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Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy

BACKGROUND: Suboptimal translation of valid and relevant information in clinical practice is a problem for all health systems. Lack of information independent from commercial influences, limited efforts to actively implement evidence-based information and its limited comprehensibility are important...

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Autores principales: Magrini, Nicola, Formoso, Giulio, Marata, Anna Maria, Capelli, Oreste, Maestri, Emilio, Voci, Claudio, Nonino, Francesco, Brunetti, Massimo, Paltrinieri, Barbara, Maltoni, Susanna, Magnano, Lucia, Bonacini, Maria Isabella, Daya, Lisa, Viani, Nilla
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2007
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2100051/
https://www.ncbi.nlm.nih.gov/pubmed/17903266
http://dx.doi.org/10.1186/1472-6963-7-158
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author Magrini, Nicola
Formoso, Giulio
Marata, Anna Maria
Capelli, Oreste
Maestri, Emilio
Voci, Claudio
Nonino, Francesco
Brunetti, Massimo
Paltrinieri, Barbara
Maltoni, Susanna
Magnano, Lucia
Bonacini, Maria Isabella
Daya, Lisa
Viani, Nilla
author_facet Magrini, Nicola
Formoso, Giulio
Marata, Anna Maria
Capelli, Oreste
Maestri, Emilio
Voci, Claudio
Nonino, Francesco
Brunetti, Massimo
Paltrinieri, Barbara
Maltoni, Susanna
Magnano, Lucia
Bonacini, Maria Isabella
Daya, Lisa
Viani, Nilla
author_sort Magrini, Nicola
collection PubMed
description BACKGROUND: Suboptimal translation of valid and relevant information in clinical practice is a problem for all health systems. Lack of information independent from commercial influences, limited efforts to actively implement evidence-based information and its limited comprehensibility are important determinants of this gap and may influence an excessive variability in physicians' prescriptions. This is quite noticeable in Italy, where the philosophy and methods of Evidence-Based Medicine still enjoy limited diffusion among practitioners. Academic detailing and pharmacist outreach visits are interventions of proven efficacy to make independent and evidence-based information available to physicians; this approach and its feasibility have not yet been tested on a large scale and, moreover, they have never been formally tested in Italy. METHODS/DESIGN: Two RCTs are planned: 1) a two-arm cluster RCT, carried out in Emilia-Romagna and Friuli Venezia Giulia, will evaluate the effectiveness of small group meetings, randomising about 150 Primary Care Groups (corresponding to about 2000 GPs) to pharmacist outreach visits on two different topics. Physicians' prescriptions (expressed as DDD per 1000 inhabitants/day), knowledge and attitudes (evaluated through the answers to a specific questionnaire) will be compared for target drugs in the two groups (receiving/not receiving each topic). 2) A three-arm RCT, carried out in Sardinia, will evaluate both the effectiveness of one-to-one meetings (one pharmacist visiting one physician per time) and of a 'new' information format (compared to information already available) on changing physicians' prescription of specific drugs. About 900 single GPs will be randomised into three groups: physicians receiving a visit supported by "traditional" information material, those receiving a visit with "new" information material on the same topic and those not receiving any visit/material. DISCUSSION: The two proposed RCTs aim to evaluate the organisational feasibility and barriers to the implementation of independent information programs led by NHS pharmacists. The objective to assess a 10 or 15% decreases in the prescription of the targeted drugs is quite ambitious in such 'natural' settings, which will be minimally altered by the interventions themselves; this in spite of the quite large sample sizes used comparing to other studies of these kind. Complex interventions like these are not easy to evaluate, given the many different variables into play. Anyway, the pragmatic nature of the two RCTs appears to be also one of their major strengths, helping to provide a deeper insight on what is possible to achieve – in terms of independent information – in a National Health System, with special reference to Italy. TRIAL REGISTRATION: ISRCTN05866587 (cluster RCT) and ISRCTN28525676 (single GPs RCT)
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spelling pubmed-21000512007-12-01 Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy Magrini, Nicola Formoso, Giulio Marata, Anna Maria Capelli, Oreste Maestri, Emilio Voci, Claudio Nonino, Francesco Brunetti, Massimo Paltrinieri, Barbara Maltoni, Susanna Magnano, Lucia Bonacini, Maria Isabella Daya, Lisa Viani, Nilla BMC Health Serv Res Study Protocol BACKGROUND: Suboptimal translation of valid and relevant information in clinical practice is a problem for all health systems. Lack of information independent from commercial influences, limited efforts to actively implement evidence-based information and its limited comprehensibility are important determinants of this gap and may influence an excessive variability in physicians' prescriptions. This is quite noticeable in Italy, where the philosophy and methods of Evidence-Based Medicine still enjoy limited diffusion among practitioners. Academic detailing and pharmacist outreach visits are interventions of proven efficacy to make independent and evidence-based information available to physicians; this approach and its feasibility have not yet been tested on a large scale and, moreover, they have never been formally tested in Italy. METHODS/DESIGN: Two RCTs are planned: 1) a two-arm cluster RCT, carried out in Emilia-Romagna and Friuli Venezia Giulia, will evaluate the effectiveness of small group meetings, randomising about 150 Primary Care Groups (corresponding to about 2000 GPs) to pharmacist outreach visits on two different topics. Physicians' prescriptions (expressed as DDD per 1000 inhabitants/day), knowledge and attitudes (evaluated through the answers to a specific questionnaire) will be compared for target drugs in the two groups (receiving/not receiving each topic). 2) A three-arm RCT, carried out in Sardinia, will evaluate both the effectiveness of one-to-one meetings (one pharmacist visiting one physician per time) and of a 'new' information format (compared to information already available) on changing physicians' prescription of specific drugs. About 900 single GPs will be randomised into three groups: physicians receiving a visit supported by "traditional" information material, those receiving a visit with "new" information material on the same topic and those not receiving any visit/material. DISCUSSION: The two proposed RCTs aim to evaluate the organisational feasibility and barriers to the implementation of independent information programs led by NHS pharmacists. The objective to assess a 10 or 15% decreases in the prescription of the targeted drugs is quite ambitious in such 'natural' settings, which will be minimally altered by the interventions themselves; this in spite of the quite large sample sizes used comparing to other studies of these kind. Complex interventions like these are not easy to evaluate, given the many different variables into play. Anyway, the pragmatic nature of the two RCTs appears to be also one of their major strengths, helping to provide a deeper insight on what is possible to achieve – in terms of independent information – in a National Health System, with special reference to Italy. TRIAL REGISTRATION: ISRCTN05866587 (cluster RCT) and ISRCTN28525676 (single GPs RCT) BioMed Central 2007-09-28 /pmc/articles/PMC2100051/ /pubmed/17903266 http://dx.doi.org/10.1186/1472-6963-7-158 Text en Copyright © 2007 Magrini et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( (http://creativecommons.org/licenses/by/2.0) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Magrini, Nicola
Formoso, Giulio
Marata, Anna Maria
Capelli, Oreste
Maestri, Emilio
Voci, Claudio
Nonino, Francesco
Brunetti, Massimo
Paltrinieri, Barbara
Maltoni, Susanna
Magnano, Lucia
Bonacini, Maria Isabella
Daya, Lisa
Viani, Nilla
Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy
title Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy
title_full Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy
title_fullStr Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy
title_full_unstemmed Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy
title_short Randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in General Practice in Italy
title_sort randomised controlled trials for evaluating the prescribing impact of information meetings led by pharmacists and of new information formats, in general practice in italy
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2100051/
https://www.ncbi.nlm.nih.gov/pubmed/17903266
http://dx.doi.org/10.1186/1472-6963-7-158
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