German HIV cohort study Nicole Skoetz, Ulrike Bergmann, Sinidu - PowerPoint PPT Presentation

German HIV cohort study Nicole Skoetz, Ulrike Bergmann, Sinidu Deneke, Claudia Michalik, Dietmar Theisen, Sven Wiegelmann, Ursula Paulus, Norbert Brockmeyer

Content •The German HIV cohort study • Networking • Data set • Quality assurance • Summary

The Cohort: Facts • Data collection since June 2004 • 14,200 patients • 11,000 follow up 1 • 7,500 follow up 2 • 4,000 retrospective data • 560 variables • Information on blood samples

•German HIV cohort study •Quality assurance •Networking Networking •Data set •Summary

Networking: project management SOP group Data security Competence group KKSK network on Since HIV/AIDS 09/2005 Analysis group Future group

Networking: centers HIV centers paediatrics neurology obstetrics KKSK Competence network on HIV/AIDS central office

Networking: Data transfer Validierter MACRO Laptop zur Datenerfassung Zertifizierter MACRO Oracle UMTS Firewall 1 Web Server Firewall 2 DB Server Internetzugang https - Unidirektionaler Patientendatentransfer von MDATs vom Laptop zum Server - Zentrale KKSK KompNet HIV - Bidirektionale Kommunikation Patientendatenbank mit MDATs mit zentralem Server (z.B. und KompNet HIV Pseudonym Lokale Erfassung von: MACRO Laptopadministration) - IDATs (identifizierende Daten) - MDATs (medizinische Daten) KompNET HIV Pseodonym: - Sitecode und lfd.Nr (z.B. koeln01/99)

•German HIV cohort study •Quality assurance •Networking •Data set Data set •Summary

pregnancy exposed children basic hepatitis neurology Data set

pregnancy exposed economic health children basic Data set: in progress hepatitis resistance neurology

•German HIV cohort study Quality assurance •Quality assurance •Networking •Data set •Summary

Quality assurance SOPs Macro (InferMed Ltd., London) quality plausibility- helpdesk checks

Quality assurance: on-site monitoring according patients‘ monitoring concerns manual training, on-site samples support for monitoring asservation centers SDV, standardised informed data entry consent

Quality assurance: dublicates • In progress: implementation of TMF‘s data security concept • PID generator • Pseudonymisation • Electronic data custodian: HIV/TMF-project • Until then: PIDs

Quality assurance: feedback to centers

Auswertungen: Öffentlichkeit • Online-Auswertungen • KompNet Website • Doku-Seite individueller Patient

•German HIV cohort study •Quality assurance •Networking Summary •Data set •Summary

Summary: the cohort •Quality •Quantity •15,000 patients •Different modules •Blood