Changes in admissions, and hospitalization outcomes of IBD patients in an Italian tertiary referral center over a 13-year period.

OBJECTIVE: The management of Inflammatory Bowel Disease (IBD) has changed significantly in recent years, mainly due to the introduction of biologic medications, however, other factors may also have a role. The aim of this study was to evaluate the evolution of IBD admissions, including trends, modality of admission and rates of surgical intervention, in a tertiary care center. PATIENTS AND METHODS: Hospitalization of patients with a diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) were identified between 2000 and 2013, using ICD-9-CM codes for IBD, from our hospital database. The following parameters were evaluated for each admission: type of admission (ordinary vs. day care service), mode of admission (elective vs. emergency care, for ordinary admissions only), admission code, surgical procedures and complication rates. Comparison between pre- and post-biologic therapy introduction years was also performed. RESULTS: Between 2000 and 2013 a total of 8834 IBD-related admissions were recorded. Hospitalizations increased linearly reaching a peak in 2006, with a downward trend in the following years. The downward trend was especially marked for patients younger than 40 years. No significant differences in hospitalization trends between CD and UC were recorded. Disease flare represented the cause of hospitalization in approximately 50% of cases. Overall, 10.8% of patients underwent surgery with no difference between the two conditions. Complications occurred in 28.7% of admissions. CONCLUSIONS: Hospitalizations for IBD patients have decreased in recent years, especially in younger patients. However, a significant proportion of patients are still admitted to complete diagnostic workup, indicating the need to better implement outpatient services. A clear reduction in surgery occurrence over time could not be observed in our study.

A transition clinic model for inflammatory bowel disease between two tertiary care centers: outcomes and predictive factors.

OBJECTIVE: Few models of transition have been proposed for inflammatory bowel disease (IBD). The aim of the present study is to evaluate the feasibility of a transition model and the predictive factors for success/failure. PATIENTS AND METHODS: Patients with low activity or remission IBD were enrolled. Proposed model: three meetings every four-six weeks: the first one in the pediatric center (Bambino Gesù Children's Hospital); the second one, in the adult center (Foundation Polyclinic University A. Gemelli), with pediatric gastroenterologists; the last one, in the adult center, with adult gastroenterologists only. Questionnaires included anxiety and depression clinical scale, self-efficacy, quality of life, visual-analogic scale (VAS). Transition was considered successful if the three steps were completed. RESULTS: Twenty patients were enrolled (range 18-25 years; M/F: 12/8; Ulcerative Colitis/Crohn's Disease 10/10); eight accepted the transition program, four delayed the process and eight refused. Patients who completed transition generated higher scores on the resilience scale, better scores on well-being perception, and had lower anxiety scores. Patients who failed transition were mostly women. The perceived utility of the transition program was scored 7.3 on a VAS scale. CONCLUSIONS: The proposed transition program seems to be feasible. Psychological scores may help in selecting patients and predicting outcomes.

Quality improvement of medical records through internal auditing: a comparative analysis.

INTRODUCTION: The systematic evaluation of the quality of medical records is crucial. Nevertheless, even if the improvement of medical records quality represents a priority for every health organization, it might be difficult to realize.This is the first study to assess the efficacy of internal audit as a tool to improve the quality of medical records in hospital setting. METHODS: The program was carried out in a third level teaching hospital. Trained ad hoc evaluation teams carried out two retrospective assessments of quality of medical records using a random sampling strategy. The quality assessment was performed using a 48-items evaluation grid divided into 9 domains: General; Patient Medical History and Physical Examination; Daily Clinical Progress Notes; Daily Nursing Progress Notes; Drug Therapy Chart; Pain Chart; Discharge Summary; Surgery Register; Informed Consent. After the first evaluation of 1.460 medical records, an audit departmental program was set up. The second evaluation was carried out after the internal auditing for 1.402 medical records. RESULTS: Compared to the first analysis, a significant quality amelioration in all the sections of the medical chart was shown with the second analysis, with an increase of all the scores above 50%. The differences found for each section of medical records between the first and second analysis are all significant (p<0.01). CONCLUSIONS: Internal audits are not just measurement activities but a necessary activity to support the organization in achieving its objectives and assessing the quality of clinical care and maintaining high quality professional performance.

The unpredictability of seasonal variations in serum vitamin D levels in children with asthma and/or rhinitis

Background: Some studies have showed that seasonality is an important determinant of vitamin D (vitD) status. Objective: We evaluated whether there are differences in individual trends of serum vitD level over one year in asthmatic and rhinitic children. Materials and methods: Ninety-two asthmatic and rhinitic paediatric patients were followed up for one year and their serum vitD level was detected at three-month intervals, once in each season. Results: We observed higher vitD levels at the end of summer and lower at the end of winter. However, the individual seasonal trend was very variable and unpredictable. If it is true that in a given season the majority of patients followed one direction (increase or decrease of serum vitD levels), nevertheless a substantial percentage behaved differently and unpredictably. For example, at the end of spring, 70% of patients showed an increase in serum vitD levels, but 30% showed a decrease. In addition, five individuals had a value ≥ 50 ng/ml in September and showed serum vitD levels ≥ 30ng/ml throughout the year; 16 patients presented vitD value ≥ 40 ng/ml in September and always had ≥ 20 ng/ml in the other months. Conclusions: The wide and unpredictable variability of the individual trend of serum vitD levels should be taken into account before deciding whether or not a drug supplementation is appropriate

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The unpredictability of seasonal variations in serum vitamin D levels in children with asthma and/or rhinitis.

BACKGROUND: Some studies have showed that seasonality is an important determinant of vitamin D (vitD) status. OBJECTIVE: We evaluated whether there are differences in individual trends of serum vitD level over one year in asthmatic and rhinitic children. MATERIALS AND METHODS: Ninety-two asthmatic and rhinitic paediatric patients were followed up for one year and their serum vitD level was detected at three-month intervals, once in each season. RESULTS: We observed higher vitD levels at the end of summer and lower at the end of winter. However, the individual seasonal trend was very variable and unpredictable. If it is true that in a given season the majority of patients followed one direction (increase or decrease of serum vitD levels), nevertheless a substantial percentage behaved differently and unpredictably. For example, at the end of spring, 70% of patients showed an increase in serum vitD levels, but 30% showed a decrease. In addition, five individuals had a value ≥50ng/ml in September and showed serum vitD levels ≥30ng/ml throughout the year; 16 patients presented vitD value ≥40ng/ml in September and always had ≥20ng/ml in the other months. CONCLUSIONS: The wide and unpredictable variability of the individual trend of serum vitD levels should be taken into account before deciding whether or not a drug supplementation is appropriate.

Sustainability of Endovenous Iron Deficiency Anaemia Treatment: Hospital-Based Health Technology Assessment in IBD Patients.

Iron deficiency anaemia (IDA) is the main extraintestinal manifestation affecting patients with inflammatory bowel disease (IBD). The Health Technology Assessment approach was applied to evaluate the sustainability of intravenous (IV) iron formulations in the Italian hospital setting, with particular focus on ferric carboxymaltose. Data on the epidemiology of IBD and associated IDA, in addition to the efficacy and safety of IV iron formulations currently used in Italy, were retrieved from scientific literature. A hospital-based cost-analysis of the outpatient delivery of IV iron treatments was performed. Organizational and ethical implications were discussed. IDA prevalence in IBD patients varies markedly from 9 to 73%. IV iron preparations were proven to have good efficacy and safety profiles, and ferric carboxymaltose provided a fast correction of haemoglobin and serum ferritin levels in iron-deficient patients. Despite a higher price, ferric carboxymaltose would confer a beneficial effect to the hospital, in terms of reduced cost related to individual patient management and additionally to the patient by reducing the number of infusions and admissions to healthcare facilities. Ethically, the evaluation is appropriate due to its efficacy and compliance. This assessment supports the introduction of ferric carboxymaltose in the Italian outpatient setting.

Role of personalized medication training in improving efficacy and adherence to a topical therapy in psoriatic patients.

BACKGROUND: Poor adherence to topical therapy, defined as the degree to which patients use medication as prescribed by their healthcare provider, represents a frequent cause of poor treatment outcomes. OBJECTIVE: To evaluate the impact of individualized medication training on efficacy, adherence and patient satisfaction to 4 weeks of a topical therapy in psoriasis. METHODS: All enrolled psoriatic patients were given a prescription for calcipotriol/betamethasone dipropionate gel once daily and were randomly assigned to one of the two following groups with a 1:1 allocation ratio. Patients in group 1 and group 2 underwent an initial visit, including the physical examination and provision of information by the dermatologist. Patients in group 2 also received an additional 20 min of individualized medication training. Efficacy, adherence and patient satisfaction were evaluated after 4 weeks of treatment. RESULTS: We enrolled 104 consecutive patients with psoriasis: patients in group 2, who were trained, had a significant improvement at week 4 in BSA, PASI, dPGA and higher PPQ score, and were more adherent compared to those in group 1 who were not trained. CONCLUSION: Individualized medication training on the correct application of a topical therapy from a healthcare professional may improve patients' adherence, treatment tolerability and clinical outcomes.

The sustainability of influenza vaccination programs: considerations and perspectives from Italy.

Influenza constitutes an annually recurring threat to society, from both the clinical and economic points of view. The impact of influenza is often underestimated, especially among frail elderly people, who are at increased risk of serious complications, including hospitalization and death. In Italy, around 10 million individuals aged 65 years and older are at risk of contracting influenza, and it can be estimated that the lack of a vaccination strategy would lead to more than 2 million cases and about 30,000 deaths. However, adherence to routinely recommended adult immunizations remains suboptimal despite the availability of safe and effective vaccines. Indeed, a monitoring program from the National Institute of Health in Italy has shown that influenza vaccination coverage in the elderly dropped to 49% in the 2014-2015 season, which is far below the maximum values (68%) recorded in the 2005-2006 season. The current situation in Italy imposes a need for greater sustainability in order to face the challenges related to the changing epidemiological situation, demographic transition and social transformations. Our review sums up the key elements of influenza vaccine sustainability and makes suggestions for improving the organizational structure of the present initiatives.

Radiofrequency volumetric inferior turbinate reduction: long-term clinical results.

The aim of our study was to assess long-term results of radiofrequency volumetric tissue reduction of inferior turbinates (RVTR). We performed a prospective long-term longitudinal evaluation of 305 patients affected by rhinitis (114 allergic and 191 non-allergic) who were unresponsive to medical treatment and underwent RVTR (January 2004 - December 2010). Subjects were followed for a mean period of 39.70 ± 19.41 months (range 24-60). Patients completed the NOSE-scale questionnaire pre- and post-operatively after 1 month and yearly for 5-years. Recurrence was assumed if the post-operative total NOSE score increased by at least 75% during follow-up and the patient restarted medical treatments. Estimation of relapse over time was performed by Kaplan-Meyer analyses. We documented overall good satisfaction of patients regarding the procedure, with a good rate of pain control and a low rate of complications. Post-operatively there was a significant improvement in nasal stuffiness, nasal obstruction and mouth breathing (p < 0.05). We observed a worsening trend for symptoms after 36 months with progressive increasing rate of recurrences that were significantly higher in allergic than non-allergic patients (p < 0.05). We also observed a slight worsening trend of global satisfaction of patients. Our study confirms the minor discomfort and low risk of side effects of RVTR. Our data showed good efficacy of the procedure in the majority of patients for at least 36 months after surgery, and in fact in this time period the cumulative probability to remain relapse-free was up to 0.8. In the following 2 years, we observed a worse temporal trend in term of recurrence rate, and in particular in allergic patients with a significant difference vs non-allergic individuals (p < 0.05).

Efficacy and Mechanisms of Action of Fecal Microbiota Transplantation in Ulcerative Colitis: Pitfalls and Promises From a First Meta-Analysis.

BACKGROUND: Inflammatory bowel disease (IBD) is the results of a chronic inflammatory process deriving from disequilibrium between self-microbiota composition and immune response. METHODS: New evidence, coming from Clostridium difficile infection, clearly showed that active and powerful modulation of microbiota composition by fecal microbiota composition (FMT) is safe, easy to perform, and efficacious, opening new frontiers in gastrointestinal and extra-intestinal diseases. FMT has been proposed also for IBD as well as other non-gastrointestinal conditions related to intestinal microbiota dysfunctions, with good preliminary data. RESULTS: In this setting, ulcerative colitis (UC) represents one of the most robust potential indications for FMT after C difficile colitis. CONCLUSIONS: In the present review, we focus on FMT and its application on ulcerative colitis, clarifying mechanisms of actions and efficacy data, trough completion of a meta-analysis on available randomized, controlled trial data in UC. Because microbiota is so crucially involved in this topic, a short review of microbial alterations in UC will also be performed.

[Alcohol and work. Consensus Document of the La.R.A. (Workers representing a risk for others) group]. / Alcol e Lavoro. Documento di consenso del gruppo La.R.A.

AIM: Current Italian legislation obliges employers to prevent workers who are occupationally at risk or who perform jobs that may be hazardous for the safety or health of third parties from consuming alcohol. The LaRA Group undertook to assess whether the law fully safeguards the health and safety of both workers and third parties, without impinging upon the civil rights of workers. METHOD: A written document expressing agreement was produced following discussions between doctors, lawyers, bioethicists and social partners. RESULTS: There are gaps and inconsistencies in current laws; the differences in local and regional provisions prevent authorities from applying a single strategy at national level. There should be a change in existing rules under which the employer's obligation to enforce the ban on consumption alcohol in the workplace is enacted solely by the "competent" physician whose institutional role is to safeguard and promote health. Some occupational categories that are subject to a ban on alcohol consumption do not currently under-go health surveillance. For example, if road transport drivers are not exposed to a specific occupational risk foreseen under another law, they can be placed under health surveillance only in those regions where the local laws contemplate this type of control. In other cases, the practice of assessing the risk to third parties and providing for compulsory health surveillance in the Risk Assessment Document, is considered by some jurists to be a "consuetudo praeter legem" and therefore acceptable in a field not yet covered by a specific law, but to be "contra legem" or unlawful by other jurists. Moreover, the competent physician who uses a breathanalyser or tests for alcohol addiction faces an ethical dilemma, since by communicating the results to an employer or authorities responsible for the issuing of licenses, he may be violating his professional oath of secrecy. Furthermore, the emphasis placed on testing has induced companies and inspectors to overlook educational and rehabilitation aspects. It is essential to involve general practitioners, educators and specialist services in addressing the problems of alcohol abuse so as to inform/train, recover and rehabilitate. The few studies available indicate that the rules are poorly enforced and that non-compliance may go unobserved. CONCLUSIONS: The Group urges all employers to assess the risk for third parties caused by alcohol abuse and to devise a policy on alcohol. Controlling alcohol-related risks in the workplace calls for a better definition of the roles of Vigilance Bod-ies and Company Physicians together with a shift from a reactive to a proactive attitude of all the parties involved.

13C-octanoic acid breath test to study gastric emptying time.

Digestion is a complex process regulated by several factors. Among these, one of the most important is the time of gastric emptying. A delayed gastric emptying time can be caused by several factors and can generate considerable discomfort in humans. It ranges from mild to real debilitating disorders. Until now, different tests are suggested to study the gastric emptying time. The present review presents the mayor cause and the main symptoms linked to delayed gastric emptying and will focus on the (13)C-octanoid acid breath test, as a good candidate for studying solid gastric emptying time.

Breath tests sustainability in hospital settings: cost analysis and reimbursement in the Italian National Health System.

The high demand of Breath Tests (BT) in many gastroenterological conditions in time of limited resources for health care systems, generates increased interest in cost analysis from the point of view of the delivery of services to better understand how use the money to generate value. This study aims to measure the cost of C13 Urea and other most utilized breath tests in order to describe key aspects of costs and reimbursements looking at the economic sustainability for the hospital. A hospital based cost-analysis of the main breath tests commonly delivery in an ambulatory setting is performed. Mean salary for professional nurses and gastroenterologists, drugs/preparation used and disposable materials, purchase and depreciation of the instrument and the testing time was used to estimate the cost, while reimbursements are based on the 2013 Italian National Health System ambulatory pricelist. Variables that could influence the model are considered in the sensitivity analyses. The mean cost for C13--Urea, Lactulose and Lactose BT are, respectively, Euros 30,59; 45,20 and 30,29. National reimbursement often doesn't cover the cost of the analysis, especially considering the scenario with lower number of exam. On the contrary, in high performance scenario all the reimbursement could cover the cost, except for the C13 Urea BT that is high influenced by the drugs cost. However, consideration about the difference between Italian Regional Health System ambulatory pricelist are done. Our analysis shows that while national reimbursement rates cover the costs of H2 breath testing, they do not cover sufficiently C13 BT, particularly urea breath test. The real economic strength of these non invasive tests should be considered in the overall organization of inpatient and outpatient clinic, accounting for complete diagnostic pathway for each gastrointestinal disease.

[Availability and quality of vaccines information on the Web: a systematic review and implication in Public Health]. / Disponibilità e qualità delle informazioni presenti sul web riguardo alle vaccinazioni. Revisione sistematica e implica- zioni in Sanità Pubblica.

Adherence to vaccination campaigns can be negatively influenced by Web presence of unreliable information. Aim of study is qualitative and quantitative evaluation of Italian WebPages contents about vaccinations to address prevention strategies in countries that, like Italy, wouldn't like vaccination to be mandatory any longer In August 2011 two researchers conducted a Systematic Review in Italian WebPages about vaccination risks. First 100 results of 9 common search engines have been combined; pro and against pages were compared (CHI2, p <0,05). 144 WebPages were analysed: 67% of them, often on top positions, was against vaccinations and 24% of them was written by Medical Doctors. All institutional pages (12%) were pro vaccinations but they resulted in less important positions. Against WebPages were different from pro ones in terms of use of emotional images, personal negative experiences, advertising purposes (books or alternative medicine products). Main criticism was: inefficacy, low safety profile and stakeholder's interests. This study would like to represent a useful tool for parents and Medical Doctors, especially because many of them are progressively more sceptical about vaccination practises. The great number of anti-vaccination movements on Italian Web should improve public health strategies in terms of "Evidence-Based prevention".

[Occupational exposure to sevoflurane in pediatric operating rooms: the multi-point sampling method for risk assessment]. / Esposizione professionale al sevoflurano nelle sale operatorie di pertinenza pediatrica: il contributo del monitoraggio ambientale con tecnica multi-punto nella valutazione del rischio.

Several studies have shown that occupational exposure to anesthetic gases might be higher during pediatric surgery, probably due to the increased use of inhalational induction techniques. Our study aims to assess the level of exposure to sevoflurane in two rooms of pediatric surgery, using multi-point sampling method for environmental monitoring. The gas concentrations as well as its dispersion were measured in strategic points in the rooms for a total of 44 surgical interventions. Although the average of these concentrations has been rather low (1.32, SD +/- 1:55 ppm), the results obtained have documented a significant distribution kinetics difference inside the rooms as function of multiple factors among which there were the anesthetic technique used and the team involved. Therefore the method described allows to correctly analyze the spread of anesthetic gases and suggests a different risk stratification which may be dependent on the professional work.

Novel planar glucose biosensors for continuous monitoring use.

Novel planar glucose biosensors to be used for continuous monitoring have been developed. The electrodes are produced with the "screen printing" technique, and present a high degree of reproducibility together with a low cost and the possibility of mass production. Prior to enzyme immobilisation, electrodes are chemically modified with ferric hexacyanoferrate (Prussian Blue). This allows the detection of the hydrogen peroxide produced by the enzymatic reaction catalysed by GOD, at low applied potential (ca. 0.0 V versus Ag/AgCl), highly limiting any electrochemical interferences. The layer of Prussian Blue (PB) showed a high stability at the working conditions (pH 7.4) and also after 1 year of storage dry at RT, no loss of activity was observed. The assembled glucose biosensors, showed high sensitivity towards glucose together with a long-term operational and storage stability. In a continuous flow system, with all the analytical parameters optimised, the glucose biosensors detected glucose concentration as low as 0.025 mM with a linear range up to 1.0mM. These probes were also tested over 50-60 h in a continuous flow mode to evaluate their operational stability. A 0.5 mM concentration of glucose was continuously fluxed into a biosensor wall-jet cell and the current due to the hydrogen peroxide reduction was continuously monitored. After 50-60 h, the drift of the signal observed was around 30%. Because of their high stability, these sensors suggest the possibility of using such biosensors, in conjunction with a microdialysis probe, for a continuous monitoring of glucose for clinical purposes.

A novel continuous subcutaneous lactate monitoring system.

A novel continuous lactate monitoring system has been developed modifying the GlucoDay portable medical device (A. Menarini Diagnostics), already present in the European market, and used to continuously measure glucose levels. Lactate oxidase based biosensors have been developed immobilising the enzyme on nylon net and placing it on a Pt electrode. The biosensor was connected to the portable device provided with a micro-pump and coupled to a microdialysis system. It is capable to record subcutaneous lactate every 3 min. In vitro analytical results confirmed that the sensors respond linearly in the interval of concentration between 0.1 and 10 mmol/L, covering the whole physiological range. During prolonged monitoring periods, the response of the biosensors remained stable, showing a limited drift of 8%, within 60 h. Stability tests are still on route. However, preliminary results have shown a shelf life of about 10 months. In vivo experiments performed on healthy rabbits have demonstrated the good accuracy and reproducibility of the system. A correlation coefficient equal to 0.9547 (N=80) was found, which represents a good correlation between the GlucoDay and the laboratory reference analyser. A 16 h in vivo monitoring on a healthy volunteer has been also performed.

A microdialysis technique for continuous subcutaneous glucose monitoring in diabetic patients (part 1).

The performances and the stability of a novel subcutaneous glucose monitoring system have been evaluated. GlucoDay (A. Menarini I.F.R. S.r.l, Florence Italy) is a portable instrument provided with a micro-pump and a biosensor coupled to a microdialysis system capable of recording the subcutaneous glucose level every 3 min. Long and short term stability of the biosensor are discussed and the results of some critical in vitro and in vivo (on rabbits) experiments are reported. A linear response up to 30 mM has been found for in vivo glucose concentration. The sensitivity referred to blood glucose is better than 0.1 mM and the zero current is typically below the equivalent of 0.1 mM. In the accuracy study a mean bias of 2.7 mg/dl and a correlation coefficient equal to 0.9697 have been found. At room temperature, an excellent membrane stability assures good performances up to 6 months from the first use.

An electrochemical multienzymatic biosensor for determination of cholesterol.

This paper describes an electrochemical biosensor for free cholesterol monitoring. The sensor is a multienzymatic electrodic system in which horseradish peroxidase and cholesterol oxidase are simultaneously immobilized within a polymeric film, on the surface of a pyrolitic graphite electrode. From voltammetric and amperometric (flow-injection) data obtained, the efficiency, reproducibility and stability of the system are discussed. Results obtained, of interest for basic and applied biochemistry, represent a first step for construction of a mediator-free biosensor with potentialities for a successful application in the biosensor area.