luisa Arna - Academia.edu (original) (raw)
Papers by luisa Arna
![Research paper thumbnail of [Hormonal contraception and venous thromboembolism.]](https://attachments.academia-assets.com/64062428/thumbnails/1.jpg)
](Medicina Clinica, Jun 19, 2013
Estudios Penales En Homenaje Al Profesor Rodrigo Fabio Suarez Montes 2013 Isbn 978 84 940407 8 8 Pags 747 775, 2013
Revista Galego Portuguesa De Psicoloxia E Educacion Revista De Estudios E Investigacion En Psicologia Y Educacion, 2004
Behavioural Brain Research, 2015
Chromogranins are acidic proteins; both chromogranins A and B constitute the main protein compone... more Chromogranins are acidic proteins; both chromogranins A and B constitute the main protein component in the vesicular matrix of large dense core vesicles. Chromogranins are a natural source of peptides with different physiological activities that have been associated with vascular and neurological diseases. We have used three different genetic mutant models of mice lacking chromogranin A, chromogranin B and both all on the same C57BL/6J background, to characterize the physiological roles of these proteins using metabolic, cardiovascular and behavioural tests. In mice from 3 to 18 months of age, the lack of any chromogranin promoted age-dependent hypersensitivity to insulin, while the lack of both chromogranins provoked progressive lack of response to stress, as restriction did not promote tachycardia in old mice. Moreover, the lack of chromogranin B produced a depressive-like and aggressive phenotype, while the lack either or both chromogranins increased barbering behaviour. In addition, we observed no effects on light-dark box or RotaRod tests. Mice lacking chromogranin B exhibited lower exploratory activity. Based on this extensive phenotyping with more than 2800 mice, these findings support roles of chromogranins, or the peptides derived from them, in the control of aggressive behaviour along with changes in their metabolic profile beyond their previously described activities in the secretory pathway.
![Research paper thumbnail of ['Third day intervention': an analysis of the factors associated with following the recommendations on the prescribing of antibiotics]](https://attachments.academia-assets.com/64062431/thumbnails/1.jpg)
](Enfermedades infecciosas y microbiología clínica, 2014
Stewardship programs on the use of antibiotics usually include interventions based on non-compuls... more Stewardship programs on the use of antibiotics usually include interventions based on non-compulsory recommendations for the prescribers. Factors related to the adherence to expert recommendations, and the implementation of these programmes in daily practice, are of interest. A randomized, controlled, multicentre intervention study was performed in 32 hospitalization units. Antibiotic prescriptions were evaluated by an infectious disease specialist on the third day. We describe the implementation of the intervention, the factors associated with adherence to recommendations, and the impact of the intervention. A total of 3,192 interventions were carried out. Information sources used to prepare the recommendations varied significantly between centres. A modification was recommended in 65% of cases: withdrawal (47%), change in administration route (26%), change of drugs or number of antibiotics (27%), and change in dose (5%). Simplification of treatment accounted for 75% of all recomme...
Oncogene, 2002
Mice of the C57BL/6J inbred strain develop thymic lymphomas at very high frequency after acute gi... more Mice of the C57BL/6J inbred strain develop thymic lymphomas at very high frequency after acute girradiation, while mice of several inbred strains derived from the wild progenitor of the Mus spretus species and their F1 hybrids with C57BL/6J appear extremely resistant. Analysis of the genetic determinism of the gradiation-induced thymic lymphoma (RITL) resistance with the help of inter-specific consomic strains (ICS), which carry a single introgressed Mus spretus chromosome on a C57BL/6J genetic background, provide significant evidence for the existence of a thymic lymphoma resistance (Tlyr1) locus on chromosome 19. The subsequent analysis of the backcross progeny resulting from a cross between consomic mice heterozygous for the Mus spretus chromosome 19 and C57BL/ 6J mice, together with the study of inter-specific recombinant congenic strains (IRCS), suggest that this Tlyr1 locus maps within the D19Mit60 -D19Mit40 chromosome interval. In addition to the discovery of a new locus controlling RITL development, our study emphasizes the value of ICS and IRCS for the genetic analysis of cancer predisposition.
Nutrition & Metabolism, 2009
Background: Vitamin A may have some influence on the immune system, but the role in allergy modul... more Background: Vitamin A may have some influence on the immune system, but the role in allergy modulation is still unclear.
Journal of Neurochemistry, 2010
Chromogranins (Cgs) constitute the main protein component in the vesicular matrix of large dense ... more Chromogranins (Cgs) constitute the main protein component in the vesicular matrix of large dense core vesicles (LDCV). These acidic proteins have been implicated in several physiological processes such as vesicle sorting, the generation of bioactive peptides and the accumulation of soluble species inside LDCV. This latter feature of Cgs accounts for the ability of vesicles to concentrate catecholamines and Ca 2+ . Indeed, the low affinity and high capacity of Cgs to bind solutes at the low pH of the LDCV lumen seems to be behind the delay in the neurotransmitter exit towards the extracellular milieu after vesicle fusion. The availability of new mouse strains lacking Cgs in combination with the arrival of several techniques for the direct monitoring of exocytosis (like amperometry, patchamperometry and intracellular electrochemistry), have helped advance our understanding of how these granins concentrate catecholamines and Ca 2+ in LDCV, and how they influence the kinetics of exocytosis. In this review, we will discuss the roles of Cgs A and B in maintaining the intravesicular environment of secretory vesicles and in exocytosis, bringing together the most recent findings from adrenal chromaffin cells.
Inflammation Research, 2010
Background Several reports have been published on the gender differences associated with allergie... more Background Several reports have been published on the gender differences associated with allergies in mice. Goal In the present study we investigate the influence of gender on allergy response using a strain of mice, B10.RIII, which is commonly used in the collagen-induced arthritis murine model. Methods Both male and female B10.RIII young mice were immunized with OVA and challenged four times with OVA intranasally. Samples were taken 24 h after the last challenge, and eosinophils in bronchoalveolar lavage (BAL) and parenchyma, Th-2 cytokines in BAL, total and antigen-specific IgE in sera, and antigen-specific T-cell proliferation were measured.
Genetics, 2007
Complex traits are under the genetic control of multiple genes, often with weak effects and stron... more Complex traits are under the genetic control of multiple genes, often with weak effects and strong epistatic interactions. We developed two new collections of mouse strains to improve genetic dissection of complex traits. They are derived from several backcrosses of the Mus spretus SEG/Pas or STF/Pas strains on the C57BL/6J background. Each of the 55 interspecific recombinant congenic strains (IRCSs) carries up to eight SEG/Pas chromosomal segments with an average size of 11.7 Mb, totalizing 1.37% of the genome. The complete series covers 39.7% of the SEG/Pas genome. As a complementary resource, six partial or complete interspecific consomic strains were developed and increased genome coverage to 45.6%. To evaluate the usefulness of these strains for QTL mapping, 16 IRCSs were compared with C57BL/6J for seven hematological parameters. Strain 66H, which carries three SEG/Pas chromosomal segments, had lower red blood cell volume and higher platelet count than C57BL/6J. Each chromosomal segment was isolated in a congenic strain to evaluate individual effects. Congenic strains were combined to assess epistasis. Our data show that both traits were controlled by several genes with complex epistatic interactions. IRCSs are therefore useful to unravel QTL with small effects and gene-by-gene interactions.
Gastrointestinal Endoscopy, 2011
Endoscopic submucosal dissection (ESD) is the standard of care for treating gastric intramucosal ... more Endoscopic submucosal dissection (ESD) is the standard of care for treating gastric intramucosal neoplasias in Japan. However, it is seldom performed in Western countries, mainly because it is technically very challenging. Several traction methods have been proposed to facilitate submucosal dissection, but they are usually not widely available or are difficult to apply. Our main aim was to evaluate the feasibility of a new method, the clip-band technique, for improving the visualization of the submucosal layer during ESD. Observational, experimental, feasibility study conducted in a porcine model. University Hospital of the Canary Islands, Research Animal Laboratory. Animal study. After completion of the circumferential cutting, a clip-band traction system was applied. Efficacy and safety of the clip-band technique. Eighteen ESDs performed in live domestic pigs were completed without any serious complications. The mean specimen size was 35.38 ± 12.17 mm, the mean cutting time was 13.06 ± 10.52 minutes, and the mean dissection time was 16.67 ± 9.01 minutes. The clip-band technique was not compared with the standard ESD technique. This initial study shows that the clip-band traction technique is feasible and that it permits safe, effective, and relatively inexpensive gastric ESD.
Gastrointestinal Endoscopy, 2010
Gastrointestinal Endoscopy, 2010
Background: Magnets have previously been shown to be useful in endoscopic foreign body removal, E... more Background: Magnets have previously been shown to be useful in endoscopic foreign body removal, EMR, and also in a NOTES surgical/navigation system. Endoscopic methods: Three endoscopic applications are presented that feature the novel use of rare-earth magnets. (1) NOTES magnetic retraction using and external magnet interacting with smaller endoscopically delivered magnets affixed to organs requiring retraction. (2) Magnetically, retrievable pancreaticobiliary stents, obviating the need for a follow-up endoscopy. (3) Compression anastomosis using endoscopically delivered, smart, self-assembling magnets. Clinical implications: The applications presented herin offer potential solutions to (1) NOTES retraction, (2) pancreaticobiliary stent retrieval, and (3) endoscopoic means of gastrojejunostomy and cholecysto-gastrostomy creation.
European Journal of Clinical Pharmacology, 2010
Background.-A continuous intervention based on healthcare management agreements was associated in... more Background.-A continuous intervention based on healthcare management agreements was associated in our hospital with an increase in the absolute number of spontaneous reporting of adverse drug reactions (ADRs), and also with an increase in the number of reports of serious or unexpected ADRs and ADRs associated with new drugs.
European Journal of Clinical Pharmacology, 2008
Objective To describe the results and conclusions of DECnet, an international, publicly available... more Objective To describe the results and conclusions of DECnet, an international, publicly available register of paediatric drug therapy clinical trials, and to assess which paediatric health areas are covered by research and by which trial types. Methods The contents of the register, which was set up by four groups (Italy, UK, France, Spain) who searched for paediatric trials and collected data between 2004-2006, were analysed. The disease areas reflected were compared with those covered by published trials and Burden of Disease (BD) data. Results In all, 257 trial records were analysed, 86 of which were entered by the Italian partner, 84 by the UK partner, 56 by the French partner and 31 by the Spanish partner. Spain entered the majority of multinational trials, while the UK had the majority of single-centre national trials. Most trials were experimental (79%), and the most commonly represented diseases were neoplasms (14% trials). In all, 28% were double-blind randomised controlled trials (RCTs). The most common disease areas addressed in the 257 trials were similar to the published trials' areas. In contrast, the primary research area was low on the BD list.
European Journal of Clinical Pharmacology, 2014
To assess the prevalence of hospital admission related to adverse drug reactions (ADRs) in a thir... more To assess the prevalence of hospital admission related to adverse drug reactions (ADRs) in a third-level hospital, to analyse the associated factors, and to describe the reactions and the drugs involved. A cross-sectional study was conducted for a 120-day period. Patients that were urgently hospitalized entered the study. The primary endpoint was the ADR-related urgent admission. A descriptive analysis of demographic, clinical, and drug-related variables was performed. The association between the likelihood of urgent admission due to ADRs and age, gender, and number of drugs used was analysed. A descriptive analysis of the suspected drugs and the reactions in ADR-related admissions was performed. Overall, 186 out of 4,403 hospital admissions were due to ADRs (prevalence: 4.2 % [95 % CI 3.7-4.8 %]). Age (≥65 years: OR 1.59 [95 % CI 1.10-2.29]) and number of drugs used at the time of admission (3-5 drugs: OR 5.07 [95 % CI 2.71-9.59]; 6-9 drugs: OR 5.90 [95 % CI 3.16-11.0]; ≥10 drugs: OR 8.94 [95 % CI 4.73-16.89]), but not gender, were identified as independent factors associated with ADR-related hospitalization. The overall in-hospital stay for patients admitted with ADRs amounted to 1,785 days. The ADRs were mainly type A reactions (92 %). Acute renal failure related to renin-angiotensin system inhibitors, haemorrhage due to anticoagulants, and upper gastrointestinal bleeding related to antiplatelet drugs and/or non-steroidal anti-inflammatory drugs were the most frequent. Over 4 % of urgent hospitalizations are caused by ADRs, which are dose-related and predictable in more than 90 % of cases. The main risk factors are advanced age and polypharmacy.
Contemporary Clinical Trials, 2010
To assess participants&am... more To assess participants' knowledge of key aspects about the clinical trials in which they are enrolled, describe the consent process, and assess the importance that investigators give to various aspects of trial information when verbally informing candidates. Prospective study based on a structured questionnaire interview of participants within 3 months after trial enrollment and an anonymous questionnaire sent to clinical trial investigators. A total of 140 participants included in 40 clinical trials were interviewed, and 51 investigators answered the questionnaire. The formal steps to obtain informed consent were usually carried out. Participants were aware of the purpose of the trial and the right to discontinue participation, but only 23% knew that treatment was randomly allocated, 57% knew they might receive a placebo, and 42% was aware that adverse effects could occur. Patients who had read the information sheet had better knowledge of most aspects, except for the risk of adverse effects. The investigators considered that compensation, insurance coverage, possibility of receiving a placebo, and treatment allocation were the least important aspects of the trial when informing candidates for participation. Although the formal steps for obtaining informed consent were usually carried out, a relevant percentage of patients included in clinical trials were unaware of important aspects of their participation. Patients showed more limited knowledge about the same points that investigators considered less important when informing potential participants. Deferring signature on the consent form and encouraging reading of the information sheet may improve participants' knowledge about clinical trials.
Medicina Clinica, Jun 19, 2013
Estudios Penales En Homenaje Al Profesor Rodrigo Fabio Suarez Montes 2013 Isbn 978 84 940407 8 8 Pags 747 775, 2013
Revista Galego Portuguesa De Psicoloxia E Educacion Revista De Estudios E Investigacion En Psicologia Y Educacion, 2004
Behavioural Brain Research, 2015
Chromogranins are acidic proteins; both chromogranins A and B constitute the main protein compone... more Chromogranins are acidic proteins; both chromogranins A and B constitute the main protein component in the vesicular matrix of large dense core vesicles. Chromogranins are a natural source of peptides with different physiological activities that have been associated with vascular and neurological diseases. We have used three different genetic mutant models of mice lacking chromogranin A, chromogranin B and both all on the same C57BL/6J background, to characterize the physiological roles of these proteins using metabolic, cardiovascular and behavioural tests. In mice from 3 to 18 months of age, the lack of any chromogranin promoted age-dependent hypersensitivity to insulin, while the lack of both chromogranins provoked progressive lack of response to stress, as restriction did not promote tachycardia in old mice. Moreover, the lack of chromogranin B produced a depressive-like and aggressive phenotype, while the lack either or both chromogranins increased barbering behaviour. In addition, we observed no effects on light-dark box or RotaRod tests. Mice lacking chromogranin B exhibited lower exploratory activity. Based on this extensive phenotyping with more than 2800 mice, these findings support roles of chromogranins, or the peptides derived from them, in the control of aggressive behaviour along with changes in their metabolic profile beyond their previously described activities in the secretory pathway.
Enfermedades infecciosas y microbiología clínica, 2014
Stewardship programs on the use of antibiotics usually include interventions based on non-compuls... more Stewardship programs on the use of antibiotics usually include interventions based on non-compulsory recommendations for the prescribers. Factors related to the adherence to expert recommendations, and the implementation of these programmes in daily practice, are of interest. A randomized, controlled, multicentre intervention study was performed in 32 hospitalization units. Antibiotic prescriptions were evaluated by an infectious disease specialist on the third day. We describe the implementation of the intervention, the factors associated with adherence to recommendations, and the impact of the intervention. A total of 3,192 interventions were carried out. Information sources used to prepare the recommendations varied significantly between centres. A modification was recommended in 65% of cases: withdrawal (47%), change in administration route (26%), change of drugs or number of antibiotics (27%), and change in dose (5%). Simplification of treatment accounted for 75% of all recomme...
Oncogene, 2002
Mice of the C57BL/6J inbred strain develop thymic lymphomas at very high frequency after acute gi... more Mice of the C57BL/6J inbred strain develop thymic lymphomas at very high frequency after acute girradiation, while mice of several inbred strains derived from the wild progenitor of the Mus spretus species and their F1 hybrids with C57BL/6J appear extremely resistant. Analysis of the genetic determinism of the gradiation-induced thymic lymphoma (RITL) resistance with the help of inter-specific consomic strains (ICS), which carry a single introgressed Mus spretus chromosome on a C57BL/6J genetic background, provide significant evidence for the existence of a thymic lymphoma resistance (Tlyr1) locus on chromosome 19. The subsequent analysis of the backcross progeny resulting from a cross between consomic mice heterozygous for the Mus spretus chromosome 19 and C57BL/ 6J mice, together with the study of inter-specific recombinant congenic strains (IRCS), suggest that this Tlyr1 locus maps within the D19Mit60 -D19Mit40 chromosome interval. In addition to the discovery of a new locus controlling RITL development, our study emphasizes the value of ICS and IRCS for the genetic analysis of cancer predisposition.
Nutrition & Metabolism, 2009
Background: Vitamin A may have some influence on the immune system, but the role in allergy modul... more Background: Vitamin A may have some influence on the immune system, but the role in allergy modulation is still unclear.
Journal of Neurochemistry, 2010
Chromogranins (Cgs) constitute the main protein component in the vesicular matrix of large dense ... more Chromogranins (Cgs) constitute the main protein component in the vesicular matrix of large dense core vesicles (LDCV). These acidic proteins have been implicated in several physiological processes such as vesicle sorting, the generation of bioactive peptides and the accumulation of soluble species inside LDCV. This latter feature of Cgs accounts for the ability of vesicles to concentrate catecholamines and Ca 2+ . Indeed, the low affinity and high capacity of Cgs to bind solutes at the low pH of the LDCV lumen seems to be behind the delay in the neurotransmitter exit towards the extracellular milieu after vesicle fusion. The availability of new mouse strains lacking Cgs in combination with the arrival of several techniques for the direct monitoring of exocytosis (like amperometry, patchamperometry and intracellular electrochemistry), have helped advance our understanding of how these granins concentrate catecholamines and Ca 2+ in LDCV, and how they influence the kinetics of exocytosis. In this review, we will discuss the roles of Cgs A and B in maintaining the intravesicular environment of secretory vesicles and in exocytosis, bringing together the most recent findings from adrenal chromaffin cells.
Inflammation Research, 2010
Background Several reports have been published on the gender differences associated with allergie... more Background Several reports have been published on the gender differences associated with allergies in mice. Goal In the present study we investigate the influence of gender on allergy response using a strain of mice, B10.RIII, which is commonly used in the collagen-induced arthritis murine model. Methods Both male and female B10.RIII young mice were immunized with OVA and challenged four times with OVA intranasally. Samples were taken 24 h after the last challenge, and eosinophils in bronchoalveolar lavage (BAL) and parenchyma, Th-2 cytokines in BAL, total and antigen-specific IgE in sera, and antigen-specific T-cell proliferation were measured.
Genetics, 2007
Complex traits are under the genetic control of multiple genes, often with weak effects and stron... more Complex traits are under the genetic control of multiple genes, often with weak effects and strong epistatic interactions. We developed two new collections of mouse strains to improve genetic dissection of complex traits. They are derived from several backcrosses of the Mus spretus SEG/Pas or STF/Pas strains on the C57BL/6J background. Each of the 55 interspecific recombinant congenic strains (IRCSs) carries up to eight SEG/Pas chromosomal segments with an average size of 11.7 Mb, totalizing 1.37% of the genome. The complete series covers 39.7% of the SEG/Pas genome. As a complementary resource, six partial or complete interspecific consomic strains were developed and increased genome coverage to 45.6%. To evaluate the usefulness of these strains for QTL mapping, 16 IRCSs were compared with C57BL/6J for seven hematological parameters. Strain 66H, which carries three SEG/Pas chromosomal segments, had lower red blood cell volume and higher platelet count than C57BL/6J. Each chromosomal segment was isolated in a congenic strain to evaluate individual effects. Congenic strains were combined to assess epistasis. Our data show that both traits were controlled by several genes with complex epistatic interactions. IRCSs are therefore useful to unravel QTL with small effects and gene-by-gene interactions.
Gastrointestinal Endoscopy, 2011
Endoscopic submucosal dissection (ESD) is the standard of care for treating gastric intramucosal ... more Endoscopic submucosal dissection (ESD) is the standard of care for treating gastric intramucosal neoplasias in Japan. However, it is seldom performed in Western countries, mainly because it is technically very challenging. Several traction methods have been proposed to facilitate submucosal dissection, but they are usually not widely available or are difficult to apply. Our main aim was to evaluate the feasibility of a new method, the clip-band technique, for improving the visualization of the submucosal layer during ESD. Observational, experimental, feasibility study conducted in a porcine model. University Hospital of the Canary Islands, Research Animal Laboratory. Animal study. After completion of the circumferential cutting, a clip-band traction system was applied. Efficacy and safety of the clip-band technique. Eighteen ESDs performed in live domestic pigs were completed without any serious complications. The mean specimen size was 35.38 ± 12.17 mm, the mean cutting time was 13.06 ± 10.52 minutes, and the mean dissection time was 16.67 ± 9.01 minutes. The clip-band technique was not compared with the standard ESD technique. This initial study shows that the clip-band traction technique is feasible and that it permits safe, effective, and relatively inexpensive gastric ESD.
Gastrointestinal Endoscopy, 2010
Gastrointestinal Endoscopy, 2010
Background: Magnets have previously been shown to be useful in endoscopic foreign body removal, E... more Background: Magnets have previously been shown to be useful in endoscopic foreign body removal, EMR, and also in a NOTES surgical/navigation system. Endoscopic methods: Three endoscopic applications are presented that feature the novel use of rare-earth magnets. (1) NOTES magnetic retraction using and external magnet interacting with smaller endoscopically delivered magnets affixed to organs requiring retraction. (2) Magnetically, retrievable pancreaticobiliary stents, obviating the need for a follow-up endoscopy. (3) Compression anastomosis using endoscopically delivered, smart, self-assembling magnets. Clinical implications: The applications presented herin offer potential solutions to (1) NOTES retraction, (2) pancreaticobiliary stent retrieval, and (3) endoscopoic means of gastrojejunostomy and cholecysto-gastrostomy creation.
European Journal of Clinical Pharmacology, 2010
Background.-A continuous intervention based on healthcare management agreements was associated in... more Background.-A continuous intervention based on healthcare management agreements was associated in our hospital with an increase in the absolute number of spontaneous reporting of adverse drug reactions (ADRs), and also with an increase in the number of reports of serious or unexpected ADRs and ADRs associated with new drugs.
European Journal of Clinical Pharmacology, 2008
Objective To describe the results and conclusions of DECnet, an international, publicly available... more Objective To describe the results and conclusions of DECnet, an international, publicly available register of paediatric drug therapy clinical trials, and to assess which paediatric health areas are covered by research and by which trial types. Methods The contents of the register, which was set up by four groups (Italy, UK, France, Spain) who searched for paediatric trials and collected data between 2004-2006, were analysed. The disease areas reflected were compared with those covered by published trials and Burden of Disease (BD) data. Results In all, 257 trial records were analysed, 86 of which were entered by the Italian partner, 84 by the UK partner, 56 by the French partner and 31 by the Spanish partner. Spain entered the majority of multinational trials, while the UK had the majority of single-centre national trials. Most trials were experimental (79%), and the most commonly represented diseases were neoplasms (14% trials). In all, 28% were double-blind randomised controlled trials (RCTs). The most common disease areas addressed in the 257 trials were similar to the published trials' areas. In contrast, the primary research area was low on the BD list.
European Journal of Clinical Pharmacology, 2014
To assess the prevalence of hospital admission related to adverse drug reactions (ADRs) in a thir... more To assess the prevalence of hospital admission related to adverse drug reactions (ADRs) in a third-level hospital, to analyse the associated factors, and to describe the reactions and the drugs involved. A cross-sectional study was conducted for a 120-day period. Patients that were urgently hospitalized entered the study. The primary endpoint was the ADR-related urgent admission. A descriptive analysis of demographic, clinical, and drug-related variables was performed. The association between the likelihood of urgent admission due to ADRs and age, gender, and number of drugs used was analysed. A descriptive analysis of the suspected drugs and the reactions in ADR-related admissions was performed. Overall, 186 out of 4,403 hospital admissions were due to ADRs (prevalence: 4.2 % [95 % CI 3.7-4.8 %]). Age (≥65 years: OR 1.59 [95 % CI 1.10-2.29]) and number of drugs used at the time of admission (3-5 drugs: OR 5.07 [95 % CI 2.71-9.59]; 6-9 drugs: OR 5.90 [95 % CI 3.16-11.0]; ≥10 drugs: OR 8.94 [95 % CI 4.73-16.89]), but not gender, were identified as independent factors associated with ADR-related hospitalization. The overall in-hospital stay for patients admitted with ADRs amounted to 1,785 days. The ADRs were mainly type A reactions (92 %). Acute renal failure related to renin-angiotensin system inhibitors, haemorrhage due to anticoagulants, and upper gastrointestinal bleeding related to antiplatelet drugs and/or non-steroidal anti-inflammatory drugs were the most frequent. Over 4 % of urgent hospitalizations are caused by ADRs, which are dose-related and predictable in more than 90 % of cases. The main risk factors are advanced age and polypharmacy.
Contemporary Clinical Trials, 2010
To assess participants&am... more To assess participants' knowledge of key aspects about the clinical trials in which they are enrolled, describe the consent process, and assess the importance that investigators give to various aspects of trial information when verbally informing candidates. Prospective study based on a structured questionnaire interview of participants within 3 months after trial enrollment and an anonymous questionnaire sent to clinical trial investigators. A total of 140 participants included in 40 clinical trials were interviewed, and 51 investigators answered the questionnaire. The formal steps to obtain informed consent were usually carried out. Participants were aware of the purpose of the trial and the right to discontinue participation, but only 23% knew that treatment was randomly allocated, 57% knew they might receive a placebo, and 42% was aware that adverse effects could occur. Patients who had read the information sheet had better knowledge of most aspects, except for the risk of adverse effects. The investigators considered that compensation, insurance coverage, possibility of receiving a placebo, and treatment allocation were the least important aspects of the trial when informing candidates for participation. Although the formal steps for obtaining informed consent were usually carried out, a relevant percentage of patients included in clinical trials were unaware of important aspects of their participation. Patients showed more limited knowledge about the same points that investigators considered less important when informing potential participants. Deferring signature on the consent form and encouraging reading of the information sheet may improve participants' knowledge about clinical trials.