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To estimate the economic burden of varicella among children in France from family and societal perspectives. We conducted an online cross-sectional survey of caregivers of 185 French children (≤ 17 years) diagnosed with varicella in the previous six weeks. Data collected included varicella-related healthcare resource use, out-of-pocket costs, missed school days, and workdays missed by either parents or other caregivers. Mean and median direct and indirect costs (2022 Euros) were calculated using survey data and published literature. The annual societal burden of pediatric varicella in France was estimated. Of the 185 children, 95.1% had ≥ 1 outpatient visit, 10.3% had ≥ 1 emergency room visit, and 2.2% were hospitalized. The median [interquartile range, IQR] number of outpatient visits/child was 1.0 [1.0 – 2.0]. The median length of hospital stay among those hospitalized (n = 4) was 5.0 [3.5 – 6.5] days. Caregivers of 185 children missed a median of 2.0 [0 – 5.0] workdays; 113 families (61.1%) had ≥ 1 parent miss work. A median of 5.0 [3.0 – 7.0] school days were missed by 170 children who attended preschool or school. The median direct out-of-pocket cost to the family was €30.0 [€17.0 – €60.0]. The median [IQR] societal costs per varicella case were €455.2 [€70.5 – €1013.5]; the median [IQR] direct and indirect costs per child were €60.8 [€39.0 – €102.7] and €364.7 [€0.0 – €911.7] respectively. The annual societal burden of varicella among children in France was estimated to be €450,427,578 (95% CI: €357,144,618 – €543,710,538), with indirect costs accounting for 85%. Conclusions: A substantial economic burden is associated with pediatric varicella in France, primarily due to the productivity loss among caregivers. What is Known: • Although varicella is considered a mild disease, it poses a significant burden on caregivers and society. Our study aimed to estimate the economic burden of varicella among children in France from family and societal perspectives to support policymakers in understanding the value of UVV in France. What is New: • We conducted an online survey of caregivers of 185 French children (≤17 years) diagnosed with varicella and collected data on varicella-related healthcare resource use, missed school days and workdays. Our study estimated annual societal burden of pediatric varicella in France. Out of 185 children with varicella, most (95.1%) had at least one outpatient visit, 10.3% had at least one emergency room visit, and 2.2% were hospitalized. 61.1% of parents with sick child, missed work and median productivity loss was 2.0 workdays. Additionally, 170 children who attended school or preschool missed a median of 5.0 school days. • The societal burden of pediatric varicella in France was estimated to be €450,427,578 (95% CI, €357,144,618 - €543,710,538), with indirect costs accounting for 85%. Pediatric varicella is associated with a substantial economic burden in France, primarily due to high productivity losses among parents and caregivers. [ABSTRACT FROM AUTHOR]

To understand the preferences of healthcare providers (HCPs) in Switzerland for pediatric hexavalent vaccine attributes. A discrete-choice experiment included a series of choices between 2 hypothetical pediatric hexavalent vaccines with varying attributes: device type (including preparation time and risk of dosage errors), proportion of infants seroprotected against Haemophilus influenzae type b (Hib) at 11–12 months (pre-booster), packaging size, years on the market, and the thermostability at room temperature. Odds ratios (ORs) and conditional relative attribute importance (CRAI) were calculated using random-parameters logit. HCPs (150 pediatricians and 40 nursing staff) in Switzerland were unlikely to choose a vaccine conferring 50% (OR 0.00; 95% CI 0.00–0.00) or 70% (OR 0.01; 95% CI 0.00–0.01) of infants with Hib seroprotection at 11-12 months (pre-booster) compared with a vaccine conferring 90% seroprotection. The odds of choosing a vaccine available on the market for more than 3 years were nearly 5 times the odds of choosing a vaccine available on the market for less than 1 year (OR 4.76; 95% CI 1.87–7.65). The odds of choosing a vaccine in a prefilled syringe were nearly 3 times the odds of choosing a reconstituted vaccine (OR 2.77; 95% CI 1.39–4.15), and the odds of choosing a vaccine with a smaller package size were nearly 2 times the odds of choosing a vaccine with larger package size (OR 1.89; 95% CI 1.23–2.55). HCPs were equally likely to choose vaccines that can stay at room temperature for 6 versus 3 days (OR 1.07; 95% CI 0.73–1.42). According to CRAI, the most important attribute was Hib seroprotection, followed by years on the market, device type, and packaging size. Hib seroprotection at 11–12 months was the most important hexavalent vaccine attribute to HCPs in this study. [ABSTRACT FROM AUTHOR]

To understand physician preferences for various attributes of pediatric combination vaccines. An online survey was completed by 400 US physicians (pediatricians and family physicians) who routinely administer vaccines to infants aged 1–12 months in outpatient settings. Respondents completed a discrete choice experiment (DCE) by selecting their preferred options from different hypothetical vaccine profiles with systematic variation in the levels of five attributes: vaccine presentation, number of injections administered at a single visit, completion rates, timeliness rates (within 30 days of recommended age), and years of availability for routine use, assuming similar cost, safety, and efficacy. Odds ratios and relative attribute importance scores were estimated using a random parameters logit model. Physicians (mean age 50.4 years, 52.5% women) preferred combination vaccines that reduced the number of injections administered at a single visit, facilitated higher completion and timeliness rates for the primary DTaP series, were available as a pre-filled syringe rather than a vial needing reconstitution and had been available for routine use for more than 1 year. All odds ratios were statistically significant. Physicians were twice as likely to prefer administering three injections in a single visit instead of four. The most important attribute was the number of injections administered at a single visit (relative importance 38%), followed by timeliness, completion rates, and vaccine presentation; years a vaccine has been available was the least important attribute. US physicians prefer pediatric combination vaccines that enable fewer injections to be administered at a single visit, facilitate higher completion and timeliness rates, are offered as a pre-filled syringe, and have been available for routine use for more than 1 year. The most important attribute of pediatric combination vaccines was a reduction in the number of injections administered at a single visit. [ABSTRACT FROM AUTHOR]

Despite widespread childhood immunization programs, pneumococcal disease (PD) continues to be associated with significant clinical and economic burden worldwide. This retrospective study assessed the PD-related economic burden in children from the Veneto region of Italy following the introduction of a 13-valent pneumococcal conjugate vaccine (PCV13) to the Italian immunization schedule in 2010. Between 2010 and 2017, the annual incidences of pneumonia, acute otitis media (AOM), and invasive pneumococcal disease (IPD), as well as syndromic-disease-related episodes, declined. In our analysis of data from regional expenditure and healthcare resource utilization (HCRU) databases related to children < 15 years of age, we found that regional expenditures decreased between 2010 and 2017 for pneumonia (EUR 8.88 to EUR 3.59 million), AOM (EUR 3.78 to EUR 2.76 million), and IPD (EUR 1.40 to EUR 1.00 million). Despite reductions in PD-related expenditure following the introduction of PCV13, there continues to be an economic burden associated with PD in Veneto, Italy. [ABSTRACT FROM AUTHOR]

Universal varicella vaccination (UVV) in England and Wales has been hindered by its potential impact on exogenous boosting and increase in herpes zoster (HZ) incidence. We projected the impact of ten UVV strategies in England and Wales on the incidence of varicella and HZ and evaluated their cost-effectiveness over 50 years. The Maternal-Susceptible-Exposed-Infected-Recovered-Vaccinated transmission model was extended in a dynamically changing, age-structured population. Our model estimated that one- or two-dose UVV strategies significantly reduced varicella incidence (70–92%), hospitalizations (70–90%), and mortality (16–41%) over 50 years. A small rise in HZ cases was projected with UVV, peaking 22 years after introduction at 5.3–7.1% above pre-UVV rates. Subsequently, HZ incidence steadily decreased, falling 12.2–14.1% below pre-UVV rates after 50 years. At a willingness-to-pay threshold of 20,000 GBP/QALY, each UVV strategy was cost-effective versus no UVV. Frontier analysis showed that one-dose UVV with MMRV-MSD administered at 18 months is the only cost-effective strategy compared to other strategies. HZ incidence varied under alternative exogenous boosting assumptions, but most UVV strategies remained cost-effective. HZ vaccination decreased HZ incidence with minimal impact on the cost-effectiveness. Introducing a UVV program would significantly reduce the clinical burden of varicella and be cost-effective versus no UVV after accounting for the impact on HZ incidence. [ABSTRACT FROM AUTHOR]

Despite advances in preventative interventions, invasive pneumococcal disease and pneumonia cause significant morbidity and mortality in children. We studied the annual incidence of pneumococcal-specific and syndromic invasive disease and non-invasive pneumonia in children <15 years of age during the early (2010–2013) and late (2014–2017) 13-valent pneumococcal conjugate vaccine (PCV13) periods in Veneto, Italy. In this retrospective observational study, pneumococcal-specific and syndromic invasive disease and non-invasive pneumonia cases were identified from several sources, including the Pedianet database. Interrupted time series analysis and Mann–Kendall tests were conducted to explore trends in incidence rates (IRs). Among 72,570 patients <15 years of age between 2010–2017, 88 episodes of pneumococcal-specific and syndromic invasive disease and 3926 episodes of non-invasive pneumonia were reported. Overall IR of pneumococcal-specific and syndromic invasive disease was 0.4/1000 person-years and did not change significantly (p = 0.46) throughout the study. Overall IR of non-invasive pneumonia was 10/1000 person-years and decreased significantly (−0.64, p = 0.026) over the study period. Following PCV13 introduction, the IRs of non-invasive pneumonia in children <15 years of age declined significantly, with no significant change in the IRs of pneumococcal-specific and syndromic invasive disease. There is a continuing clinical burden associated with pediatric pneumococcal diseases in Veneto, Italy. [ABSTRACT FROM AUTHOR]

Background: Acute otitis media (AOM) remains a common infection in children despite the introduction of pneumococcal conjugate vaccines. This study estimated AOM incidence rates (IRs) over time in children < 16 years old in Germany following PCV13 introduction.Methods: AOM episodes were identified in the InGef healthcare claims database from 2014-2019 in children aged < 16 years. Each AOM episode was classified as either simple or recurrent. Recurrent AOM was defined as 3 or more episodes identified within a 6-month period; or 4 or more episodes within a 12-month period with at least one episode in the prior 6 months. AOM-related surgical procedures within 12 months and complications within 21 days of an AOM episode were also identified. Annual IRs were calculated as number of episodes/child-years (CY) at risk. 95% Confidence intervals (95%CI) were calculated using the Wilson method. The Mann-Kendall test was used to assess trends over time.Results: Between 2014 and 2019, the study population comprised 916,805 children with 327,726 AOM episodes, of which 15% (49,011) of all episodes were identified as recurrent AOM and 85% (278,715) as simple AOM. There were significant declines in AOM (p = 0.003) in the study population overall and in all age groups over the study period; from 101 (95%CI 101-102)/1000 CY to 79 (95%CI 78-80)/1000 CY in the total study population, from 209 (95%CI 206-212)/1000 CY to 147 (95%CI 145-150)/1000 CY in < 2-year-olds, from 239 (95%CI 237-242) to 179 (95%CI 177-182)/1000 CY in 2-4-year-olds, and from 50 (95%CI 49-50) to 38 (95%CI 37-39)/1000 CY in 5-15-year-olds. No significant trends were identified for AOM-related surgical procedures over the study period; however, AOM-related complications overall increased (p = 0.003).Conclusion: Between 2014 and 2019, AOM incidence overall declined in children aged 0-15 years in Germany. Over the study period, the incidence of complicated AOM cases increased, however the incidence of AOM-related surgical procedures remained constant. Despite the impact of PCV13, the burden associated with AOM in Germany remains substantial. [ABSTRACT FROM AUTHOR]

This study aimed to assess trends in the incidence of acute otitis media (AOM), a common childhood condition, following the introduction of the 13-valent pneumococcal conjugate vaccine (PCV13) in the Veneto region of Italy in 2010. AOM episodes (overall, simple, and recurrent (≥3 or ≥4 episodes in 6 or 12 months, respectively, with ≥1 episode in the preceding 6 months)) in children <15 years of age were identified in Pedianet from 2010–2017. Interrupted time series analyses were conducted to assess changes in the annual incidence rates (IRs) in early (2010–2013) and late (2014–2017) PCV13 periods. In total, 72,570 children (402,868 person-years) were identified; 21,048 had 41,683 AOM episodes. Mean annual AOM IR was 103/1000 person-years (95% confidence interval: 102–104), decreasing from 126 to 79/1000 person-years. AOM IRs were highest in children 2–4 years of age, followed by <2 and 5–14 years of age. Overall and simple AOM IRs decreased among children 0–14 years of age, including 2–4 and 5–14 years of age, while recurrent AOM IRs decreased in children <2 years of age. Following PCV13 introduction, AOM IRs decreased substantially in children <15 years of age, with the greatest benefit observed in older children, driven by a reduction in simple AOM IRs. AOM disease burden remains substantial. [ABSTRACT FROM AUTHOR]

Aims: V114, a 15-valent pneumococcal conjugate vaccine (PCV15) currently approved in adults in the US, contains the 13 S. pneumoniae serotypes in PCV13 and two additional serotypes, 22 F and 33 F, which are important contributors to residual PD. This study quantified the health and economic burden of pediatric invasive pneumococcal disease (IPD) associated with V114 serotypes in eight countries in Europe. Materials and methods: A Markov model estimated V114-type IPD cases and costs in hypothetical unvaccinated birth cohorts from Denmark, France, Germany, Italy, Norway, Spain, Switzerland, and the UK over 20 years. Inputs were obtained from published literature. IPD cases and costs were calculated for three time periods using time-specific epidemiological data: (a) pre-PCV7; (b) pre-PCV13; and (c) post-PCV13. Costs were estimated from a societal perspective (2018 Euros) and discounted at 3%. Results: The model estimated that 4,649 IPD cases in the pre-PCV7 period, 3,248 cases in the pre-PCV13 period, and 958 cases in the post-PCV13 period were attributable to V114 serotypes. Total discounted costs associated with V114 serotypes were e109.1 million (pre-PCV7 period), e65.7 million (pre-PCV13 period), and e18.7 million (post-PCV13 period). Limitations: Post-meningitis sequelae, acute otitis media, and non-bacteremic pneumonia were not considered. Direct non-medical costs were not included. Conclusions on effectiveness of V114 or added value over existing infant vaccination programs cannot be drawn. Conclusions: IPD cases and costs were estimated in hypothetical birth cohorts in eight European countries followed for 20 years during three time periods. Serotypes included in V114 were associated with significant morbidity and costs in pre-PCV7, pre-PCV13, and post-PCV13 periods. Future pediatric pneumococcal vaccines should maintain protection against serotypes in licensed vaccines while extending coverage to additional serotypes to ensure reductions in IPD burden are maintained. [ABSTRACT FROM AUTHOR]

Although the incidence of invasive pneumococcal disease (IPD) and acute otitis media (AOM) in young children has decreased since the introduction of pneumococcal conjugate vaccines (PCVs), the subsequent emergence of non-vaccine Streptococcus pneumoniae serotypes and the persistence of certain vaccine serotypes both contribute to substantial residual pneumococcal disease. There is a need for the development of new pneumococcal vaccines to address the clinical and economic burden presented by emerging non-vaccine serotypes, while maintaining suppression of serotypes in existing vaccines. To assess the full value of next-generation vaccines, public health evaluations must consider epidemiological and economic data across all vaccine serotypes, including those included in existing vaccines and those unique to the new product. This is supported by two recent analyses that estimated the health and economic burden of IPD (in the United States and Europe) and AOM (in the United States only) associated with the serotypes in V114, a 15-valent pneumococcal conjugate vaccine (PCV15), which contains all serotypes in the licensed 13-valent pneumococcal conjugate vaccine (PCV13) as well as the unique serotypes 22 F and 33 F and was recently approved for use in adults in the US. The analyses demonstrated considerable health and economic burden associated with PCV13 serotypes, as well as increasing burden associated with serotypes 22 F and 33 F. In addition to addressing the burden of non-vaccine serotypes, ability to maintain or improve protection against disease caused by serotypes in existing vaccines will be an important consideration for decision makers. [ABSTRACT FROM AUTHOR]

Background: The World Health Organization (WHO)-defined radiological pneumonia is a preferred endpoint in pneumococcal vaccine efficacy and effectiveness studies in children. Automating the WHO methodology may support more widespread application of this endpoint. Methods: We trained a deep learning model to classify pneumonia CXRs in children using the World Health Organization (WHO)'s standardized methodology. The model was pretrained on CheXpert, a dataset containing 224,316 adult CXRs, and fine-tuned on PERCH, a pediatric dataset containing 4,172 CXRs. The model was then tested on two pediatric CXR datasets released by WHO. We also compared the model's performance to that of radiologists and pediatricians. Results: The average area under the receiver operating characteristic curve (AUC) for primary endpoint pneumonia (PEP) across 10-fold validation of PERCH images was 0.928; average AUC after testing on WHO images was 0.977. The model's classification performance was better on test images with high inter-observer agreement; however, the model still outperformed human assessments in AUC and precision-recall spaces on low agreement images. Conclusion: A deep learning model can classify pneumonia CXR images in children at a performance comparable to human readers. Our method lays a strong foundation for the potential inclusion of computer-aided readings of pediatric CXRs in vaccine trials and epidemiology studies. [ABSTRACT FROM AUTHOR]

V114, a 15-valent pneumococcal conjugate vaccine (PCV15) currently approved in adults in the US, contains the 13 S. pneumoniae serotypes in PCV13 and two additional serotypes, 22 F and 33 F, which are important contributors to residual PD. This study quantified the health and economic burden of pediatric invasive pneumococcal disease (IPD) associated with V114 serotypes in eight countries in Europe. A Markov model estimated V114-type IPD cases and costs in hypothetical unvaccinated birth cohorts from Denmark, France, Germany, Italy, Norway, Spain, Switzerland, and the UK over 20 years. Inputs were obtained from published literature. IPD cases and costs were calculated for three time periods using time-specific epidemiological data: (a) pre-PCV7; (b) pre-PCV13; and (c) post-PCV13. Costs were estimated from a societal perspective (2018 Euros) and discounted at 3%. The model estimated that 4,649 IPD cases in the pre-PCV7 period, 3,248 cases in the pre-PCV13 period, and 958 cases in the post-PCV13 period were attributable to V114 serotypes. Total discounted costs associated with V114 serotypes were €109.1 million (pre-PCV7 period), €65.7 million (pre-PCV13 period), and €18.7 million (post-PCV13 period). Post-meningitis sequelae, acute otitis media, and non-bacteremic pneumonia were not considered. Direct non-medical costs were not included. Conclusions on effectiveness of V114 or added value over existing infant vaccination programs cannot be drawn. IPD cases and costs were estimated in hypothetical birth cohorts in eight European countries followed for 20 years during three time periods. Serotypes included in V114 were associated with significant morbidity and costs in pre-PCV7, pre-PCV13, and post-PCV13 periods. Future pediatric pneumococcal vaccines should maintain protection against serotypes in licensed vaccines while extending coverage to additional serotypes to ensure reductions in IPD burden are maintained. [ABSTRACT FROM AUTHOR]

Although the incidence of invasive pneumococcal disease (IPD) and acute otitis media (AOM) in young children has decreased since the introduction of pneumococcal conjugate vaccines (PCVs), the subsequent emergence of non-vaccine Streptococcus pneumoniae serotypes and the persistence of certain vaccine serotypes both contribute to substantial residual pneumococcal disease. There is a need for the development of new pneumococcal vaccines to address the clinical and economic burden presented by emerging non-vaccine serotypes, while maintaining suppression of serotypes in existing vaccines. To assess the full value of next-generation vaccines, public health evaluations must consider epidemiological and economic data across all vaccine serotypes, including those included in existing vaccines and those unique to the new product. This is supported by two recent analyses that estimated the health and economic burden of IPD (in the United States and Europe) and AOM (in the United States only) associated with the serotypes in V114, a 15-valent pneumococcal conjugate vaccine (PCV15), which contains all serotypes in the licensed 13-valent pneumococcal conjugate vaccine (PCV13) as well as the unique serotypes 22 F and 33 F and was recently approved for use in adults in the US. The analyses demonstrated considerable health and economic burden associated with PCV13 serotypes, as well as increasing burden associated with serotypes 22 F and 33 F. In addition to addressing the burden of non-vaccine serotypes, ability to maintain or improve protection against disease caused by serotypes in existing vaccines will be an important consideration for decision makers. [ABSTRACT FROM AUTHOR]

Objective: The comparative effectiveness of low-dose budesonide inhalation suspension (BIS) versus oral montelukast (MON) in managing asthma control among children with mild asthma was assessed in Korea. Methods: Claims from Korea's national health insurance database for children (2–17 years) with mild asthma (GINA 1 or 2) who initiated BIS or MON during 2015 were retrospectively analyzed. Pre- and post-index windows were 1 year each. Adherence, persistency, asthma control, asthma-related health-care resource utilization, and costs were evaluated using unadjusted descriptive statistics and propensity score-matched regression analyses. Results: The number of children identified was 26,052 for unmatched (n = 1,221 BIS; n = 24,831 MON) and 2,290 for matched populations (n = 1,145 per cohort). Medication adherence, measured by proportion of days covered, was low for both cohorts but significantly higher for MON versus BIS (13.8% vs. 4.5%; p <.001). Time to loss of persistency was longer for MON versus BIS (82.3 vs. 78.4 days, respectively; p <.001). Mean number of post-index asthma-related office visits was 6.6 for BIS versus 8.3 for MON (p <.001). However, a greater proportion of patients in the BIS cohort had an asthma exacerbation-related office visit than the MON cohort (78.3% vs. 56.1%; p <.001). Asthma-related total health-care costs were higher with MON versus BIS (₩ 190,185 vs. ₩ 167,432, respectively; p <.001), likely driven by higher pharmaceutical costs associated with MON (₩ 69,113 vs. ₩ 49,225; p <.001). Conclusions: Montelukast patients had better adherence, a longer time to loss of persistency, and were less likely to experience an exacerbation-related office visit in the post-index period than BIS patients. [ABSTRACT FROM AUTHOR]

V114 is an investigational 15-valent pneumococcal conjugate vaccine (PCV) containing the 13 Streptococcus pneumoniae serotypes in 13-valent PCV (PCV13) plus two additional serotypes. This study quantified the health and economic burden of invasive pneumococcal disease (IPD) and acute otitis media (AOM) caused by V114 types among children in the United States. A Markov model estimated the number of V114-type IPD and AOM cases and costs in a hypothetical, unvaccinated US birth cohort over 20 years. Three time periods were analyzed using time-specific epidemiological data to determine the number of IPD and AOM cases associated with all 15 serotypes in V114. The time periods were: (1) pre-PCV7 (1999); (2) pre-PCV13 (2009); (3) post-PCV13 (2017). Costs were estimated from a societal perspective (2018 US dollars) and discounted at 3%. The model estimated 18,983 IPD cases and 5.4 million AOM cases associated with V114 serotypes pre-PCV7, 4,697 IPD cases and 3.0 million AOM cases pre-PCV13, and 948 IPD cases and 0.2 million AOM cases post-PCV13. Total discounted costs associated with V114 serotypes were $1.7 billion pre-PCV7, $730 million pre-PCV13, and $75 million US dollars post-PCV13. Post-meningitis sequelae, cases of non-bacteremic pneumonia, and direct non-medical costs were not included. IPD and AOM cases and costs were estimated in a hypothetical US birth cohort followed for 20 years at three time periods. In all three periods, the serotypes targeted by V114 contributed to significant morbidity and costs. New pediatric pneumococcal vaccines must continue to retain serotypes in licensed vaccines to maintain disease reduction while extending coverage to non-vaccine serotypes. [ABSTRACT FROM AUTHOR]

Objectives The 23-valent pneumococcal polysaccharide vaccine (PPSV23) was included in Japan's national immunisation programme for older adults in 2014. While vaccination coverage has increased following the implementation of the national immunisation programme, little is known about the factors that have influenced changes in PPSV23 uptake in Japan. This study aimed to investigate the effects of municipality-level activities implemented to improve vaccine uptake during the fiscal year 2015 (April 2015-March 2016). Design Community-based national survey. A postal and web-based nationwide survey was sent to all municipalities in Japan in June 2016 (n=1741). The survey included questions regarding PPSV23 coverage, out-of-pocket costs by individuals for vaccination and community-level activities implemented to improve and promote PPSV23 uptake. Municipality-level and prefecture-level variables (eg, unemployment rates, average per capita income) retrieved from published sources were also incorporated to explore the impact of social determinants on vaccine uptake. Setting Japan. Participants Municipal vaccination officers. Primary and secondary outcome measures The primary study outcome was PPSV23 coverage among adults aged 65 years in Japanese municipalities. Results A total of 1010 municipalities (58.0%) responded to the survey. The median PPSV23 coverage among responding municipalities was 41.8%. Vaccine coverage increased by 18.7% (16.7%-20.7%)%) in municipalities that sent a direct mail notification to the target population of adults compared with municipalities that did not send any notification. Vaccine coverage decreased by 3.02% (2.4%-3.6%)%) for every 1000 JPY increase in out-ofpocket costs. Municipality-level unemployment rates and average per capita income were negatively associated with PPSV23 coverage. Conclusions This nationwide survey provides insight into factors that may influence PPSV23 coverage in Japanese municipalities. Reduced out-of-pocket costs and direct mail notifications to the target population were associated with higher PPSV23 coverage in Japanese municipalities. [ABSTRACT FROM AUTHOR]

Objectives To quantify the risk of pneumococcal pneumonia (PP) and invasive pneumococcal disease (IPD) in adults aged =19 years with underlying medical conditions compared with healthy adults of the same age in Japan. Design An observational, retrospective, cohort study using two healthcare claims databases in Japan: Japan Medical Data Center (JMDC) and Medical Data Vision (MDV) databases. Participants A total of 10.4 million individuals, representing 9.3 million person-years of follow-up, were included in the analysis. Eleven medical conditions as well as PP and IPD were identified by the International Statistical Classification of Diseases and Related Health Problems version 10 diagnostic codes and/or local disease codes used in Japan. Primary outcome measures Adjusted rate ratios (RRs) for PP and IPD in adults with a medical condition versus adults without any medical condition were calculated using multivariate Poisson regression models with age and/or sex as covariates. Results In the JMDC and MDV databases, respectively, adults =19 years with a medical condition (RRs for PP: 3.3 to 13.4, 1.7 to 5.2; RRs for IPD: 12.6 to 43.3, 4.4 to 7.1), adults with two or more medical conditions (PP: 11.6, 2.8; IPD: 18.7, 5.8) and high-risk adults (PP: 12.9, 1.8; IPD: 29.7, 4.0) were at greater risk of PP and IPD compared with their healthy counterparts. Adults aged 50-64 years with an underlying medical condition (PP rate: 38.6 to 212.1 per 100 000 person-years) had a higher rate of PP than those aged =65 years without any condition (PP rate: 13.2 to 93.0 per 100 000 person-years). Conclusions Adults of all ages with an underlying medical condition are at greater risk of PP and IPD compared with adults without any medical condition. This risk increases with the number of underlying medical conditions. Our results support extending pneumococcal vaccination to younger adults with an underlying medical condition, especially those aged 50-64 years. [ABSTRACT FROM AUTHOR]

Objective: Orally disintegrating tablets (ODTs) offer a valuable treatment option, particularly when swallowing solid tablets with water is difficult or inconvenient. Montelukast is an effective treatment for asthma and allergic rhinitis (AR), and an ODT formulation became available in Japan in 2015. This study investigated levels of satisfaction with this new formulation among adults with asthma and/or AR in Japan.Methods: Patients aged 20 years or older who were refilling a prescription for montelukast ODT in pharmacies across Japan completed questions on satisfaction with key features of montelukast ODT and the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). Study variables were analyzed descriptively. Factors associated with TSQM-9 global satisfaction and convenience domain scores were examined using analysis of covariance.Results: Of the 201 patients who participated, 89.6% reported overall satisfaction with montelukast ODT. Overall satisfaction was highest in patients with AR only (94.7% satisfied) or with asthma and AR (90.2% satisfied), and in patients with treatment duration <4 weeks (98.5% satisfied). Mean TSQM-9 global satisfaction and convenience domain scores were 58.9 and 66.7, respectively; scores were higher for patients with both asthma and AR and for those with longer disease duration. Overall ease of taking and dissolving speed were most closely associated with TSQM-9 global satisfaction scores, and ability to take without water and taste were most closely associated with TSQM-9 convenience scores.Limitations: The generalizability of the findings was limited by the convenience sample and the descriptive, single-arm study design. The study was limited to adults with asthma and/or AR.Conclusion: Montelukast ODT may be an acceptable dosage formulation for adults with mild-to-moderate asthma and/or AR in Japan. Satisfaction was high, particularly with respect to tablet size, dissolving speed, taste, and ease of taking. [ABSTRACT FROM AUTHOR]

Background: Acute otitis media (AOM) is a leading cause of office visits and antibiotic prescriptions in children. Pneumococcal conjugate vaccines were introduced in the USA in 2000 (7-valent, PCV7) and 2010 (13-valent, PCV13). Expanded valency PCVs are currently under development. To describe the impact of PCVs and quantify the residual burden of AOM, this study estimated annual incidence rates (IRs) of AOM and AOM-related complications and surgical procedures in children < 18 years in the USA before and after the introduction of PCV7 and PCV13.Methods: AOM episodes were identified in the IBM MarketScan® Commercial and Medicaid databases using diagnosis codes (ICD-9-CM: 382.x; ICD-10-CM: H66.xx and H67.xx). Annual IRs were calculated as the number of episodes per 1000 person-years (PYs) for all children < 18 years and by age group (< 2, 2-4, and 5-17 years). National estimates of annual AOM IRs were extrapolated using Census Bureau data. Interrupted time series analyses were used to assess immediate and gradual changes in monthly AOM IRs, controlling for seasonality.Results: In the commercially insured population, AOM IRs declined between the pre-PCV7 period (1998-1999) and the late PCV13 period (2014-2018) from 1170.1 to 768.8 episodes per 1000 PY for children < 2 years, from 547.4 to 410.3 episodes per 1000 PY in children 2-4 years, and from 115.6 to 91.8 episodes per 1000 PY in children 5-17 years. The interrupted time series analyses indicated significant immediate or gradual decreases in the early PCV7 period (2001-2005), and gradual increases in the late PCV7 period (2006-2009) in children < 2 years; however, crude IRs trended downward in all time periods. In older children, IRs decreased in the early PCV7 and early PCV13 period (2011-2013), but gradually increased in the late PCV7 period. IRs of AOM-related surgical procedures decreased, and IRs of AOM-related complications increased during the study timeframe.Conclusions: AOM disease burden remains high in children of all ages despite overall reductions in AOM IRs during 1998-2018 following the introduction of PCV7 and PCV13. The impact of investigational PCVs on the disease burden of AOM will likely depend on AOM etiology and circulating pneumococcal serotypes. [ABSTRACT FROM AUTHOR]

Background: Despite the high burden of pneumococcal disease, pneumococcal vaccine coverage continues to fall short of Healthy People 2020 goals. A quasi-experimental design was used to investigate the impact of pneumococcal-specific best-practice alerts (BPAs) with and without workflow redesign compared to health maintenance notifications only, on pneumococcal vaccination rates in at-risk and high-risk adults, and on series completion in immunocompetent adults aged 65+ years.Methods: This retrospective study used electronic health record and administrative data to identify pneumococcal vaccinations using cross sectional and historical cohorts of adults age 19+ years from 2013 to 2017 who attended clinics associated with the University of Utah Health. Difference-in-differences (DD) analyses was used to assess the impact of interventions across three observation periods (Baseline, Interim, and Follow Up). Adherence to the 2-dose vaccination schedule in older adults was measured through a longitudinal analysis.Results: In DD analyses, implementing both workflow redesign and the BPA raised the vaccination rate by 8 percentage points (pp) (P < 0.001) and implementing the BPA only raised the rate by 7 pp. (P < 0.001) among at-risk adults age 19-64 years, relative to implementing health maintenance notifications (i.e., usual care) only in comparison clinics. In high-risk adults age 19-64 years, the BPA with or without workflow redesign did not significantly affect vaccination rates from baseline to follow up relative to health maintenance notifications. Per DD analyses, the effect of the BPA was mixed in immunocompetent and immunocompromised adults age 65+ years. However, immunocompetent older adults attending a clinic that implemented the BPA plus health maintenance notifications and workflow redesign (all 3 interventions) had 1.94 times higher odds (Odds ratio (OR) 1.94; P = 0.0003, 95% CI 1.24, 3.01) to receive the second pneumococcal dose than patients attending a usual practice clinic (i.e., no intervention).Conclusions: A pneumococcal BPA tool that reflects current guidelines implemented with and without workflow redesign improved vaccination rates for at-risk adults age 19-64 years and increased the likelihood of adults aged 65+ to complete the recommended 2-dose series. However, in other adult patient groups, the BPA was not consistently associated with improvements in pneumococcal vaccination rates. [ABSTRACT FROM AUTHOR]

Background: Despite the widespread availability of pneumococcal vaccines, rates of pneumococcal disease are disproportionately high in adults with chronic and immunocompromising conditions. This study investigated pneumococcal disease rates and associated resource utilization and costs in this group.Methods: A retrospective, observational study was conducted using the Truven Health MarketScan® Commercial Claims and Encounters database. The study population was adults aged 19-64 years with continuous health plan enrollment for at least one year before and at least one day after January 1st 2012, 2013 and/or 2014. Medical conditions were identified using ICD-9-CM diagnosis codes and grouped into at-risk (chronic) and high-risk (immunocompromising) conditions. Pneumococcal disease was stratified into all-cause pneumonia (ACP) and invasive pneumococcal disease (IPD).Results: Thirty-six million adults aged 19-64 years were included in the study. 17% had a condition that put them at increased risk for pneumococcal disease. Rates of ACP and IPD in adults with at-risk conditions were 3.6 and 4.6 times the rate in healthy adults, respectively, and 5.3 and 10.5 for adults with high-risk conditions. Risk was particularly high in adults with ≥2 medical conditions: rates of ACP and IPD were 8.1 and 10.6 times higher in adults with at-risk conditions than healthy adults and 6.3 and 13.4 times higher in adults with high-risk conditions, respectively. Resource use and costs were substantially higher per episode of ACP in at-risk and high-risk adults, with costs reaching $6,534 and $9,168, compared to $4,725 for healthy adults.Conclusions: Pneumococcal disease rates in at-risk and high-risk adults are significantly higher than healthy adults leading to substantial economic burden. [ABSTRACT FROM AUTHOR]