Rationale: Few previous studies have evaluated primary adherence (whether a new prescription is filled within 30 d) to controller medications in individuals with persistent asthma.
Objective: To compare adherence to the major controller medication regimens for asthma.
Methods: This was a retrospective cohort study of enrollees from five large health plans. We used electronic medical data on patients of all ages with asthma who had experienced an asthma-related exacerbation in the prior 12 months. We studied adherence measures including proportion of days covered and primary adherence (first prescription filled within 30 d).
Measurements and Main Results: Our population included 69,652 subjects who had probable persistent asthma and were prescribed inhaled corticosteroids (ICSs), leukotriene antagonists (LTRAs), or ICS/long-acting β-agonists (ICS/LABAs). The mean age was 37 years and 58% were female. We found that 14–20% of subjects who were prescribed controller medicines for the first time did not fill their prescriptions. The mean proportion of days covered was 19% for ICS, 30% for LTRA, and 25% for ICS/LABA over 12 months. Using multivariate logistic regression, subjects prescribed LTRA were less likely to be primary adherent than subjects prescribed ICS (odds ratio, 0.82; 95% confidence interval, 0.74–0.92) or ICS/LABA (odds ratio, 0.88; 95% confidence interval, 0.80–0.97). Black and Latino patients were less likely to fill the prescription compared with white patients.
Conclusions: Adherence to controller medications for asthma is poor. In this insured population, primary adherence to ICSs was better than to LTRAs and ICS/LABAs. Adherence as measured by proportion of days covered was better for LTRAs and ICS/LABAs than for ICSs.
asthma; adherence; medications; inhaled corticosteroids; leukotriene antagonists
Advances in health information technology and widespread use of electronic health data offer new opportunities for development of large scale multisite disease-specific patient registries. Such registries use existing data, can be constructed at relatively low cost, include large numbers of patients, and once created can be used to address many issues with a short time between posing a question and obtaining an answer. Potential applications include comparative effectiveness research, public health surveillance, mapping and improving quality of clinical care, and others. This paper describes selected conceptual and practical challenges related to development of multisite diabetes and asthma registries, including development of case definitions, validation of case identification methods, variation in electronic health data sources; representativeness of registry populations, including the impact of attrition. Specific challenges are illustrated with data from actual registries.
Registries; Comparative Effectiveness Research; Surveillance; Diabetes; Asthma
High-deductible health plans – typically with deductibles of at least $1,000 per individual and $2,000 per family -- require greater enrollee cost sharing than traditional plans. But they also may provide more affordable premiums and may be the lowest-cost, or only, coverage option for many families with members who are chronically ill. We surveyed families with chronic conditions in high-deductible plans and families in traditional plans to compare health care-related financial burden – such as experiencing difficulty paying medical or basic bills or having to set up payment plans. Almost half (48 percent) of the families with chronic conditions in high-deductible plans reported health care-related financial burden, compared to a fifth of families (21 percent) in traditional plans. Almost twice as many lower-income families in high-deductible plans spent more than 3 percent of income on health care expenses as lower-income families in traditional plans (53 percent versus 29 percent). As health reform efforts advance, policy makers must consider how to modify high-deductible plans to reduce the financial burden for families with chronic conditions.
To compare asthma care quality for children with and without minority-serving providers.
Cross-sectional telephone survey of parents, linked with a mailed survey of their children’s providers.
A Medicaid-predominant health plan and multispecialty provider group in Massachusetts.
Children with persistent asthma identified from claims and encounter data.
Whether the child’s provider was minority-serving (>25% of patients black or Latino).
Parent report of whether the child had: 1) ever received inhaled steroids; 2) received influenza vaccination during the past season and 3) received an asthma action plan in the past year.
The study included 563 children. In unadjusted analyses, Latino children and those with minority-serving providers were more likely to have never received inhaled steroids. In adjusted models, the odds of never receiving inhaled steroids were not significantly different for children with minority-serving providers (OR 1.29, 95% CI 0.63–2.64), or for Latino vs. white children (OR 1.76, 95% CI 0.74–4.18); odds were increased for children receiving care in community health centers (OR 4.88, 95% CI 1.70–14.02) or hospital clinics (OR 4.53, 95% CI 1.09–18.92) vs. multi-specialty practices. Such differences were not seen for influenza vaccinations or action plans.
Children with persistent asthma were less likely to receive inhaled steroids if they received care in community health centers or hospital clinics. Practice setting mediated initially-observed disparities in inhaled steroid use by Latino children and those with minority-serving providers. No differences by race/ethnicity or minority-serving provider were observed for influenza vaccinations and asthma action plans.
Managing emerging vaccine safety signals during an influenza pandemic is challenging. Federal regulators must balance vaccine risks against benefits while maintaining public confidence in the public health system.
We developed a multi-criteria decision analysis model to explore regulatory decision-making in the context of emerging vaccine safety signals during a pandemic. We simulated vaccine safety surveillance system capabilities and used an age-structured compartmental model to develop potential pandemic scenarios. We used an expert-derived multi-attribute utility function to evaluate potential regulatory responses by combining four outcome measures into a single measure of interest: 1) expected vaccination benefit from averted influenza; 2) expected vaccination risk from vaccine-associated febrile seizures; 3) expected vaccination risk from vaccine-associated Guillain-Barre Syndrome; and 4) expected change in vaccine-seeking behavior in future influenza seasons.
Over multiple scenarios, risk communication, with or without suspension of vaccination of high-risk persons, were the consistently preferred regulatory responses over no action or general suspension when safety signals were detected during a pandemic influenza. On average, the expert panel valued near-term vaccine-related outcomes relative to long-term projected outcomes by 3∶1. However, when decision-makers had minimal ability to influence near-term outcomes, the response was selected primarily by projected impacts on future vaccine-seeking behavior.
The selected regulatory response depends on how quickly a vaccine safety signal is identified relative to the peak of the pandemic and the initiation of vaccination. Our analysis suggested two areas for future investment: efforts to improve the size and timeliness of the surveillance system and behavioral research to understand changes in vaccine-seeking behavior.
Rationale: Statins, or HMG-CoA reductase inhibitors, may aid in the treatment of asthma through their pleiotropic antiinflammatory effects.
Objectives: To examine the effect of statin therapy on asthma-related exacerbations using a large population-based cohort.
Methods: Statin users aged 31 years or greater with asthma were identified from the Population-Based Effectiveness in Asthma and Lung population, which includes data from five health plans. Statin exposure and asthma exacerbations were assessed over a 24-month observation period. Statin users with a statin medication possession ratio greater than or equal to 80% were matched to non–statin users by age, baseline asthma therapy, site of enrollment, season at baseline, and propensity score, which was calculated based on patient demographics and Deyo-Charlson conditions. Asthma exacerbations were defined as two or more oral corticosteroid dispensings, asthma-related emergency department visits, or asthma-related hospitalizations. The association between statin exposure and each of the three outcome measures was assessed using conditional logistic regression.
Measurements and Main Results: Of the 14,566 statin users, 8,349 statin users were matched to a nonuser. After adjusting for Deyo-Charlson conditions that remained unbalanced after matching, among statin users, statin exposure was associated with decreased odds of having asthma-related emergency department visits (odds ratio [OR], 0.64; 95% confidence interval [CI], 0.53–0.77; P < 0.0001) and two or more oral corticosteroid dispensings (OR, 0.90; 95% CI, 0.81–0.99; P = 0.04). There were no differences in asthma-related hospitalizations (OR, 0.91; 95% CI, 0.66–1.24; P = 0.52).
Conclusions: Among statin users with asthma, statin exposure was associated with decreased odds of asthma-related emergency department visits and oral corticosteroid dispensings.
HMG-CoA reductase inhibitors; asthma therapy; exacerbations
Health insurance exchanges created under the Affordable Care Act will offer coverage to people who lack employer-sponsored insurance or have incomes too high to qualify for Medicaid. However, plans offered through an exchange may include high levels of cost sharing. We surveyed families participating in unsubsidized plans offered in the Massachusetts Commonwealth Health Insurance Connector Authority, an exchange created prior to the 2010 national health reform law, and found high levels of financial burden and higher-than-expected costs among some enrollees. The financial burden and unexpected costs were even more pronounced for families with greater numbers of children and in families with incomes below 400 percent of the federal poverty level. We conclude that those with lower incomes, increased health care needs, and more children will be at particular risk after they obtain coverage through exchanges in 2014. Policy makers should develop strategies to further mitigate the financial burden for enrollees who are most susceptible to encountering higher-than-expected out-of-pocket costs, such as cost calculators or price transparency tools.
Little is known about how geographic variation of cardiovascular procedures compares between beneficiaries with Medicare Advantage (MA) and Medicare fee-for-service (MFFS).
To compare regional cardiovascular procedure rates between MFFS and MA beneficiaries.
Cross-sectional study comparing rates of coronary angiography, percutaneous coronary intervention (PCI), and coronary artery bypass grafting (CABG).
32 Hospital Referral Regions (HRRs) in 12 states.
Patients (or Participants)
Medicare beneficiaries over age 65 between 2003–2007.
Main Outcome Measure(s)
Rates of coronary angiography, PCI and CABG.
We evaluated a total of 878,339 MA patients and 5,013,650 MFFS patients across 32 HRRs. Compared with MFFS patients, MA patients had lower age-, sex-, race, and income-adjusted procedure rates for angiography (16.5/1000 person-years vs. 25.9/1000; p <0.001) and PCI (6.8/1000 vs. 9.8/1000; p<0.0001) but similar rates for CABG (3.1/1000 vs. 3.4/1000; p=0.33). Procedure rates varied widely among both MA and MFFS patients. For angiography, the rates ranged from 9.8/1000 to 40.6/1000 for MA beneficiaries and from 15.7/1000 to 44.3/1000 for MFFS beneficiaries. For PCI, the rates ranged from 3.5/1000 to 16.8/1000 for MA and from 4.7/1000 to 16.1/1000 for MFFS. The rates for CABG ranged from 1.5/1000 to 6.1/1000 for MA and from 2.5/1000 to 6.0/1000 for MFFS. Across regions, we found no statistically significant correlation between MA and MFFS beneficiary utilization for angiography (r = 0.19, p = 0.29) and modest correlations for PCI (r= 0.33, p = 0.06) and CABG (r = 0.35, p =0.05). Among MA beneficiaries, demographic(age, gender, race, and income) adjusted rates were highly correlated with demographic and disease adjusted rates ( r = 0.82 for angiography, 0.87 for PCI, and 0.97 for CABG; p<0.0001).
Rates of angiography and PCI, were significantly lower among MA than MFFS beneficiaries while rates of CABG were not significantly different. Rates varied widely at the HRR level among both MA beneficiaries and MFFS beneficiaries. While capitation through MA is associated with lower angiography and PCI procedure rates, the substantial geographic variation suggests that capitation alone will not lead to reductions in the variations seen in cardiovascular procedure use.
The Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) network engages four healthcare delivery systems (Kaiser Permanente, Group Health Cooperative, HealthPartners, and Denver Health) and their affiliated research centers to create a new national network infrastructure that builds on existing relationships among these institutions. PORTAL is enhancing its current capabilities by expanding the scope of the common data model, paying particular attention to incorporating patient-reported data more systematically, implementing new multi-site data governance procedures, and integrating the PCORnet PopMedNet platform across our research centers. PORTAL is partnering with clinical research and patient experts to create cohorts of patients with a common diagnosis (colorectal cancer), a rare diagnosis (adolescents and adults with severe congenital heart disease), and adults who are overweight or obese, including those with pre-diabetes or diabetes, to conduct large-scale observational comparative effectiveness research and pragmatic clinical trials across diverse clinical care settings.
comparative effectiveness research; distributed databases; data sharing; colon cancer; congenital heart defects; obesity
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.
Many children with persistent asthma use inhaled corticosteroids on a periodic basis. Clinical trials in adults suggest that periodic use of inhaled corticosteroids may be effective for patients with mild persistent asthma. However, scant information exists on the clinical outcomes of children with asthma who are using inhaled corticosteroids on a periodic basis in real-world settings.
This prospective cohort study compared clinical outcomes during a 12-month follow-up period between children with persistent asthma whose parents believed that they were supposed to use inhaled steroids either (a) periodically or (b) daily year-round at the start of the period. The clinical outcomes studied were (1) asthma-related emergency department (ED) visits or hospitalizations, (2) uncontrolled asthma based on health care and medication use, and (3) outpatient visits for asthma.
Patients and methods
The study population included children with persistent asthma from two health plans whose parents reported that they were using inhaled corticosteroids during a baseline telephone interview. The interviews collected information on whether the children’s parents believed they were supposed to use inhaled corticosteroids on a periodic or daily basis, as well as baseline asthma symptom status, sociodemographic, and behavioral variables. We used computerized databases to identify clinical events for each child during the 12 months after their baseline interview. Uncontrolled asthma was defined as any asthma-related ED visit or hospitalization, two or more oral steroid prescription fills, or four or more beta-agonists canisters filled during the 12-month period. We compared these outcomes between the periodic versus daily users of inhaled corticosteroids using logistic regression analyses. We conducted both (1) a traditional logistic regression analysis in which we adjusted for selection bias by including covariates such as age, asthma physical status, sociodemographic and behavioral variables, and history of asthma-related health care use during the year before interview and (2) an analysis using propensity scores to more fully adjust for selection bias.
Of a total of 476 children in the study, 55% of parents believed their children were supposed to be using inhaled corticosteroids on a periodic basis and 45% believed their children were supposed to be using them daily year-round based on the baseline parent interview. At baseline, periodic inhaled corticosteroid users had less severe asthma than daily users based on several measures including better asthma physical status scores on the Children’s Health Survey for Asthma (mean 87 ± 16.0 vs. 81 ± 17.4, p = < 0.0001). During the year before the baseline interview, periodic users compared with daily users were less likely to have an ED visit or hospitalization (10% vs. 23%, p = 0.0001) and less likely to have had five or more albuterol prescription fills (13% vs. 31%, p < 0.0001). During the follow-up year, those who believed inhaled steroids were for periodic use were less likely than those who believed inhaled steroids were for daily use to have an ED visit or hospitalization for asthma (OR 0.36, 95% CI: 0.18–0.73), even after adjusting for baseline asthma status and other covariates. Similarly, those who believed inhaled steroids were for periodic use were less likely to have uncontrolled asthma, OR 0.38 (95% CI: 0.24–0.62). Analyses using propensity score adjustment yielded similar results to the logistic regression analyses.
Children whose parents believed they were supposed to use inhaled corticosteroids on a periodic basis had less severe asthma at baseline than those whose parents believed they were supposed to be using them daily. Periodic users were less likely than daily users to have adverse asthma outcomes during 1-year follow-up. This suggests that clinicians may be applying appropriate selection criteria by choosing patients with less severe asthma for periodic inhaled corticosteroid regimens.
asthma; periodic inhaled corticosteroids; children
To examine how enrollment in high-deductible health plans (HDHPs) affects use of well-child visits relative to traditional plans, in plans where preventive care is exempt from the deductible.
Pre-post comparison between groups.
We selected children aged ≤ 18 years enrolled in a large Massachusetts health plan through employers offering only one type of plan. Children were in traditional plans for a 12-month baseline period between 2001 and 2004, then were either switched by a decision of the parent’s employer to an HDHP or kept in the traditional plan (controls) for a 12-month follow-up period. Preventive and other office visits were exempt from the deductible and subject to co-payments as in traditional plans. The primary outcome was whether the child received well-child visits recommended for the 12-month period. Using generalized linear mixed models, we compared the change in receipt of recommended well-child visits between baseline and follow-up for the HDHP group relative to controls.
We identified 1,598 children who were switched to HDHPs and 10,093 controls. Between baseline and follow-up, the mean proportion of recommended well-child visits received by HDHP children decreased slightly from 0.846 to 0.841, and from 0.861 to 0.855 for controls. In adjusted models, there was no significant difference in the change in probability that recommended well-child visits were received for HDHP children relative to controls (p=0.69).
Receipt of recommended well-child visits did not change for children switching to HDHPs which exempt preventive care from the deductible compared to those remaining in traditional plans.
consumer-directed healthcare; cost sharing/co-payments; benefit design; insurance type; pediatrics; healthcare utilization
In 2022 twenty-five million people are expected to purchase health insurance through exchanges to be established under the Affordable Care Act. Understanding how people seek information and make decisions about the insurance plans that are available to them may improve their ability to select a plan and their satisfaction with it. We conducted a survey in 2010 of enrollees in one plan offered through Massachusetts’s unsubsidized health insurance exchange to analyze how a sample of consumers selected their plans. More than 40 percent found plan information difficult to understand. Approximately one-third of respondents had help selecting plans—most commonly from friends or family members. However, one-fifth of respondents wished they had had help narrowing plan choices; these enrollees were more likely to report negative experiences related to plan understanding, satisfaction with affordability and coverage, and unexpected costs. Some may have been eligible for subsidized plans. Exchanges may need to provide more resources and decision-support tools to improve consumers’ experiences in selecting a health plan.
High-deductible health plans (HDHPs) are an increasingly common strategy to contain health care costs. Individuals with chronic conditions are at particular risk for increased out-of-pocket costs in HDHPs and resulting cost-related underuse of essential health care.
To evaluate whether families with chronic conditions in HDHPs have higher rates of delayed or forgone care due to cost, compared with those in traditional health insurance plans.
This mail and phone survey used multiple logistic regression to compare family-level rates of reporting delayed/forgone care in HDHPs vs. traditional plans.
We selected families with children that had at least one member with a chronic condition. Families had employer-sponsored insurance in a Massachusetts health plan and >12 months of enrollment in an HDHP or a traditional plan.
The primary outcome was report of any delayed or forgone care due to cost (acute care, emergency department visits, chronic care, checkups, or tests) for adults or children during the prior 12 months.
Respondents included 208 families in HDHPs and 370 in traditional plans. Membership in an HDHP and lower income were each independently associated with higher probability of delayed/forgone care due to cost. For adult family members, the predicted probability of delayed/forgone care due to cost was higher in HDHPs than in traditional plans [40.0% vs 15.1% among families with incomes <400% of the federal poverty level (FPL) and 16.0% vs 4.8% among those with incomes ≥400% FPL]. Similar associations were observed for children.
Among families with chronic conditions, reporting of delayed/forgone care due to cost is higher for both adults and children in HDHPs than in traditional plans. Families with lower incomes are also at higher risk for delayed/forgone care.
health insurance; deductible; cost sharing; utilization; health policy
Black and Latino children with asthma have worse morbidity and receive less controller medication than their white peers. Scant information exists on racial/ethnic differences in parent perceptions of asthma. To compare parent perceptions among black, Latino, and white children with asthma in 4 domains: (1) expectations for functioning with asthma; (2) concerns about medications; (3) interactions with providers; and (4) competing family priorities.
In this cross-sectional study, we conducted telephone interviews with parents of children with persistent asthma in a Medicaid health plan and a multispecialty provider group in Massachusetts. To measure expectations for functioning and other domains, we adapted multi-item scales from past studies. Associations between race/ethnicity and these domains were evaluated in multivariate analyses that controlled for age, gender, household income, parental education, insurance, and language. The response rate was 72%.
Of the 739 study children, 24% were black, 21% Latino, and 43% white. Parents of black and Latino children had lower expectations for their children’s functioning with asthma (P < .001), higher levels of worry about their children’s asthma (P < .001), and more competing family priorities (P = 004) compared with parents of white children. Parents of Latino children had higher levels of concern about medications for asthma than parents of black or white children (P = 002). There were no differences among racial/ethnic groups in reports of interactions with the provider of their children’s asthma care.
Efforts to eliminate disparities in childhood asthma may need to address variation in expectations and competing priorities between minority and white families.
asthma; health care disparities; racial/ethnic variation
The Division of Lung Diseases of the National Heart, Lung, and Blood Institute (NHLBI) held a workshop to develop recommendations on topics, methodologies, and resources for comparative effectiveness research (CER) that will guide clinical decision making about available treatment options for lung diseases and sleep disorders. A multidisciplinary group of experts with experience in efficacy, effectiveness, implementation, and economic research identified (a) what types of studies the domain of CER in lung diseases and sleep disorders should include, (b) the criteria and process for setting priorities, and (c) current resources for and barriers to CER in lung diseases. Key recommendations were to (1) increase efforts to engage stakeholders in developing CER questions and study designs; (2) invest in further development of databases and other infrastructure, including efficient methods for data sharing; (3) make full use of a broad range of study designs; (4) increase the appropriate use of observational designs and the support of methodologic research; (5) ensure that committees that review CER grant applications include persons with appropriate perspective and expertise; and (6) further develop the workforce for CER by supporting training opportunities that focus on the methodologic and practical skills needed.
randomized controlled trials; observational studies; implementation; study designs; methodology
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.
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.
health policy; health insurance; health care reform; costs; decision-making
The emergence of pandemic H1N1 influenza in 2009 has prompted public health responses, including production and licensure of new influenza A (H1N1) 2009 monovalent vaccines. Safety monitoring is a critical component of vaccination programs. As proof-of-concept, the authors mimicked near real-time prospective surveillance for prespecified neurologic and allergic adverse events among enrollees in 8 medical care organizations (the Vaccine Safety Datalink Project) who received seasonal trivalent inactivated influenza vaccine during the 2005/06–2007/08 influenza seasons. In self-controlled case series analysis, the risk of adverse events in a prespecified exposure period following vaccination was compared with the risk in 1 control period for the same individual either before or after vaccination. In difference-in-difference analysis, the relative risk in exposed versus control periods each season was compared with the relative risk in previous seasons since 2000/01. The authors used Poisson-based analysis to compare the risk of Guillian-Barré syndrome following vaccination in each season with that in previous seasons. Maximized sequential probability ratio tests were used to adjust for repeated analyses on weekly data. With administration of 1,195,552 doses to children under age 18 years and 4,773,956 doses to adults, no elevated risk of adverse events was identified. Near real-time surveillance for selected adverse events can be implemented prospectively to rapidly assess seasonal and pandemic influenza vaccine safety.
cohort studies; influenza, human; influenza vaccines; managed care programs; population surveillance; safety; vaccines
There is concern that high-deductible health plans may have negative effects on vulnerable groups. The objective of this study was to compare the characteristics of families who have children and switch to high-deductible health plans with those who stay in traditional plans.
This double-cohort study included families who had children aged <18 years and were enrolled in a Massachusetts health plan through employers who did not offer a choice of health plans. We identified families who had traditional health maintenance organization plans for a 12-month baseline period between 2001 and 2004 and compared families whose coverage was then switched to a high-deductible health plan by their employers with similar families whose employer chose to remain in the traditional plan (controls). Data came from health plan enrollment and claims datasets and census data. We used multivariate logistic regression models to compare the characteristics of families who were switched to high-deductible health plans with controls.
We identified 839 families who had children and whose employer switched them to high-deductible health plans and 5133 controls. Among families with large employers, the adjusted odds of the employer switching to a high-deductible health plan were higher for families living in high-poverty neighborhoods. Among families with small employers, the adjusted odds of the employer switching to a high-deductible health plan were lower for families with more children, above-average family morbidity, and baseline total expenditures >$7000.
Among families with large employers offering a single health plan, those from low-income neighborhoods are more likely to be switched to high-deductible health plans. In contrast, families with small employers offering a single plan are more likely to be switched to high-deductible health plans if they are healthier and have lower baseline costs. These findings suggest that families with children in high-deductible plans may represent two distinct groups, one with higher-risk characteristics and another with lower-risk characteristics compared with those in traditional plans.
health insurance; deductible; cost sharing; health policy; health services research
Self-assessment of symptoms by patients with chronic conditions is an important element of disease management. A recent study in a commercially-insured population found that patients who received automated telephone calls for asthma self-assessment felt they benefitted from the calls. Few studies have evaluated the effectiveness of disease self-assessment in Medicaid populations. The goals of this study were to: (1) assess the feasibility of asthma self-assessment in a population predominantly insured by Medicaid, (2) study whether adding a gift card incentive increased completion of the self-assessment survey, and (3) evaluate how the self-assessment affected processes and outcomes of care.
We studied adults and children aged 4 years and older who were insured by a Medicaid-focused managed care organization (MCO) in a pre- and post-intervention study. During the pre-incentive period, patients with computerized utilization data that met specific criteria for problematic asthma control were mailed the Asthma Control Test (ACT), a self-assessment survey, and asked to return it to the MCO. During the intervention period, patients were offered a $20 gift card for returning the completed ACT to the MCO. To evaluate clinical outcomes, we used computerized claims data to assess the number of hospitalization visits and emergency department visits experienced in the 3 months after receiving the ACT. To evaluate whether the self-management intervention improved processes of care, we conducted telephone interviews with patients who returned or did not return the ACT by mail.
During the pre-incentive period, 1183 patients were identified as having problems with asthma control; 25 (2.0%) of these returned the ACT to the MCO. In contrast, during the incentive period, 1612 patients were identified as having problems with asthma control and 87 (5.4%) of these returned the ACT to the MCO (p < 0.0001). Of all 95 ACTs that were returned, 87% had a score of 19 or less, which suggested poor asthma control.
During the 3 months after they received the ACT, patients who completed it had similar numbers of outpatient visits, emergency department visits, and hospitalizations for asthma as patients who did not complete the ACT. We completed interviews with 95 patients, including 28 who had completed the ACT and 67 who had not. Based on an ACT administered at the time of the interview, patients who had previously returned the ACT to the MCO had asthma control similar to those who had not (mean scores of 14.2 vs. 14.6, p = 0.70). Patients had similar rates of contacting their providers within the past 2 months whether they had completed the mailed ACT or not (71% vs. 76%, p = 0.57).
Mailing asthma self-assessment surveys to patients with poorly controlled asthma was not associated with better asthma-associated outcomes or processes of care in the Medicaid population studied. Adding a gift card incentive did not meaningfully increase response rates. Asthma disease management programs for Medicaid populations will most likely need to involve alternative strategies for engaging patients and their providers in managing their conditions.
Many children with asthma do not take medications as prescribed. We studied parents of children with asthma to define patterns of non-concordance between families’ use of asthma controller medications and clinicians’ recommendations, examine parents’ explanatory models (EM) of asthma, and describe relationships between patterns of non-concordance and EM.
Qualitative study using semi-structured interviews with parents of children with persistent asthma. Grounded theory analysis identified recurrent themes and relationships between reported medication use, EMs, and other factors.
Twelve of the 37 parents reported non-concordance with providers’ recommendations. Three types of non-concordance were identified: unintentional – parents believed they were following recommendations; unplanned – parents reported intending to give controller medications but could not; and intentional – parents stated giving medication was the wrong course of action. Analysis revealed two EMs of asthma: chronic – parents believed their child always has asthma; and intermittent – parents believed asthma was a problem their child sometimes developed.
Concordance or non-concordance with recommended use of medications were related to EM’s and family context and took on three different patterns associated with medication underuse.
Efforts to reduce medication underuse in children with asthma may be optimized by identifying different types of non-concordance and tailoring interventions accordingly.
asthma; adherence; concordance; qualitative methods; explanatory models
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.
The objectives of this study were to: (1) identify modifiable factors influencing receipt of influenza vaccination among children with asthma, and (2) to evaluate the effect of heightened media attention on vaccination rates.
During November and December 2003, we interviewed parents of children with asthma about their experiences with and beliefs about influenza vaccination. We randomly selected 500 children from a study population of 2,140 children identified with asthma in a managed care organization in Massachusetts. We obtained data on influenza vaccination status from computerized medical records and determined significant factors influencing receipt of influenza vaccination.
Children were more likely to be vaccinated if their parent recalled a physician recommendation (odds ratio [OR] 2.6; 95% confidence interval [CI] 1.5, 4.5), believed the vaccine worked well (OR 2.0; 95% CI 1.4, 2.8), or expressed little worry about vaccine adverse effects (OR 1.3; 95% CI 1.0, 1.6), or if the child was younger (OR 1.1 per year of age; 95% CI 1.0, 1.2).
During the study period, there was heightened media attention about influenza illness and the vaccine. The influenza vaccination rate for children with asthma was 43% in 2003–04 compared with 27% in 2002–03. Comparison of weekly influenza vaccination rates in 2003–04 and 2002–03 suggested that the media attention was associated with the increase in vaccination rates.
Physician recommendations and parental education about influenza vaccine availability, effectiveness, and adverse effects are potentially important influences on influenza vaccination. Our findings suggest that media coverage of the risks of influenza was associated with a significant increase in vaccination rates.
In 1999, the American Academy of Pediatrics and U.S. Public Health Service recommended suspending the birth dose of hepatitis B vaccine due to concerns about potential mercury exposure. A previous report found that overall national hepatitis B vaccination coverage rates decreased in association with the suspension. It is unknown whether this underimmunization occurred uniformly or was associated with how providers changed their practices for the timing of hepatitis B vaccine doses. We evaluate the impact of the birth dose suspension on underimmunization for the hepatitis B vaccine series among 24-month-olds in five large provider groups and describe provider practices potentially associated with underimmunization following the suspension.
Retrospective cohort study of children enrolled in five large provider groups in the United States (A-E). Logistic regression was used to evaluate the association between the birth dose suspension and a child's probability of being underimmunized at 24 months for the hepatitis B vaccine series.
Prior to July 1999, the percent of children who received a hepatitis B vaccination at birth varied widely (3% to 90%) across the five provider groups. After the national recommendation to suspend the hepatitis B birth dose, the percent of children who received a hepatitis B vaccination at birth decreased in all provider groups, and this trend persisted after the policy was reversed. The most substantial decreases were observed in the two provider groups that shifted the first hepatitis B dose from birth to 5–6 months of age. Accounting for temporal trend, children in these two provider groups were significantly more likely to be underimmunized for the hepatitis B series at 24 months of age if they were in the birth dose suspension cohort compared with baseline (Group D OR 2.7, 95% CI 1.7 – 4.4; Group E OR 3.1, 95% CI 2.3 – 4.2). This represented 6% more children in Group D and 9% more children in Group E who were underimmunized in the suspension cohort compared with baseline. Children in the reversal cohort in these groups remained significantly more likely to be underimmunized compared with baseline. In contrast, in a third provider group where the typical timing of the third dose was unchanged and in two other provider groups whose hepatitis B vaccination schedules were unaffected by the birth dose suspension, hepatitis B vaccination coverage either was maintained or improved.
When the hepatitis B birth dose was suspended, provider groups that moved the first dose of vaccination to 5–6 months of age or later had decreases in hepatitis B vaccine coverage at 24 months. These findings suggest that as vaccine policy changes occur, providers could attempt to minimize underimmunization by adopting vaccination schedules that minimize delays in the recommended timing of vaccine doses.