Herpes zoster risk and burden of disease in immunocompromised populations: a population-based study using health system integrated databases, 2009–2014

Background: Estimate the incidence of herpes zoster (HZ), its complications and healthcare utilization rates in adults (≥ 18-years-old) with a wide range of immunocompromised (IC) conditions compared to IC-free cohort. Method: A population-based retrospective study using the Valencia healthcare Integrated Databases (VID) (2009– 2014). HZ and IC were defined using ICD-9 codes in primary care (PC) and hospitalization registers. Incidence rates (IR), risk of HZ, HZ-recurrence, HZ-complications and healthcare utilization rates were estimated in the IC-cohort compared to IC-free. Results: The study population consisted of 4,382,590 subjects, of which 578,873 were IC (13%). IR (in 1000 persons-year) of HZ overall, in IC and in IC-free cohort was 5.02, 9.15 and 4.65, respectively. IR of HZ increased with age in both cohorts and it was higher for all IC conditions studied, reaching up to twelvefold in subjects with stem cell transplantation. IC subjects had 51% higher risk of developing HZ, 25% higher HZrecurrence and the risk of HZ-complications was 2.37 times higher than in IC-free. HZ-related healthcare utilization was higher in the IC-cohort than in IC-free (number of hospitalizations 2.93 times greater, hospital stays 12% longer, 66% more HZ-specialist visits, 2% more PC visits, sick leaves 18% longer and 20% higher antiviral dispensation). Conclusions: Patients suffering from all the IC conditions studied are at higher risk of developing HZ, HZrecurrence and post-herpetic complications, which implies a substantial morbidity and a high consumption of resources. These results should be considered for vaccine policy implementation.Funding for this study was provided by GlaxoSmithKline Biologicals SA (GSK study identifier 207685). GlaxoSmithKline Biologicals SA was provided the opportunity to review a preliminary version of this manuscript for factual accuracy but the authors are solely responsible for final content and interpretation. The Company (GSK) had no role in the analysis or discussion of the results.Medicin

Epidemiology of schizophrenia and its management over 8-years period using real-world data in Spain

Background: Real-World Data (RWD) studies provide important insights in disease epidemiology, in real clinical populations, with long follow-up periods. The aim of the present study was to describe the epidemiology of schizophrenia spectrum disorders (SD) during an 8-year period in Spain. Methods: A retrospective cohort of subjects aged 15 to 64 years was followed-up using electronic healthcare databases of the Valencia region (2008–2015). SD cases included outpatient and inpatient settings (ICD 9 codes 295.XX). Prevalence of SD was assessed. Incidence rate (IR) in the subpopulation aged between 15 and 34 years was also provided. Healthcare utilization (HCU) rates, including outpatient, specialists, hospitalizations and antipsychotic dispensations were estimated. Results: The cohort included 3,976,071 subjects; 24,749 of them had a prevalent diagnosis of SD. The overall prevalence for SD was 6.2 per 1000 persons. SD were 76% more prevalent in men than women. IR in the subpopulation aged between 15 and 34 years was 50.25 per 100,000 persons years and was more than 2 times higher for men than for women. 83.4% of the overall outpatient visits from the cohort of patients were related to SD. The 21,095 overall hospitalizations with the SD code resulted in 286,139 days of hospitalization, with a median of 4 days (IQR: 1.6–9.2) per person-year. 93.2% of subjects diagnosed with SD were ever treated with some antipsychotic drug during the study period, and 70% of the patients were ever treated with antipsychotic polypharmacy. Conclusions: This large population-based study using RWD provides novel and recent information SD in a southern European country. The prevalence and IR of SD showed is greater than previously published and higher in men than in women. The fact of having used a large arsenal of electronic data (including outpatient and inpatient) for 8 years may have influenced. SD represents high burden and healthcare utilization. Contrary to guidelines recommendations the majority of patients were ever treated with antipsychotic polypharmacy.This study was supported by Janssen pharmaceutical. The company had no role in the analysis or discussion of the resultMedicin

Human papillomavirus vaccines effectiveness to prevent genital warts: A population-based study using health system integrated databases, 2009-2017.

Objectives: To assess the effectiveness of the HPV vaccines in preventing genital warts (GW) in women aged 14–23 years and to estimate the incidence of GW in the whole population aged from 14 to 65. Design: Population-based retrospective cohort study using real-world data from the Valencia health system Integrated Databases (VID). Study population: All subjects aged 14–65 years residing in the Valencia Region during 2009–2017 (n = 4,492,724), including a cohort of 563,240 females aged 14–23 years followed-up for the vaccine effectiveness (VE) estimations. Main outcome measures: Incident cases of GW defined as the first activation of GW-related codes (ICD-9- CM 078.11 or ICD-10-CM A63.0) in hospital, primary and specialized care during the study period. Adjusted VE was estimated as (1-Relative Risk (RR)) 100 by a negative binomial Bayesian model. Results: There were 23,049 cases of GW in the overall population and 2,565 in the females’ cohort 14– 23 years old. The incidence rate (IR) (in 100,000 persons-year) was 69.1 (95% CI 68.21–69.99) in the population overall, being higher in men (72.73; 95% CI 71.45–74.04). The IR of GW was 104.08 (95% CI 100.79–108.94) in the cohort of young women. The RR of GW increased with age from 14 to 21 years, reaching a plateau from 21 to 23. The VE of a complete schedule was 74% (95% CrI 68–79) for quadrivalent HPV vaccine (HPV4v). No effectiveness was seen with a full vaccination course with the bivalent HPV vaccine (HPV2v) in girls up to 21 years old. GW IR tends to be higher in unvaccinated cohorts covered by HPV4v vaccine than in unvaccinated cohorts not covered by HPV4v vaccine. Conclusions: A complete HPV4v vaccination schedule was 74% effective in reducing GW in our population. Our results also suggest an indirect protection to unvaccinated and HPV2v vaccinated girlsThis study has been funded by MSD. MSD had no role in the design, collection, analysis, interpretation of the data and writing of the article, and had no access to the data. MSD did not intervene in the decision to submit the manuscript for publication.Medicin

Data Resource Profile: The Valencia Health System Integrated Database (VID)

The Valencia Health System Integrated Database (VID) is a set of multiple, public, population-wide electronic databases for the Valencia Region, the fourth most populated Spanish region, with ∼5 million inhabitants and an annual birth cohort of 48 000 newborns, representing 10.7% of the Spanish population and around 1% of the European population. The VID provides exhaustive longitudinal information including sociodemographic and administrative data (sex, age, nationality, etc.), clinical (diagnoses, procedures, diagnostic tests, imaging, etc.), pharmaceutical (prescription, dispensation) and healthcare utilization data from hospital care, emergency departments, specialized care (including mental and obstetrics care), primary care and other public health services. It also includes a set of associated population databases and registries of significant care areas such as cancer, rare diseases, vaccines, congenital anomalies, microbiology and others, and also public health databases from the population screening programmes. All the information in the VID databases can be linked at the individual level through a single personal identification code. The databases were initiated at different moments in time (see details in the Data collected section), but all in all the VID provides comprehensive individual-level data fed by all the databases from 2008 to date.Medicin

The impact of childhood RSV infection on children’s and parents’ quality of life: a prospective multicenter study in Spain

Background: Several immunisation candidates against RSV are in late-stage clinical trials. To evaluate the benefts of a potential vaccination programme, both economic and health benefts will be needed. Health benefts are usually measured in Health-related Quality of Life (HRQoL) loss using standardised questionnaires. However, there are no RSV-specifc questionnaires validated for children under 2 years, in whom most RSV episodes occur. Therefore, HRQoL estimates are taken from literature or inadequate tools. We determined HRQoL loss and direct costs due to an RSV episode in children younger than 2 years and their caregivers during a month of follow up, using a new questionnaire administered online. Methods: An observational prospective multicentre surveillance study was conducted in children aged younger than two years. Children were recruited from 8 primary care centres and 1 hospital in the Valencia region and Cata‑ lonia (Spain). RSV-positive cases were obtained by immunochromatographic test. HRQoL was assessed using a new ad-hoc 38 item-questionnaire developed. Parents of infected children completed 4 questionnaires at four timepoints (day 0, 7, 14 and 30) after diagnosis. Results: 117 children were enrolled in the study and 86 (73.5%) were RSV+. Median (interquartile range; IQR) scores were 0.52 (0.42–0.68), 0.65 (0.49–0.79), 0.82 (0.68–0.97) and 0.94 (0.81–1), for days 0, 7, 14 and 30, respectively. Compared to total recovery (Q30), HRQoL loss was 37.5%, 31.5% and 8.9% on days 0, 7 and 14 since diagnosis of the disease. The total median cost per patient (including treatments) was €598.8 (IQR: 359.63–2425.85). Conclusions: RSV had almost 40% impact on HRQoL during the frst week since onset of symptoms and the median cost per episode and patient was about €600. These results represent a substantial input for health-economic evalua‑ tions of future RSV-related interventions such as vaccination.This study was funded by Conselleria d’Educació, Cultura i Esport of The Valencia Region of Spain.Medicin

Real-world impact of rotavirus vaccination in European healthcare settings: a systematic literature review

Introduction: Rotavirus is one of the most common pathogens causing diarrhea in children <5 years and has a major impact on childhood morbidity and mortality. Since the implementation of rotavirus vaccines into childhood immunization programs across Europe, there has been a reduction in rotavirus burden, including hospitalizations, outpatient cases, costs, and deaths. Areas covered: A systematic literature review identified publications describing the clinical and economic impact of rotavirus vaccinations across Europe, from their introduction in 2006 to the end of 2020. A total of 3,137 articles were identified, of which 46 were included in the review. Included articles reported the impact of rotavirus vaccination on disease in any age group. Expert opinion: Rotavirus vaccination has resulted in substantial reductions in hospitalizations and rotavirus-associated costs across Europe, particularly in children <5 years. There is some evidence of herd protection afforded to older age groups where vaccine uptake is high among infants, highlighting the potential for vaccination to confer a greater societal benefit as programs become more established. Increasing vaccination coverage and continuing investment in widespread rotavirus vaccination programs across countries will likely increase the substantial public health benefits associated with vaccination and further reduce the clinical and economic burden of disease.This manuscript was funded by Merck & Co., Inc., Kenilworth, NJ, USA. The funder contributed to the design of the study, collection, analysis, and interpretation of data as well as the writing and revision of the manuscript.Medicin