Vilanova-Bolto, M. (M.)

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2011 - 20122

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    Caracterización y variabilidad de los informes de evaluación de medicamentos en la página web del grupo GENESIS de la SEFH
    (Elsevier, 2011) Ortega-Eslava, A. (Ana); Puigventos, F. (Francesc); Santos-Ramos, B. (B.); Calderon-Hernaz, B. (B.); Vilanova-Bolto, M. (M.)
    To analyse the assessment reports published on the GENESIS webpage (Group for Innovation, Assessment, Standardisation and Research in the Selection of Drugs) and assess the variability of the group's proposals to include drugs in the Formulary. METHOD: We analysed reports published by hospitals on the GENESIS webpage between 2004 and 2007. Data were collected on drugs and indications, ATC group, open or restricted access publications, hospital, and publication date. We drafted a questionnaire that would measure to what extent to what extent the 9-section model recommended by GENESIS was included in each report. For drugs with two or more reports, we analysed whether the recommendation coincided and the possible cause in the event of conflict. RESULTS: We analysed 416 reports corresponding to 185 different drug indications. 93% included 6 or more of the recommended sections, a number which increased over time. The most frequently included sections were: approved indications (92%), mechanism of action (95%), and references (86%) (percentages from 2007). Sections which had an increasing but lower percentage were: differential characteristics (60%), literature search method (40%) and conclusions with a summary of efficacy, safety and cost data (52%). 73% of which had definite recommendations, which coincided for 42 out of the 67 drugs with more than one recommendation report. CONCLUSIONS: The work carried out by the GENESIS group has enabled Spanish hospitals to share their drug assessment reports and making them more complete, although there are still some aspects that can be improved.
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    Comparaciones indirectas en los informes de evaluación de medicamentos en la web del grupo GENESIS de la SEFH
    (Elsevier, 2012) Ortega-Eslava, A. (Ana); Puigventos, F. (Francesc); Clopes-Estela, A. (A.); Fraga-Fuentes, M.D. (M.D.); Santos-Ramos, B. (B.); Vilanova-Bolto, M. (M.)
    An active comparator was present in 95% of the 337 analysed reports; 50% included a direct comparative study vs comparator. In 114 reports (34%), an IC was used; 69% of the ICs were made by the report author. Most ICs were narrative and none were adjusted. An IC could have been made in an additional 16% of the cases and possibly in 24% more. Conclusions: Most evaluated drugs have an active comparator but studies comparing them directly are not as common. ICs could be included in more reports along with quality control criteria. © 2011 SEFH. Published