[Methodology and quality control in EPIGRAM, a pharmacoepidemiological study of obesity in general practice].
The EPIGRAM pharmacoepidemiological study was conducted in general practitioners prescribing orlistat (Xenical) in order to describe, under real clinical conditions, the management of obese or overweight patients. A 1-year follow-up of a patient cohort treated with orlistat was also conducted. Quality criteria specific to the study were defined to ensure the scientific validity of the results; these criteria mainly involved the following items: independent scientific committee, sampling investigator's recruitment, study organisation and quality control of the collected data. On-site control visits of a sample of 13% of participating GPs revealed that 75% of the controlled data were documented in a source file of which 85% were consistent with the source data. Only 1% of the 130 000 controlled data (data were controlled only on visits for which information was available) gave rise to correction requests. Of the patients treated with orlistat on inclusion, 17% were lost to follow-up by their GP and 25% were contacted directly at the end of the study.
Vray
Muriel
M
Unité d'Epidémiologie des Maladies Emergentes, Institut Pasteur, Bâtiment Laveran, Paris, France vray@pasteur.fr
Joubert
Jean-Michel
JM
Eschwège
Eveline
E
Liard
François
F
Fagnani
Francis
F
Commenges
Bénédicte
B
Steinberg
Ghislaine
G
Bégaud
Bernard
B
D000328:Adult; D019440:Anti-Obesity Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D005194:Family Practice / Q000706:statistics & numerical data*; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D007783:Lactones / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy* / Q000453:epidemiology*; D000077403:Orlistat; D017891:Pharmacoepidemiology / Q000592:standards; D011786:Quality Control
D019440:Anti-Obesity Agents; D007783:Lactones; D000077403:Orlistat