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BACKGROUND: Antimicrobial stewardship programs (ASPs) are recommended in nursing homes (NHs), although data are limited. We aimed to determine the clinical and ecological impact of an ASP for NHs. METHODS: We performed a cluster, randomized, controlled trial and a before-after study with interrupted time-series analyses in 14 NHs for 30 consecutive months from July 2018 to December 2020 in Andalusia, Spain. Seven facilities implemented an ASP with a bundle of 5 educational measures (general ASP) and 7 added 1-to-1 educational interviews (experimental ASP). The primary outcome was the overall use of antimicrobials, calculated monthly as defined daily doses (DDD) per 1000 resident days (DRD). RESULTS: The total mean antimicrobial consumption decreased by 31.2% (-16.72 DRD; P = .045) with respect to the preintervention period; the overall use of quinolones and amoxicillin-clavulanic acid dropped by 52.2% (P = .001) and 42.5% (P = .006), respectively; and the overall prevalence of multidrug-resistant organisms (MDROs) decreased from 24.7% to 17.4% (P = .012). During the intervention period, 12.5 educational interviews per doctor were performed in the experimental ASP group; no differences were found in the total mean antimicrobial use between groups (-14.62 DRD; P = .25). Two unexpected coronavirus disease 2019 waves affected the centers increasing the overall mean use of antimicrobials by 40% (51.56 DRD; P < .0001). CONCLUSIONS: This study suggests that an ASP for NHs appears to be associated with a decrease in total consumption of antimicrobials and prevalence of MDROs. This trial did not find benefits associated with educational interviews, probably due to the coronavirus disease 2019 pandemic. Clinical Trials Registration. NCT03543605.
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Anti-Infecciosos , COVID-19 , Humanos , Antibacterianos/uso terapêutico , Anti-Infecciosos/uso terapêutico , Casas de Saúde , Combinação Amoxicilina e Clavulanato de PotássioRESUMO
The development of health information technology available and accessible to professionals is increasing in the last few years. However, a low number of electronic health tools included some kind of information about medication reconciliation. To identify all the electronic medication reconciliation tools aimed at healthcare professionals and summarize their main features, availability, and clinical impact on patient safety. A systematic review of studies that included a description of an electronic medication reconciliation tool (web-based or mobile app) aimed at healthcare professionals was conducted. The review protocol was registered with PROSPERO: registration number CRD42022366662, and followed PRISMA guidelines. The literature search was performed using four healthcare databases: PubMed, EMBASE, Cochrane Library, and Scopus with no language or publication date restrictions. We identified a total of 1227 articles, of which only 12 met the inclusion criteria.Through these articles,12 electronic tools were detected. Viewing and comparing different medication lists and grouping medications into multiple categories were some of the more recurring features of the tools. With respect to the clinical impact on patient safety, a reduction in adverse drug events or medication discrepancies was detected in up to four tools, but no significant differences in emergency room visits or hospital readmissions were found. 12 e-MedRec tools aimed at health professionals have been developed to date but none was designed as a mobile app. The main features that healthcare professionals requested to be included in e-MedRec tools were interoperability, "user-friendly" information, and integration with the ordering process.
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Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Reconciliação de Medicamentos , Humanos , Pessoal de Saúde , Eletrônica , IdiomaRESUMO
Vancomycin pharmacokinetic/pharmacodynamic (PK/PD) targets have not been validated in the neonatal population as no specifically designed studies are available. The main goal of this study was to analyze the therapeutic vancomycin regimen, the 24-h area under the curve (AUC24), and the trough plasma concentration (Ct) obtained that achieved clinical and microbiological effectiveness in a cohort of neonates. This was an observational, prospective, single-center study covering a period of 2 years. Eligible patients were neonates and young infants who were undergoing treatment with intravenous vancomycin for ≥72 h with ≥1 Ct available. The primary outcome was the association of Ct and AUC24 with clinical and microbiological efficacy at the beginning (early clinical evolution [ECE]) and the end (late clinical evolution [LCE]) of treatment with vancomycin. A total of 43 patients were included, 88.4% of whom were cured. In ECE, the cutoff points of the receiver operating characteristic (ROC) curve were 238 mg · h/L (sensitivity of 61% and specificity of 88%) for AUC24 and 6.8 µg/mL (sensitivity of 61% and specificity of 92%) for Ct. In LCE, the Ct value was 11 µg/mL, with a sensitivity of 80% and a specificity of 92%. In this analysis, AUC24 was not considered a good predictor. Logistic regression showed that a vancomycin Ct of ≤6.8 µg/mL was associated with an unfavorable ECE (P = 0.001), being 18 times more likely to progress poorly compared to those with higher levels. AUC24 and Ct are good predictors of ECE in this population. Concentrations close to 7 µg/mL and an AUC24 of around 240 mg · h/L 48 h after antibiotic initiation seem to be sufficient to achieve clinical cure in most cases.
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Antibacterianos , Vancomicina , Humanos , Recém-Nascido , Vancomicina/farmacocinética , Estudos Prospectivos , Testes de Sensibilidade Microbiana , Área Sob a Curva , Antibacterianos/farmacocinética , Estudos RetrospectivosRESUMO
WHAT IS KNOWN AND OBJECTIVES: Bartonella henselae is the etiologic agent of "cat scratch disease (CSD)". We describe a case of atypical CSD in a paediatric patient and include a review of the antibiotic treatment for this disease. CASE DESCRIPTION: A 2-year-old child, with convulsive status and loss of consciousness, was admitted to hospital. Several antiepileptics and antibiotics were prescribed due to suspected central nervous system infection. When serology revealed Bartonella henselae antibodies, targeted antibiotic therapy was initiated and symptoms improved. However, seizures reappeared days after finishing the treatment so antiepileptics and antibiotics were reintroduced. WHAT IS NEW AND CONCLUSION: A wide variety of antibiotic regimens have been used for the treatment of atypical CSD in paediatric patients. This report includes the case of a paediatric patient diagnosed with atypical CSD who presented neurological manifestations, and for which a regimen consisting of azithromycin and rifampin was employed to achieve recovery.
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Antibacterianos/uso terapêutico , Doença da Arranhadura de Gato/tratamento farmacológico , Convulsões/tratamento farmacológico , Anticonvulsivantes/uso terapêutico , Doença da Arranhadura de Gato/complicações , Pré-Escolar , Humanos , MasculinoRESUMO
OBJECTIVE: To develop by consensus a dashboard model to standardize and promote the evaluation of research activity in Spanish Hospital Pharmacy Services. METHODS: The study was carried out in 5 phases following the modified Delphi methodology: constitution of the coordinating group, elaboration of a list of scenarios, selection of participating centers, evaluation of the list of scenarios, and analysis of the results. The coordinating group designed a questionnaire with 114 questions. General research questions and different scenarios (indicators) were included to form the dashboard. The Hospital Pharmacy Services with the highest number of publications were identified to participate in the Delphi consultation. Two rounds of consultations were conducted in which the "Need" and/or "Feasibility" of their measurement was evaluated for each of the scenarios, using a numerical scale from 1 (lowest score) to 9 (highest score). RESULTS: Sixteen Hospital Pharmacy Services, belonging to 8 different autonomous communities, participated in the Delphi consultation. A total of 100% of them responded to all the questions in the 2 rounds of consultations. It was considered that the Hospital Pharmacy Services should have a research dashboard (need = 100%) with a basic structure and a common minimum set of data for all them (need = 87.5%). The consensus was reached on distinguishing research projects led by the Hospital Pharmacy Services from those led by other groups in which the Hospital Pharmacy Services collaborate (need = 87.5%), and a definition was approved on the leadership of these projects according to whether they are single-center or multicenter. A consensus was reached on 40 indicators to form the dashboard, which evaluates publications (13 indicators), human resources (12 indicators), research projects (9 indicators), doctoral theses (4 indicators), and patents and intellectual property registrations (2 indicators). CONCLUSIONS: This is the first consensus dashboard developed to evaluate the research activity of the Hospital Pharmacy Services, which will help to analyze the productivity and impact of research systematically and continuously. In addition, it will allow comparison between them and will help to establish synergies and identify trends, patterns, and challenges.
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Técnica Delphi , Serviço de Farmácia Hospitalar , Serviço de Farmácia Hospitalar/organização & administração , Espanha , Inquéritos e Questionários , Consenso , HumanosRESUMO
OBJECTIVE: To develop by consensus a dashboard model to standardise and promote the evaluation of research activity in Spanish Hospital Pharmacy Services. METHODS: The study was carried out in 5 phases following the modified Delphi methodology: constitution of the coordinating group, elaboration of a list of scenarios, selection of participating centres, evaluation of the list of scenarios, and analysis of the results. The coordinating group designed a questionnaire with 114 questions. General research questions and different scenarios (indicators) were included to form the dashboard. The Hospital Pharmacy Services with the highest number of publications were identified to participate in the Delphi consultation. Two rounds of consultations were conducted in which the "Need" and/or "Feasibility" of their measurement was evaluated for each of the scenarios, using a numerical scale from 1 (lowest score) to 9 (highest score). RESULTS: Sixteen Hospital Pharmacy Services, belonging to 8 different Autonomous Communities, participated in the Delphi consultation. A total of 100% of them responded to all the questions in the 2 rounds of consultations. It was considered that the Hospital Pharmacy Services should have a research dashboard (Need=100%) with a basic structure and a common minimum set of data for all them (Need=87.5%). The consensus was reached on distinguishing research projects led by the Hospital Pharmacy Services from those led by other groups in which the Hospital Pharmacy Services collaborate (Need=87.5%), and a definition was approved on the leadership of these projects according to whether they are single-centre or multicentre. A consensus was reached on 40 indicators to form the dashboard, which evaluates publications (13 indicators), human resources (12 indicators), research projects (9 indicators), doctoral theses (4 indicators), and patents and intellectual property registrations (2 indicators). CONCLUSIONS: This is the first consensus dashboard developed to evaluate the research activity of the Hospital Pharmacy Services, which will help to analyse the productivity and impact of research systematically and continuously. In addition, it will allow comparison between them and will help to establish synergies and identify trends, patterns, and challenges.
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Técnica Delphi , Serviço de Farmácia Hospitalar , Serviço de Farmácia Hospitalar/organização & administração , Espanha , Consenso , Inquéritos e Questionários , HumanosRESUMO
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We aimed to define a novel indicator for monitoring antimicrobial use specifically in the Emergency Department Observation Unit (EDOU) and to assess the long-term impact of an institutional education-based antimicrobial stewardship program (ASP) on the antimicrobial prescribing pattern and clinical outcomes in this setting. A quasi-experimental interrupted time-series study was performed from 2011 to 2022. An educational ASP was implemented at the EDOU in 2015. To estimate changes in antimicrobial use, we designed an indicator adjusted for patients at risk of antimicrobial prescribing: defined daily doses (DDDs) per 100 patients transferred from the Emergency Department to the Observation Unit (TOs) per quarter. The number of bloodstream infections (BSIs) and the crude all-cause 14-day mortality were assessed as clinical outcomes. Antimicrobial use showed a sustained reduction with a trend change of -1.17 DDD per 100 TO and a relative effect of -45.6% (CI95% -64.5 to -26.7), particularly relevant for meropenem and piperacillin-tazobactam, with relative effects of -80.4% (-115.0 to -45.7) and -67.9% (-93.9 to -41.9), respectively. The incidence density of all BSIs increased significantly during the ASP period, with a relative effect of 123.2% (41.3 to 284.7). The mortality rate remained low and stable throughout the study period, with an absolute effect of -0.7% (-16.0 to 14.7). The regular monitoring of antimicrobial use in the EDOU by using this new quantitative indicator was useful to demonstrate that an institutional education-based ASP successfully achieved a long-term reduction in overall antimicrobial use, with a low and steady BSI mortality rate.
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BACKGROUND: Pharmacokinetic nomograms, equations, and software are considered the main tools available for Therapeutic Drug Monitoring (TDM). Model-informed precision dosing (MIPD) is an advanced discipline of TDM that allows dose individualization, and requires a software for knowledge integration and statistical calculations. Due to its precision and extensive applicability, the use of these software is widespread in clinical practice. However, the currently available evidence on these tools remains scarce. OBJECTIVES: To review and summarize the available evidence on MIPD software tools to facilitate its identification, evaluation, and selection by users. METHODS: An electronic literature search was conducted in MEDLINE, EMBASE, OpenAIRE, and BASE before July 2022. The PRISMA-ScR was applied. The main inclusion criteria were studies focused on developing software for use in clinical practice, research, or modelling. RESULTS: Twenty-eight software were classified as MIPD software. Ten are currently unavailable. The remaining 18 software were described in depth. It is noteworthy that all MIPD software used Bayesian statistical methods to estimate drug exposure and all provided a population model by default, except NONMEN. CONCLUSIONS: Pharmacokinetic software have become relevant tools for TDM. MIPD software have been compared, facilitating its selection for use in clinical practice. However, it would be interesting to standardize the quality and validate the software tools.
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This study explored the feasibility of a bundle of indicators aimed at assessing the quality of antimicrobial use in intensive care units (ICUs) through an observational prospective study spanning 12 quarters (January 2019-December 2021) in a 1290-bed teaching hospital in Spain. Members of the antimicrobial stewardship programme team selected the indicators to analyse the quality of antimicrobial use based on consumption data from a list proposed in a previous study. Antimicrobial use in the ICU was measured as defined daily dose (DDD) per 100 occupied bed-days. Trends and points of change were analysed with segmented regression. The intravenous macrolides/intravenous respiratory fluoroquinolones ratio in the ICU increased progressively, although not significantly, by 11.14% per quarter, likely related to prioritization of the use of macrolides in serious community-acquired pneumonia and the coronavirus disease 2019 pandemic. A remarkable upward trend of 2.5% per quarter was detected in the anti-methicillin-susceptible Staphylococcus aureus/anti-methicillin-resistant S. aureus agents ratio in the ICU, which could be explained by the low prevalence of methicillin-resistant S. aureus at the study centre. Patterns of amoxicillin-clavulanic acid/piperacillin-tazobactam ratio and diversification of anti-pseudomonal beta-lactams showed an increment in use over the study. The use of these novel indicators provides additional information for the current analysis of DDD. Implementation is feasible, and led to the detection of patterns that agree with local guidelines and cumulative antibiogram reports, and foster targeted improvement actions within antimicrobial stewardship programmes.
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Anti-Infecciosos , COVID-19 , Infecção Hospitalar , Staphylococcus aureus Resistente à Meticilina , Humanos , Infecção Hospitalar/tratamento farmacológico , Estudos Prospectivos , Anti-Infecciosos/uso terapêutico , Antibacterianos/uso terapêutico , Hospitais de Ensino , Unidades de Terapia Intensiva , Macrolídeos/uso terapêuticoRESUMO
Surgical antibiotic prophylaxis is one of the most useful measures to prevent surgical wound infection. OBJECTIVE: The aim of this project is to evaluate the appropriateness of the use of antibiotic prophylaxis in surgical procedures performed in Spanish hospitals, both globally and according to the type of surgery performed. METHOD: For this purpose, an observational, retrospective, cross-sectional and multicenter study has been designed to collect all the variables that allow the evaluation of the appropriateness of surgical antibiotic prophylaxis by comparing the prescribed treatment, the recommendations included in the local guidelines and the consensus document of the Spanish Society of Infectious Diseases and Clinical Microbiology and the Spanish Association of Surgeons. Indication, choice of antimicrobial, dose, route and duration of administration, timing, re-dosing and duration of the prophylaxis will be taken into account. The sample will consist of patients who underwent scheduled or emergency surgery, either as inpatients or outpatients, in hospitals in Spain. A sample size of 2,335 patients has been established to estimate, with 95% confidence and 80% power, a percentage of appropriateness that is expected to be around 70%. Differences between variables will be analyzed using Student's t-test, Mann-Whitney U test, Chi-square test, or Fisher's test, as appropriate. The degree of agreement between the antibiotic prophylaxis recommended by the guidelines of the different hospitals and that recommended in the literature will be analyzed by calculating the Cohen's kappa indicator. Binary logistic regression analysis using generalized linear mixed models will be performed to identify possible factors associated with differences in the appropriateness of antibiotic prophylaxis. DISCUSSION: The results of this clinical study will allow us to focus on specific surgical areas with higher rates of inappropriateness, identify key points of action and guide future strategies for antimicrobial stewardship programs in the area of antibiotic prophylaxis.
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Antibacterianos , Antibioticoprofilaxia , Humanos , Antibioticoprofilaxia/métodos , Estudos Retrospectivos , Espanha , Estudos Transversais , Antibacterianos/uso terapêutico , Infecção da Ferida Cirúrgica/prevenção & controle , Infecção da Ferida Cirúrgica/tratamento farmacológico , Estudos Observacionais como Assunto , Estudos Multicêntricos como AssuntoRESUMO
Surgical antibiotic prophylaxis is one of the most useful measures to prevent surgical wound infection. OBJECTIVE: The aim of this project is to evaluate the appropriateness of the use of antibiotic prophylaxis in surgical procedures performed in Spanish hospitals, both globally and according to the type of surgery performed. METHOD: For this purpose, an observational, retrospective, cross-sectional, and multicentre study has been designed to collect all the variables that allow the evaluation of the appropriateness of surgical antibiotic prophylaxis by comparing the prescribed treatment, the recommendations included in the local guidelines, and the consensus document of the Spanish Society of Infectious Diseases and Clinical Microbiology and the Spanish Association of Surgeons. Indication, choice of antimicrobial, dose, route and duration of administration, timing, re-dosing, and duration of the prophylaxis will be taken into account. The sample will consist of patients who underwent scheduled or emergency surgery, either as inpatients or outpatients, in hospitals in Spain. A sample size of 2335 patients has been established to estimate, with 95% confidence and 80% power, a percentage of appropriateness that is expected to be around 70%. Differences between variables will be analysed using Student's t-test, Mann-Whitney U test, Chi-square test, or Fisher's test, as appropriate. The degree of agreement between the antibiotic prophylaxis recommended by the guidelines of the different hospitals and that recommended in the literature will be analysed by calculating the Cohen's kappa indicator. Binary logistic regression analysis using generalised linear mixed models will be performed to identify possible factors associated with differences in the appropriateness of antibiotic prophylaxis. DISCUSSION: The results of this clinical study will allow us to focus on specific surgical areas with higher rates of inappropriateness, identify key points of action and guide future strategies for antimicrobial stewardship programs in the area of antibiotic prophylaxis.
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Antibacterianos , Antibioticoprofilaxia , Humanos , Antibioticoprofilaxia/métodos , Estudos Retrospectivos , Espanha , Estudos Transversais , Antibacterianos/uso terapêutico , Infecção da Ferida Cirúrgica/prevenção & controle , Infecção da Ferida Cirúrgica/tratamento farmacológico , Estudos Observacionais como Assunto , Estudos Multicêntricos como AssuntoRESUMO
OBJECTIVE: To assess the influence of the emergence of severe acute respiratory syndrome coronavirus 2 and the implementation of public health measures on the seasonality of outpatient antibiotic use and their possible association with the incidence of influenza. METHODS: We performed a time-series ecological study in 1516 primary care centres of Andalusia, Spain, comparing the coronavirus disease 2019 period (April 2020 to March 2021) with the 6 previous years. We assessed the number of packs and defined daily doses per 1000 inhabitants of antibacterials and key antibiotics commonly used for acute respiratory tract infections and the number of influenza-positive cases per 100 000 inhabitants. We calculated the correlation between variables and analyzed the seasonal patterns and differences in quarterly antibiotic use. RESULTS: For all quarters, a significant correlation was observed between influenza activity and antibiotic use (Spearman's r = 0.94; p < 0.001). Before the pandemic period, both variables presented similar seasonal patterns. After the start of the pandemic, influenza activity was suppressed and the pattern of antibiotic use flattened into a straight line (R2 = 0.96; p = 0.022) with a quarterly change of 3.9% (p = 0.007). Total antibiotic use and antibiotics used for treating acute respiratory tract infections showed significant reductions in all quarters compared to the previous year (p < 0.01). DISCUSSION: The coronavirus disease 2019 pandemic has strongly influenced the seasonality of antibiotic use in primary care. The decline in respiratory viruses, among which the influenza virus is a major player that may act as a proxy for general prevalence, is proposed as a reason for the flattening of the seasonal fluctuations of outpatient antibiotic use in our region.
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Tratamento Farmacológico da COVID-19 , COVID-19 , Influenza Humana , Infecções Respiratórias , Antibacterianos/uso terapêutico , COVID-19/epidemiologia , Humanos , Influenza Humana/tratamento farmacológico , Influenza Humana/epidemiologia , Pacientes Ambulatoriais , Pandemias , Infecções Respiratórias/tratamento farmacológico , Infecções Respiratórias/epidemiologia , Estações do AnoRESUMO
Malignant melanoma (MM) is the most aggressive form of skin cancer, and around 30% of them may develop from pre-existing dysplastic nevi (DN). Diagnosis of DN is a relevant clinical challenge, as these are intermediate lesions between benign and malignant tumors, and, up to date, few studies have focused on their diagnosis. In this study, the accuracy of Raman spectroscopy (RS) is assessed, together with multivariate analysis (MA), to classify 44 biopsies of MM, DN and compound nevus (CN) tumors. For this, we implement a novel methodology to non-invasively quantify and localize the eumelanin pigment, considered as a tumoral biomarker, by means of RS imaging coupled with the Multivariate Curve Resolution-Alternative Least Squares (MCR-ALS) algorithm. This represents a step forward with respect to the currently established technique for melanin analysis, High-Performance Liquid Chromatography (HPLC), which is invasive and cannot provide information about the spatial distribution of molecules. For the first time, we show that the 5, 6-dihydroxyindole (DHI) to 5,6-dihydroxyindole-2-carboxylic acid (DHICA) ratio is higher in DN than in MM and CN lesions. These differences in chemical composition are used by the Partial Least Squares-Discriminant Analysis (PLS-DA) algorithm to identify DN lesions in an efficient, non-invasive, fast, objective and cost-effective method, with sensitivity and specificity of 100% and 94.1%, respectively.
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BACKGROUND AND OBJECTIVE: The "Structured HIstory of Medication use" (SHIM) questionnaire is a tool developed to obtain an accurate pre-admission overview of medications, involving a structured interview with patients, and has demonstrated its potential to prevent reconciliation errors. The objective of this study was to cross-culturally adapt the SHIM questionnaire to Spanish. PATIENTS AND METHODS: Forward and blind-back translations followed by a synthesis and adaptation, with the participation of an expert panel, to guarantee the equivalence between the original questionnaire and the Spanish version. Subsequently, pilot testing of the Spanish version was carried out through cognitive interviews in a sample of polymedicated patients under follow-up by the Department of Internal Medicine. RESULTS: The Spanish version of the SHIM questionnaire (SHIM-e) was obtained. Scores for difficulty assigned by translators involved in forward and back translations were low. During the synthesis and adaptation phase, three discrepancies were resolved, and the expert panel decided to include some terms commonly used for clinical interviews in the Spanish version of the questionnaire. The pilot testing, which was performed in a sample of 10 polymedicated patients admitted to the Department of General and Digestive Surgery, showed 100% comprehensibility for all items, except for number 13, which was 90%. CONCLUSIONS: This work presents the first cross-cultural adaptation to Spanish of the SHIM questionnaire. The forward and blind-back translations presented low difficulty and the results of the pilot testing showed a high level of comprehensibility for the Spanish version of this tool.
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Comparação Transcultural , Reconciliação de Medicamentos , Adaptação Fisiológica , Humanos , Inquéritos e Questionários , TraduçõesRESUMO
BACKGROUND: Research priorities in Antimicrobial Stewardship (AMS) have rapidly evolved in the last decade. The need for a more efficient use of antimicrobials have fueled plenty of studies to define the optimal duration for antibiotic treatments, and yet, there still are large areas of uncertainty in common clinical scenarios. Pseudomonas aeruginosa has been pointed as a priority for clinical research, but it has been unattended by most randomized trials tackling the effectiveness of short treatments. The study protocol of the SHORTEN-2 trial is presented as a practical example of new ways to approach common obstacles for clinical research in AMS. OBJECTIVE: To determine whether a 7-day course of antibiotics is superior to 14-day schemes for treating bloodstream infections by P. aeruginosa (BSI-PA). METHODS: A superiority, open-label, randomized controlled trial will be performed across 30 Spanish hospitals. Adult patients with uncomplicated BSI-PA will be randomized to receive a 7 versus 14-day course of any active antibiotic. The primary endpoint will be the probability for the 7-day group of achieving better outcomes than the control group, assessing altogether clinical effectiveness, severe adverse events, and antibiotic exposure through a DOOR/RADAR analysis. Main secondary endpoints include treatment failure, BSI-PA relapses, and mortality. A superiority design was set for the primary endpoint and non-inferiority for treatment failure, resulting in a sample size of 304 patients. CONCLUSIONS: SHORTEN-2 trial aligns with some of the priorities for clinical research in AMS. The implementation of several methodological innovations allowed overcoming common obstacles, like feasible sample sizes or measuring the clinical impact and unintended effects. TRIAL REGISTRATION: EudraCt: 2021-003847-10; ClinicalTrials.gov: NCT05210439.
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Infecções por Pseudomonas , Sepse , Adulto , Humanos , Pseudomonas aeruginosa , Antibacterianos/uso terapêutico , Infecções por Pseudomonas/tratamento farmacológico , Resultado do Tratamento , Sepse/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Cefazolin is a recommended treatment for methicillin-susceptible Staphylococcus aureus (MSSA) infections that has been successfully used in outpatient parenteral antibiotic therapy (OPAT) programs. The aim of this study was to assess the clinical outcomes of cefazolin delivered each day (Group 24) vs. every two days (Group 48) for MSSA infections in OPAT programs. It was a prospective observational study with retrospective analysis of a cohort of MSSA infections attended in OPAT. The primary outcome was treatment success, defined as completing the antimicrobial regimen without death, treatment discontinuation, or readmission during treatment and follow-up. A univariate and multivariate logistic regression model was built. A two-sided p < 0.05 was considered statistically significant. Of the 149 MSSA infections treated with cefazolin 2 g/8 h in OPATs, 94 and 55 patients were included in the delivery Group 24 and Group 48, respectively. Treatment failure and unplanned readmission rates were similar in both groups (11.7% vs. 7.3% p = 0.752 and 8.5% vs. 5.5% p = 0.491). There was a significant increase in vascular access complications in Group 24 (33.0%) with respect to Group 48 (7.3%) (p < 0.001). Treating uncomplicated MSSA infection with cefazolin home-delivered every two days through an OPAT program is not associated with an increased risk of treatment failure and entails a significant reduction in resource consumption compared to daily delivery.
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This paper evaluates gender bias in the published clinical trials of Vortioxetine. We conducted a systematic review of controlled clinical trials of Vortioxetine for the treatment of depression. The literature search was performed using MEDLINE and following the corresponding international recommendations. We identified 42 articles, of which 23 were included. The proportion of women ranged from 47%-75% and the percentage of women included in the 10,404 total patients sample was 65%. The separate analysis of the main variable between the subpopulations of men and women was only carried out in 3/23 publications included. In contrast, 6/23 trials analyzed secondary variables separated by sex. No trials discussed the results separately by sex. The proportion of women included was slightly higher than that in clinical trials of other antidepressants. However, the analysis of the main result or secondary variables by sex, as well as discussing the results separately by sex, are scarce. This gives rise to gender bias in these works.
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Antidepressivos/uso terapêutico , Ensaios Clínicos Fase I como Assunto/métodos , Transtorno Depressivo Maior/tratamento farmacológico , Sexismo/tendências , Vortioxetina/uso terapêutico , Ensaios Clínicos Fase I como Assunto/normas , Transtorno Depressivo Maior/epidemiologia , Transtorno Depressivo Maior/psicologia , Feminino , Humanos , Masculino , Sexismo/psicologiaRESUMO
Asthma is one of the most common chronic diseases characterized by sex disparities. Gender bias is a well-documented issue detected in the design of published clinical trials (CTs). International guidelines encourage researchers to analyze clinical data by sex, gender, or both where appropriate. The objective of this work was to evaluate gender bias in the published CTs of biological agents for the treatment of severe asthma. A systematic review of randomized controlled CTs of the biological agents (omalizumab, benralizumab, reslizumab, mepolizumab or dupilumab) for the treatment of severe asthma was conducted. The literature search was performed using PubMed and EMBASE without language restrictions. This study followed the corresponding international recommendations. We identified a total of 426 articles, of which 37 were finally included. Women represented 60.4% of patients included. The mean percentage of women in these trials was 59.9%, ranged from 40.8% to 76.7%. The separate analysis by sex of the main variable was only performed in 5 of the 37 publications included, and none of the trials analyzed secondary variables by sex. Only 1 of the articles discussed the results separately by sex. No study included the concept of gender in the text or analyzed the results separately by gender. The proportion of women included in CTs was higher compared to publications of other disciplines, where women were under-represented. The analysis of the main and secondary variables by sex or gender, even the discussion separately by sex, was insufficient. This gives rise to potential gender bias in these CTs.
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Asma/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Sexismo/estatística & dados numéricos , Feminino , Humanos , Masculino , Seleção de Pacientes , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVE: Nomograms, equations and pharmacokinetic software are considered the main tools available for therapeutic drug monitoring. Due to its great applicability to various groups of drugs, the use of software is widely extended in clinical practice. The main goals of the studies using this type of software do not normally include the description of its features, therefore, the information about its characteristic is scarce. Moreover, no review of the literature has been published that brings together all the information available about these software. The present study aimed to synthesize the available evidence regarding software applied to therapeutic drug monitoring to facilitate its identification, evaluation and election by users. METHOD: This article describe a scoping review protocol, developed following the PRISMA-P and PRISMA-ScR guidelines. An electronic literature search was performed in MEDLINE, EMBASE, OpenAire and BASE (Bielefeld Academic Search Engine) databases. Only those software for which the following information was available were included: name of the software, developer/marketer, type of pharmacokinetic analysis allowed, and drugs included in the analysis. Results: In this study we will synthesized the most relevant characteristics for the clinical practice of the pharmacokinetic software available. A critical ppraisal of the sources if information will be included. Also, if it is possible, a comparison of the available tools will be carried out in order to facilitate the evaluation and selection of pharmacokinetic software. CONCLUSIONS: Pharmacokinetic software has become a relevant tool for therapeutic drugs monitoring. Currently available evidence on such tools is scarce, which precludes a rapid and effective comparative analysis between the different options available. An analysis of the main characteristics and a comparison between different pharmacokinetic software will be useful to the users, leading to a greater integration of these tools in healthcare practice.
OBJETIVO: Los nomogramas, ecuaciones y software de contenido armacocinético se consideran las principales herramientas disponibles para la monitorización farmacocinética clínica. Debido a su gran aplicabilidad en numerosos grupos de fármacos, el empleo de software se encuentra ampliamente extendido en la práctica clínica. Generalmente, el objetivo principal de los estudios que incluyen el uso de estos software no es la descripción de los mismos, por lo que la información disponible es escasa y, además, no se dispone de una revisión que aúne toda la información disponible referente a este tipo de software El objetivo de este estudio será sintetizar la evidencia disponible sobre los distintos software de aplicación en la monitorización farmacocinética para facilitar a los usuarios su identificación, evaluación y selección.Método: Se realizará una revisión exploratoria de la literatura cuyo protocolo se describe en este artículo, de acuerdo con las recomendaciones PRISMA para la elaboración de revisiones exploratorias y publicación de protocolos. Se realizará una búsqueda bibliográfica en las bases de datos Medline, Embase, OpenAire y Bielefeld Academic Search Engine. Se incluirán en el estudio aquellos software detectados de los que se disponga de la siguiente información: nombre del software, desarrollador/ comercializador, tipo de análisis farmacocinético y fármacos incluidos. Resultados: En este estudio se espera realizar una síntesis de las características más relevantes en la práctica clínica de los software de contenido farmacocinético disponibles en el mercado. Se realizará una síntesis narrativa crítica de las fuentes de información utilizadas. Además, se llevará a cabo, si es posible, una comparación de los mismos para facilitar la evaluación y selección por parte de los usuarios. CONCLUSIONES: Los software de contenido farmacocinético se han convertido en un recurso fundamental en la práctica de la monitorización terapéutica de fármacos. La evidencia disponible en la actualidad es escasa y no permite a los usuarios realizar de forma rápida y eficiente un análisis comparativo entre los distintos software disponibles. El análisis sobre las características principales y comparación entre los distintos software de plicación farmacocinética será de gran utilidad a sus usuarios para una mayor integración de estas herramientas en la práctica asistencial.