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1.  Health Care Use and Decision-Making among Lower-Income Families in High-DeductibleHealth Plans 
Archives of internal medicine  2010;170(21):1918-1925.
Lower-income families may face unique challenges in high-deductible health plans (HDHPs).
We administered a cross-sectional survey to a stratified random sample of families in a New England health plan’s HDHP with ≥$500 in annualized out-of-pocket expenditures. Lower-income families were defined as having incomes < 300% FPL. Primary outcomes were cost-related delayed or foregone care, difficulty understanding plans, unexpected costs, information-seeking, and likelihood of asking their physician about hypothetical recommended services subject to the plan deductible. Multivariatelogistic regression was used to control for potential confounders of associations between income group and primary outcomes.
Lower-income families (n = 141) were more likely than higher-income families (n = 273) to report cost-related delayed or foregone care (57% vs. 42%, adjusted odds ratio (AOR) 1.81 [95% CI, 1.15-2.83]). There were no differences in plan understanding, unexpected costs, or information-seeking by income. Lower-income families were more likely than others to say they would ask their physician about a $100 blood test (79% vs. 63%, AOR 1.97 [95% CI, 1.18-3.28]) or a $1000 screening colonoscopy (89% vs. 80%,AOR 2.04 [95% CI, 1.06-3.93]) subject to the plan deductible.
Lower-income families with out-of-pocket expenditures in an HDHP were more likely than higher-income families to report cost-related delayed or foregone care but did not report more difficulty understanding or using their plans, and mightbe more likely to question services requiring out-of-pocket expenditures. Policymakers and physicians should consider focused monitoring and benefit design modifications to support lower-income families in HDHPs.
PMCID: PMC4004054  PMID: 21098352
2.  Using Electronic Medical Records to Enhance Detection and Reporting of Vaccine Adverse Events 
We implemented an automated vaccine adverse event surveillance and reporting system based in an ambulatory electronic medical record to improve underreporting and incomplete reporting that prevails in spontaneous systems. This automated system flags potential vaccine adverse events for the clinician when a diagnosis is entered, prompts clinicians to consider the vaccine as a cause of the condition, and facilitates reporting of suspected adverse events to the Vaccine Adverse Event Reporting System (VAERS).
During five months, a total of 33,420 vaccinations were administered during 14,466 encounters. There were 5,914 follow-up contacts by vaccinees within 14 days of the vaccination visits; 686 (11.6%) generated an alert. Clinicians submitted VAERS reports for 23 of these (0.69 per 1,000 vaccine doses), which is almost 6 times the dose-based reporting rate to VAERS. 1 Clinician surveys indicated that it took a minimal amount of time to respond to the alerts. Of those who felt that an alert corresponded to an actual vaccine adverse event, the majority used the reporting feature to file a VAERS report.
We believe that elicited surveillance via real time prompts to clinicians holds substantial promise. By coupling simplified reporting with the initial prompt, clinicians can consider and report a vaccine adverse event electronically in a few moments during the office visit.
PMCID: PMC2213485  PMID: 17712091
3.  Pneumococcal Carriage and Antibiotic Resistance in Young Children before 13-Valent Conjugate Vaccine 
We sought to measure trends in Streptococcus pneumoniae (SP) carriage and antibiotic resistance in young children in Massachusetts communities after widespread adoption of heptavalent pneumococcal conjugate vaccine (PCV7) and before the introduction of the 13-valent pneumococcal conjugate vaccine (PCV13).
We conducted a cross-sectional study including collection of questionnaire data and nasopharyngeal specimens among children <7 years in primary care practices from 8 Massachusetts communities during the winter season of 2008–9 and compared with to similar studies performed in 2001, 2003–4, and 2006–7. Antimicrobial susceptibility testing and serotyping were performed on pneumococcal isolates, and risk factors for colonization in recent seasons (2006–07 and 2008–09) were evaluated.
We collected nasopharyngeal specimens from 1,011 children, 290 (29%) of whom were colonized with pneumococcus. Non-PCV7 serotypes accounted for 98% of pneumococcal isolates, most commonly 19A (14%), 6C (11%), and 15B/C (11%). In 2008–09, newly-targeted PCV13 serotypes accounted for 20% of carriage isolates and 41% of penicillin non-susceptible S. pneumoniae (PNSP). In multivariate models, younger age, child care, young siblings, and upper respiratory illness remained predictors of pneumococcal carriage, despite near-complete serotype replacement. Only young age and child care were significantly associated with PNSP carriage.
Serotype replacement post-PCV7 is essentially complete and has been sustained in young children, with the relatively virulent 19A being the most common serotype. Predictors of carriage remained similar despite serotype replacement. PCV13 may reduce 19A and decrease antibiotic-resistant strains, but monitoring for new serotype replacement is warranted.
PMCID: PMC3288953  PMID: 22173142
Streptococcus pneumoniae; pneumococcal conjugate vaccine; antibiotic resistance; serotype; colonization
4.  Methicillin-Resistant Staphylococcus aureus Infection and Hospitalization in High-Risk Patients in the Year following Detection 
PLoS ONE  2011;6(9):e24340.
Many studies have evaluated methicillin-resistant Staphylococcus aureus (MRSA) infections during single hospitalizations and subsequent readmissions to the same institution. None have assessed the comprehensive burden of MRSA infection in the period after hospital discharge while accounting for healthcare utilization across institutions.
Methodology/Principal Findings
We conducted a retrospective cohort study of adult patients insured by Harvard Pilgrim Health Care who were newly-detected to harbor MRSA between January 1991 and December 2003 at a tertiary care medical center. We evaluated all MRSA-attributable infections associated with hospitalization in the year following new detection, regardless of hospital location. Data were collected on comorbidities, healthcare utilization, mortality and MRSA outcomes. Of 591 newly-detected MRSA carriers, 23% were colonized and 77% were infected upon detection. In the year following detection, 196 (33%) patients developed 317 discrete and unrelated MRSA infections. The most common infections were pneumonia (34%), soft tissue (27%), and primary bloodstream (18%) infections. Infections occurred a median of 56 days post-detection. Of all infections, 26% involved bacteremia, and 17% caused MRSA-attributable death. During the admission where MRSA was newly-detected, 14% (82/576) developed subsequent infection. Of those surviving to discharge, 24% (114/482) developed post-discharge infections in the year following detection. Half (99/185, 54%) of post-discharge infections caused readmission, and most (104/185, 55%) occurred over 90 days post-discharge.
In high-risk tertiary care patients, newly-detected MRSA carriage confers large risks of infection and substantial attributable mortality in the year following acquisition. Most infections occur post-discharge, and 18% of infections associated with readmission occurred in hospitals other than the one where MRSA was newly-detected. Despite gains in reducing MRSA infections during hospitalization, the risk of MRSA infection among critically and chronically ill carriers persists after discharge and warrants targeted prevention strategies.
PMCID: PMC3174953  PMID: 21949707
5.  Evidence that pneumococcal serotype replacement in Massachusetts following conjugate vaccination is now complete 
Epidemics  2010;2(2):80-84.
Invasive pneumococcal disease (IPD) has been reduced in the US following conjugate vaccination (PCV7) targeting seven pneumococcal serotypes in 2000. However, increases in IPD due to other serotypes have been observed, in particular 19A. How much this “serotype replacement” will erode the benefits of vaccination and over what timescale is unknown. We used a population genetic approach to test first whether the selective impact of vaccination could be detected in a longitudinal carriage sample, and secondly how long it persisted for following introduction of vaccine in 2000. To detect the selective impact of the vaccine we compared the serotype diversity of samples from pneumococcal carriage in Massachusetts children collected in 2001, 2004 and 2007 with others collected in the pre-vaccine era in Massachusetts, the UK and Finland. The 2004 sample was significantly (p >0.0001) more diverse than pre-vaccine samples, indicating the selective pressure of vaccination. The 2007 sample showed no significant difference in diversity from the pre-vaccine period, and exhibited similar population structure, but with different serotypes. In 2007 the carriage frequency of 19A was similar to that of the most common serotype in pre-vaccine samples. We suggest that serotype replacement involving 19A may be complete in Massachusetts due to similarities in population structure to pre-vaccine samples. These results suggest that the replacement phenomenon occurs rapidly with high vaccine coverage, and may allay concerns about future increases in disease due to 19A. For other serotypes, the future course of replacement disease remains to be determined.
PMCID: PMC2963072  PMID: 21031138
Streptococcus pneumoniae; Infectious disease epidemiology; Nasopharyngeal carriage; Population genetics
6.  Reliability of a patient survey assessing cost-related changes in health care use among high deductible health plan enrollees 
Recent increases in patient cost-sharing for health care have lent increasing importance to monitoring cost-related changes in health care use. Despite the widespread use of survey questions to measure changes in health care use and related behaviors, scant data exists on the reliability of such questions.
We administered a cross-sectional survey to a stratified random sample of families in a New England health plan's high deductible health plan (HDHP) with ≥ $500 in annualized out-of-pocket expenditures. Enrollees were asked about their knowledge of their plan, information seeking, behavior change associated with having a deductible, experience of delay in care due in part to cost, and hypothetical delay in care due in part to cost. Initial respondents were mailed a follow-up survey within two weeks of each family returning the original survey. We computed several agreement statistics to measure the test-retest reliability for select questions. We also conducted continuity adjusted chi-square, and McNemar tests in both the original and follow-up samples to measure the degree to which our results could be reproduced. Analyses were stratified by self-reported income.
The test-retest reliability was moderate for the majority of questions (0.41 - 0.60) and the level of test-retest reliability did not differ substantially across each of the broader domains of questions. The observed proportions of respondents with delayed or foregone pediatric, adult, or any family care were similar when comparing the original and follow-up surveys. In the original survey, respondents in the lower-income group were more likely to delay or forego pediatric care, adult care, or any family care. All of the tests comparing income groups in the follow-up survey produced the same result as in the original survey.
In this population of HDHP beneficiaries, we found that survey questions concerning plan knowledge, information seeking, and delayed or foregone care were moderately reliable. Our results offer reassurance for researchers using survey information to study the effects cost sharing on health care utilization.
PMCID: PMC3116474  PMID: 21619647
7.  Consumer Awareness and Strategies Among Families with High-deductible Health Plans 
High-deductible health plans (HDHPs) are a new and controversial approach to increasing the share of health care costs paid by patients. Our study had the following aims: (1) to describe the experiences of families with HDHPs who had incurred high out-of-pocket costs and (2) to identify areas where clinicians could support more effective health care decisions by such families.
We conducted four focus groups with adults whose families had HDHPs in a New England-based health plan and had experienced high or unexpected out-of-pocket health care costs during the past 12 months. Transcripts of audio recordings were independently coded by three investigators using modified grounded theory techniques.
The 21 focus group participants had a good general understanding of how their HDHP worked, but reported confusion about specific processes due to the plans' complexity. They described heightened awareness of health care costs, and identified important barriers to their ability to control costs. These included needing to seek care for urgent problems without having the time to assess potential costs; having mistaken expectations about what services the HDHP covered; and being reluctant to discuss costs with doctors. They attempted to control costs by delaying or avoiding visits to doctors, but felt they had little control over costs once a clinical encounter had begun.
Patients with HDHPs reported heightened sensitivity to health care costs, and described important barriers to their ability to make effective choices. Helping such patients make optimal decisions will likely require systems-level changes that involve clinicians and health insurers.
PMCID: PMC2839340  PMID: 20033623
health policy; health insurance; health care reform; costs; decision-making
8.  Continued Impact of Pneumococcal Conjugate Vaccine on Carriage in Young Children 
Pediatrics  2009;124(1):e1-11.
The goals were to assess serial changes in Streptococcus pneumoniae serotypes and antibiotic resistance in young children and to evaluate whether risk factors for carriage have been altered by heptavalent pneumococcal conjugate vaccine (PCV7).
Nasopharyngeal specimens and questionnaire/medical record data were obtained from children 3 months to <7 years of age in primary care practices in 16 Massachusetts communities during the winter seasons of 2000–2001 and 2003–2004 and in 8 communities in 2006–2007. Antimicrobial susceptibility testing and serotyping were performed with S pneumoniae isolates.
We collected 678, 988, and 972 specimens during the sampling periods in 2000–2001, 2003–2004, and 2006–2007, respectively. Carriage of non-PCV7 serotypes increased from 15% to 19% and 29% (P < .001), with vaccine serotypes decreasing to 3% of carried serotypes in 2006–2007. The relative contribution of several non-PCV7 serotypes, including 19A, 35B, and 23A, increased across sampling periods. By 2007, commonly carried serotypes included 19A (16%), 6A (12%), 15B/C (11%), 35B (9%), and 11A (8%), and high-prevalence serotypes seemed to have greater proportions of penicillin nonsusceptibility. In multivariate models, common predictors of pneumococcal carriage, such as child care attendance, upper respiratory tract infection, and the presence of young siblings, persisted.
The virtual disappearance of vaccine serotypes in S pneumoniae carriage has occurred in young children, with rapid replacement with penicillin-nonsusceptible nonvaccine serotypes, particularly 19A and 35B. Except for the age group at highest risk, previous predictors of carriage, such as child care attendance and the presence of young siblings, have not been changed by the vaccine.
PMCID: PMC2782668  PMID: 19564254
Streptococcus pneumoniae; pneumococcal conjugate vaccine; antibiotic resistance; serotype; colonization
9.  Epidemiology and risk factors for Staphylococcus aureus colonization in children in the post-PCV7 era 
The incidence of community-associated methicillin-resistant Staphylococcus aureus (MRSA) has risen dramatically in the U.S., particularly among children. Although Streptococcus pneumoniae colonization has been inversely associated with S. aureus colonization in unvaccinated children, this and other risk factors for S. aureus carriage have not been assessed following widespread use of the heptavalent pneumococcal conjugate vaccine (PCV7). Our objectives were to (1) determine the prevalence of S. aureus and MRSA colonization in young children in the context of widespread use of PCV7; and (2) examine risk factors for S. aureus colonization in the post-PCV7 era, including the absence of vaccine-type S. pneumoniae colonization.
Swabs of the anterior nares (S. aureus) were obtained from children enrolled in an ongoing study of nasopharyngeal pneumococcal colonization of healthy children in 8 Massachusetts communities. Children 3 months to <7 years of age seen for well child or sick visits in primary care offices from 11/03–4/04 and 10/06–4/07 were enrolled. S. aureus was identified and antibiotic susceptibility testing was performed. Epidemiologic risk factors for S. aureus colonization were collected from parent surveys and chart reviews, along with data on pneumococcal colonization. Multivariate mixed model analyses were performed to identify factors associated with S. aureus colonization.
Among 1,968 children, the mean age (SD) was 2.7 (1.8) years, 32% received an antibiotic in the past 2 months, 2% were colonized with PCV7 strains and 24% were colonized with non-PCV7 strains. The prevalence of S. aureus colonization remained stable between 2003–04 and 2006–07 (14.6% vs. 14.1%), while MRSA colonization remained low (0.2% vs. 0.9%, p = 0.09). Although absence of pneumococcal colonization was not significantly associated with S. aureus colonization, age (6–11 mo vs. ≥5 yrs, OR 0.39 [95% CI 0.24–0.64]; 1–1.99 yrs vs. ≥5 yrs, OR 0.35 [0.23–0.54]; 2–2.99 yrs vs. ≥5 yrs, OR 0.45 [0.28–0.73]; 3–3.99 yrs vs. ≥5 yrs, OR 0.53 [0.33–0.86]) and recent antibiotic use were significant predictors in multivariate models.
In Massachusetts, S. aureus and MRSA colonization remained stable from 2003–04 to 2006–07 among children <7 years despite widespread use of pneumococcal conjugate vaccine. S. aureus nasal colonization varies by age and is inversely correlated with recent antibiotic use.
PMCID: PMC2716346  PMID: 19594890
10.  Evaluation of the performance of tests for spatial randomness on prostate cancer data 
Spatial global clustering tests can be used to evaluate the geographical distribution of health outcomes. The power of several of these tests has been evaluated and compared using simulated data, but their performance using real unadjusted data and data adjusted for individual- and area-level covariates has not been reported previously.
We evaluated data on prostate cancer histologic tumor grade and stage of disease at diagnosis for incident cases of prostate cancer reported to the Maryland Cancer Registry during 1992–1997. We analyzed unadjusted data as well as expected counts from models that were adjusted for individual-level covariates (race, age and year of diagnosis) and area-level covariates (census block group median household income and a county-level socioeconomic index). We chose 3 spatial clustering tests that are commonly used to evaluate the geographic distribution of disease: Cuzick-Edwards' k-NN (k-Nearest Neighbors) test, Moran's I and Tango's MEET (Maximized Excess Events Test).
For both grade and stage at diagnosis, we found that Cuzick-Edwards' k-NN and Moran's I were very sensitive to the percent of population parameter selected. For stage at diagnosis, all three tests showed that the models with individual- and area-level adjustments reduced clustering the most, but did not reduce it entirely.
Based on this specific example, results suggest that these tests provide useful tools for evaluating spatial clustering of disease characteristics, both before and after consideration of covariates.
PMCID: PMC2714079  PMID: 19575788
11.  Health Benefits, Risks, and Cost-Effectiveness of Influenza Vaccination of Children 
Emerging Infectious Diseases  2006;12(10):1548-1558.
Vaccinating children aged 6–23 months, plus all other children at high-risk, will likely be more effective than vaccinating all children against influenza.
We estimated cost-effectiveness of annually vaccinating children not at high risk with inactivated influenza vaccine (IIV) to range from US $12,000 per quality-adjusted life year (QALY) saved for children ages 6–23 months to $119,000 per QALY saved for children ages 12–17 years. For children at high risk (preexisting medical conditions) ages 6–35 months, vaccination with IIV was cost saving. For children at high risk ages 3–17 years, vaccination cost $1,000–$10,000 per QALY. Among children not at high risk ages 5–17 years, live, attenuated influenza vaccine had a similar cost-effectiveness as IIV. Risk status was more important than age in determining the economic effects of annual vaccination, and vaccination was less cost-effective as the child's age increased. Thus, routine vaccination of all children is likely less cost-effective than vaccination of all children ages 6–23 months plus all other children at high risk.
PMCID: PMC3290928  PMID: 17176570
influenza; vaccination; child health; cost-effectiveness analysis; economic; dispatch

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