Malpractice and patient safety descriptors: an innovative grid to evaluate the quality of clinical records

Introduction: The medical record contains all the health information related to the patient’s clinical condition and its evolution during hospitalization. It was defined by the Italian Ministry of Health in 1992 as "The information tool designed to record all relevant demographic and clinical information about a patient during a single episode of hospitalization". The documents and information in a Medical Record must meet the following criteria: traceability, clarity, accuracy, authenticity, pertinence and completeness. The objectives of our study was to develop a tool capable of assessing the quality of the clinical record and pointed the critical point at the Organizational, Technical - Professional, Managerial level. Methods: To evaluate the quality of the medical documentation, we created an assessment grid composed of 4 sections with a total of 92 criteria. This grid was tested on 200 medical records that were randomly selected from 25 (18 medical and 7 surgical) wards of a teaching hospital in Rome. Results: The grid contains 4 sections. The first part regards administrative and clinical data; the second assesses the quality of hospital stay and surgical/invasive procedures; the third part is concerned with the discharge of the patient and the fourth aims to identify the presence of advisory reports given to the patient. This grid has been validated to verify internal consistency with Cronbach's Alpha = 0,743. Conclusions: Medical records were analyzed using a validated tool with grids to identify critical issues in care activities. Weaknesses in the system were identified in order to improve planning. The sample testing also in terms of ‘self-assessment' represents a tool to introduce activities to improve safety and quality of care, greatly reducing the costs of litigation

Quality assessment of medical record as a tool for clinical risk management: a three year experience of a teaching hospital Policlinico Umberto I, Rome

Introduction: The medical record was defined by the Italian Ministry of Health in 1992 as "the information tool designed to record all relevant demographic and clinical information on a patient during a single hospitalization episode". Retrospective analysis of medical records is a tool for selecting direct and indirect indicators of critical issues (organizational, management and technical). The project’s aim being the promotion of an evaluation and self-evaluation process of medical records as a Clinical Risk Management tool to improve the quality of care within hospitals. Methods: The Authors have retrospectively analysed, using a validated grid, 1,184 medical records of patients admitted to the Teaching Hospital “Umberto I” in Rome during a three-year period (2013-2015). Statistical analysis was performed using SPSS for Windows © 19:00. All duly filled out criteria (92) were examined. “Strengths” and "Weaknesses" were identified through data analysis and Best and Bad Practice were identified based on established criteria. Conclusion: The data analysis showed marked improvements (statistically significant) in the quality of evaluated clinical documentation and indirectly upon behaviour. However, when examining some sub-criteria, critical issues emerge; these could be subject to future further corrective action

The new engineering geological map (carta litotecnica) of Tuscany (Italy)

Municipal administrations in Italy must be provided with thematic maps and documentation which describe the geological, geomorphological, lithological, hydrogeological and hydraulic characters useful to manage spatial planning issues. Among these documents, a “Lithotechnical” (or “Lithological-Technical”) map is drawn up, generally at the scale of 1:10,000, by organizing the geological formations into lithotechnical units according to their lithological and physical-mechanical properties. Often, this map also integrates the results of previous field and borehole investigations. However, this map is characterized by a certain degree of subjectivity because it is supported by few specific quantitative data. We present a new method for the regional scale engineering geological classification of sub-surface rock and soil masses obtained by integrating the geological map at the scale of 1:10,000 as a reference document, with a large set of data obtained through the collection and processing of new lithological and physical-mechanical observations and measurements of the outcropping geological formations. The adopted procedure involves both the extensive in situ use of the Schmidt's hammer and the execution of laboratory tests, such as the Slake Durability Test (Franklin & Chandra, 1972) and the determination of the rock unit weight. These tools and tests allow us to acquire a large set of quantitative in situ and laboratory data with known repeatability to obtain a regional scale GIS database providing the classification of the lithological and physical-mechanical characteristics of a wide range of geological formations. As a first step, each outcrop is classified according to a new engineering geological nomenclature system described by the code XXv[y]_[Z] whose values are obtained by integrating: i) a lithological parameter XXv evaluated from both typical characters of the geological formations under analysis and outcrop observations; ii) an engineering geological parameter [y] obtained by the results of the Slake Durability Test; iii) an engineering geological parameter [Z] (Rockmass Quality Index - RQI) evaluated at the outcrop scale on the basis of a large set of sclerometric measurements. The results of outcrop classification are stored into a point topology GIS dataset and are then processed and spatialized in order to assign the XXv[y]_[Z] code to the geological formations, thus obtaining the new engineering geological map. Within the framework of research agreements among Regione Toscana administration, the Consorzio LaMMA, the CNRIGG and the Department of Earth, Environmental and Physical Sciences of the University of Siena, the latter being the leader for their implementation, more than 300 geological formations were analysed and classified, and the new engineering geological GIS map was realized in Tuscany for the provinces of Arezzo, Florence, Lucca, Massa-Carrara, Pistoia, Prato and Siena (ca. 15,000 km2)

Early Antiangiogenic Activity of SU11248 Evaluated <i>In vivo</i> by Dynamic Contrast-Enhanced Magnetic Resonance Imaging in an Experimental Model of Colon Carcinoma

Abstract Purpose: To compare two dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) techniques in terms of their ability in assessing the early antiangiogenic effect of SU11248, a novel selective multitargeted tyrosine kinase inhibitor, that exhibits direct antitumor and antiangiogenic activity via inhibition of the receptor tyrosine kinases platelet-derived growth factor receptor, vascular endothelial growth factor receptor, KIT, and FLT3. Experimental Design: A s.c. tumor model of HT29 human colon carcinoma in athymic mice was used. Two DCE-MRI techniques were used based, respectively, on macromolecular [Gd-diethylenetriaminepentaacetic acid (DTPA)-albumin] and low molecular weight (Gd-DTPA) contrast agents. The first technique provided a quantitative measurement of transendothelial permeability and fractional plasma volume, accepted surrogate markers of tumor angiogenesis. With the second technique, we quantified the initial area under the concentration-time curve, which gives information related to tumor perfusion and vascular permeability. Experiments were done before and 24 hours after a single dose administration of SU11248. Results: The early antiangiogenic effect of SU11248 was detected by DCE-MRI with macromolecular contrast agent as a 42% decrease in vascular permeability measured in the tumor rim. The effect was also detected by DCE-MRI done with Gd-DTPA as a 31% decrease in the initial area under the concentration-time curve. Histologic slices showed a statistically significant difference in mean vessel density between the treated and control groups. Conclusions: The early antiangiogenic activity of SU11248 was detected in vivo by DCE-MRI techniques using either macromolecular or low molecular weight contrast agents. Because DCE-MRI techniques with low molecular weight contrast agents can be used in clinical studies, these results could be relevant for the design of clinical trials based on new paradigms

Managing chronic pathologies with a stepped mHealth-based approach in clinical psychology and medicine

Chronic diseases and conditions typically require long-term monitoring and treatment protocols both in traditional settings and in out-patient frameworks. The economic burden of chronic conditions is a key challenge and new and mobile technologies could offer good solutions. mHealth could be considered an evolution of eHealth and could be defined as the practice of medicine and public health supported by mobile communication devices. mHealth approach could overcome limitations linked with the traditional, restricted, and highly expensive in-patient treatment of many chronic pathologies. Possible applications include stepped mHealth approach, where patients can be monitored and treated in their everyday contexts. Unfortunately, many barriers for the spread of mHealth are still present. Due the significant impact of psychosocial factors on disease evolution, psychotherapies have to be included into the chronic disease protocols. Existing psychological theories of health behavior change have to be adapted to the new technological contexts and requirements. In conclusion, clinical psychology and medicine have to face the "chronic care management" challenge in both traditional and mHealth settings

Acute ischemic STROKE – from laboratory to the Patient’s BED (STROKELABED): A translational approach to reperfusion injury. Study Protocol

Cerebral edema (CE) and hemorrhagic transformation (HT) are frequent and unpredictable events in patients with acute ischemic stroke (AIS), even when an effective vessel recanalization has been achieved. These complications, related to blood-brain barrier (BBB) disruption, remain difficult to prevent or treat and may offset the beneficial effect of recanalization, and lead to poor outcomes. The aim of this translational study is to evaluate the association of circulating and imaging biomarkers with subsequent CE and HT in stroke patients with the dual purpose of investigating possible predictors as well as molecular dynamics underpinning those events and functional outcomes. Concurrently, the preclinical study will develop a new mouse model of middle cerebral artery (MCA) occlusion and recanalization to explore BBB alterations and their potentially harmful effects on tissue. The clinical section of the study is based on a single-center observational design enrolling consecutive patients with AIS in the anterior circulation territory, treated with recanalization therapies from October 1, 2015 to May 31, 2020. The study will employ an innovative evaluation of routine CT scans: in fact, we will assess and quantify the presence of CE and HT after stroke in CT scans at 24 h, through the quantification of anatomical distortion (AD), a measure of CE and HT. We will investigate the relationship of AD and several blood biomarkers of inflammation and extracellular matrix, with functional outcomes at 3 months. In parallel, we will employ a newly developed mouse model of stroke and recanalization, to investigate the emergence of BBB changes 24 h after the stroke onset. The close interaction between clinical and preclinical research can enhance our understanding of findings from each branch of research, enabling a deeper interpretation of the underlying mechanisms of reperfusion injury following recanalization treatment for AIS

The ACTyourCHANGE study protocol: promoting a healthy lifestyle in patients with obesity with Acceptance and Commitment Therapy-a randomized controlled trial

BackgroundAs treatment of choice in promoting psychological flexibility, Acceptance and Commitment Therapy (ACT) was found to be effective in several conditions, and among different populations, including weight management in individuals with obesity. However, the mechanism of action of psychological flexibility is less known. The aim of the present study is, within the context of a brief ACT intervention for behavioral change and behavioral maintenance of a healthy lifestyle in a sample of inpatients with obesity, to explore the effect of each subcomponent of the psychological flexibility model on treatment processes and outcomes.MethodsA randomized controlled trial will be conducted. Ninety Italian adult inpatients with obesity attending a rehabilitation program for weight loss will be randomly allocated into three experimental conditions targeting respectively each subcomponent of the psychological flexibility model: group Engage focused on values-oriented behaviors, group Openness focused on acceptance and cognitive defusion, and group Awareness focused on being present and aware of thoughts, feelings, and behaviors at every moment. Weight, BMI (kg/m(2)), the Psychological General Well-Being Inventory (PGWBI), the Outcome Questionnaire-45.2 (OQ-45.2), the Depression Anxiety and Stress Scale (DASS-21), the Difficulties in Emotion Regulation Scale (DERS), the Dutch Eating Behaviors Questionnaire (DEBQ), the Brief Values Inventory (BVI), the Committed Action Questionnaire (CAQ), the Italian-Cognitive Fusion Questionnaire (I-CFQ), the Five Facet Mindfulness Questionnaire (FFMQ), and the Acceptance and Action Questionnaire (AAQ-II) will be assessed at the beginning (time 0), at the end of psychological intervention (time 1), and after 3 (time 2) and 6months (time 3) and 9months (time 4) from discharge. During the following month after discharge, outpatients will be monitored in their adherence to a healthy lifestyle, using a wearable device.To assess the effectiveness of the intervention, mixed between-within 3 (conditions) x4 (times) repeated measure ANOVAs will be conducted to examine changes from time 0 to time 1, 2, 3, and 4 in means of weight, BMI, and means of scores PGWBI, OQ-45.2, DASS, DERS, DEBQ, AAQ-II, BVI, CAQ, I-CFQ, and FFMQ, between three groups.DiscussionThis study will contribute to clarify the mechanism of action of each subcomponent of the psychological flexibility model and understand its impact on the promotion of a healthy lifestyle.Trial registrationClinicalTrials.govNCT04474509. Registered on July 4, 202

Surgical and survival outcomes with perioperative or neoadjuvant immune-checkpoint inhibitors combined with platinum-based chemotherapy in resectable NSCLC: A systematic review and meta-analysis of randomised clinical trials

: The use of neoadjuvant or perioperative anti-PD(L)1 was recently tested in multiple clinical trials. We performed a systematic review and meta-analysis of randomised trials comparing neoadjuvant or perioperative chemoimmunotherapy to neoadjuvant chemotherapy in resectable NSCLC. Nine reports from 6 studies were included. Receipt of surgery was more frequent in the experimental arm (odds ratio, OR 1.39) as was pCR (OR 7.60). EFS was improved in the experimental arm (hazard ratio, HR 0.55) regardless of stage, histology, PD-L1 expression (PD-L1 negative, HR 0.74) and smoking exposure (never smokers, HR 0.67), as was OS (HR 0.67). Grade &gt;&nbsp;= 3 treatment-related adverse events were more frequent in the experimental arm (OR 1.22). The experimental treatment improved surgical outcomes, pCR rates, EFS and OS in stage II-IIIB, EGFR/ALK negative resectable NSCLC; confirmatory evidence is warranted for stage IIIB tumours and with higher maturity of the OS endpoint