title: CNODES: the Canadian Network for Observational Drug Effect Studies.
abstract: Although administrative health care databases have long been used to evaluate adverse drug effects, responses to drug safety signals have been slow and uncoordinated. We describe the establishment of the Canadian Network for Observational Drug Effect Studies (CNODES), a collaborating centre of the Drug Safety and Effectiveness Network (DSEN). CNODES is a distributed network of investigators and linked databases in British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec and Nova Scotia. Principles of operation are as follows: (1) research questions are prioritized by the coordinating office of DSEN; (2) the linked data stay within the provinces; (3) for each question, a study team formulates a detailed protocol enabling consistent analyses in each province; (4) analyses are "blind" to results obtained elsewhere; (5) protocol deviations are permitted for technical reasons only; (6) analyses using multivariable methods are lodged centrally with a methods team, which is responsible for combining the results to provide a summary estimate of effect. These procedures are designed to achieve high internal validity of risk estimates and to eliminate the possibility of selective reporting of analyses or outcomes. The value of a coordinated multi-provincial approach is illustrated by projects studying acute renal injury with high-potency statins, community-acquired pneumonia with proton pump inhibitors, and hyperglycemic emergencies with antipsychotic drugs. CNODES is an academically based distributed network of Canadian researchers and data centres with a commitment to rapid and sophisticated analysis of emerging drug safety signals in study populations totalling over 40 million.
authors.affiliation: Institute for Clinical Evaluative Sciences, Sunnybrook Health Sciences Centre, 2075 Bayview Ave.,Toronto ON M4N 3M5, Canada.
authors.forename: Samy
authors.initials: S
authors.lastname: Suissa
authors.forename: David
authors.initials: D
authors.lastname: Henry
authors.forename: Patricia
authors.initials: P
authors.lastname: Caetano
authors.forename: Colin R
authors.initials: CR
authors.lastname: Dormuth
authors.forename: Pierre
authors.initials: P
authors.lastname: Ernst
authors.forename: Brenda
authors.initials: B
authors.lastname: Hemmelgarn
authors.forename: Jacques
authors.initials: J
authors.lastname: Lelorier
authors.forename: Adrian
authors.initials: A
authors.lastname: Levy
authors.forename: Patricia J
authors.initials: PJ
authors.lastname: Martens
authors.forename: J Michael
authors.initials: JM
authors.lastname: Paterson
authors.forename: Robert W
authors.initials: RW
authors.lastname: Platt
authors.forename: Ingrid
authors.initials: I
authors.lastname: Sketris
authors.forename: Gary
authors.initials: G
authors.lastname: Teare
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D002170:Canada; D019058:Community Networks; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D006801:Humans; D008498:Medical Record Linkage / Q000379:methods*; D054539:Medication Therapy Management / Q000458:organization & administration*; D009937:Organizational Objectives; D017063:Outcome Assessment, Health Care; D012107:Research Design; D018570:Risk Assessment