Outcomes of off-label drug uses in hospitals: a multicentric prospective study

Purpose: The study aims to assess the clinical evidence, outcome and cost of off-label use of medicines in the hospital setting. Methods: A multicentric prospective cohort study of patients treated with off-label medicines was carried out in five tertiary hospitals from May 2011 to May 2012. Information on clinical characteristics of patients, drugs, outcomes and costs was collected. Patients were followed up to 6 months, and information was assessed by reviewing clinical records and interviewing physicians. Results: A total of 226 patients were included. The median (interquartile range (IQR)) age of patients was 46 (3362) years; 59 % were women. Patients had received a median of three previous treatments, and a lack of response (or suboptimal) was the main reason for off-label use (72.1 %). A total of 232 off-label medicines were administered for 102 different indications. The most frequent medicines were rituximab (49; 21.1 %), botulinum toxin (25; 10.7 %) and omalizumab (14; 6.0 %). In 117 (51.8 %) cases, the level of clinical evidence for their use was low. A partial clinical response was observed in 82 patients (36.3 %), complete response in 71 (31.4 %) and stabilization in 11 (4.9 %). A total of 58 (26.5 %) patients had adverse effects, which in 11 (4.9 %) were severe. The median (IQR) cost per patient was 2,943.07 (541.95,872.54). Conclusions: There was a high variability of off-label medicines and indications. Although the clinical evidence of off-label medicines was often low, clinical response was observed in many patients with previous multiple treatment failure, but at the expense of some adverse effects and a high cost. Registers of patients would be helpful for clinical decisions, although clinical trials are needed

Government-Opposition Dynamics in Spain under the Pressure of Economic Collapse and the Debt Crisis

Government - opposition relations in Spain have been long characterised by a high level of consensus and cooperation. The question analysed here is whether the economic crisis initiated in 2008 has created unprecedented levels of conflict in the political system or whether opposition parties have maintained a cooperative strategy oriented to influence far-reaching policy decisions. Results illustrate that patterns of consensus have decreased significantly since the outbreak of the crisis, and this is partly explained by the rising amount of legislation with socio-economic content, variations in the government's popularity, and the type of government. The analysis also shows that the crisis has increased the incentives of opposition parliamentary groups to oppose European Union legislation, especially among left parties

Outcomes of off-label drug uses in hospitals : a multicentric prospective study

Altres ajuts: We would to thank the Spanish Ministry of Health, Social Affairs and Equality for their financial support given though a grant from the scholarship EC-206 in the public call for the promotion of independent clinical research (SAS/2370/2010 order of September 27)The study aims to assess the clinical evidence, outcome and cost of off-label use of medicines in the hospital setting. A multicentric prospective cohort study of patients treated with off-label medicines was carried out in five tertiary hospitals from May 2011 to May 2012. Information on clinical characteristics of patients, drugs, outcomes and costs was collected. Patients were followed up to 6 months, and information was assessed by reviewing clinical records and interviewing physicians. A total of 226 patients were included. The median (interquartile range (IQR)) age of patients was 46 (33-62) years; 59 % were women. Patients had received a median of three previous treatments, and a lack of response (or suboptimal) was the main reason for off-label use (72.1 %). A total of 232 off-label medicines were administered for 102 different indications. The most frequent medicines were rituximab (49; 21.1 %), botulinum toxin (25; 10.7 %) and omalizumab (14; 6.0 %). In 117 (51.8 %) cases, the level of clinical evidence for their use was low. A partial clinical response was observed in 82 patients (36.3 %), complete response in 71 (31.4 %) and stabilization in 11 (4.9 %). A total of 58 (26.5 %) patients had adverse effects, which in 11 (4.9 %) were severe. The median (IQR) cost per patient was €2,943.07 (541.9-5,872.54). There was a high variability of off-label medicines and indications. Although the clinical evidence of off-label medicines was often low, clinical response was observed in many patients with previous multiple treatment failure, but at the expense of some adverse effects and a high cost. Registers of patients would be helpful for clinical decisions, although clinical trials are needed. The online version of this article (doi:10.1007/s00228-014-1746-2) contains supplementary material, which is available to authorized users

All News is Bad News: Newspaper Coverage of Political Parties in Spain

Spain has a highly partisan media system, with newspapers reaching self-selected partisan audiences and espousing explicitly partisan editorial preferences. Do the newspapers of the left and right differ in how they cover politics in ways that can be predicted by their partisan leanings? We review theories of issue-ownership, journalistic standards, and information scarcity and test hypotheses derived from each. We find that the parties converge substantially in virtually every aspect of their coverage. Few differences emerge when we look at what topics are covered or in the dynamics of which topics gain attention over time. However, we confirm important differences across the papers when they make explicit reference to individual political parties. Journalistic norms result in a surprising focus on the faults of one’s enemies, however, rather than the virtues of one’s allies. Our assessment is based on a comprehensive database of all front-page stories in El País and El Mundo, Spain’s largest daily newspapers, from 1996 through 2011

Comparing government agendas: executive speeches in the Netherlands, United Kingdom, Denmark and Spain

At the beginning of each Parliamentary session, almost all European governments give a speech in which they present the government’s policy goals and legislative agenda for the year to come. Despite the enormous body of literature on governments in European parliamentary democracies, systematic work on these executive policy agendas is surprisingly limited. In this paper we compare the evolvement of executive policy agendas - measured through the annual government speeches in four West European countries, UK, Spain, the Netherlands and Denmark over the past 50 years. We find that government policy agendas on the one hand are relatively stable on a year to year basis, On the other hand, when looking at the long-term development, government policy agendas do show significant patterns of change, which furthermore looks remarkably similar across the four countries despite the differences in the four countries’ political institutional structure. Hence, over the long run, executive policy agendas do change substantially, but contrary to election-based explanations of policy change, elections are not the main driver of change. Instead, the results are consistent with a more general model of issue intrusio

Risk levels for suffering a traffic injury in primary health care. The LESIONAT* project

Background: Literature shows that not only are traffic injuries due to accidents, but that there is also a correlation between different chronic conditions, the consumption of certain types of drugs, the intake of psychoactive substances and the self perception of risk (Health Belief Model) and the impact/incidence of traffic accidents. There are few studies on these aspects in primary health care. The objectives of our study are: Main aim: To outline the distribution of risk factors associated with Road Traffic Injuries (RTI) in a driving population assigned to a group of primary health care centres in Barcelona province. Secondly, we aim to study the distribution of diverse risk factors related to the possibility of suffering an RTI according to age, sex and population groups, to assess the relationship between these same risk factors and self risk perception for suffering an RTI, and to outline the association between the number of risk factors and the history of reported collisions. Methods/Design: Design: Cross-sectional, multicentre study. Setting: 25 urban health care centres. Study population: Randomly selected sample of Spanish/Catalan speakers age 16 or above with a medical register in any of the 25 participating primary health care centres. N = 1540. Unit of study: Basic unit of care, consisting of a general practitioner and a nurse, both of whom caring for the same population (1,500 to 2,000 people per unit). Instruments of measurement: Data collection will be performed using a survey carried out by health professionals, who will use the clinical registers and the information reported by the patient during the visit to collect the baseline data: illnesses, medication intake, alcohol and psychoactive consumption, and self perception of risk. Discussion: We expect to obtain a risk profile of the subjects in relation to RTI in the primary health care field, and to create a group for a prospective follow-up. Trial Registration: Clinical Trials.gov Identifier: NCT00778440. </p