EFFECTIVENESS OF A REGIONAL REPORTING PROGRAM IN IMPROVING QUALITY OF ADVERSE DRUG REACTION CASE REPORTS
Notice bibliographique
Résumé
The Canadian voluntary adverse drug reaction (ADR) reporting program is an established surveillance method for monitoring drug safety, using case report data for signaling the occurrence of new or unexpected adverse drug reactions in a timely manner. In 1990, as part of improvements to the Canadian system of post-marketing drug surveillance, a pilot regional ADR reporting program (SaskADR) was developed in the province of Saskatchewan to investigate whether ADR reporting could be enhanced through decentralintion of the national program. \nDuring the first two years of SaskADR operation, there was a four-fold increase in the annual number of reports submitted by Saskatchewan practitioners to SaskADR as compared to the national program. The purpose of this research was to evaluate whether implementation of the SaskADR program not only improved the quantity of ADR reports, but also improved the quality of information documented on the ADR case reports. \nComparisons of ADR case report quality were made between 566 case reports submitted by Saskatchewan health professionals to the SaskADR program during the first two years of operation and 281 case reports submitted by Saskatchewan health professionals to the national ADR reporting program in the four years prior to implementation of SaskADR. The methodology for this research involved the development of indicators and criteria for the measurement of case report quality, which \nreflected the purpose and function of voluntary ADR reporting programs. \nImplementation of the SaskADR reporting program was associated with an improvement in the quality of ADR case report data in comparison to case reports submitted to the national program. The SaskADR program demonstrated an increased reporting of "important reactions" or reactions which are serious or unexpected, or occur with a newly marketed drug. Information useful for characterization of the reaction and assessment of drug causality were better documented in the SaskADR reports. In addition, information considered essential for the submission of a valid ADR case report was more complete on the SaskADR reports. \nImprovement in the quality of ADR information enhances the utility of the case report submissions in meeting the goals and objectives of the voluntary ADR reporting program. Demonstration of an improved quality of case reports, in combination with an increased rate of reporting, supports the development of regional ADR reporting centres as a mechanism of improving the Canadian voluntary ADR reporting program.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,001 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,001 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».