[Medico-legal and management issues in patient blood management era.] / Aspetti medico-legali e organizzativi nell'era del Patient blood management.

In recent decades, the approach to blood transfusion has changed radically around the world. In the past, transfusion represented the only solution for anemia, today the paradigm has changed: through the implementation of the Patient blood management (Pbm) program it is possible to manage the patient's own blood in order to reduce and, in many cases, eliminate the administration of blood components for transfusion. This approach increases patient safety by reducing clinical risks as well as costs. The implementation of the PBM program in Australia has demonstrated that the use of blood is not strictly necessary but, on the contrary, is largely avoidable. Through change management the traditional attitude of doctors and healthcare facilities can be modified. Law no. 24/2017 focuses on the safety of care by encouraging the necessary implementation of Pbm in hospital settings; the failure to adopt an organized Pbm program may constitute, in the event of an adverse transfusion event, a clear profile of health responsibility on the part of the management and clinicians.

Emilia-Romagna Surgical Colorectal Cancer Audit (ESCA): a value-based healthcare retro-prospective study to measure and improve the quality of surgical care in colorectal cancer.

PURPOSE: Surgery is the main treatment for non-metastatic colorectal cancer. Despite huge improvements in perioperative care, colorectal surgery is still associated with a significant burden of postoperative complications and ultimately costs for healthcare organizations. Systematic clinical auditing activity has already proven to be effective in measuring and improving clinical outcomes, and for this reason, we decided to evaluate its impact in a large area of northern Italy. METHODS: The Emilia-Romagna Surgical Colorectal Audit (ESCA) is an observational, multicentric, retro-prospective study, carried out by 7 hospitals located in the Emilia-Romagna region. All consecutive patients undergoing surgery for colorectal cancer during a 54-month study period will be enrolled. Data regarding baseline conditions, preoperative diagnostic work-up, surgery and postoperative course will be collected in a dedicated case report form. Primary outcomes regard postoperative complications and mortality. Secondary outcomes include each center's adherence to the auditing (enrolment rate) and evaluation of the systematic feedback activity on key performance indicators for the entire perioperative process. CONCLUSION: This protocol describes the methodology of the Emilia-Romagna Surgical Colorectal Audit. The study will provide real-world clinical data essential for benchmarking and feedback activity, to positively impact outcomes and ultimately to improve the entire healthcare process of patients undergoing colorectal cancer surgery. CLINICAL TRIAL REGISTRATION: The study ESCA is registered on the clinicaltrials.gov platform (Identifier: NCT03982641).

Fall predictors in hospitalized patients living with cancer: a case-control study.

PURPOSE: To identify fall predictors and develop an assessment tool to be used for screening hospitalized cancer patients at risk for fall. METHODS: A retrospective case-control study was conducted in 2018 at a cancer center in Northern Italy. The study participants were 448 adult cancer patients admitted to the oncology ward from 2009 to 2013. The case group consisted of 112 patients presenting at least one fall, while controls were randomly chosen by matching each case for age, sex, and admission period with three patients who did not fall. Data for the fall predictors were extracted from the electronic medical records. Conditional logistic regression was used to evaluate the association between patient's characteristics and fall risk. RESULTS: The overall prevalence of patients having at least one candidate fall predictor was high (98%). Seven of the studied variables showed an independent association with fall risk at multivariate analysis. These were tumor site, the presence of neurologic diseases, gait imbalance disorders, fatigue, and the assumption of certain medications such as diuretics, hypnotics, and opioids (odds ratios and 95% confidence intervals in brackets were 3.78 (1.78-8.13), 2.26 (1.08-4.77), 4.22 (1.87-9.52), 2.76 (1.45-5.26), 2.66 (1.52-4.66), 2.41 (1.20-4.85), and 3.03 (1.68-5.45), respectively). CONCLUSIONS: In this study, we identified falling risk factors in an Italian population of hospitalized cancer patients and developed a new risk assessment tool. An external validation is necessary before implementing our screening tool in clinical practice.

Appropriateness and Economic Analysis of Conventional Circulating Biomarkers Assessment in Early Breast Cancer: A Real-World Experience from the E.Pic.A Study.

The risk of relapse for early breast cancer (BC) patients persists even after decades and to date, no specific and sensitive effective circulating biomarker for recurrence prediction has been identified yet. The international guidelines do not recommend the assessment of the serum tumor markers CEA and CA15-3 in the follow-up of asymptomatic early BC patients. In our institute, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", as part of the E.Pic.A study, which was designed to assess the economic appropriateness of integrated care pathways in early BC, the use of CEA and CA15-3 as circulating tumor biomarkers in early BC patients was evaluated in 1502 patients one year after surgery, from 2015 to 2018, with an overall expense of EUR 51,764. A total of EUR 47,780 (92%) was used for execution of circulating tumor markers in early BC patients with stage 0, I and II tumors, neglecting the current guidelines and considered inappropriate by our professional board. We found that no patients with stage I BC experienced relapse in the 365 days after surgery, and in any case examination of the circulating markers CEA and CA15-3 was considered crucial for diagnosis of relapse. Our findings suggest that this inadequacy is a low-value area, supporting the reallocation of economic resources for interventions of a higher value for patients.

How has COVID-19 pandemic changed flu vaccination attitudes among an Italian cancer center healthcare workers?

A retrospective study was conducted among Italian cancer healthcare workers (HCWs) to describe how influenza vaccination attitudes have changed during the COVID-19 pandemic. The analysis was conducted on the last three influenza seasons (2018/19, 2019/20 and 2020/21). To account for different relationships and proximity with patients, the study population was grouped into three main professional categories: health personnel, administrative staff and technicians. Moreover, to explore the factors affecting the coverage of influenza vaccine, a multinomial regression analysis was performed.Over the years, the influenza vaccination uptake showed a gradual increase across the overall staff, the highest coverage (53.8%) was observed in the season 2020/21, in particular, for health personnel (57.7%). In general, males resulted in more adherent to vaccination campaigns; nevertheless, this gap decreased in the last season. A total of 28.6% workers were always vaccinated throughout the past three seasons, a remarkable 25.2% (mainly young and females) received for the first time the influenza vaccination in 2020/21.In this dramatic health crisis, the attitudes of HCWs toward flu vaccination have changed. The COVID-19 outbreak increased adherence to flu vaccination, reaching the highest coverage in the campaign 2020/21. However, further efforts should be made to achieve greater vaccination coverage.

Effects on Clinical Outcomes of a 5-Year Surgical Safety Checklist Implementation Experience: A Large-scale Population-Based Difference-in-Differences Study.

The adoption of a surgical checklist is strongly recommended worldwide as an effective practice to improve patient safety; however, several studies have reported mixed results and a number of issues are still unresolved. The main objective of this study was to explore the impact of the first 5-year period of a surgical checklist-based intervention in a large regional health care system in Italy (4 500 000 inhabitants). We conducted a retrospective longitudinal study on 1 166 424 patients who underwent surgery in 48 public hospitals between 2006 and 2014. The adherence to the checklist was measured between 2011 and 2013 through a computerized database. The effects of the intervention were explored through multivariable logistic regression and difference-in-differences (DID) approaches, based on current administrative data sources. In-hospital and 30-days mortality, 30-days readmissions and length-of-stay (LOS) ⩾8 days were the observed outcomes. Adherence to the checklist showed marked variations across hospitals (0%-93.3%). A pre/post analysis detected statistically significant differences between surgical interventions performed in hospitals with higher adherence to the checklist (⩾75% of the surgeries) and those performed in other hospitals, as for the 30-days readmissions rate (odds ratio [OR]: 0.96; 95% confidence interval [CI]: 0.94-0.98) and LOS ⩾ 8 days rate (OR: 0.88; 95% CI: 0.87-0.89). These findings were confirmed after risk adjustment and DID analysis. No association was observed with mortality outcomes. On the whole, our study attained mixed results. Although a protective effect of the surgical checklist use could not be proved over the first 5 years of this regional implementation experience, our research offers some methodological insights for practical use in the evaluation process of large-scale implementation projects.

[OssERvare Project: direct observation of use of the Safety Surgery CheckList in the operating room.] / Progetto OssERvare: osservazione diretta dell'uso della Safety Surgery Checklist in sala operatoria.

INTRODUCTION: Safety Surgery CheckList (SSCL) is a support tool for operating teams, used to carry out safety checks while also encouraging compliance with the implementation of recommended quality and safety standards. In Emilia-Romagna it was deemed appropriate to check actual surgical team compliance with correct checklist application in the operating theatre, through a project called "OssERvare". METHODS: Direct observation was identified as the preferred inspection method. With the use of special report sheets, observers proceeded with the guided observation of behaviour in the operating room, recording any inconsistencies with correct SSCL use methods. The project began in January 2017 and all observations were carried out from 1st January-15th April 2017. RESULTS: In 43% of observed operation sign in, all three team members were not present, whereas in 7% of observed cases, sign out was not carried out. All three team members were present in 88% of observed operation time out. There are two evidently critical phases: sign in and sign out. Results obtained for time out were better. DISCUSSION AND CONCLUSION: Compliance data collected from observations differed markedly from reported compliance in administrative flow records. The results of the observational study indicate that the SSCL is not properly filled in many times; there is also a great possibility to improve the correct use of this tool. In conclusion, we think that the combined approach of use of administrative data and assessing compliance appeared to be a useful instrument to investigate the implementation and to promote the real utilization of safety tools such as the SSCL.

[Cost analysis of sterilization facilities in the Rizzoli Hospital (Bologna, Italy): a study of different organizational models]. / Analisi dei costi della Centrale di Sterilizzazione dell'Istituto Rizzoli: analisi dei diversi modelli organizzativi.

Preventing healthcare-associated infections requires a number of actions, including adequate disinfection and sterilization of medical devices. A cost analysis of hospital sterilization processes is fundamental to increase quality and safety, reduce costs and to make a decision about outsourcing. The aim of this analysis was to determine the cost of sterilization and the average cost of surgical procedures at the Rizzoli hospital in Bologna (Italy), a largesurgical hospital that performs more than 11,000 surgical procedures per year.

Factors influencing surgical delay after hip fracture in hospitals of Emilia Romagna Region, Italy: a multilevel analysis.

Hip fracture is becoming a major public health concern, with associated mortality and morbidity particularly in the elderly. This study aims to investigate factors (i.e. patient factors and hospital variables) associated with increased risk for delaying surgery after hip fractures, and to assess whether and to what extent timing was associated with mortality risk. All patients aged 65 and over, resident in Emilia Romagna Region (Italy) and admitted to hospital for hip fracture (2009 - 2010) were selected. Data on surgical delay were adjusted using multilevel logistic regression model. A Cox proportional hazard model was fitted to a propensity score matched sample to assess mortality between delayed and early treated patients. Of the 10, 995 patients included (mean age: 83.3 years), 44.9% underwent surgery within 2 days. Significant risk factors for delayed surgery were: gender (OR: 1.16), comorbidity (OR: 1.29), anticoagulant (OR: 7.64) ,antiplatelet medication (OR: 2.43) , type of procedure (OR: 1.37) and day of admission (OR: Thu-Fri: 6.05; Sat-Sun: 1.17). Type of hospital and annual volume of hip fracture surgeries were not sufficient to explain hospital variability. A significant difference in mortality rate between early and delayed surgery emerged six months post surgery.