Predictive Power of Dependence and Clinical-Social Fragility Index and Risk of Fall in Hospitalized Adult Patients: A Case-Control Study.

OBJECTIVES: Accidental falls are among the leading hospitals' adverse events, with incidence ranging from 2 to 20 events per 1.000 days/patients. The objective of this study is to assess the relationship between in-hospital falls and the score of 3 DEPendence and Clinical-Social Fragility indexes. METHODS: A monocentric case-control study was conducted by retrieving data of in-hospital patients from the electronic health records. RESULTS: Significant differences between the mean scores at the hospital admission and discharge were found. The BRASS scale mean (SD) values at the admission and at the discharge were also significantly higher in cases of in-hospital falls: at the admission 10.2 (±7.7) in cases versus 7.0 (±8.0) in controls ( P = 0.003); at the discharge 10.0 (±6.4) versus 6.7 (±7.5) ( P = 0.001). Barthel index mean (SD) scores also presented statistically significant differences: at the admission 60.3 (±40.6) in cases versus 76.0 (±34.8) in controls ( P = 0.003); at discharge 51.3 (±34.9) versus 73.3 (±35.2) ( P = 0.000).Odds ratios were as follows: for Barthel index 2.37 (95% CI, 1.28-4.39; P = 0.003); for Index of Caring Complexity 1.45 (95% CI, 0.72-2.91, P = 0. 255); for BRASS index 1.95 (95% CI, 1.03-3.70, P = 0.026). With BRASS index, the area under the curve was 0.667 (95% CI, 0.595-0.740), thus indicating a moderate predictive power of the scale. CONCLUSIONS: The use of only Conley scale-despite its sensitivity and specificity-is not enough to fully address this need because of the multiple and heterogeneous factors that predispose to in-hospital falls. Therefore, the combination of multiple tools should be recommended.

Transcranial Doppler and Color-Coded Doppler Use for Brain Death Determination in Adult Patients: A Pictorial Essay.

Transcranial Doppler (TCD) is a repeatable, at-the-bedside, helpful tool for confirming cerebral circulatory arrest (CCA). Despite its variable accuracy, TCD is increasingly used during brain death determination, and it is considered among the optional ancillary tests in several countries. Among its limitations, the need for skilled operators with appropriate knowledge of typical CCA patterns and the lack of adequate acoustic bone windows for intracranial arteries assessment are critical. The purpose of this review is to describe how to evaluate cerebral circulatory arrest in the intensive care unit with TCD and transcranial duplex color-coded doppler (TCCD).

Co-administration of SARS-CoV-2 and influenza vaccines in healthcare workers: Results of two vaccination campaigns in a large teaching hospital in Rome.

The concurrent administration of COVID-19 and influenza vaccines has arisen as a promising approach to bolster protection against respiratory pathogens and improve vaccination rates. However, there remains a lack of data regarding the prevalence of co-administration across several vaccination campaigns, especially among healthcare workers (HCWs). Therefore, this study aims to shed light on the acceptance of co-administration strategies among HCWs during the two campaigns following the introduction of the anti-SARS-CoV-2 vaccine. A retrospective cohort study was conducted among the HCWs of the Fondazione Policlinico Universitario "A. Gemelli" IRCCS, a research hospital in Rome. Hospital administrative databases were accessed to gather information about vaccination for SARS-CoV-2 and influenza during the 2021/2022 and 2022/2023 vaccination campaigns. The study included 7399 HCWs. The co-administration of anti-SARS-CoV-2 and influenza vaccines presented a significant rise in 2022/2023 compared to the previous vaccination campaign (+38%): this was confirmed for every professional category, with the largest increases among resident doctors (+47%) and physicians (+44%), and also for every age category, but it was particularly evident for the youngest health professionals. The probability of co-administration uptake during the 2022/2023 campaign was significantly higher for males, and for those that received co-administration during the 2021/2022 campaign, while the probability was lower for nurses and administrative staff. This study highlights the co-administration procedure as a valuable and effective tool in annual vaccination campaigns for SARS-CoV-2 and influenza. The procedure's safety and streamlined logistics make it increasingly attractive for implementation, particularly among HCWs.

Medical Professional Liability in Obstetrics and Gynecology: A Pilot Study of Criminal Proceedings in the Public Prosecutor's Office at the Court of Rome.

Criminal trials and claims against physicians for malpractice-related damages have increased dramatically in recent years, and, with Obstetrics and Gynecology being one of the medical specialties that is at the highest risk, we carried out a retrospective analysis aimed at examining all Obstetrics- and Gynecology-related medical professional liability prosecutions within the General Register of Criminal Records of the Rome Public Prosecutor's Office between the years 2000 and 2014. The number of prosecutions increased steadily in the years 2000-2005, with varying trends in the following years. A total of 727 healthcare professionals were involved in criminal charges, and most prosecuted crimes were related to Articles 590 and 589 of the Italian Penal Code, followed by violations of Article 17 of Law 194/78. In most cases, filing was requested and granted without opposition. In 95 cases, an expert witness was appointed by the Court, and in 68 cases, the technical consultants of the State Prosecutor found culpable conduct. Public hospitals, private nursing homes and outpatient clinics, or private practices were mostly involved; in 45% of the cases, the physicians were hospital employees. In this setting, Italy is prepared to introduce new measures and regulations to address the issues posed by defensive medicine and charges of professional liability for healthcare providers.

Analysis of Medico-Legal Complaint Data: A Retrospective Study of Three Large Italian University Hospitals.

(1) Background: Identifying hospital-related critical, and excellent, areas represents the main goal of this paper, in both a national and local setting. Information was collected and organized for an internal company's reports, regarding civil litigation that has been affecting the hospital, to relate the obtained results with the phenomenon of medical malpractice on a national scale. This is for the development of targeted improvement strategies, and for investing available resources in a proficient way. (2) Methods: In the present study, data from claims management in Umberto I General Hospital, Agostino Gemelli University Hospital Foundation and Campus Bio-Medico University Hospital Foundation, from 2013 to 2020 were collected. A total of 2098 files were examined, and a set of 13 outcome indicators in the assessment of "quality of care" was proposed. (3) Results: From the total number, only 779 records (37.1%) were attributable to the categories indexable for the present analysis. This data highlights how, following a correct and rigorous categorization of hospital events, it is possible to analyze these medico-legal aspects using a small number of indicators. Furthermore, it is important to consider how a consistent percentage of remaining events was difficult to index, and was also of poor scientific interest. (4) Conclusions: The proposed indicators do not require standards to be compared to, but provide a useful instrument for comparative purposes. In fact, in addition to comparative assessment between different business realities distributed throughout the territory, the use of outcome indicators allows for a longitudinal analysis evaluating the performance of an individual structure over time.

Comparative Impact Analysis of Low-Deductible Insurance Versus In-house Hospital Assumption of Risk and Management on Medical Malpractice Claims.

OBJECTIVES: Claims management is critical to ensure the safe and high-quality medical care for which liability insurers and/or hospitals are responsible. The aim of this research is to determine whether increasing hospital malpractice risk exposure, with increasing deductibles, has an impact on malpractice claims and payouts. METHODS: The study was conducted at a single tertiary hospital, the Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy. Payouts on closed reported and registered claims were analyzed during 4-study periods, which ranged from 1.5 million euro annual aggregate deductibles entirely managed by the insurance company to 5 million euro annual aggregate deductibles entirely managed by the hospital. We retrospectively analyzed 2034 medical malpractice claims submitted between January 1, 2007, and August 31, 2021. Four periods were examined depending on the claims management model adopted, ranging from total outsourcing to the insurer (period A) to an almost total hospital assumption of risk method (period D). RESULTS: We found that progressive hospital assumption of risk is associated with a decrease in the incidence of medical malpractice claims (average variation per year: -3.7%; P = 0.0029 if the 2 initial periods and the 2 last periods-characterized by the highest risk retention-are respectively aggregated and compared), an initial decrease in the mean claims cost followed by an increase that is still lower than the national increase (-5.4% on average), and an increase in the total claims cost (when compared with the period where the insurer solely managed claims). We also found that the rate of increase in payouts was less than the national average. CONCLUSIONS: The assumption of more malpractice risk by the hospital was associated with the adoption of numerous patient safety and risk management initiatives. The decrease in claims incidence could be due to the implementation of patient safety policies, while the cost increase could be attributed to inflation and rising costs of healthcare services and claims. Notably, only the hospital assumption of risk model with a high-deductible insurance coverage is sustainable for the studied hospital, while also being profitable for the insurer. In conclusion, as hospitals progressively assumed more risk and management responsibility of malpractice claims, there was a progressive decrease in the total number of claims, and a less rapid rise in claim payouts as compared with the national average. Even a small assumption of risk appeared to elicit meaningful changes in claim filings and payouts.

A Fifteen-Year Survey for Orthopedic Malpractice Claims in the Criminal Court of Rome.

The number of legal disputes in the field of medical liability has increased exponentially in the last decades. The aim of this study is to investigate the outcomes of criminal cases against healthcare professionals in Italian criminal courts. The hypothesis is that the majority of cases are dismissed and/or most professionals in these cases are acquitted. This retrospective analysis considers criminal proceedings related to medical professional liability registered with the general register of crime reports of the Public Prosecutor's Office of Rome in the time interval between 1 January 2000 and 31 December 2015. A total of 4793 criminal proceedings were ultimately identified. Proceedings related to the field of orthopedic trauma were then examined and identified. A complete analysis of 132 of the identified files (76.7%) was carried out. The field with the highest risk of disputes was determined to be the field of trauma. The most frequent complaint was found to arise from unsatisfactory surgical outcomes following elective surgery. The most affected anatomical district is the lower limb in both elective and trauma cases, followed by the upper limb in traumatology and spine cases. The surgeon is the most frequently quoted role of the professional involved. The number of physicians actually convicted (3.93%) and for whom liability was thus recognized, i.e., the existence of a causal link between their conduct and the event that took place was established, appears to be extremely small when compared with the far more significant values related to dismissals (53%) and acquittals (14.2%). Adequate legal reform aiming to reduce this disproportion is necessary to ensure physicians experience a more relaxed daily profession and to restore the original connotations of the doctor-patient relationship with the abolition of defensive medicine.

Blood alcohol concentration and road accidents: Underestimation due to time of the arrival to the emergency department (ED) or delay in blood sampling. A 4-Year Retrospective Study in Rome.

Alcohol is a significant public health issue, according to the World Health Organization. Our study aims to analyze the correlation between blood alcohol concentrations (BACs) of drivers, their demographic features, and the possible underestimation of BACs due to the time elapsed between hospital admission and blood sampling. Methods: This study includes patients evaluated for BAC levels in the emergency department (ED) of Fondazione Policlinico Universitario A. Gemelli IRCCS from January 2013 to December 2016. BAC levels were compared in patients involved in road crashes according to age group, sex, and time of the accident. The delays in blood sampling and BAC measurement in the ED were recorded for each patient. The time between the accident and access to the hospital in most cases was unknown. Results: A total of 398 patients were included in the analysis, 107 of them had BACs more than 0.05 g/L., and 86 of these individuals had BAC levels more than 0.5 g/L. Road accident patients had higher rates of positive BAC readings at night and on weekends. A significant delay in blood sampling for BAC determination was observed. Discussion: This study demonstrates a critical bias due to the arrival time at the ED and the delay in blood sampling that inevitably influences and underestimates the BAC, resulting in possible false negative results (BAC values below the cutoff). Zero tolerance or a retrospective BAC calculation could mitigate this bias. It is necessary to implement preventive strategies to reduce instances of driving under the influence (DUI) of alcohol.

BNT162b2 COVID-19 Vaccine Safety among Healthcare Workers of a Tertiary Hospital in Italy.

Millions of people have died because of the COVID-19 pandemic. The vaccination campaign helped tackle the pandemic and saved millions of lives. In a retrospective pharmacovigilance study, we explored the safety of the BNT162b2 (Comirnaty) vaccine among healthcare workers (HCWs) in a large Italian teaching hospital, and 2428 Adverse Events Reports (AERs) filed by HCWs after the administration of the first dose of vaccine were collected and analyzed, reporting the results quantitively and comparing them to the vaccine Summary of Product Characteristics (SPC). Spearman's correlation coefficients were computed to investigate the correlation among reported adverse effects, and recurrent clusters of symptoms were investigated through the Principal Component Analysis (PCA) and k-means Cluster Analysis. The BNT162b2 vaccine's safety profile was favorable, with predominant reports of early onset, mild, non-serious and short-term resolved symptoms. We observed higher than the expected frequency for various non-serious undesirable effects, especially among those listed and classified as less common in the SPC. Furthermore, we identified three clusters of adverse effects that were frequently reported together, defined by the presence/absence of fatigue, malaise, localized pain, chills, pyrexia, insomnia, nausea and injection site pain. Post-marketing pharmacovigilance activities, together with targeted public health interventions, can be valuable tools to promote vaccination and improve the control of the spread of the pandemic, especially in sensitive settings and populations such as hospitals and healthcare professionals.

Malpractice Claims and Incident Reporting: Two Faces of the Same Coin?

Incident reporting is an important method to identify risks because learning from the reports is crucial in developing and implementing effective improvements. A medical malpractice claims analysis is an important tool in any case. Both incident reports and claims show cases of damage caused to patients, despite incident reporting comprising near misses, cases where no event occurred and no-harm events. We therefore compare the two worlds to assess whether they are similar or definitively different. From 1 January 2014 to 31 December 2021, the claims database of Policlinico Universitario A. Gemelli IRCCS collected 843 claims. From 1 January 2020 to 31 December 2021, the incident-reporting database collected 1919 events. In order to compare the two, we used IBNR calculation, usually adopted by the insurance industry to determine loss to a company and to evaluate the real number of adverse events that occurred. Indeed, the number of reported adverse events almost overlapped with the total number of events, which is indicative that incurred-but-not-reported events are practically irrelevant. The distribution of damage events reported as claims in the period from 1 January 2020 to 31 December 2021 and related to incidents that occurred in the months of the same period, grouped by quarter, was then compared with the distribution of damage events reported as adverse events and sentinel events in the same period, grouped by quarter. The analysis of the claims database showed that the claims trend is slightly decreasing. However, the analysis of the reports database showed that, in the period 2020-2021, the reports trend was increasing. In our study, the comparison of the two, malpractice claims and incident reporting, documented many differences and weak areas of overlap. Nevertheless, this contribution represents the first attempt to compare the two and new studies focusing on single types of adverse events are, therefore, desirable.

Effect of Lockdowns on Hospital Staff in a COVID Center: A Retrospective Observational Study.

At the onset of the SARS-CoV-2 pandemic, individual and social measures were strengthened through restrictive non-pharmaceutical interventions, labelled with the term "lockdown". In Italy, there were two lockdowns (9 March 2020−3 May 2020 and 3 November 2020−27 March 2021). As part of preventive measures, healthcare workers and the administrative staff population of Policlinico A. Gemelli underwent nasopharyngeal swab tests from 1 March 2020 to 9 February 2022, a long time interval that includes the two aforementioned lockdowns. The population included 8958 people from 1 March 2020 to 31 December 2020; 8981 people from 1 January 2021 to 31 December 2021; and 8981 people from 1 January 2022 to 9 February 2022. We then analysed pseudo-anonymized data, using a retrospective observational approach to evaluate the impact of the lockdown on the incidence of SARS-CoV-2 infections within the population. Given the 14 day contagious period, the swab positivity rate (SPR) among the staff decreased significantly at the end of the first lockdown, every day prior to 18 May 2020, by 0.093 (p < 0.0001, CI = (−0.138−−0.047)). After the fourteenth day post the end of the first lockdown (18 May 2020), the SPR increased daily at a rate of 0.024 (p < 0.0001, 95% CI = (0.013−0.034)). In addition, the SPR appeared to increase significantly every day prior to 17 November 2020 by 0.024 (p < 0.0001, CI = (0.013−0.034)). After the fourteenth day post the start of the second lockdown (17 November 2020), the SPR decreased daily at a rate of 0.039 (p < 0.0001, 95% CI = (−0.050−−0.027)). These data demonstrate that, in our Institution, the lockdowns helped to both protect healthcare workers and maintain adequate standards of care for COVID and non-COVID patients for the duration of the state of emergency in Italy.

Trend in 167 cases of minors witnessing violence: The role played by COVID-19 pandemic.

Background: There currently is no evidence that COVID-19 has had an impact on the rates of psychological abuses occurring when a minor witnesses interpersonal violence. Aim: Our aim was to describe the accesses of the last four years to the Emergency Department of a tertiary hospital (Careggi University Hospital-Florence, Italy) due to this issue and then to evaluate whether the COVID-19 has had an impact on this trend. Methods: We collected data regarding cases of abuse in which at least a minor had reportedly witnessed the event. Medical records stored between January 1, 2018 to January 1, 2022 were analyzed, extracting sex, age and nationality of the victim; sex of the perpetrator and relationship with the victim; known previous episodes of abuse in the medical history of the victim; setting of the abuse (domestic vs. non-domestic); type of abuse (physical, psychological, sexual); whether the perpetrator was under the influence of alcohol/drugs; whether the victim was hospitalized; prognosis of the victim; number, relation with the victim and involvement in the abuse (as co-victim) of the minor(s) who witnessed the abuse. Results: A total of 167 eligible cases were registered. 69% of victims had previous episodes of abuse. The perpetrators were all known and mainly males (96%).The abuses were mainly domestic (79%). In 74% of the cases only a type of violence was perpetrated. In 12% of the cases, the minors were also victims of physical abuse. No statistically significant relationships were found between the start of the COVID-19 pandemic and the changes in the number of cases of domestic abuse (p = 0.07), physical abuse (p = 0.62), psychological abuse (p = 0.83) or sexual abuse (p = 0.88). However, during the institutional lockdown in Italy (March-May 2022) only two cases occurred - a number that did not allow period-specific statistical inference. Conclusions: Empowering the hospital policies specifically aimed at identifying and protecting the victims of violence/witnessed violence remains a critical goal from both a public health and medico-legal point of view.

Microbiological screening tests for SARS-CoV-2 in the first hour since the hospital admission: A reliable tool for enhancing the safety of pediatric care.

Introduction/purpose: Since a significant proportion of SARS-CoV-2 infections occur within healthcare facilities, a multidisciplinary approach is required for careful and timely assessment of the risk of infection in asymptomatic patients or those whose COVID-19 diagnosis has not yet been made. The aim of this study was to investigate whether an adaptative model based on microbiological testing can represent a valid risk management strategy. Material and methods: We collected data from the risk management unit database of a 1,550-bed tertiary hospital (Fondazione Policlinico Gemelli IRCCS, Rome, Italy) concerning pediatric admissions to the Emergency Department (ED) from 1 March 2020 to 31 December 2021. The study period was subdivided in period A and period B according to the technique used for the microbiological screening, respectively reverse-transcription polymerase chain reaction (RT-PCR) and antigen-detection test. Results: In Period A, 426 children (mean age: 6 years) underwent microbiological screening at the ED. The total number of molecular tests performed was 463. 459/463 tested negative at the molecular test. In Period B, 887 children (mean age: 6 years) underwent microbiological screening in the ED. The total number of molecular tests performed was 1,154. 1,117/1,154 tested negative at the molecular test. Neither in Period A nor in Period B hospital-acquired SARS-CoV-2 infections were reported. Discussion and conclusion: Despite high volumes, no cases of hospital-acquired SARS-CoV-2 infection have been reported. SARS-CoV-2 antigen-based tests can be used as a first-line option as they provide rapid results compared to RT-PCR, reducing the risk of infection in ED waiting rooms.

COVID-19 Vaccination Campaign among the Health Workers of Fondazione Policlinico Universitario Agostino Gemelli IRCCS: A Cost-Benefit Analysis.

Vaccinations generate health, economic and social benefits in both vaccinated and unvaccinated populations. The aim of this study was to conduct a cost-benefit analysis to estimate the costs and benefits associated with the COVID-19 vaccination campaign for health workers in Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG). The analysis included 5152 healthcare workers who voluntarily received the Pfizer-BioNTech COVID-19 vaccine, divided into physicians, nurses and other health workers. Data about vaccine cost, administration and materials were derived from administrative databases of the FPG from 28 December 2020 to 31 March 2021. The costs associated with the COVID-19 vaccination campaign amounted to EUR 2,221,768, while the benefits equaled EUR 10,345,847. The benefit-to-cost ratio resulted in EUR 4.66, while the societal return on investment showed a ratio of EUR 3.66. The COVID-19 vaccination campaign for health workers in FPG has high social returns and it strengthens the need to inform and update decision-making about the economic and social benefits associated with a vaccination campaign. Health economic evaluations on vaccines should always be considered by decision-makers when considering the inclusion of a new vaccine into the national program.

Flu and COVID-19 Vaccination: What Happens to the Flu Shot When the Campaigns Overlap? Experience from a Large Italian Research Hospital.

Influenza represents a threat to global health and health care workers (HCWs) have an increased risk of contracting the influenza virus in the workplace. The COVID-19 pandemic has brought back the importance of influenza vaccination, as the influenza virus can circulate together with SARS-CoV-2. The aim of this report is to describe the actual flu vaccination coverage among healthcare workers of a research hospital and the trend changes, with respect to the past flu vaccination campaigns, in light of the present pandemic and COVID-19 vaccination. A Pearson's χ2 test was used to test the correlation of flu vaccination coverage, across all professional categories, between the last two years. A linear regression model was adopted to predict the total vaccination coverage of this year. A statistically significant decrease (p < 0.01) was observed in vaccination coverage among all the professional categories with a 50% reduction in vaccination trends between the last two years. Analyzing the data from the previous six flu vaccination campaigns, the expected value, according to the linear regression model, was estimated to be 38.5% while the observed value was 24%. The decrease in vaccination coverage may be due to the fear of the pandemic situation and especially to the uncertainty related to the consequences of a concurrent administration which may overload the immune system or may be more reactogenic. The COVID-19 pandemic represents an opportunity to promote and support large-scale influenza vaccination among HCWs through structured programs, adequate funding, and tailored communication strategies.

How to manage falls in hospitalized patients: A single center experience in allogeneic stem cell transplantation setting.

ABSTRACT: In allogeneic hematopoietic stem cell transplantation (AHSCT), falls can lead to immediate and late consequences and in some cases to death. We analyzed risks and causes of falls with root cause analysis (RCA) based on which improvement interventions were implemented.A retrospective observational study was conducted to analyze with RCA data of incidence reports and medical records of patients admitted; an expert panel identified actions to prevent falls, which were collected in a checklist.Between December 2017 and November 2019, 214 patients were admitted to ordinary hospital stays for AHSCT or AHSCTrelated complications. In this period, 15 falls, involving 11 patients, occurred resulting in a 2.32 d/patient incidence. In 66.67% of cases minor head trauma occurred. Diuretic drugs (93.33%), induced hyper-diuresis in nonbladder catheter patients (93.33%) and antihypertensive drugs (93.33%) were reported as most common cause in our incident reports. The most frequent fall time slot was between 10 PM and 7 AM (60%). We determined with RCA diuretics and consequent induced hyper-diuresis (80%), self-insufficiency (40%), antihypertensive (33.3%) and noncompliance (33.3%) as the most common cause of falls. Finally, 16 actions, collected in a "safe comfort" checklist, were identified to prevent falls.Diuretic drugs inducing hyper-diuresis, self-insufficiency, poor patient compliance, orthostatic hypotension, fever, night-time and obstacles within inpatient units are the most common contributing factors. Therefore, administration of diuretic and antihypertensive drugs should be rescheduled and a multidimensional risk assessment scale integrated with a preventive action plan, such as the safe comfort checklist, should be implemented to reduce falls.