Efficacy and safety of aripiprazole in the treatment of bipolar disorder: a systematic review.

Abstract BACKGROUND: The current article is a systematic review concerning the efficacy and safety of aripiprazole in the treatment of bipolar disorder. METHODS: A systematic Medline and repositories search concerning the usefulness of aripiprazole in bipolar disorder was performed, with the combination of the words 'aripiprazole' and 'bipolar'. RESULTS: The search returned 184 articles and was last updated on 15 April 2009. An additional search included repositories of clinical trials and previous systematic reviews specifically in order to trace unpublished trials. There were seven placebo-controlled randomised controlled trials (RCTs), six with comparator studies and one with add-on studies. They assessed the usefulness of aripiprazole in acute mania, acute bipolar depression and during the maintenance phase in comparison to placebo, lithium or haloperidol. CONCLUSION: Aripiprazole appears effective for the treatment and prophylaxis against mania. The data on bipolar depression are so far negative, however there is a need for further study at lower dosages. The most frequent adverse effects are extrapyramidal signs and symptoms, especially akathisia, without any significant weight gain, hyperprolactinaemia or laboratory test changes.

Construction and validation of a scoring system for the selection of high-quality data in a Spanish population primary care database (SIDIAP)

Background Computerised databases of primary care clinical records are widely used for epidemiological research. In Catalonia, the InformationSystem for the Development of Research in Primary Care (SIDIAP) aims to promote the development of research based on high-quality validated data from primary care electronic medical records. Objective The purpose of this study is to create and validate a scoring system (Registry Quality Score, RQS) that will enable all primary care practices (PCPs) to be selected as providers of researchusable data based on the completeness of their registers. Methods Diseases that were likely to be representative of common diagnoses seen in primary care were selected for RQS calculations. The observed/ expected cases ratio was calculated for each disease. Once we had obtained an estimated value for this ratio for each of the selected conditions we added up the ratios calculated for each condition to obtain a final RQS. Rate comparisons between observed and published prevalences of diseases not included in the RQS calculations (atrial fibrillation, diabetes, obesity, schizophrenia, stroke, urinary incontinenceand Crohn’s disease) were used to set the RQS cutoff which will enable researchers to select PCPs with research-usable data. Results Apart from Crohn’s disease, all prevalences were the same as those published from the RQS fourth quintile (60th percentile) onwards. This RQS cut-off provided a total population of 1 936 443 (39.6% of the total SIDIAP population). Conclusions SIDIAP is highly representative of the population of Catalonia in terms of geographical, age and sex distributions. We report the usefulness of rate comparison as a valid method to establish research-usable data within primary care electronic medical records

Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease

Background: The long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Methods: In two double-blind, 52-week studies, ACCLAIM/COPD I (n = 843) and II (n = 804), patients were randomised to inhaled aclidinium 200 μg or placebo once-daily. Patients were required to have a postbronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio of ≤70% and FEV1 <80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George"s Respiratory Questionnaire (SGRQ) and time to first moderate or severe COPD exacerbation. Results: At 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM/COPD I (by 61 and 67 mL; both p < 0.001) and ACCLAIM/COPD II (by 63 and 59 mL; both p < 0.001). More patients had a SGRQ improvement ≥4 units at 52 weeks with aclidinium versus placebo in ACCLAIM/COPD I (48.1% versus 39.5%; p = 0.025) and ACCLAIM/COPD II (39.0% versus 32.8%; p = 0.074). The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM/COPD II (hazard ratio [HR] 0.7; 95% confidence interval [CI] 0.55 to 0.92; p = 0.01), but not ACCLAIM/COPD I (HR 1.0; 95% CI 0.72 to 1.33; p = 0.9). Adverse events were minor in both studies. Conclusion: Aclidinium is effective and well tolerated in patients with moderate to severe COPD. Trial registration: ClinicalTrials.gov: NCT00363896 ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II).

Efficacy and safety of tigecycline versus levofloxacin for community-acquired pneumonia.

Abstract Background: Tigecycline, an expanded broad-spectrum glycylcycline, exhibits in vitro activity against many common pathogens associated with community-acqui red pneumonia (CAP), as well as penetration into lung tissues that suggests effectiveness in ho spitalized CAP patients. The aim of the present study was to compare the efficacy and safety of intravenous (IV) tigecycline with IV levofloxacin in hospitalized adults with CAP. Methods: In this prospective, double-blin d, non-inferiority phase 3 trial, eligible patients with a clinical diagnosis of CAP supported by radiographic evidence were stratified by Fine Pneumonia Severity Index and randomized to tigecycline or levofloxacin for 7-14 days of therapy. Co-primary efficacy endpoints were clinical response in the clinically evaluable (CE) and clinical modified intent- to-treat (c-mITT) populations at te st-of-cure (Day 10-21 post-therapy). Results: Of the 428 patients who received at least on e dose of study drug, 79% had CAP of mild-moderate severity according to their Fine score. Clinical cure rates for the CE population were 88.9% for tigecycline and 85.3% for levofloxac in. Corresponding c-mITT population rates were 83.7% and 81.5%, respectively. Eradication rates for Streptococcus pneumoniae were 92% for tigecycline and 89% for levofloxac in. Nausea, vomiting, and diarrhoea were the most frequently reported adverse events. Rates of premature disc continuation of study drug or study withdrawal because of any adverse event were similar for both study drugs. Conclusion: These findings suggest that IV tigecycline is non-inferior to IV levofloxacin and is generally well-tolerated in the treatment of hospitalized adults with CAP.

ESTRO-HERO survey: Guidelines for equipment and staffing of radiotherapy facilities in the European countries: Final results of the ESTRO-HERO survey

Background and purpose: In planning to meet evidence based needs for radiotherapy, guidelines for the provision of capital and human resources are central if access, quality and safety are not to be compromised. A component of the ESTRO-HERO (Health Economics in Radiation Oncology) project is to document the current availability and content of guidelines for radiotherapy in Europe. Materials and methods: An 84 part questionnaire was distributed to the European countries through their national scientific and professional radiotherapy societies with 30 items relating to the availability of guidelines for equipment and staffing and selected operational issues. Twenty-nine countries provided full or partial evaluable responses. Results: The availability of guidelines across Europe is far from uniform. The metrics used for capital and human resources are variable. There seem to have been no major changes in the availability or specifics of guidelines over the ten-year period since the QUARTS study with the exception of the recent expansion of RTT staffing models. Where comparison is possible it appears that staffing for radiation oncologists, medical physicists and particularly RTTs tend to exceed guidelines suggesting developments in clinical radiotherapy are moving faster than guideline updating. Conclusion: The efficient provision of safe, high quality radiotherapy services would benefit from the availability of well-structured guidelines for capital and human resources, based on agreed upon metrics, which could be linked to detailed estimates of need

The Complementarity between segment disclosure and earnings quality, and its effect on cost of capital

We investigate the role of earnings quality in determining the levels of segment disclosure, and whether and how better quality earnings and segment disclosure influences cost of capital. Using a large US sample for the period 2001-2006, we find a positive relation between earnings quality and levels of segment disclosures. We also find that firms providing better quality segment information, contingent upon good earnings quality, enjoy lower cost of capital. We base our empirical tests on a self created index of segment disclosure. Our results contribute to a better understanding of (1) the incentives for providing segment disclosures, and (2) how accounting quality (quality of segment information and earnings quality) is related to the cost of capital.

New technologies and nursing: use and perception of primary healthcare nurses about electronic health record in Catalonia, Spain

This study was aimed to analyze and assess the use and perception of electronic health records (EHRs) by nurses. The study sample included 113 nurses from different shifts of primary health facilities in Catalonia, Spain, devoted to adult as well as pediatric outpatients using EHRs throughout the year 2010. A majority of the sample (87.5%) were women and 12.5% were men. The average age was 44.27 years and the average time working in primary healthcare was 47.15 months. A majority (80.4%) received specific training on the use of the EHR and 19.6% did not. The use of the application required side technical support (mean: 3.42) and it is considered necessary to learn more about the performance of the application (mean: 3.50). The relationship between the average ratings that nurses have about the EHR and age shows that there is no statistically significant linear relationship (r = - 0.002, p-value = 0.984). As to how long they have used the EHRs, there are significant differences (r= -0.304, p-value = 0.00), so the more time the nurse takes using the EHR, the greater degree of satisfaction is shown. In addition, there are significant differences between nurses" perceptions regarding the EHR and gender (t = - 0.421, p-value = 0.675). Nurses assessed as positive the contribution of the EHRs in their nursing care day work (average score: 2.55/5). Considering that the usability of the EHR device is assessed as satisfactory, the results of the perception of nurses show that we must also take into account the training and emphasize the need for a side technical support in the implementation process of the EHR. Doing so, the positive perception that nurses have in regard to information and communication technology in general and with respect to the EHR in particular may be increased.

New technologies and nursing: use and perception of primary healthcare nurses about electronic health record in Catalonia, Spain

This study was aimed to analyze and assess the use and perception of electronic health records (EHRs) by nurses. The study sample included 113 nurses from different shifts of primary health facilities in Catalonia, Spain, devoted to adult as well as pediatric outpatients using EHRs throughout the year 2010. A majority of the sample (87.5%) were women and 12.5% were men. The average age was 44.27 years and the average time working in primary healthcare was 47.15 months. A majority (80.4%) received specific training on the use of the EHR and 19.6% did not. The use of the application required side technical support (mean: 3.42) and it is considered necessary to learn more about the performance of the application (mean: 3.50). The relationship between the average ratings that nurses have about the EHR and age shows that there is no statistically significant linear relationship (r = - 0.002, p-value = 0.984). As to how long they have used the EHRs, there are significant differences (r= -0.304, p-value = 0.00), so the more time the nurse takes using the EHR, the greater degree of satisfaction is shown. In addition, there are significant differences between nurses" perceptions regarding the EHR and gender (t = - 0.421, p-value = 0.675). Nurses assessed as positive the contribution of the EHRs in their nursing care day work (average score: 2.55/5). Considering that the usability of the EHR device is assessed as satisfactory, the results of the perception of nurses show that we must also take into account the training and emphasize the need for a side technical support in the implementation process of the EHR. Doing so, the positive perception that nurses have in regard to information and communication technology in general and with respect to the EHR in particular may be increased.

Design and implementation of a leisure program to improve function and wellbeing in people with depressive disorder

Depression is a major cause of disability and disease with significant costs to the health system and for the whole society. Regarding the treatment, in recent years has questioned the effectiveness of antidepressant drugs, with a recognition that although depressive disorders tend to improve with these treatments, residual symptoms seems to be still the norm, which is associated with the risk of new episodes or relapses, and faster its appearance. Otherwise many of the specialized clinical guidelines, propose a based on stepped-care model intervention, prioritizing less intrusive actions, including low-intensity psychosocial-interventions.

Identificació de marcadors biològics amb potencial per a l’optimització sensorial i tecnològica de la carn de porc i pernil curat

L’aplicació de tecnologies innovadores per a l’anàlisi de la qualitat (proteòmica) i per al processat de productes carnis (envasament actiu i altes pressions hidrostàtiques) amb la finalitat d’optimitzar la qualitat i la seguretat de productes carnis llestos per al consum fou evaluat. Els resultats obtinguts amb l’anàlisi proteòmic van permetre la detecció de pèptids/ proteïnes candidats a marcadors proteics de la qualitat dels lloms i dels pernils. La detecció d’aquests marcadors a la matèria primera (llom i pernil fresc) ajudaria a predir la qualitat final dels productes carnis processats (llom cuit i pernil curat), i proporcionaria una eina per al control de la qualitat de la carn de porc. No obstant, la validació del paper d’aquestes proteïnes a la qualitat final dels productes carnis és necessària abans de poder-los considerar marcadors proteics. Per altra banda, es va estudiar la possiblitat de millorar la seguretat alimentària de llonganissa sense sal afegida obtinguda amb el procés QDS® process a través l’ús de tecnologies innovadores (envasament actiu i altes pressions hidrostàtiques). La llonganissa sense sal afegida no va permetre el creixement de L. monocytogenes. No obstant, el patogen seria capaç de sobreviure durant la vida útil del producte en cas de recontaminació. L’envasament antimicrobià amb la inclusió de nisina com a antimicrobià natural es pot considerar un mètode efectiu per a millorar la seguretat de la llonganissa estudiada. L. monocytogenes va sobreviure al tractament d’alta pressió hidrostàtica (600 MPa, 5 min, 12ºC) gràcies a les característiques del producte de baixa activitat d’aigua i presència de lactat a la seva formulació. Per aquest motiu, la APH no es consideraria un tractament apropiat per a reduir la presència de L. monocytogenes en aquest tipus de producte.

Inter-rater agreement and reliability of the COSMIN (COnsensus-based Standards for the selection of health status Measurement Instruments) Checklist

Background: The COSMIN checklist is a tool for evaluating the methodological quality of studies on measurement properties of health-related patient-reported outcomes. The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist (n = 114). Methods: 75 articles evaluating measurement properties were randomly selected from the bibliographic database compiled by the Patient-Reported Outcome Measurement Group, Oxford, UK. Raters were asked to assess the methodological quality of three articles, using the COSMIN checklist. In a one-way design, percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item. Results: 88 raters participated. Of the 75 selected articles, 26 articles were rated by four to six participants, and 49 by two or three participants. Overall, percentage agreement was appropriate (68% was above 80% agreement), and the kappa coefficients for the COSMIN items were low (61% was below 0.40, 6% was above 0.75). Reasons for low inter-rater agreement were need for subjective judgement, and accustom to different standards, terminology and definitions.Conclusions: Results indicated that raters often choose the same response option, but that it is difficult on item level to distinguish between articles. When using the COSMIN checklist in a systematic review, we recommend getting some training and experience, completing it by two independent raters, and reaching consensus on one final rating. Instructions for using the checklist are improved.

A Preliminary Review of Behavioural Biometrics for Health Monitoring in the Elderly

This article explores the potential of ICT-based biometrics for monitoring the health status of the elderly people. It departs from specific ageing and biometric traits to then focus on behavioural biometric traits like handwriting, speech and gait to finally explore their practical application in health monitoring of elderly.

Health and reproduction of red mullet, Mullus barbatus, in the western Mediterranean Sea

The reproductive and general health of exploited fish stocks is an essential element of sustainable and profitable fisheries. The main purpose of this study was to assess the relationships between reproduction and two important parameters of fish health (parasitism and energy reserves) in female specimens of red mullet, Mullus barbatus, from the western Mediterranean Sea. We present new data for this species on (i) the prevalence and intensity of infection by metazoan parasites; (ii) the total lipid content in muscle and gonads as a measure of condition and (iii) fecundity and egg quality as a measure of their reproductive capacity. The results show that M. barbatus is a batch spawner with an income breeding strategy, an asynchronous development of oocytes and indeterminate fecundity. The results also indicate that the three most abundant and prevalent parasites significantly affect the condition and reproduction of M. barbatus. Specifically, the digenean, Opecoeloides furcatus, causes a reduction in the female"s energy reserves, while the nematodes, Hysterothylacium fabri and H. aduncum, produce a rise in egg production but impair egg quality. These implications of the relationships between parasitism, fish health and fish reproduction should be taken into consideration in the assessment and management of exploited species

Effect of biological surlie ageing on the sparkling wines’ quality and elaoration

Report for the scientific sojourn at the Université de Bourgogne, France, from July until October 2007..Surlie ageing after second fermentation is a fundamental operation in the production of quality sparkling wine like Cava and Champagne. Recently, the importance of the interaction between wine and lees cell surface has been reported. Cell surface properties depending on wall biochemical composition are major determinants in microbial interactions, having important repercussions in several technological aspects. Sorption and flocculation are especially important in sparkling wine production, and are governed by distinct cell surface properties. The aim of the present research carried out during the four months of the stage was to know the implication of lees surface modifications occurring during surlie ageing in sparkling wine quality and elaboration. The relationship between physico-chemical properties such as hydrophobicity, charge and electron-donor characteristics, and the yeast surface sorption capacities, we determined these factors in a model system. Then, real industrial lees samples were investigated. The surface properties of sparkling wine lees from the same strain of Saccharomyces cerevisiae were characterized according to the time of surlie ageing, and their possible influence on lees sorption and flocculation capacity was evaluated. Surlie ageing after second fermentation is a fundamental operation in the production of quality sparkling wine like Cava and Champagne. Recently, the importance of the interaction between wine and lees cell surface has been reported. Cell surface properties depending on wall biochemical composition are major determinants in microbial interactions, having important repercussions in several technological aspects. Sorption and flocculation are especially important in sparkling wine production, and are governed by distinct cell surface properties. The aim of the present research carried out during the four months of the stage was to know the implication of lees surface modifications occurring during surlie ageing in sparkling wine quality and elaboration. The relationship between physico-chemical properties such as hydrophobicity, charge and electron-donor characteristics, and the yeast surface sorption capacities, we determined these factors in a model system. Then, real industrial lees samples were investigated. The surface properties of sparkling wine lees from the same strain of Saccharomyces cerevisiae were characterized according to the time of surlie ageing, and their possible influence on lees sorption and flocculation capacity was evaluated.