Suchergebnisse

Questo Dossier è dedicato alla presentazione del background scientifico e dei risultati del Progetto AFO (Appropriatezza farmaci oncologici) sviluppato dall'Agenzia sanitaria e sociale della Regione Emilia-Romagna nell'ambito del Programma Ricerca e innovazione (PRI E-R). Dal punto di vista del background scientifico l'elemento di originalità del progetto è stato la sperimentazione dell'uso del metodo GRADE (Grading of Recommendations Assessment, Development and Evaluation) per la produzione e graduazione di raccomandazioni cliniche relative all'effetto degli interventi sanitari. Il metodo GRADE è nato dall'attività avviata nel 2000 di un gruppo di lavoro internazionale che ha ritenuto necessario mettere a punto un approccio unificato alla produzione di raccomandazioni cliniche in presenza di una molteplicità di sistemi di grading tra loro non sempre coerenti e la cui variabilità mette in serio pericolo la fruibilità dello strumento linee guida/raccomandazioni. Dal punto di vista dei contenuti e delle modalità operative, il Progetto AFO - che ha anche ottenuto un finanziamento da parte del Ministero del Lavoro, della salute e delle politiche sociali nell'ambito del Programma Ricerca finalizzata (Fondo ex art. 12 DLgs 502/1992) - è nato con l'obiettivo di sperimentare la possibilità di coinvolgere gruppi multidisciplinari di clinici nella produzione di raccomandazioni sull'uso appropriato di farmaci oncologici, sia nuovi sia già registrati ma in evoluzione per quanto riguarda le indicazioni cliniche. Nella prima parte del Dossier, dopo una breve introduzione relativa alla filosofia del programma PRI E-R e agli scopi del progetto AFO, viene presentato il metodo GRADE, le sue assunzioni e le tappe operative di applicazione. Nella seconda parte vengono presentati i risultati del lavoro dei tre panel multisciplinari che hanno prodotto complessivamente 32 raccomandazioni per la terapia adiuvante e la fase avanzata del trattamento dei tumori della mammella, del colon retto e del polmone. Conclude la seconda parte del Dossier una discussione circa le criticità di applicazione del metodo e le potenzialità e i limiti del suo utilizzo per la produzione di strumenti utili al miglioramento dell'appropriatezza d'uso dei farmaci. Nell'Appendice viene infine riportato, a scopo esemplificativo, il testo di due raccomandazioni relative all'uso del trastuzumab nella terapia adiuvante del tumore della mammella e delle fluoropirimidine nella terapia adiuvante del tumore del colon. ; This report is devoted to the presentation of the scientific background and results of the AFO (an acronym standing for Appropriateness of Oncologic Drugs) project developed by the Health Care and Social Agency of Emilia-Romagna region in the framework of the Research and Innovation program (PRI E-R). From the methodological standpoint the novelty of the project stems from the utilisation of the GRADE method (Grading of Recommendation, Assessment, Development and Evaluation) for the production and grading of clinical recommendations on the effects of health care interventions. The GRADE method originated from the work of an international working group that, starting 2001, was convened to go beyond the variations in the existing methods for producing and grading clinical recommendations. These variations were mostly due to conceptual inconsistencies that, if not properly recognised and addressed, would jeopardise the credibility of the entire guidelines movement. From the subject matter standpoint the AFO project - which was also partially supported by a research grant from the Italian Ministry of Welfare, Health and Social Affairs - was conceived to test the feasibility of a working methodology where multidisciplinary panels of clinicians would be convened to produce clinical recommendations on newly registered drugs as well as those already in widespread use but whose indications change over time. In the first part of the report, after a brief introduction on the working hypotheses and objectives of the PRI ER program and the AFO project, the GRADE method is presented and discussed. In the second part the results of the activities of the three panels that produced a total of 32 recommendations for the adjuvant and advanced treatment of breast, colorectal and lung cancer are reported. The final session of the report addresses some open issues relative to the application of the GRADE method to the production of clinical recommendations construed with the explicit aim of improving quality and appropriateness of care in oncology. In the Appendix, two examples of the recommendations produced though this project are presented: they refer to Trastuzumab in the treatment of early breast cancer and Fluoropirimide in the adjuvant therapy of colon cancer.

Networks of no-take marine protected areas (MPAs), where all extractive activities are prohibited, are the most effective tool to directly protect marine ecosystems from destructive and unsustainable human activities. No-take MPAs and MPA networks have been globally implemented in coastal seas, and their success has been significantly enhanced where science-based biophysical guidelines have informed their design. Increasingly, as human pressure on marine ecosystems is expanding further offshore, governments are establishing offshore MPAs—some very large—or MPA networks. Globally, there are growing calls from scientists, non-government organisations, and national governments to set global conservation targets upwards of 30%. Given that most of the ocean is found either in the high seas or offshore within national Exclusive Economic Zones, large offshore MPAs or networks of MPAs must be a major component of these global targets for ocean protection. However, without adequate design, these offshore MPAs risk being placed to minimise conflict with economic interests, rather than to maximise biodiversity protection. This paper describes detailed biophysical guidelines that managers can use to design effective networks of no-take MPAs in offshore environments. We conducted a systematic review of existing biophysical design guidelines for networks of MPAs in coastal seas, and found consistent elements relating to size, shape, connectivity, timeframes, and representation of biophysical features. However, few of the guidelines are tailored to offshore environments, and few of the large offshore MPAs currently in place were designed systematically. We discuss how the common inshore design guidelines should be revised to be responsive to the characteristics of offshore ecosystems, including giving consideration of issues of scale, data availability, and uncertainty. We propose 10 biophysical guidelines that can be used to systematically design offshore networks of MPAs which will also contribute to the global goal of at ...