Complexity of nursing care at 24 h from admission predicts in-hospital mortality in medical units: a cohort study.

BACKGROUND: The Informative System of Nursing Performance was developed to measure complexity of nursing care based on the actual interventions performed by nurses at the point of care. The association of this score with in-hospital mortality was not investigated before. Having this information is relevant to define evidence-based criteria that hospital administrators can use to allocate nursing workforce according to the real and current patients' need for nursing care. The aim of this study is to assess the association between complexity of nursing care and in-hospital mortality. METHODS: Register-based cohort study on all patients admitted to acute medical wards of a middle-large hospital in the North of Italy between January 1, 2014, to December 31, 2015 and followed up to discharge. Out of all the eligible 7247 records identified in the Hospital Discharge Register, 6872 records from 5129 patients have been included. A multivariable frailty Cox model was adopted to estimate the association between the Informative System of Nursing Performance score, both as continuous variable and dichotomized as low (score < 50) or high (score ≥ 50), and in-hospital mortality adjusting for several factors recorded at admission (age, gender, type of admission unit, type of access and Charlson Comorbidity Index). RESULTS: The median age of the 5129 included patients was 76 [first-third quartiles 64-84] and 2657(52%) patients were males. Over the 6872 admissions, there were 395 in-hospital deaths among 2922 patients at high complexity of nursing care (13.5%) and 74/3950 (1.9%) among those at low complexity leading to a difference of 11.6% (95% CI: 10.3-13.0%). Adjusting by relevant confounders, the hazard rate of mortality in the first 10 days from admission resulted 6 times significantly higher in patients at high complexity of nursing care with respect to patients at low complexity (hazard ratio, HR 6.58, 95%CI: 4.50;9.62, p < 0.001). The HR was lower after 10 days from admission but still significantly higher than 1. By considering the continuous score, the association was confirmed. CONCLUSION: Complexity of nursing care is strongly associated to in-hospital mortality of acute patients admitted to medical departments. It predicts in-hospital mortality better than widely used indicators, such as comorbidity.

FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients.

Adverse drug reactions (ADRs) reduce patients' quality of life, increase mortality and morbidity, and have a negative economic impact on healthcare systems. Nevertheless, the importance of ADR reporting is often underestimated. The project "FarmaREL" has been developed to monitor and evaluate ADRs in haematological patients and to increase pharmacovigilance culture among haematology specialists. In 13 haematology units, based in Lombardy, Italy, a dedicated specialist with the task of encouraging ADRs reporting and sensitizing healthcare professionals to pharmacovigilance has been assigned. The ADRs occurring in haematological patients were collected electronically and then analysed with multiple logistic regression. Between January 2009 and December 2011, 887 reports were collected. The number of ADRs was higher in older adults (528; 59%), in male (490; 55%), and in non-Hodgkin lymphoma patients (343; 39%). Most reactions were severe (45% required or prolonged hospitalization), but in most cases, they were fully resolved at the time of reporting. According to Schumock and Thornton criteria, a percentage of ADRs as high as 7% was found to be preventable versus 2% according to reporter opinion. Patients' haematological diagnosis, not age or gender, resulted to be the variable that most influenced ADR, in particular severity and outcome. The employment of personnel specifically dedicated to pharmacovigilance is a successful strategy to improve the number and quality of ADR reports. "FarmaREL", the first programme of active pharmacovigilance in oncohaematologic patients, significantly contributed to reach the WHO "Gold Standard" for pharmacovigilance in Lombardy, Italy.

Efficacy of extra-peritoneal pelvic packing in hemodynamically unstable pelvic fractures, a Propensity Score Analysis.

BACKGROUND: An option for emergency control of pelvic hemorrhage is Extra-peritoneal Pelvic Packing (EPP), which addresses the retroperitoneal source of exsanguination in pelvic fractures. The aim of this study was to demonstrate the efficacy of early EPP in reducing mortality due to hemorrhage from pelvic fractures, and to evaluate the impact of packing on transfusion requirements within the first 24 h and ICU length of stay (ICU-LOS). All data pertaining trauma patients admitted from October 2002 and December 2103 with hemodynamic instability and pelvic fractures were selected from the Hospital Trauma Registry. Patients with severe brain injury and bleeding from extra-pelvic sources were excluded. Patient population was divided into two groups: EPP group, including patients admitted from 2009 to 2013, with EPP as part of the treatment algorithm, and NO-EPP group, from 2002 to 2008, without EPP as atherapeutic option. Descriptive statistical analysis was performed on allpatients. Twenty-five patients of each group with similar features were matched using Propensity Score Analysis (PSA). RESULTS: Six hundred eighty out of 4659 major trauma (14.6 %) presented a pelvic fracture. In 78 hemodynamically unstable patients (30 in EPP group,48 in NO-EPP group) the major source of bleeding was the pelvis. Among patients selected by PSA early mortality was significantly reduced in EPP group (20 vs 52 %, p = .03) compared to NO-EPP, notwithstanding similar hemodynamic impairment. No difference was observed in transfusion requirements and ICU-LOS. CONCLUSIONS: The EPP is a safe and quick procedure, able to improve hemodynamic stabilization and to reduce acute mortality due to hemorrhage in patients with pelvic fracture, in combination with optimized transfusion protocol. EPP may be useful as a bridge for time-consuming procedures, such as angio-embolization.

Seriousness, preventability, and burden impact of reported adverse drug reactions in Lombardy emergency departments: a retrospective 2-year characterization.

OBJECTIVE: The purpose of this study was to determine the prevalence of adverse drug reactions (ADRs) reported in emergency departments (EDs) and carry out a thorough characterization of these to assess preventability, seriousness that required hospitalization, subsequent 30-day mortality, and economic burden. METHODS: This was a retrospective cohort study of data from an active pharmacovigilance project at 32 EDs in the Lombardy region collected between January 1, 2010 and December 31, 2011. Demographic, clinical, and pharmacological data on patients admitted to EDs were collected by trained and qualified monitors, and deterministic record linkage was performed to estimate hospitalizations. Pharmacoeconomic analyses were based on Diagnosis-Related Group reimbursement. RESULTS: 8,862 ADRs collected with an overall prevalence rate of 3.5 per 1,000 visits. Of all ADRs, 42% were probably/definitely preventable and 46.4% were serious, 15% required hospitalization, and 1.5% resulted in death. The System Organ Classes most frequently associated with ADRs were: skin and subcutaneous tissue, gastrointestinal, respiratory thoracic and mediastinal, and nervous system disorders. The most common Anatomical Therapeutic Chemical classes involved in admissions were J (anti-infectives and immunomodulating agents), B (blood and blood-forming organs), and N (nervous system). Older age, yellow and red triage, higher number of concomitantly taken drugs, and previous attendance in ED for the same ADR were significantly associated with an increased risk of hospitalization. The total cost associated with ADR management was €5,184,270, with a mean cost per patient of €585. Fifty-eight percent of the economic burden was defined as probably/definitely preventable. CONCLUSION: ADRs are a serious health/economic issue in EDs. This assessment provides a thorough estimation of their seriousness, preventability, and burden impact in a large population from a representative European region.