Farmacoepidemiologia 03/2012
Ricerca bibliografica periodo dal 2 gennaio 2012 al 15 marzo 2012
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Stringa: ((Pharmacoepidemiolog*[All] OR "Pharmacoepidemiology"[Mesh]) OR ((“epidemiologyâ€[Mesh] OR "epidemiology"[subheading]) AND ("Pharmaceutical Preparations"[Mesh]))) AND ("italy"[MeSH Terms] OR "italy"[All Fields] OR ital*[Title/Abstract] OR ita*[Language] OR ital*[ad]) AND ("2012/01/02"[PDat] : "2012/03/15"[PDat])
1. Gülmez SE, Lignot-Maleyran S, Devries CS, Sturkenboom M, Micon S, Hamoud F, Blin P, Moore N. Administrative complexities for a European observational study despite directives harmonising requirements. Pharmacoepidemiol Drug Saf. 2012 Feb 16. doi: 10.1002/pds.3204. [Epub ahead of print]
Départment de Pharmacologie, Université de Bordeaux, INSERM CIC-P0005, Bordeaux, France.
Comment in "Ann Thorac Surg. 2011 Nov;92(5):1557-8"
Abstract
PURPOSE: For pharmacoepidemiological studies in Europe, accessing data should require only authorisation by the relevant data protections committees, as expected from the 1995 Data Protection Directive (95/46/EC). Our experience from a multinational observational study across seven European countries shows that this is certainly not the case.
METHODS: The study was a multicentre,multinational, case-population study in European liver transplant centres in seven countries, retrospectively evaluating a 3-year period. Before data collection started, the procedures to obtain the necessary authorisations for the participating countries were defined.
REMARKS: In France, a single opinion from a single data protection committee was enough to start the study. In Italy, Portugal, Greece and the UK, there was a national authority, but the hospitals requested the approval by their local committees/bodies irrespective of whether the authorisation of the national committee came after or before that of local ones. In Ireland, only one hospital participated, and the opinion of its ethics committee was sufficient. In the Netherlands, the opinion of the institutional review board of the local coordinating centre was necessary to obtain the opinions from the institutional review boards of the other hospitals. The information requested by the different committees and the time to obtain the approvals varied, even within the same country.
CONCLUSION: This degree of complexity and disharmony, and resulting cost, was observed in a simple retrospective study. Regulators will need to be aware that these time-consuming, expensive and useless complexities must be factored in when estimating the time and cost of a study.
Comment in "Ann Thorac Surg. 2011 Nov;92(5):1557-8"
Abstract
PURPOSE: For pharmacoepidemiological studies in Europe, accessing data should require only authorisation by the relevant data protections committees, as expected from the 1995 Data Protection Directive (95/46/EC). Our experience from a multinational observational study across seven European countries shows that this is certainly not the case.
METHODS: The study was a multicentre,multinational, case-population study in European liver transplant centres in seven countries, retrospectively evaluating a 3-year period. Before data collection started, the procedures to obtain the necessary authorisations for the participating countries were defined.
REMARKS: In France, a single opinion from a single data protection committee was enough to start the study. In Italy, Portugal, Greece and the UK, there was a national authority, but the hospitals requested the approval by their local committees/bodies irrespective of whether the authorisation of the national committee came after or before that of local ones. In Ireland, only one hospital participated, and the opinion of its ethics committee was sufficient. In the Netherlands, the opinion of the institutional review board of the local coordinating centre was necessary to obtain the opinions from the institutional review boards of the other hospitals. The information requested by the different committees and the time to obtain the approvals varied, even within the same country.
CONCLUSION: This degree of complexity and disharmony, and resulting cost, was observed in a simple retrospective study. Regulators will need to be aware that these time-consuming, expensive and useless complexities must be factored in when estimating the time and cost of a study.
2. Macchia A, Romero M, D'Ettorre A, Mariani J, Tognoni G. Temporal trends of the gaps in post-myocardial infarction secondary prevention strategies of co-morbid and elderly populations vs. younger counterparts: an analysis of three successive cohorts between 2003 and 2008. Eur Heart J. 2012 Feb;33(4):515-22. Epub 2011 Nov 16.
Laboratory of Pharmacoepidemiology, Consorzio Mario Negri Sud, Via Nazionale 8, Santa Maria Imbaro (CH), Italy. macchia@negrisud.it
Abstract
Aims: Epidemiological studies reported two contrasting trends: on one hand, a significant improvement in the use of evidence-based treatments of patients discharged with a myocardial infarction (MI). On the other hand, the increasing number of elderly and co-morbid patients who are usually less treated. The aim of this study is to examine whether improvements in the treatment of MI are homogeneously distributed throughout all subgroups of patients. .
Methods and results: Based on record linkage of administrative registers, 21 423 patients discharged with MI in three different periods (2003, 2005, and 2007), were identified and followed up for major clinical events up to 1 year. Using as a reference temporal category those patients discharged in 2003 (odds ratios, 95% confidence intervals) and as a demographic category male patients aged ≤75 years (1.00), the study identified: in-hospital mortality significantly decreased in all periods and in all groups of patients; out-of-hospital mortality decreased only in younger patients and not in older patients; prescription of evidence-based treatments increased in all periods for all patients; however, the magnitude of improvement was mostly concentrated in younger patients.
Conclusion:Although there was a mean improvement in the treatment and outcome of patients discharged from an MI, most of these benefits were strongly concentrated in younger, healthier patients. Old and co-morbid populations-although representing a substantial proportion of the burden of disease-received significant less attention and barely improved their survival.
Abstract
Aims: Epidemiological studies reported two contrasting trends: on one hand, a significant improvement in the use of evidence-based treatments of patients discharged with a myocardial infarction (MI). On the other hand, the increasing number of elderly and co-morbid patients who are usually less treated. The aim of this study is to examine whether improvements in the treatment of MI are homogeneously distributed throughout all subgroups of patients. .
Methods and results: Based on record linkage of administrative registers, 21 423 patients discharged with MI in three different periods (2003, 2005, and 2007), were identified and followed up for major clinical events up to 1 year. Using as a reference temporal category those patients discharged in 2003 (odds ratios, 95% confidence intervals) and as a demographic category male patients aged ≤75 years (1.00), the study identified: in-hospital mortality significantly decreased in all periods and in all groups of patients; out-of-hospital mortality decreased only in younger patients and not in older patients; prescription of evidence-based treatments increased in all periods for all patients; however, the magnitude of improvement was mostly concentrated in younger patients.
Conclusion:Although there was a mean improvement in the treatment and outcome of patients discharged from an MI, most of these benefits were strongly concentrated in younger, healthier patients. Old and co-morbid populations-although representing a substantial proportion of the burden of disease-received significant less attention and barely improved their survival.
Commento a cura di Giuseppe Traversa
Numerosi studi hanno dimostrato che l’applicazione di terapie evidence based in pazienti dimessi dopo infarto del miocardio (IMA) sia in grado di ridurre l’insorgenza di nuovi eventi cardiovascolari e di migliorare la sopravvivenza. Vi sono anche studi che dimostrano che nel tempo aumenti la proporzione di pazienti dimessi dopo IMA che riceve le terapie appropriate. Si sa molto meno, invece, se il miglioramento sia omogeneo nei diversi sottogruppi di pazienti e, in particolare, se i pazienti più anziani e con comorbosità ricevano o meno la stessa attenzione dei pazienti più giovani. Nell’articolo, Macchia e collaboratori hanno studiato gli esiti in 21.423 pazienti dimessi dopo IMA negli anni 2003, 20005 e 2007. Nel follow up di un anno dopo la dimissione gli autori documentano non solo che la riduzione di mortalità si verifichi solo fra pazienti più giovani, ma che su questo gruppo si concentri anche il miglioramento nel tempo di utilizzo dei trattamenti appropriati. Sebbene si tratti di un fenomeno in parte atteso, questo articolo richiama ancora una volta la necessità che vi siano interventi attivi di presa in carico dei pazienti, allo scopo di assicurare che le terapie di dimostrata efficacia siano in effetti disponibili per tutti coloro che ne possono potenzialmente beneficiare.
3. Corsonello A, Lattanzio F, Pedone C, Garasto S, Laino I, Bustacchini S, Pranno L, Mazzei B, Passarino G, Incalzi On Behalf Of The Pharmacosurveillance In The Elderly Care Pvc Study Investigators RA Prognostic significance of the short physical performance battery in older patients discharged from acute care hospitals. Rejuvenation Res. 2012 Feb;15(1):41-8. Epub 2011 Oct 17.
Unit of Geriatric Pharmacoepidemiology, Research Hospital of Cosenza , Italian National Research Centre on Aging (INRCA), Cosenza, Italy .
Abstract
We investigated the prognostic role of the Short Physical Performance Battery (SPPB) in elderly patients discharged from the acute care hospital. Our series consisted of 506 patients aged 70 years or more enrolled in a multicenter collaborative observational study. We considered three main outcomes: 1-year survival after discharge, functional decline, and hospitalization during follow-up. Independent predictors/correlates of the outcomes were investigated by Cox regression or logistic regression analysis when appropriate. The diagnostic accuracy of SPPB in relation to study outcomes was investigated by receiver operating characteristic (ROC) curve. SPPB score was associated with reduced mortality (hazard ratio [HR]=0.86, 95% confidence interval [CI] 0.78-0.95). When the analysis was adjusted for functional status at discharge, such an association was still near significant only for SPPB values >8 (HR=0.51; 95% CI 0.30-1.05). An SPPB score<5 could identify patients who died during follow-up with fair sensitivity (0.66), specificity (0.62), and area under the ROC curve (0.66). SPPB also qualified as independent correlate of functional decline (odds ratio [OR]=0.82; 95% CI 0.70-0.96), but not of rehospitalization or combined end-point death or rehospitalization. An SPPB score <5 could identify patients experiencing functional decline during follow-up with lower sensitivity (0.60), but higher specificity (0.69), and area under the ROC curve (0.69) with respect to mortality. In conclusion, SPPB can be considered a valid instrument to identify patients at major risk of functional decline and death after discharge from acute care hospital. However, it could more efficiently target patients at risk of functional decline than those at risk of death.
Abstract
We investigated the prognostic role of the Short Physical Performance Battery (SPPB) in elderly patients discharged from the acute care hospital. Our series consisted of 506 patients aged 70 years or more enrolled in a multicenter collaborative observational study. We considered three main outcomes: 1-year survival after discharge, functional decline, and hospitalization during follow-up. Independent predictors/correlates of the outcomes were investigated by Cox regression or logistic regression analysis when appropriate. The diagnostic accuracy of SPPB in relation to study outcomes was investigated by receiver operating characteristic (ROC) curve. SPPB score was associated with reduced mortality (hazard ratio [HR]=0.86, 95% confidence interval [CI] 0.78-0.95). When the analysis was adjusted for functional status at discharge, such an association was still near significant only for SPPB values >8 (HR=0.51; 95% CI 0.30-1.05). An SPPB score<5 could identify patients who died during follow-up with fair sensitivity (0.66), specificity (0.62), and area under the ROC curve (0.66). SPPB also qualified as independent correlate of functional decline (odds ratio [OR]=0.82; 95% CI 0.70-0.96), but not of rehospitalization or combined end-point death or rehospitalization. An SPPB score <5 could identify patients experiencing functional decline during follow-up with lower sensitivity (0.60), but higher specificity (0.69), and area under the ROC curve (0.69) with respect to mortality. In conclusion, SPPB can be considered a valid instrument to identify patients at major risk of functional decline and death after discharge from acute care hospital. However, it could more efficiently target patients at risk of functional decline than those at risk of death.
4. Napoleone E, Radice S. From pharmacovigilance to therapy amelioration in paediatric patients: the role of the clinical pharmacologists and family paediatricians. Part of a series on Paediatric Pharmacology, guest edited by Gianvincenzo Zuccotti, Emilio Clementi, and Massimo Molteni. Pharmacol Res. 2012 Feb;65(2):168-70. Epub 2011 Sep 10.
Italian Paediatric Federation and FIMP-MCRN (Family Paediatricians-Medicines for Children Research Network), Rome, Italy.
Abstract
An active pharmacovigilance approach is advisable in paediatric pharmacotherapy as it contributes to generate knowledge promptly and to enhance the estimation of true risk in clinical practice. Reports and studies from the scientific community and regulatory agencies have shown that effective methods for early detection of adverse drug reaction and pharmacoepidemiological studies are a primary need since they increase drug safety in the paediatric population. In this perspective article we describe how pharmacologists and paediatricians may actively synergise to optimise drug therapies and their management in paediatric patients.
Abstract
An active pharmacovigilance approach is advisable in paediatric pharmacotherapy as it contributes to generate knowledge promptly and to enhance the estimation of true risk in clinical practice. Reports and studies from the scientific community and regulatory agencies have shown that effective methods for early detection of adverse drug reaction and pharmacoepidemiological studies are a primary need since they increase drug safety in the paediatric population. In this perspective article we describe how pharmacologists and paediatricians may actively synergise to optimise drug therapies and their management in paediatric patients.