Patient Safety and Surgery: the Experience of the Lombardy Region. A Project on External Evaluation of Best Practices Implementation.

Meta-analysis studies published over the past 20 years document that approximately 10 -14 % of hospitalised patients have an adverse event in Surgery and at least half of these adverse events are considered preventable using the current standards of care. In order to improve the safety of surgical patients and increasing adherence to current standard of care in surgery, including communication within the team and teamwork, in 2007 the WHO launched the campaign "Safe Surgery Saves Lives". The WHO has also built a checklist for safety in the operating room containing 19 item in support of the operating team. The Ministry of Health in 2009 has taken the instruments produced by WHO in the "Guide to Safety in the operating room: Recommendations and Checklist". Studies conducted in industrialized countries report a strong heterogeneity in compliance to the check list for the surgical safety, with a range of between 38% and 96%. The aim of this project was to adopt the methodology of the external "peer review" to improve quality and patient safety applied to the surgical process and assess the degree of implementation of good practice in the operating room, both in public and private structures. Between 2015 and 2018 we have carried out 16 external evaluation visits. These visits included a first plenary session followed by the inspection of the operating theaters identified and a second plenary session. Several factors emerged during the visits; these factors represent both the strengths and criticalities of the organizations. The creation of a team of experts, coordinated by the Lombardy Region with the role of leadership, using the "peer review" methodology, is the leverage to promote among operators the growth of awareness of the usefulness of the tools.

Scaleable manufacture of HIV-1 entry inhibitor griffithsin and validation of its safety and efficacy as a topical microbicide component.

To prevent sexually transmitted HIV, the most desirable active ingredients of microbicides are antiretrovirals (ARVs) that directly target viral entry and avert infection at mucosal surfaces. However, most promising ARV entry inhibitors are biologicals, which are costly to manufacture and deliver to resource-poor areas where effective microbicides are urgently needed. Here, we report a manufacturing breakthrough for griffithsin (GRFT), one of the most potent HIV entry inhibitors. This red algal protein was produced in multigram quantities after extraction from Nicotiana benthamiana plants transduced with a tobacco mosaic virus vector expressing GRFT. Plant-produced GRFT (GRFT-P) was shown as active against HIV at picomolar concentrations, directly virucidal via binding to HIV envelope glycoproteins, and capable of blocking cell-to-cell HIV transmission. GRFT-P has broad-spectrum activity against HIV clades A, B, and C, with utility as a microbicide component for HIV prevention in established epidemics in sub-Saharan Africa, South Asia, China, and the industrialized West. Cognizant of the imperative that microbicides not induce epithelial damage or inflammatory responses, we also show that GRFT-P is nonirritating and noninflammatory in human cervical explants and in vivo in the rabbit vaginal irritation model. Moreover, GRFT-P is potently active in preventing infection of cervical explants by HIV-1 and has no mitogenic activity on cultured human lymphocytes.

Bioaccessibility and antioxidant activity stability of phenolic compounds from extra-virgin olive oils during in vitro digestion.

The impact of an in vitro procedure that mimics the physiochemical changes occurring in gastric and small intestinal digestion on the bioaccessibility and antioxidant activity of phenols from 10 extra-virgin olive oil samples was assessed. Extra-virgin olive oil phenols were totally extracted in the aqueous phase, which reproduces gastric fluids during the digestion procedure. A linear bioaccessibility model, based on tyrosol behavior in model oil samples, was used to estimate the bioaccessibility index (BI%) of extra-virgin olive oil phenols. The BI% varied amongst samples from a maximum of 90% to a minimum of 37%, thus indicating that only a fraction of phenols can be considered bioaccessible. The specific antioxidant activity of olive oil phenols proved to be negatively affected by the digestion procedure. By computing a principal component analysis, it was possible to show that differences in the potential bioactive effect of extra-virgin olive oil samples were related to different phenolic profiles.