Burden of vaccine-preventable diseases in adults (50+) in the United States: a retrospective claims analysis.

Background: In adults aged 50 + years, vaccine-preventable diseases (VPDs) pose a significant health burden and can lead to additional 'downstream effects' of infection beyond the acute phase e.g., increasing the risk for non-communicable disease and exacerbating chronic conditions.

The Incidence of Skin and Soft Tissue Infections in the United States and Associated Healthcare Utilization Between 2010 and 2020.

Background: The number of patients with skin and soft tissue infections (SSTIs) in the United States appeared to be increasing well into the 21st century. However, no recent data have confirmed this trend.

Methods: This retrospective, observational cohort study used claims data over 11 years (2010-2020) from Optum's de-identified Clinformatics Data Mart Database.

Burden of Pertussis in Adults Aged 50 Years and Older: A Retrospective Database Study in England.

Introduction: Pertussis, a highly infectious respiratory disease caused by Bordetella pertussis, affects people of all ages. Older adults are particularly susceptible to its severe outcomes and complications.

Methods: In this retrospective cohort study, the incidence rate of pertussis among individuals aged ≥ 50 years was assessed during 2009-2018 using Clinical Practice Research Datalink and Hospital Episode Statistics databases, United Kingdom.

Vaccine clinical trials with dynamic borrowing of historical controls: Two retrospective studies.

Traditional vaccine efficacy trials usually use fixed designs with fairly large sample sizes. Recruiting a large number of subjects requires longer time and higher costs. Furthermore, vaccine developers are more than ever facing the need to accelerate vaccine development to fulfill the public's medical needs.

Capturing the value of vaccination: impact of vaccine-preventable disease on hospitalization.

Evidence from epidemiological studies suggests that vaccine-preventable disease (VPD) such as influenza or herpes zoster contribute significantly to the increased risk of older adults for cardiovascular, cerebrovascular, neurological, and renal complications in the period after illnesses. However, since the period of elevated risk can persist well beyond the duration of the acute illness, the connection is not always recognized. To obtain insights into the relationship between diagnoses for vaccine-preventable disease and for other conditions, we analyzed principal and secondary diagnoses for 3,127,768 inpatient admissions of adults 50 years and older in the United States, using medical insurance claims drawn from the IBM MarketScan Research Databases (Marketscan).

Increased Risk of Herpes Zoster in Adults ≥50 Years Old Diagnosed With COVID-19 in the United States.

Background: Case reports have described herpes zoster (HZ) in patients with coronavirus disease 2019 (COVID-19). However, this constitutes low-quality evidence for an association. We therefore performed a retrospective cohort study to assess the risk of developing HZ following a COVID-19 diagnosis.

Burden of Pertussis in Individuals with a Diagnosis of Asthma: A Retrospective Database Study in England.

Purpose: The impact of pertussis in individuals with asthma is not fully understood. We estimated the incidence, health care resource utilization (HCRU), and direct medical costs (DMC) of pertussis in patients with asthma.

Patients And Methods: In this retrospective cohort study, the incidence rate of pertussis (identified using diagnostic codes) among individuals aged ≥50 years with an asthma diagnosis was assessed during 2009-2018 using Clinical Practice Research Datalink and Hospital Episode Statistics databases.

Long-Term Mortality and State Financial Support in Invasive Meningococcal Disease-Real-World Data Analysis Using the French National Claims Database (SNIIRAM).

Objectives: Invasive meningococcal disease (IMD) is an uncommon disease known for its acute phase mortality and long-term sequelae. The objective was to assess the impact of IMD on post-discharge mortality risk and dependence on the French state for financial aid.

Methods: A 6-year retrospective analysis in the national insurance database (SNIIRAM) assessed mortality in IMD cases (both during acute phase and post-discharge) and matched controls as well as benefit claims (i.

Healthcare Resource Consumption and Cost of Invasive Meningococcal Disease in France: A Study of the National Health Insurance Database.

Introduction: Invasive meningococcal disease (IMD) is an uncommon but serious infectious disease. Its economic burden is known to be high but is poorly characterised. The objective of this study was to determine costs, as captured in the healthcare claims database, incurred by all patients hospitalised for IMD in France over a 6-year period.

Effectiveness of "Priorix" Against Measles and Mumps Diseases in Children Born After 2004 in the United Kingdom: A Retrospective Case-control Study Using the Clinical Practice Research Datalink GOLD Database.

Background: Evidence on vaccine effectiveness (VE) may encourage vaccination and help fight the reemergence of measles and mumps in Europe. However, limited data exist on real-life effectiveness of individual measles, mumps and rubella (MMR) vaccines. This study evaluated VE of GSK's MMR vaccine ("Priorix") against measles and mumps.

Burden of Pertussis in COPD: A Retrospective Database Study in England.

Chronic obstructive pulmonary disease (COPD) may increase the risk and severity of pertussis infection. Health care resource utilization (HCRU) and direct medical costs (DMC) of treating pertussis among patients with COPD are unknown. Reported incidence of pertussis among individuals aged ≥ 50 years with COPD was assessed in Clinical Practice Research Datalink and Hospital Episode Statistics databases during 2009-2018 using a retrospective cohort design.

Causal inference concepts applied to three observational studies in the context of vaccine development: from theory to practice.

Background: Randomized controlled trials are considered the gold standard to evaluate causal associations, whereas assessing causality in observational studies is challenging.

Methods: We applied Hill's Criteria, counterfactual reasoning, and causal diagrams to evaluate a potentially causal relationship between an exposure and outcome in three published observational studies: a) one burden of disease cohort study to determine the association between type 2 diabetes and herpes zoster, b) one post-authorization safety cohort study to assess the effect of AS04-HPV-16/18 vaccine on the risk of autoimmune diseases, and c) one matched case-control study to evaluate the effectiveness of a rotavirus vaccine in preventing hospitalization for rotavirus gastroenteritis.

Results: Among the 9 Hill's criteria, 8 (Strength, Consistency, Specificity, Temporality, Plausibility, Coherence, Analogy, Experiment) were considered as met for study c, 3 (Temporality, Plausibility, Coherence) for study a, and 2 (Temporary, Plausibility) for study b.

Association between rotavirus gastroenteritis and intussusception: suggested evidence from a retrospective study in claims databases in the United States.

The etiology of intussusception (IS), a serious gastrointestinal obstruction, remains unclear. Limited evidence suggests a role for viral infection. We investigated the risk of IS after rotavirus gastroenteritis (RV GE) in the first year of life.

Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age.

This phase 3B, open-label, extension study (NCT01962207) evaluated long-term persistence of antibodies induced by the quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) compared with the meningococcal serogroup C vaccine conjugated to CRM (MenC-CRM) and the quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS) 6 to 10 y after primary vaccination in toddlers (aged 1-<2 y; MenACWY-TT and MenC-CRM) and children (aged 2-<11 y; MenACWY-TT and MenACWY-PS). Antibody responses against meningococcal serogroups A, C, W, and Y were assessed by serum bactericidal antibody assays using rabbit (rSBA) or human (hSBA) complement. A MenACWY-TT booster dose at Year 10 was given to all eligible subjects regardless of the primary vaccine received.

A phase 2b/3b MenACWY-TT study of long-term antibody persistence after primary vaccination and immunogenicity and safety of a booster dose in individuals aged 11 through 55 years.

Background: A previous phase 2 study demonstrated the immunogenicity of a single dose of meningococcal A, C, W, Y-tetanus toxoid conjugate (MenACWY-TT) or polysaccharide (MenACWY-PS) vaccine for up to 5 years in individuals aged 11-55 years. This follow-up study evaluated long-term antibody persistence up to 10 years and the immunogenicity and safety of a single MenACWY-TT booster dose given 10 years after primary vaccination.

Methods: Blood draws were conducted annually in Years 7-10.

The adult vaccination landscape in the United States during the Affordable Care Act era: Results from a large retrospective database analysis.

Background: Early provisions of the Affordable Care Act (ACA) reduced financial barriers to preventive care, including routinely recommended vaccines; however, vaccination coverage remains suboptimal. This study examined characteristics of routine adult vaccinations and potential missed opportunities for vaccinations through the lens of healthcare resource utilization among adults in the ACA era.

Methods: This was a retrospective analysis of healthcare claims from the Truven Health MarketScan Commercial Claims and Encounters (CCAE), Medicare Supplemental (MS), and Multi-State Medicaid databases among adults aged 19 years or older.

Drivers of year-to-year variation in exacerbation frequency of COPD: analysis of the AERIS cohort.

The association between exacerbation aetiology and exacerbation frequency is poorly understood. We analysed 2-year follow-up data from a prospective observational study of patients with chronic obstructive pulmonary disease (COPD) (www.clinicaltrials.

A note on tests for relevant differences with extremely large sample sizes.

A well-known problem in classical two-tailed hypothesis testing is that P-values go to zero when the sample size goes to infinity, irrespectively of the effect size. This pitfall can make the testing of data consisting of large sample sizes potentially unreliable. In this note, we propose to test for relevant differences to overcome this issue.

Impact of radiologically stratified exacerbations: insights into pneumonia aetiology in COPD.

Background: COPD patients have increased risk of developing pneumonia, which is associated with poor outcomes. It can be symptomatically indistinguishable from exacerbations, making diagnosis challenging. Studies of pneumonia in COPD have focused on hospitalised patients and are not representative of the ambulant COPD population.

Relationship of CT-quantified emphysema, small airways disease and bronchial wall dimensions with physiological, inflammatory and infective measures in COPD.

Background: COPD is a complex, heterogeneous disease characterised by progressive development of airflow limitation. Spirometry provides little information about key aspects of pathology and is poorly related to clinical outcome, so other tools are required to investigate the disease. We sought to explore the relationships between quantitative CT analysis with functional, inflammatory and infective assessments of disease to identify the utility of imaging to stratify disease to better predict outcomes and disease response.

An analysis of factors associated with influenza, pneumoccocal, Tdap, and herpes zoster vaccine uptake in the US adult population and corresponding inter-state variability.

Despite longstanding recommendations for routine vaccination against influenza; pneumococcal; tetanus, diphtheria, acellular pertussis (Tdap); and herpes zoster (HZ) among the United States general adult population, vaccine uptake remains low. Understanding factors that influence adult vaccination and coverage variability beyond the national level are important steps toward developing targeted strategies for increasing vaccination coverage. A retrospective analysis was conducted using data from the Behavioral Risk Factor Surveillance System (2011-2014).

Impact and associations of eosinophilic inflammation in COPD: analysis of the AERIS cohort.

Eosinophilic inflammation in chronic obstructive pulmonary disease (COPD) predicts response to treatment, especially corticosteroids. We studied the nature of eosinophilic inflammation in COPD prospectively to examine the stability of this phenotype and its dynamics across exacerbations, and its associations with clinical phenotype, exacerbations and infection.127 patients aged 40-85 years with moderate to very severe COPD underwent repeated blood and sputum sampling at stable visits and within 72 h of exacerbation for 1 year.

A prospective, observational cohort study of the seasonal dynamics of airway pathogens in the aetiology of exacerbations in COPD.

Background: The aetiology of acute exacerbations of COPD (AECOPD) is incompletely understood. Understanding the relationship between chronic bacterial airway infection and viral exposure may explain the incidence and seasonality of these events.

Methods: In this prospective, observational cohort study (NCT01360398), patients with COPD aged 40-85 years underwent sputum sampling monthly and at exacerbation for detection of bacteria and viruses.