Epidemiology, molecular characterisation and antimicrobial susceptibility of Neisseria gonorrhoeae isolates in Madrid, Spain, in 2016.

With the aim to elucidate gonococcal antimicrobial resistance (AMR)-risk factors, we undertook a retrospective analysis of the molecular epidemiology and AMR of 104 Neisseria gonorrhoeae isolates from clinical samples (urethra, rectum, pharynx and cervix) of 94 individuals attending a sexually transmitted infection clinic in Madrid (Spain) from July to October 2016, and explored potential links with socio-demographic, behavioural and clinical factors of patients. Antimicrobial susceptibility was determined by E-tests, and isolates were characterised by N. gonorrhoeae multi-antigen sequence typing. Penicillin resistance was recorded for 15.4% of isolates, and most were susceptible to tetracycline, cefixime and azithromycin; a high incidence of ciprofloxacin resistance (~40%) was found. Isolates were grouped into 51 different sequence types (STs) and 10 genogroups (G), with G2400, ST5441, ST2318, ST12547 and G2992 being the most prevalent. A significant association (P = 0.015) was evident between HIV-positive MSM individuals and having a ciprofloxacin-resistant strain. Likewise, a strong association (P = 0.047) was found between patient age of MSM and carriage of isolates expressing decreased susceptibility to azithromycin. A decrease in the incidence of AMR gonococcal strains and a change in the strain populations previously reported from other parts of Spain were observed. Of note, the prevalent multi-drug resistant genogroup G1407 was represented by only three strains in our study, while the pan-susceptible clones such as ST5441, and ST2318, associated with extragenital body sites were the most prevalent.

[From a pathogen's genome to an effective vaccine: the four-component meningococcal serogroup B vaccine]. / Del genoma de un patógeno a una vacuna efectiva: la vacuna de cuatro componentes frente a los meningococos del serogrupo B.

Invasive meningococcal disease (IMD), caused by the bacterium Neisseria meningitidis, entails significant mortality and morbidity. Disease incidence is highest in infants <1 year and young children globally. In Europe, N. meningitidis serogroup B is responsible for over 50% of overall IMD cases, whereas the majority of IMD cases in Latin America is caused either by serogroup B or C. The development of an effective vaccine against serogroup B has challenged the researchers for over half a century. Serogroup B capsular polysaccharide was an inappropriate vaccine antigen, and the success of outer membrane vesicle (OMV) vaccines was restricted to homologous bacterial strains. Reverse vaccinology led to the development of a 4-component meningococcal vaccine including three novel antigens, and OMVs (4CMenB). Each vaccine component has a different target. 4CMenB has been authorised based on its immunogenicity and safety data because the low disease incidence precluded formal clinical efficacy studies. Human serum bactericidal antibody (hSBA) assay tests functional antibodies in the serum of vaccinated individuals (i.e. the vaccine immunogenicity), and is the accepted correlate of protection. Vaccine strain coverage has been assessed both through hSBA assays and a more conservative method named Meningococcal Antigen Typing System (MATS). Effectiveness data of 4CMenB have been collected in the field since 2013. The vaccine proved effective in outbreak control in North America, and recent data from the introduction of the vaccine in the United Kingdom infant national immunisation programme reveal a vaccine effectiveness of 82.9% for the first two doses, with an acceptable safety profile.

Perceived efficacy and satisfaction of patients with subcutaneous hypoallergenic high-dose house dust mite extract.

SUMMARY: The efficacy and safety of subcutaneous immunotherapy with modified, high-dose, major allergen house dust mite extract is widely supported by double-blind, placebo-controlled studies. However, little is known regarding patient-perceived efficacy and satisfaction. An observational, retrospective, multicentre study in patients treated with Acaroid® was conducted to assess the efficacy and degree of satisfaction of the patients after the first six months of treatment with it. All the clinical study procedures were performed according to the routine clinical practice. This study demonstrates that Acaroid® is effective and well tolerated. The patients' condition demonstrated a clear and marked improvement in the first 6 months after treatment initiation. Patients treated with Acaroid® were very satisfied, with a correlation to improvement in patient-perceived symptoms and the administration of treatment by a healthcare professional.

A large portion of meningococcal antigen typing system-negative meningococcal strains from spain is killed by sera from adolescents and infants immunized with 4CMenB.

A new vaccine (the 4CMenB 4-component protein vaccine [Bexsero], which includes PorA, factor H-binding protein [fHbp], neisserial heparin-binding antigen [NHBA], and Neisseria adhesin A [NadA]) against serogroup B meningococci has recently been approved for use in people older than age 2 months in Europe, Australia, and Canada. Preapproval clinical efficacy studies are not feasible for invasive meningococcal disease because its incidence is low/very low, and the serum bactericidal antibody (SBA) titer (or the human SBA [hSBA] titer when human complement is used in the assay) has been used as a surrogate marker of protection. However, the hSBA assay cannot be used on a large scale, and therefore, a meningococcal antigen typing system (MATS) was developed. MATS combines conventional PorA genotyping with an enzyme-linked immunosorbent assay (ELISA) that quantifies both the expression and the cross-reactivity of antigenic variants. The assay has been used to evaluate the potential of the 4CMenB meningococcal group B vaccine to cover group B strains in several countries. Some recent data suggest that MATS is a conservative predictor of strain coverage. We used pooled sera from adolescents and infants to test by the hSBA assay 10 meningococcal group B strains isolated in Spain that were negative for the 3 antigens (n = 9) or that had very low levels of the 3 antigens (n = 1) by MATS. We found that all strains were killed by sera from adolescents and that 5 of the 10 strains were also killed, although at a low titer, by sera from infants. Our data confirm that MATS underestimates vaccine coverage.

Vacunas multivalentes frente a enfermedad meningocócica: ¿dentro o fuera de nuestras agendas? / Polyvalent meningococcal vaccines. Within or outside our agenda?

El desarrollo de vacunas tetravalentes frente a enfermedad meningocócica invasiva (EMI) ha venido motivado en gran medida por el incremento de serogrupos considerados poco habituales y su expansión geográfica, pero también por la necesidad de contar con vacunas que ofrezcan un amplio espectro de protección en una enfermedad de efectos devastadores como la EMI. Estos cambios en los serogrupos considerados como habituales (B y C) han sido detectados tanto para el serogrupo Y como para el W, lo que ha llevado a que estas vacunas multivalentes sean utilizadas por un buen número de países con diferentes estrategias que serán comentadas. Los datos epidemiológicos en España, por sí solos actualmente no justifican su utilización en los calendarios de vacunación pero hay un riesgo potencial de introducción de clones virulentos de serogrupos poco habituales (fundamentalmente Y y W) y esto nos llevaría a abrir una discusión sobre su potencial de utilización pensando fundamentalmente en población adolescente/preadolescente como grupo diana para la intervención

The development of tetravalent vaccines against Invasive Meningococcal Disease (IMD) has been driven mainly due to the increase of the prevalence and geographic expansion of several serogroups considered unusual, but also because of the need for vaccines that offer broad spectrum protection in a devastating disease such as IMD. These changes in serogroups considered usual (B and C) have been detected for both serogroup Y and W, which has led to the multivalent vaccines being used by a number of countries with different strategies that will be discussed in the article. Epidemiological data in Spain, currently do not justify its use in immunization schedules, but there is a potential risk for the introduction of virulent clones of those uncommon serogroups (Y and W), and this would lead us to open a discussion of their potential use, particularly in the adolescent/pre-teen population as a target group for intervention

[Polyvalent meningococcal vaccines: within or outside our agenda?]. / Vacunas multivalentes frente a enfermedad meningocócica: ¿dentro o fuera de nuestras agendas?

The development of tetravalent vaccines against Invasive Meningococcal Disease (IMD) has been driven mainly due to the increase of the prevalence and geographic expansion of several serogroups considered unusual, but also because of the need for vaccines that offer broad spectrum protection in a devastating disease such as IMD. These changes in serogroups considered usual (B and C) have been detected for both serogroup Y and W, which has led to the multivalent vaccines being used by a number of countries with different strategies that will be discussed in the article. Epidemiological data in Spain, currently do not justify its use in immunization schedules, but there is a potential risk for the introduction of virulent clones of those uncommon serogroups (Y and W), and this would lead us to open a discussion of their potential use, particularly in the adolescent/pre-teen population as a target group for intervention.

Serogroup W meningococcal disease: global spread and current affect on the Southern Cone in Latin America.

Meningococcal serogroup W strains have been emerging throughout the current century with most of the isolates belonging to the sequence type (ST11)/electrophoretic type (ET37) clonal complex (ST11/E37 CC), particularly since the international outbreak following Hajj 2000. That outbreak appears to have triggered off that trend, contributing to the spread of W ST11/ET37 CC strains globally; however, local strains could be also responsible for increases in the percentage and/or incidence rates of this serogroup in some countries. More recently, unexpected increases in the percentage and incidence rate of W has been noticed in different countries located in the South Cone in Latin America, and W ST11/ET37 CC strains now appear as endemic in the region and an extensive immunization programme with tetravalent conjugate vaccine (covering serogroups A, C, Y and W) has been recently implemented in Chile. It is difficult to ascertain whether we are observing the emergence of W ST11 CC strains in different geographical areas or whether the Hajj 2000 strain is still spreading globally. Several aspects of the evolution of that situation are analysed in this paper, reviewing also the implications in immunization programmes. Closely related with the analysis of this potential evolution, it will be very interesting to monitor the evolution of serogroup W in the African meningitis belt after implementation of the extensive immunization programme with serogroup A conjugate vaccine that is currently underway. More data about carriers, transmission, clonal lineages, etc. are needed for taking decisions (target groups, outbreak control, defining the extent, etc.) to adapt the response strategy with potential interventions with broad coverage vaccines against the emergent serogroup W.

Caídas desde grandes alturas en Pediatría. Epidemiología y evolución de 54 pacientes / Falls from heights in Pediatrics. Epidemiology and evolution of 54 patients

Objetivo: Las caídas desde altura son una importante causa de morbimortalidad prevenible en la edad pediátrica. Los objetivos de este estudio son describir la evolución y el pronóstico a largo plazo de los pacientes precipitados, identificar la población pediátrica con mayor riesgo de sufrir caídas desde altura en nuestro medio y definir las variables al ingreso asociadas a mortalidad. Diseño: Estudio de una cohorte retrospectivo. Ámbito: Pediatría. Participantes: Pacientes politraumatizados ingresados en el servicio de unidad de cuidados intensivos pediátricos tras haberse precipitado desde una altura superior a dos metros a lo largo de 10 años. Resultados: El 92% de las caídas se produjeron desde edificios. De 54 pacientes precipitados, el 51% fueron preescolares. En adolescentes, el intento de suicidio ha sido la causa en la mitad de los casos. Un 52% pertenece a familias inmigrantes. El traumatismo craneoencefálico fue la lesión más frecuente. La mortalidad fue del 12%. De los pacientes en los que se realizó seguimiento a los dos años, el 82% llevaban una vida independiente sin secuelas. Los factores independientes asociados a mortalidad fueron: la altura de la caída, la puntuación en la escala de coma de Glasgow y en el índice de trauma pediátrico, la anemia, la acidosis y la hipotensión al ingreso, la necesidad de drogas vasoactivas, y la presencia de TCE grave con desarrollo de hipertensión intracraneal. Conclusiones: Las caídas desde grandes alturas se producen sobre todo en preescolares sin supervisión y en adolescentes por tentativa de suicidio. Estos pacientes presentan un gran número de lesiones, una alta mortalidad y altas necesidades asistenciales. La mayoría de los supervivientes llevan una vida independiente a largo plazo. Sería necesario implantar medidas preventivas, sobre todo en la población de riesgo (AU)

Objective: Falls from heights are a major preventable cause of morbidity and mortality in children. The aims of this study are to describe the evolution and long-term prognosis of such patients, to identify the pediatric population at greatest risk of falling from heights in our setting, and to define the variables at admission capable of predicting mortality. Design: A retrospective patient cohort review was carried out. Setting: Pediatric patients. Population: Pediatric patients admitted to the pediatric intensive care unit following a fall from a height of over two meters, in the last 10 years. Results: Ninety-two percent of the patients fell from buildings. Out of a total of 54 patients suffering falls, 51% were preschoolers. Fifty percent of the adolescents cases corresponded to attempted suicide. Fifty-two percent of the children were immigrants. Head injuries were the most common type of traumatism. The mortality rate was 12%. Eighty-two percent of the patients with a follow-up period of two years were leading an independent life. The independent predictors of mortality were the height of the fall, the Glasgow coma score and pediatric trauma index score upon admission, the presence of anemia, acidosis and hypotension upon admission, the need for vasoactive drugs, and the presence of severe head injury with the development of intracranial hypertension. Conclusions: Falls from heights occur mainly in unsupervised preschool children and teenagers attempting suicide. These patients have a high number of injuries, a high mortality rate, and important care needs. Most survivors are able to lead an independent life over the long term. Preventive measures should be implemented in risk populations (AU)

[Falls from heights in Pediatrics. Epidemiology and evolution of 54 patients]. / Caídas desde grandes alturas en Pediatría. Epidemiología y evolución de 54 pacientes.

OBJECTIVE: Falls from heights are a major preventable cause of morbidity and mortality in children. The aims of this study are to describe the evolution and long-term prognosis of such patients, to identify the pediatric population at greatest risk of falling from heights in our setting, and to define the variables at admission capable of predicting mortality. DESIGN: A retrospective patient cohort review was carried out. SETTING: Pediatric patients. POPULATION: Pediatric patients admitted to the pediatric intensive care unit following a fall from a height of over two meters, in the last 10 years. RESULTS: Ninety-two percent of the patients fell from buildings. Out of a total of 54 patients suffering falls, 51% were preschoolers. Fifty percent of the adolescents cases corresponded to attempted suicide. Fifty-two percent of the children were immigrants. Head injuries were the most common type of traumatism. The mortality rate was 12%. Eighty-two percent of the patients with a follow-up period of two years were leading an independent life. The independent predictors of mortality were the height of the fall, the Glasgow coma score and pediatric trauma index score upon admission, the presence of anemia, acidosis and hypotension upon admission, the need for vasoactive drugs, and the presence of severe head injury with the development of intracranial hypertension. CONCLUSIONS: Falls from heights occur mainly in unsupervised preschool children and teenagers attempting suicide. These patients have a high number of injuries, a high mortality rate, and important care needs. Most survivors are able to lead an independent life over the long term. Preventive measures should be implemented in risk populations.

Síndrome de tako-tsubo. Discinesia transitoria del ventrículo izquierdo. Presentación de nuestra casuística / Tako-tsubo syndrome. Transient left ventricular dyskinesia. Presentation of our casuistics

Este síndrome fue descrito en 1990, y se caracteriza por dolor torácico que simula un síndrome coronario agudo (SCA), alteraciones en el ECG y coronarias sin lesiones. Presentamos 16 pacientes ingresados en nuestra UCI, con criterios de síndrome de discinesia transitoria del ventrículo izquierdo (SDTVI). Todos nuestros pacientes menos uno eran mujeres con edad, en general, mayor de 55 años. Se detectó dolor torácico en el 75% de los pacientes. Un 43% tuvo como desencadenante una situación estresante emocional. Un 56% tuvo elevación del ST. La elevación de biomarcadores fue ligera-moderada, salvo en un paciente que fue especialmente elevado. A todos se les realizó coronariografía y ventriculografía, detectándose una discinesia septal o anterolateral, con fracción de eyección normal en el 75% de los casos. La discinesia desapareció entre los 4 días y las 6 semanas (AU)

This syndrome was described in 1990. It is characterized by chest pain that simulatesan acute coronary syndrome (ACS), with alterations in the ECG, but with normal coronaryarteries. We present 16 patients admitted in our ICU, who met the criteria of transient leftventricular dysfunction syndrome (TLVDS). All but 1 patient were women, with age in generalhigher than 55 years. Chest pain was detected in the 75% of them. A total of 43% had emotionalstress as 56% had an elevation of the ST segment, essentially anterolateral. The increase of thebiomarkers was slight-to-moderate, with the exception of one patient in whom it was especiallyhigh. All of them had undergone a coronary arteriogram and ventriculography, and either septalor anterolateral dyskinesia had been detected, with normal ejection fraction. In 75% of the casesthe dyskinesia had disappeared between 4 days to 6 weeks (AU)

Hemorragia cerebelosa secundaria a fuga de líquido cefalorraquídeo tras cirugía del canal lumbar / Cerebellar hemorrhage secondary to cerebrospinal fluid leak after lumbar canal surgery

No disponible

[Tako-tsubo syndrome. Transient left ventricular dyskinesia. Presentation of our casuistics]. / Síndrome de tako-tsubo. Discinesia transitoria del ventrículo izquierdo. Presentación de nuestra casuística.

This syndrome was described in 1990. It is characterized by chest pain that simulates an acute coronary syndrome (ACS), with alterations in the ECG, but with normal coronary arteries. We present 16 patients admitted in our ICU, who met the criteria of transient left ventricular dysfunction syndrome (TLVDS). All but 1 patient were women, with age in general higher than 55 years. Chest pain was detected in the 75% of them. A total of 43% had emotional stress as 56% had an elevation of the ST segment, essentially anterolateral. The increase of the biomarkers was slight-to-moderate, with the exception of one patient in whom it was especially high. All of them had undergone a coronary arteriogram and ventriculography, and either septal or anterolateral dyskinesia had been detected, with normal ejection fraction. In 75% of the cases the dyskinesia had disappeared between 4 days to 6 weeks.

Usefulness of endoscopic ultrasonography (EUS) for selecting carcinoid tumors as candidates to endoscopic resection.

INTRODUCTION: Carcinoid tumors (CTs) represent the most common type of neuroendocrine tumors (NETs). Digestive CTs in the gastroduodenal and colorectal tracts may be assessed using endoscopy and echoendoscopy or endoscopic ultrasonography (EUS) with the goal of attempting local resection with curative intent without having recourse to surgery. OBJECTIVE: Endpoints in this study included:--Assessing the usefulness of EUS for selecting CTs as candidates to endoscopic excision. --Assessing the effectiveness of local resection (complete carcinoid resection) and the safety (complications) of the technique involved. PATIENTS AND METHODS: OUr series included 18 patients (12 males and 6 females) with 23 tumors. Sixteen patients (10 males and 6 females) were selected, with age ranging from 40 to 81 years (mean: 57 years), biopsied, endoscopically treated digestive carcinoid tumors, and a previous negative extension study. Twenty-one 2-to-20-mm (mean size 8 mm) tumors were resected in 23 procedures. After endoscopy plus biopsy and echoendoscopy (EUS), excision was carried out with conventional polypectomy snare mucosectomy and submucosal injection with saline and/or adrenaline in most cases (15), and mucosectomy technique following lesion ligation with elastic bands for six cases. Two cases underwent transanal endoscopic surgery (TEM), one of them following non-curative polypectomy. A total of 23 local procedures were performed with the key goal of assessing efficacy (complete resection: CR) and safety (complications). RESULTS: There were no severe complications except for the last gastric mucosectomy for a 6-mm carcinoid, where a miniperforation occurred that was solved by using 3 clips (1/23: 4.3%).EUS sensitivity was 94%. Complete resection was 90.5% (19/21). CONCLUSIONS: The endoscopic mucosal resection of selected carcinoid tumors is a safe, effective technique. EUS is the technique of choice to select patients eligible for endoscopic resection (carcinoids smaller than 20 mm in superficial layers, with an unscathed muscularis propria and negative extension study).

Utilidad de la ultrasonografía endoscópica (USE) para seleccionar tumores carcinoides como candidatos a una resección endoscópica / No disponible

Introduccion: los tumores carcinoides (TC) son los tumores neuroendocrinos (TNEs) más frecuentes. Los TC digestivos localizados en el tracto gastroduodenal y rectocolónico pueden ser evaluados por endoscopia y por ecoendoscopia o ultrasonografía endoscópica (USE), con el objetivo de efectuar una resección local como tratamiento curativo sin recurrir a la cirugía. Objetivo: los objetivos finales de este estudio fueron: —Analizar si es útil la USE en la selección de TC como candidatos a una extirpación endoscópica. —La evaluación de la eficacia de la resección local (resección completa del carcinoide) y la seguridad (complicaciones) de la técnica efectuada. Pacientes y metodos: la serie consta de 18 pacientes (12 varones y 6 mujeres) con 23 tumores. Se han seleccionado 16 pacientes (10 varones y 6 mujeres) con un rango de 40 a 81 años (media: 57 años), con tumores carcinoides digestivos biopsiados y tratados endoscópicamente, con estudio previo de extensión negativo. Se resecaron 21 tumores de 2 a 20 mm (tamaño medio: 8 mm), en 23 procedimientos. Después de endoscopia más biopsia y ecoendoscopia (USE), se llevó a cabo la extirpación mediante mucosectomía con asa de polipectomía convencional e inyección submucosa con suero salino y/o adrenalina en la mayoría de casos (15) y en seis con técnica de mucosectomía tras ligar la lesión con bandas elásticas. En dos casos con cirugía endoscópica transanal (TEM) (uno después de haber efectuado polipectomía no curativa). Se efectuaron en total 23 tratamientos localizados con el objetivo fundamental de evaluar la eficacia (resección completa: RC) y seguridad (complicaciones). Resultados: no hubo complicaciones muy importantes, excepto en la última mucosectomía gástrica por un carcinoide de 6 mm, en la que se produjo una miniperforación (1/23: 4,3%) que se resolvió con la colocación de 3 clips. La sensibilidad de la USE fue del 94%. La resección completa fue del 90,5% (19/21). Conclusiones: la resección mucosa endoscópica de tumores carcinoides seleccionados es una técnica segura y eficaz. La USE es la técnica de elección para seleccionar los pacientes candidatos a resección endoscópica (carcinoides menores de 20 mm situados en las primeras capas, con muscular propia indemne y con estudio de extensión negativo(AU)

Introduction: carcinoid tumors (CTs) represent the most common type of neuroendocrine tumors (NETs). Digestive CTs in the gastroduodenal and colorectal tracts may be assessed using endoscopy and echoendoscopy or endoscopic ultrasonography (EUS) with the goal of attempting local resection with curative intent without having recourse to surgery. Objective: endpoints in this study included: —Assessing the usefulness of EUS for selecting CTs as candidates to endoscopic excision. —Assessing the effectiveness of local resection (complete carcinoid resection) and the safety (complications) of the technique involved. Patients and methods: our series included 18 patients (12 males and 6 females) with 23 tumors. Sixteen patients (10 males and 6 females) were selected, with age ranging from 40 to 81 years (mean: 57 years), biopsied, endoscopically treated digestive carcinoid tumors, and a previous negative extension study. Twenty- one 2-to-20-mm (mean size 8 mm) tumors were resected in 23 procedures. After endoscopy plus biopsy and echoendoscopy (EUS), excision was carried out with conventional polypectomy snare mucosectomy and submucosal injection with saline and/or adrenaline in most cases (15), and mucosectomy technique following lesion ligation with elastic bands for six cases. Two cases underwent transanal endoscopic surgery (TEM), one of them following noncurative polypectomy. A total of 23 local procedures were performed with the key goal of assessing efficacy (complete resection: CR) and safety (complications). Results: there were no severe complications except for the last gastric mucosectomy for a 6-mm carcinoid, where a miniperforation occurred that was solved by using 3 clips (1/23: 4.3%). EUS sensitivity was 94%. Complete resection was 90.5% (19/21). Conclusions: the endoscopic mucosal resection of selected carcinoid tumors is a safe, effective technique. EUS is the technique of choice to select patients eligible for endoscopic resection (carcinoids smaller than 20 mm in superficial layers, with an unscathed muscularis propria and negative extension study)(AU)

Mejora de la calidad de la especificación de la inclusión en ensayo clínico sobre prescripciones en quimioterapia / Improving the specification quality of inclusion criteria of patients in chemotherapy clinical trials

Objetivos: Evaluar la mejora de la calidad de las prescripciones de quimioterapia para pacientes en ensayo clínico (EC) y analizar si en la orden médica se especifica la participación en el ensayo tras determinar los principales factores de riesgo y mediante la aplicación de medidas correctoras. Método: Estudio retrospectivo de omisiones recogidas durante 2006 y 2007. Con los datos del 2006 se analizaron los factores de riesgo y se implantaron medidas de mejora (información a prescriptores e inicio de prescripción electrónica). Posteriormente, se evaluaron los datos del 2007. Variables analizadas: EC, número de prescripciones, investigador principal, prescriptor, servicio, antineoplásicos y enfermedad. Resultados: Los servicios de Oncología y Hematología realizaron el 57,1% de los ensayos del hospital. En 2006 se recibieron 1.625 prescripciones y se detectaron 151 incorrectas (9,3%), y en 2007 se recibieron 1.858 prescripciones y se detectaron 65 incorrectas (3,5%). En 2006 se observó mayor frecuencia de prescripciones incorrectas en Hematología (34,1%) que en Oncología (8,6%). En 2007 Hematología apenas tuvo omisiones (1,8%) y en Oncología disminuyeron al 3,6%. Respecto a la enfermedad, la tasa de error desapareció prácticamente en mieloma múltiple (del 34,1 al 2,2%) y disminuyó en mama (del 10,8 al 4,4%). El incumplimiento siempre fue mayor cuando el prescriptor difería del investigador principal. Conclusiones: La frecuencia de las prescripciones con error se redujo (pasó del 9,3 al 3,5%). Destaca la reducción extraordinaria en Hematología relacionada con ensayos en mieloma múltiple. Las medidas correctoras han resultado útiles en la mejora de la calidad (AU)

Objectives: To assess the quality improvement of chemotherapy prescriptions for patients included in clinical trials (CT) analyzing whether the prescription is specified for patient participation, after having identified the major risks factors and the appropriate corrective measures are applied. Methods: Retrospective study of omissions collected during 2006 and 2007. After collecting all the information, we analyzed the risks factors and introduced improvement measures (information to prescribers and the beginning of electronic prescription). The 2007 data were then evaluated. Variables analyzed: CT, number of prescriptions, principal investigator, prescriber, department, anti-neoplastic involved and pathology. Results: Oncology and Haematology make up 57.1% of hospital trials. In 2006, 1625 chemotherapy prescriptions were received and there were 151 incorrect prescriptions (9.3%), and in 2007, 1858 prescriptions with 65 (3.5%) incorrect. In 2006, there was a higher frequency of incorrect prescriptions in Haematology (34.1%) and (Oncology (8.6%)). In 2007 Hematology had just 1.8% of omissions and in Oncology it decreased to 3.6%. As regards the pathology, the error rate has virtually disappeared in multiple myeloma prescriptions (34.1 to 2.2%) and decreased in breast cancer (10.8 to 4.4%). The non-fulfilment rate is higher when the prescriber is not the principal investigator. Conclusions: The overall frequency of prescriptions with errors decreased significantly from 9.3% to 3.5%, with an extraordinary reduction in Haematology (34.1% to 1.8%) related to the multiple myeloma trials. The corrective measures implemented have proved to be useful in CT (AU)

[Improving the specification quality of inclusion criteria of patients in chemotherapy clinical trials]. / Mejora de la calidad de la especificación de la inclusión en ensayo clínico sobre prescripciones en quimioterapia.

OBJECTIVES: To assess the quality improvement of chemotherapy prescriptions for patients included in clinical trials (CT) analyzing whether the prescription is specified for patient participation, after having identified the major risks factors and the appropriate corrective measures are applied. METHODS: Retrospective study of omissions collected during 2006 and 2007. After collecting all the information, we analyzed the risks factors and introduced improvement measures (information to prescribers and the beginning of electronic prescription). The 2007 data were then evaluated. Variables analyzed: CT, number of prescriptions, principal investigator, prescriber, department, anti-neoplastic involved and pathology. RESULTS: Oncology and Haematology make up 57.1% of hospital trials. In 2006, 1625 chemotherapy prescriptions were received and there were 151 incorrect prescriptions (9.3%), and in 2007, 1858 prescriptions with 65 (3.5%) incorrect. In 2006, there was a higher frequency of incorrect prescriptions in Haematology (34.1%) and (Oncology (8.6%)). In 2007 Hematology had just 1.8% of omissions and in Oncology it decreased to 3.6%. As regards the pathology, the error rate has virtually disappeared in multiple myeloma prescriptions (34.1 to 2.2%) and decreased in breast cancer (10.8 to 4.4%). The non-fulfillment rate is higher when the prescriber is not the principal investigator. CONCLUSIONS: The overall frequency of prescriptions with errors decreased significantly from 9.3% to 3.5%, with an extraordinary reduction in Haematology (34.1% to 1.8%) related to the multiple myeloma trials. The corrective measures implemented have proved to be useful in CT.