Reliability and validity of PRO-CTCAE® daily reporting with a 24-hour recall period.

PURPOSE: The standard recall period for the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE®) is the past 7 days, but there are contexts where a 24-hour recall may be desirable. The purpose of this analysis was to investigate the reliability and validity of a subset of PRO-CTCAE items captured using a 24-hour recall. METHODS: 27 PRO-CTCAE items representing 14 symptomatic adverse events (AEs) were collected using both a 24-hour recall (24 h) and the standard 7 day recall (7d) in a sample of patients receiving active cancer treatment (n = 113). Using data captured with a PRO-CTCAE-24h on days 6 and 7, and 20 and 21, we computed intra-class correlation coefficients (ICC); an ICC ≥ 0.70 was interpreted as demonstrating high test-retest reliability. Correlations between PRO-CTCAE-24h items on day 7 and conceptually relevant EORTC QLQ-C30 domains were examined. In responsiveness analysis, patients were deemed changed if they had a one-point or greater change in the corresponding PRO-CTCAE-7d item (from week 0 to week 1). RESULTS: PRO-CTCAE-24h captured on two consecutive days demonstrated that 21 of 27 items (78%) had ICCs ≥ 0.70 (day 6/7 median ICC 0.76), (day 20/21 median ICC 0.84). Median correlation between attributes within a common AE was 0.75, and the median correlation between conceptually relevant EORTC QLQ-C30 domains and PRO-CTCAE-24 h items captured on day 7 was 0.44. In the analysis of responsiveness to change, the median standardized response mean (SRM) for patients with improvement was - 0.52 and that for patients with worsening was 0.71. CONCLUSION: A 24-hour recall period for PRO-CTCAE items has acceptable measurement properties and can inform day-to-day variations in symptomatic AEs when daily PRO-CTCAE administration is implemented in a clinical trial.

Carcinoma papilar tiroideo con invasión locorregional: reporte de caso / Papillary thyroid crcinoma with locoregional invasion: case report

El cáncer diferenciado de tiroides incluye el tipo papilar y folicular que representan más del 80% de los casos y tienen un excelente pronóstico. Existen varios subtipos histológicos y las variantes foliculares son probablemente las más comunes. La incidencia de cáncer papilar variante folicular ha ido en aumento. En un reporte de un solo centro, cerca del 40% de los cánceres papilares eran variantes foliculares1. El subtipo infiltrativo de la variante folicular presenta sectores que invaden el parénquima tiroideo no neoplásico y carece de una cápsula tumoral bien definida. Tiene un comportamiento biológico y un perfil molecular que es más similar al tumor papilar clásico2. Existen características clínicas y patológicas asociadas con riesgo más alto de recurrencia tumoral y mortalidad; entre ellos se describen el tamaño del tumor primario y la presencia de invasión de tejidos blandos3. En la invasión de estructuras adyacentes, los sitios más comprometidos incluyen los músculos pretiroideos, el nervio laríngeo recurrente, el esófago, la faringe, laringe y la tráquea. Además, puede haber otras estructuras involucradas como: la vena yugular interna, la arteria carótida y los nervios vago, frénico y espinal4. El compromiso de los ganglios linfáticos y la incidencia de metástasis ganglionares en adultos depende de la extensión de la cirugía. Entre los que se realizan una disección radical modificada del cuello, hasta el 80% tienen metástasis en los ganglios linfáticos y el 50% de ellas son microscópicas5. Clínicamente los tumores localmente avanzados cursan con disfonía, disfagia, disnea, tos o hemoptisis, pero la ausencia de síntomas no descarta la invasión local. Según las guías de la American Thyroid Association6 son variables de mal pronóstico: la edad del paciente, el tamaño del tumor primario, la extensión extra tiroidea y la resección quirúrgica incompleta.

Differentiated thyroid cancer includes papillary and follicular types that represent more than 80% of cases and have an excellent prognosis. There are several histologic subtypes, and follicular variants are probably the most common. The incidence of papillary follicular variant cancer has been increasing. In a singlecenter report, about 40% of papillary cancers were follicular variants1. The infiltrative subtype of the follicular variant presents sectors that invade the non-neoplastic thyroid parenchyma and lacks a well-defined tumor capsule. It has a biological behavior and a molecular profile that is more similar to the classic papillary tumor2. There are clinical and pathological characteristics associated with a higher risk of tumor recurrence and mortality; These include the size of the primary tumor and the presence of soft tissue invasion3. In the invasion of adjacent structures, the most compromised sites include the pre-thyroid muscles, the recurrent laryngeal nerve, the esophagus, the pharynx, larynx and trachea. In addition, there may be other structures involved such as: the internal jugular vein, the carotid artery and the vagus, phrenic and spinal nerves4. The involvement of the lymph nodes and the incidence of lymph node metastases in adults depends on the extent of the surgery. Among those who undergo a modified radical neck dissection, up to 80% have lymph node metastases and 50% of them are microscopic5. Clinically locally advanced tumors present with dysphonia, dysphagia, dyspnea, cough, or hemoptysis, but the absence of symptoms does not rule out local invasion. According to the American Thyroid Association guidelines6, there are variables with a poor prognosis: the age of the patient, the size of the primary tumor, the extra-thyroid extension, and incomplete surgical resection.

Variante células altas de cáncer papilar de tiroides: reporte de casos / Tall cell variant of papillary thyroid cancer: case report

El cáncer papilar constituye aproximadamente el 80% de todos los casos de cáncer de tiroides y el 85% de los tumores diferenciados. La variante de células altas representa el 1,3 al 12% del cáncer papilar siendo la variante agresiva más común de estos tumores. Posee un comportamiento agresivo, con mayor incidencia de invasión extratiroidea, linfovascular y metástasis a distancia, responsables de tasas de recurrencia más altas y peor pronóstico. Los casos aquí reportados reflejan las características que hacen sospechar mayor agresividad tumoral, desde el diagnóstico. Describimos dos pacientes de sexo femenino, entre 40 y 50 años, con historia de corta evolución, cuya presentación fue con síntomas de compresión locorregional y adenopatías metastásicas en cuello. Con hallazgos ecográficos e intraoperatorios de relevancia en cuanto la agresividad tumoral que hicieron sospechar la presencia de una variante agresiva del cáncer papilar. La histopatología de la variante de células altas posee una base molecular diferente respecto al papilar clásico que le confiere mayor morbi-mortalidad, constituyendo un factor de pronóstico independiente para la recurrencia. El tratamiento quirúrgico es la tiroidectomía total con vaciamiento profiláctico de los ganglios linfáticos centrales y eventualmente vaciamiento lateral de cuello según valoración preoperatoria, con posterior ablación postoperatoria de restos tiroideos mediante yodo radiactivo.

Papillary cancer constitutes approximately 80% of all thyroid cancer cases and 85% of differentiated tumors. The tall cell variant represents 1.3 to 12% of papillary cancers, being the most common aggressive variant of these tumors. It has an aggressive behavior, showing a higher incidence of extrathyroid and lymphovascular invasion and distant metastasis, responsible for higher recurrence rates and a worse prognosis. The cases reported here reflect characteristics that make us suspect tumor aggressiveness. These are female patients, between 40 and 70 years old, with a history of short evolution. They present locoregional symptoms or metastatic adenopathies, with ultrasound and intraoperative findings of relevance in terms of tumor aggressiveness that led to the suspicion of the presence of an aggressive variant of papillary cancer. The histopathology of the tall cell variant has a different molecular basis that confers its own morbidity and mortality, being an independent prognostic factor for recurrence. Total thyroidectomy is recommended with prophylactic dissection of the central lymph nodes and eventually lateral neck dissection according to preoperative evaluation followed by postoperative ablation with radioactive iodine.

Low rates of osteoporosis treatment after hospitalization for hip fracture in Hawaii.

We evaluated osteoporosis treatment and DEXA utilization rates of patients who were admitted for hip fracture in a single healthcare system in Hawaii from 2015 to 2016. We found that osteoporosis treatment and DEXA utilization rates were low, highlighting a critical gap in osteoporosis care after admission for hip fracture. INTRODUCTION: The objective of this study was to evaluate osteoporosis care after an admission for hip fracture at three community hospitals within a single healthcare system in Hawaii. METHODS: A retrospective chart review was conducted (n = 428) of patients ≥ 50 years and hospitalized for hip fractures between January 1, 2015, and May 31, 2016, at three major hospitals within Hawaii Pacific Health, a large healthcare system in Hawaii. Basic demographics were collected, and medications prescribed were quantified and described within 1 year of hip fracture. Logistic regression was used to evaluate the association between collected variables and the odds of osteoporosis treatment. RESULTS: Only 115 (26.9%) patients were prescribed a medication for osteoporosis as a secondary prevention within a year of hospitalization for hip fracture. DEXA scans were performed in 137 (32.0%) patients. Most of the treated patients were prescribed oral bisphosphonates. Treatment facility, female gender, and higher BMI were found to be predictive factors for osteoporosis treatment. CONCLUSION: The use of osteoporosis medication for secondary prevention after admission for hip fracture in Hawaii is low. Efforts need to be made to improve treatment rates, especially among males.

The contribution of pain in determining the health status of cancer patients with bone metastases: A secondary analysis of data from three Phase III registration trials.

BACKGROUND: We aimed to provide a simple, descriptive health-status profile for cancer patients with bone metastases, based on the EuroQol EQ-5D, a tool commonly used to measure health utility scores, and to evaluate its association with the Brief Pain Inventory (BPI), a legacy pain-assessment tool. Although pain is one of five health-status dimensions measured by the EQ-5D, our understanding of how pain relates to the other EQ-5D dimensions is limited. METHODS: We derived data from 5500 patients with bone metastases who completed the EQ-5D and BPI. Regression analyses examined how BPI severity and interference scores correlated with EQ-5D utility scores and how BPI items associated with EQ-5D items, for the entire sample and by disease-type subgroup. RESULTS: Regardless of cancer site, the percentage of patients reporting moderate/severe problems in each of the five EQ-5D dimensions were pain/discomfort, 78%; usual activities, 58%; mobility, 55%; anxiety/depression, 57%; and self-care, 26%. BPI pain interference explained more of the variability in the EQ-5D utility scores than did pain severity (R2  = 41% vs. 34%). BPI worst pain, average pain, pain now, interference with general activity, and interference with work significantly predicted EQ-5D pain/discomfort, with odds ratio estimates <1. CONCLUSIONS: Pain/discomfort was the worst-rated dimension of the EQ-5D in this population, but the relationship of this item to BPI pain severity was modest, suggesting that the single pain item of the EQ-5D may be of limited utility in studies for which pain is an endpoint. SIGNIFICANCE: Health-status dimensions include more than pain. We examine the contribution of pain severity and pain-related functional interference in determining the health status of cancer patients with bone metastases. The pain dimension from a health-status measure may be an inadequate metric in clinical trials/clinical practice when pain is an important outcome.

Siltuximab (CNTO 328) with lenalidomide, bortezomib and dexamethasone in newly-diagnosed, previously untreated multiple myeloma: an open-label phase I trial.

The safety and efficacy of siltuximab (CNTO 328) was tested in combination with lenalidomide, bortezomib and dexamethasone (RVD) in patients with newly-diagnosed, previously untreated symptomatic multiple myeloma. Fourteen patients were enrolled in the study, eleven of whom qualified to receive therapy. A majority of patients (81.8%) completed the minimal number or more of the four required cycles, while two patients completed only three cycles. The maximum tolerated dose (MTD) of siltuximab with RVD was dose level -1 (siltuximab: 8.3 mg/kg; bortezomib: 1.3 mg/m(2); lenalidomide: 25 mg; dexamethasone: 20 mg). Serious adverse events were grade 3 pneumonia and grade 4 thrombocytopenia, and no deaths occurred during the study or with follow-up (median follow-up 28.1 months). An overall response rate, after 3-4 cycles of therapy, of 90.9% (95% confidence interval (CI): 58.7%, 99.8%) (9.1% complete response (95% CI: 0.2%, 41.3%), 45.5% very good partial response (95% CI: 16.7%, 76.6%) and 36.4% partial response (95% CI: 10.9%, 69.2%)) was seen. Two patients withdrew consent, and nine patients (81.8%) opted for autologous stem cell transplantation.

[A diagnostic predictive scale for urinary tract infection in febrile infants without an apparent focus]. / Escala predictiva diagnóstica de infección urinaria en neonatos febriles sin foco aparente.

INTRODUCTION: Urinary tract infection (UTI) is the most frequent bacterial infection in infants with nonspecific clinical manifestations. OBJECTIVE: To validate a predictive scale for UTI in febrile infants without apparent source and hospitalized in a neonatal unit. PATIENTS AND METHOD: A nested case-control study was conducted on 158 infants with febrile UTI, culture-confirmed, and on 346 febrile infants without apparent focus in whom UTI was ruled out, and also, hospitalized in a neonatal unit. The analysis was performed using Stata® 11. Associations were determined using odds ratio (OR) with 95% confidence interval. To find the predictive scale, multivariate analysis was performed using logistic regression and establishing major and minor criteria according to regression coefficient. Yield was calculated by sensitivity, specificity and area under ROC curve. The new predictive scale was validated by 108 new febrile neonates. RESULTS: The major criteria to predict UTI were abnormal urinalysis and Gram positive cells without centrifugation, and among the minor criteria, male, age at time of fever, previous neonatal hospitalization, abnormal temperature (38.5°C or more, persistent fever, hypothermia) and 1.7 mg/dL C reactive protein or higher, resulting positive with the presence of one mayor or three minor criteria. It showed good performance with 100% sensitivity (CI 95%:98.3-100%), 92.3% specificity (CI 95%: 85.8-98.9%) and 0.962 area under ROC (95% CI: 0.932-0.991) when validated on 108 new febrile neonates without focus. CONCLUSIONS: The new predictive scale allows predicting UTI with good yield in infants with fever without an identified source.

Factores asociados a estancia hospitalaria prolongada en neonatos / Factors associated with prolonged hospital stay in infants

Objetivo: Evaluar los factores que están presentes al ingreso del recién nacido a una unidad de cuidados intensivos neonatales y que están asociados a una estancia prolongada. Pacientes y Método: Estudio de casos y controles no pareado, con 555 neonatos, 111 con estancia superior a 7 días y 444 con estancia entre 1 y 7 días, hospitalizados entre los años 2005 y 2010. Se evaluaron factores maternos (edad, gravidez, seguridad social, educación, control prenatal, estado civil, antecedente de preeclampsia, ruptura prolongada de membranas, corioamnionitis, infecciones) y neonatales (edad al ingreso, edad gestacional, peso al nacer, sexo, vía de nacimiento, vía de ingreso, Apgar y tipo de reanimación) previos a la hospitalización que estuvieron asociados con estancias prolongadas. Los análisis se hicieron con STATA® 11.0, empleando la regresión logística en el análisis multivariado. Resultados: Factores maternos como control prenatal con menos de 5 visitas (ORa: 2,7; IC 95 por ciento: 1,3-5,5), carencia de seguridad social en salud (ORa: 1,9; IC 95 por ciento: 1,4-29), gravidez de 3 o más gestaciones (ORa: 1,7; IC 95 por ciento: 1,1-2,7) y neonatales como peso al nacer menor a 2.000 g (ORa: 4,2; IC 95 por ciento: 1,9-9,5), necesidad de reanimación cardiorespiratoria (ORa: 4,2; IC 95 por ciento: 2-9,1), edad gestacional menor a 36 semanas (ORa: 3,9; IC 95 por ciento: 2-7,7) e ingreso a la unidad neonatal por urgencia o remisión desde otro centro hospitalario (ORa: 2,8; IC 95 por ciento: 1,7-4,6), se hallaron asociados a estancia mayor a 7 días. Conclusiones: Las complicaciones intrahospitalarias que condicionan una estancia prolongada fueron seguridad social en salud, escolaridad materna y control prenatal, y deben ser consideradas en la evaluación de los indicadores de calidad de atención hospitalaria.

Objective: To evaluate factors present on newborn admission to a neonatal intensive care and associated with a prolonged hospital stay. Patients and Method: Non-matched case-control study, with 555 infants, 111 with more than 7 days of hospital stay and 444 who stayed hospitalized between 1 and 7 days, between 2005 and 2010. Pre hospitalization maternal factors (age, pregnancy, health insurance, education, prenatal care, marital status, history of preeclampsia, prolonged rupture of membranes, chorioamnionitis infection) and neonatal ones (age at admission, gestational age, birth weight, gender, delivery practice, route of admission, Apgar and type of resuscitation) that were associated with prolonged hospital stay were analyzed. Analyses were conducted using STATA 11.0 and logistic regression in the multivariate analysis. Results: Maternal factors such as prenatal care with less than 5 doctor visits (AOR 2.7, 95 percent CI 1.3-5.5), lack of social health insurance (AOR 1.9, 95 percent CI 1.4-29), pregnant three or more times (AOR 1.7, 95 percent CI 1.1-2.7), neonatal birth weight under 2,000 g (AOR 4.2, 95 percent CI 1.9-9.5), need for cardiopulmonary resuscitation (AOR 4.2, 95 percent CI 2-9.1), gestational age less than 36 weeks (AOR 3.9, 95 percent CI 2-7.7) and admission to the neonatal unit through emergency room or referral from another hospital (AOR 2.8, 95 percent CI 1.7-4.6) were associated with hospital stays longer than 7 days. Conclusions: In-hospital complications that affect a prolonged stay at the health center were social health insurance, maternal education and prenatal care, and these should be considered in the evaluation of the hospital care quality indicators.

Artemisia dracunculus L. extract ameliorates insulin sensitivity by attenuating inflammatory signalling in human skeletal muscle culture.

AIMS: Bioactives of Artemisia dracunculus L. (termed PMI 5011) have been shown to improve insulin action by increasing insulin signalling in skeletal muscle. However, it was not known if PMI 5011's effects are retained during an inflammatory condition. We examined the attenuation of insulin action and whether PMI 5011 enhances insulin signalling in the inflammatory environment with elevated cytokines. METHODS: Muscle cell cultures derived from lean, overweight and diabetic-obese subjects were used. Expression of pro-inflammatory genes and inflammatory response of human myotubes were evaluated by real-time polymerase chain reaction (RT-PCR). Insulin signalling and activation of inflammatory pathways in human myotubes were evaluated by multiplex protein assays. RESULTS: We found increased gene expression of monocyte chemoattractant protein 1 (MCP1) and TNFα (tumour necrosis factor alpha), and basal activity of the NFkB (nuclear factor kappa-light-chain-enhancer of activated B cells) pathway in myotubes derived from diabetic-obese subjects as compared with myotubes derived from normal-lean subjects. In line with this, basal Akt phosphorylation (Ser473) was significantly higher, while insulin-stimulated phosphorylation of Akt (Ser473) was lower in myotubes from normal-overweight and diabetic-obese subjects compared with normal-lean subjects. PMI 5011 treatment reduced basal phosphorylation of Akt and enhanced insulin-stimulated phosphorylation of Akt in the presence of cytokines in human myotubes. PMI 5011 treatment led to an inhibition of cytokine-induced activation of inflammatory signalling pathways such as Erk1/2 and IkBα (nuclear factor of kappa light polypeptide gene enhancer in B-cells inhibitor, alpha)-NFkB and moreover, NFkB target gene expression, possibly by preventing further propagation of the inflammatory response within muscle tissue. CONCLUSIONS: PMI 5011 improved insulin sensitivity in diabetic-obese myotubes to the level of normal-lean myotubes despite the presence of pro-inflammatory cytokines.

Escala predictiva diagnóstica de infección urinaria en neonatos febriles sin foco aparente / A diagnostic predictive scale for urinary tract infection in febrile infants without an apparent focus

Introduction: Urinary tract infection (UTI) is the most frequent bacterial infection in infants with nonspecific clinical manifestations. Objective: To validate a predictive scale for UTI in febrile infants without apparent source and hospitalized in a neonatal unit. Patients and Method: A nested case-control study was conducted on 158 infants with febrile UTI, culture-confirmed, and on 346 febrile infants without apparent focus in whom UTI was ruled out, and also, hospitalized in a neonatal unit. The analysis was performed using Stata® 11. Associations were determined using odds ratio (OR) with 95 percent confidence interval. To find the predictive scale, multivariate analysis was performed using logistic regression and establishing major and minor criteria according to regression coefficient. Yield was calculated by sensitivity, specificity and area under ROC curve. The new predictive scale was validated by 108 new febrile neonates. Results: The major criteria to predict UTI were abnormal urinalysis and Gram positive cells without centrifugation, and among the minor criteria, male, age at time of fever, previous neonatal hospitalization, abnormal temperature (38.5°C or more, persistent fever, hypothermia) and 1.7 mg/dL C reactive protein or higher, resulting positive with the presence of one mayor or three minor criteria. It showed good performance with 100% sensitivity (CI 95 percent:98.3-100 percent), 92.3 percent specificity (CI 95 percent: 85.8-98.9 percent) and 0.962 area under ROC (95 percent CI: 0.932-0.991) when validated on 108 new febrile neonates without focus. Conclusions: The new predictive scale allows predicting UTI with good yield in infants with fever without an identified source.

Introducción: La infección de tracto urinario (ITU) es la infección bacteriana más frecuente en neonatos, con manifestaciones clínicas inespecíficas. Objetivo: Validar una Escala Predictiva de ITU en neonatos febriles sin foco aparente, hospitalizados en una unidad neonatal. Pacientes y Método: Estudio caso control anidado en una cohorte, realizado en 158 neonatos febriles con ITU, confirmada por cultivo y 346 neonatos febriles sin foco aparente, en quienes se descartó ITU, hospitalizados en una unidad neonatal. El análisis se realizó con Stata® 11. Las asociaciones se determinaron mediante odds ratio (OR), con su intervalo de confianza de 95 por ciento. Para hallar la Escala Predictiva, se realizó análisis multivariado mediante regresión logística, estableciendo criterios mayores y menores de acuerdo al coeficiente de regresión, mientras el rendimiento se determinó con sensibilidad, especificidad y área bajo ROC. La nueva Escala Predictiva se validó con 108 neonatos febriles nuevos. Resultados: Los criterios mayores para la predicción diagnóstica de ITU fueron uroanálisis alterado y Gram de orina sin centrifugar positivo, y los criterios menores, sexo masculino, edad al momento de la fiebre mayor a 7 días, hospitalización neonatal previa, alteración de la temperatura (38,5°C o más, fiebre persistente, hipotermia) y proteína C reactiva 1,7 mg/dL o mayor, siendo positiva con un criterio mayor o tres menores. Esta mostró buen rendimiento con sensibilidad 100 por ciento (IC 95 por ciento: 98,3-100 por ciento), especificidad 92,3 por ciento (IC 95 por ciento: 85,8-98,9 por ciento) y área bajo ROC 0,962 (IC 95 por ciento: 0,932-0,991) cuando se validó en 108 nuevos neonatos febriles sin foco. Conclusiones: La nueva Escala Predictiva permite con buen rendimiento predecir una ITU en neonatos con fiebre sin foco aparente.

[Factors associated with prolonged hospital stay in infants]. / Factores asociados a estancia hospitalaria prolongada en neonatos.

OBJECTIVE: To evaluate factors present on newborn admission to a neonatal intensive care and associated with a prolonged hospital stay. PATIENTS AND METHOD: Non-matched case-control study, with 555 infants, 111 with more than 7 days of hospital stay and 444 who stayed hospitalized between 1 and 7 days, between 2005 and 2010. Pre hospitalization maternal factors (age, pregnancy, health insurance, education, prenatal care, marital status, history of preeclampsia, prolonged rupture of membranes, chorioamnionitis infection) and neonatal ones (age at admission, gestational age, birth weight, gender, delivery practice, route of admission, Apgar and type of resuscitation) that were associated with prolonged hospital stay were analyzed. Analyses were conducted using STATA 11.0 and logistic regression in the multivariate analysis. RESULTS: Maternal factors such as prenatal care with less than 5 doctor visits (AOR 2.7, 95% CI 1.3-5.5), lack of social health insurance (AOR 1.9, 95% CI 1.4-29), pregnant three or more times (AOR 1.7, 95% CI 1.1-2.7), neonatal birth weight under 2,000 g (AOR 4.2, 95% CI 1.9-9.5), need for cardiopulmonary resuscitation (AOR 4.2, 95% CI 2-9.1), gestational age less than 36 weeks (AOR 3.9, 95% CI 2-7.7) and admission to the neonatal unit through emergency room or referral from another hospital (AOR 2.8, 95% CI 1.7-4.6) were associated with hospital stays longer than 7 days. CONCLUSIONS: In-hospital complications that affect a prolonged stay at the health center were social health insurance, maternal education and prenatal care, and these should be considered in the evaluation of the hospital care quality indicators.

Eficacia de tres tipos de surfactante exógeno en prematuros con enfermedad de membrana hialina / Effectiveness of three types of exogenous surfactant in preterm infants with hyaline membrane disease

Introducción: La enfermedad de membrana hialina es causa importante de mortalidad neonatal. El objetivo de esta investigación fue evaluar la eficacia de tres tipos de surfactante exógeno en prematuros. Pacientes y Método: Estudio de cohorte retrospectiva, en 93 neonatos prematuros, > 24 semanas y > 500 g de peso al nacer, 31 para cada surfactante. La exposición fue la administración de 1ª dosis bovactant (Alveofact®) 50 mg/kg, beractant (Survanta®) 100 mg/kg inicial, y poractant alfa (Curosurf®) 200 mg/kg. Las variables en estudio incluyeron tiempo de ventilación mecánica, tiempo de oxigenoterapia, estancia hospitalaria, necesidad de segunda dosis de surfactante, eventos adversos por la administración del surfactante y complicaciones por prematuridad. Además, se evaluó mortalidad, displasia broncopulmonar (DBP) y mortalidad o DBP. Análisis estadístico mediante Stata® 11.0, empleando X² o Prueba Exacta de Fisher para variables cualitativas y Pruebas ANOVA o Kruskal-Wallis para cuantitativas y riesgo relativo para las asociaciones, todas con su intervalo de confianza de 95%. Resultados: No hubo diferencias para sexo, peso y edad gestacional al nacer entre los 3 grupos. No se hallaron diferencias estadísticamente significativas para tiempo de ventilación mecánica, tiempo de oxigenoterapia, administración de una segunda dosis de surfactante, estancia hospitalaria y complicaciones entre los 3 grupos. Los eventos adversos por administración de surfactante se presentaron para beractant y poractant alfa. Ocurrieron 30 (32,3 por ciento) muertes, 8 (25,8 por ciento) para bovactant, 10 (32,3 por ciento) beractant y 12 (38,7 por ciento) poractant alfa (p > 0,05). La mortalidad y/o DBP ocurrió en 10 (32,2 por ciento) neonatos con bovactant, 10 (32,2 por ciento) con beractant y 14 (45,2 por ciento) con poractant alfa (p > 0,05). Conclusiones: Los resultados primarios y secundarios entre los tres surfactantes evaluados fueron muy similares...

Introduction: Hyaline membrane disease is an important cause of neonatal mortality. The objective of this research is to evaluate the efficacy of three different exogenous surfactants in premature infants. Patients and Method: A retrospective cohort analysis in 93 preterm infants > 24 weeks and birth weight > 500 g was performed, 31 infants for each surfactant. Exposure consisted of the 1st dose of bovactant (Alveofact®) 50 mg/kg, beractant (Survanta®) 100 mg/kg initially, and poractant alfa (Curosurf®) 200 mg/kg. The variables included duration of mechanical ventilation, duration of oxygen therapy, hospital stay, need for second dose of surfactant, adverse events surfactant administration and prematurity complications. Mortality and bronchopulmonary dysplasia (BPD) were evaluated. Statistical analysis was performed using Stata® 11.0, X² or Fisher exact test for qualitative variables and ALNOVA or Kruskal-Wallis tests for quantitative and association relative risk, all with 95 percent confidence level. Results: There were no gender, weight and gestational age differences at birth among the three groups. No statistically significant differences were found regarding duration of mechanical ventilation, duration of oxygen therapy, administration of a second dose of surfactant, hospital stay and complications among the three groups. Adverse events related to surfactant administration occurred for beractant and poractant alpha. There were 30 (32.3 percent) deaths, 8 (25.8 percent) associated to bovactant, 10 (32.3%) to beractant and 12 (38.7 percent) to poractant alpha (p > 0.05). Mortality and/or BDP occurred in 10 (32.2 percent) infants who received bovactant, 10 (32.2 percent) beractant and 14 (45.2 percent) with poractant alpha (p > 0.05). Conclusions: The primary and secondary outcomes among the three surfactants tested were similar, taking into account the limitations of the work.

Sepsis neonatal por streptococcus grupo B y bacterias gram negativas: prevalencia y riesgo de meningitis / Sepsis neonatal group B streptococcus and gram negative bacteria: prevalence and risk of meningitis

Introducción: La sepsis y meningitis son importante causa de morbi-mortalidad neonatal. Objetivo: Identificar la prevalencia y riesgo de meningitis en neonatos con sepsis por Streptococcus del grupo B (SGB) y bacterias Gram negativas (BGN), además de comparar factores de riesgo, características clínicas y de laboratorio. Pacientes y Método: Estudio de corte transversal con 30 neonatos con SGB y 41 con BGN. Los datos fueron analizados en Stata® 11.0, empleando medidas de tendencia central y dispersión de acuerdo a su distribución para comparar diferencias. Las variables categóricas fueron comparadas con prueba de χ2 o Exacta de Fisher y las asociaciones mediante razones de prevalencia (RP) y odds ratio (OR) con su intervalo de confianza de 95 por ciento. Se empleó un nivel de probabilidad < 0,05 como criterio de significancia. Resultados: La prevalencia de meningitis entre neonatos con sepsis fue 16,9 por ciento (IC 95 por ciento: 7,5-26,3 por ciento). El 33,3 por ciento (10/30) de sepsis por SGB se asoció a meningitis, mientras 4,9 por ciento (2/40) a sepsis por BGN, hallándose una asociación entre sepsis y meningitis en neonatos con SGB (OR: 9,5; IC 95 por ciento: 1,7-94,3). El 80 por ciento (IC 95 por ciento: 44,4-97,5 por ciento) de casos de meningitis asociada a sepsis por SGB ocurrió en neonatos mayores de 72 h de vida. Conclusión: La meningitis fue más frecuente en neonatos con sepsis por SGB, principalmente en casos de sepsis tardía. La asociación entre sepsis por BGN y meningitis fue menos frecuente en sepsis temprana, y no se halló en sepsis tardía.

Introduction: Sepsis and meningitis are major causes of neonatal morbidity and mortality. Objective: To identify the prevalence and risk of meningitis in neonates with sepsis due to group B Streptococcus (GBS) and gram-negative bacteria (GNB), and to compare risk factors, clinical and laboratory characteristics. Patients and Method: Cross-sectional study of 30 infants with infections due to GBS and 41 due to BGN. Data were analyzed by Stata® 11.0, using measures of central tendency and dispersion, according to their distribution, to compare differences. Categorical variables were compared using χ2 test or Fisher's Exact Test and associations using prevalence ratios (PR) and odds ratio (OR) with 95 percent confidence interval. A level of probability of < 0.05 was used as a significance criterion. Results: The prevalence of meningitis among infants with sepsis was 16.9 percent (95 percent CI: 7.5-26.3 percent. 33.3 percent(10/30) of sepsis due to GBS was associated with meningitis, while 4.9 percent (2/40) was associated with GNB, finding a clear connection between sepsis and meningitis in neonates with GBS (OR: 9.5; CI 95 percent:1.7-94.3). 80 percent (CI 95 percent: 44,4-97,5 percent) of cases of meningitis associated with GBS sepsis occurred in infants older than 72 hours. Conclusion: Meningitis was more common in infants with GBS sepsis, mainly in cases of late-onset sepsis. The association between GNB sepsis and meningitis was less frequent in early sepsis, and was not found in late sepsis.

Factores asociados al inicio de la actividad sexual en adolescentes de Tuluá, Colombia / Age of onset and factors associated with the onset of the sexual activity in adolescent students of a Colombian city

Objetivo: determinar la prevalencia de actividad sexual (AS) y factores asociados del debut sexual en adolescentes escolarizados de una ciudad colombiana. Métodos: estudio observacional, de corte transversal, con 947 estudiantes de 14 a 19 años. Las asociaciones se determinaron mediante Odds Ratio con 95 por ciento de intervalo de confianza. Para el análisis multivariado se empleó regresión logística. Resultados: la prevalencia de AS fue 52,8 por ciento. La mediana de edad de inicio fue 15 años (RI: 14-16). Las variables asociadas al inicio temprano de la AS para el nivel individual fueron: sexo masculino, aprobación y actitudes permisivas hacia el sexo del adolescente, consumo de licor, tabaco y drogas. Para el nivel familiar fueron: madre no da educación sexual al hijo, hermano/a que en la adolescencia hayan sido padre/madre, aprobación y actitudes permisivas de los padres hacia el sexo en la adolescencia. Para el nivel socio-cultural fueron: como factores de riesgo el pertenecer a los estratos socioeconómicos 1 y 2, aprobación y actitudes permisivas de los pares o grupo de amigos del adolescente a la AS en la adolescencia, y como factor protector el haber recibido educación en anticoncepción por personas diferentes a los padres, como equipos de educación en colegios o personal de salud. Conclusión: factores individuales como sexo masculino, propia toma de decisiones, papel que desempeña la madre en la educación sexual de sus hijos y la influencia de pares o amigos en la toma de decisiones, se asociaron con el inicio temprano de la AS entre adolescentes.

Objective: to determine the prevalence of sexual activity (SA), age of onset and factors associated with the onset of the SA in adolescent students of a Colombian city. Methods: an observational, cross-sectional, with 947 students from 14 to 19 years old. Associations were determined using Odds Ratio with confidence interval of 95 percent. For multivariate analysis logistic regression was used. Results: the prevalence of SA was 52.8 percent. The median age of onset of SA was 15 years (RI: 14-16). The variables associated with early onset of SA for the individual were male approval and permissive attitudes toward sex by adolescent alcohol consumption, snuff and illicit drugs. For the family level, were the mother gives sex education to his children, a brother/daughter that in adolescence has been a parent and approval and permissive attitudes toward sex parents in adolescence. For the socio-cultural, socio-economic strata belong to 1 and 2, approval and permissive attitudes couple or group of friends to the AS teenager in adolescence, as risk factors and received education in contraception for persons other than parents and education teams in schools or health care as a protective factor, were associated with the onset of SA in adolescence. Conclusions: individual factors such as male gender, one's decision-making, the role of the mother in the sex education of their children and the influence of peers and friends in decision making were found associated with early onset AS among adolescents.

Actividad sexual en adolescencia temprana: problema de salud pública en una ciudad colombiana / Sexual activity in early adolescence: a public health problem in a Colombian city

Antecedentes: El inicio de Ia actividad sexual en adolescentes, está asociada a pobre planificación familiar (PF), mayor tasa de fecundidad y riesgo de adquisición de enfermedades de transmisión sexual (ETS). Objetivo: Evaluar el impacto sobre la fecundidad, planificación familiar y lesiones de cuello uterino en una población de adolescentes y jóvenes, que iniciaron actividad sexual en la adolescencia. Método: Estudio de cohorte retrospectiva. Incluyó 845 adolescentes y jóvenes que iniciaron actividad sexual en la adolescencia y que consultaron a una Institución Prestadora de Servicios de Salud en Tuluá, Colombia. El análisis incluyó estadísticas descriptivas, análisis de riesgo relativo (RR) y atribuible a la exposición (RAexp) expresado en porcentaje, como indicadores de asociación. Resultados: Hubo 203 adolescentes y 642 jóvenes. El promedio de edad de inicio de la actividad sexual fue 16 años (+/-1,6 años). El 49 por ciento no realizaba PF, 34,7 por ciento tenía ≥1 hijo y 6,9 por ciento alguna lesión en cuello uterino. Hubo asociación entre actividad sexual en la adolescencia temprana y tener un hijo, al compararlo con el inicio de la actividad sexual en la adolescencia media (RR: 1,6; IC 95 por ciento: 1,2-2,1. RAexp0/35,7 por ciento; IC 95 por ciento: 13,3-52,4 por ciento) y tardía (RR: 2; IC 95 por ciento: 1,5-2,6. RAexp0/49 por ciento; IC 95 por ciento: 31,7-62 por ciento). Conclusiones: Nuestros resultados confirman el inicio precoz de la actividad sexual en adolescentes, el bajo uso de anticonceptivos y el riesgo de lesiones cervicales. Programas educativos conducentes al retraso del inicio de la actividad sexual, el uso de métodos anticonceptivos efectivos y de barrera, permitirán reducir las cifras encontradas en este estudio.

Background: The onset of sexual activity in adolescents is associated with poor family planning, a higher fertility rate and risk of acquiring sexually transmitted diseases. Objective: To evaluate the impact on fertility, family planning and cervical lesions in a population who initiated sexual activity in adolescence. Method: A retrospective cohort study. Included 845 adolescents and young people who initiated sexual activity during adolescence and who consulted a Lender Institution Health Services in Tuluá, Colombia. The analysis included descriptive statistics, analysis of relative risk (RR) and attributable to exposure (RAexp) expressed in percentage, as indicators of association. Results: There were 203 adolescents and 642 young people. The average age of onset of sexual activity was 16 (+/- 1.6 years). 49 percent did not perform family planning, 34.7 percent had ≥ 1 child and 6.9 percent cervical lesions. There was an association between sexual activity in early adolescence and have a child, when compared with the onset of sexual activity in middle (RR: 1.6, 95 percent CI 1.2 to 2.1. RAexp percent: 35.7 percent, 95 percent CI: 13.3 to 52.4 percent) and late adolescence (RR: 2, 95 percent CI: 1.5 to 2.6. RAexp percent: 49 percent, 95 percent CI: 31.7-62 percent). Conclusions: Our results confirm the early onset of sexual activity in adolescents, low contraceptive use and risk of cervical lesions. Educational programs leading to delayed onset of sexual activity, the use of effective contraceptive methods and barrier methods will reduce the numbers found in this study.

Prevalencia de lesiones de bajo y alto grado de cuello uterino en una ciudad colombiana / Prevalence of lesions of low and high grade cervical in a Colombian city

Objetivo: Determinar la prevalencia de las lesiones de bajo y alto grado de cuello uterino en una Institución Prestadora de Servicios de Salud de Tuluá, Colombia, entre los años 2008-2010. Métodos: Se realizó un estudio descriptivo retrospectivo en el que se incluyeron mujeres entre los 15 y 75 años, residentes en el Municipio de Tuluá. Se evaluó la normalidad de las variables cuantitativas, empleándose la mediana o el promedio con sus varianzas según su distribución, y frecuencias y proporciones para las variables categóricas. Resultados: Se incluyeron 3.539 mujeres. La mediana de la edad fue 38 años con rango intercuartil (RI: 29-46 años), la mediana del número de partos 1 (RI: 0-3). En relación a la seguridad social y uso de métodos anticonceptivos, la mayoría eran particulares y no utilizaban ningún método. El 87,5 por ciento de las citologías se reportaron como negativas, 8,2 por ciento lesión de bajo grado (LSIL), 2,6 por ciento células escamosas atípicas de significado indeterminado (ASC-US), 0,9 por ciento lesiones de alto grado (HSIL), 0,4 por ciento células escamosas atípicas de significado indeterminado de alto grado ASC-H, 0,4 por ciento células glandulares atípicas de significado incierto (ASGUS) y 0,2 por ciento carcinoma invasor. Conclusión: La prevalencia de las anormalidades citológicas fue baja en todos los grupos analizados, sin embargo, existe un mayor número de LSIL hacia la cuarta década de la vida y en aquellas que iniciaron su vida sexual después de los 40 años. De igual manera se encontró una relación inversa entre el número de partos, planificación familiar hormonal y aparición de lesiones pre neoplásicas.

Objective: To determine the prevalence of lesions of low and high grade cervical in a Lender Institution Health Services, Tuluá, Colombia, 2008-2010. Methods: We performed a retrospective study which included women between 15 and 75 years living in Tuluá. We evaluated the normality of quantitative variables, using the median or average with their variances for quantitative variables according to their distribution and frequencies and proportions for categorical variables. Results: 3539 women were included. The median age was 38 years with interquartile range (IR: 29-46 years) and the median parity was 1 (IR: 0-3). In relation to social security and family planning birth control, most were private and did not use any method. The 87.5 percent of smears was reported as negative, low-grade squamous intraepitelial lesions (LSIL) 8.2 percent atypical squamous cells of undetermined significance (ASC-US) 2.6 percent, high-grade squamous intraepitelial lesions (HSIL) 0.9 percent, atypical squamous cells cannot rule out a high grade lesion (ASC-H) 0.0 percent, atypical squamous glandular cells of undetermined significance (ASGUS) 0.4 percent and invasive carcinoma 0.2 percent. Conclusion: The prevalence of cytological abnormalities was low in all groups studied, however, a greater number of LSIL to the fourth decades of life and those who began their sexual life after 40 years. Similarly, an inverse relationship was found between parity, hormonal family planning and pre-neoplastic lesions.

Hijo de madre adolescente: riesgos, morbilidad y mortalidad neonatal / Risks in adolescent mothers and their children's: morbidity and mortality

Antecedentes: El embarazo en adolescentes es un problema de salud pública por las consecuencias para el binomio madre-hijo. Objetivo: Determinar las características y riesgos en madres adolescentes y sus hijos (antropometría, condición de nacimiento y morbi-mortalidad), en comparación con un grupo de madres adultas control de 20-34 años. Métodos: Estudio de cohorte prospectiva con 379 hijos de mujeres adolescentes y 928 adultas. Los datos fueron analizados empleando mediana, promedio y medidas de dispersión, pruebas t-test no pareado o Wilcoxon rank-sum (Prueba de Mann-Whitney), ANOVA o Kruskall-Wallis, Chi2 o Exacta de Fisher, riesgo relativo y riesgo atribuible a la exposición porcentual con sus intervalos de confianza de 95 por ciento. Resultados: Entre adolescentes hubo mayor número de madres solteras (25,6 por ciento), menor escolaridad y seguridad social en salud (25,9 por ciento) (p<0,05). En adolescentes tempranas hubo más casos de preeclampsia (26,3 por ciento) y trabajo de parto prematuro (10,5 por ciento). Entre madres adolescentes el 30,9 por ciento de los hijos fueron prematuros, y presentaron más patología cardiaca, infecciones bacterianas, sífilis congénita, labio y paladar hendido, y mayor mortalidad, cuando se compararon con hijos de madres adultas (p<0,05). Conclusiones: La maternidad en adolescentes conlleva mayores riesgos de salud para ellas y sus hijos, aumentando la morbilidad, mortalidad, con una perspectiva de exclusión social a lo largo de la vida, pues la mayoría son pobres, con poca educación y madres solteras y sin pareja.

Background: Adolescent pregnancy is a public health problem because of the consequences for mother and child. Objective: To determine the characteristics and risks in adolescent mothers and their children's (anthropometry, birth status, morbidity and mortality) compared with a group of older mothers 20-34 years and control their children. Methods: Prospective cohort study with 379 children and 928 adult female adolescents. Data were analyzed using median, mean and dispersion measures, tests unpaired t-test or Wil-coxon rank-sum (Mann-Whitney test), ANOVA or Kruskal-Wallis, Chi2 or Fisher's exact, relative risk and attributable risk percentage exposure with confidence intervals of 95 percent. Results: Among adolescents there were more single mothers (25.6 percent), lower education and social health insurance (25.9 percent) (p<0.05). In early adolescents were more cases of preeclampsia (26.3 percent) and preterm labor (10.5 percent). Among teenage mothers, 30.9 percent of the children were premature, and had more heart disease, bacterial infections, syphilis, and congenital cleft lip and palate and higher mortality when compared with children of older mothers (p<0.05). Conclusions: Teenage motherhood carries greater health risks to themselves and their children, increasing morbidity, mortality, with a perspective of social exclusion throughout life, as most are poor, poorly educated and single mothers without partner.

T-cell responses and in vivo cytotoxicity in the target organ and the regional lymphoid tissue during airborne infection with the virulent Mycobacterium tuberculosis MT103 and its lipid mutant fadD26.

To ascertain the in vivo role of mycobacterial lipids phthiocerol dimycocerosates (PDIM) in experimental murine tuberculosis (Tb), airways infection was used to compare the parental virulent clinical isolate MT103 with its mutant fadD26, lacking PDIM. Lungs were assessed as the Tb-target organ and mediastinal lymph nodes as the corresponding lymphoid tissue, in order to quantify: the major T-cell subsets (CD4+/CD8+/gammadelta+) and their activation kinetics, bacillary burden, and in vivo cytotoxicity against inoculated target cells loaded with mycobacterial Ags. After 4 weeks, infection augmented total and activated CD4+ and CD8+ T cells in lungs and nodes mainly with MT103, while gammadelta+ T cells increased earlier in nodes. MT103 bacillary burden was bigger and appeared earlier than the mutant fadD26, especially in the lung than in mediastinal nodes. At day 14 of MT103 infection, there was no cytotoxicity in lungs and nodes; while with fadD26 there was some in the nodes. At day 21 of MT103 infection, important cytotoxicity was detected only in lungs; while with fadD26 both tissues showed important activity. Interestingly, unlike the infection with fadD26, cytotoxicity under MT103 fell considerably in the target organ (lung) from days 21 to 60, the advanced phase. Although upon airways infection both mycobacteria behaved similarly regarding T cell (CD4/CD8/gammadelta) stimulation kinetics; they differed in the magnitude of these responses, in the bacterial load within tissues, and to trigger in vivo cytotoxicity in lungs and regional lymph nodes. This highlights the relevance of certain mycobacterial lipids to modify crucial effector branches of immunity.

Artroplastia de rodilla / Knee arthroplasty

La artroplastia de rodilla es hoy en día una de las intervenciones más eficientes y consolidadas en el campo de la cirugía ortopédica. En la mayor parte de los pacientes que son sometidos a este tipo de cirugía se obtienen unos buenos resultados funcionales e importante mejoría del dolor. El avance tecnológico ha conseguido una cada vez mayor longevidad de la prótesis, lo que junto con el progresivo asentamiento de las prótesis unicompartimentales en artrosis no demasiado evolucionada han hecho de esta intervención una opción terapéutica cada vez menos limitada por razones de edad. En este trabajo realizamos una puesta al día de este tema comentando los aspectos de mayor interés para el médico rehabilitador, tanto en lo referente a la fase quirúrgica como a la de los cuidados posteriores

Knee arthroplasty is currently one of the most efficient and supported surgical intervention in orthopedic surgery. Most of the patients who undergo this kind of surgery obtain good functional outcomes and important pain relief. Technological advance has achieved longer longevity of the prosthesis, which, together with the progressive establishment of unicompartimental prosthesis in not too developed arthrosis, has changed this surgery into a therapeutic option less and less restricted according to people¿s age. An update to discuss the most interesting topics for the rehabilitation physician, referring either to the surgical phase and later care, is made in this article

Symptom burden in patients undergoing autologous stem-cell transplantation.

Patients who undergo autologous peripheral blood stem cell (PBSC) transplantation experience multiple symptoms that adversely affect quality of life. We assessed symptoms during the acute phase of autologous PBSC transplantation to determine the severity of individual symptoms and to determine overall symptom profiles in 100 patients with multiple myeloma or non-Hodgkin's lymphoma. Study subjects completed the blood and marrow transplantation module of the M. D. Anderson Symptom Inventory before hospitalization, during conditioning, on day of transplantation, at nadir (the time of lowest white blood cell count) and on day 30 post-transplantation. Additional symptom, quality-of-life and medical status measures were collected. Symptom means were mild at baseline, intensified during conditioning, peaked at nadir and decreased by day 30. At nadir, the most severe symptoms for the entire patient sample were lack of appetite, fatigue, weakness, feeling sick, disturbed sleep, nausea and diarrhea. Cancer diagnosis was a significant predictor of changes in symptoms over time. The patterns of fatigue, pain, sleep disturbance and lack of appetite were significantly different for patients with multiple myeloma as compared with patients with non-Hodgkin's lymphoma.