يعرض 1 - 10 نتائج من 73 نتيجة بحث عن '"Catherine A. Panozzo"', وقت الاستعلام: 1.04s تنقيح النتائج
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    دورية أكاديمية

    المصدر: Human Vaccines & Immunotherapeutics, Vol 15, Iss 7-8, Pp 1708-1714 (2019)

    الوصف: Background. Health insurers are well-positioned to address low HPV vaccination coverage in the US through initiatives such as provider assessment and feedback. However, little is known about the feasibility of using administrative claims data to assess provider performance on vaccine delivery. Methods. We used administrative claims data from a regional health plan to estimate provider performance on the 2013–2015 Healthcare Effectiveness Data and Information Set (HEDIS) measure for HPV vaccine. This measure required that a girl receive three doses of HPV vaccine by age 13. Providers who administered ≥1 dose in a HEDIS-consistent series received credit for meeting the goal. Results. From January 2008-April 2015, 1,975 (8.5%) of 11–12 year-old girls in our sample received a HEDIS-consistent HPV vaccine series. Our sample of providers consisted of 1,236 who had ≥10 well-visits with different female patients, and 94% of these were pediatricians. A substantial minority of providers (39.4%) did not administer any HEDIS-consistent HPV vaccine doses. Only 5.5% of providers administered HPV vaccine doses that were part of a HEDIS-consistent series to at least one-quarter of their patients. These estimates did not vary by provider sex or age. Doses in a HEDIS-consistent vaccine series were often attributed to multiple providers. Conclusions. In a regional health plan, only 5.5% of providers in our sample administered doses that were part of a complete, three-dose HPV vaccine series to at least one-quarter of their 11–12 year-old female patients.

    وصف الملف: electronic resource

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    دورية أكاديمية

    المصدر: Human Vaccines & Immunotherapeutics, Vol 15, Iss 7-8, Pp 1824-1830 (2019)

    الوصف: The human papillomavirus (HPV) vaccine has been available in the United States for over a decade. We sought to examine the associations between self-reported receipt of HPV vaccination among women and their 11–14-year-old children in 27 low-coverage states. Among the 3,261 mothers we surveyed, 18% reported receiving ≥1 dose of HPV vaccine. A significantly higher proportion of vaccinated women reported vaccination of their children compared to unvaccinated women (83% vs. 56%, p < .001). In multivariable logistic regression, vaccinated women (vs. unvaccinated) had 3.58 (95% CI: 2.81–4.56) times the adjusted-odds of vaccinating their children (≥1 dose HPV vaccine). Among unvaccinated children, vaccinated mothers (vs. unvaccinated) had 3.32 (95% CI: 2.09–5.26) times the adjusted odds of high intention to vaccinate their children in the next 12 months. We did not observe associations between mothers’ vaccination confidence and their vaccination status. We conclude that mothers who received ≥1 dose of HPV vaccine may be more likely to initiate or highly intend to initiate the HPV vaccine series for their children. This may have important implications for meeting population goals for HPV vaccination coverage as an increasing proportion of mothers are likely to be vaccinated over time.

    وصف الملف: electronic resource

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    دورية أكاديمية

    المصدر: Preventive Medicine Reports, Vol 23, Iss , Pp 101413- (2021)

    الوصف: We assessed differences in response to a tailored recommendation intervention for HPV vaccine by participants’ sociodemographic characteristics in this exploratory sub-analysis of a larger web-based, randomized-controlled trial on tailored messaging among mothers with low intent to vaccinate their 11–14-year-old child against HPV. The intervention consisted of pre-recorded video messages tailored to 1–5 common concerns about HPV vaccine. In these exploratory analyses, we used generalized linear models to assess differences in post-intervention intent across intervention arms, stratified by sociodemographic characteristics among 496 trial participants. We found significantly higher post-intervention intent in the intervention participants versus the control group among mothers: 1) with younger children; 2) with white vs. black children; 3) with Non-Hispanic children; 4) who were younger; 5) with some college or vocational training; with household incomes of ≥$100,000; and 7) with 1–2 children. Our findings of effect modification by certain sociodemographic factors such as age, race/ethnicity, and household income should be considered when designing similar tailored messaging interventions.

    وصف الملف: electronic resource

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    دورية أكاديمية

    المصدر: Therapeutic Advances in Drug Safety, Vol 12 (2021)

    مصطلحات موضوعية: Therapeutics. Pharmacology, RM1-950

    الوصف: Background: Identifying pregnancy episodes and accurately estimating their beginning and end dates are imperative for observational maternal vaccine safety studies using electronic health record (EHR) data. Methods: We modified the Vaccine Safety Datalink (VSD) Pregnancy Episode Algorithm (PEA) to include both the International Classification of Disease, ninth revision (ICD-9 system) and ICD-10 diagnosis codes, incorporated additional gestational age data, and validated this enhanced algorithm with manual medical record review. We also developed the new Dynamic Pregnancy Algorithm (DPA) to identify pregnancy episodes in real time. Results: Around 75% of the pregnancy episodes identified by the enhanced VSD PEA were live births, 12% were spontaneous abortions (SABs), 10% were induced abortions (IABs), and 0.4% were stillbirths (SBs). Gestational age was identified for 99% of live births, 89% of SBs, 69% of SABs, and 42% of IABs. Agreement between the PEA-assigned and abstractor-identified pregnancy outcome and outcome date was 100% for live births, but was lower for pregnancy losses. When gestational age was available in the medical record, the agreement was higher for live births (97%), but lower for pregnancy losses (75%). The DPA demonstrated strong concordance with the PEA and identified pregnancy episodes ⩾6 months prior to the outcome date for 89% of live births. Conclusion: The enhanced VSD PEA is a useful tool for identifying pregnancy episodes in EHR databases. The DPA improves the timeliness of pregnancy identification and can be used for near real-time maternal vaccine safety studies. Plain Language Summary Improving identification of pregnancies in the Vaccine Safety Datalink electronic medical record databases to allow for better and faster monitoring of vaccination safety during pregnancy Introduction: It is important to monitor of the safety of vaccines after they have been approved and licensed by the Food and Drug Administration, especially among women vaccinated during pregnancy. The Vaccine Safety Datalink (VSD) monitors vaccine safety through observational studies within large databases of electronic medical records. Since 2012, VSD researchers have used an algorithm called the Pregnancy Episode Algorithm (PEA) to identify the medical records of women who have been pregnant. Researchers then use these medical records to study whether receiving a particular vaccine is linked to any negative outcomes for the woman or her child. Methods: The goal of this study was to update and enhance the PEA to include the full set of medical record diagnostic codes [both from the older International Classification of Disease, ninth revision (ICD-9 system) and the newer ICD-10 system] and to incorporate additional sources of data about gestational age. To ensure the validity of the PEA following these enhancements, we manually reviewed medical records and compared the results with the algorithm. We also developed a new algorithm, the Dynamic Pregnancy Algorithm (DPA), to identify women earlier in pregnancy, allowing us to conduct more timely vaccine safety assessments. Results: The new version of the PEA identified 2,485,410 pregnancies in the VSD database. The enhanced algorithm more precisely estimated the beginning of pregnancies, especially those that did not result in live births, due to the new sources of gestational age data. Conclusion: Our new algorithm, the DPA, was successful at identifying pregnancies earlier in gestation than the PEA. The enhanced PEA and the new DPA will allow us to better evaluate the safety of current and future vaccinations administered during or around the time of pregnancy.

    وصف الملف: electronic resource

  5. 5
    دورية أكاديمية

    المصدر: Emerging Infectious Diseases, Vol 18, Iss 2, Pp 294-297 (2012)

    الوصف: To confirm whether respiratory virus infections increase susceptibility to invasive pneumococcal pneumonia, we examined data from 11 influenza seasons (1994–2005) in the United States. Invasive pneumococcal pneumonia was significantly associated with influenza and respiratory syncytial virus activities in 5 seasons. Association strength was higher when strain H3N2 was the predominant influenza A virus strain.

    وصف الملف: electronic resource

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    دورية أكاديمية

    المصدر: PLoS ONE, Vol 14, Iss 12, p e0223515 (2019)

    مصطلحات موضوعية: Medicine, Science

    الوصف: Background Data from randomized controlled trials and observational studies on older adults who take statins for primary prevention of atherosclerotic cardiovascular disease are limited. To determine the incidence of statin use in older adults with and without cardiovascular disease (CVD) and/or diabetes (DM), we conducted a descriptive observational study. Methods The cohort consisted of health plan members in the NIH Collaboratory Distributed Research Network aged >75 years who had continuous drug and medical benefits for ≥183 days during the study period, January 1, 2008- March 31, 2018. We defined DM and CVD using diagnosis codes, and identified statins using dispensing data. Statin use was considered incident if a member had no evidence of statin exposure in the claims during the previous 183 days, and the use was considered long-term if statins were supplied for ≥180 days. Incidence rates were reported among members with and without CVD and/or diabetes, and stratified by year, sex, and age group. Results Among 757,569 eligible members, 109,306 older adults initiated statins and 54,624 became long-term users. Health plan members with CVD had the highest incidence of statin use (143.9 initiators per 1,000 member-years for CVD & DM; 114.5 initiators per 1,000 member-years for CVD & No DM). Among health plan members without CVD, those with DM had rates of statin use that were over two times higher than members without DM (76.1 versus 34.5 initiators per 1,000 member-years, respectively). Statin initiation remained steady throughout 2008-2016, was slightly higher in males, and declined with increasing age. Conclusion Incidence of statin use varied by CVD and DM comorbidity, and was lowest among those without CVD. These results highlight the potential clinical equipoise to conduct large pragmatic clinical trials to generate evidence that could be used to inform future blood cholesterol guidelines.

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    المصدر: Open Forum Infectious Diseases. 9

    مصطلحات موضوعية: Infectious Diseases, Oncology

    الوصف: Background RSV causes acute respiratory disease (ARD), including severe lower respiratory tract disease (LRTD) in older adults, which can lead to hospitalization and death. Currently, there are no vaccines approved to prevent RSV disease. This study estimated the potential clinical impact of a hypothetical RSV vaccine over a 1-year time horizon in older adults aged ≥ 60 years. Methods A decision-analytic model was developed (Figure 1). A strategy was used where the entire US population aged ≥ 60 years was given a single dose vaccine with an assumed efficacy of 75% against ARD, LRTD, and LRTD-hospitalizations and compared to a population who did not receive a vaccine. Given the uncertainty around RSV hospitalization rates, 2 base-case scenarios were created: (1) hospitalization rates that used RSV-specific claim codes and (2) hospitalization rates increased by 49% to account for underreporting in claims; Table 1 shows key inputs. One-way sensitivity analyses were used to assess the impact of specific parameter estimates. Results The vaccine would prevent 1.8 million and 0.6 million upper respiratory disease and LRTD cases, respectively; Figure 2 shows additional results for both base-case scenarios. The number needed to vaccinate (NNV) to prevent 1 LRTD case is 119; the NNV to prevent 1 LRTD hospitalization or death ranges from 792 to 1180 and 10,452 to 15,574, respectively. Sensitivity analyses indicate that results mainly depend on vaccine efficacy, and incidence of ARD and LRTD. Conclusion There is substantial US public health benefit associated with utilization of an effective RSV vaccine in individuals ≥ 60 years of age to reduce RSV-associated morbidity and mortality; however, the magnitude of impact depends on RSV epidemiology, which is still being defined for older adults. Several model parameters were based on assumptions, and robust evidence generation is needed including the efficacy of an RSV vaccine, which is an important consideration in assessing the impact of vaccination in this age group. Disclosures Kelly Fust, MS, Quadrant Health Economics Inc: Contractor at Quadrant Health Economics Inc who was funded by Moderna to perform this study Michele Kohli, PhD, Quadrant Health Economics Inc: Shareholder at Quadrant Health Economics Inc who was funded by Moderna to perform this study|Quadrant Health Economics Inc: Stocks/Bonds Catherine A. Panozzo, PhD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Philip Buck, PhD, MPH, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Parinaz Ghaswalla, PhD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds.

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    المصدر: Open Forum Infectious Diseases. 9

    مصطلحات موضوعية: Infectious Diseases, Oncology

    الوصف: Background Respiratory syncytial virus (RSV) is a public health burden; no vaccine is currently available. An mRNA-based RSV vaccine (mRNA-1345) encoding the RSV prefusion stabilized F (preF) glycoprotein is under clinical investigation. Methods A phase 1, randomized, observer-blind, placebo-controlled, dose-ranging study assessed safety and immunogenicity of mRNA-1345 in younger adults (YA; 18-49 years) and older adults (OA; 65-79 years) (NCT04528719). YA and OA were randomized to receive 1 dose of mRNA-1345 (50, 100, or 200 µg) or placebo. Results In all, 74 YA participants (mRNA-1345, n=19-20; placebo, n=15) and 202 OA participants (mRNA-1345, n=47-48; placebo, n=59) received study injections. mRNA-1345 was well-tolerated in both groups, with lower reactogenicity observed in OA vs YA at higher doses. Injection site pain was the most frequent local solicited adverse reaction (SAR, YA: mRNA-1345, 73.7-100%; placebo, 0%; OA: mRNA-1345, 61.7-78.7%; placebo, 12.7% [Fig 1]). Erythema and swelling were less frequent (mRNA-1345: YA, 5.3-15.0%; OA, 0-4.3%; and YA, 5.0-15.0%; OA, 2.1-4.3%; respectively vs placebo 0% for all). Overall, 57.9-100% (YA) and 53.2-78.7% (OA) of mRNA-1345 and 40.0% (YA) and 45.5% (OA) of placebo groups reported ≥ 1 systemic SAR, most commonly headache, fatigue, myalgia, and arthralgia. As expected, neutralizing antibodies (nAbs) were present at baseline (BL; Fig 2); mRNA-1345 significantly boosted antibody titers through month (M) 1 in YA and OA, with comparable immunogenicity observed across age groups. M1 geometric mean fold rise (GMFR) for RSV-A nAbs were 20.0-22.3 (YA) and 12.1-16.6 (OA) and for RSV-B, nAbs were 11.7-14.4 (YA) and 8.7-12.6 (OA). M1 PreF binding antibody (bAb) GMFRs were 16.1-21.7 (YA) and 8.4-12.1 (OA; Fig 3). Peak antibody titers declined through M6, but levels remained ≥ 4.1-fold above BL with minimal dose response. M6 GMFR for RSV-A nAbs were 7.0-9.6 (YA) and 4.1-5.8 (OA) and for RSV-B, nAbs were 5.0-8.9 (YA) and 4.5-5.5 (OA). M6 PreF bAbs GMFR were 5.9-7.0 (YA) and 4.1-4.7 (OA). Antibody decline over time was comparable in YA and OA cohorts. Conclusion mRNA-1345 is well-tolerated in YA and OA. Antibody levels were boosted substantially above BL through M6 in both cohorts. These data support the continued development of mRNA-1345 as an RSV vaccine. Disclosures Grace L. Chen, MD, MPH, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Runa Mithani, PharmD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Archana Kapoor, PhD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Sophia Lu, PhD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Laila El Asmar, PhD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Catherine A. Panozzo, PhD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Christine A. Shaw, PhD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Sonia K. Stoszek, PhD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds Allison August, MD, Moderna, Inc.: Salary|Moderna, Inc.: Stocks/Bonds.

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  10. 10

    المصدر: Pharmacoepidemiology and Drug Safety

    الوصف: Background and purpose The transition from International Classification of Diseases, 9th revision, clinical modification (ICD‐9‐CM) to ICD‐10‐CM poses a challenge to epidemiologic studies that use diagnostic codes to identify health outcomes and covariates. We evaluated coding trends in health outcomes in the US Food and Drug Administration's Sentinel System during the transition. Methods We reviewed all health outcomes coding trends reports on the Sentinel website through November 30, 2019 and analyzed trends in incidence and prevalence across the ICD‐9‐CM and ICD‐10‐CM eras by visual inspection. Results We identified 78 unique health outcomes (22 acute, 32 chronic, and 24 acute or chronic) and 140 time‐series graphs of incidence and prevalence. The reports also included code lists and code mapping methods used. Of the 140 graphs reviewed, 81 (57.9%) showed consistent trends across the ICD‐9‐CM and ICD‐10‐CM eras, while 51 (36.4%) and 8 (5.7%) graphs showed inconsistent and uncertain trends, respectively. Chronic HOIs and acute/chronic HOIs had higher proportions of consistent trends in prevalence definitions (83.9% and 78.3%, respectively) than acute HOIs (28.6%). For incidence, 55.6% of acute HOIs showed consistent trends, while 41.2% of chronic HOIs and 39.3% of acute/chronic HOIs showed consistency. Conclusions Researchers using ICD‐10‐CM algorithms obtained by standardized mappings from ICD‐9‐CM algorithms should assess the mapping performance before use. The Sentinel reports provide a valuable resource for researchers who need to develop and assess mapping strategies. The reports could benefit from additional information about the algorithm selection process and additional details on monthly incidence and prevalence rates. Key points We reviewed health outcomes coding trends reports on the US FDA Sentinel website through November 30, 2019 and analyzed trends in incidence and prevalence across the International Classification of Diseases, 9th revision, Clinical Modification (ICD‐9‐CM) and ICD‐10‐CM eras by code mapping method and the type of health outcomes of interest (acute, chronic, acute or chronic).More than a third of the 140 time‐series graphs of incidence and prevalence of health outcomes showed inconsistent or uncertain trends. Consistency in trends varied by code mapping method, type of health outcomes of interest, and whether the measurement was incidence or prevalence.Studies using ICD‐9‐CM‐based algorithms mapped to ICD‐10‐CM codes need to assess the performance of the mappings and conduct manual refinement of the algorithms as needed before using them.