Patient safety implications of wearing a face mask for prevention in the era of COVID-19 pandemic: a systematic review and consensus recommendations.

In the past, the use of face masks in western countries was essentially limited to occupational health. Now, because of the COVID-19 pandemic, mask-wearing has been recommended as a public health intervention. As potential side effects and some contraindications are emerging, we reviewed the literature to assess the impact of them in daily life on patient safety and to provide appropriate guidelines and recommendations. We performed a systematic review of studies investigating physiological impact, safety, and risk of masks in predefined categories of patients, which have been published in peer-reviewed journals with no time and language restrictions. Given the heterogeneity of studies, results were analyzed thematically. We used PRISMA guidelines to report our findings. Wearing a N95 respirator is more associated with worse side effects than wearing a surgical mask with the following complications: breathing difficulties (reduced FiO2, SpO2, PaO2 increased ETCO2, PaCO2), psychiatric symptoms (panic attacks, anxiety) and skin reactions. These complications are related to the duration of use and/or disease severity. Difficulties in communication is another issue to be considered especially with young children, older person and people with hearing impairments. Even if benefits of wearing face masks exceed the discomfort, it is recommended to take an "air break" after 1-2 h consecutively of mask-wearing. However, well-designed prospective studies are needed. The COVID-19 pandemic could represent a unique opportunity for collecting large amount of real-world data.

Careggi Re-Engineered Discharge project: standardize discharge and improve care coordination between healthcare professionals.

BACKGROUND: The hospital discharge process plays a key role in patient care. Careggi Re-Engineered Discharge (CaRED) aimed at establishing a meaningful relationship among general practitioners (GPs) and patients, throughout the discharge process. OBJECTIVE: The aim is to describe the activities and results in the period 2014-17 of the CaRED. METHODS: CaRED is a restructured discharge protocol, which foresees a different, more direct form of communication between hospital and GPs, enabled by an ad hoc electronic medical record. The 30-day hospital readmission rate and/or accesses to the emergency department were evaluated as proxy for effective communication. A pre-post survey was launched to assess the GPs' perceived quality, and patient and family satisfaction. RESULTS: A total of 1549 hospitalizations were included, respectively, 717 in the pre and 832 in the post-intervention period. The 30-day hospital readmission rate decreased significantly in the post-intervention period (14.4% vs. 19.4%, χ2(1) = 8.03, P < 0.05).Eighty-two and 52 GPs participated, respectively, in the pre- and post-survey. In the post-phase the percentage of GPs declaring the discharge letter facilitated the communication on the admission causes (χ2(1) = 0.56, P = 0.03) and on what to do if conditions change (χ2(31) = 19.0, P < 0.01) significantly increased, as well as the perception of an easier contact with the hospitalist (χ2(3) = 19.6, P < 0.01).Two-hundred-eighty and 282 patients were enrolled in the pre- and post-survey. The level of understanding of key parts of the discharge letter (reason for hospitalization, post-discharge therapy, follow-up examinations and how to contact the hospital ward) improved significantly (P < 0.01). CONCLUSIONS: CaRED significantly improved the discharge process and became a benchmark for local improvements in communication patterns with GPs.

Looking for the right balance between human and economic costs during COVID-19 outbreak.

Since the beginning of Coronavirus 2019 (COVID-19) disease outbreak, there has been a heated debate about public health measures, as they can presumably reduce human costs in the short term but can negatively impact economies and well-being over a longer period. MATERIALS AND METHODS: To study the relationship between health and economic impact of COVID-19, we conducted a secondary research on Italian regions, combining official data (mortality due to COVID-19 and contractions in value added of production for a month of lockdown). Then, we added the tertiles of the number of people tested for COVID-19 and those of health aids to evaluate the correspondence with the outcome measures. RESULTS: Five regions out of 20, the most industrialized northern regions, which were affected both earlier and more severely by the outbreak, registered both mortality and economic value loss above the overall medians. The southern regions, which were affected later and less severely, had low mortality and less economic impact. CONCLUSIONS: Our analysis shows that considering health and economic outcomes in the assessment of response to pandemics offers a bigger picture perspective of the outbreak and could allow policymakers and health managers to choose systemic, 'personalized' strategies, in case of a feared second epidemic wave.

HFE at the frontiers of COVID-19. Human factors/ergonomics to support the communication for safer care in Italy during the COVID-19 pandemic.

Italy was the first country after China to be affected by COVID-19. The wave of the emergency found our country unprepared to cope with the surge of patients going to first aid departments to seek assistance in the almost complete paralysis of community health. Human factors and ergonomics (HFE) can effectively contribute to, and improve the effectiveness of, a pandemic response working on several key areas: training, adapting workflows and processes, restructuring teams and tasks, effective mechanisms and tools for communication, engaging patients and families and learning from failures and successes. In Italy, HFE expertise has been able to provide our healthcare systems with some easy-to-realize solutions (particularly dedicated to improving communication, team work and situational awareness) in order to cope with the need for rapid adaptations to new and unknown scenarios: ensuring information and communication continuity in the different levels of the healthcare system; identifying hazard opportunity through risk management tool; providing training through simulation; organizing regular briefing and debriefing; enhancing the reporting and learning system as an informal way of communicating adverse events and supporting information campaign and education initiatives for the public.

International survey of COVID-19 management strategies.

BACKGROUND: While individual countries have gained considerable knowledge and experience in coronavirus disease of 2019 (COVID-19) management, an international, comparative perspective is lacking, particularly regarding the measures taken by different countries to tackle the pandemic. This paper elicits the views of health system staff, tapping into their personal expertise on how the pandemic was initially handled. METHODS: From May to July 2020, we conducted a cross-sectional, online, purpose-designed survey comprising 70 items. Email lists of contacts provided by the International Society for Quality in Health Care, the Italian Network for Safety in Health Care and the Australian Institute of Health Innovation were used to access healthcare professionals and managers across the world. We snowballed the survey to individuals and groups connected to these organizations. Key outcome measures were attitudes and information about institutional approaches taken; media communication; how acute hospitals were re-organized; primary health organization; personal protective equipment; and staffing and training. RESULTS: A total of 1131 survey participants from 97 countries across the World Health Organization (WHO) regions responded to the survey. Responses were from all six WHO regions; 57.9% were female and the majority had 10 or more years of experience in healthcare; almost half (46.5%) were physicians; and all other major clinical professional groups participated. As the pandemic progressed, most countries established an emergency task force, developed communication channels to citizens, organized health services to cope and put in place appropriate measures (e.g. pathways for COVID-19 patients, and testing, screening and tracing procedures). Some countries did this better than others. We found several significant differences between the WHO regions in how they are tackling the pandemic. For instance, while overall most respondents (71.4%) believed that there was an effective plan prior to the outbreak, this was only the case for 31.9% of respondents from the Pan American Health Organization compared with 90.7% of respondents from the South-East Asia Region (SEARO). Issues with swab testing (e.g. delay in communicating the swab outcome) were less frequently reported by respondents from SEARO and the Western Pacific Region compared with other regions. CONCLUSION: The world has progressed in its knowledge and sophistication in tackling the pandemic after early and often substantial obstacles were encountered. Most WHO regions have or are in the process of responding well, although some countries have not yet instituted widespread measures known to support mitigation, for example, effective swab testing and social control measures.

Human factors and ergonomics at time of crises: the Italian experience coping with COVID-19.

Several of the key organizational issues that we have had to face with the emergence of COVID-19 crisis are related to human factors/ergonomics (HFE) and the safety culture. During the crisis the main activities of the healthcare services have been profoundly affected. Patient safety and risk management units have also experienced the need to adapt rapidly. What can we do as HFE experts, now that the scenario has completely changed? We contend that: (a) we can favour and support the heuristics that are applied to manage the load of psycho-cognitive stress. (b) We can observe, collect strategies and develop analytic schemes, thereby creating a memory of the organization for improvement in the future. (c) And we can support in educating and engaging the public. This crisis has forced the community of healthcare experts to broaden their reflections: for the future to come, our communities of experts in the field of risk management HF/E, quality and safety of care and public health should play together an important role from the very beginning, from the time of peace.

New Rules on Patient's Safety and Professional Liability for the Italian Health Service.

BACKGROUND: The phenomenon of clinical negligence claims has rapidly spread to United States, Canada and Europe assuming the dimensions and the severity of a pandemia. Consequently, the issues related to medical malpractice need to be studied from a transnational perspective since they raise similar problems in different legal systems. METHODS: Over the last two decades, medical liability has become a prominent issue in healthcare policy and a major concern for healthcare economics in Italy. The failures of the liability system and the high cost of healthcare have led to considerable legislative activity concerning medical malpractice liability, and a law was enacted in 2012 (Law no. 189/2012), known as the "Balduzzi Law". RESULTS: The law tackles the mounting concern over litigation related to medical malpractice and calls for Italian physicians to follow guidelines. Briefly, the law provided for the decriminalisation of simple negligence of a physician on condition that he/she followed the guidelines and "good medical practice" while carrying out his/her duties, whilst the obligation for compensation, as defined by the Italian Civil Code, remained. Judges had to consider that the physician followed the provisions of the guidelines but nevertheless caused injury to the patient. CONCLUSION: However, since the emission of the law, thorny questions remain which have attracted renewed interest and criticism both in the Italian courts and legal literature. Since then, several bills have been presented on the topic and these have been merged into a single text entitled "Regulations for healthcare and patient safety and for the professional responsibility of healthcare providers".

Safety and quality in maternal and neonatal care: the introduction of the modified WHO Safe Childbirth Checklist.

Maternal and neonatal mortality and morbidity associated with childbirth is a problem of the highest priority. This research has been aimed at testing a modified version of the WHO Safe Childbirth Checklist in one Italian hospital and to evaluate the tool in terms of its impact on clinical practice and safety. Results show that the presence of correctly compiled partogram tool is strongly and significantly associated with the checklist implementation (OR = 14.9, 95% confidence interval [CI] = 3.5, 63.9). Compliance to the checklist was high for mid-wives (96%) and very low for obstetricians (3%). The discrepancy is the result of a misinterpretation by obstetricians: they signed only in case they prescribed therapy or when they identified risk factors, but not to underline that they checked for those factors independently by their existence. While the checklist promotes the interdisciplinary work, field studies generally show strong hierarchical rather than partnership interaction. Practitioner Summary: The study is aimed at evaluating: the checklist impact on clinical practice through a prospective pre- and post-intervention study based on clinical records review, the usability of the tool and the user's compliance. The research gives evidences on the importance of the tool for reducing risks related to delivery.