Influence of the Mediterranean diet on carotid intima-media thickness in hypercholesterolaemic children: a 12-month intervention study.

BACKGROUND AND AIMS: The Mediterranean diet has been recognised as having a protective role on the cardiovascular system due to its low lipid and high antioxidant content. Lipid profile and oxidant status represent two important risk factors related to endothelial dysfunction, even at early stages of cardiovascular diseases. The aim of the study was to evaluate the influence of a 12-month Mediterranean diet on the variation of lipid profile and carotid intima-media thickness (cIMT) in pre-pubertal hypercholesterolaemic children. METHODS AND RESULTS: We performed a cross-sectional study comparing lipid profile and cIMT in a group of 68 pre-pubertal children (36 with hypercholesterolaemia and 32 controls). In addition, in the hypercholesterolaemic children a 12-month intervention programme with a Mediterranean diet was started to evaluate the variation of lipid profile and cIMT. At baseline, hypercholesterolaemic children showed a significantly higher cIMT (both right and left carotid artery) compared to controls (both p < 0.05). After 12 months of diet intervention, a significant reduction of total cholesterol, LDL-cholesterol and cIMT was documented (all p < 0.05). Furthermore, at the end of follow-up, delta body mass index-Standard Deviation score and delta LDL-cholesterol were significantly and independently related to the changes of cIMT (both p < 0.05). CONCLUSION: The Mediterranean diet represents a valid approach in the treatment of hypercholesterolaemia even during childhood.

Health research and systems' governance are at risk: should the right to data protection override health?

The European Union (EU) Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most innovations brought by the Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services,but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government,corporate or market research, falls under the same rule.The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical,administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe.

Privacy impact assessment in the design of transnational public health information systems: the BIRO project.

OBJECTIVES: To foster the development of a privacy-protective, sustainable cross-border information system in the framework of a European public health project. MATERIALS AND METHODS: A targeted privacy impact assessment was implemented to identify the best architecture for a European information system for diabetes directly tapping into clinical registries. Four steps were used to provide input to software designers and developers: a structured literature search, analysis of data flow scenarios or options, creation of an ad hoc questionnaire and conduction of a Delphi procedure. RESULTS: The literature search identified a core set of relevant papers on privacy (n = 11). Technicians envisaged three candidate system architectures, with associated data flows, to source an information flow questionnaire that was submitted to the Delphi panel for the selection of the best architecture. A detailed scheme envisaging an "aggregation by group of patients" was finally chosen, based upon the exchange of finely tuned summary tables. CONCLUSIONS: Public health information systems should be carefully engineered only after a clear strategy for privacy protection has been planned, to avoid breaching current regulations and future concerns and to optimise the development of statistical routines. The BIRO (Best Information Through Regional Outcomes) project delivers a specific method of privacy impact assessment that can be conveniently used in similar situations across Europe.

Strategies for the prevention of asthmatic, anaphylactic and anaphylactoid reactions during the administration of anesthetics and/or contrast media.

General anesthetics and contrast media can cause anaphylactic as well as anaphylactoid reactions. These events are of great concern to radiologists and anesthesiologists because of their relatively high prevalence, possible threat to life, and medical-legal consequences. Points discussed in this review are the critical evaluation of risk factors affecting prevention strategies, the need to be aware of pathogenic mechanisms relevant to prevention strategies, the use of alternative products if a culprit agent is known, the recognition of early signs of a reaction, the need to keep records of reactions on a patient's medical chart, the planning of prophylactic therapy, recommended actions after a reaction to an anesthetic or contrast medium, and the suggested establishment of allergy-anesthesiology centers to improve cooperation, and medical-legal issues. As any drug or contrast medium administered during general anesthesia or a diagnostic procedure can induce a potentially life-threatening or fatal event even in the absence of any evident risk factor in the patient's medical history or clinical status, we usually premedicate susceptible individuals at least to attenuate the severity of an unpredictable reaction, although we cannot rely on the efficacy of premedication to completely prevent a severe event. These recommendations, which are based on the literature and on the experience of our working group, aim to provide useful information for physicians and other specialists who operate in the absence of an allergy consultant.

Nutritional strategies for psoriasis: current scientific evidence in clinical trials.

OBJECTIVE: Several nutritional strategies for the management of psoriasis are promising. Even if recent data support that nutrition may play a pivotal role in prevention and co-treatment and despite patient's concerns regarding the best nutritional habits, the consensus regarding the nutritional strategies to be adopted lacks in clinical settings. In this manuscript, the effects of several nutritional strategies for psoriasis patients such as hypocaloric diet, vitamin D, fish oil, selenium, and zinc supplementation were systematically reviewed. Randomized controlled trials (RCTs) on beneficial botanical oral supplements were also included in the analysis. MATERIALS AND METHODS: For each topic, a search was conducted in MEDLINE electronic databases for articles published in English between January 1, 1990 and September 2018. Two independent reviewers assessed and extracted the data. Only controlled clinical trials were selected. RESULTS: The evidence regarding the current nutritional strategies for psoriasis patients were summarized and translated into a global, comprehensible recommendation. CONCLUSIONS: Weight loss combined with a healthy lifestyle was shown to be very beneficial for patients with moderate to severe disease with a significant reduction of the Psoriasis Area and Severity Index (PASI) score. Currently, oral vitamin D supplementation for prevention or treatment of psoriasis in adults with normal vitamin D levels is not recommended; however, psoriasis patients with a deficit in plasma vitamin D levels are advised to complement with oral supplements to prevent psoriasis-related comorbidities. Instead of zinc, selenium, and omega 3 supplements have been proven beneficial for psoriasis patients. Among botanical species, Dunaliella bardawil (D. bardawil), Tripterygium wilfordii (T. wilfordii), Azadirachta indica (A. indica), Curcuma longa (C. longa), and HESA-A are the most beneficial. In conclusion, a close cooperation between nutritionists and dermatologists may be useful for the management of psoriasis.

Building a Privacy, Ethics, and Data Access Framework for Real World Computerised Medical Record System Data: A Delphi Study. Contribution of the Primary Health Care Informatics Working Group.

BACKGROUND: Privacy, ethics, and data access issues pose significant challenges to the timely delivery of health research. Whilst the fundamental drivers to ensure that data access is ethical and satisfies privacy requirements are similar, they are often dealt with in varying ways by different approval processes. OBJECTIVE: To achieve a consensus across an international panel of health care and informatics professionals on an integrated set of privacy and ethics principles that could accelerate health data access in data-driven health research projects. METHOD: A three-round consensus development process was used. In round one, we developed a baseline framework for privacy, ethics, and data access based on a review of existing literature in the health, informatics, and policy domains. This was further developed using a two-round Delphi consensus building process involving 20 experts who were members of the International Medical Informatics Association (IMIA) and European Federation of Medical Informatics (EFMI) Primary Health Care Informatics Working Groups. To achieve consensus we required an extended Delphi process. RESULTS: The first round involved feedback on and development of the baseline framework. This consisted of four components: (1) ethical principles, (2) ethical guidance questions, (3) privacy and data access principles, and (4) privacy and data access guidance questions. Round two developed consensus in key areas of the revised framework, allowing the building of a newly, more detailed and descriptive framework. In the final round panel experts expressed their opinions, either as agreements or disagreements, on the ethics and privacy statements of the framework finding some of the previous round disagreements to be surprising in view of established ethical principles. CONCLUSION: This study develops a framework for an integrated approach to ethics and privacy. Privacy breech risk should not be considered in isolation but instead balanced by potential ethical benefit.

Core Standards of the EUBIROD Project. Defining a European Diabetes Data Dictionary for Clinical Audit and Healthcare Delivery.

BACKGROUND: A set of core diabetes indicators were identified in a clinical review of current evidence for the EUBIROD project. In order to allow accurate comparisons of diabetes indicators, a standardised currency for data storage and aggregation was required. We aimed to define a robust European data dictionary with appropriate clinical definitions that can be used to analyse diabetes outcomes and provide the foundation for data collection from existing electronic health records for diabetes. METHODS: Existing clinical datasets used by 15 partner institutions across Europe were collated and common data items analysed for consistency in terms of recording, data definition and units of measurement. Where necessary, data mappings and algorithms were specified in order to allow partners to meet the standard definitions. A series of descriptive elements were created to document metadata for each data item, including recording, consistency, completeness and quality. RESULTS: While datasets varied in terms of consistency, it was possible to create a common standard that could be used by all. The minimum dataset defined 53 data items that were classified according to their feasibility and validity. Mappings and standardised definitions were used to create an electronic directory for diabetes care, providing the foundation for the EUBIROD data analysis repository, also used to implement the diabetes registry and model of care for Cyprus. CONCLUSIONS: The development of data dictionaries and standards can be used to improve the quality and comparability of health information. A data dictionary has been developed to be compatible with other existing data sources for diabetes, within and beyond Europe.

Usefulness of a tilt training program for the prevention of refractory neurocardiogenic syncope in adolescents: A controlled study.

BACKGROUND: Recurrent syncope represents a debilitating disorder and quality of life deteriorates as a function of recurrence of symptoms. Although the administration of beta-blockers, vasoconstrictors, fludrocortisone, and serotonin reuptake inhibitors may be helpful in preventing episodes, many patients are intolerant of or respond poorly to these agents. Orthostatic training has been reported to be effective in preventing refractory syncope. Thus, to determine whether a tilt training program could prevent symptoms in adolescents, the following controlled study was undertaken. METHODS AND RESULTS: Forty-seven consecutive adolescents (18 male and 29 female, mean age 16.0+/-2.2 years) with recurrent syncope and positive head-up tilt test refractory to previous traditional therapies were distributed between 2 groups, depending on their consent (24 patients) or refusal (controls, 23 patients) to enter the program. Orthostatic training was started, in the presence of a family member, with a series of 5 in-hospital sessions. The 24 patients and their relatives were then instructed to perform the tilt training at home by standing against a wall twice a day for a planned duration of up to 40 minutes, depending on the in-hospital orthostatic tolerance. Head-up tilt response was reevaluated after 1 month, and the clinical effect was noted over a mean follow-up of 18. 2+/-5.3 months (range 15 to 23); 26.1% of patients in the control group and 95.8% of patients in the training group became tilt-negative (P<0.0001). Spontaneous syncope was observed in 56.5% versus 0% in the control and training group, respectively (P<0.0001). CONCLUSIONS: Orthostatic training was found to significantly improve symptoms of adolescents with neurocardiogenic syncope unresponsive to or intolerant of traditional medications. Twice-a-day training sessions of 40 minutes were well accepted by patients.

Effects of paroxetine hydrochloride, a selective serotonin reuptake inhibitor, on refractory vasovagal syncope: a randomized, double-blind, placebo-controlled study.

OBJECTIVES: The purpose of the study was to determine whether the well tolerated serotonin reuptake inhibitor paroxetine hydrochloride could prevent vasovagal syncope in patients resistant to or intolerant of previous traditional therapies. BACKGROUND: Serotonergic mechanisms play a major role in the processes leading to neurocardiogenic vasovagal syncope, and serotonin reuptake inhibitors have been reported to be effective in preventing refractory syncope. METHODS: Sixty-eight consecutive patients (26 men and 42 women, mean age 44.7+/-16.5 years) with recurrent syncope and positive head-up tilt test and in whom standard therapies with beta-adrenergic blocking agents, vagolytic, negative inotropic or mineral corticoid agents were ineffectual or poorly tolerated were referred for study. Patients randomly received either paroxetine at 20 mg once a day or a placebo. A head-up tilt test was then reperformed after one month of treatment, and the clinical effect was noted over a mean follow-up of 25.4+/-7.9 months. RESULTS: The response rates (negative tilt test) after one month of treatment were 61.8% versus 38.2% (p < 0.001) in the paroxetine and placebo groups, respectively. During follow-up spontaneous syncope was reported in six patients (17.6%) in the paroxetine group as compared to 18 patients (52.9%) in the placebo group (p < 0.0001). Only one patient (2.9%) asked to be discontinued from the drug for severe side effects. CONCLUSIONS: Paroxetine was found to significantly improve the symptoms of patients with vasovagal syncope unresponsive to or intolerant of traditional medications and was well tolerated by patients.

Detection of feline immunodeficiency proviral sequences in lymphoid tissues and the central nervous system by in situ gene amplification.

The availability of sensitive methods for detecting and localising the feline immunodeficiency virus (FIV) may help shed light on its role in generating tissue damage observed during infection. As immunohistochemical and in situ hybridisation techniques might not be sufficiently sensitive for this type of study, we adapted to FIV PCR-in situ hybridisation (PCR-ISH) that combine the extreme sensitivity of PCR with the precise localisation provided by ISH. The steps important for the success of PCR-ISH, such as sample preparation, permeabilisation, amplification profile, type of labels, and hybridisation conditions were optimised using paraformaldehyde-fixed and formalin-fixed paraffin-embedded sections of cells infected in vitro with FIV. As controls for amplification, the feline tumor necrosis factor-alpha gene (TNF-alpha) and the non-related EBNA-1 gene of the human Epstein-Barr virus were used. Once the method proved sufficiently sensitive and specific with these cells, the PCR-ISH assay was applied to paraffin sections of the lymph nodes, spleen and central nervous system of a 2-year FIV infected cat that, at the time of challenge, harboured low copy numbers of proviral genomes. Comparison of the results of PCR-ISH, competitive PCR and immunohistochemical analysis are described.

Studies on peroxidation of arachidonic acid in different liposomes below and above phase transition temperature.

The mechanism of Fe-induced peroxidation of arachidonic acid (AA) in small unilamellar vesicles (SUV) of dipalmitoylphosphatidylcholine (DPPC) and dipalmitoylphosphatidylethanolamine (DPPE) was studied below and above gel to liquid-crystalline phase transition temperature (Tm). In both liposomes the AA peroxidation resulted higher in the temperature range below Tm, but the extent of malonyldialdehyde (MDA) formation was dramatically lower in DPPE vesicles when compared with corresponding DPPC liposomes. A possible explanation for this is discussed.

[Antibiotic prophylaxis in the implantation of permanent pacemakers]. / Profilassi antibiotica nell'impianto di pace-makers permanenti.

Prophylactic antibiotics are prescribed frequently at pacemaker placements despite a paucity of data indicating effectiveness. Battery pack replacement procedures usually are not followed by infections and prophylactic antibiotics in this setting are controversial. Pacing wire and battery pack placement have higher infection rate (about 5%), thus antibiotics may be useful in the prevention of serious infections. In this study three different schemes of antibiotics prophylaxis (local prophylaxis, Short term prophylaxis, conventional postoperative prophylaxis) were compared in 72 patients receiving permanent transvenous cardiac pacemakers. No significant differences were found among these three groups also if S.T.P. showed a greatest simplicity.

[Value of vectorcardiography in the diagnosis of postero-septal infarct]. / Validità del vettorcardiogramma nella diagnosi di infarto postero-settale.

Posteroinferior infarction often complicated by the contemporaneous antero-septal necrosis due to anterior descending coronary artery critical stenosis. To confirm the value of VCG in the diagnosis of these two necrosis as regards ECG, the Authors have studied with echocardiogram, 19 patients with postero infarction, with or without inferior necrosis. The results were: frequent association of antero-septal infarction in postero-inferior necrosis; morphological and chronological VCG criteria in the diagnosis of postero-septal infarct; VCG use as bloodless method, to distinguish among the subjects with postero necrosis, the patients who must be subjected coronary angiography.

[9 years of electric stimulation in Abruzzo. cognitive findings]. / 9 anni di elettrostimolazione in Abruzzo. Indagine conoscitiva.

Data relating to 9 years of definitive electrostimulation in the Abruzzo region are presented. An account is given of the epidemiology, the indications for implantation, the stimulation and control technology, and the complications. It is pointed out that the implantability index rose from 1976 to 1978 to reach values of 130.5 implants/mil/inhab. This is in comparable with that in the literature. The technologies and modalities are rapidly developing, and a definitive picture cannot be drawn as yet. Further cognitive investigations are envisaged.

[Comparison between clinical and electrophysiological data before and after definitive pacemaker implantation for the sick sinus syndrome]. / Confronto tra dati clinici ed elettrofisiologici prima e dopo impianto di PM definitivo per sindrome del seno malato.

Personal observations of 22 patients with permanent inhibited ventricular PM for SSS during the period July 1976-February 1979 and re-examined with electrophysiological study after a follow-up made for an average period 25,5 months (14 to 49 months), after PM inhibition from the outside are presented. Patients were divided into 2 groups (group 1 with bradycardia and group 2 with brady-tachy arrhythmia). In spite of relative exiguity and uniformity of this casuistry, the conclusion is drawn that CSNRT and atropine test were more significant than SACT, in particular in forms with less pathological electrophysiological parameters.

QT interval and QT dispersion during the induction of anesthesia and tracheal intubation: a comparison of remifentanil and fentanyl.

BACKGROUND: The aim of this paper was to determine if there were any significant differences between the effects of fentanyl delivered as a bolus or remifentanil delivered as a continuous infusion on the QT interval and QT dispersion (QTD) during the induction of anesthesia and tracheal intubation. METHODS: This was a prospective, randomized and single blind study. A total of 50 ASA I-II patients scheduled to undergo elective minor abdominal surgery were divided into two groups. In the remifentanil group (N=25), patients received a continuous infusion (c.i.) of remifentanil (0.25 mcg/kg · min). In the fentanyl group (N=25), a bolus dose of fentanyl (2.0 mcg/kg) was administered. The QT interval, the difference between QTmax and QTmin (QTD), the heart rate-corrected QT (QTc) and the QT dispersion (QTcD) were calculated using a 12-lead computerized electrocardiogram (ECG). RESULTS: In both groups, there was no significant change in QT or QTc intervals during the study period. In the remifentanil group, a significant decrease in QTD and QTcD was observed during induction compared with baseline values (P<0.05). There was a significant increase in QTD at 1 min and in QTcD at 1 and 3 min after intubation in the fentanyl group (P<0.05). CONCLUSION: Both remifentanil and fentanyl did not prolong the QT interval. QTD decreased after the induction of anesthesia and did not increase after tracheal intubation in patients receiving c.i. remifentanil in comparison with fentanyl. Overall, remifentanil infusion may be the opioid-based treatment regimen of choice in patients at risk of dysrhythmias.

The effects of pneumoperitoneum and head-up position on heart rate variability and QT interval dispersion during laparoscopic cholecystectomy.

BACKGROUND: The aim of the study was to evaluate the effects of pneumoperitoneum and head-up position on autonomic cardiac function changes during inhalational or total intravenous anesthesia by using the analysis of QT dispersion and heart rate variability (HRV). METHODS: In this prospective, single-blind study, 30 patients scheduled for elective laparoscopic cholecystectomy were randomly divided in two groups: a sevoflurane-based inhalational anesthesia group (N=15) and an intravenous anesthesia group with propofol (N=15). Propofol 2.0 mg/kg-1 and cisatracurium 0.15 mg/kg-1 during induction of anesthesia and Remifentanil as titrated infusion for analgesia were used in both groups. Pneumoperitoneum was established at 12 mmHg with patients in the supine position. ECG was recorded before the induction of anesthesia; 1 and 3 min after pneumoperitoneum (supine position); 1 and 3 min after shifting the patient to a head-up position (HUP) of 60 degrees; after abdominal deflation; and after awakening. RR interval, QT interval, corrected QT interval (QTc), QT interval dispersion (QTD), corrected QT interval dispersion (QTcD), low-frequency power (LF), high-frequency power (HF) and LF/HF ratio were recorded. RESULTS: The LF/HF ratio increased significantly after 3 min HUP in the SEVO group (P<0.05). QTD and QTcD increased significantly at 3 min after abdominal insufflation and at 1 and 3 min after HUP in both groups (P<0.05). CONCLUSION: Statistically significant increases of QTD and QTcD occurred during pneumoperitoneum and HUP, regardless of the anesthetic techniques used. In patients receiving inhalational anesthesia, the LF/HF ratio increased significantly after HUP.

The slide rule: a new method for the assessment of acid-base equilibrium disorders.

AIM: Maps and nomograms are routinely used to evaluate acid-base equilibrium (ABE), but often require previous skilled practice and time to be used in the clinical setting; moreover, some definite alterations may be missed. The aim of this study was to evaluate the new slide rule (patented by Authors) for the rapid, precise and complete assessment and diagnosis of altered blood gas analysis (ABG) parameters and compare it to traditional methods. METHODS: Once pH, bicarbonate and PaCO(2) values are known by arterial blood gas analysis (ABG), the slide rule can calculate, show and instantly diagnose the related alteration, including possible mixed partial compensated ones. In this regard, 330 patients coming from 6 (4 national and 2 foreign) clinics were studied; each patient underwent evaluation of ABG alterations using traditional methods and the slide rule immediately thereafter. RESULTS: The results of consecutive evaluations on involved patients made by specialists in all clinics were in agreement; nonetheless, the slide rule was far more user friendly, rapid and complete in the ABE alterations' diagnostic range, in comparison with traditional methods. CONCLUSION: All involved specialists confirmed that the new slide rule was able to rapidly diagnose ABE alterations, including mixed or partially compensated ones that may be missed by traditional methods.

Non-invasive cardiac monitoring by aortic blood flow determination in patients undergoing hyperthermic intraperitoneal intraoperative chemotherapy.

AIM: The aim of this study was to evaluate the haemodynamic changes in patients undergoing cytoreductive surgery and intraperitoneal hyperthermic chemotherapy (IPHC) using an echo-Doppler device (Hemosonic 100). EXPERIMENTAL DESIGN: haemodynamic and cardiac function variables during IPHC, using a closed abdomen technique, were measured with the use of a non-invasive esophageal echo-Doppler monitor. SETTING: operating room in an oncologic surgery department in hospital. Fifteen patients, ASA II or III with age ranging from 59 to 66 years were successively studied. All patients were under general anaesthesia with sevoflurane, remifentanil as titrated infusion, and cisatracurium for muscle relaxation. The standard monitoring included ECG, capnometry, invasive measurement of blood pressure and central venous pressure, pulsoximetry, diuresis, esophageal and tympanic temperature. Haemodynamic changes evaluated by an echo-Doppler device were recorded at predetermined times. RESULTS: A significant reduction in stroke volume (SV) and aortic blood flow (ABF) values was recorded (P<0.05) during the abdominal cavity filling, followed by a significant increase in total systemic vascular resistance values (P<0.05). A significant increase in SV, ABF and left ventricular ejection time was recorded 90 min after the start of IPHC procedure (P<0.05) when the body temperature increased. Peak velocity and acceleration values increased significantly at the same time. CONCLUSIONS: These results suggest that the echo-Doppler device (Hemosonic 100) provided an easy-to-handle, non-invasive and reliable tool to monitor changes in cardiac parameters during IPHC.