The CADEUS study: methods and logistics.
OBJECTIVE
At the request of the French Health authorities, a study called CADEUS (COX-2 inhibitors and NSAIDs: description of users) aimed to describe the users of cyclo-oxygenase (COX)-2 inhibitors and traditional non-selective non-steroidal anti-inflammatory drugs (tNSAIDs). We report here the methodology, logistics and study design performances.


METHODS
CADEUS is a cohort study designed to include 40,000 patients randomly sampled monthly in the French National Healthcare Insurance database, who received at least one dispensation of celecoxib, rofecoxib or tNSAIDs (1:1:2), from September 2003 to August 2004. Patients and prescribers were asked to fill a questionnaire on indication, medical history, risk factors and hospitalizations since drug acquisition. There was no reminder. For each respondent, healthcare resources used for the 6 months before and after inclusion were extracted from the database. Response rate, response delay, responders and non-responders characteristics were assessed.


RESULTS
Of the 222,879 patients and their prescribers contacted, 20.8% patients and 32.6% prescribers responded. Median response delay was 16 days for patients and 17 days for physicians. Factors associated with patient response were age, cohort, type of prescriber and period of inclusion.


CONCLUSIONS
This is the first study of this design in France, combining data from a claims database and direct patient and prescriber questionnaires.
Depont
F
F
Département de Pharmacologie, Université Victor Segalen, Bordeaux, France.
Fourrier
A
A
Merlière
Y
Y
Droz
C
C
Amouretti
M
M
Bégaud
B
B
Bénichou
J
J
Moride
Y
Y
Blin
P
P
Moore
N
N
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D015331:Cohort Studies; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D016208:Databases, Factual / Q000706:statistics & numerical data; D017723:Drug Utilization Review / Q000379:methods* / Q000458:organization & administration / Q000706:statistics & numerical data; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced / Q000453:epidemiology; D015340:Epidemiologic Research Design; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D012737:Sex Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors