Computerised record linkage systems have great potential for enhancing or even replacing traditional methods of adverse event reporting based on active patient follow-up, both in clinical trials and in epidemiological studies.
The West of Scotland Coronary Prevention Study (WOSCOPS) is a randomised double-blind clinical trial of pravastatin versus placebo in the primary prevention of coronary heart disease, with coronary heart disease death plus nonfatal myocardial infarction as its primary end point.
Adverse event reporting is based on active patient follow-up at routine trial visits.
In parallel with this approach, we have obtained computer records of all deaths, incident cancers, and hospitalisations for our subjects by linking their names, dates of birth, and postcodes of their home addresses with a Scottish national database operated by the Scottish Record Linkage system.
The results of this comparative study, based on follow-up of the 6595 men ages 45-64 randomised in WOSCOPS, demonstrate minor flaws in both systems, show that follow-up based on computerised linkage alone can be as effective as reporting based on direct contact with the patients, and show that a system based on both approaches provides a direct cross-validation of the two approaches to adverse event reporting while minimising the frequency of unreported events.
Mots-clés Pascal : Pravastatine, Prévention, Chimiothérapie, Cardiopathie coronaire, Complication, Essai clinique, Epidémiologie, Informatique, Linkage, Information, Enregistrement, Surveillance, Etude longitudinale, Base donnée, Méthodologie, Appareil circulatoire pathologie
Mots-clés Pascal anglais : Prevention, Chemotherapy, Coronary heart disease, Complication, Clinical trial, Epidemiology, Computer science, Linkage, Information, Recording, Surveillance, Follow up study, Database, Methodology, Cardiovascular disease
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 96-0056406
Code Inist : 002B30A08. Création : 199608.