Person: Lieu, Tracy
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Publication Values for Preventing Influenza-related Morbidity and Vaccine Adverse Events in Children
(BioMed Central, 2005) Prosser, Lisa; Bridges, Carolyn Buxton; Uyeki, Timothy M; Rêgo, Virginia H; Ray, G Thomas; Meltzer, Martin I; Schwartz, Benjamin; Thompson, William W; Fukuda, Keiji; Lieu, TracyBackground: Influenza vaccination recently has been recommended for children 6–23 months old, but is not currently recommended for routine use in non-high-risk older children. Information on disease impact, costs, benefits, risks, and community preferences could help guide decisions about which age and risk groups should be vaccinated and strategies for improving coverage. The objective of this study was to measure preferences and willingness-to-pay for changes in health-related quality of life associated with uncomplicated influenza and two rarely-occurring vaccination-related adverse events (anaphylaxis and Guillain-Barré syndrome) in children. Methods: We conducted telephone interviews with adult members selected at random from a large New England HMO (n = 112). Respondents were given descriptions of four health outcomes: uncomplicated influenza in a hypothetical 1-year-old child of their own, uncomplicated influenza in a hypothetical 14-year-old child of their own, anaphylaxis following vaccination, and Guillain-Barré syndrome. "Uncomplicated influenza" did not require a physician's visit or hospitalization. Preferences (values) for these health outcomes were measured using time-tradeoff and willingness-to-pay questions. Time-tradeoff questions asked the adult to assume they had a child and to consider how much time from the end of their own life they would be willing to surrender to avoid the health outcome in the child. Results: Respondents said they would give a median of zero days of their lives to prevent an episode of uncomplicated influenza in either their (hypothetical) 1-year-old or 14-year-old, 30 days to prevent an episode of vaccination-related anaphylaxis, and 3 years to prevent a vaccination-related case of Guillain-Barré syndrome. Median willingness-to-pay to prevent uncomplicated influenza in a 1-year-old was $175, uncomplicated influenza in a 14-year-old was $100, anaphylaxis $400, and Guillain-Barré syndrome $4000. The median willingness-to-pay for an influenza vaccination for their children with no risk of anaphylaxis or Guillain-Barré syndrome was $50 and $100, respectively. Conclusion: Most respondents said they would not be willing to trade any time from their own lives to prevent uncomplicated influenza in a child of their own, and the time traded did not vary by the age of the hypothetical affected child. However, adults did indicate a willingness-to-pay to prevent uncomplicated influenza in children, and that they would give more money to prevent the illness in a 1-year-old than in a 14-year-old. Respondents also indicated a willingness to pay a premium for a vaccine without any risk of severe complications.
Publication Reliability of a Patient Survey Assessing Cost-Related Changes in Health Care Use Among High Deductible Health Plan Enrollees
(BioMed Central, 2011) Penfold, Robert B; Kullgren, Jeffrey T; Miroshnik, Irina; Galbraith, Alison; Hinrichsen, Virginia L; Lieu, TracyBackground: 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. Methods: 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. Results: 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. Conclusions: 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.
Publication Health Benefits, Risks, and Cost-Effectiveness of Influenza Vaccination of Children
(U.S. National Center for Infectious Diseases, 2006) Prosser, Lisa; Bridges, Carolyn Buxton; Uyeki, Timothy M.; Hinrichsen, Virginia L; Meltzer, Martin I.; Molinari, Noelle-Angelique M.; Schwartz, Benjamin; Thompson, William W.; Fukuda, Keiji; Lieu, TracyWe 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.
Publication Effects of a Law against Early Postpartum Discharge on Newborn Follow-up, Adverse Events, and HMO Expenditures
(New England Journal of Medicine (NEJM/MMS), 2002) Madden, Jeanne; Soumerai, Stephen; Lieu, Tracy; Mandl, Kenneth; Zhang, Fang; Ross-Degnan, DennisBACKGROUND Concern about harm to newborns from early postpartum discharges led to laws establishing minimum hospital stays in the mid-1990s. We evaluated the effects of an early-discharge protocol (a hospital stay of one postpartum night plus a home visit) in a health maintenance organization (HMO) and a subsequent state law guaranteeing a 48-hour hospital stay. METHODS Using interrupted–time-series analysis and data on 20,366 mother–infant pairs with normal vaginal deliveries, we measured changes in length of stay, newborn examinations on the third or fourth day of life, and office visits, emergency department visits, and hospital readmissions for newborns. We also examined expenditures for hospitalizations and home-based care. RESULTS The early-discharge program increased the rate of stays of less than two nights from 29.0 percent to 65.6 percent (P<0.001). The rate declined to 13.7 percent after the state mandate (P<0.001). The rate of newborn examinations on the third or fourth day of life increased from 24.5 percent to 64.4 percent with the program (P<0.001), then dropped to 53.0 percent after the mandate (P<0.001) — changes that primarily reflected changes in the rate of home visits. The rate of nonurgent visits to a health center increased from 33.4 percent to 44.7 percent (P<0.001) after the reduced-stay program was implemented. There were no significant changes in the rate of emergency department visits (quarterly mean, 1.1 percent) or rehospitalizations (quarterly mean, 1.5 percent). Results were similar for a vulnerable subgroup with lower incomes, younger maternal age, a lower level of education, or some combination of these characteristics. Average HMO expenditures on hospital and home-based services decreased by $90 per delivery with the early-discharge program and increased by $100 after the mandate. CONCLUSIONS Neither policy appears to have affected the health outcomes of newborns. After the mandate, newborns were less likely to be examined as recommended on day 3 or 4. Because of changes in hospital prices, the two policies had minimal effects on HMO expenditures for hospital and home-based services.
Publication Asthma Self-assessment in a Medicaid Population
(BioMed Central, 2009) Wu, Ann; Glauber, James Howard; Gay, Charlene; Lieu, TracyBackground: 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. Methods: 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. Results: 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). Conclusion: 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.
Publication Attitudes of Healthcare Workers in U.S. Hospitals Regarding Smallpox Vaccination
(BioMed Central, 2003) Yih, Katherine; Lieu, Tracy; Rêgo, Virginia H; O'Brien, Megan A; Shay, David K; Yokoe, Deborah S.; Platt, RichardBackground: The United States is implementing plans to immunize 500,000 hospital-based healthcare workers against smallpox. Vaccination is voluntary, and it is unknown what factors drive vaccine acceptance. This study's aims were to estimate the proportion of workers willing to accept vaccination and to identify factors likely to influence their decisions. Methods: The survey was conducted among physicians, nurses, and others working primarily in emergency departments or intensive care units at 21 acute-care hospitals in 10 states during the two weeks before the U.S. national immunization program for healthcare workers was announced in December 2002. Of the questionnaires distributed, 1,165 were returned, for a response rate of 81%. The data were analyzed by logistic regression and were adjusted for clustering within hospital and for different number of responses per hospital, using generalized linear mixed models and SAS's NLMIXED procedure. Results: Sixty-one percent of respondents said they would definitely or probably be vaccinated, while 39% were undecided or inclined against it. Fifty-three percent rated the risk of a bioterrorist attack using smallpox in the United States in the next two years as either intermediate or high. Forty-seven percent did not feel well-informed about the risks and benefits of vaccination. Principal concerns were adverse reactions and the risk of transmitting vaccinia. In multivariate analysis, four variables were associated with willingness to be vaccinated: perceived risk of an attack, self-assessed knowledge about smallpox vaccination, self-assessed previous smallpox vaccination status, and gender. Conclusions: The success of smallpox vaccination efforts will ultimately depend on the relative weight in people's minds of the risk of vaccine adverse events compared with the risk of being exposed to the disease. Although more than half of the respondents thought the likelihood of a bioterrorist smallpox attack was intermediate or high, less than 10% of the group slated for vaccination has actually accepted it at this time. Unless new information about the threat of a smallpox attack becomes available, healthcare workers' perceptions of the vaccine's risks will likely continue to drive their ongoing decisions about smallpox vaccination.
Publication Asthma Treatments and Mental Health Visits After a Food and Drug Administration Label Change for Leukotriene Inhibitors
(Elsevier BV, 2015) Lu, Christine; Zhang, Fang; Lakoma, Matthew D.; Butler, Melissa G.; Fung, Vicki; Larkin, Emma K.; Kharbanda, Elyse O.; Vollmer, William M.; Lieu, Tracy; Soumerai, Stephen; Chen Wu, AnnPurpose
In 2009, the US Food and Drug Administration (FDA) mandated a label change for leukotriene inhibitors (LTIs) to include neuropsychiatric adverse events (eg, depression and suicidality) as a precaution. This study investigated how this label change affected the use of LTIs and other asthma controller medications, mental health visits, and suicide attempts.
Methods
We analyzed data (2005–2010) from 5 large health plans in the US Population-Based Effectiveness in Asthma and Lung Diseases (PEAL) Network. The study cohort included children and adolescents (n = 30,000), young adults (n = 20,000), and adults (n = 90,000) with asthma. We used interrupted time series to examine changes in rates of LTI dispensings, non-LTI dispensings, mental health visits, and suicide attempts (using a validated algorithm based on a combination of diagnoses of injury or poisoning and psychiatric conditions).
Findings
The label change was associated with abrupt reductions in LTI use among all age groups (relative reductions of 8.3%, 15.1%, and 6.0% among adolescents, young adults, and adults, respectively, compared with expected rates at 1 year after the warnings). Although we detected immediate offset increases in non-LTI asthma medication use, these increases were not sustained among adolescents and young adults. There were small increases in mental health visits among LTI users.
Implications
The FDA label change for LTIs communicated possible risk of neuropsychiatric events. Communication and enhanced awareness may have increased reporting of mental health symptoms among young adults and adults. It is important to assess intended and unintended consequences of FDA warnings and label changes.