Vaccine-Preventable Disease Incidence Based on Clinically, Radiologically, and Etiologically Confirmed Outcomes: Systematic Literature Review and Re-analysis of Pneumococcal Conjugate Vaccine Efficacy Trials.

BACKGROUND: Vaccine regulatory decision making is based on vaccine efficacy against etiologically confirmed outcomes, which may underestimate the preventable disease burden. To quantify this underestimation, we compared vaccine-preventable disease incidence (VPDI) of clinically defined outcomes with radiologically/etiologically confirmed outcomes. METHODS: We performed a systematic review of efficacy trials for several vaccines (1997-2019) and report results for pneumococcal conjugate vaccines. Data were extracted for outcomes within a clinical syndrome, organized from most sensitive to most specific. VPDI was determined for each outcome, and VPDI ratios were calculated, with a clinically defined outcome (numerator) and a radiologically/etiologically confirmed outcome (denominator). RESULTS: Among 9 studies, we calculated 27 VPDI ratios; 24 had a value >1. Among children, VPDI ratios for clinically defined versus vaccine serotype otitis media were 0.6 (95% CI not calculable), 2.1 (1.5-3.0), and 3.7 (1.0-10.2); the VPDI ratios comparing clinically defined with radiologically confirmed pneumonia ranged from not calculable to 2.7 (1.2-10.4); the VPDI ratio comparing clinically suspected invasive pneumococcal disease (IPD) with laboratory-confirmed IPD was 3.8 (95% CI not calculable). Among adults, the ratio comparing clinically defined with radiologically confirmed pneumonia was 1.9 (-6.0 to 9.1) and with vaccine serotype-confirmed pneumonia was 2.9 (.5-7.8). CONCLUSIONS: While there is substantial uncertainty around individual point estimates, there is a consistent trend in VPDI ratios, most commonly showing under-ascertainment of 1.5- to 4-fold, indicating that use of clinically defined outcomes is likely to provide a more accurate estimate of a pneumococcal conjugate vaccine's public health value.

One-Year Quality of Life Post-Pneumonia Diagnosis in Japanese Adults.

BACKGROUND: Pneumonia is a common, serious illness in the elderly, with a poorly characterized long-term impact on health-related quality of life (HRQoL). The Japanese Goto Epidemiology Study is a prospective, active, population-based surveillance study of adults with X-ray/CT scan-confirmed community-onset pneumonia, assessing the HRQoL outcome quality-adjusted life-years (QALYs). We report QALY scores and losses among a subset of participants in this study. METHODS: QALYs were derived from responses to the Japanese version of the EuroQol-5D-5L health-state classification instrument at days 0, 7, 15, 30, 90, 180, and 365 after pneumonia diagnosis from participants enrolled from June 2017 to May 2018. We used patients as their own controls, calculating comparison QALYs by extrapolating EuroQol-5D-5L scores for day -30, accounting for mortality and changes in scores with age. RESULTS: Of 405 participants, 85% were aged ≥65 years, 58% were male, and 69% were hospitalized for clinically and radiologically confirmed pneumonia. Compliance with interviews by patients or proxies was 100%. Adjusted EuroQol-5D-5L scores were 0.759, 0.561, 0.702, and 0.689 at days -30, 0 (diagnosis), 180, and 365, respectively. Average scores at all time points remained below the average day -30 scores (P ≤ .001). Pneumonia resulted in a 1-year adjusted loss of 0.13 QALYs (~47.5 quality-adjusted days) (P < .001). CONCLUSIONS: Substantial QALY losses were observed among Japanese adults following pneumonia diagnosis, and scores had not returned to prediagnosis levels at 1 year postdiagnosis. QALY scores and cumulative losses were comparable to those in US adults with chronic heart failure, stroke, or renal failure.

Effectiveness of 13-Valent Pneumococcal Conjugate Vaccine Against Invasive Disease Caused by Serotype 3 in Children: A Systematic Review and Meta-analysis of Observational Studies.

The 13-valent pneumococcal conjugate vaccine (PCV13) is the only licensed PCV with serotype 3 polysaccharide in its formulation. Postlicensure PCV13 effectiveness studies against serotype 3 invasive pneumococcal disease (IPD) in children have shown inconsistent results.  We performed a systematic review and meta-analysis of observational studies to assess PCV13 vaccine effectiveness (VE) for serotype 3 IPD in children. We systematically searched PubMed, Embase, and the Cochrane library for studies published before 14 August 2017. We identified 4 published studies and 2 conference posters that provided PCV13 VE estimates stratified by serotype. The pooled PCV13 VE against serotype 3 IPD from the random-effects meta-analysis was 63.5% (95% confidence interval [CI], 37.3%-89.7%). A sensitivity analysis including conference posters gave a pooled VE estimate of 72.4% (95% CI, 56.7%-88.0%). The pooled data from case-control studies with similar methodologies and high quality support direct PCV13 protection against serotype 3 IPD in children.

Incidence of skin and soft tissue infections in ambulatory and inpatient settings, 2005-2010.

BACKGROUND: The emergence of community-associated methicillin-resistant S. aureus was associated with dramatically increased skin and soft tissue infection (SSTI) incidence in the first few years of the 21(st) century in the U.S. However, subsequent trends are poorly understood. METHODS: We examined ambulatory and inpatient data of over 48 million persons years aged 0-64 years from the HealthCore Integrated Research Database (HIRD) between 2005 and 2010. Data were extracted from medical, pharmacy, and eligibility databases. We quantified SSTI incidence, type, and complications and comparative incidence trends for urinary tract infections (UTIs) and pneumonia. RESULTS: A total of 2,301,803 SSTIs were identified. Most SSTIs (95 %) were treated in the ambulatory setting and most (60 %) were categorized as abscesses or cellulitis. During the study period, SSTI incidence remained relatively stable from 47.9 (95 % CI: 47.8-48.1) cases/1,000 PY in 2005 to 48.5 cases/1,000 PY (95 % CI: 48.3-48.6) in 2010). Persons aged 45-64 years had the highest incidence of both ambulatory-treated and inpatient-treated SSTIs (51.2 (95 % CI: 51.1-51.3) and 3.87 (95 % CI: 3.84-3.90) cases/1,000 PY, respectively). SSTI complications such as myositis, gangrene, and sepsis occurred in 0.93 % (95 % CI: 0.92-0.94 %) and 16.92 % (95 % CI: 16.87-16.97 %) of ambulatory-treated and inpatient-treated patients, respectively. SSTI incidence was approximately twice that of UTIs and tenfold of that of pneumonia. CONCLUSIONS: Among our large, diverse population of persons less than 65 years, SSTI incidence 2005 through 2010 has remained relatively constant at approximately 4.8 SSTIs per 100 person years, suggesting that previously observed increases in SSTI incidence remain sustained.

Incidence and cost of hospitalizations associated with Staphylococcus aureus skin and soft tissue infections in the United States from 2001 through 2009.

BACKGROUND: The emergence of community-associated methicillin-resistant Staphylococcus aureus (SA) and its role in skin and soft tissue infections (SSTIs) accentuated the role of SA-SSTIs in hospitalizations. METHODS: We used the Nationwide Inpatient Sample and Census Bureau data to quantify population-based incidence and associated cost for SA-SSTI hospitalizations. RESULTS: SA-SSTI associated hospitalizations increased 123% from 160,811 to 358,212 between 2001 and 2009, and they represented an increasing share of SA- hospitalizations (39% to 51%). SA-SSTI incidence (per 100,000 people) doubled from 57 in 2001 to 117 in 2009 (p<0.01). A significant increase was observed in all age groups. Adults aged 75+ years and children 0-17 years experienced the lowest (27%) and highest (305%) incidence increase, respectively. However, the oldest age group still had the highest SA-SSTI hospitalization incidence across all study years. Total annual cost of SA-SSTI hospitalizations also increased and peaked in 2008 at $4.84 billion, a 44% increase from 2001. In 2009, the average associated cost of a SA-SSTI hospitalization was $11,622 (SE=$200). CONCLUSION: There has been an increase in the incidence and associated cost of SA-SSTI hospitalizations in U.S.A. between 2001 and 2009, with the highest incidence increase seen in children 0-17 years. However, the greatest burden was still seen in the population over 75 years. By 2009, SSTI diagnoses were present in about half of all SA-hospitalizations.

Trends and characteristics of culture-confirmed Staphylococcus aureus infections in a large U.S. integrated health care organization.

Infections due to Staphylococcus aureus present a significant health problem in the United States. Between 1990 and 2005, there was a dramatic increase in community-associated methicillin-resistant S. aureus (MRSA), but recent reports suggest that MRSA may be declining. We retrospectively identified S. aureus isolates (n = 133,450) that were obtained from patients in a large integrated health plan between 1 January 1998 and 31 December 2009. Trends over time in MRSA were analyzed, and demographic risk factors for MRSA versus methicillin-susceptible S. aureus (MSSA) were identified. The percentage of S. aureus isolates that were MRSA increased from 9% to 20% between 1998 and 2001 and from 25% to 49% between 2002 and 2005 and decreased from 49% to 43% between 2006 and 2009. The increase in MRSA was seen in blood and in other bacteriological specimens and occurred in all age and race/ethnicity groups, though it was most pronounced in persons aged 18 to <50 years and African-Americans. Hospital onset infections were the most likely to be MRSA (odds ratio [OR], 1.58; confidence interval [CI], 1.46 to 1.70, compared to community-associated cases), but the largest increase in MRSA was in community-associated infections. Isolates from African-Americans (OR, 1.73; CI, 1.64 to 1.82) and Hispanics (OR, 1.11; CI, 1.06 to 1.16) were more likely to be MRSA than those from whites. After substantial increases between 1998 and 2005 in the proportion of S. aureus isolates that were MRSA, the proportion decreased between 2006 and 2009. Hospital onset S. aureus infections are disproportionately MRSA, as are those among African-Americans.

Prevalence and sequence variation of panton-valentine leukocidin in methicillin-resistant and methicillin-susceptible staphylococcus aureus strains in the United States.

Panton-Valentine leukocidin (PVL), encoded by the lukSF-PV genes, is a putative virulence factor and marker for community-associated methicillin-resistant Staphylococcus aureus. Here we report the prevalence of PVL among a representative sample of 1,055 S. aureus infection isolates from the United States and describe the sequence variation of the lukSF-PV genes. We performed multilocus sequence typing (MLST) on all isolates and sequenced fragments of the lukSF-PV genes from a sample of 86 isolates. We assigned isolates to a PVL R or H sequence type based on a polymorphism that results in an amino acid change from arginine (R) to histidine (H). Overall, we found that 36% of S. aureus isolates were positive for lukSF-PV. Among the 86 we typed, we identified 72 R variants and 14 H variants. Among the 47 methicillin-resistance S. aureus (MRSA) isolates, 43 harbored the R variant, and among the 39 methicillin-susceptible S. aureus (MSSA) isolates, 29 harbored the R variant. Almost all (97%) of the R variants were found in MLST clonal complex 8 (CC8), while the H variant was broadly distributed among 6 CCs. Within CC8, all 38 MRSA (USA300) and all 28 MSSA isolates harbored the R variant. Of the 20 isolates from blood and the lower respiratory tract, 19 (95%) harbored the R variant. While the R variant had been linked primarily to USA300 MRSA, we found that all CC8 MSSA isolates also contained the R variant, suggesting that some strains of USA300 may have lost methicillin resistance as an adaptation in the community.

Comorbidities as a driver of the excess costs of community-acquired pneumonia in U.S. commercially-insured working age adults.

BACKGROUND: Adults with certain comorbid conditions have a higher risk of pneumonia than the overall population. If treatment of pneumonia is more costly in certain predictable situations, this would affect the value proposition of populations for pneumonia prevention. We estimate the economic impact of community-acquired pneumonia (CAP) for adults with asthma, diabetes, chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF) in a large U.S. commercially-insured working age population. METHODS: Data sources consisted of 2003 through 2007 Thomson Reuters MarketScan Commercial Claims and Encounters and Thomson Reuters Health Productivity and Management (HPM) databases. Pneumonia episodes and selected comorbidities were identified by ICD-9-CM diagnosis codes. By propensity score matching, controls were identified for pneumonia patients. Excess direct medical costs and excess productivity cost were estimated by generalized linear models (GLM). RESULTS: We identified 402,831 patients with CAP between 2003 through 2007, with 25,560, 32,677, 16,343, and 5,062 episodes occurring in patients with asthma, diabetes, COPD and CHF, respectively. Mean excess costs (and standard error, SE) of CAP were $14,429 (SE=44) overall. Mean excess costs by comorbidity subgroup were lowest for asthma ($13,307 (SE=123)), followed by diabetes ($21,395 (SE=171)) and COPD ($23,493 (SE=197)); mean excess costs were highest for patients with CHF ($34,436 (SE=549)). On average, indirect costs comprised 21% of total excess costs, ranging from 8% for CHF patients to 27% for COPD patients. CONCLUSIONS: Compared to patients without asthma, diabetes, COPD, or CHF, the excess cost of CAP is nearly twice as high for patients with diabetes and COPD and nearly three times as high for patients with CHF. Indirect costs made up a significant but varying portion of excess CAP costs. Returns on prevention of pneumonia would therefore be higher in adults with these comorbidities.

Invasive pneumococcal disease in Canada 2010-2017: The role of current and next-generation higher-valent pneumococcal conjugate vaccines.

BACKGROUND: In 2010-2011, the 13-valent pneumococcal conjugate vaccine (PCV13) replaced the 7- or 10-valent vaccine (PCV7 and PCV10, respectively) in pediatric immunization programs across Canada. For adults aged ≥65 years, the 23-valent pneumococcal polysaccharide vaccine (PPSV23) has been publicly funded for several decades; PCV13 funding was not recommended in this population, partly due to expected ongoing vaccine-serotype disease decline stemming from herd effects of the pediatric program. Higher-valent PCVs (ie, 15- and 20-valent PCVs [PCV15 and PCV20, respectively]) currently in development may become available in Canada in the coming years. METHODS: Using the National Microbiology Laboratory surveillance reports, annual case counts and serotype distribution of invasive pneumococcal disease (IPD) from 2010 to 2017 in Canada were examined to assess the impact of existing programs on PCV13-serotype IPD and determine the proportion of IPD that can potentially be prevented by current and forthcoming higher-valent PCVs. RESULTS: The percentages of PCV13-serotype IPD decreased from 55% [1492/2708] in 2010 to 30% [902/3006] in 2017 in all age groups combined, including a decline from 67% [221/331] to 18% [40/219] in children aged <5 years and from 50% [487/967] to 23% [287/1238] in adults aged ≥65 years. Overall, IPD cases declined mainly before 2014 and have plateaued since then. In 2017, PCV15- and PCV20-serotypes (inclusive of PCV13 serotypes) accounted for 42% and 58% of IPD cases, respectively, in all ages. CONCLUSIONS: In Canada, publicly funded pediatric PCV13 use was associated with large declines in IPD due to vaccine serotypes. Substantial residual PCV13-serotype IPD proportions observed among all ages imply limits to indirect protection afforded by the pediatric PCV13 program at the current uptake level and suggest the adult PPSV23 program alone is insufficient. Higher-valent PCVs have the potential to address a substantial proportion of remaining IPD cases among all age groups.

Hospital discharge diagnosis position: impact on adult pneumonia burden estimates.

OBJECTIVES: Pneumonia hospitalization studies using administrative claims rely on pneumonia coded in the first discharge diagnosis field over pneumonia in any coded field, and few have evaluated disposition following discharge. This study reports the total disease burden and discharge disposition among patients with pneumonia coded in any diagnosis field. STUDY DESIGN: Retrospective database review. METHODS: Data from the 2014 National Inpatient Sample of the Healthcare Cost and Utilization Project, a population-weighted, 20% sample of all US community hospitalizations, were analyzed for all pneumonia hospitalizations in adults aged 18 to 64 years and 65 years or older. Number of hospitalizations, hospital stay length, direct medical costs, in-hospital mortality, patient discharge disposition, illness severity, and likelihood of dying were evaluated based on the diagnosis field of pneumonia as a discharge diagnosis (eg, first, second, third, or further). RESULTS: In 2014, an estimated 2.4 million US adult hospitalizations were associated with pneumonia in any of the discharge diagnosis positions (33%-35% in first, 33%-36% in second, and 29%-34% in further positions). When estimates were based only on hospitalizations with pneumonia in the first diagnosis field, approximately 66% of hospitalizations, 78% of hospital days, 87% of in-hospital deaths, 76% and 73% of transfers to short-term hospitals and skilled nursing facilities, 68% of discharges with home health care services, and 82% of direct medical costs were excluded. CONCLUSIONS: Pneumonia hospitalizations were associated with substantial health care resource utilization and in-hospital mortality. Relying only on pneumonia in the first hospital diagnosis field may potentially underestimate the burden associated with pneumonia hospitalizations.

Streptococcus pneumoniae serotype distribution and antimicrobial nonsusceptibility trends among adults with pneumonia in the United States, 2009‒2017.

Background In the United States, the 13-valent pneumococcal conjugate vaccine has been recommended for children since 2010 and for adults aged ≥65 years since 2014. We assessed S. pneumoniae antimicrobial nonsusceptibility among adults with suspected pneumonia from hospital settings. Methods Isolates were collected from 105 US sites between 2009 and 2017 in the SENTRY Antimicrobial Surveillance Program. Clinical and Laboratory Standards Institute methods were used for susceptibility testing. Serotypes were determined by cpsB sequence obtained by PCR or whole genome sequencing, plus multiplex PCR and/or Neufeld Quellung reactions as needed. Findings Of 7254 S. pneumoniae isolates analyzed, 63.6% and 36.4% were from patients aged 18‒64 and ≥65 years, respectively. Among all isolates, penicillin and ceftriaxone nonsusceptibility declined by 72.3% and 73.8%, respectively, with smaller changes observed for other antibiotics. Nonsusceptibility patterns were serotype-specific; for example, nonsusceptibility was relatively stable for serotype 19A but declined for 19F. Simultaneously, the percentage of serotype 19A isolates decreased from 17.4% to 3.9%, whereas for serotype 19F this percentage increased from 2.8% to 5.0%. The percentage of serotype 3 isolates that were nonsusceptible increased for select antibiotic classes, and the percentage of serotype 3 among all isolates increased minimally from 10.2% to 11.8%. Interpretation Overall pneumococcal nonsusceptibility patterns were influenced by distinct patterns within serotypes, indicating the likelihood of serotype-specific resistance mechanisms. Serotype 19A observations were consistent with vaccine-induced reductions in circulation with no change in the organism susceptibility, whereas the nonsusceptibility increases for serotypes 3 and 19F may indicate circulation of more antibiotic-resistant clones.

Diabetes mellitus as a vaccine-effect modifier: a review.

INTRODUCTION: Diabetes mellitus (DM) is a highly prevalent, chronic condition in adults worldwide. Little is known about the potential role of diabetes as an effect modifier of vaccine protective responses. AREAS COVERED: We conducted a literature review of the immunogenicity, efficacy and effectiveness of immunization in individuals, in studies that compared subjects with DM (DM+) and without DM (DM-). We found few published studies, which were only for vaccines against hepatitis B, influenza, pneumococcal disease, or varicela zoster. Except for a consistent attenuation of the immune response to hepatitis B vaccine among DM+ individuals, we found little other consistent evidence for DM as an effect modifier of vaccine responses. EXPERT OPINION: There are substantial gaps in our knowledge of the impact of DM on the immune response to immunization or effect of vaccination.

Use of cardiac rehabilitation by Medicare beneficiaries after myocardial infarction or coronary bypass surgery.

BACKGROUND: Cardiac rehabilitation (CR) is effective in prolonging survival and reducing disability in patients with coronary heart disease. However, national use patterns and predictors of CR use have not been evaluated thoroughly. METHODS AND RESULTS: Using Medicare claims, we analyzed outpatient (phase II) CR use after hospitalizations for acute myocardial infarctions or coronary artery bypass graft surgery in 267,427 fee-for-service beneficiaries aged > or = 65 years who survived for at least 30 days after hospital discharge. We used multivariable analyses to identify predictors of CR use and to quantify geographic variations in its use. We obtained unadjusted, adjusted-smoothed, and standardized rates of CR use by state. Overall, CR was used in 13.9% of patients hospitalized for acute myocardial infarction and 31.0% of patients who underwent coronary artery bypass graft surgery. Older individuals, women, nonwhites, and patients with comorbidities (including congestive heart failure, previous stroke, diabetes mellitus, or cancer) were significantly less likely to receive CR. Coronary artery bypass graft surgery during the index hospitalization, higher median household income, higher level of education, and shorter distance to the nearest CR facility were important predictors of higher CR use. Adjusted CR use varied 9-fold among states, ranging from 6.6% in Idaho to 53.5% in Nebraska. The highest CR use rates were clustered in the north central states of the United States. CONCLUSIONS: CR use is relatively low among Medicare beneficiaries despite convincing evidence of its benefits and recommendations for its use by professional organizations. Use is higher after coronary artery bypass graft surgery than with acute myocardial infarctions not treated with revascularization procedures and varies dramatically by state and region of the United States.

Acute otitis media, antimicrobial prescriptions, and medical expenses among children in the United States during 2011-2016.

INTRODUCTION: We analyzed outpatient visits, incidence, antimicrobial prescriptions, and medical expenditures for acute otitis media (AOM) in the United States during 2011-2016. METHODS: Data sources included the National Disease and Therapeutic Index (NDTI™) projections by IQVIA (for AOM cases), The Medical Expenditure Panel Survey (for medical expenditures) and the US Census (for population estimates). Analyses focused on children aged ≤9 years between 2011 and 2016. We used the 2014 medical expenditure estimate per otitis media episode ($520) as proxy for all years. RESULTS: In 2011, there were an estimated 11.5 million AOM episodes in children aged 0-9 years in the US with AOM incidence rates (IR) of 476, 204, and 284 episodes per 1000 children aged 0-2, 3-9, and 0-9 years, respectively. All subsequent years had lower IRs, and by 2016, IR was 25.1% lower than in 2011 in children 0-9 years. In addition, there were estimates of 10.8 million and 9.2 million fewer cumulative AOM episodes and antimicrobial prescriptions for AOM nationwide between 2012 and 2016, compared to annual 2011 estimates, representing a ∼$5.6 billion decrease in direct medical expenditures. The average number of antibiotic prescriptions per AOM visit remained stable with 0.89 and 0.86 prescriptions per visit in 2011 and 2016, respectively. CONCLUSIONS: AOM incidence, antimicrobial prescriptions, and associated medical expenses decreased substantially between 2011 and 2016 in the United States. Antimicrobial prescribing practices remain unchanged. Additional studies are warranted to assess causality.

Post hoc analysis of the efficacy of the 13-valent pneumococcal conjugate vaccine against vaccine-type community-acquired pneumonia in at-risk older adults.

BACKGROUND: Individuals with certain chronic medical conditions are at higher risk of developing pneumonia and pneumococcal disease than those without. Using data from the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), this post hoc analysis assessed the efficacy of the 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ≥65 years with at-risk conditions. METHODS: The Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) was a double-blind, parallel-group, randomized, placebo-controlled study in the Netherlands in which adults aged ≥65 years received either PCV13 or placebo. Outcomes of interest were identified using prespecified clinical criteria, radiographic confirmation, routine microbiologic testing, and a serotype-specific urinary antigen detection assay. In this post hoc analysis, participants were classified by at-risk status based on self-reporting of any of the following chronic medical conditions: heart disease, lung disease, asthma, diabetes, liver disease, and smoking. The objective of this analysis was to assess PCV13 vaccine efficacy (VE) against a first episode of vaccine-serotype community-acquired pneumonia (VT-CAP) in at-risk participants. RESULTS: Of the 84,496 adults enrolled in the study, 41,385 (49.2%) were considered at risk owing to chronic medical conditions. Of the 139 VT-CAP cases, 115 (82.7%) occurred in these participants. VE of PCV13 against a first episode of VT-CAP among participants with at-risk conditions was 40.3% (95.2% CI: 11.4%, 60.2%). Average duration of follow-up since vaccination was 3.95 years for at-risk participants; protection did not wane over the study period. CONCLUSIONS: This post hoc analysis of the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) showed significant and persistent efficacy of PCV13 against VT-CAP in at-risk older adults. ClinicalTrials.gov identifier: NCT00744263.

Cost of Herpes Zoster in Patients With Selected Immune-Compromised Conditions in the United States.

Background. This retrospective study investigates the healthcare costs of herpes zoster (HZ) in patients with selected immune-compromised (IC) conditions in the United States (US). Methods. Patients with incident HZ diagnosis (index date) were selected from nationwide administrative claims databases from 2005 to 2009. Baseline IC groups, analyzed separately, included adults aged 18-64 years with the following: human immunodeficiency virus infection (HIV), solid organ transplant (SOT), bone marrow or stem cell transplant (BMSCT), or cancer; and older adults (aged ≥65 years) with cancer. Herpes zoster patients (n = 2020, n = 1053, n = 286, n = 13 178, and n = 9089, respectively) were 1-to-1 matched to controls without HZ (with randomly selected index date) in the same baseline group. The healthcare resource utilization and costs (2014 US dollars) during the first 2 postindex quarters were compared between matched cohorts with continuous enrollment during the quarter. Results. Herpes zoster patients generally had greater use of inpatient, emergency room and outpatient services, and pain medications than matched controls (P < .05). The incremental costs of HZ during the first postindex quarter were $3056, $2649, $13 332, $2549, and $3108 for HIV, SOT, BMSCT, cancer in adults aged 18-64 years, and cancer in older adults, respectively (each P < .05). The incremental costs of HZ during the second quarter were only significant for adults aged 18-64 years with cancer ($1748, P < .05). The national incremental costs of HZ were projected to be $298 million annually across the 5 IC groups. Conclusions. The healthcare cost associated with HZ among patients with studied IC conditions was sizable and occurred mainly during the first 90 days after diagnosis.

spa Typing and Multilocus Sequence Typing Show Comparable Performance in a Macroepidemiologic Study of Staphylococcus aureus in the United States.

A number of molecular typing methods have been developed for characterization of Staphylococcus aureus isolates. The utility of these systems depends on the nature of the investigation for which they are used. We compared two commonly used methods of molecular typing, multilocus sequence typing (MLST) (and its clustering algorithm, Based Upon Related Sequence Type [BURST]) with the staphylococcal protein A (spa) typing (and its clustering algorithm, Based Upon Repeat Pattern [BURP]), to assess the utility of these methods for macroepidemiology and evolutionary studies of S. aureus in the United States. We typed a total of 366 clinical isolates of S. aureus by these methods and evaluated indices of diversity and concordance values. Our results show that, when combined with the BURP clustering algorithm to delineate clonal lineages, spa typing produces results that are highly comparable with those produced by MLST/BURST. Therefore, spa typing is appropriate for use in macroepidemiology and evolutionary studies and, given its lower implementation cost, this method appears to be more efficient. The findings are robust and are consistent across different settings, patient ages, and specimen sources. Our results also support a model in which the methicillin-resistant S. aureus (MRSA) population in the United States comprises two major lineages (USA300 and USA100), which each consist of closely related variants.

Postoperative Staphylococcus aureus infections in Medicare beneficiaries.

Staphylococcus aureus (S. aureus) infections are important because of their increasing frequency, resistance to antibiotics, and high associated rates of disabilities and deaths. We examined the incidence and correlates of S. aureus infections following 219,958 major surgical procedures in a 5% random sample of fee-for-service Medicare beneficiaries from 2004-2007. Of these surgical patients, 0.3% had S. aureus infections during the hospitalizations when index surgical procedures were performed; and 1.7% and 2.3%, respectively, were hospitalized with infections within 60 days or 180 days following admissions for index surgeries. S. aureus infections occurred within 180 days in 1.9% of patients following coronary artery bypass graft surgery, 2.3% following hip surgery, and 5.9% following gastric or esophageal surgery. Of patients first hospitalized with any major infection reported during the first 180 days after index surgery, 15% of infections were due to S. aureus, 18% to other documented organisms, and no specific organism was reported on claim forms in 67%. Patient-level predictors of S. aureus infections included transfer from skilled nursing facilities or chronic hospitals and comorbid conditions (e.g., diabetes, congestive heart failure, chronic obstructive pulmonary disease, and chronic renal disease). In a logarithmic regression, elective index admissions with S. aureus infection stayed 130% longer than comparable patients without that infection. Within 180 days of the index surgery, 23.9% of patients with S. aureus infection and 10.6% of patients without this infection had died. In a multivariate logistic regression of death within 180 days of admission for the index surgery with adjustment for demographics, co-morbidities, and other risks, S. aureus was associated with a 42% excess risk of death. Due to incomplete documentation of organisms in Medicare claims, these statistics may underestimate the magnitude of S. aureus infection. Nevertheless, this study generated a higher rate of S. aureus infections than previous studies.

Smoking cessation and attempted cessation among adults in the United States.

AIMS: With growing recognition of stagnant rates of attempted cigarette smoking cessation, the current study examined demographic and psychometric characteristics associated with successful and attempted smoking cessation in a nationally representative sample. This additional understanding may help target tobacco cessation treatments toward sub-groups of smokers in order to increase attempts to quit smoking. DESIGN, SETTING, AND PARTICIPANTS: Data were used from the 2011 U.S. National Health and Wellness Survey (n = 50,000). MEASUREMENTS: Current smoking status and demographics, health characteristics, comorbidities, and health behaviors. FINDINGS: In 2011, 18%, 29%, and 52% of U.S. adults were current, former, or never smokers, respectively. Over one quarter (27%) of current smokers were attempting to quit. Current smokers (vs. others) were significantly more likely to be poorer, non-Hispanic White, less educated, ages 45-64, and uninsured, and they had fewer health-conscious behaviors (e.g., influenza vaccination, exercise). Attempting quitters vs. current smokers were significantly less likely to be non-Hispanic White and more likely to be younger, educated, insured, non-obese, with family history of chronic obstructive pulmonary disease, and they had more health-conscious behaviors. CONCLUSIONS: Smokers, attempting quitters, and successful quitters differ on characteristics that may be useful for targeting and personalizing interventions aiming to increase cessation attempts, likelihood, and sustainability.

Incidence of herpes zoster and persistent post-zoster pain in adults with or without diabetes in the United States.

BACKGROUND: This study was designed to assess the association between diabetes and herpes zoster (HZ) and persistent post-zoster pain (PPZP). METHODS: We used a United States-based, 2005-2009 retrospective observational study of medical and pharmacy claims from adults in 3 large national databases. Incidence rate ratios were used to compare HZ incidence by diabetes status. Multivariate regressions assessed the age and sex-adjusted risk of diabetes on HZ and PPZP as a function of immune competence. National projections of HZ and PPZP cases were obtained. RESULTS: Among 51 million enrollees (∼88 million person-years [PYs] at risk), we identified 420 515 HZ cases. Patients with diabetes represented 8.7% of the PYs analyzed but accounted for 14.5% of the HZ cases and 20.3% of the PPZP cases. The crude incidence of HZ was 78% higher (7.96 vs 4.48 cases/1000 PY; P < .01) and the rate of PPZP was 50% higher (5.97% vs 3.93%; P < .01) in individuals with diabetes than without. Individuals with diabetes had 45% higher adjusted risk of HZ (hazard ratio [HR] = 1.45; 95% confidence intervals [CIs], 1.43-1.46) and 18% higher adjusted odds of PPZP (odds ratio = 1.18; 95% CI, 1.13-1.24). The risk of HZ associated with diabetes among immune-compromised individuals was weaker (HR = 1.10; 95% CI, 1.07-1.14) and the risk of PPZP was no longer significant. Every year, approximately 1.2 million HZ cases occur in US adults, 13% of these occur in individuals with diabetes. CONCLUSIONS: Diabetes is a risk factor for HZ and PPZP in the US adult population. This association is stronger in immune-competent individuals.