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Existing data sources for clinical epidemiology: Scandinavian Cohort for osteonecrosis of the jaw - work in progress and challenges.

Artikel i vetenskaplig tidskrift
Författare Morten Schiodt
Cecilia Larsson Wexell
Bente Brokstad Herlofson
Karen Marie Giltvedt
Sven Erik Norholt
Vera Ehrenstein
Publicerad i Clinical epidemiology
Volym 7
Sidor 107-16
ISSN 1179-1349
Publiceringsår 2015
Publicerad vid Institutionen för kliniska vetenskaper, Avdelningen för biomaterialvetenskap
Sidor 107-16
Språk en
Länkar dx.doi.org/10.2147/CLEP.S71796
Ämneskategorier Biomaterial

Sammanfattning

Osteonecrosis of the jaw (ONJ) is a severe side effect associated with antiresorptive treatment. Monitoring of ONJ using routine databases in Scandinavian countries is a challenge owing to lack of valid algorithms and to heterogeneous referral practices. The aim of this paper is to describe the process of establishing a Scandinavian ONJ Cohort enrolling all ONJ cases related to antiresorptive treatment arising in Denmark, Norway, and Sweden between 2011 and 2019. The initial purpose of the cohort is to support an ongoing pharmacovigilance study of denosumab and zoledronic acid in Denmark, Norway, and Sweden. The three countries, with their 199 clinics, departments, and units of oral and maxillofacial surgery, both hospital-based and freestanding, differ somewhat in referral practices of the ONJ patients. By directly contacting all providers of care to ONJ patients in the three countries, we established a network for reporting incident cases to each country's research database directly or through a member of the Scandinavian ONJ task force as a liaison. The task force includes a Scandinavian coordinator and three national coordinators collaborating directly with the clinics. A uniform ONJ registration form has been developed, and the relevant medical community has been informed either directly or through presentations at professional meetings. A website with study information is published in each country, and data entry is ongoing. This large-scale systematic uniform registration of ONJ cases in Denmark, Norway, and Sweden, with an underlying total population of more than 20 million people, merged into the Scandinavian ONJ Cohort, will contribute to better knowledge and understanding of this challenging group of patients, and ultimately, help improve patient care. The Scandinavian ONJ Cohort as a whole and its component national ONJ research databases may offer the potential for large-scale multinational intervention and safety studies in the future.

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