ABSTRACT
BACKGROUND: Patient safety within healthcare systems is a central aspect of health policy in most developed countries. From April 2007 to May 2009, the pilot project ExpIR-RO tested a voluntary incident reporting system in a public hospital in Bucharest Romania, in collaboration with two Italian hospitals (in Genoa and Milan). METHODS: Data were collected anonymously through a form based on the Australian Incident Monitoring System. After appropriate training in reporting adverse events (AEs), staff in the participating Departments voluntarily completed the form. The study lasted 12 months in the Bucharest and Genoa hospitals and 3 months in the Milan hospital. Frequency distributions of replies and AE rates per 1,000 hospitalization days per month were assessed. RESULTS: Overall, 185 AEs were reported (58 in Bucharest, 75 in Genoa and 52 in Milan). The corresponding rates (per 1,000 hospitalization days per month) were 1 in Bucharest, 3 in Genoa and 15 in Milan. Most AEs were related to diagnostic (28%) and surgical (14%) procedures and patient falls (12%) in Bucharest; patient falls (32%), nursing care (20%) and diagnostic procedures (19%) in Genoa; and nursing care (25%), drug prescription/administration (21%) and diagnostic procedures (17%) in Milan. Seventy-three per cent of respondents in Bucharest informed the patient of the AE, versus 64% in Genoa and 43% in Milan. Conversely, 75% of respondents in Genoa entered AEs in medical records versus 53% in Bucharest and 36% in Milan. CONCLUSION: ExpIR-RO experience suggests that incident reporting could be introduced on a larger scale in Romania.
ABSTRACT
OBJECTIVE: To assess the role of IgM antibodies to hepatitis C virus core protein (anti-HCV IgM) as a marker of chronic HCV infection and as a predictor of successful interferon (IFN) treatment. DESIGN: Anti-HCV IgM levels were evaluated at baseline, during IFN therapy and during a follow-up period. METHODS: Anti-HCV IgM levels were evaluated in 62 patients (47 men and 15 women, aged 25-65 years) with biopsy-proven chronic active hepatitis C. Fifty-one of the patients received alpha-IFN 3 MU three times a week for 6 months and 11 received the same therapy for 12 months. Twenty patients showed a long-term response; fourteen responded but subsequently suffered a relapse; twenty-eight did not respond to the treatment. Follow-up in all patients lasted for at least 6 (mean +/- SD 9.8 +/- 5.4, range 6-29) months after the end of the therapy. RESULTS: Anti-HCV IgM were detected in 35 patients (56.4%) at baseline; no significant differences were observed between the three groups studied. Almost all members of the groups showing a relapse or no response remained positive at the end of therapy and follow-up. In contrast, we observed a progressive disappearance of anti-HCV IgM in patients responsive to interferon therapy over the long term. CONCLUSION: The loss of anti-HCV IgM positivity in patients positive at baseline can predict the long-term response to IFN therapy.
