Passive cigarette smoke exposure and other risk factors for invasive pneumococcal disease in children: a case-control study.

OBJECTIVE: To investigate whether passive cigarette smoke exposure increases the risk of invasive pneumococcal disease in children. METHODS: In a population-based case-control study, 171 children aged 0 to 12 years with culture-confirmed invasive pneumococcal disease during the years 1994 to 2004 were identified. Two controls were matched to each case on age and patterns of Health Plan membership. We reviewed medical records of subjects and family members for information on household cigarette smoke exposure within 2 years of the diagnosis of invasive pneumococcal disease. We collected information on sex, race, pneumococcal vaccination, selected medical conditions, and medications in the 3 months before the diagnosis. RESULTS: Similar proportions of cases (25%) and controls (30%) had definite or probable passive smoke exposure (odds ratio [OR] = 0.76, 95% confidence interval [CI] = 0.47-1.2). Cases of invasive pneumococcal disease were more likely to be nonwhite than controls (OR = 4.4, 95% CI = 2.3-8.2). Elevated risk of invasive pneumococcal disease was found in subjects with recent pulmonary diagnoses (OR = 2.2, 95% CI = 1.2-4.0) and recent antibiotic use (OR = 1.6, 95% CI = 1.1-2.3). CONCLUSIONS: Passive cigarette smoke exposure was not associated with invasive pneumococcal disease in this pediatric population. Invasive pneumococcal disease was associated with recent pulmonary diagnoses and recent antibiotic use.

Incidence and clinical characteristics of herpes zoster among children in the varicella vaccine era, 2005-2009.

BACKGROUND: Vaccine-strain herpes zoster (HZ) can occur after varicella vaccination. This study determined the number and proportion of HZ cases caused by vaccine-strain varicella zoster virus (VZV), assessed the positive predictive value of provider diagnosis of HZ, and computed HZ incidence rates in vaccinated and unvaccinated children. METHODS: We used electronic medical records to identify all office visits with an HZ diagnosis for children aged <18 years in a managed care plan. Providers collected skin specimens and completed a questionnaire. Specimens were tested by polymerase chain reaction to identify wild-type or vaccine-strain VZV. RESULTS: From May 2005 to September 2009, we enrolled 322 subjects. VZV was detected in 82% of specimens (84% wild-type, 15% vaccine-strain, 1% possible vaccine-wild-type recombinant). Among the 118 vaccinated subjects, VZV was detected in 70% (52% wild-type). The positive predictive value for provider diagnosis of "definite HZ" was 93% for unvaccinated and 79% for vaccinated children. The incidence of laboratory-confirmed HZ was 48 per 100,000 person-years in vaccinated children (both wild-type and vaccine-strain) and 230 per 100,000 person-years in unvaccinated children (wild-type only). CONCLUSIONS: HZ incidence in vaccinated children was 79% lower than in unvaccinated children. Among vaccinated children, half of HZ cases were due to wild-type VZV.

Identifying pregnancy episodes, outcomes, and mother-infant pairs in the Vaccine Safety Datalink.

BACKGROUND: The need for research on the safety of vaccination during pregnancy is widely recognized. Large, population-based data systems like the Vaccine Safety Datalink (VSD) may be useful for this research, but identifying pregnancies using electronic medical record (EMR) and claims data can be challenging. METHODS: We modified an existing data processing algorithm to identify pregnancies within seven of the ten VSD sites. We validated the algorithm by calculating the agreement in pregnancy outcome type, end date, and gestational age between the algorithm and manual medical record review. At each participating site, we randomly sampled 15 episodes within four outcome type strata (live births, spontaneous abortions, elective abortions, and other pregnancy outcomes) for a total of 60 episodes per site. We also developed and validated methods to link mothers to their infants in the electronic data. RESULTS: We identified 595,929 pregnancy episodes ending in 2002 through 2006 among women 12 through 55 years of age. Of these pregnancies, 75% ended in live births, 12% in spontaneous abortions, and 9% in elective abortions. We were able to confirm a pregnancy within 28 days of the algorithm-estimated pregnancy start date for 99% of live births, 93% of spontaneous abortions, 92% of elective abortions, and 90% of other outcomes sampled. The agreement between the algorithm-identified and the abstractor-identified outcome date ranged from 70% (elective abortion) to 96% (live birth) depending on outcome type. When gestational age was available in the EMR, agreement ranged from 82% (other) to 98% (live birth) depending on outcome type. We confirmed 100% of the 350 sampled mother-infant linkages with manual medical record review. CONCLUSIONS: The VSD algorithm accurately identifies pregnancy episodes and mother-infant pairs across participating sites. Additional manual record review may be needed to improve the precision of the pregnancy date estimates depending on specific study needs. These algorithms will allow us to conduct large, population-based studies of the safety of vaccination during pregnancy.

Factors predicting completion of the human papillomavirus vaccine series.

PURPOSE: This study identified factors associated with completion of the three dose quadrivalent human papillomavirus vaccine (HPV4) series by female adolescents. METHODS: Between February and September 2008, we prospectively surveyed 11- to 26-year-old female members of an integrated managed care organization shortly after their first HPV4 dose to identify factors that predicted series completion. We used regression analyses to assess whether self-reported experiences at the index visit, knowledge/attitudes about HPV and HPV4, and medical record data on adverse events, demographic characteristics, care-utilization frequency, and visit characteristics, were associated with vaccine series completion within one year of the first HPV4 dose. RESULTS: Of 899 survey respondents (27% of 3347 survey recipients), 786 (87%) maintained continuous enrollment in the health plan in the year following the first HPV4 dose. Fifty percent (n = 393) completed the vaccine series within that year. In multivariate analyses of survey respondents, only respondents' ability to correctly identify the number of shots required for series completion was significantly associated with series completion. Reported bruising was associated with decreased likelihood of completion, and the clinician stating that future shots were required was associated with increased likelihood, but both were of borderline significance. Females ages 16-20 had the lowest series completion. CONCLUSIONS: Improving HPV4 completion will require targeted efforts. Our results suggest that providers may help by stressing the need for additional doses of vaccine, and confirming that patients understand this information. Special attention should be given to females ages 16-20. Future randomized trials should assess the effect on vaccine completion of these simple, low-cost interventions.

Prevalence of HPV types in cervical specimens from an integrated healthcare delivery system: baseline assessment to measure HPV vaccine impact.

PURPOSE: Two human papillomavirus (HPV) vaccines are available to prevent cervical cancer. One early measure of HPV vaccine impact would be a reduction in vaccine-related HPV types (HPV 6, 11, 16, or 18, or HPV 16, 18) in cervical samples from young women. We aimed to assess feasibility of specimen collection and baseline HPV prevalence in an integrated healthcare delivery system. METHODS: Residual cervical specimens collected during routine cervical cancer screening (2006-2008) were retained consecutively from eligible females aged 11-29 years, stratified by age group. Specimens were evaluated for 37 HPV genotypes using the Roche Linear Array assay. RESULTS: Of 10,124 specimens submitted, 10,103 (99 %) were adequate for HPV testing. Prevalence of HPV 6, 11, 16, or 18 genotype was 11.4 % overall and was the highest in the youngest age group (18.1 % in the 11-19-year-olds, 12.5 % in the 20-24-year-olds, and 7.0 % in the 25-29-year-olds). CONCLUSIONS: HPV types 6, 11, 16, or 18 prevalence could be measured over time to assess early HPV vaccine impact using residual specimens from an integrated healthcare delivery system, particularly if sampling focused on young women.

A large, population-based study of 2009 pandemic Influenza A virus subtype H1N1 infection diagnosis during pregnancy and outcomes for mothers and neonates.

BACKGROUND: Pregnant women were at increased risk for serious outcomes of 2009 pandemic influenza A virus subtype H1N1 (influenza A[H1N1]pdm09) infection, but little is known about the overall impact of the pandemic on neonatal and maternal outcomes. METHODS: We identified live births that occurred from 1 July 2008 through 31 May 2010 in 5 Kaiser Permanente regions. Pregnant women were considered to have influenza if they had a positive result of a laboratory test for influenza virus or if they received a diagnosis of influenza during a period in which seasonal influenza virus or A(H1N1)pdm09 was the predominant circulating virus. RESULTS: There were 111 158 births from 109 015 pregnancies involving 107 889 mothers; 368 pregnant women (0.3%) received a diagnosis of influenza due to seasonal virus, and 959 (0.9%) received a diagnosis of influenza due to A(H1N1)pdm09; 107 688 did not receive an influenza diagnosis. Pregnant women with influenza due to A(H1N1)pdm09 were more likely than women with seasonal influenza infection to be hospitalized within 30 days of the diagnosis (27% vs 12%; odds ratio [OR], 2.84 [95% confidence interval {CI}, 2.01-4.02]). Pregnant women with A(H1N1)pdm09 who started antiviral treatment ≥2 days after the diagnosis were significantly more likely to be hospitalized than those who started antiviral treatment <2 days after diagnosis (OR, 3.43 [95% CI, 1.55-7.56]). Mothers with seasonal influenza virus infection had an increased risk for having a small-for-gestational-age infant (OR, 1.59 [95% CI, 1.15-2.20]). CONCLUSIONS: In this large, geographically diverse population, A(H1N1)pdm09 infection increased the risk for hospitalization during pregnancy. Late initiation of antiviral treatment was also associated with an increased risk for hospitalization.

A pragmatic framework for single-site and multisite data quality assessment in electronic health record-based clinical research.

INTRODUCTION: Answers to clinical and public health research questions increasingly require aggregated data from multiple sites. Data from electronic health records and other clinical sources are useful for such studies, but require stringent quality assessment. Data quality assessment is particularly important in multisite studies to distinguish true variations in care from data quality problems. METHODS: We propose a "fit-for-use" conceptual model for data quality assessment and a process model for planning and conducting single-site and multisite data quality assessments. These approaches are illustrated using examples from prior multisite studies. APPROACH: Critical components of multisite data quality assessment include: thoughtful prioritization of variables and data quality dimensions for assessment; development and use of standardized approaches to data quality assessment that can improve data utility over time; iterative cycles of assessment within and between sites; targeting assessment toward data domains known to be vulnerable to quality problems; and detailed documentation of the rationale and outcomes of data quality assessments to inform data users. The assessment process requires constant communication between site-level data providers, data coordinating centers, and principal investigators. DISCUSSION: A conceptually based and systematically executed approach to data quality assessment is essential to achieve the potential of the electronic revolution in health care. High-quality data allow "learning health care organizations" to analyze and act on their own information, to compare their outcomes to peers, and to address critical scientific questions from the population perspective.

Reported adverse events in young women following quadrivalent human papillomavirus vaccination.

PURPOSE: To assess and describe young women's experiences with their first dose of quadrivalent human papillomavirus vaccine (HPV4) (Gardasil®) in a large managed care organization. METHODS: We collected survey and electronic medical record (EMR) data for 899 young women aged 11-26 receiving their first HPV4 injection from February through September 2008. Survey items included questions about adverse events, interactions with healthcare providers, and knowledge and attitudes toward HPV disease and HPV4. RESULTS: Six hundred ninety-six (78%) participants reported pain at the injection site. Other common reactions included injection site bruising or discoloration (n=155, 17%) or swelling (n=127, 14%) and presyncope or syncope (n=134, 15%). Overall, preteens and teens were more likely than adult participants to report vaccine adverse events. Most respondents, particularly in the adult age group, reported that their healthcare provider reviewed important information about HPV infection and about the risks and benefits of receiving the vaccine. Knowledge and attitudes about HPV and HPV4 also varied by age, with older women generally exhibiting more accurate knowledge about HPV and perceived susceptibility to cervical cancer. CONCLUSIONS: There were significant age differences in young women's experiences with their first HPV4 injection. These findings highlight the importance of age-appropriate education and provider communications about HPV disease and vaccination.

Completion and timing of the three-dose human papillomavirus vaccine series among adolescents attending school-based health centers in Oregon.

OBJECTIVE: Many adolescents do not complete the 3-dose human papillomavirus vaccine series in the recommended time frame, or at all. Given the challenges of administering a multi-dose vaccine to adolescents, especially those in vulnerable populations, we evaluated completion of the human papillomavirus vaccine series in 19 of Oregon's school-based health centers. METHODS: Among persons aged 0-17 who initiated the human papillomavirus vaccine series at a study school-based health center in 2007, we identified all subsequent human papillomavirus doses administered at the school-based health centers, or found in Oregon's immunization information system, in 2007-2008. We describe the proportion completing the vaccine series and mean intervals between doses, stratified by age, race, and insurance status. RESULTS: Four hundred fifty persons initiated the human papillomavirus series in 2007. By December 2008, 51% of these had received all 3 doses. Series completion increased significantly with age, differed significantly between race groups (highest among white persons (56%); lowest among black persons (38%)), and did not differ significantly by insurance status. Mean intervals between doses did not differ significantly by race or insurance status. CONCLUSIONS: Even in challenging conditions, school-based health centers provide excellent preventive care to vulnerable youth. These results support the importance of maintaining and expanding school-based health center access in vulnerable adolescent populations.

Laboratory characteristics of suspected herpes zoster in vaccinated children.

Varicella vaccination of children has decreased varicella disease incidence, but introduced the occurrence of herpes zoster (HZ) from vaccine-type virus. We identified 14 vaccinated children with suspected HZ and confirmed varicella virus by polymerase chain reaction in 6 cases. Two cases were due to vaccine-type virus. Serum varicella IgM and IgG were not useful for diagnosis of HZ among vaccinated children.

Laboratory diagnosis and characteristics of breakthrough varicella in children.

The atypical features of varicella in vaccinated persons (breakthrough varicella [BTV]) present diagnostic challenges. We examined varicella-zoster virus (VZV) polymerase chain reaction (PCR) and immunoglobulin (Ig) M and IgG serologic test results for confirming BTV cases. Among 33 vaccinated children with varicella-like rash, we identified wild-type VZV in 58% overall and in 76% of those with adequate tissue specimens; no vaccine-type virus was found. Of the 12 subjects with PCR-confirmed BTV and acute-phase serum samples, 9 had detectable IgM, and all had highly elevated acute-phase IgG titers. Six subjects with negative PCR results had lower IgG titers and negative IgM results. Although PCR is the preferred method for laboratory confirmation of BTV, a positive serum varicella IgM test result should also be considered to be diagnostic in a suspected BTV case; however, a negative IgM test result cannot be used to rule out the diagnosis. The value of highly elevated IgG titers needs further evaluation. Larger studies are needed to confirm these results.

The effectiveness and cost effectiveness of telephone counselling and the nicotine patch in a state tobacco quitline.

OBJECTIVES: State and national tobacco quitlines have expanded rapidly and offer a range of services. We examined the effectiveness and cost effectiveness of offering callers single session versus multisession counselling, with or without free nicotine patches. METHODS: This 3x2 randomised trial included 4614 Oregon tobacco quitline callers and compared brief (one 15-minute call), moderate (one 30-minute call and a follow-up call) and intensive (five proactive calls) intervention protocols, with or without offers of free nicotine patches (nicotine replacement therapy, NRT). Blinded staff assessed tobacco use by phone at 12 months. RESULTS: Abstinence odds ratios were significant for moderate (OR = 1.22, CI = 1.01 to 1.48) and intensive (OR = 1.29, CI = 1.07 to 1.56) intervention, and for NRT (OR = 1.58, CI = 1.35 to 1.85). Intent to treat quit rates were as follows: brief no NRT (12%); brief NRT (17%); moderate no NRT (14%); moderate NRT (20%); intensive no NRT (14%); and intensive NRT (21%). Relative to brief no NRT, the added costs for each additional quit was $2467 for brief NRT, $1912 for moderate no NRT, $2109 for moderate NRT, $2641 for intensive no NRT, and $2112 for intensive NRT. CONCLUSION: Offering free NRT and multisession telephone support within a state tobacco quitline led to higher quit rates, and similar costs per incremental quit, than less intensive protocols.

Developing and testing new smoking measures for the Health Plan Employer Data and Information Set.

OBJECTIVE: To develop and test items for the Health Plan Employee Data and Information Set (HEDIS) that assess delivery of the full range of provider-delivered tobacco interventions. MATERIALS AND METHODS: The authors identified potential items via literature review; items were reviewed by national experts. Face validity of candidate items was tested in focus groups. The final survey was sent to a random sample of 1711 adult primary care patients; the re-test survey was sent to self-identified smokers. RESULTS: The process identified reliable items to capture provider assessment of motivation and provision of assistance and follow-up. CONCLUSIONS: One can reliably assess patient self-report of provider delivery of the full range of brief tobacco interventions. Such assessment and feedback to health plans and providers may increase use of evidence-based brief interventions.