Key Performance Indicators in Claims Management: Definition of a Set of Indicators for the Evaluation of the Medico-Legal Activity.

BACKGROUND: In recent decades, in the field of healthcare, awareness of the problems inherent to the quality has steadily increased. Currently, the evaluation of healthcare activities is one of the ways in which health systems regulate internal relationships and define strategic decisions. OBJECTIVE: The study aims to describe in detail the entire process of developing a group of Key Performance Indicators for monitoring and implementing the management of litigation due to medical liability. Particularly, the objective is to centralize and standardize the indicators to provide scientifically reliable data on claims management to hospital professionals responsible for strategic choices. METHODS: The study was conducted to analyze data relating to the claims management at Umberto I General Hospital in Rome from 2012 to 2018. All claims reported were classified according to a selection of the categories coded in the International Classification for Patient Safety system, the economic features, and the chronological references of the main management extrajudicial and judicial phases. The Process Analysis Method was followed to develop significant indicators for measuring the performance and the quality of claims management. RESULTS AND CONCLUSION: The results obtained demonstrate how the assessment of performance in claims management can potentially lead to greater risk control with significant repercussions in terms of reduction of disputes, speed in settling claims, reduction of management times, planning of loss prevention measures, and implementation of quality of care.

Information, Sharing, and Self-Determination: Understanding the Current Challenges for the Improvement of Pediatric Care Pathways.

Despite the considerable progress of medical science over the years, pediatric patients can still be affected by serious illnesses that, regardless of age, lead to experiencing all the clinical, psychological, ethical and spiritual problems related to incurable diseases and death. The interaction between the peculiarities of individuals, and the clinical conditions presented define a changing and complex profile of health needs, which requires organized, dynamic and multidimensional responses. The approach to the pediatric patient must consider its biological, psychological, relational and clinical characteristics. Such aspects in fact determine and modulate the type and quantity of the needs presented, conditioning the actions to be taken and the organizational models to be implemented. In accordance with some international regulations, it is essential that healthcare professionals provide adequate information to the patient's understanding in order to enhance participation in the decision-making process regardless of the possibility of expressing consent or dissent to the treatment. Frequently, the sharing of decisions on the care path not only fails to involve children, but often lacks rigorously designed interventions for parental involvement. Therefore, the development of care models that focus on the needs of the pediatric population is crucial. The present paper aims to analyze the problems of information quality and sharing in pediatric care pathways in order to promote shared decision-making and improve the knowledge of the professionals involved. As a secondary objective, the study will provide useful insights for the prevention of decision-making conflicts frequently at the basis of the dispute in the pediatric field.

Mesenchymal stem cells in neurodegenerative diseases: Opinion review on ethical dilemmas.

The treatment of neurodegenerative diseases presents a growing need for innovation in relation to recent evidence in the field of reconstructive therapy using stem cells. Understanding the molecular mechanisms underlying neurodegenerative disorders, and the advent of methods able to induce neuronal stem cell differentiation allowed to develop innovative therapeutic approaches offering the prospect of healthy and perfectly functional cell transplants, able to replace the sick ones. Hence the importance of deepening the state of the art regarding the clinical applications of advanced cell therapy products for the regeneration of nerve tissue. Besides representing a promising area of tissue transplant surgery and a great achievement in the field of neurodegenerative disease, stem cell research presents certain critical issues that need to be carefully examined from the ethical perspective. In fact, a subject so complex and not entirely explored requires a detailed scientific and ethical evaluation aimed at avoiding improper and ineffective use, rather than incorrect indications, technical inadequacies, and incongruous expectations. In fact, the clinical usefulness of stem cells will only be certain if able to provide the patient with safe, long-term and substantially more effective strategies than any other treatment available. The present paper provides an ethical assessment of tissue regeneration through mesenchymal stem cells in neurodegenerative diseases with the aim to rule out the fundamental issues related to research and clinical translation.

Advanced Loss Eventuality Assessment and Technical Estimates: An Integrated Approach for Management of Healthcare-Associated Infections.

BACKGROUND: Healthcare Associated Infections (HAIs) represent a crucial issue in health and patient safety management due to the persistent nature, economic impact and possible preventability of the phenomenon. Compensation claims for damages resulting from HAI could provide insights that can improve the understanding of suboptimal steps in the therapeutic process, enable an estimate of costs related to infectious complications, and guide the development of planning tools for implementation of the quality of care. OBJECTIVE: This paper analyzes all the HAI claims received at the Umberto I General Hospital of Rome across a five-year period with the aim of outlining a methodological approach to the litigation management and of characterizing the economic impact of infections on health facilities resources. METHODS: All claims received during the study period have been classified according to the International Classification for Patient Safety (ICPS) system. Subsequently, claims related to Healthcare Associated Infections were evaluated through an innovative tool for determination of the risk of loss, the Advanced Loss Eventuality Assessment (ALEA) score. RESULTS: The results obtained demonstrate the relevance of a correct management of HAI claims in the administration of a health care system. Specifically, the cases examined during the study highlighted the significant impact of infectious diseases of a nosocomial nature in terms of frequency and economic exposure. CONCLUSION: The proposed methodological approach allows a productive analysis of the internal processes, providing fundamental data for the refinement of the preventive strategies and for the rationalization of the resources through the expenditure forecasts. Article Highlights Box: Healthcare-Associated Infections represent an essential element to consider in the management of health facilities. • Many studies highlight the economic burden of Healthcare-Associated Infections in health policies. • Litigation management represents a useful resource in the prevention of Healthcare Associated Infections. • Appropriate clinical risk management policies in the field of Healthcare-Associated Infections allow the implementation of preventive measures, the reduction of the incidence of the phenomenon and the quality of care. • The costs of Healthcare-Associated Infections can be limited through a systematic methodological approach based on Advanced Loss Eventuality Assessment and technical estimate of the value of each case. • The application of a standardized system would be desirable in any health facility despite the potential methodological, technical, behavioral and financial issues.

Improve Healthcare Quality Through Mortality Committee: Retrospective Analysis of Bambino Gesù Children Hospital's Ten Years' Experience 2008-2017.

BACKGROUND: Healthcare quality improvements are one of the most important goals to reach a better and safer healthcare system. Reviewing in-hospital mortality data is useful to identify areas for improvement, and to monitor the impact of actions taken to avoid preventable cases, such as those related to healthcare associated infections (HAI). METHODS: In this paper, we present the experience of the Mortality Committee of Bambino Gesù Children Hospital (OPBG). OPBG has instituted a process of systematic revision of all in-hospital deaths conducted by a multidisciplinary team. The goal is to identify system-wide issues that could be improved to reduce in-hospital preventable deaths. In this way, the mortality review goes alongside all the other risk management activities for the continuous quality improvement and patient safety. RESULTS: In years 2008-2017, we performed a systematic analysis of 1148 inpatient deaths. In this time period, the overall mortality rate was 0.4%. Forty-seven deaths were caused due to infections, 10 of which involved patients with HAI transferred to OPBG from other facilities or patients with community- acquired infections. Six deaths related to HAI were followed by claims compensations. All these cases were not followed by compensation because the onset of HAI was considered an inevitable consequence of the underlying disease. CONCLUSION: Introduction of the mortality review committee has proved to be a valid instrument to improve the quality of the care provided in a hospital, allowing early identification of care gaps that could lead to an increase in mortality rates. Article Highlights Box: Reduction of preventable deaths is one of the most important goals to be achieved for any health-care system and to improve the quality of care. • Several studies have shown that analysis of morbidity and mortality rate helps to detect any factors that can lead to an increase in in-hospital mortality rates. • The review of in-hospital deaths allows to learn how to improve the quality and safety of care through identification of critical issues that lead to an increase in mortality ratio. • In some medical areas, such as intensive care units or surgery, the implementation of the conference on mortality and morbidity is more useful for assessing procedures at high risk of errors. • The implementation of existing databases with data deriving from the systematic review of medical records and in-hospital deaths appears to be desirable. • Mortality Review Committees can represent a very useful tool for all the health facilities for the reduction of preventable deaths, such as those related to HAI.

Postmortem computed tomography angiography (PMCTA) and traditional autopsy in cases of sudden cardiac death due to coronary artery disease: a systematic review and meta-analysis.

INTRODUCTION: Several studies have been performed to assess the efficacy of postmortem computed tomography angiography (PMCTA) in solving cases of sudden cardiac death, even in comparison with the traditional autopsy. However, the results were often inconsistent and inconclusive. Therefore, a global discussion on the subject through a systematic review of the literature and a meta-analysis is necessary. METHODS: A systematic search of PubMed was performed up to April 23, 2018. Studies exploring the role of PMCTA in cases of sudden cardiac death and the accuracy of this method in diagnosing the cause of death compared to traditional autopsy were included. RESULTS: The overall sensitivity and specificity of the seven included studies, using conventional autopsy as a reference standard, were 92% and 95%, respectively. The positive and negative likelihood ratios were, respectively, 20.76 (95% CI 1.16-370.2) and 0.08 (95% CI 0.03-0.17), showing that PMCTA represents a strong indicator of the posttest probability of disease. The diagnostic odds ratio and the area under the curve were, respectively, 261.54 (95% CI 1.87-5760.53) and 0.93 (95% CI 0.90-0.95), indicating a high diagnostic power of the test. CONCLUSION: PMCTA demonstrated a high accuracy in the diagnosis of parietal and luminal coronary changes but was less effective in detecting myocardial ischemia and necrosis. Therefore, the only radiological investigation is often insufficient to determine the cause of sudden death and the conventional autopsy remains the gold standard. However, PMCTA can improve the performance of the autopsy, serving as an aid and guide in the sampling phase for histopathological investigations.

Clinical-pathological study on ß-APP, IL-1ß, GFAP, NFL, Spectrin II, 8OHdG, TUNEL, miR-21, miR-16, miR-92 expressions to verify DAI-diagnosis, grade and prognosis.

Traumatic brain injury (TBI) is one of the most important death and disability cause, involving substantial costs, also in economic terms, when considering the young age of the involved subject. Aim of this paper is to report a series of patients treated at our institutions, to verify neurological results at six months or survival; in fatal cases we searched for ßAPP, GFAP, IL-1ß, NFL, Spectrin II, TUNEL and miR-21, miR-16, and miR-92 expressions in brain samples, to verify DAI diagnosis and grade as strong predictor of survival and inflammatory response. Concentrations of 8OHdG as measurement of oxidative stress was performed. Immunoreaction of ß-APP, IL-1ß, GFAP, NFL, Spectrin II and 8OHdG were significantly increased in the TBI group with respect to control group subjects. Cell apoptosis, measured by TUNEL assay, were significantly higher in the study group than control cases. Results indicated that miR-21, miR-92 and miR-16 have a high predictive power in discriminating trauma brain cases from controls and could represent promising biomarkers as strong predictor of survival, and for the diagnosis of postmortem traumatic brain injury.

Diffuse Axonal Injury and Oxidative Stress: A Comprehensive Review.

Traumatic brain injury (TBI) is one of the world's leading causes of morbidity and mortality among young individuals. TBI applies powerful rotational and translational forces to the brain parenchyma, which results in a traumatic diffuse axonal injury (DAI) responsible for brain swelling and neuronal death. Following TBI, axonal degeneration has been identified as a progressive process that starts with disrupted axonal transport causing axonal swelling, followed by secondary axonal disconnection and Wallerian degeneration. These modifications in the axonal cytoskeleton interrupt the axoplasmic transport mechanisms, causing the gradual gathering of transport products so as to generate axonal swellings and modifications in neuronal homeostasis. Oxidative stress with consequent impairment of endogenous antioxidant defense mechanisms plays a significant role in the secondary events leading to neuronal death. Studies support the role of an altered axonal calcium homeostasis as a mechanism in the secondary damage of axon, and suggest that calcium channel blocker can alleviate the secondary damage, as well as other mechanisms implied in the secondary injury, and could be targeted as a candidate for therapeutic approaches. Reactive oxygen species (ROS)-mediated axonal degeneration is mainly caused by extracellular Ca2+. Increases in the defense mechanisms through the use of exogenous antioxidants may be neuroprotective, particularly if they are given within the neuroprotective time window. A promising potential therapeutic target for DAI is to directly address mitochondria-related injury or to modulate energetic axonal energy failure.

Stem Cell Research and Clinical Translation: A Roadmap about Good Clinical Practice and Patient Care.

The latest research achievements in the field of stem cells led in 2016 to the publication of "Guidelines for Stem Cell Research and Clinical Translation" by the International Society for Stem Cell Research (ISSCR). Updating the topics covered in previous publications, the new recommendations offer interesting ethical and scientific insights. Under the common principles of research integrity, protection of patient's welfare, respect for the research subjects, transparency and social justice, the centrality of good clinical practice, and informed consent in research and translational medicine is supported. The guidelines implement the abovementioned publications, requiring rigor in all areas of research, promoting the validity of the scientific activity results and emphasizing the need for an accurate and efficient public communication. This paper aims to analyze the aforementioned guidelines in order to provide a valid interpretive tool for experts. In particular, a research activity focused on the bioethical, scientific, and social implications of the new recommendations is carried out in order to provide food for thought. Finally, as an emerging issue of potential impact of current guidelines, an overview on implications of compensation for egg donation is offered.

Personalized Medicine and Adverse Drug Reactions: The Experience of An Italian Teaching Hospital.

BACKGROUND: The personalized medicine is a model of medicine based on inherent difference given by the genetic heritage that characterizes us, diversity that can affect also our response to administered therapy. Nowadays, the term "adverse drug reaction" is identified with any harmful effect involuntary resulting from the use of a medicinal product; pharmacogenomics, in this field, has the aim to improve the drug response and to reduce the adverse reaction. METHODS: We analyzed all reports of adverse reaction collected in the Pharmacovigilance Centre database of an Italian University Hospital, at the Sant'Andrea Hospital Sapienza University of Rome, in a period of two years. RESULTS: Comparing the data result from our analysis with several studies found in literature, it is evident that adverse drug reactions represent an important problem in the management of a health care system. However, the development of pharmacogenetics and pharmacogenomics, allowing a personalized treatment, can improve clinical practice. CONCLUSION: This study highlights the great potential of pharmacogenomics in reducing adverse reactions and suggests the need for further pharmacogenomic clinical trials to better personalize drug treatment and to refine the current pharmacovigilance strategies.

Oral treatment with the melatonin agonist agomelatine lowers the intraocular pressure of glaucoma patients.

PURPOSE: Agomelatine is an agonist of melatonin that is used in the treatment of major depressive disorders. It has also shown an ability to decrease IOP in experiment animals and in normal human subjects. This pilot study addresses for the first time agomelatine effects on the IOP of patients affected by POAG. METHODS: Ten patients affected by hypertensive POAG treated by multiple hypotensive topical drugs and under further treatment with agomelatine (25 mg day(-1) per os) for psychiatric problems, were enrolled. IOP tonometric values were measured at enrolment and after 15 and 30 days of agomelatine supplementation. RESULTS: Agomelatine given orally showed a significant hypotonising effect, stably decreasing IOP by roughly 30% of the enrolment value after 15 and 30 days of treatment. CONCLUSIONS: The hypotonising effect of oral systemic agomelatine at 25 mg day(-1) was able to further decrease IOP in both eyes of all enrolled POAG patients in which multiple drug treatment with anti-glaucoma eye drops had no further effect.