Clinical effectiveness of seven-valent pneumococcal conjugate vaccine (Prevenar) against invasive pneumococcal diseases: prospects for children in France]

A seven-valent pneumococcal polysaccharide-CRM197 carrier protein conjugate vaccine (PNC7V; Prevenar, Wyeth, Paris) targets the serotypes (belonging to serogroups 14, 6, 19, 18, 23, 9, and 4) most often responsible for invasive pneumococcal disease (IPD) among children. A randomized, controlled, double-masked study among 37,868 children in northern California (Northern California Kaiser Permanente, USA) provided a per protocol vaccine efficacy value of 97.7% against invasive pediatric IPD due to the vaccine serotypes. The PNC7V vaccine was registered by the European Agency for the Evaluation of Medicinal Products (EMEA) in October 2000; a favorable "Community Marketing Decision" under the Centralized Procedure was granted in February 2001. PNC7V was recommended for most infants by the Conseil Supérieur d'Hygiène Publique de France in March 2002, on the advice of the Comité Technique des Vaccinations, as S. pneumoniae in children less than 2 years of age is the primary cause of bacterial meningitis and of mortality associated with community-acquired bacterial infections. The theoretical coverage of the vaccine towards pneumococcal invasive disease in France is about 80%, which represents one of the best serotype coverage estimates in Europe, and vaccines serotypes account for 90% of penicillin-nonsusceptible strains. Distinctive characteristics in France in terms of epidemiology, life style, and therapeutic attitudes justify a precise follow up of the consequences of the vaccination on a national level during the coming years. Hence, surveillance programs have been established: (i) to ascertain the future impact of large-scale PNC7V vaccination on invasive pneumococcal disease incidence, (ii) to follow the evolution of carriage and ecology of the pneumococcus, and (iii) to establish an active "vaccinovigilance".     

Measurement of three major subtypes of child neglect

This study examines the relationships among three major subtypes of neglect (physical, psychological, and environmental), a summary measure of neglect, and neglect as defined by Child Protective Services (CPS). The predictive validity of the subtypes of neglect assessed when children were 5 years of age was examined using children's behavior at age 6. Study findings include modest to moderate correlations among the neglect subtypes, CPS neglect, and children's behavior. After controlling for CPS neglect, the subtypes remained predictive of children's behavior. The set of three subtypes was more strongly related to children's behavior, particularly maternal report of internalizing problems, than was the summary neglect measure. These findings suggest that considering the subtypes of neglect may enhance our understanding of neglect and lead to interventions tailored to families' specific needs.     

Expectations for oocyte fertilization and embryo cleavage after whole sperm versus sperm head intracytoplasmic sperm injection

OBJECTIVE: To compare oocyte fertilization and embryo development after intracytoplasmic sperm injection (ICSI) with a whole sperm vs. a sperm head. DESIGN: Retrospective study. SETTING: Hospital-based IVF practice. PATIENT(S): Fifty-three women undergoing 54 IVF-embryo transfer plus ICSI procedures between January 1999 and June 2002. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Oocyte fertilization, zygote cleavage, and embryo stage after 72 hours of culture. RESULT(S): A significantly higher fertilization rate was observed using whole sperm (72.2%) than when using sperm heads (56.4%). Zygote cleavage rates for whole sperm vs. sperm head ICSI were 96.4% and 92.7%, respectively. Embryo cell stage after 72 hours of culture for whole sperm vs. sperm head ICSI was 6.5 +/- 2.1 cells and 5.6 +/- 1.8 cells, respectively. Embryo grade at this same time point was not different (2.3 +/- 1.0 and 2.5 +/- 0.9, respectively). CONCLUSION(S): The ICSI using whole sperm produces superior fertilization rates compared to ICSI using sperm heads, but once oocytes were fertilized, zygote cleavage rates were not different between the two sperm sources. Oocytes injected with a whole sperm produced embryos of higher cell stage but equivalent quality compared to oocytes injected with sperm heads. Therefore, having only sperm heads for use in ICSI should not be a deterrent to using this procedure.     

Patterns and outcomes of chemotherapy for elderly patients with stage II ovarian cancer: a population-based study

BACKGROUND: The optimal treatment for patients with stage II ovarian cancer is controversial, although most experts recommend adjuvant chemotherapy. The purpose of this study was to assess the patterns of use of chemotherapy in women with stage II ovarian cancer, and to compare the survival of treated and untreated patients aged 65+ years in a population-based sample. METHODS: Using the Surveillance, Epidemiology, and End Results (SEER)-Medicare database of cancers diagnosed in approximately 14% of the U.S. population, we identified women who were diagnosed with stage II ovarian cancer between 1992 and 1996, survived >or=120 days beyond diagnosis, and were >or=65 years of age. Multivariate regression was used to compare those treated to those not treated with chemotherapy. Cox proportional hazards regression models were used to analyze patient survival. RESULTS: Of 236 women with stage II ovarian cancer, 160 (67.8%) received chemotherapy, and 118 (50%) received platinum-based regimens. Younger patients and those with higher-grade tumors were more likely to receive chemotherapy. The adjusted hazards ratio for mortality associated with any chemotherapy use was 0.67 (95% CI, 0.45-0.98), corresponding to an increase in median survival from 28 months to 35 months (P < 0.0001). CONCLUSIONS: This observational study found that most patients aged >or=65 years and diagnosed with stage II ovarian cancer between 1992 and 1996 were treated with chemotherapy. Grade and younger age were the most significant predictors of treatment, and treatment was associated with a 5-year mortality reduction of 33%. These findings are not definitive, but they may provide some guidance in the absence of randomized trials of adjuvant chemotherapy for older women with stage II ovarian cancer.     

Effectiveness of platinum-based chemotherapy among elderly patients with advanced ovarian cancer

BACKGROUND: Platinum-based chemotherapy is the standard of care for women with advanced ovarian cancer based on the results of randomized trials. We previously showed that only about half of women over the age of 65 years with this disease received platinum-based chemotherapy, and that the likelihood of receiving it decreases with age. METHODS: We used the Surveillance, Epidemiology, and End Results (SEER)-Medicare database to identify women diagnosed from 1/1/92 to 12/31/96 with stage III or IV ovarian cancer who survived > or =120 days beyond diagnosis, and were > or =65 years of age. Cox proportional hazards models and propensity scores were used to control for known predictors of receiving treatment and to estimate the relative effectiveness of different platinum-based regimens. RESULTS: Of the 1759 patients in the sample who met our eligibility criteria, 53% received platinum-based therapy. For this sample, the Cox proportional hazard ratio was 0.72 (95% CI, 0.62-0.91) for mortality associated with the use of any platinum-based therapy, and 0.59 (95% CI, 0.45-0.76) for combination platinum/paclitaxel therapy. Similar results were obtained using propensity score modeling. CONCLUSIONS: In this population-based study, we found that only about half of women with advanced ovarian cancer over age 65 were treated with platinum-based chemotherapy; however, survival improved by 38% in treated women, similar to the benefits described in randomized controlled trials among younger patients, and were greatest when platinum was combined with paclitaxel. An effort to increase the utilization of platinum combination therapy among older patients with advanced ovarian cancer is justified.     

Effectiveness of influenza vaccine during pregnancy in preventing hospitalizations and outpatient visits for respiratory illness in pregnant women and their infants

The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends influenza vaccination for women who will be in the second or third trimester of pregnancy during the influenza season. We analyzed hospital admissions with principal diagnoses of influenza or pneumonia and influenza-like illness (ILI) outpatient visits to study the effectiveness of influenza vaccine during pregnancy in protecting women and infants from influenza-related morbidity. Estimates of influenza vaccine effectiveness across five flu seasons (Fall 1997 to Spring 2002) were calculated using Cox proportional hazards models for women and infant study populations in Kaiser Permanente Northern California. Outpatient utilization outcomes included physician visits with a diagnosis of upper respiratory infection, pharyngitis, otitis media, asthma, bronchial asthma, viral infection, pneumonia, fever, cough, or wheezing associated with respiratory illness. Inpatient outcomes included hospitalizations with principal diagnoses of influenza or pneumonia. Women who received influenza vaccine during pregnancy had the same risk for ILI visits compared with unvaccinated women, adjusting for women's age and week of delivery. When asthma visits were excluded from the outcome measure, we also found no difference in the risk of outpatient visits for vaccinated and unvaccinated women. Hospital admissions for influenza or pneumonia for women in the study population were quite rare and no women died of respiratory illness during pregnancy. Infants born to women who received influenza vaccination had the same risks for influenza or pneumonia admissions compared with infants born to unvaccinated women, adjusting for infant's gender, gestational age, week of birth, and birth facility. Maternal influenza vaccination was also not a significant determinant of risk of ILI (excluding otitis media) outpatient visits for infants, nor did it significantly affect the risk of otitis media visits. Influenza vaccination during pregnancy did not significantly affect the risk of cesarean section, adjusting for the woman's age. It also did not affect the risk of preterm delivery. Although the immunogenicity of influenza vaccination in pregnancy in mother and infant has been well documented, in this study, we were unable to demonstrate the effectiveness of influenza vaccination with data for hospital admissions and physician visits. One possible interpretation of these findings is that typical influenza surveillance measures based on utilization data are not reliable in distinguishing influenza from other respiratory illness. Hospitalizations for respiratory illness were uncommon in both vaccinees and nonvaccinees.     

Longevity of Donor Serum

PURPOSE: To determine the viability of long-term, stored serum, which is used in human in vitro production as a source of energy substrates, amino acids, vitamins, growth factors, and other nutrients. METHOD: Two-cell mouse embryos were used in this prospective, cohort study. Serum stored for 1-, 5-, 10-, and 12-year intervals was subjected to four replications of mouse-embryo testing. RESULT(S): There were no significant differences in blastocyst rates between any of the replicates by year (80-100% blastocyst rate; P > 00.1) or between pooled replicate means by time period. CONCLUSION(S): Serum may be frozen up to 12 years.