The general aim of the Laboratory of Clinical Epidemiology is to contribute to the improvement of health care in different medical fields.
The are two main guiding principles: to help physicians in using the available knowledge and resources at their best, and to contribute to the growth of applied knowledge for clinical practice.
The laboratory operates in the field of intensive care medicine. As the main area of activity the laboratory coordinates one of the first and largest groups of collaborative research in the world, the GiViTI (Italian Group for theEvaluation of Interventions in ICU).
Quality of Care in the Intensive Care Units
The main purpose of these research projects is the assessment and improvement of the quality of care in Italian Intensive Care Units (ICUs). It is a multi-annual project promoted on behalf of GiViTI, a collaborative network composed by more than half of the Italian ICUs and coordinated by the laboratory. The main focus is the Margherita Project, whose aim is the continuous evaluation of the quality of care. It is based on a free software developed by the laboratory and distributed to all the ICUs adhering to the GiViTI group. The software has been created with a modular structure, which easily enables the integration of the basic data collection (the “core” of Margherita) with the data collection for specific research projects (the Margherita “petals”). In January 2011 Margherita became an international project. Thanks to funding from the European Union and other contracts, the laboratory has, in fact, been able to develop new software and to distribute the project to eight countries: Slovenia, Hungary, Poland, Cyprus, Israel, Afghanistan, Sudan, and Switzerland. http://www.giviti.marionegri.it/
Appropriateness of the Intensive Care Units
ICU is a high technology environment that requires a large number of highly specialized personnel. Hence, the cost of these units is extremely significant and special attention to not wasting resources is mandatory. In this field, the laboratory launched a study to assess the level of appropriateness of the use of ICU beds in two Italian regions: Toscana and Piemonte. Such an evaluation is based on the understanding that the level of care provided by an ICU should correspond to the level of care it can theoretically provide, given the available resources. In this framework, patients are classified as requiring high-, low-, or ordinary-care, and beds are independently classified as high- or low-level. The appropriateness evaluation protocol adopted verifies the agreement between these two separate classifications. Ideally, an ICU bed equipped to provide a certain level of assistance should be used only for the corresponding level of complexity of the problem and of the healthcare need. When this occurs, it can be considered an appropriate healthcare assistance level. Again, ideally, there should be clear boundaries between levels: a higher healthcare assistance level should not be used to treat a problem of a smaller size, just as a low or medium assistance level should not be employed to treat a problem of greater need. When this occurs, it is considered an inappropriate use of resources. An inappropriate service is therefore one that could be provided at a lower assistance level (the inappropriateness, in this case, can be referred to as a waste of high-level resources), or one that should be provided at a higher assistance level (inappropriateness in terms of suitability of the ICU). The StART study’s aim is to assess these phenomenons and identify their causes in order to improve the appropriateness of ICU admissions.
An Electronic Health Record to Promote Research in Intensive Care Medicine
The main aim of this project is to develop an electronic health record (EHR) that allows the assessment of indicators of the process of care in the ICU. A multidisciplinary team of intensivists, ICU nurses, epidemiologists, statisticians, and IT specialists had the responsibility of planning the HER, which is now already shared by 30 Italian ICUs. This made it possible to launch the first analysis of the process that has as its goal the improvement of the practice of weaning from the ventilator.
Antibiotic Pharmacokinetics in Critically Ill Patients
AbioKin is a multicenter prospective observational study aimed at studying the pharmacokinetic properties of some of the most used antimicrobial drugs in Intensive Care Units (ICUs) and is carried out in ICUs adopting the electronic clinical record MargheritaTre. In the first phase of the project, plasma samples will be withdrawn from critically ill patients undergoing antibiotic therapy with at least one of the investigated molecules. In the second phase we will develop pharmacokinetics models describing the evolution of the plasma concentrations (measured in the collected samples) as a function of the patients' clinical conditions (extracted from MargheritaTre). The third phase will consist in the creation of a simulator to be integrated in MargheritaTre. This tool will allow the plasma concentrations of antimicrobial drugs, as a function of patients' conditions, to be computed and predicted in order to support clinicians in designing personalized therapies meeting the optimal therapeutic targets.
Emergency and out-of-hospital urgency
At the request of the 118 operations centre in Bologna, a project was started for the establishment of a trauma register for the Bologna area, with the aim of collecting clinical and epidemiological data of all patients with trauma and assistance from the emergency-urgency service, coordinated by the 118 operations centre. Data collection will take place on the trauma’s scene, through the use of an App developed specifically by the Laboratory and installed on the tablets of the emergency vehicles. Both aggregated reports and, where possible, customized reports will be produced for each individual operator. A similar project was discussed with the Treviso hospital.
The collaboration with the world of emergency medicine began around a project on semi-intensive care units and continued with the Emergency Departments. This led to the establishment of a new collaborative research group called Fenice (fenice.marionegri.it). Regarding the semi-intensive care units, the aim is to carry out a project for the continuous evaluation and improvement of the care quality based on outcome indicators. In this sense, various indicators will be developed according to the characteristics of the patients. Each department will receive not only an annual report accompanied by various personalized performance indicators, but also it will have the opportunity to conduct data analyses independently through appropriate systems developed ad hoc. The project will also make it possible to promote the research activity in these departments. With regard to the Emergency Department, a study was launched on the appropriateness of hospitalizations of patients who access the ED with non-specific manifestations affecting the pulmonary, cardiovascular and abdominal districts. The aim is the construction and validation of an appropriateness classification algorithm based on databases. Two projects related to the CoViD-19 pathology have also been launched. The first (EC-COVID) is a randomized study embedded into an ambispective cohort study on CoViD-19 patients in ED. The objectives are to evaluate the effectiveness of early non-invasive ventilation with continuous positive airway pressure (CPAP) for the experimental part, and to evaluate the prognostic significance of the clinical and demographic characteristics of patients for the observational part. The second project (Tsunami) is a study to evaluate the impact of the CoViD-19 epidemic on the Lombardy EDs, in terms of input (calls to 118, accesses in ED and observed cases), throughput (waiting and processing time) and output (number of hospitalizations and discharges). Furthermore, the intention is to build a predictive model to forecast the number of patients afferent to the EDs during the epidemic, which takes into account access to the ED, calls to 118 in the previous days, social alert indicators, containment measures and organizational-structural characteristics of the specific EDs.
Intensive rehabilitation in severe brain injuries
With the departments of intensive rehabilitation for severe brain injuries a collaboration has been started with the CREACTIVE project on severe head injury. The collaboration led to the creation of a collaborative group (Tiresia) with the aim of continuously evaluating the care quality and making comparative evaluations of the effectiveness of different rehabilitation treatments. It was designed a first study in which the participating centres will be compared on the ability to achieve three treatment goals 4 months after the acute event on patients with acquired severe brain injuries: the achievement of total nutrition by mouth, satisfactory trunk control and tracheostomy tube removal.
Home care for the patient affected by Covid-19
This project (MonCOVID) aims at the evaluation of the feasibility and the effect of a home advanced monitoring method for patients affected by CoViD-19 or suspect cases. The objective is to carry out home monitoring and triage in order to ensure an early admission in ED and a more timely and therefore more effective treatment for worsening patients.
International Consensus on Cardiopulmonary Resuscitation.