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Castel Guelfo di Bologna, Italy

Caricati L.,University of Parma | Mancini T.,University of Parma | Bianconcini M.,Azienda USL of Bologna | Guidi C.,Azienda Ospedaliero Universitaria of Ferrara | And 4 more authors.
Acta Biomedica | Year: 2014

Background and aim of the work: Works from healthcare management and organizational psychology prove that psychosocial variables linked to professional identity are strongly associated with nurse-physician collaborative practice. However, literature pays little attention to the role of these variables. Moreover, evidence for the relation between collaborative practice on psychosocial variables for physicians is rather sparse. The purpose of this study was to investigate the relationship among self-efficacy, team commitment, professional commitment, and collaborative practice in both nurses and physicians. Methods: A cross-sectional survey was adopted and questionnaire was distributed to 269 nurses and 124 physicians working in different hospitals. Results: The perception of collaborative practice enhanced the self-efficacy and team commitment of both professionals. For nurses, professional commitment and self-efficacy positively predicted a willingness to collaborate; for physicians, professional commitment hindered a willingness to collaborate, while selfefficacy had no effect. Conclusions: The study indicates that collaborative practice is an important contextual resource bolstering self-efficacy and team commitment in both professional groups. However, strong professional commitment hinders the willingness of physicians to collaborate with nurses in a way that recognizes the autonomy of nurses. © Mattioli 1885.

Iudicello A.,Azienda USL of Modena | Alberghini L.,Azienda USL of Bologna | Benini G.,Azienda USL of Bologna | Mosconi P.,Istituto di Ricerche Farmacologiche Mario Negri
Trials | Year: 2016

Therapeutic use of an unauthorised drug (or of an authorised drug for an unauthorised indication) for patients with a life-threating disease is permitted outside a clinical trial as an Expanded Access Programme (EAP). The regulations regarding EAPs is not the same all over the world. For example, the recommendation of the European Medicines Agency (EMA) in EU countries also includes within EAPs patients who have been treated in a clinical trial and who wish to continue the treatment. Nevertheless, the patients treated in a clinical trial could have the option of continuing treatment for an extended period in an Open-label Extension study, aimed to generate long-term data on efficacy, safety, tolerability and administration. The aims of this paper - based on the difficulties and incoherence encountered by an Italian Ethic Committee (EC) during the authorisation process of EAPs - are: understanding the origin of this misclassification by analysing differences and similarities among USA, European and Italian regulations concerning EAPs; and showing difficulties in classifying international study protocols as a consequence of the lack of harmonisation of definitions. We performed a critical review of the current USA, European and Italian regulations and we analysed some practical cases by retrieving protocols from Clinicaltrials.gov and the Italian Clinical Trials Registry (OsSC) containing in the title the keywords 'Expanded Access Programme', "'Expanded Access', 'Open-label Extension study' or 'Early Access'. We observed that the Food and Drug Administration ( FDA) definition of EAP is very clear while the EMA definition is similar to that of an Open-label Extension study. This lack of a clear definition generates misclassification and it is possible to find an EAP with an efficacy or safety endpoint; or an EAP managed as a clinical trial; or an EAP classified in Clinical Trials Registries as a phase II, III or IV clinical trial. The internationalisation of the studies requires a harmonisation on a global level of legislation and definitions to eliminate misclassification of protocols. For this reason, the authors suggest that: a) the EMA definition should be harmonised with the FDA definition of EAPs, b) European regulation, even if optional, should be adopted in a compulsory way by national regulations. Moreover, separate registries for both EAPs and clinical trials should be organised. © 2016 Iudicello et al.

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