Contributions of cost-effectiveness analyses (CEA) to influenza vaccination policy for older adults in Europe.

This review describes the importance of economic evaluations and real-world evidence (RWE) for the assessment of enhanced influenza vaccines for older adults in Europe. Individuals ≥65 years of age are at increased risk of severe influenza outcomes and many countries in Europe recommend enhanced vaccines for this population to mitigate immunosenescence. Some National Immunization Technical Advisory Groups (NITAGs) may preferentially recommend a specific enhanced vaccine, necessitating comparative economic evaluation and estimation of relative vaccine effectiveness between enhanced vaccine options in the absence of direct head-to-head efficacy data. Distinct approaches to economic modeling and cost-effectiveness analysis (CEA) guide national vaccination policies in Europe, including how underlying data, such as RWE, are used in these models. RWE is an important evidence source for input into CEA models based on disease factors (e.g., antigenic shift and seasonal variation) and practical factors (e.g., limitations of performing multiple randomized clinical trials to capture seasonal variation; the need to obtain relevant patient-oriented, real-world endpoints, such as hospitalizations). CEA is considered crucial to vaccine assessment among certain countries in Europe, but further harmonization of economic evaluations, including the use of RWE, across NITAGs in Europe may be of benefit, alongside standardized approaches for vaccine appraisal. In the future, more countries may use RWE as an input in CEA models to support NITAG recommendations for enhanced influenza vaccines in older populations, especially considering the value of RWE for the assessment of influenza epidemiology and vaccine effectiveness as stated by the World Health Organization, and the availability of a broad RWE base for certain enhanced vaccines.

Eficacia, efectividad y seguridad de la vacuna antigripal adyuvada en población de 65 o más años de edad / Efficacy, effectiveness and safety of the adjuvanted influenza vaccine in the population aged 65 or over

La mayoría de las complicaciones y fallecimientos relacionados con la gripe estacional ocurren en población de 65 años o más y con enfermedades de base, y la vacuna frente a la gripe es la forma más efectiva de prevenirlas. La inmunización es menos eficaz en los adultos mayores debido a la inmunosenescencia. Las vacunas adyuvadas con MF59, diseñadas para mejorar la magnitud, persistencia y amplitud de la respuesta inmunitaria en personas de 65 años o más, se vienen utilizando en la práctica clínica desde 1997 en su formulación trivalente y, desde 2020, en formulación tetravalente. Los datos de diversos estudios muestran que estas vacunas son seguras para todos los grupos de edad, con un perfil de reactogenicidad similar al de la vacuna convencional, y que resultan especialmente efectivas para potenciar la respuesta inmunitaria en la población de 65 años o más, al aumentar los títulos de anticuerpos tras la vacunación y reducir significativamente el riesgo de ingreso hospitalario. Las vacunas adyuvadas han demostrado otorgar protección cruzada frente a cepas heterólogas y ser igual de efectivas que la vacuna de alta dosis en población de 65 años o más. En esta revisión se analiza la evidencia científica sobre la eficacia y la efectividad de la vacuna adyuvada con MF59 en la práctica clínica real en personas ≥65 años mediante una revisión narrativa y descriptiva de los datos publicados en ensayos clínicos, estudios observacionales y revisiones sistemáticas o metaanálisis (AU)

Most of the complications and deaths related to seasonal flu occur in the elderly population (≥65 years) with comorbidities, and the influenza vaccine is the most effective way to prevent them. Immunization is less effective in older adults due to immunosenescence. MF59-adjuvanted vaccines, designed to improve the magnitude, persistence and amplitude of the immune response in elderly people, have been used in clinical practice since 1997 in their trivalent formulation and, since 2020, in their tetravalent formulation. Data from various studies show that these vaccines are not only safe for all age groups, with a reactogenicity profile similar to that of the conventional vaccine, but also that they are especially effective in boosting the immune response in the population aged 65 or over by increasing antibody titers after vaccination and significantly reducing the risk of hospital admission. Adjuvanted vaccines have been shown to provide cross-protection against heterologous strains and to be as effective as the high-dose vaccine in the population aged 65 or over. In this review, the scientific evidence on the efficacy and effectiveness of the MF59-adjuvanted vaccine in real clinical practice in people ≥65 years of age is analyzed through a narrative and descriptive review of the literature with data from clinical trials, observational studies and systematic reviews or meta-analysis (AU)

Real-World Evidence in Cost-Effectiveness Analysis of Enhanced Influenza Vaccines in Adults ≥ 65 Years of Age: Literature Review and Expert Opinion.

Influenza vaccination can benefit most populations, including adults ≥ 65 years of age, who are at greater risk of influenza-related complications. In many countries, enhanced vaccines, such as adjuvanted, high-dose, and recombinant trivalent/quadrivalent influenza vaccines (aTIV/aQIV, HD-TIV/HD-QIV, and QIVr, respectively), are recommended in older populations to provide higher immunogenicity and increased relative vaccine efficacy/effectiveness (rVE) than standard-dose vaccines. This review explores how efficacy and effectiveness data from randomized controlled trials and real-world evidence (RWE) are used in economic evaluations. Findings from published cost-effectiveness analyses (CEA) on enhanced influenza vaccines for older adults are summarized, and the assumptions and approaches used in these CEA are assessed alongside discussion of the importance of RWE in CEA. Results from many CEA showed that adjuvanted and high-dose enhanced vaccines were cost-effective compared with standard vaccines, and that differences in rVE estimates and acquisition price may drive differences in cost-effectiveness estimates between enhanced vaccines. Overall, RWE and CEA provide clinical and economic rationale for enhanced vaccine use in people ≥ 65 years of age, an at-risk population with substantial burden of disease. Countries that consider RWE when making vaccine recommendations have preferentially recommended aTIV/aQIV, as well as HD-TIV/HD-QIV and QIVr, to protect older individuals.

An Economic Comparison in the Elderly of Adjuvanted Quadrivalent Influenza Vaccine with Recombinant Quadrivalent Influenza Vaccine in Spain.

Influenza infections impose a high burden of morbidity and mortality among older adults, at great cost to individuals and society. Enhanced influenza vaccines, which contain either an immune adjuvant or higher than normal doses of influenza virus antigens, are recommended for older adults. We used a health economics model to evaluate the cost effectiveness in Spain of a recently licensed recombinant quadrivalent influenza vaccine (QIVr), which contains three times the standard dose of influenza virus hemagglutinin but no neuraminidase, compared with an MF59-adjuvanted quadrivalent influenza vaccine (aQIV). Based on current tender prices in Spain and a conservative assumption that QIVr is 10.7% relatively more effective than aQIV, the incremental cost-effectiveness ratio (ICER) for QIVr was EUR 101,612.41 per quality-adjusted life year (QALY) gained. To meet the Spanish willingness-to-pay threshold of EUR 25,000 per QALY gained, QIVr would need to be 34.1% relatively more effective than aQIV. In a probabilistic sensitivity analysis conducted to confirm the robustness of the analysis, 99.7% of simulations for QIVr were higher than the willingness-to-pay curve. These findings suggest that QIVr is not currently a cost-effective influenza vaccine option relative to aQIV for older persons living in Spain.

An Economic Evaluation of the Adjuvanted Quadrivalent Influenza Vaccine Compared with Standard-Dose Quadrivalent Influenza Vaccine in the Spanish Older Adult Population.

Standard-dose quadrivalent influenza vaccines (QIV) are designed to provide protection against all four influenza strains. Adjuvanted QIV (aQIV), indicated for individuals aged 65+ years, combines MF59® adjuvant (an oil-in-water emulsion of squalene oil) with a standard dose of antigen, and is designed to produce stronger and longer immune response, especially in the elderly where immunosenescence reduces vaccine effectiveness. This study evaluated the cost-effectiveness of aQIV vs. egg-based standard-dose QIV (QIVe) in the elderly population, from the payer and societal perspective in Spain. A dynamic transmission model, which accounts for herd protection, was used to predict the number of medically attended infections in Spain. A decision tree structure was used to forecast influenza-related costs and benefits. Influenza-related probabilities of outpatient visit, hospitalization, work absenteeism, mortality, and associated utilities and costs were extracted from Spanish and European published literature. Relative vaccine effectiveness (rVE) was sourced from two different meta-analyses: the first meta-analysis was informed by laboratory-confirmed influenza studies only, resulting in a rVE = 34.6% (CI95% 2-66%) in favor of aQIV; the second meta-analysis included real world evidence influenza-related medical encounters outcomes, resulting in a rVE = 13.9% (CI95% 4.2-23.5%) in benefit of aQIV. All costs were expressed in 2021 euros. Results indicate that replacing QIVe with aQIV in the Spanish elderly population would prevent on average 43,664 influenza complicated cases, 1111 hospitalizations, and 569 deaths (with a rVE = 34.6%) or 19,104 influenza complicated cases, 486 hospitalizations, and 252 deaths (with a rVE = 13.9%). When the rVE of aQIV vs. QIVe is 34.6%, the incremental cost per quality adjusted life years (QALY) gained was €2240 from the payer; from the societal perspective, aQIV was cost saving compared with QIVe. If the rVE was 13.9%, the incremental cost per QALY was €6694 and €3936 from the payer and societal perspective, respectively. Sensitivity analyses validated the robustness of these findings. Results indicate that replacing QIVe with aQIV in the Spanish elderly population is a cost-effective strategy for the Spanish healthcare system.

Cost-Effectiveness and Burden of Disease for Adjuvanted Quadrivalent Influenza Vaccines Compared to High-Dose Quadrivalent Influenza Vaccines in Elderly Patients in Spain.

Influenza is a contagious respiratory disease that causes severe illness and death, particularly in elderly populations. Two enhanced formulations of quadrivalent influenza vaccine (QIV) are available in Spain. Adjuvanted QIV (aQIV) is available for those aged 65+ and high-dose QIV (HD-QIV) for those aged 60+. In this study, we used a health economic model to assess the costs and outcomes associated with using aQIV or HD-QIV in subjects aged 65+. Using aQIV instead of HD-QIV to vaccinate an estimated 5,126,343 elderly people results in reductions of 5405 symptomatic cases, 760 primary care visits, 171 emergency room visits, 442 hospitalizations, and 26 deaths in Spain each year. Life-years (LYs) and quality-adjusted LYs (QALYs) increases by 260 and 206, respectively, each year. Savings from a direct medical payer perspective are EUR 63.6 million, driven by the lower aQIV vaccine price and a minor advantage in effectiveness. From a societal perspective, savings increase to EUR 64.2 million. Results are supported by scenario and sensitivity analyses. When vaccine prices are assumed equal, aQIV remains dominant compared to HD-QIV. Potential savings are estimated at over EUR 61 million in vaccine costs alone. Therefore, aQIV provides a highly cost-effective alternative to HD-QIV for people aged 65+ in Spain.

Estimated cost-effectiveness and burden of disease associated with quadrivalent cell-based and egg-based influenza vaccines in Spain.

Influenza is a viral respiratory disease that causes significant clinical and economic burden globally. Quadrivalent influenza vaccine (QIV) is frequently used to protect people who have a high-risk of developing influenza complications due to comorbidities. QIV offers protection against influenza A (A/H1N1 and H3N2) and B (B/Victoria, and B/Yamagata) strains. The European Medicines Agency has recently approved a cell-based QIV (QIVc) in people aged over 9 years old. QIVc has been shown to be more effective at preventing influenza than traditional egg-based QIV (QIVe). In this study, we use a health economic model adapted to Spain to assess the costs and outcomes associated with using QIVc instead of QIVe in people aged 9-64 at high-risk of complications. Observed vaccine coverage of 32% in the 9-17 age group, 17% in those aged 18-59, and 22% for ages 60-64 was used in the analysis. In total, 2.5 million people were vaccinated in the simulations. Using QIVc instead of QIVe was associated with 16,221fewer symptomatic cases, 4,522 fewer primary care visits, 1,015 fewer emergency room visits and 88 fewer hospitalizations. From a societal perspective, QIVc was more effective and less expensive compared to QIVe, leading to a cost-saving of €3.4 million. From a public payer perspective, the incremental cost-effectiveness ratio for QIVc vs QIVe was €12,852 per QALY gained. In conclusion, QIVc offers a cost-effective alternative to QIVe and should be considered as an alternative vaccine to QIVe for people aged 9-64 at high-risk of influenza complications in Spain.

[Evaluation of susceptibility of multidrug-resistant Pseudomonas aeruginosa strains against ceftolozane/tazobactam]. / Evaluación de la sensibilidad de cepas de Pseudomonas aeruginosa multi-resistentes frente a ceftolozano/tazobactam.

BACKGROUND: Pseudomonas aeruginosa is an opportunistic pathogen associated with high morbidity and mortality. For multidrug-resistant strains (MDR), ceftolozane/tazobactam (CTZ) has been authorized by the European Medicines Agency (EMA) for complicated urinary tract infections, acute pyelonephritis, and complicated intraabdominal infections. AIM: To determine the susceptibility to CTZ of P. aeruginosa MDR in isolated clinical samples at the University Hospital Puerto Real. METHODS: The susceptibility according to the EUCAST to CTZ criteria of strains of P. aeruginosa MDR, between January 2015 and August 2017 has been studied. The multiresistance criteria were those defined by the Centers for Disease Control and Prevention. The antibiotic susceptibility was obtained by automated MicroScan® system (Beckman Coulter). Susceptibility to CTZ was determined using gradient strips (Liofilchem®, Werfen). RESULTS: Of 1253 strains isolated, 7% presented MDR. We studied the susceptibility of a total of 78 strains of MDR P. aeruginosa, of which 5 (6.4%) were resistant to CTZ according to the EUCAST criteria. CONCLUSIONS: In our environment, the in vitro resistance to CTZ in MDR P. aeruginosa strains is approximately 6%. CTZ is an option for the treatment of infections by MDR P. aeruginosa when there is no other alternative and its in-vitro susceptibility has been proven.

Evaluación de la sensibilidad de cepas de Pseudomonas aeruginosa multi-resistentes frente a ceftolozano/tazobactam / Evaluation of susceptibility of multidrug-resistant Pseudomonas aeruginosa strains against ceftolozane/tazobactam

Resumen Introducción: Pseudomonas aeruginosa es un patógeno oportunista asociado a alta morbi-mortalidad. Para cepas multi-resistentes (MDR), ceftolozano/tazobactam (CTZ) se ha autorizado por la Agencia Europea del Medicamento (EMA) para infecciones del tracto urinario complicadas, pielonefritis aguda e infecciones intra-abdominales complicadas. Objetivo: Determinar la sensibilidad a CTZ de P. aeruginosa MDR en muestras clínicas aisladas en el Hospital Universitario Puerto Real. Material y Métodos: Se estudió la sensibilidad según criterios EUCAST a CTZ de cepas de P. aeruginosa MDR, entre enero de 2015 y agosto de 2017. Los criterios de multi-resistencia fueron definidos por el Centers for Disease Control and Prevention. La sensibilidad antimicrobiana se obtuvo mediante sistema MicroScan® (Beckman Coulter). La sensibilidad a CTZ se determinó mediante tiras de gradiente (Liofilchem®, Werfen). Resultados: De 1253 cepas, 7% fueron MDR. Se estudió la sensibilidad de 78 cepas de P. aeruginosa MDR, de las cuales cinco (6,4%) resultaron resistentes a CTZ según criterios EUCAST. Conclusiones: En nuestro medio la resistencia in vitro a CTZ en cepas de P. aeruginosa MDR es aproximadamente 6%; CTZ es una opción de tratamiento de infecciones por cepas de P. aeruginosa MDR cuando no exista otra alternativa y se haya comprobado su sensibilidad in vitro.

Background: Pseudomonas aeruginosa is an opportunistic pathogen associated with high morbidity and mortality. For multidrug-resistant strains (MDR), ceftolozane/tazobactam (CTZ) has been authorized by the European Medicines Agency (EMA) for complicated urinary tract infections, acute pyelonephritis, and complicated intraabdominal infections. Aim: To determine the susceptibility to CTZ of P. aeruginosa MDR in isolated clinical samples at the University Hospital Puerto Real. Methods: The susceptibility according to the EUCAST to CTZ criteria of strains of P. aeruginosa MDR, between January 2015 and August 2017 has been studied. The multiresistance criteria were those defined by the Centers for Disease Control and Prevention. The antibiotic susceptibility was obtained by automated MicroScan® system (Beckman Coulter). Susceptibility to CTZ was determined using gradient strips (Liofilchem®, Werfen). Results: Of 1253 strains isolated, 7% presented MDR. We studied the susceptibility of a total of 78 strains of MDR P. aeruginosa, of which 5 (6.4%) were resistant to CTZ according to the EUCAST criteria. Conclusions: In our environment, the in vitro resistance to CTZ in MDR P. aeruginosa strains is approximately 6%. CTZ is an option for the treatment of infections by MDR P. aeruginosa when there is no other alternative and its in-vitro susceptibility has been proven.

Úlcera ocular por Moraxella nonliquefaciens / Ocular ulcer due to Moraxella nonliquefaciens

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Direct bacterial identification from positive blood cultures using matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry: A systematic review and meta-analysis / Identificación bacteriana directa a partir de hemocultivos positivos usando espectrometría de masas MALDI-TOF (matrix-assisted laser desorption/ionization time-of-flight): una revisión sistemática y metaanálisis

INTRODUCTION: The rapid identification of bacteraemia-causing pathogens could assist clinicians in the timely prescription of targeted therapy, thereby reducing the morbidity and mortality of this infection. In recent years, numerous techniques that rapidly and directly identify positive blood cultures have been marketed, with matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) being one of the most commonly used. METHODS: The aim of this systematic review and meta-analysis was to evaluate the accuracy of MALDI-TOF (Bruker(R)) for the direct identification of positive blood culture bottles. RESULTS: A meta-analysis was performed to summarize the results of the 32 studies evaluated. The overall quality of the studies was moderate. For Gram-positive bacteria, overall rates of correct identification of the species ranged from 0.17 to 0.98, with a cumulative rate (random-effects model) of 0.72 (95% CI: 0.64-0.80). For Gram-negative bacteria, correct identification rates ranged from 0.66 to 1.00, with a cumulative effect of 0.92 (95% CI: 0.88-0.95). For Enterobacteriaceae, the rate was 0.96 (95% CI: 0.94-0.97). CONCLUSION: MALDI-TOF mass spectrometry shows high accuracy for the correct identification of Gram-negative bacteria, particularly Enterobacteriaceae, directly from positive blood culture bottles, and moderate accuracy for the identification of Gram-positive bacteria (low for some species)

INTRODUCCIÓN: La identificación rápida de los patógenos causantes de bacteriemia orienta a los clínicos a prescribir con mayor celeridad un tratamiento dirigido y reducir así la morbimortalidad de dicha infección. Durante los últimos años, han aparecido en el mercado numerosas técnicas con la intención de cubrir esta necesidad, que logran una identificación rápida y directa a partir de los frascos de hemocultivos positivos. La espectrometría de masas matrix-assisted laser desorption/ionization with time-of-flight mass spectrometry (MALDI-TOF MS) es una de las tecnologías más utilizadas en este campo. MÉTODOS: El objetivo de ese estudio es realizar una revisión sistemática y metaanálisis que evalúe la precisión de MALDI-TOF MS (Bruker) para la identificación directa a partir de frascos de hemocultivos positivos. RESULTADOS: El metaanálisis fue realizado para sintetizar los resultados de los 32 estudios evaluados. La calidad total de los estudios fue moderada. Para las bacterias grampositivas, el ratio total de identificaciones correctas a nivel de especie fue del 0,17 al 0,98 con un ratio acumulativo (modelo de efectos aleatorios) de 0,72 (IC 95%: 0,64-0,80). Para las bacterias gramnegativas, el rango de identificaciones correctas fue del 0,66 al 1,00 con un efecto acumulativo de 0,92 (IC 95%: 0,88-0,95), llegando a un 0,96 (IC 95%: 0,94-0,97) en Enterobacteriaceae. CONCLUSIONES: La espectrometría de masas MALDI-TOF muestra una alta precisión para la correcta identificación de bacterias gramnegativas realizada directamente a partir de los frascos de hemocultivos positivos, siendo mayor en el grupo de las enterobacterias. Para grampositivas, la precisión es moderada, llegando a ser baja para alguna especie

Direct bacterial identification from positive blood cultures using matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry: A systematic review and meta-analysis.

INTRODUCTION: The rapid identification of bacteraemia-causing pathogens could assist clinicians in the timely prescription of targeted therapy, thereby reducing the morbidity and mortality of this infection. In recent years, numerous techniques that rapidly and directly identify positive blood cultures have been marketed, with matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) being one of the most commonly used. METHODS: The aim of this systematic review and meta-analysis was to evaluate the accuracy of MALDI-TOF (Bruker®) for the direct identification of positive blood culture bottles. RESULTS: A meta-analysis was performed to summarize the results of the 32 studies evaluated. The overall quality of the studies was moderate. For Gram-positive bacteria, overall rates of correct identification of the species ranged from 0.17 to 0.98, with a cumulative rate (random-effects model) of 0.72 (95% CI: 0.64-0.80). For Gram-negative bacteria, correct identification rates ranged from 0.66 to 1.00, with a cumulative effect of 0.92 (95% CI: 0.88-0.95). For Enterobacteriaceae, the rate was 0.96 (95% CI: 0.94-0.97). CONCLUSION: MALDI-TOF mass spectrometry shows high accuracy for the correct identification of Gram-negative bacteria, particularly Enterobacteriaceae, directly from positive blood culture bottles, and moderate accuracy for the identification of Gram-positive bacteria (low for some species).

Evaluación de la eficacia y seguridad de tigeciclina en el tratamiento de infecciones del tracto respiratorio: Revisión sistemática de la literatura científica / Evaluation of the efficacy and safety of tigecycline for treatment of respiratory tract infections: Systematic review of literature

Background: Tigecycline is indicated for the treatment of complicated skin infections, soft tissue and intraabdominal infections. Its use could be extended to community-acquired pneumonia (CAP) and hospital pneumonia (HN). The objective was to evaluate the efficacy and safety of tigecycline in the treatment of respiratory infections. Methods: systematic review (2012). Databases used were MEDLINE, EMBASE, Cochrane Library, CRD and WOK. We identified clinical trials of adults with respiratory infection, treated with tigecycline. The quality of the studies was assessed using CASPe checklist. Results: We selected four clinical trials of high-moderate quality. Three studies with patients with CAP and a trial with HN patients. In patients with CAP, efficacy of tigecycline (88.6 to 90.6%) was higher than levofloxacin (85.3 to 87.2%). The non inferiority testing was statistically significant (p < 0.001). In the study of patients with HN tigecycline showed an efficiency of 67.9% versus 78.2% for imipenem/cilastatin. Main adverse effects were gastrointestinal. Conclusions: The efficacy of tigecycline is non inferior than levofloxacin in patients with CAP, but less than imipenem in patients with HN. Tigecycline demonstrates noninferiority versus others tested antibiotics, and it shows a good safety profile.

Introducción: Tigeciclina está indicada en el tratamiento de infecciones complicadas de piel, tejidos blandos e intra-abdominales. Su utilización podría extenderse para neumonías adquiridas en la comunidad (NAC) y neumonías hospitalarias (NH). El objetivo ha sido evaluar la eficacia y seguridad de tigeciclina en el tratamiento de infecciones respiratorias. Material y Métodos: Revisión sistemática (2012). Se realizaron búsquedas en MedLine, Embase, Cochrane Library, CRD y WOK. Se localizaron ensayos clínicos de adultos con infección respiratoria, tratados mediante tigeciclina. La calidad de los estudios se valoró mediante los criterios CASPe. Resultados: Se seleccionaron cuatro ensayos clínicos de calidad alta-moderada. Tres estudios incluyeron pacientes con NAC y un estudio a pacientes con NH. En pacientes con NAC la eficacia de tigeciclina (88,6-90,6%) fue no inferior a la de levofloxacina (85,3-87,2%). El "test de no inferioridad" fue estadísticamente significativo (p < 0,001). En el estudio de pacientes con NH, tigeciclina presentó una eficacia de 67,9% frente a 78,2% de imipenem/cilastatina. Los principales efectos adversos fueron gastrointestinales. Conclusiones: la eficacia de tigeciclina es no inferior a la de levofloxacina en pacientes con NAC, pero inferior a imipenem en pacientes con NH. Tigeciclina ha demostrado no inferioridad frente a los otros antimicrobianos testados. Tigeciclina demuestra tener un buen perfil de seguridad.

Prevalencia de dolor en pacientes ingresados en un hospital de atención terciaria / Prevalence of pain in hospitalized patients in a tertiary hospital

Estudio de prevalencia del dolor en pacientes ingresados en el Hospital Universitario Virgen de la Nieves de Granada mediante entrevistas personales a una muestra representativa de 271 pacientes con una media de edad de 56.79 años (desviación estándar: 18.21); el 49.07% eran hombres. El porcentaje de pacientes que afirmó presentar dolor en el momento de la entrevista fue del 49.1%, si bien aumentó al 76% cuando se les preguntó si habían tenido dolor en algún momento durante la hospitalización. En cuanto a la intensidad del dolor, los pacientes contestaron que fue dolor leve en un 28% de los casos, moderado en un 16.2%, intenso en un 4.1%, e insoportable en un 0.7%. Más del 85% de los pacientes recibieron tratamiento adecuado para el dolor. Los analgésicos más frecuentemente utilizados fueron los antiinflamatorios no esteroides (77.5%), la vía de acceso más frecuente fue la oral-sublingual (52%) y la eficacia analgésica se consideró muy buena o buena en el 68.3%, según los pacientes. La pauta analgésica a demanda alcanzó la cifra del 27.7%. Los resultados fueron similares a los de otros estudios de prevalencia del dolor, aunque algo más bajos si nos basamos en dicha cifra en el momento de la entrevista. Resulta preocupante la elevada pauta analgésica a demanda del paciente, y la carencia de una escala o medida de referencia del dolor, de lo que se concluye que es necesaria la promoción de actividades formativas en relación con la terapéutica del dolor...

[Evaluation of the efficacy and safety of tigecycline for treatment of respiratory tract infections: systematic review of literature]. / Evaluación de la eficacia y seguridad de tigeciclina en el tratamiento de infecciones del tracto respiratorio: Revisión sistemática de la literatura científica.

BACKGROUND: Tigecycline is indicated for the treatment of complicated skin infections, soft tissue and intraabdominal infections. Its use could be extended to community-acquired pneumonia (CAP) and hospital pneumonia (HN). The objective was to evaluate the efficacy and safety of tigecycline in the treatment of respiratory infections. METHODS: systematic review (2012). Databases used were MEDLINE, EMBASE, Cochrane Library, CRD and WOK. We identified clinical trials of adults with respiratory infection, treated with tigecycline. The quality of the studies was assessed using CASPe checklist. RESULTS: We selected four clinical trials of high-moderate quality. Three studies with patients with CAP and a trial with HN patients. In patients with CAP, efficacy of tigecycline (88.6 to 90.6%) was higher than levofloxacin (85.3 to 87.2%). The non inferiority testing was statistically significant (p < 0.001). In the study of patients with HN tigecycline showed an efficiency of 67.9% versus 78.2% for imipenem/cilastatin. Main adverse effects were gastrointestinal. CONCLUSIONS: The efficacy of tigecycline is non inferior than levofloxacin in patients with CAP, but less than imipenem in patients with HN. Tigecycline demonstrates noninferiority versus others tested antibiotics, and it shows a good safety profile.

Análisis de coste-efectividad de la prueba de citología cervicovaginal / Cost-effectiveness analysis of conventional and liquid cervicovaginal cytology

Introducción. El cáncer de cérvix es un importante problema de salud pública, ya que produce cerca del 10% de las defunciones femeninas por cáncer en el todo el mundo. Objetivo. Determinar el ratio coste-efectividad de la citología de base líquida frente a la citología convencional para la detección de lesiones precancerosas de cérvix. Metodología. Se ha realizado un modelo de análisis de decisión, desde la perspectiva del sistema sanitario público. Las alternativas de comparación han sido la citología convencional frente a la citología líquida. La evaluación económica comparó la efectividad a corto plazo y el coste de realización de la prueba. Las medidas de efectividad utilizadas han sido los casos encontrados y los casos efectivos (casos encontrados menos falsos negativos). Los valores de exactitud diagnóstica (sensibilidad y especificidad) y prevalencia se extrajeron de un metaanálisis y los costes fueron facilitados por el Hospital Virgen de las Nieves de Granada. Con objeto de evaluar la incertidumbre de las variables incluidas en el modelo, se realizaron diversos análisis de sensibilidad univariante y probabilístico. Resultados. El coste de la determinación de lesiones mediante citología líquida en lugar de citología convencional será de 919,49euros por cada lesión superior a CIN1 encontrada. De la misma manera, al utilizar como medida de efectividad los casos efectivos se observa una efectividad incremental de 0,0375, siendo el ratio coste-efectividad incremental de 574,33euros por lesión identificada (AU)

Introduction. Cervical cancer is a major public health concern, causing approximately 10% of deaths from cancer in women worldwide. Objective. To determine the cost-effectiveness ratio of liquid-based cytology compared with the conventional cytological smear test for the detection of precancerous lesions of the cervix. Methods. A decision analysis model was constructed from the perspective of the public healthcare system. The alternatives compared were conventional and liquid-based cytology. The economic evaluation compared the short-term effectiveness and cost of testing. The measures of effectiveness used were the yield of the test (the proportion of correctly identified cases of cervical lesion in the population) and the «adjusted yield» (the proportion of cases identified minus false negatives). Data on diagnostic accuracy (sensitivity and specificity) and prevalence were obtained from a meta-analysis. Cost values were provided by the Virgen de las Nieves Hospital (Granada, Spain). To assess the uncertainty of the variables included in the model, several univariate and probabilistic sensitivity analyses were carried out. Results. The incremental cost of liquid-based cytology compared with conventional cytology was €919.49 for each cervical intraepithelial neoplasia (CIN1) or higher-stage lesion found. When the adjusted yield was used as the measure of effectiveness, the incremental cost-effectiveness ratio increased to €574 per lesion identified (AU)

Evaluación del sistema de navegación magnética intracardiaca Niobe, revisión sistemática de la literatura científica / Assessment of intracardiac magnetic navigation system Niobe, systematic review

Introducción y objetivos. Los métodos actuales de ablación conllevan sistemas de navegación manual y ablación cardiaca, y presentan ciertas limitaciones. El objetivo de este trabajo ha sido evaluar la eficacia y seguridad de los nuevos sistemas de navegación magnética intracardiaca. Métodos. Se hizo una revisión sistemática en las bases MedLine, Embase, Cochrane Library, CRD, ECRI, Hayes y bases de datos de HTA. Como términos Mesh se usaron: "electrophisiologic techniques", "magnetics", "stereotaxic techniques", "heart catheterization" y "catheter ablation". Los criterios de inclusión fueron estudios con adultos y lesiones cardíacas. La intervención fue el sistema de navegación magnética intracardiaca Niobe®. Los resultados medidos fueron: tiempos totales de procedimiento, tiempo de fluoroscopia, tiempo de colocación del catéter, tiempo de mapeo y tiempo de ablación. La calidad se evaluó con los cuestionarios CASPe y STROBE...

Introduction and objective: Current methods of ablation involving manual navigation systems and cardiac ablation have some limitations. The aim of this study was to evaluate the efficacy and safety of intracardiac magnetic navigation systems. Methods: Systematic review in MedLine, Embase, Cochrane Library, Center for Review and Dissemination, ECRI, Hayes and HTA databases was performed. The used Mesh terms were: electrophisiologic techniques, magnetic, stereotaxic techniques, heart catheterization, and catheter ablation. Inclusion criteria werestudies whose populations were adults with cardiac lesions. The intervention was intracardiac magnetic navigation system Niobe ® versus manual cardiacnavigation techniques and manual ablation. The outcomes were total procedure time, fluoroscopy time, time of catheter positioning, mapping and ablation time. Quality of studies was assessed by CASPe and STROBE...

Eficacia y seguridad de la utilización del óxido nitroso al 50% como analgesia en el parto / Efficacy and safety of 50% nitrous oxide as analgesia during delivery

Objetivos. Evaluar la eficacia y seguridad del óxido nitroso mezclado al 50% con oxigeno en la utilización como analgésico inhalado durante el parto. Material y métodos. Revisión sistemática de la literatura científica. Para ello se realizó una búsqueda bibliográfica (2010) en bases de datos electrónicas. Como criterios de inclusión se seleccionaron estudios que comparasen la administración del óxido nitroso inhalado al 50% frente a otra intervención, en mujeres adultas durante la fase de parto, y que mostrasen resultados de seguridad y eficacia. Resultados. Se obtuvieron un total de 230 referencias, seleccionándose 24 trabajos que podían cumplir los criterios de inclusión. Tras el análisis a texto completo, se seleccionaron una revisión sistemática y 3 ensayos clínicos. La calidad de los ensayos incluidos ha sido moderada-alta. El óxido nitroso como técnica analgésica frente a placebo presenta resultados aceptables, pero frente a otros analgésicos sus resultados son menos satisfactorios. Los resultados de seguridad son similares a los que ocurren con otros tratamientos analgésicos. Conclusiones. La administración inhalada de óxido nitroso al 50% a mujeres durante el parto podría ser una alternativa frente a las intervenciones utilizadas habitualmente para este fin (AU)

Objectives. To evaluate the safety and efficacy of 50% nitrous oxide with oxygen as an inhaled analgesic during delivery. Material and methods. We performed a systematic review of the literature through a literature search (2010) of electronic databases. Studies comparing administration of inhaled nitrous oxide at 50% with another intervention in adult women during labor and reporting results on efficacy and safety were included. Results. A total of 230 references were obtained and 24 studies that met the inclusion criteria were selected. After analysis of the texts, one systematic review and three clinical trials were selected. The quality of the trials included was moderate-high. Nitrous oxide as an analgesic technique produced acceptable results when compared with placebo but the results were less satisfactory when nitrous oxide was compared with other analgesics. Safety results were similar to those found with other analgesic treatments. Conclusions. Administration of inhaled 50% nitrous oxide in women during labor could be an alternative to routinely used techniques (AU)

Evaluación de las técnicas de amplificación genómica (NAT) para el tamizaje de hepatitis B en donantes de sangre: revisión sistemática / Assessment of nucleic acid testing (NAT) for screening hepatitis B in blood donors: systematic review

Las nuevas técnicas de biología molecular, denominadas técnicas de amplificación del ADN genómico “nucleic acid testing” (NAT), permiten la detección de partículas del ADN viral de la hepatitis B, independientemente de la fase de la enfermedad. Estas técnicas aumentan la sensibilidad del tamizaje, así el riesgo de infección mediante transfusiones podría reducirse. Se han evaluado las técnicas NAT para el tamizaje de hepatitis B en donantes de sangre. Se ha realizado una revisión sistemática en las bases Medline y Embase (2000-2008), así como en INAHTA, Cochrane Library y Euroscan con términos MeSH “Hepatitis B”, “Blood Transfusion”, “Blood Donors", y “Nucleic Acid Amplification Techniques”, y la terminología libre “hepatitis b”, “hbv”, “nat”, “nat-hbv” y “nucleic acid amplification testing”. Se incluyeron doce estudios, cuatro de ellos utilizaron PCR de fabricación propia, obteniendo resultados dispares; tres emplearon Procleix® (dos determinaron muestras mediante NAT que fueron HBsAg (-), 0,05 por ciento y 0,013 por ciento y el tercero, con 135 pacientes con terapia anti-VHB y HBsAg (-), obtuvo un 80 por ciento de muestras positivas mediante técnicas NAT). Cuatro trabajos con MPX® registraron porcentajes comprendidos entre 0,083 y 0,0015. En el estudio de pruebas diagnósticas incluido, las dos técnicas resultaron tener la misma sensibilidad. Por ello, se puede afirmar que las dos técnicas NAT poseen buena capacidad de tamizaje de hepatitis B, ofreciendo resultados en sensibilidad similares y podrían constituir un avance significativo en la automatización de los bancos de sangre y aumentar la seguridad de los pacientes que reciben transfusiones.

The new techniques of molecular biology called “nucleic acid testing” (NAT), enable the detection of particles of viral DNA in hepatitis B, regardless of the disease stage. These NAT techniques increase the sensitivity of screening, so the risk of infection through transfusion could be reduced. The aim of the study was to assess NAT techniques for screening hepatitis B in blood donors. We carried out a systematic review in Medline and Embase databases (2000-2008), as well as INAHTA, Cochrane Library and EuroScan. MeSH terms used were “Hepatitis B”, “Blood Transfusion”, “Blood Donors”, and “Nucleic Acid Amplification Techniques”, and free terms as “hepatitis B”, “hbv”, “nat”, “nat-hbv” and “nucleic acid amplification testing”. Twelve studies were included, four of them used self-made PCRs, obtaining mixed results, three used Procleix® (two samples identified by NAT were HBsAg (-), 0.05 percent and 0.013 percent; and the third study with 135 patients who received anti-HBV therapy and had HBsAg (-), showed 80 percent of positive samples by NAT techniques). Four papers about MPX® reported percentages ranging between 0.083 and 0.0015. In the study of diagnostic tests including the two techniques, they showed the same sensitivity. Both NAT techniques, have a good capacity for screening hepatitis B and showed similar results in sensitivity. They may be a significant advance in automation of blood banks and increase the safety of transfused patients.