Risk of spontaneous abortion and other pregnancy outcomes in 15-25 year old women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom.

BACKGROUND: We assessed the risk of spontaneous abortion (SA) after inadvertent exposure to HPV-16/18-vaccine during pregnancy using an observational cohort design. METHODS: The study population included women aged 15-25 years registered with the Clinical Practice Research Datalink General Practice OnLine Database in the United Kingdom (UK), who received at least one HPV-16/18-vaccine dose between 1st September 2008 and 30th June 2011. Exposed women had the first day of gestation between 30 days before and 45 days (90 days for the extended exposure period) after any HPV-16/18-vaccine dose. Non-exposed women had the first day of gestation 120 days-18 months after the last dose. SA defined as foetal loss between weeks 1 and 23 of gestation (UK definition). RESULTS: The frequency of SA was 11.6% (among 207 exposed) and 9.0% (632 non-exposed), women: hazard ratio (HR) adjusted for age at first day of gestation 1.30 (95% confidence interval: 0.79-2.12). Sensitivity analysis per number of doses administered (-30 to +45-day risk period) showed a HR for SA of 1.11 (0.64-1.91) for 18/178 women with one dose during the risk period versus 2.55 (1.09-5.93) in 6/29 women with two doses within a 4-5 weeks period. The proportion of pre-term/full-term/postterm deliveries, small/large for gestational age infants, and birth defects was not significantly different between exposed and non-exposed women. Results were consistent using a (United States) SA definition of foetal loss between weeks 1-19 and/or the extended risk period. CONCLUSION: There was no evidence of an increased risk of SA and other adverse pregnancy outcomes in young women inadvertently HPV-16/18-vaccinated around gestation. Nevertheless, women who are pregnant or trying to become pregnant are advised to postpone vaccination until completion of pregnancy.

The burden of varicella from a parent's perspective and its societal impact in The Netherlands: an Internet survey.

BACKGROUND: Varicella is a common childhood disease. Only 5% of first varicella-zoster-virus infections occur asymptomatically. Most data on the burden of varicella stem from health service databases. This study aims to provide insight in the burden of varicella from a parent's perspective including cases outside the healthcare system. METHODS: An internet questionnaire was developed for parents in the Netherlands to report health care resource use and productivity losses during the varicella episode in their child younger than 6 years. 11,367 invitations were sent out to members with children of an internet panel of a market research agency. 4,168 (37%) parents started the questionnaire (response rate), of which 360 (9%) stopped before completion and 1,838 (44%) were out of the target group. In total 1,970 parents completed the questionnaire. The questionnaire provided a symptom list ranging from common symptoms, such as skin vesicles, itching to fits or convulsions. A posteriori, in the analyses, the symptoms 'skin infections', 'fits/convulsions', 'unconsciousness', and 'balance and movement disorders' were labelled as complications. There was no restriction to time since the varicella episode for inclusion in the analyses. RESULTS: The 1,970 respondents had in total 2,899 children aged younger than six years, of which 2,564 (88%) children had had varicella. In 62% of the episodes the parent did not seek medical help. In 18% of all episodes symptoms labelled as complications were reported; in 11% of all episodes parents visited a medical doctor (MD) for a complication. Reporting of complications did not differ (X2 ; p = 0.964) between children with a recent (≤ 12 months ago) or a more distant (> 12 months) history of varicella. Prescription drugs were used in 12% of the children with varicella; OTC drugs in 72%. Parents reported work loss in 17% of the varicella-episodes (23% when MD visit; 14% when no MD-visit) for on average 14 hours, which equals to 2.5 hours of work loss for any given varicella-episode. CONCLUSIONS: This study shows the full spectrum of varicella-episodes and associated healthcare use, including the large proportion of cases not seeking medical care and the societal impact associated with those cases.

The health care burden and societal impact of acute otitis media in seven European countries: results of an Internet survey.

This paper estimates medical resource use, direct costs, and productivity losses and costs (indirect costs) during episodes of acute otitis media (AOM) in young children. A 24-item Internet questionnaire was developed for parents in Belgium (Flanders), France, Germany, Italy, The Netherlands, Spain, and the United Kingdom (UK) to report health care resource use and productivity losses during the most recent episode of AOM in their child, younger than 5 years. The percentage who did not seek medical help for AOM was considerable in The Netherlands (28.3%) and the UK (19.7%). Antibiotic use was high, ranging from 60.8% (Germany) to 87.1% (Italy). Total costs per AOM episode ranged from €332.00 (The Netherlands) to €752.49 (UK). Losses in productivity accounted for 61% (France) to 83% (Germany) of the total costs. AOM poses a significant medical and economic burden to society.

School performance and social-emotional behavior of primary school children before and after a disaster.

OBJECTIVES: The purpose of this work was to evaluate the cognitive and social-emotional consequences in a general population of primary school children affected by the firework disaster in Enschede, The Netherlands, on May 13, 2000. The explosions caused tremendous damage in the surrounding neighborhood. Twenty-two people immediately died and >1000 were injured. METHODS: This retrospective study assessed school performance and social-emotional behavior before and up to 3 years after the disaster. Objectively measured school test results in spelling and arithmetic/mathematics and multi-informant social-emotional behavioral assessments were compared between exposed and nonexposed primary school children. Multivariate logistic-regression was used to assess the relationship between exposure and cognitive and social emotional functioning. RESULTS: On school performances, the children exposed to the disaster performed over a period of 3 years after the disaster as good as or better than classmates, controls, and a national reference population. Shortly after the disaster, exposed children even seemed to have better school test results than nonexposed children. Two to 3 years after the disaster, a significant effect of disaster exposure was found on social-emotional behavior. Problematic behavior was reported by teachers, parents, and the school doctor. CONCLUSIONS: This study demonstrates a limited influence of disaster exposure on school performance in primary school children. This study also shows that teachers and youth health care practitioners especially should be aware of children starting school several years after a disaster. Although very young at the time of a disaster (1-4 years of age), they may experience disaster-related problems.

Substandard factors in perinatal care in The Netherlands: a regional audit of perinatal deaths.

BACKGROUND: To determine: 1) whether substandard factors were present in cases of perinatal death, and to what extent another course of action might have resulted in a better outcome, and 2) whether there were differences in the frequency of substandard factors by level of care, particularly between midwives and gynecologists/obstetricians and between home and hospital births. METHODS: Population-based perinatal audit, with explicit evidence-based audit criteria. SETTING: The northern part of the province of South-Holland in The Netherlands. All levels of perinatal care (primary, secondary and tertiary care, and home and hospital births) were included. CASES: Three hundred and forty-two cases of perinatal mortality (24 weeks of pregnancy--28 days after birth). MAIN OUTCOME MEASURES: Scores by a Dutch and a European audit panel. Score 0: no substandard factors identified; score 1, 2 or 3: one or more substandard factors identified, which were unlikely (1), possibly (2) or probably (3) related to the perinatal death. RESULTS: In 25% of the perinatal deaths (95% Confidence Interval: 20-30%) a substandard factor was identified that according to the Dutch panel was possibly or probably related to the perinatal death. These were mainly maternal/social factors (10% of all perinatal deaths; most frequent substandard factor: smoking during pregnancy), and antenatal care factors (10% of all perinatal deaths; most frequent substandard factor: detection of intra-uterine growth retardation). We did not find statistically significant differences in scores between midwives and gynecologists/obstetricians or between home and hospital births. The European panel identified more substandard factors, but these were again equally distributed by level of care. CONCLUSIONS: Perinatal deaths might be partly preventable in The Netherlands. There is no evidence that the frequency of substandard factors is related to specific aspects of the perinatal care system in The Netherlands.