Publications by authors named "Eva Montané"

23 Publications

  • Page 1 of 1

Epidemiology of drug-related deaths in European hospitals: A systematic review and meta-analysis of observational studies.

Br J Clin Pharmacol 2021 Feb 24. Epub 2021 Feb 24.

Department of Medical Sciences, University of Girona, Girona, Spain.

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http://dx.doi.org/10.1111/bcp.14799DOI Listing
February 2021

Patient characterization and adverse health care-related events in SARS-CoV-2 infected patients who died in a tertiary hospital.

Med Clin (Engl Ed) 2021 Mar 10;156(6):277-280. Epub 2021 Feb 10.

Dirección de Calidad, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.

Objective: To characterize health care-related adverse events in patients with SARS-CoV-2 infection who died in a tertiary hospital.

Methods: This is a retrospective, observational study, that included patients who died at HUGTiP hospital between 16 March and 10 April 2020. Data was extracted from the electronic medical record.

Results: The median age of the 164 SARS-CoV-2 infected patients who died in the center in the study period was 77.5 years and >90% of patients had ≥1 comorbidity. Forty point two percent of patients had at least ≥1 health care-related adverse event. Twenty three point eight of patients had an adverse drug reaction, the leading cause of adverse events in patients who died. Of patients who died in intensive care units, the frequency of problems related to mechanical ventilation was 8.8%.

Conclusions: Although the case fatality rate associated with the adverse events detected was very low, close monitoring of potential health care-related adverse events, especially drug reactions, as the therapeutic management of the disease remains unclear.
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http://dx.doi.org/10.1016/j.medcle.2020.11.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7874922PMC
March 2021

[Patient characterization and adverse health care-related events in SARS-CoV-2 infected patients who died in a tertiary hospital].

Med Clin (Barc) 2021 03 5;156(6):277-280. Epub 2020 Dec 5.

Dirección de Calidad, Hospital Universitari Germans Trias i Pujol, Badalona, España.

Objective: To characterize health care-related adverse events in patients with SARS-CoV-2 infection who died in a tertiary hospital.

Methods: This is a retrospective, observational study, that included patients who died at HUGTiP hospital between 16 March and 10 April 2020. Data was extracted from the electronic medical record.

Results: The median age of the 164 SARS-CoV-2 infected patients who died in the center in the study period was 77.5 years and> 90% of patients had ≥ 1 comorbidity. Forty point two percent of patients had at least ≥ 1 health care-related adverse event. Twenty three point eight of patients had an adverse drug reaction, the leading cause of adverse events in patients who died. Of patients who died in intensive care units, the frequency of problems related to mechanical ventilation was 8.8%.

Conclusions: Although the case fatality rate associated with the adverse events detected was very low, close monitoring of potential health care-related adverse events, especially drug reactions, as the therapeutic management of the disease remains unclear.
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http://dx.doi.org/10.1016/j.medcli.2020.11.002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7832921PMC
March 2021

Combination of Tocilizumab and Steroids to Improve Mortality in Patients with Severe COVID-19 Infection: A Spanish, Multicenter, Cohort Study.

Infect Dis Ther 2021 Mar 6;10(1):347-362. Epub 2020 Dec 6.

Infectious Diseases Unit, Internal Medicine Department, Hospital Universitario Puerta de Hierro-Majadahonda, Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana, Madrid, Spain.

Background: We aimed to determine the impact of tocilizumab use on severe COVID-19 (coronavirus disease 19) pneumonia mortality.

Methods: We performed a multicentre retrospective cohort study in 18 tertiary hospitals in Spain from March to April 2020. Consecutive patients admitted with severe COVID-19 treated with tocilizumab were compared to patients not treated with tocilizumab, adjusting by inverse probability of the treatment weights (IPTW). Tocilizumab's effect in patients receiving steroids during the 48 h following inclusion was analysed.

Results: During the study period, 506 patients with severe COVID-19 fulfilled the inclusion criteria. Among them, 268 were treated with tocilizumab and 238 patients were not. Median time to tocilizumab treatment from onset of symptoms was 11 days [interquartile range (IQR) 8-14]. Global mortality was 23.7%. Mortality was lower in patients treated with tocilizumab than in controls: 16.8% versus 31.5%, hazard ratio (HR) 0.514 [95% confidence interval (95% CI) 0.355-0.744], p < 0.001; weighted HR 0.741 (95% CI 0.619-0.887), p = 0.001. Tocilizumab treatment reduced mortality by 14.7% relative to no tocilizumab treatment [relative risk reduction (RRR) 46.7%]. We calculated a number necessary to treat of 7. Among patients treated with steroids, mortality was lower in those treated with tocilizumab than in those treated with steroids alone [10.9% versus 40.2%, HR 0.511 (95% CI 0.352-0.741), p = 0.036; weighted HR 0.6 (95% CI 0.449-0.804), p < 0.001] (interaction p = 0.094).

Conclusions: These results show that survival of patients with severe COVID-19 is higher in those treated with tocilizumab than in those not treated and that tocilizumab's effect adds to that of steroids administered to non-intubated patients with COVID-19 during the first 48 h of presenting with respiratory failure despite oxygen therapy. Randomised controlled studies are needed to confirm these results.

Trial Registration: European Union electronic Register of Post-Authorization Studies (EU PAS Register) identifier, EUPAS34415.
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http://dx.doi.org/10.1007/s40121-020-00373-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7719057PMC
March 2021

Cinemeducation in clinical pharmacology: using cinema to help students learn about pharmacovigilance and adverse drug reactions.

Eur J Clin Pharmacol 2020 Dec 4;76(12):1653-1658. Epub 2020 Sep 4.

School of Medicine, Universitat de Vic - Universitat Central de Catalunya, Vic, Spain.

Purpose: Feature films are increasingly being used in teaching health sciences. However, few publications address the effectiveness of this approach. We hypothesized that using feature films could help students learn. We aimed to assess the effectiveness of using a feature film to teach students about adverse drug reactions and pharmacovigilance.

Methods: The study population comprised third-, fifth-, and sixth-year undergraduate students of medicine, third-year undergraduate students of human biology, and graduate students in a master's degree program about the pharmaceutical and biotechnology industry. Students watched clips from the film 150 Miligrams (La fille de Brest) and discussed them afterward. To measure learning, we administered a 10-question multiple-choice test about pharmacovigilance concepts. We assessed students' satisfaction with the activity through a questionnaire. An exploratory comparative analysis was performed.

Results: A total of 237 students participated. Postintervention assessment scores were significantly higher than preintervention scores for the entire population and for all subgroups. The mean number of correct answers was 4.41 on the preintervention assessment and 5.78 on the postintervention assessment (mean gain: 1.37; 95% CI: 1.10-1.65). Similar results were found when analyzing groups of students from each group. Student satisfaction with this teaching activity was high in all groups.

Conclusions: Cinemeducation is a useful tool for teaching about adverse drug reactions and pharmacovigilance processes. Most students were highly satisfied.
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http://dx.doi.org/10.1007/s00228-020-02985-yDOI Listing
December 2020

Adverse drug reactions.

Med Clin (Barc) 2020 03 23;154(5):178-184. Epub 2019 Nov 23.

Servicio de Medicina Interna, Hospital Universitari Germans Trias i Pujol, Barcelona, España; Departamento de Medicina, Universitat Autònoma de Barcelona, Barcelona, España.

An adverse drug reaction (ADR) is defined as a response to a medicinal product which is noxious and unintended. ADRs are an important cause of morbidity and mortality and increase health costs. The pharmacovigilance systems allow the identification and prevention of the risks associated with use of a drug, especially of recently marketed drugs; they detect signals from data of the global ADR register and also support decisions taken by regulatory agencies in different countries. Only a few drugs are withdrawn from the market, mainly due to hepatotoxicity. Spontaneous notification of ADR is the cheapest, simplest and most used method to recognize new safety drug problems, under-reporting being its main limitation. The future of pharmacovigilance and ADRs will include a higher involvement of patients, doctors, health authorities and pharmaceutical companies, and the use of new technologies.
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http://dx.doi.org/10.1016/j.medcli.2019.08.007DOI Listing
March 2020

Drug-related deaths in hospital inpatients: A retrospective cohort study.

Br J Clin Pharmacol 2018 03 11;84(3):542-552. Epub 2018 Jan 11.

Department of Clinical Pharmacology, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain.

Aims: To determine the incidence of drug-related deaths (DRD) in a university hospital in 2015, to describe their characteristics, and to discover risk factors of DRD.

Methods: An analytic and retrospective cohort study. Patients with a death diagnosed predefined from a list of medical conditions potentially caused by drugs were the selected cases for further review. Causality assessment was evaluated by a local drug safety committee.

Results: Out of 1135 inpatient deaths, 73 DRD were included (six were hospital-acquired). The incidence of DRD of all hospital admissions was 0.34%, and the incidence of all deaths cases was 7%. Drugs were the cause of death in 38 patients (52%) and a contributive role in 35 (48%). The median age of DRD patients was 72 years (range 19-94) and 72.6% were men. The median hospital stay, Charlson score and number of drugs were 5 days, 2 points and seven drugs respectively. The most frequent DRD were cerebral haemorrhages and infections in drug-immunosuppressed patients (32, 43.8%, each group). The most frequently involved drugs were antineoplastics and glucocorticosteroids (40% and 18%), and antithrombotics (33%); drug-drug interactions were present in 44% DRD. Sex, age and number of drugs were risk factors of DRD.

Conclusions: Adverse drug reactions were a significant cause of death in hospitalized patients, mainly haemorrhages and infections precipitated by drug-drug interactions. Risk factors for DRD were sex, age and number of drugs. Preventable DRD and measures to avoid them should be accurately assessed in further studies.
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http://dx.doi.org/10.1111/bcp.13471DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5809345PMC
March 2018

Multiple adverse drug reactions and genetic polymorphism testing: A case report with negative result.

Medicine (Baltimore) 2017 Nov;96(45):e8505

Department of Clinical Pharmacology, Hospital Universitari Germans Trias i Pujol, Barcelona Department of Pharmacology, Therapeutics, and Toxicology, Universitat Autònoma de Barcelona, Barcelona Department of Psychiatry, Hospital Universitari Germans Trias i Pujol, Barcelona FIDMAG Research Foundation, Barcelona Department of Anesthesiology and Reanimation, Pain Unit, Hospital Universitari Germans Trias i Pujol, Barcelona CICAB Clinical Research Center, Extremadura University Hospital and Medical School, Badajoz, Spain.

Rationale: Defects in drug metabolic pathways could explain why some patients have a history of multiple adverse drug reactions (ADR); therefore we aimed to analyze genetic polymorphisms in a patient with multiple ADR related to drugs with a common hepatic metabolic pathway through CYP2D6.

Patient Concerns: We report a patient with psychosis and hypertension related to amitriptyline, tramadol, and duloxetine within a 2-year period.

Interventions And Outcomes: A pharmacogenetic test was performed to assess the causative role of the CYP2D6 enzyme, but did not demonstrate a metabolic deficiency.

Lessons: Although negative results in the reported case; typing for cytochrome P450 isoenzyme polymorphisms could be a useful diagnostic tool in some patients with a history of multiple ADR.
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http://dx.doi.org/10.1097/MD.0000000000008505DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5690739PMC
November 2017

Risk Stratification of Patients With Current Generation Continuous-Flow Left Ventricular Assist Devices Being Bridged to Heart Transplantation.

ASAIO J 2018 Mar/Apr;64(2):196-202

Patients bridged to transplant (BTT) with continuous-flow left ventricular assist devices (CF-LVADs) have increased in the past decade. Decision support tools for these patients are limited. We developed a risk score to estimate prognosis and guide decision-making. We included heart transplant recipients bridged with CF-LVADs from the United Network for Organ Sharing (UNOS) database and divided them into development (2,522 patients) and validation cohorts (1,681 patients). Univariate and multivariate Cox proportional hazards models were performed. Variables that independently predicted outcomes (age, African American race, recipient body mass index [BMI], intravenous [IV] antibiotic use, pretransplant dialysis, and total bilirubin) were assigned weight using linear transformation, and risk scores were derived. Patients were grouped by predicted posttransplant mortality: low risk (≤ 38 points), medium risk (38-41 points), and high risk (≥ 42 points). We performed Cox proportional hazards analysis on wait-listed CF-LVAD patients who were not transplanted. Score significantly discriminated survival among the groups in the development cohort (6.7, 12.9, 20.7; p = 0.001), validation cohort (6.4, 10.1, 13.6; p < 0.001), and ambulatory cohort (6.4, 11.5, 17.2; p < 0.001). We derived a left ventricular assist device (LVAD) BTT risk score that effectively identifies CF-LVAD patients who are at higher risk for worse outcomes after heart transplant. This score may help physicians weigh the risks of transplantation in patients with CF-LVAD.
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http://dx.doi.org/10.1097/MAT.0000000000000635DOI Listing
March 2019

Pilot, double-blind, randomized, placebo-controlled clinical trial of the supplement food Nyaditum resae® in adults with or without latent TB infection: Safety and immunogenicity.

PLoS One 2017 9;12(2):e0171294. Epub 2017 Feb 9.

Unitat de Tuberculosi Experimental, Universitat Autònoma de Barcelona, CIBERES, Fundació Institut Germans Trias i Pujol, Badalona, Catalonia, Spain.

Background: Nyaditum resae® (NR) is a galenic preparation of heat-killed Mycobacterium manresensis, a new species of the fortuitum complex, that is found in drinkable water, and that has demonstrated to protect against the development of active TB in a murine experimental model that develop human-like lesions.

Methods: Double-blind, randomized, placebo-controlled Clinical Trial (51 volunteers included). Two different doses of NR and a placebo were tested, the randomization was stratified by Latent Tuberculosis Infection (LTBI)-positive (n = 21) and LTBI-negative subjects (n = 30). Each subject received 14 drinkable daily doses for 2 weeks.

Results: All patients completed the study. The 46.3% of the overall reported adverse events (AE) were considered related to the investigational treatment. None of them were severe (94% were mild and 6% moderate). No statistical differences were found when comparing the median number of AE between the placebo group and both treatment groups. The most common AE reported were gastrointestinal events, most frequently mild abdominal pain and increase in stool frequency. Regarding the immunogenic response, both LTBI-negative and LTBI-positive volunteers treated with NR experienced a global increase on the Treg response, showed both in the population of CD25+CD39-, mainly effector Treg cells, or CD25+CD39+ memory PPD-specific Treg cells.

Conclusion: This clinical trial demonstrates an excellent tolerability profile of NR linked to a significant increase in the population of specific effector and memory Tregs in the groups treated with NR in both LTBI-positive and negative subjects. NR shows a promising profile to be used to reduce the risk of active TB.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0171294PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5300153PMC
September 2017

Definition and risk factors for chronicity following acute idiosyncratic drug-induced liver injury.

J Hepatol 2016 09 13;65(3):532-42. Epub 2016 May 13.

Unidad de Gestión Clínica de Aparato Digestivo, Servicio de Farmacología Clínica, Instituto de Investigación Biomédica de Málaga-IBIMA, Hospital Universitario Virgen de la Victoria, Universidad de Málaga, Málaga, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Spain.

Background & Aims: Chronic outcome following acute idiosyncratic drug-induced liver injury (DILI) is not yet defined. This prospective, long-term follow-up study aimed to analyze time to liver enzyme resolutions to establish the best definition and risk factors of DILI chronicity.

Methods: 298 out of 850 patients in the Spanish DILI registry with no pre-existing disease affecting the liver and follow-up to resolution or ⩾1year were analyzed. Chronicity was defined as abnormal liver biochemistry, imaging test or histology one year after DILI recognition.

Results: Out of 298 patients enrolled 273 (92%) resolved ⩽1year from DILI recognition and 25 patients (8%) were chronic. Independent risk factors for chronicity were older age [OR: 1.06, p=0.011], dyslipidemia [OR: 4.26, p=0.04] and severe DILI [OR: 14.22, p=0.005]. Alanine aminotransferase (ALT), alkaline phosphatase (ALP) and total bilirubin (TB) median values were higher in the chronic group during follow-up. Values of ALP and TB >1.1 x upper limit of normal (xULN) and 2.8 xULN respectively, in the second month from DILI onset, were found to predict chronic DILI (p<0.001). Main drug classes involved in chronicity were statins (24%) and anti-infectives (24%). Histological examination in chronic patients demonstrated two cases with ductal lesion and seven with cirrhosis.

Conclusions: One year is the best cut-off point to define chronic DILI or prolonged recovery, with risk factors being older age, dyslipidemia and severity of the acute episode. Statins are distinctly related to chronicity. ALP and TB values in the second month could help predict chronicity or very prolonged recovery.

Lay Summary: Drug-induced liver injury (DILI) patients who do not resolve their liver damage during the first year should be considered chronic DILI patients. Risk factors for DILI chronicity are older age, dyslipidemia and severity of the acute episode. Chronic DILI is not a very common condition; normally featuring mild liver profile abnormalities and not being an important clinical problem, with the exception of a small number of cases of early onset cirrhosis.
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http://dx.doi.org/10.1016/j.jhep.2016.05.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458366PMC
September 2016

Quality assessment of peripheral artery disease clinical guidelines.

J Vasc Surg 2016 Apr;63(4):1091-8

Department of Pharmacology, Therapeutic and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain; Clinical Pharmacology Service, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain. Electronic address:

Background: Clinical practice guidelines (CPGs) provide recommendations to assist health professionals and patients in the process of making decisions for specific clinical conditions to improve the quality of the patient care. However, there are concerns about the quality of some CPGs. The aim of this study was to review the quality of CPGs in pharmacologic management of peripheral artery disease (PAD).

Methods: A systematic review of CPGs for the pharmacologic treatment of PAD was performed. CPGs published between 2003 and January 2015 in English, Spanish, or French were retrieved using PubMed, Cochrane, and TRIP databases; guideline developer organization Web sites, and European and American scientific societies related to PAD Web sites. One reviewer performed the search and guideline selection, which was validated by a second reviewer. Three appraisers independently assessed the quality of CPGs using the Appraisal of Guidelines, REsearch and Evaluation II (AGREE II) instrument.

Results: A total of seven CPGs, published between 2006 and 2012, were included. All except one were written in English. Average AGREE II guidelines scores varied from 45% to 72%. There was considerable variation in the quality of the CPGs across the AGREE II domain scores (ranging from 4% to 85%). The highest scored domains were 'clarity of presentation' and 'editorial independence' and the lowest scored domain was 'applicability.' The reviewers consider that six CPGs could be recommended with modifications for use and one without modification.

Conclusions: There is great variability in the quality of the CPGs on pharmacologic treatment in PAD. All of the assessed guidelines could be recommended; however, there is considerable scope to improve their quality by highlighting aspects of applicability, the involvement of the stakeholder, as well as the rigor of development.
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http://dx.doi.org/10.1016/j.jvs.2015.12.040DOI Listing
April 2016

Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study.

PLoS One 2016 17;11(2):e0149244. Epub 2016 Feb 17.

Department of Pharmacology, Therapeutics and Toxicology, Universitat Autònoma de Barcelona, Barcelona, Spain.

Background: During the last decade, the use of 5-aminolevulinic acid (5-ALA) has been steadily increasing in neurosurgery. The study's main objectives were to prospectively evaluate the effectiveness and safety of 5-ALA when used in clinical practice setting on high-grade gliomas' patients.

Methods: National, multicenter and prospective observational study.

Inclusion Criteria: authorized conditions of use of 5-ALA.

Exclusion Criteria: contraindication to 5-ALA, inoperable or partial resected tumors, pregnancy and children. Epidemiological, clinical, laboratory, radiological, and safety data were collected. Effectiveness was assessed using complete resection of the tumor, and progression-free and overall survival probabilities.

Results: Between May 2010 and September 2014, 85 patients treated with 5-ALA were included, and 77 were suitable for the effectiveness analysis. Complete resection was achieved in 41 patients (54%). Surgeons considered suboptimal the fluorescence of 5-ALA in 40% of the patients assessed. The median duration of follow-up was 12.3 months. The progression-free survival probability at 6 months was 58%. The median duration overall survival was 14.2 months. Progression tumor risk factors were grade of glioma, age and resection degree; and death risk factors were grade of glioma and gender. No severe adverse effects were reported. At one month after surgery, new or increased neurological morbidity was 6.5%. Hepatic enzymes were frequently increased within the first month after surgery; however, they subsequently normalized, and this was found to have no clinical significance.

Conclusion: In clinical practice, the 5-ALA showed a good safety profile, but the benefits related to 5-ALA have not been yet clearly shown. The improved differentiation expected by fluorescence between normal and tumor cerebral tissue was suboptimal in a relevant number of patients; in addition, the expected higher degree of resection was lower than in clinical trials as well as incomplete resection was not identified as a prognostic factor risk for death. Because optimal fluorescence was correlated to higher complete resection rate, further research is needed to identify patients (or tumors) with more surgery benefits when using the 5-ALA.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0149244PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4757411PMC
August 2016

[Tacrolimus-induced gynecomastia in a patient with polymyositis].

Med Clin (Barc) 2016 Mar 8;146(6):284-5. Epub 2015 Dec 8.

Servicio de Reumatología, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, España.

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http://dx.doi.org/10.1016/j.medcli.2015.10.012DOI Listing
March 2016

Serious QT interval prolongation with ranolazine and amiodarone.

Int J Cardiol 2014 Mar 28;172(1):e60-1. Epub 2013 Dec 28.

Pharmacology, Therapeutics and Toxicology Department, UniversitatAutònoma de Barcelona, 08193 Bellaterra (Cerdanyola del Vallès), Spain; FundacióInstitutCatalà de Farmacologia, PasseigValld'Hebron 119-129, 08035 Barcelona, Spain.

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http://dx.doi.org/10.1016/j.ijcard.2013.12.061DOI Listing
March 2014

[Characteristics and design of the studies evaluating pharmacological interactions].

Med Clin (Barc) 2013 Jul 22;141(2):82-6. Epub 2013 May 22.

Servicio de Farmacología Clínica, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, España.

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http://dx.doi.org/10.1016/j.medcli.2013.04.006DOI Listing
July 2013

[Practical aspects for the assessment of clinical trials with prophylactic vaccines against infectious diseases].

Med Clin (Barc) 2010 Nov 15;135(15):707-12. Epub 2010 Oct 15.

Fundació Institut per a la Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona, Barcelona, España.

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http://dx.doi.org/10.1016/j.medcli.2010.09.009DOI Listing
November 2010

[Influenza A, pregnancy and neuraminidase inhibitors].

Med Clin (Barc) 2011 May 22;136(15):688-93. Epub 2010 Apr 22.

Servicio de Farmacología Clínica, Hospital Universitari Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona, España.

Following the explosion of the influenza A pandemic (H1N1) during the first semester of 2009, oseltamivir and zanamivir were used as the treatment of choice in the absence of rigorous clinical studies demonstrating their efficacy in the treatment and prophylaxis of this disease. Knowledge of seasonal influenza, flu pandemics and particularly the H1N1, which produces more severe infection and a higher mortality rate during pregnancy, led to the use of antiviral treatment despite the scarcity of clinical studies on their efficacy and effectiveness, mainly due to the influence of the media. This study reviewed the experimental and clinical studies performed on the safety of oseltamivir and zanamivir in pregnancy. Likewise, the recommendations made by the different health care and governmental authorities as well as other institutions and scientific and health care organizations on the therapeutic management and prophylaxis of influenza A 2009 in pregnant women were reviewed.
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http://dx.doi.org/10.1016/j.medcli.2010.02.006DOI Listing
May 2011

Reporting randomised clinical trials of analgesics after traumatic or orthopaedic surgery is inadequate: a systematic review.

BMC Clin Pharmacol 2010 Jan 12;10. Epub 2010 Jan 12.

Fundació Institut Català de Farmacologia, Clinical Pharmacology Service, Hospital Universitari Vall d'Hebron, Pg Vall d'Hebron, no 119-129, 08035 Barcelona, Universitat Autònoma de Barcelona, Spain.

Background: Several randomised clinical trials (RCTs) of analgesics in postoperative pain after traumatic or orthopaedic surgery (TOS) have been published, but no studies have assessed the quality of these reports. We aimed to examine the quality of reporting RCTs on analgesics for postoperative pain after TOS.

Methods: Reports of RCTs assessing analgesics in postoperative pain after TOS were systematically searched from electronic databases. The quality of reports was assessed using the CONSORT checklist (scoring range from 0 to 22). The quality was considered poor when scoring was 12 or lesser. The publication year and the impact factor of journals were recorded.

Results: A total of 92 reports of RCTs were identified and 69 (75%) scored 12 or lesser in CONSORT checklist (range 5-17). The mean (SD) CONSORT score of all reports was 10.6 (2.7). Missing CONSORT items included primary and secondary outcome measures (11%), the specific objectives and hypothesis definition (12%), the sample size calculation (12%), the dates defining the periods of recruitment (12%), the discussion of external validity of findings (14%), the allocation sequence generation (24%), and the interpretation of potential bias or imprecision of results (25%). There was a little improvement in CONSORT scores over time (r = 0.62; p < 0.001) and with impact factor of journals (r = 0.30; p < 0.001).

Conclusion: Quality of reporting RCTs on analgesics after TOS is poor. Reporting of those RCTs should be improved according to methodological standard checklists in the next years.
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http://dx.doi.org/10.1186/1472-6904-10-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2822812PMC
January 2010

Epidemiology of aplastic anemia: a prospective multicenter study.

Haematologica 2008 Apr 5;93(4):518-23. Epub 2008 Mar 5.

Fundació Institut Català de Farmacologia, Barcelona, Spain.

Background: Aplastic anemia is a rare and severe disease. Its incidence varies considerably worldwide. We aimed at describing the epidemiology of this disease, including the incidence, mortality and survival trends, in a well-defined population.

Design And Methods: Since 1980, a case-control surveillance study of aplastic anemia has been carried out by a cooperative group, in the metropolitan area of Barcelona. Inclusion is dependent on the patient having at least two of the following features: white blood cell count < or = 3.5 x 10(9)/L, platelet count < or = 50 x 10(9)/L, hemoglobin <10 g/L or hematocrit of <30%; when only one of these last two criteria is fulfilled, a reticulocyte count of < or = 30 x 10(9)/L is also required. The bone marrow biopsy has to be compatible with the diagnosis of aplastic anemia.

Results: Between 1980 and 2003, a total of 235 cases of aplastic anemia were identified. The overall incidence was 2.34 per million inhabitants per year and the incidence increased with age. Most of the cases were classified as severe or very severe aplastic anemia. Survival rates at 3 months, and at 2 and 15 years after the diagnosis were 73%, 57%, and 51%, respectively. Advanced age and more severe disease at the time of diagnosis were associated with a lower survival rate. There was a trend to a better 2-year survival rate among patients treated with bone marrow transplantation. Forty-nine cases (20.8%) were exposed to drugs reported to be associated with aplastic anemia, and 21 (8.9%) to toxic agents.

Conclusions: The incidence of aplastic anemia in Barcelona is low but the case fatality rate is high. Advanced age and severe disease at the time of diagnosis were associated with decreased survival.
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http://dx.doi.org/10.3324/haematol.12020DOI Listing
April 2008

Scientific drug information in newspapers: sensationalism and low quality. The example of therapeutic use of cannabinoids.

Eur J Clin Pharmacol 2005 Jul 28;61(5-6):475-7. Epub 2005 Jun 28.

Fundació Institut Català de Farmacologia, Hospitals Vall d'Hebron, Universitat Autònoma de Barcelona, 08035, Barcelona, Spain.

Objective: We aimed to analyse the quality of newspaper articles (NAs) concerning the therapeutic use of cannabis published in Spanish newspapers.

Methods: A preliminary questionnaire of the Index of Scientific Quality was used [scores ranged from 0 (no misleading) to 14 (misinformation in each item)].

Results: Of the 29 NAs analysed, 16 (55.2%) were scored as 4 or lower, and 6 (20.7%) scored 7 or higher. Up to 23 NAs (79.3%) did not manage the knowledge related to cannabinoids; 20 (69%) gave a sensationalist message; 11 (37.9%) were able to wrongly influence clinical decision taking; and 8 (27.6%) misled medical concepts.

Conclusion: The leading medical journals could play an especially relevant role while preparing their press releases if they specify study limitations and context.
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http://dx.doi.org/10.1007/s00228-005-0916-7DOI Listing
July 2005