Looking Back on Rear-Facing Car Seats: Surveying US Parents in 2011 and 2013.

OBJECTIVE: We sought to determine the age at which US parents first turned their child's car seat to face forward and information sources used to make that decision at the time of the release of the 2011 guidelines for child passenger safety and 30 months later. METHODS: We administered 2 separate cross-sectional Web-based surveys of nationally representative panels of US parents in May 2011 and November 2013. Survey participation rate was 54% in both years. Parents of children ≤4 years old responded to questions about transitioning from rear-facing to forward-facing car seats (n = 495 in 2011; n = 521 in 2013). RESULTS: In 2011, 33% of parents of 1- to 4-year-old children who had been turned to face forward (n = 409) turned at or before 12 months and 16% turned at 2 years or older. In 2013, 24% of parents of 1- to 4-year-old children who had been turned to face forward (n = 413) turned at or before 12 months and 23% turned at 2 years or older. Car seat packaging and clinicians were the most common information sources. Demographic characteristics associated with turning to face forward at or before 12 months of age in 2011 (parent age, education, household income, rural residence) were not significantly associated with transitioning at or before 12 months in 2013. CONCLUSIONS: Delaying the transition to a forward-facing car seat still represents an opportunity to improve passenger safety in the United States. As common sources of information, clinicians may be influential in a parent's decision to turn their child's car seat to face forward.

Public participation in, and awareness about, medical research opportunities in the era of clinical and translational research.

CONTEXT: In the United States, levels of public participation in medical research in the era of Clinical and Translational Science Awards (CTSAs) are unknown. METHODS: In 2011, a household survey was administered to a sample of U.S. adults, asking whether they (and children <18 years old) had participated, or were aware of opportunities to participate, in medical research. Respondents living within 100 miles of CTSA sites were identified. Regression analyses of participation and awareness (PA) were performed, applying sampling weights to permit nationally representative inferences. RESULTS: Overall, 2,150 individuals responded (completion rate = 60%); 65% of adults and 63% of families with children resided within 100 miles of ≥1 CTSA location. Research participation rates were 11% among adults and 5% among children. Among nonparticipants, awareness rates were 64% among adults and 12% among parents of children. PA among adults was associated with higher income and education, older age, presence of chronic conditions, and living within 100 miles of four specific CTSA locations. For children, PA was associated with higher household income and parents' chronic health conditions. CONCLUSIONS: PA of medical research opportunities is substantially higher for adults than children. Higher PA levels near specific CTSAs merit investigation to identify their successful approaches.

Size of clinical trials and Introductory prices of prophylactic vaccine series.

Costs of completing the recommended immunization schedule have increased over the last decade. Access to prophylactic vaccines may become limited due to financing obstacles within current delivery systems. Vaccine prices reflect research and development expenses incurred by vaccine manufacturers, including costs associated with evaluating candidate vaccines in human subjects. If the number of subjects in clinical trials is increasing over time and associated with vaccine price, this may help explain increases in prices of vaccine series. We examined whether: (A) the initial public- and private-sector prices for recommended prophylactic vaccine series licensed and recommended in the US increased from 2000-2011, (B) the number of human subjects per licensed vaccine increased during the time period, and (C) the number of human subjects was associated with the initial public-and private-sector prices of the vaccine series. In regression analyses of 13 vaccines, approval year was not significantly associated with the number of human subjects, initial public-sector prices, or initial private-sector prices. While the number of phase II subjects was not significantly associated with prices, the numbers of phase III and combined late phase (phases II + III) subjects were significantly associated with initial public- and private-sector series prices (p < 0.05). The association between number of subjects and initial prices demonstrated diminishing marginal increases in price with increasing numbers of subjects. These findings may help guide the number of subjects required by the FDA in clinical trials, in order to reduce expenses for manufacturers and thereby help mitigate increases in initial vaccine series prices.

CHIAS: a standardized measure of parental HPV immunization attitudes and beliefs and its associations with vaccine uptake.

BACKGROUND: Despite the burden of human papillomavirus (HPV)-associated morbidity, less than half of US adolescent females had begun the 3-dose HPV vaccination series as of 2010. Given that parental attitudes significantly influence vaccine uptake, having a standardized measure of parental beliefs that predict HPV vaccine uptake would contribute substantially to the development of effective immunization strategies. We explored whether a modified version of the previously published Carolina HPV Immunization Attitudes and Beliefs Scale (CHIAS) could be applied nationally to identify attitudinal constructs that were associated with HPV vaccine uptake and maternal HPV vaccination intention. METHODS: We administered the modified CHIAS as part of a cross-sectional, web-based survey to a nationally representative sample of mothers of adolescent females. Exploratory factor analysis was used to identify underlying attitudinal constructs, which were compared with those identified in the original CHIAS. Bivariate and multivariate analyses determined associations between these attitudinal constructs and HPV vaccine uptake as well as vaccination intention. RESULTS: Overall survey response rate was 57%. The modified CHIAS yielded a factor structure that was similar to the original CHIAS, identifying 3 attitudinal constructs: harms/ineffectiveness, barriers, and social norms. In multivariate models, harms/ineffectiveness and social norms were independently associated with HPV vaccine uptake. CONCLUSIONS: The CHIAS seems to be a valid instrument for identifying important factors associated with HPV-vaccine uptake and parental vaccination intention nationally. Longitudinal studies are merited to explore whether these attitudinal constructs also reliably predict HPV-vaccine uptake.

Carpooling and booster seats: a national survey of parents.

OBJECTIVE: Booster seat use among school-aged children has been consistently lower than national goals. In this study, we sought to explore associations between parental experiences with booster seats and carpooling. METHODS: We conducted a cross-sectional Web-based survey of a nationally representative panel of US parents in January 2010. As part of a larger survey, parents of 4- to 8-year-old children responded to 12 questions related to booster seats and carpooling. RESULTS: Of 1612 parents responding to the full survey (response rate = 71%), 706 had a 4- to 8-year-old child and 681 met inclusion rules. Most parents (76%) reported their child used a safety seat when riding in the family car. Of children reported to use seat belts, 74% did so in accordance with their state law. Parent report of child safety seat use was associated with younger child age and with the presence of state booster seat laws. Sixty-four percent of parents carpool. Among parents who carpool and whose children use a child safety seat: 79% indicated they would always ask another driver to use a booster seat for their child and 55% reported they always have their child use their booster seat when driving friends who do not have boosters. CONCLUSIONS: Carpooling is a common driving situation during which booster seat use is inconsistent. Social norms and self-efficacy are associated with booster seat use. Clinicians who care for children should increase efforts to convey the importance of using the size-appropriate restraint for every child on every trip.

Failure-to-success ratios, transition probabilities and phase lengths for prophylactic vaccines versus other pharmaceuticals in the development pipeline.

Research and development of prophylactic vaccines carries a high risk of failure. In the past, industry experts have asserted that vaccines are riskier to produce than other pharmaceuticals. This assertion has not been critically examined. We assessed outcomes in pharmaceutical research and development from 1995 to 2011, using a global pharmaceutical database to identify prophylactic vaccines versus other pharmaceuticals in preclinical, Phase I, Phase II, or Phase III stages of development. Over 16 years of follow-up for 4367 products (132 prophylactic vaccines; 4235 other pharmaceuticals), we determined the failure-to-success ratios for prophylactic vaccines versus all other products. The overall ratio of failures to successes for prophylactic vaccines for the 1995 cohort over 16 years of follow-up was 8.3 (116/14) versus 7.7 (3650/475) for other pharmaceuticals. The probability of advancing through the development pipeline at each point was not significantly different for prophylactic vaccines than for other pharmaceuticals. Phase length was significantly longer for prophylactic vaccines than other pharmaceuticals for preclinical development (3.70 years vs 2.80 years; p<.0001), but was equivalent for all 3 human clinical trial phases between the two groups. We conclude that failure rates, phase transition probabilities, and most phase lengths for prophylactic vaccines are not significantly different from those of other pharmaceutical products, which may partially explain rapidly growing interest in prophylactic vaccines among major pharmaceutical manufacturers.

Sources and perceived credibility of vaccine-safety information for parents.

CONTEXT: The source of health information can have an impact on the manner and frequency of its use. In the arena of vaccine safety, a variety of sources promulgate information from very different perspectives. The spectrum runs from traditional sources such as public health officials and physicians to nontraditional sources, such as celebrities. OBJECTIVE: To assess what proportion of parents trust vaccine information from different sources and whether different groups of parents vary in their trust of such information. METHODS: In January 2009, as part of a larger study of parents and nonparents, 2521 online surveys were fielded to a nationally representative sample of parents of children aged ≤ 17 years. The main outcome measure was the source credibility of vaccine-safety information used by parents. RESULTS: The response rate was 62%. Parents reported trusting their children's doctor for vaccine-safety information most often (76% endorsed a lot of trust), followed by other health care providers (26%), government vaccine experts/officials (23%), and family and friends (15%). In contrast, celebrities were trusted a lot by 2% of the respondents and not at all by 76% of the respondents. Levels of trust in specific sources of vaccine-safety information varied significantly by gender (women > men) and race/ethnicity (Hispanics > other groups). CONCLUSIONS: Although most parents place a lot of trust in their child(ren)'s physician, parents' trust in non-health professional sources for such information should not be discounted. Those who design public health efforts to provide evidence-based information must recognize that different strategies may be required to reach some groups of parents who use other information sources.

Parental vaccine safety concerns in 2009.

OBJECTIVE: Vaccine safety concerns can diminish parents' willingness to vaccinate their children. The objective of this study was to characterize the current prevalence of parental vaccine refusal and specific vaccine safety concerns and to determine whether such concerns were more common in specific population groups. METHODS: In January 2009, as part of a larger study of parents and nonparents, 2521 online surveys were sent to a nationally representative sample of parents of children who were aged

The expanding vaccine development pipeline, 1995-2008.

Successful launches of recently licensed vaccines contrast with pharmaceutical industry concerns about unfavorable market conditions, making the status and future of vaccine development uncertain. We assessed trends in private-sector vaccine research and development for the period 1995-2008, using a global pharmaceutical database to identify prophylactic vaccines in preclinical, Phase I, Phase II, or Phase III stages of development. We counted companies that research and/or manufacture vaccines ("vaccine originators") and their vaccine products in each year. The global number of vaccine originators doubled (to 136), as did the number of prophylactic vaccine products in development (to 354); the majority of this growth was in preclinical and early phase clinical research. Because rapid growth in earlier research phases has not yet led to growth in Phase III, it is not yet clear whether recent industry expansion will translate to an increase in the number of available vaccines in the near future.