirmations of Travel grants to ESID meetings and summer school For this project, ESID is asking for support from all physicians and researchers involved in the diagnosis, care, treatment, and support of patients with PID. intended colla. There will be a patient consent to be signed to ensure that the patient supports the initiative. It will be the centers' boration by single responsibility to obtain the patient consent. However, all documentation PID patient organizations so far supported this project since it is designed to increase awareness and diagnosis of centers PID and to facilitate research in the field. Possibility to work with personalized data plus recall-functions ESID suggests to compensate for secretarial assistence The bonus system is set up as follows: with 5 documented patient for whom a core dataset (red per fields) has been documented and 10 each documented for patient for whom an extended dataset (blue fields) has been documented. We are prepared to provide you with all documents you will need for patients consents and ethics approvals. Thank you for your collaboration!

Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry The CVID Subregistry Requirements Time schedule Support for the documenting centers Summary Prospectives

Why support the ESID-online registry? Physicians Patients Industry • research across centers • optimize Why support the ESID-online registry? Physicians Patients Industry • research across centers • optimize research • access to a core dataset using a huge database • implement standards for • additional data for post • enable genetic, and diagnosis and therapy licensing surveillance therapeutic trials within • improve quality of life • data for marketing ESID • meet the patient‘s needs • advertisement, publicity • secretarial assisitance • support the spirit of ESID • close contact to a world- • automated patient reports wide network of highprofile research institutions

Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry Registry The existing ESID Registry Up-to-date patient- and research-databases The ESID Main Patient Registry The CVID Subregistry Requirements Time schedule Support for the documenting centers Summary Prospectives for participating countries

Prospectives Decision 1: Do I need a signed consent form for the registry in Prospectives Decision 1: Do I need a signed consent form for the registry in my country? Do I need a vote from my ethical review board? Decision 2: Do I wish to have a personalized version of the ESID registry as a national registry, running behind the firewall of my university? Question 1: What do I need from ESID to facilitate the registration of my patients? Does my center have the technical requirements for runnig the ESID database? Question 2: Can I improve the ESID registry?

The online patient and research database network Bodo Grimbacher MD; Dominic Veit MA; Barbara The online patient and research database network Bodo Grimbacher MD; Dominic Veit MA; Barbara Frisch MA University of Freiburg, Germany ESID patient registries [email protected] ukl. uni-freiburg. de [email protected] ukl. uni-freiburg. de [email protected] ukl. uni-freiburg. de

Security and Dataprotection Concept and architecture of an internet based ESID database network Input Security and Dataprotection Concept and architecture of an internet based ESID database network Input requires a positive statement from the local data protection officer and a signed consent from the patient(s) or legal tutor (approved form provided in 6 languages) • SSL encrypted data transmission • Secure Server Net (audited Firewall of the Hospital of Freiburg) • User-Role Authentication • Passwords are stored in encrypted form • Multiple-User-Roles restrict views and presented data • Patient randomization (patient ID’s) • Only coded data allowed (ONLY the patient’s physician can match a specific data-set with his patients) • No demographical data or ‘free text’ that potentially directly identifies the patient is stored in the system • Meet the standards set by FDA CFR 21 Part 11 for Good Clinical Practice and ISO 9001 for Quality Control

Concept and architecture of an internet based ESID database network The network structure National Concept and architecture of an internet based ESID database network The network structure National patient registries Local patient registry A B . . . Centers b a AIEOP National CINECA DB Italy ESID registry: Disease-specific subregistries Local physicians ESID mutation databases Hospitals/INGID IPOPI

Existing registries/databases in: Italy 04/03 Spain 09/03 Poland 10/03 Czech 11/03 Paris 12/03 Hannover Existing registries/databases in: Italy 04/03 Spain 09/03 Poland 10/03 Czech 11/03 Paris 12/03 Hannover 02/04 Munich 03/04 Ulm Belgium Hungary The Netherlands Portugal Sweden. . .