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Lee, Grace

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Lee, Grace
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    Guillain-Barré Syndrome, Influenza Vaccination, and Antecedent Respiratory and Gastrointestinal Infections: A Case-Centered Analysis in the Vaccine Safety Datalink, 2009–2011
    (Public Library of Science, 2013) Greene, Sharon K.; Rett, Melisa D.; Vellozzi, Claudia; Li, Lingling; Kulldorff, Martin; Marcy, S. Michael; Daley, Matthew F.; Belongia, Edward A.; Baxter, Roger; Fireman, Bruce H.; Jackson, Michael L.; Omer, Saad B.; Nordin, James D.; Jin, Robert; Weintraub, Eric S.; Vijayadeva, Vinutha; Lee, Grace
    Background: Guillain-Barré Syndrome (GBS) can be triggered by gastrointestinal or respiratory infections, including influenza. During the 2009 influenza A (H1N1) pandemic in the United States, monovalent inactivated influenza vaccine (MIV) availability coincided with high rates of wildtype influenza infections. Several prior studies suggested an elevated GBS risk following MIV, but adjustment for antecedent infection was limited. Methods: We identified patients enrolled in health plans participating in the Vaccine Safety Datalink and diagnosed with GBS from July 2009 through June 2011. Medical records of GBS cases with 2009–10 MIV, 2010–11 trivalent inactivated influenza vaccine (TIV), and/or a medically-attended respiratory or gastrointestinal infection in the 1 through 141 days prior to GBS diagnosis were reviewed and classified according to Brighton Collaboration criteria for diagnostic certainty. Using a case-centered design, logistic regression models adjusted for patient-level time-varying sources of confounding, including seasonal vaccinations and infections in GBS cases and population-level controls. Results: Eighteen confirmed GBS cases received vaccination in the 6 weeks preceding onset, among 1.27 million 2009–10 MIV recipients and 2.80 million 2010–11 TIV recipients. Forty-four confirmed GBS cases had infection in the 6 weeks preceding onset, among 3.77 million patients diagnosed with medically-attended infection. The observed-versus-expected odds that 2009–10 MIV/2010–11 TIV was received in the 6 weeks preceding GBS onset was odds ratio = 1.54, 95% confidence interval (CI), 0.59–3.99; risk difference = 0.93 per million doses, 95% CI, −0.71–5.16. The association between GBS and medically-attended infection was: odds ratio = 7.73, 95% CI, 3.60–16.61; risk difference = 11.62 per million infected patients, 95% CI, 4.49–26.94. These findings were consistent in sensitivity analyses using alternative infection definitions and risk intervals for prior vaccination shorter than 6 weeks. Conclusions: After adjusting for antecedent infections, we found no evidence for an elevated GBS risk following 2009–10 MIV/2010–11 TIV influenza vaccines. However, the association between GBS and antecedent infection was strongly elevated.
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    Health and Economic Burden of Post-Partum Staphylococcus aureus Breast Abscess
    (Public Library of Science, 2013) Branch-Elliman, Westyn; Lee, Grace; Golen, Toni; Gold, Howard; Baldini, Linda M.; Wright, Sharon
    Objectives: To determine the health and economic burdens of post-partum Staphylococcus aureus breast abscess. Study design We conducted a matched cohort study (N = 216) in a population of pregnant women (N = 32,770) who delivered at our center during the study period from 10/1/03–9/30/10. Data were extracted from hospital databases, or via chart review if unavailable electronically. We compared cases of S. aureus breast abscess to controls matched by delivery date to compare health services utilization and mean attributable medical costs in 2012 United States dollars using Medicare and hospital-based estimates. We also evaluated whether resource utilization and health care costs differed between cases with methicillin-resistant and -susceptible S. aureus isolates. Results: Fifty-four cases of culture-confirmed post-partum S. aureus breast abscess were identified. Breastfeeding cessation (41%), milk fistula (11.1%) and hospital readmission (50%) occurred frequently among case patients. Breast abscess case patients had high rates of health services utilization compared to controls, including high rates of imaging and drainage procedures. The mean attributable cost of post-partum S. aureus breast abscess ranged from $2,340–$4,012, depending on the methods and data sources used. Mean attributable costs were not significantly higher among methicillin-resistant vs. –susceptible S. aureus cases. Conclusions: Post-partum S. aureus breast abscess is associated with worse health and economic outcomes for women and their infants, including high rates of breastfeeding cessation. Future study is needed to determine the optimal treatment and prevention of these infections.
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    Population genomics of post-vaccine changes in pneumococcal epidemiology
    (2013) Croucher, Nicholas J; Finkelstein, Jonathan; Pelton, Stephen I.; Mitchell, Patrick K.; Lee, Grace; Parkhill, Julian; Bentley, Stephen D.; Hanage, William; Lipsitch, Marc
    Whole genome sequencing of 616 asymptomatically carried pneumococci was used to study the impact of the 7-valent pneumococcal conjugate vaccine. Comparison of closely related isolates revealed the role of transformation in facilitating capsule switching to non-vaccine serotypes and the emergence of drug resistance. However, such recombination was found to occur at significantly different rates across the species, and the evolution of the population was primarily driven by changes in the frequency of distinct genotypes extant pre-vaccine. These alterations resulted in little overall effect on accessory genome composition at the population level, contrasting with the fall in pneumococcal disease rates after the vaccine’s introduction.
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    Responding to Vaccine Safety Signals during Pandemic Influenza: A Modeling Study
    (Public Library of Science, 2014) Maro, Judith; Fryback, Dennis G.; Lieu, Tracy A.; Lee, Grace; Martin, David B.
    Background: 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. Methods: 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. Results: 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. Conclusions: 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.
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    Stability of the pneumococcal population structure in Massachusetts as PCV13 was introduced
    (BioMed Central, 2015) Chang, Qiuzhi; Stevenson, Abbie E; Croucher, Nicholas J; Lee, Grace; Pelton, Stephen I; Lipsitch, Marc; Finkelstein, Jonathan; Hanage, William
    Background: The success of 7-valent pneumococcal conjugate vaccination (PCV-7) introduced to the US childhood immunization schedule in 2000 was partially offset by increases in invasive pneumococcal disease (IPD) and pneumococcal carriage due to non-vaccine serotypes, in particular 19A, in the years that followed. A 13-valent conjugate vaccine (PCV-13) was introduced in 2010. As part of an ongoing study of the response of the Massachusetts pneumococcal population to conjugate vaccination, we report the findings from the samples collected in 2011, as PCV-13 was introduced. Methods: We used multilocus sequence typing (MLST) to analyze 367 pneumococcal isolates carried by Massachusetts children (aged 3 months-7 years) collected during the winter of 2010–11 and used eBURST software to compare the pneumococcal population structure with that found in previous years. Results: One hundred and four distinct sequence types (STs) were found, including 24 that had not been previously recorded. Comparison with a similar sample collected in 2009 revealed no significant overall difference in the ST composition (p = 0.39, classification index). However, we describe clonal dynamics within the important replacement serotypes 19A, 15B/C, and 6C, and clonal expansion of ST 433 and ST 432, which are respectively serotype 22F and 21 clones. Conclusions: While little overall change in serotypes or STs was evident, multiple changes in the frequency of individual STs and or serotypes may plausibly be ascribed to the introduction of PCV-13. This 2011 sample documents the initial impact of PCV-13 and will be important for comparison with future studies of the evolution of the pneumococcal population in Massachusetts. Electronic supplementary material The online version of this article (doi:10.1186/s12879-015-0797-z) contains supplementary material, which is available to authorized users.
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    Ongoing Attention to Injurious Inpatient Falls and Pressure Ulcers
    (American Medical Association (AMA), 2015) Lee, Grace; Soumerai, Stephen
    To the Editor We read with interest the article by Waters et al1 because we believe it is vital to evaluate whether the actual effect of payment policies matches their intended effect. The authors contribute unique information about the results of the Centers for Medicare & Medicaid Services Hospital-Acquired Conditions Present on Admission Indicator (HAC POA) on pressure ulcers and injurious falls, using data from the National Database of Nursing Quality Indicators. However, their findings contradict those of our previously published study evaluating the impact of the HAC POA program on rates of central line–associated bloodstream infections (CLABSIs) and catheter-associated urinary tract infections (CAUTIs).2 We continue this important conversation for the benefit of patients, clinicians, hospital leadership, and policymakers, and we raise the following key concerns with the goal of increasing transparency and ensuring that conclusions about the effect of the HAC POA program are robust.
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    Impact of Medicare’s Hospital-Acquired Condition Policy on Infections in Safety Net and Non–Safety Net Hospitals
    (Cambridge University Press (CUP), 2015) Vaz, Louise Elaine; Kleinman, Kenneth Paul; Kawai, Alison Tse; Jin, Robert; Kassler, William J.; Grant, Patricia S.; Rett, Melisa D.; Goldmann, Donald; Calderwood, Michael S.; Soumerai, Stephen; Lee, Grace
    Policymakers may wish to align healthcare payment and quality of care while minimizing unintended consequences, particularly for safety net hospitals. To determine whether the 2008 Centers for Medicare and Medicaid Services Hospital-Acquired Conditions policy had a differential impact on targeted healthcare-associated infection rates in safety net compared with non–safety net hospitals. Interrupted time-series design. Nonfederal acute care hospitals that reported central line–associated bloodstream infection and ventilator-associated pneumonia rates to the Centers for Disease Control and Prevention’s National Health Safety Network from July 1, 2007, through December 31, 2013. We did not observe changes in the slope of targeted infection rates in the postpolicy period compared with the prepolicy period for either safety net (postpolicy vs prepolicy ratio, 0.96 [95% CI, 0.84–1.09]) or non–safety net (0.99 [0.90–1.10]) hospitals. Controlling for prepolicy secular trends, we did not detect differences in an immediate change at the time of the policy between safety net and non–safety net hospitals (P for 2-way interaction, .87). The Centers for Medicare and Medicaid Services Hospital-Acquired Conditions policy did not have an impact, either positive or negative, on already declining rates of central line–associated bloodstream infection in safety net or non–safety net hospitals. Continued evaluations of the broad impact of payment policies on safety net hospitals will remain important as the use of financial incentives and penalties continues to expand in the United States.
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    Diagnosing sepsis is subjective and highly variable: a survey of intensivists using case vignettes
    (BioMed Central, 2016) Rhee, Chanu; Kadri, Sameer S.; Danner, Robert L.; Suffredini, Anthony F.; Massaro, Anthony; Kitch, Barrett T.; Lee, Grace; Klompas, Michael
    Background: Sepsis is the focus of national quality improvement programs and a recent public reporting measure from the Centers for Medicare and Medicaid Services. However, diagnosing sepsis requires interpreting nonspecific signs and can therefore be subjective. We sought to quantify interobserver variability in diagnosing sepsis. Methods: We distributed five case vignettes of patients with suspected or confirmed infection and organ dysfunction to a sample of practicing intensivists. Respondents classified cases as systemic inflammatory response syndrome, sepsis, severe sepsis, septic shock, or none of the above. Interobserver variability was calculated using Fleiss’ κ for the five-level classification, and for answers dichotomized as severe sepsis/septic shock versus not-severe sepsis/septic shock and any sepsis category (sepsis, severe sepsis, or septic shock) versus not-sepsis. Results: Ninety-four physicians completed the survey. Most respondents (88 %) identified as critical care specialists; other specialties included pulmonology (39 %), anesthesia (19 %), surgery (9 %), and emergency medicine (9 %). Respondents had been in practice for a median of 8 years, and 90 % practiced at academic hospitals. Almost all respondents (83 %) felt strongly or somewhat confident in their ability to apply the traditional consensus sepsis definitions. However, overall interrater agreement in sepsis diagnoses was poor (Fleiss’ κ 0.29). When responses were dichotomized into severe sepsis/septic shock versus not-severe sepsis/septic shock or any sepsis category versus not-sepsis, agreement was still poor (Fleiss’ κ 0.23 and 0.18, respectively). Seventeen percent of respondents classified one of the five cases as severe sepsis/septic shock, 27.7 % rated two cases, 33.0 % respondents rated three cases, 19.2 % rated four cases, and 3.2 % rated all five cases as severe sepsis/septic shock. Among respondents who felt strongly confident in their ability to use sepsis definitions (n = 45), agreement was no better (Fleiss’ κ 0.28 for the five-category classification, and Fleiss’ κ 0.21 for the dichotomized severe sepsis/septic shock classification). Cases were felt to be extremely or very realistic in 74 % of responses; only 3 % were deemed unrealistic. Conclusions: Diagnosing sepsis is extremely subjective and variable. Objective criteria and standardized methodology are needed to enhance consistency and comparability in sepsis research, surveillance, benchmarking, and reporting. Electronic supplementary material The online version of this article (doi:10.1186/s13054-016-1266-9) contains supplementary material, which is available to authorized users.
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    The Risk of Febrile Seizures Following Influenza and 13-Valent Pneumococcal Conjugate Vaccines
    (Oxford University Press, 2017) Baker, Meghan; Jankosky, Christopher; Yih, Katherine; Gruber, Susan; Li, Lingling; Cocoros, Noelle; Lipowicz, Hana; Coronel-Moreno, Claudia; Feibelmann, Sandra; Lin, Nancy; McMahill-Walraven, Cheryl; Menschik, David; Selvan, Mano; Selvam, Nandini; Tilney, Rong Chen; Zichittella, Lauren; Lee, Grace; Kawai, Alison Tse
    Abstract Background: Evidence on the risk of febrile seizures (FS) after vaccination with inactivated influenza vaccine (IIV) and 13-valent pneumococcal conjugate vaccine (PCV13) is mixed. Among children 6–23 months, we examined the risk of FS following IIV and PCV13 during the 2013–14 and 2014–15 influenza seasons, for which vaccine virus strains were the same. Methods: We used claims data from 4 large national insurers in the FDA-sponsored Sentinel Initiative, which was developed to monitor the safety of FDA-regulated medical products. With a self-controlled risk interval design, the risk of FS in 0–1 days following IIV and following PCV13 was compared with a comparison interval (14–20 days), adjusting for confounding by age, calendar time, and concomitant vaccination with the other vaccine. In exploratory analyses, we assessed whether the effect of IIV is modified by concomitant administration of PCV13. Results: During the study period, 355,486 children received IIV and 581,868 received PCV13. We observed an incidence rate ratio (IRR) of 1.12 (95% CI 0.80, 1.56) for the risk of FS following IIV after adjustment for age, calendar time and concomitant PCV13. PCV13 was associated with an increased risk of FS (IRR adjusted for age, calendar time and concomitant IIV, 1.80, 95% CI 1.29, 2.52). The attributable risk for PCV13 ranged from 0.33 to 5.16 per 100,000 doses. The age and calendar-time adjusted IRR comparing exposed time to unexposed time was greater for concomitant IIV and PCV13 (IRR 2.80, 95% CI 1.63, 4.83), as compared with that for PCV13 without concomitant IIV (IRR 1.54, 95% CI 1.04, 2.28). However, the formal test assessing for interaction between IIV and PCV13 was not statistically significant. Conclusion: We found an elevated risk of FS after PCV13 vaccine but not after IIV, when adjusting for concomitant administration of the other vaccine. We found some evidence to suggest that concomitant administration of IIV with PCV13 might interact to increase the risk beyond the independent effects of PCV13, but the study was not powered to assess this interaction. The risk of seizures associated with PCV13 is low compared with a child’s lifetime risk of FS. Findings should be interpreted in the context of the importance of preventing influenza and pneumococcal infections in young children. Disclosures L. Li, sanofi pasteur: The author is currently employed by Sanofi Genzyme, which shares the same parent company as sanofi pasteur, the manufacturer of the Flu vaccine. However, the work was done while this author was still employed by Harvard Pilgrim Health Care Institute., No financial benefit received
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    Accuracy of administrative data for surveillance of healthcare-associated infections: a systematic review
    (BMJ Publishing Group, 2015) van Mourik, Maaike S M; van Duijn, Pleun Joppe; Moons, Karel G M; Bonten, Marc J M; Lee, Grace
    Objective: Measuring the incidence of healthcare-associated infections (HAI) is of increasing importance in current healthcare delivery systems. Administrative data algorithms, including (combinations of) diagnosis codes, are commonly used to determine the occurrence of HAI, either to support within-hospital surveillance programmes or as free-standing quality indicators. We conducted a systematic review evaluating the diagnostic accuracy of administrative data for the detection of HAI. Methods: Systematic search of Medline, Embase, CINAHL and Cochrane for relevant studies (1995–2013). Methodological quality assessment was performed using QUADAS-2 criteria; diagnostic accuracy estimates were stratified by HAI type and key study characteristics. Results: 57 studies were included, the majority aiming to detect surgical site or bloodstream infections. Study designs were very diverse regarding the specification of their administrative data algorithm (code selections, follow-up) and definitions of HAI presence. One-third of studies had important methodological limitations including differential or incomplete HAI ascertainment or lack of blinding of assessors. Observed sensitivity and positive predictive values of administrative data algorithms for HAI detection were very heterogeneous and generally modest at best, both for within-hospital algorithms and for formal quality indicators; accuracy was particularly poor for the identification of device-associated HAI such as central line associated bloodstream infections. The large heterogeneity in study designs across the included studies precluded formal calculation of summary diagnostic accuracy estimates in most instances. Conclusions: Administrative data had limited and highly variable accuracy for the detection of HAI, and their judicious use for internal surveillance efforts and external quality assessment is recommended. If hospitals and policymakers choose to rely on administrative data for HAI surveillance, continued improvements to existing algorithms and their robust validation are imperative.