Guía farmacoterapéutica de hospital : Sistema Sanitario Público de Andalucía 2014

Actualización enero de 2015. Esta guía se ha realizado en virtud de un convenio de colaboración entre el Servicio Andaluz de Salud y la Sociedad Andaluza de Famacéuticos de Hospital. Grupo hospitalario para la evaluación de medicamentos en Andalucía (GHEMA).

Use of Hy's law and a new composite algorithm to predict acute liver failure in patients with drug-induced liver injury.

BACKGROUND & AIMS Hy's Law, which states that hepatocellular drug-induced liver injury (DILI) with jaundice indicates a serious reaction, is used widely to determine risk for acute liver failure (ALF). We aimed to optimize the definition of Hy's Law and to develop a model for predicting ALF in patients with DILI. METHODS We collected data from 771 patients with DILI (805 episodes) from the Spanish DILI registry, from April 1994 through August 2012. We analyzed data collected at DILI recognition and at the time of peak levels of alanine aminotransferase (ALT) and total bilirubin (TBL). RESULTS Of the 771 patients with DILI, 32 developed ALF. Hepatocellular injury, female sex, high levels of TBL, and a high ratio of aspartate aminotransferase (AST):ALT were independent risk factors for ALF. We compared 3 ways to use Hy's Law to predict which patients would develop ALF; all included TBL greater than 2-fold the upper limit of normal (×ULN) and either ALT level greater than 3 × ULN, a ratio (R) value (ALT × ULN/alkaline phosphatase × ULN) of 5 or greater, or a new ratio (nR) value (ALT or AST, whichever produced the highest ×ULN/ alkaline phosphatase × ULN value) of 5 or greater. At recognition of DILI, the R- and nR-based models identified patients who developed ALF with 67% and 63% specificity, respectively, whereas use of only ALT level identified them with 44% specificity. However, the level of ALT and the nR model each identified patients who developed ALF with 90% sensitivity, whereas the R criteria identified them with 83% sensitivity. An equal number of patients who did and did not develop ALF had alkaline phosphatase levels greater than 2 × ULN. An algorithm based on AST level greater than 17.3 × ULN, TBL greater than 6.6 × ULN, and AST:ALT greater than 1.5 identified patients who developed ALF with 82% specificity and 80% sensitivity. CONCLUSIONS When applied at DILI recognition, the nR criteria for Hy's Law provides the best balance of sensitivity and specificity whereas our new composite algorithm provides additional specificity in predicting the ultimate development of ALF.

A delphi study to detect deficiencies and propose actions in real life treatment of neovascular age-related macular degeneration.

Purpose. Spanish retina specialists were surveyed in order to propose actions to decrease deficiencies in real-life neovascular age macular degeneration treatment (nv-AMD). Methods. One hundred experts, members of the Spanish Vitreoretinal Society (SERV), were invited to complete an online survey of 52 statements about nv-AMD management with a modified Delphi methodology. Four rounds were performed using a 5-point Linkert scale. Recommendations were developed after analyzing the differences between the results and the SERV guidelines recommendations. Results. Eighty-seven specialists completed all the Delphi rounds. Once major potential deficiencies in real-life nv-AMD treatment were identified, 15 recommendations were developed with a high level of agreement. Consensus statements to reduce the burden of the disease included the use of treat and extend regimen and to reduce the amount of diagnostic tests during the loading phase and training technical staff to perform these tests and reduce the time between relapse detection and reinjection, as well as establishing patient referral protocols to outside general ophthalmology clinics. Conclusion. The level of agreement with the final recommendations for nv-AMD treatment among Spanish retinal specialist was high indicating that some actions could be applied in order to reduce the deficiencies in real-life nv-AMD treatment.

Combined vemurafenib and cobimetinib in BRAF-mutated melanoma.

BACKGROUND The combined inhibition of BRAF and MEK is hypothesized to improve clinical outcomes in patients with melanoma by preventing or delaying the onset of resistance observed with BRAF inhibitors alone. This randomized phase 3 study evaluated the combination of the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib. METHODS We randomly assigned 495 patients with previously untreated unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma to receive vemurafenib and cobimetinib (combination group) or vemurafenib and placebo (control group). The primary end point was investigator-assessed progression-free survival. RESULTS The median progression-free survival was 9.9 months in the combination group and 6.2 months in the control group (hazard ratio for death or disease progression, 0.51; 95% confidence interval [CI], 0.39 to 0.68; P<0.001). The rate of complete or partial response in the combination group was 68%, as compared with 45% in the control group (P<0.001), including rates of complete response of 10% in the combination group and 4% in the control group. Progression-free survival as assessed by independent review was similar to investigator-assessed progression-free survival. Interim analyses of overall survival showed 9-month survival rates of 81% (95% CI, 75 to 87) in the combination group and 73% (95% CI, 65 to 80) in the control group. Vemurafenib and cobimetinib was associated with a nonsignificantly higher incidence of adverse events of grade 3 or higher, as compared with vemurafenib and placebo (65% vs. 59%), and there was no significant difference in the rate of study-drug discontinuation. The number of secondary cutaneous cancers decreased with the combination therapy. CONCLUSIONS The addition of cobimetinib to vemurafenib was associated with a significant improvement in progression-free survival among patients with BRAF V600-mutated metastatic melanoma, at the cost of some increase in toxicity. (Funded by F. Hoffmann-La Roche/Genentech; coBRIM ClinicalTrials.gov number, NCT01689519.).

Acceso abierto y repositorios

Entre los ficheros se incluye la presentación realizada como introducción al grupo de trabajo durante las jornadas en mayo de 2014

Improving integrated care in chronic kidney failure patients with a standard-based interoperability framework.

This paper introduces the evaluation report after fostering a Standard-based Interoperability Framework (SIF) between the Virgen del Rocío University Hospital (VRUH) Haemodialysis (HD) Unit and 5 outsourced HD centres in order to improve integrated care by automatically sharing patients' Electronic Health Record (EHR) and lab test reports. A pre-post study was conducted during fourteen months. The number of lab test reports of both emergency and routine nature regarding to 379 outpatients was computed before and after the integration of the SIF. Before fostering SIF, 19.38 lab tests per patient were shared between VRUH and HD centres, 5.52 of them were of emergency nature while 13.85 were routine. After integrating SIF, 17.98 lab tests per patient were shared, 3.82 of them were of emergency nature while 14.16 were routine. The inclusion of a SIF in the HD Integrated Care Process has led to an average reduction of 1.39 (p=0.775) lab test requests per patient, including a reduction of 1.70 (p=0.084) in those of emergency nature, whereas an increase of 0.31 (p=0.062) was observed in routine lab tests. Fostering this strategy has led to the reduction in emergency lab test requests, which implies a potential improvement of the integrated care.

Prospective multicenter study of the impact of carbapenem resistance on mortality in Pseudomonas aeruginosa bloodstream infections.

The impact of antimicrobial resistance on clinical outcomes is the subject of ongoing investigations, although uncertainty remains about its contribution to mortality. We investigated the impact of carbapenem resistance on mortality in Pseudomonas aeruginosa bacteremia in a prospective multicenter (10 teaching hospitals) observational study of patients with monomicrobial bacteremia followed up for 30 days after the onset of bacteremia. The adjusted influence of carbapenem resistance on mortality was studied by using Cox regression analysis. Of 632 episodes, 487 (77%) were caused by carbapenem-susceptible P. aeruginosa (CSPA) isolates, and 145 (23%) were caused by carbapenem-resistant P. aeruginosa (CRPA) isolates. The median incidence density of nosocomial CRPA bacteremia was 2.3 episodes per 100,000 patient-days (95% confidence interval [CI], 1.9 to 2.8). The regression demonstrated a time-dependent effect of carbapenem resistance on mortality as well as a significant interaction with the Charlson index: the deleterious effect of carbapenem resistance on mortality decreased with higher Charlson index scores. The impact of resistance on mortality was statistically significant only from the fifth day after the onset of the bacteremia, reaching its peak values at day 30 (adjusted hazard ratio for a Charlson score of 0 at day 30, 9.9 [95% CI, 3.3 to 29.4]; adjusted hazard ratio for a Charlson score of 5 at day 30, 2.6 [95% CI, 0.8 to 8]). This study clarifies the relationship between carbapenem resistance and mortality in patients with P. aeruginosa bacteremia. Although resistance was associated with a higher risk of mortality, the study suggested that this deleterious effect may not be as great during the first days of the bacteremia or in the presence of comorbidities.

Spatial analysis of the relationship between mortality from cardiovascular and cerebrovascular disease and drinking water hardness.

Previously published scientific papers have reported a negative correlation between drinking water hardness and cardiovascular mortality. Some ecologic and case-control studies suggest the protective effect of calcium and magnesium concentration in drinking water. In this article we present an analysis of this protective relationship in 538 municipalities of Comunidad Valenciana (Spain) from 1991-1998. We used the Spanish version of the Rapid Inquiry Facility (RIF) developed under the European Environment and Health Information System (EUROHEIS) research project. The strategy of analysis used in our study conforms to the exploratory nature of the RIF that is used as a tool to obtain quick and flexible insight into epidemiologic surveillance problems. This article describes the use of the RIF to explore possible associations between disease indicators and environmental factors. We used exposure analysis to assess the effect of both protective factors--calcium and magnesium--on mortality from cerebrovascular (ICD-9 430-438) and ischemic heart (ICD-9 410-414) diseases. This study provides statistical evidence of the relationship between mortality from cardiovascular diseases and hardness of drinking water. This relationship is stronger in cerebrovascular disease than in ischemic heart disease, is more pronounced for women than for men, and is more apparent with magnesium than with calcium concentration levels. Nevertheless, the protective nature of these two factors is not clearly established. Our results suggest the possibility of protectiveness but cannot be claimed as conclusive. The weak effects of these covariates make it difficult to separate them from the influence of socioeconomic and environmental factors. We have also performed disease mapping of standardized mortality ratios to detect clusters of municipalities with high risk. Further standardization by levels of calcium and magnesium in drinking water shows changes in the maps when we remove the effect of these covariates.

Are the health messages in schoolbooks based on scientific evidence? A descriptive study.

BACKGROUND Most textbooks contains messages relating to health. This profuse information requires analysis with regards to the quality of such information. The objective was to identify the scientific evidence on which the health messages in textbooks are based. METHODS The degree of evidence on which such messages are based was identified and the messages were subsequently classified into three categories: Messages with high, medium or low levels of evidence; Messages with an unknown level of evidence; and Messages with no known evidence. RESULTS 844 messages were studied. Of this total, 61% were classified as messages with an unknown level of evidence. Less than 15% fell into the category where the level of evidence was known and less than 6% were classified as possessing high levels of evidence. More than 70% of the messages relating to "Balanced Diets and Malnutrition", "Food Hygiene", "Tobacco", "Sexual behaviour and AIDS" and "Rest and ergonomics" are based on an unknown level of evidence. "Oral health" registered the highest percentage of messages based on a high level of evidence (37.5%), followed by "Pregnancy and newly born infants" (35%). Of the total, 24.6% are not based on any known evidence. Two of the messages appeared to contravene known evidence. CONCLUSION Many of the messages included in school textbooks are not based on scientific evidence. Standards must be established to facilitate the production of texts that include messages that are based on the best available evidence and which can improve children's health more effectively.

El blog y otras herramientas comunicativas de la biblioteca del Área de Gestión Sanitaria Este de Málaga - Axarquía

In 2006 the Library of the Andalusian Public Health System (BVSSPA) is constituted as a Virtual Library which provides Resources and Services that are accessed through inter-hospital local area network (corporate intranet) and Internet. On the other hand, the Hospital de la Axarquia still did not have any institutional or self-presence on the Internet and the librarian ask the need to create a space for communication with the "digital users" of the Library of the area through a website. MATERIALS AND METHODS. The reasons why we opted for a blog were: -It was necessary to make no financial outlay for its establishment. It allowed for great versatility, both in its administration and in its management by users. -The ability to compile on the same platform different Web 2.0 communication tools. Between different options available we chose Blogger Google Inc. The blog allowed entry to the 2.0 services or Social Web in the library. The benefits offered were many, especially the visibility of the service and communication with the user. 2.0 tools that have been incorporated into the library are: content syndication (RSS) which allowed users to stay informed about updates to the blog. Share documents and other multimedia as presentations through SlideShare, images through Flickr or Picasa, or videos (YouTube). And the presence on social network like Facebook and Twitter. RESULTS. The analysis of the activity we has been traking by Google Analytics tool, helping to determine the number of blog visits. Since its stablishment, on November 17th 2006, until November 29th 2010 the blog has received 15,787 visitors, 38,422 page views were consulted, at each visit on average 2.4 pages were consulted and each visit has an average stay at the site of 4'31''. DISCUSSION. The blog has served as a communication and information tool with the user. Since the creation of the blog we have incorporated technologies and tools to interact with the user. With all the tools used we have applied the concept of "open source" and the contents were generated from the activities organized in the Knowledge Management Unit from the anatomo-clinical sessions, the training activities, dissemination events, etc. The result has been the customization of library services, contextualized in the Knowledge Management Unit - Axarquia. In social networks we have shared information and files with the professionals and the community. CONCLUSIONS. The blog has allowed us to explore technologies that allow us to communicate with the user and the community, disseminate information and documents with the participation of users and become the "Interactive Library" we aspire to be.

Pandemic 2009 A(H1N1) infection requiring hospitalization of elderly Spanish adults.

To describe the clinical presentation and prognosis of elderly adults hospitalized with pandemic 2009 A(H1N1) influenza infection and to compare these data with those of younger patients. DESIGN: Prospective, observational, multicenter study. SETTING: Thirteen hospitals in Spain. PARTICIPANTS: Adults admitted to the hospital with confirmed pandemic 2009 A(H1N1) influenza infection. MEASUREMENTS: Demographic, clinical, laboratory, radiological, and outcome variables. RESULTS: Between June 12 and November 10, 2009, 585 adults with confirmed 2009 A(H1N1) influenza were hospitalized, of whom 50 (8.5%) were aged 65 and older (median age 72, range 65-87). Older adults (≥ 65) were more likely to have associated comorbidities (88.0% vs 51.2%; P < .001), primarily chronic pulmonary diseases (46.0% vs 27.3%; P < .001). Lower respiratory tract symptoms and signs such as dyspnea (60.0% vs 45.6%) and wheezing (46.0% vs 27.8%; P = .007) were also more common in these elderly adults, although pulmonary infiltrates were present in just 14 (28.0%) of the older adults, compared with 221 (41.3%) of the younger adults (P = .06). Multilobar involvement was less frequent in elderly adults with pulmonary infiltrates than younger adults with pulmonary infiltrates (21.4% vs 60.0%; P = .05). Rhinorrhea (4.0% vs 21.9%; P = .003), myalgias (42.0% vs 59.1%; P = .01), and sore throat (14.0% vs 29.2%; P = .02) were more frequent in younger adults. Early antiviral therapy (<48 hours) was similar in the two groups (34.0% vs 37.9%; P = .58). Two older adults (4.0%) died during hospitalization, compared with 11 (2.1%) younger adults (P = .30). CONCLUSION: Elderly adults with 2009 A(H1N1) influenza had fewer viral-like upper respiratory symptoms than did younger adults. Pneumonia was more frequent in younger adults. No significant differences were observed in hospital mortality.

A Clinical Decision Support using a Terminology Server to improve Patient Safety.

Clinical Decision Support Systems (CDSS) are software applications that support clinicians in making healthcare decisions providing relevant information for individual patients about their specific conditions. The lack of integration between CDSS and Electronic Health Record (EHR) has been identified as a significant barrier to CDSS development and adoption. Andalusia Healthcare Public System (AHPS) provides an interoperable health information infrastructure based on a Service Oriented Architecture (SOA) that eases CDSS implementation. This paper details the deployment of a CDSS jointly with the deployment of a Terminology Server (TS) within the AHPS infrastructure. It also explains a case study about the application of decision support to thromboembolism patients and its potential impact on improving patient safety. We will apply the inSPECt tool proposal to evaluate the appropriateness of alerts in this scenario.

Analysis of factors influencing telephone call response rate in an epidemiological study.

Descriptive epidemiology research involves collecting data from large numbers of subjects. Obtaining these data requires approaches designed to achieve maximum participation or response rates among respondents possessing the desired information. We analyze participation and response rates in a population-based epidemiological study though a telephone survey and identify factors implicated in consenting to participate. Rates found exceeded those reported in the literature and they were higher for afternoon calls than for morning calls. Women and subjects older than 40 years were the most likely to answer the telephone. The study identified geographical differences, with higher RRs in districts in southern Spain that are not considered urbanized. This information may be helpful for designing more efficient community epidemiology projects.