Workshop and TelephoneBased Interventions to Imp

Authors: Maria Teresa Herdeiro Inês RibeiroVaz Mónica Ferreira Jorge Polónia Amílcar Falcão Adolfo Figueiras

Publish Date: 2012/12/13

Volume: 35, Issue: 8, Pages: 655-665

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Abstract

Methods A clusterrandomized controlled trial was conducted on 6579 physicians in northern Portugal in 2008 Following randomization we allocated 1034 physicians to a telephoneinterview intervention 438 to a workshop intervention and the remaining 5107 to the control group At the workshop a real clinical case was presented and participants were then asked to report on it by completing the relevant form In the telephone intervention participants were asked i whether they had ever had any suspicion of ADRs ii whether they had experienced any difficulties in reporting iii whether they remembered the different methods that could be used for reporting purposes and iv whether they attached importance to the individual physician’s role in reporting We followed up physicians to assess ADR reporting rates to the Northern Pharmacovigilance Centre In terms of relevance adverse reactions were classified as serious or unexpected Statistical analysis was performed on an intentiontotreat basis and generalized linear mixed models were applied using the penalized quasilikelihood method The physicians studied were followed up over a period of 20 monthsResults Two hundred physicians underwent the educational intervention Comparison with the control group showed that the workshop intervention increased the spontaneous ADR reporting rate by an average of 4fold relative risk RR 397 95 CI 386 408 p 0001 across the 20 months postintervention Telephone interviews in contrast proved less efficient since they led to no significant difference p = 0052 visàvis the control group in ADR reporting RR 102 95 CI 100 104 The effects of the interventions on the reporting rate of serious and highcausality ADRs indicated that the RRs associated with workshops were 684 95 CI 669 698 p0001 for serious ADRs and 358 95 CI 351 366 p0001 for highcausality ADRsThe authors wish to express their sincere thanks to the following Professor Altamiro da Costa Pereira for his invaluable help in developing this study Professor Adolfo Figueiras whose work on this project was funded by the Consortium for Biomedical Research in Epidemiology and Public Health CIBER en Epidemiología y Salud Pública CIBERESPAC08 008 María Piñeiro CIBERESP who contributed greatly to the statistical analysis and Professor Maria Teresa Herdeiro whose work on this project was funded in part by Science and Technology Fund Fundação para a Ciência e Tecnologia grant SFRH/BPD/35746/2007 from the Portuguese Ministry of Science Technology and Higher Education

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