Direct Medical Costs of Four Vaccine-Preventable Infectious Diseases in Older Adults in Spain.

OBJECTIVE: Protection against vaccine-preventable diseases is especially relevant in older adults due to age-related decline in immunity (immunosenescence). However, adult vaccination remains a challenge with overall low coverage rates, which has an impact on both the patients who have these diseases and the health care system in terms of resource use and costs derived. This study aimed to estimate the direct economic impact of herpes zoster, pneumococcal disease, influenza and pertussis in Spanish adults 45 years and older. METHODS: Data from 2015 were extracted from two Spanish public databases: the Minimum Basic Data Set for Hospitalisations and the Clinical Database of Primary Care. Codes from the International Classification of Diseases and the International Classification of Primary Care were used to identify and classify the diseases analysed. The variables extracted and calculated were hospitalisation (cases, percentage, length of stay, costs, mortality), primary care (cases, percentage, costs) and referrals (cases, percentage, costs). Results were presented for the age groups 45-64 years, 65-74 years, > 74 years and all ages. RESULTS: In adults 45 years and older, total costs amounted to €134.1 million in 2015 (i.e. 63.9% of the total direct costs for all age groups): 44.4% due to pneumococcal disease, 39.5% due to influenza, 16.0% due to herpes zoster and 0.1% due to pertussis. Hospitalisations represented 58.1% (€77.9 million) of the total costs, with 15,910 admissions, 144,752 days of hospitalisation and 1170 deaths. Primary care registered 566,556 visits with a cost of €35.0 million, and 269,186 referrals with a cost of €21.1 million. CONCLUSION: The direct economic burden of herpes zoster, pneumococcal disease, influenza and pertussis in adults 45 years and older was high in Spain, and may be underestimated as it only considered medical assistance and not other applicable direct or indirect costs. Increasing vaccination rates in adults may potentially reduce the economic burden derived from these diseases, although future cost-effectiveness analysis including other disease-related costs, vaccination costs and vaccination effectiveness would be needed.

Cost of illness of invasive meningococcal disease caused by serogroup B Neisseria meningitidis in Spain.

INTRODUCTION: Invasive meningococcal disease (IMD) is a severe infectious disease, mainly affecting children under 5 years, associated with long-term physical, neurological and psychological sequelae. In Spain, most IMD cases are caused by meningococcal serogroup B (MenB). This study estimates its economic burden from a societal perspective in Spain. METHODS: A previously published bottom-up, model-based incidence costing approach by Scholz et al. (2019) to estimate the economic burden of MenB in Germany was adapted to the Spanish setting. Diagnosis and age-related costs for a hypothetical Spanish cohort were calculated over a lifetime horizon. Official Spanish databases, literature and expert opinion were used as data sources. The costs were updated to 2019 prices, and a 3% discount rate was applied. Direct costs related to the acute IMD phase, long-term sequelae, rehabilitation and public health response were considered. Indirect costs included productivity losses and premature mortality and were calculated using the human-capital approach (HCA) and friction-cost approach (FCA). Deterministic and probabilistic sensitivity analyses were also performed. RESULT: At base-case, the total cost for a cohort of 142 patients (2017-2018 period) was €4.74 million (€33,484/case) using the FCA and €13.14 million (€92,768/case) using the HCA. Direct costs amounted to €4.65 million (€32,765/case). Sequelae costs represented 62.46% of the total cost using the FCA and 77.63% using the HCA. Deterministic sensitivity analysis showed that variation of ± 20% in the input parameter values (population, epidemiology, productivity, costs) had the greatest influence on the base-case results, and the probabilistic sensitivity analysis showed the probability of fitting base-case estimates was > 99%, both for FCA and HCA. DISCUSSION: MenB IMD is an uncommon but severe disease, with a high economic burden for Spanish society. The elevated costs per IMD case reflect its severity in each patient suffering this disease, especially due to the development of sequelae.

Primary care-based surveillance to estimate the proportion of rotavirus gastroenteritis among Latvian children below 5 years of age with acute gastroenteritis.

Background: Rotavirus (RV) is worldwide an important cause of acute gastroenteritis (AGE) in infants and young children. There is no specific treatment for AGE caused by RV (RVGE) but since 2006 two safe and effective vaccines have been available. RV vaccination was included in the national immunization program (NIP) of Latvia in 2015 with full reimbursement, and within the first year a coverage of 87% was achieved. This surveillance study was carried out to investigate the proportion of RVGE among AGE episodes in Latvia up to the inclusion of RV vaccination in the NIP to provide a basis for future assessments of the impact of RV vaccination. Methods: Prospective, one-year observational study of children younger than 5 years presenting with AGE in the primary care setting. At first primary care contact, a stool sample was collected and tested for RV using a rapid, visual immunochromatographic kit. The parents monitored their child's symptoms over 2 weeks after the first contact and the investigator recorded these observations during a follow-up phone call. The proportion of RVGE among the AGE cases was estimated and the severity of each AGE case was assessed based on the recorded symptoms using the 20-point Vesikari scale. The seasonality of RVGE was also investigated. Results: Fifty-two primary care investigators collected data on 606 evaluable children with AGE. The proportion of RVGE was 38.1%. Severe AGE was experienced by 40.7% of the RV-positive and 19.5% of the RV-negative patients. The rate of hospitalization was 9.1% for the RV-positive and 4.8% for the RV-negative with no difference in the mean duration of hospital stays. AGE and RVGE both occurred all year round but with a clearly marked peak only for RVGE, from March to May. Conclusion: This study underlines that RV is an important cause of AGE in children under 5 years old in Latvia and that the burden of disease of RVGE in primary care was substantial before inclusion of RV vaccination in the NIP. Trial registration: NCT01733849.

[Seroprevalence of Bordetella pertussis antibodies in adults in Hungary: results of an epidemiological cross-sectional study]. / A Bordetella pertussis-antitestek szeroprevalenciája magyarországi felnottekben.

INTRODUCTION: Pertussis (whooping cough) is an acute respiratory tract infection caused by Bordetella pertussis that is characterized by a chronic, severe cough. The optimum immunization schedule for pertussis is unclear, so these vary by countries. AIM: To estimate the seroprevalence of pertussis in adults in Hungary. METHOD: Serum anti-pertussis toxin immunoglobulin G (anti-PT IgG) antibody levels were analyzed using enzyme-linked immunosorbent assay in adults in general practitioners' practices during one year. Sera were classified following manufacturer's instructions as: strongly indicative of current/recent infection (≥1.5 optical density [OD] units); indicative of current/recent infection (≥1.0 OD units); seropositive (>0.3 OD units); or seronegative (≤0.3 OD units). RESULTS: 1999 adults (60.6% female; mean age 47.4 ± 17.7 years) were included. 14.8% were seropositive, 1.1% were indicative of current/recent infection, and 0.1% were strongly indicative of current/recent infection. CONCLUSIONS: 85.2% of the subjects were seronegative and therefore susceptible to pertussis infection. Approximately 1% was suspicious of current/recent pertussis infection, potentially transmissible to susceptible young infants. Vaccination of adults is a key way to indirectly protect infants. Orv Hetil. 2018; 159(13): 503-510.

Estudio prospectivo para estimar la carga de hospitalización y visitas a urgencias de la gripe en población pediátrica en Bilbao (2010-2011) / A prospective study to assess the burden of influenza-related hospitalizations and emergency department visits among children in Bilbao, Spain (2010-2011)

Introducción: El estudio se llevó a cabo para estimar la carga de enfermedad de la gripe confirmada por laboratorio en niños menores de 15 años. Pacientes y métodos: Los niños que acudieron al Hospital Universitario de Basurto con síntomas de infección respiratoria aguda y/o fiebre aislada entre noviembre de 2010 y mayo de 2011 fueron incluidos en el estudio (NCT01592799). Se tomaron 2 muestras de secreción nasofaríngea: una para un test de diagnóstico rápido en el Servicio de Urgencias y otra para análisis en laboratorio con reacción en cadena de la polimerasa en tiempo real y cultivo viral. Resultados: Se seleccionó a un total de 501 niños, de los que 91 fueron hospitalizados. El diagnóstico de gripe se confirmó en 131 (26,1%); 120/410 (29,3%) fueron tratados ambulatoriamente y 11/91 (12,1%), hospitalizados. En 370/501 niños (73,9%) el resultado no fue positivo. La proporción de otros virus respiratorios fue 145/501 (28,9%) casos y de coinfección con otro virus respiratorio además de gripe de 7/501 (1,4%). Los tipos de virus de gripe fueron: A (H1N1 y H3N2) 53,2% (67/126); B (Victoria y Yamagata) 46,0% (58/126); A + B 0,8% (1/126). El coste médico directo medio asociado con cada caso de gripe confirmada fue de 177,00 €(N=131). No se observaron diferencias estadísticamente significativas entre el coste asociado con gripe A o B. Conclusión: Casi la mitad de los casos fueron virus de gripe B. La administración de una vacuna que incluya tipos A y B de gripe debería reducir la carga de la enfermedad (AU)

Introduction: This study was undertaken to estimate the burden of morbidity associated with laboratory-confirmed influenza in children below 15 years of age. Patients and methods: Children presenting with acute respiratory infection and/or isolated fever at the Basurto University Hospital, Bilbao, Spain between November 2010 and May 2011 were included in this study (NCT01592799). Two nasopharyngeal secretion samples were taken from each; one for a rapid influenza diagnostic test in the emergency department, and the second for laboratory analysis using real-time polymerase chain reaction and viral culture. Results: A total of 501 children were recruited, of whom 91 were hospitalized. Influenza diagnosis was confirmed in 131 children (26.1%); 120 of 410 (29.3%) treated as outpatients and 11 of 91 (12.1%) hospitalized children. A total of 370 of 501 children (73.9%) had no laboratory test positive for influenza. The proportion of subjects with other respiratory viruses was 145/501 (28.9%) cases and co-infection with the influenza virus plus another respiratory virus was detected in 7/501 (1.4%) cases. Influenza virus types were: A (H1N1 and H3N2) 53.2% (67/126); B (Victoria and Yamagata) 46.0% (58/126); A + B 0.8% (1/126). The median direct medical costs associated with each case of laboratory-confirmed influenza was € 177.00 (N = 131). No significant differences were observed between the medical costs associated with influenza A and B. Conclusion: Almost half of the cases were influenza virus B type. The administration of a vaccine containing influenza A and B types to children below 15 years of age might reduce the overall burden of the illness (AU)

A review of Haemophilus influenzae disease in Europe from 2000-2014: challenges, successes and the contribution of hexavalent combination vaccines.

INTRODUCTION: The development of diphtheria-tetanus-acellular pertussis-Haemophilus influenzae type b (Hib) conjugate vaccine combinations culminated with hexavalent vaccines, the largest, most complex vaccine combinations in the immunization calendar. Hexavalent vaccines are used widely in Europe and are co-administered with multiple other recommended vaccines. Hib immunogenicity may reduce when combined with acellular pertussis antigens, or in some co-administrations. We reviewed the epidemiology of H. influenzae disease in Europe aiming to evaluate the current level of Hib control and indirectly assess the effectiveness against Hib of GSK's hexavalent vaccine in 10 countries where it is/has been used almost exclusively. Areas covered: We reviewed surveillance data from the European Union Invasive Bacterial Infections Surveillance Network and the European Surveillance System database from 1999-2014 and extracted case and incidence/notification rates (per 100,000 population) of invasive H. influenzae disease. We included age and serotype/strains distribution among countries in the European Union/European Economic Area region that reported to the European Centre for Disease Prevention and Control surveillance system. Expert commentary: The impact of Hib vaccination in Europe is sustained, testifying to continued effectiveness against invasive Hib disease after the implementation of hexavalent vaccines into immunization programs, which, since 2006, has been almost exclusively GSK´s hexavalent DTPa-HBV-IPV/Hib vaccine.

Seroprevalence of Bordetella pertussis antibodies in adults in Hungary: results of an epidemiological cross-sectional study.

BACKGROUND: Pertussis (whooping cough) is well known to be underreported, particularly among adults, who can act as an infectious reservoir, potentially putting susceptible newborns at risk of serious illness. The purpose of this study was to estimate the seroprevalence of pertussis in adults in Hungary. METHODS: This epidemiological, cross-sectional study was conducted in adults in five general practitioners' practices in Hungary. Serum anti-pertussis toxin immunoglobulin G (anti-PT IgG) antibody levels were analyzed using enzyme-linked immunosorbent assay. Sera were classified following manufacturer's instructions as: strongly indicative of current/recent infection (≥1.5 optical density [OD] units); indicative of current/recent infection (≥1.0 OD units); seropositive (>0.3 OD units); or seronegative (≤0.3 OD units). Logistic regression was performed to describe the associations between seroprevalence and various characteristics. RESULTS: Between 24th April 2014 and 24th April 2015, 1999 adults (60.6% female; mean age 47.4 ± 17.7 years) were included in the analysis. A total of 14.8% were seropositive for anti-PT IgG, 1.1% had a level indicative of current/recent infection, and 0.1% had a level strongly indicative of current/recent infection. Logistic regression showed significant relationships between increased rates of seropositivity and: age ≥60 years (odds ratio [OR], 1.97; 95% confidence interval [CI], 1.39-2.80; p = .0002) or 18-29 years (OR, 1.67; 95% CI, 1.13-2.46; p = .0094) vs. 45-59 years; former smoker (OR, 1.46; 95% CI, 1.08-1.97; p = .014) or current smoker (OR, 1.38; 95% CI, 1.01-1.89; p = .045) vs. never smoker; and male (OR, 1.30; 95% CI, 1.01-1.68; p = .041) vs. female. Also, between increased rates of probable current/recent infection and current smoker (OR, 7.50; 95% CI, 2.32-24.31; p = .0008) or former smoker (OR, 4.07; 95% CI, 1.21-13.64; p = .023) vs. never smoker. CONCLUSIONS: Approximately 85% of the adults studied were seronegative and therefore susceptible to pertussis infection. Approximately 1% had anti-PT IgG levels indicative of current/recent pertussis infection, which could potentially be transmitted to susceptible young infants. Vaccination of adults is a key way to indirectly protect infants. TRIAL REGISTRATION: Clinical Trials.gov NCT02014519 . Prospectively registered 12 December 2013.

[A prospective study to assess the burden of influenza-related hospitalizations and emergency department visits among children in Bilbao, Spain (2010-2011)]. / Estudio prospectivo para estimar la carga de hospitalización y visitas a urgencias de la gripe en población pediátrica en Bilbao (2010-2011).

INTRODUCTION: This study was undertaken to estimate the burden of morbidity associated with laboratory-confirmed influenza in children below 15 years of age. PATIENTS AND METHODS: Children presenting with acute respiratory infection and/or isolated fever at the Basurto University Hospital, Bilbao, Spain between November 2010 and May 2011 were included in this study (NCT01592799). Two nasopharyngeal secretion samples were taken from each; one for a rapid influenza diagnostic test in the emergency department, and the second for laboratory analysis using real-time polymerase chain reaction and viral culture. RESULTS: A total of 501 children were recruited, of whom 91 were hospitalized. Influenza diagnosis was confirmed in 131 children (26.1%); 120 of 410 (29.3%) treated as outpatients and 11 of 91 (12.1%) hospitalized children. A total of 370 of 501 children (73.9%) had no laboratory test positive for influenza. The proportion of subjects with other respiratory viruses was 145/501 (28.9%) cases and co-infection with the influenza virus plus another respiratory virus was detected in 7/501 (1.4%) cases. Influenza virus types were: A (H1N1 and H3N2) 53.2% (67/126); B (Victoria and Yamagata) 46.0% (58/126); A+B 0.8% (1/126). The median direct medical costs associated with each case of laboratory-confirmed influenza was €177.00 (N=131). No significant differences were observed between the medical costs associated with influenza A and B. CONCLUSION: Almost half of the cases were influenza virus B type. The administration of a vaccine containing influenza A and B types to children below 15 years of age might reduce the overall burden of the illness.

A prospective study to assess the burden of influenza-related hospitalizations and emergency department visits among children in Bilbao, Spain (2010-2011).

INTRODUCTION: This study was undertaken to estimate the burden of morbidity associated with laboratory-confirmed influenza in children below 15 years of age. PATIENTS AND METHODS: Children presenting with acute respiratory infection and/or isolated fever at the Basurto University Hospital, Bilbao, Spain between November 2010 and May 2011 were included in this study (NCT01592799). Two nasopharyngeal secretion samples were taken from each; one for a rapid influenza diagnostic test in the emergency department, and the second for laboratory analysis using real-time polymerase chain reaction and viral culture. RESULTS: A total of 501 children were recruited, of whom 91 were hospitalized. Influenza diagnosis was confirmed in 131 children (26.1%); 120 of 410 (29.3%) treated as outpatients and 11 of 91 (12.1%) hospitalized children. A total of 370 of 501 children (73.9%) had no laboratory test positive for influenza. The proportion of subjects with other respiratory viruses was 145/501 (28.9%) cases and co-infection with the influenza virus plus another respiratory virus was detected in 7/501 (1.4%) cases. Influenza virus types were: A (H1N1 and H3N2) 53.2% (67/126); B (Victoria and Yamagata) 46.0% (58/126); A + B 0.8% (1/126). The median direct medical costs associated with each case of laboratory-confirmed influenza was €177.00 (N = 131). No significant differences were observed between the medical costs associated with influenza A and B. CONCLUSION: Almost half of the cases were influenza virus B type. The administration of a vaccine containing influenza A and B types to children below 15 years of age might reduce the overall burden of the illness.

INTRODUCCIÓN: El estudio se llevó a cabo para estimar la carga de enfermedad de la gripe confirmada por laboratorio en niños menores de 15 años. PACIENTES Y MÉTODOS: Los niños que acudieron al Hospital Universitario de Basurto con síntomas de infección respiratoria aguda y/o fiebre aislada entre noviembre de 2010 y mayo de 2011 fueron incluidos en el estudio (NCT01592799). Se tomaron 2 muestras de secreción nasofaríngea: una para un test de diagnóstico rápido en el Servicio de Urgencias y otra para análisis en laboratorio con reacción en cadena de la polimerasa en tiempo real y cultivo viral. RESULTADOS: Se seleccionó a un total de 501 niños, de los que 91 fueron hospitalizados. El diagnóstico de gripe se confirmó en 131 (26,1%); 120/410 (29,3%) fueron tratados ambulatoriamente y 11/91 (12,1%), hospitalizados. En 370/501 niños (73,9%) el resultado no fue positivo. La proporción de otros virus respiratorios fue 145/501 (28,9%) casos y de coinfección con otro virus respiratorio además de gripe de 7/501 (1,4%). Los tipos de virus de gripe fueron: A (H1N1 y H3N2) 53,2% (67/126); B (Victoria y Yamagata) 46,0% (58/126); A + B 0,8% (1/126). El coste médico directo medio asociado con cada caso de gripe confirmada fue de 177,00 € (N = 131). No se observaron diferencias estadísticamente significativas entre el coste asociado con gripe A o B. CONCLUSIÓN: Casi la mitad de los casos fueron virus de gripe B. La administración de una vacuna que incluya tipos A y B de gripe debería reducir la carga de la enfermedad.

Rotavirus gastroenteritis in children less than five years of age in primary care settings in Bulgaria: an observational study.

BACKGROUND: Rotavirus (RV) causes a high proportion of acute gastroenteritis (AGE) cases, especially among children under the age of five years old. This surveillance study was undertaken to study the incidence and severity of rotavirus gastroenteritis (RVGE) in primary care settings in Bulgaria over a one-year period. METHODS: In this prospective, observational study of AGE cases in children under five years of age presenting in the primary care setting over a one year period, stool samples were collected and tested for RV using a rapid visual immunochromatographic test kit. After the first visit, parents monitored their child for about two weeks and reported the symptoms experienced by the child during the follow-up period to the physician in a follow-up phone call. The percentage of RVGE cases among AGE was calculated and the severity of AGE (according to the 20-point Vesikari scale) was assessed by the physician based on the symptoms reported by the parents. The seasonality of RVGE was also studied. RESULTS: The proportion of RVGE among the 624 AGE cases examined was 25.5%. Severe AGE was experienced by 81.8% RV-positive and 54.6% RV-negative children (p-value <0.001) and a third of all severe AGE cases occurred in RV-positive patients. A multivariate logistic regression analysis of the determinants of hospitalization indicated that severity of disease and RV-positivity were the statistically significant variables explaining hospitalization of AGE cases; even controlling for severity, RV-positive patients were more often hospitalized than RV-negative ones. RVGE cases occurred throughout the year, with peaks during August and September. CONCLUSION: Our study emphasizes that RV is an important cause of AGE in children under five presenting in primary care settings in Bulgaria and a disproportionately high proportion of severe AGE cases may be attributed to RV infections. TRIAL REGISTRATION NUMBER: NCT01733849.

Incidence of acute otitis media in children below 6 years of age seen in medical practices in five East European countries.

BACKGROUND: Although acute otitis media (AOM) remains a major public health problem worldwide and brings economic burden on health care system and caregivers, little information is available about its epidemiology in Eastern Europe. METHODS: We conducted an epidemiological, prospective, observational, multi-centre cohort study (NCT01365390) in five East European countries (Estonia, Lithuania, Poland, Romania and Slovenia) between June 2011 and January 2013 to determine the incidence and clinical characteristics of AOM among children aged < 6 years during 1 year. RESULTS: AOM incidence was 160.7 cases (95 % confidence interval [CI]: 144.7-177.9) per 1000 person-years (PY) being the lowest in the < 1 year age group (92.3 cases [95 % CI: 59.7-136.2] per 1000 PY) and the highest in the 3- < 4 years age group (208.9 cases [95 % CI: 165.1-260.7] per 1000 PY). AOM incidence was similar across the countries, with the exception of Slovenia (340.3 cases [95 % CI: 278.3-412.0] per 1000 PY). There was a lower risk in breastfed children and a higher risk in those attending school/childcare or with allergies. AOM required 521 visits to the doctor. Antibiotics were prescribed for 276 (74.8 %) episodes with the lowest prescription rate in Estonia (51.4 %) and the highest in Romania (83.7 %). Complications were rare and hospitalisations occurred in 2 % of the cases. CONCLUSIONS: The disease burden of AOM in Eastern Europe is relevant and public health initiatives to reduce it should be considered. TRIAL REGISTRATION: ClinicalTrial.gov NCT01365390 .

A comprehensive review of the epidemiology and disease burden of Influenza B in 9 European countries.

This review was undertaken to consolidate information on the epidemiology and burden of influenza B, as well as the circulation patterns of influenza B lineage in 9 European countries. Following a comprehensive search of peer-reviewed and gray literature sources, we found that published data on influenza B epidemiology and burden are scarce. Surveillance data show frequent co-circulation of both influenza B lineages during influenza seasons, but little is known about its impact, especially in adults and the clinical burden of influenza B remains unknown. Mismatch between the circulating influenza B lineage and vaccine recommendations has been seen in at least one influenza season in every country. Such observations could impact the effectiveness of seasonal influenza vaccination programs using trivalent vaccines, which contain only one influenza B lineage (B/Yamagata or B/Victoria) and highlight the need for local studies to better understand the epidemiology and burden of influenza B in these countries.

Seroprevalence of pertussis amongst healthcare professionals in Spain.

INTRODUCTION: This multi-center, hospital-based observational study determined the seroprevalence of pertussis antibodies amongst healthcare professionals from three different hospitals in Spain to ascertain the health status of professionals attending to susceptible groups who are at risk of contracting and transmitting pertussis. METHODS: Medical professionals from three hospitals in Spain were recruited for this study (NCT01706224). Serum samples from subjects were assessed for anti-pertussis antibodies by ELISA. The percentage of subjects positive for anti-pertussis antibodies were determined by age-strata, gender, vaccination status, professional level (physicians, nurses, ancillary nurses and midwives), hospital department, number of working years, numbers of hours spent with the patient as well as number of children in the household. RESULTS: Overall, 31.2% of subjects were seropositive; 3.3% of these healthcare professionals had ELISA values indicative of current or recent infection. There were no significant differences in terms of pertussis prevalence with respect to age, gender, hospital department, profession, number of working years and number of hours spent with patients. These levels of seronegativity amongst healthcare workers further strengthen the rationale for vaccination amongst this specific population against pertussis.

EPICOR (long-tErm follow-up of antithrombotic management Patterns In acute CORonary syndrome patients) study: rationale, design, and baseline characteristics.

BACKGROUND: There is limited information about patterns of use of newer antithrombotic drugs in patients with acute coronary syndromes (ACS) in a real-life setting. The effectiveness, safety and cost-effectiveness of potential combinations during hospitalization, the duration of therapies, interruptions, or discontinuations as well as their reasons and possible consequences are unknown. METHODS: EPICOR (NCT01171404) is a prospective, multinational, observational study on patients discharged after a hospitalization for an ACS with 2-year follow-up. The study is designed to describe the patterns of antithrombotic use and to evaluate potential differences in short- and long-term clinical outcomes (ischemic and bleeding events), quality of life and economic impact associated with initial combinations during hospitalization, and treatment duration, discontinuations, or interruptions and their reasons after discharge in different clinical environments. RESULTS: Between September 1, 2010, and March 31, 2011, 10,568 consecutive patients surviving an ACS (4943 with ST-segment elevation myocardial infarction, and 5625 with non-ST-segment elevation ACS) were enrolled from 555 hospitals in 20 countries from 4 pre-defined regions: Northern Europe (n = 3,782), Southern Europe (n = 2,337), Eastern Europe (n = 2,380), and Latin America (n = 2,069). Pre- and in-hospital management and outcomes were recorded, with a special focus on antithrombotic therapies and ischemic and bleeding events. Changes in antithrombotic treatments and outcomes are currently being registered during the planned 24-month follow-up. CONCLUSION: EPICOR will show current patterns of antithrombotic use during hospitalization and after discharge in 'real-world' patients with ACS, allowing exploration of potential differences in clinical outcomes, quality of life, and costs related to the different antithrombotic practice patterns.

Variability in the management of nonvariceal upper gastrointestinal bleeding in Europe: an observational study.

INTRODUCTION: Despite recent advances in endoscopic and pharmacological management, nonvariceal upper gastrointestinal bleeding (NVUGIB) is still associated with considerable mortality and morbidity that vary between countries. The European Survey of Nonvariceal Upper Gastrointestinal Bleeding (ENERGiB) reported clinical outcomes across Europe (Belgium, Greece, Italy, Norway, Portugal, Spain, and Turkey) and evaluated management strategies in a "real-world" European setting. This article presents the differences in clinical management strategies among countries participating in ENERGiB. METHODS: Adult patients consecutively presenting with overt NVUGIB at 123 participating hospitals over a 2-month period were included. Data relevant to the initial NVUGIB episode and for up to 30 days afterwards were collected retrospectively from patient medical records. RESULTS: The number of evaluable patients was 2,660; patient demographics and clinical characteristics were similar across countries. There was wide between-country variability in the area and speciality of the NVUGIB management team and unit transfer rates after the initial hospital assessment. The mean time from admission to endoscopy was <1 day only in Italy and Spain. Wide variation in the use of preendoscopy (35.0-88.7%) and relatively consistent (86.5-96.0%) postendoscopic pharmacological therapy rates were observed. There was substantial by-country variability in the rate of therapeutic procedures performed during endoscopy (24.9-47.6%). NVUGIB-related healthcare resource consumption was high and variable (days hospitalized, mean 5.4-8.7 days; number of endoscopies during hospitalization, mean 1.1-1.7). CONCLUSIONS: ENERGiB demonstrates that there are substantial differences in the management of patients with acute NVUGIB episodes across Europe, and that in many cases the guideline recommendations for the management of NVUGIB are not being followed.

Factors associated with health-related quality of life in adults with asthma. A cross-sectional study.

BACKGROUND: The measurement of health-related quality of life (HRQoL) is increasingly recognized as an important endpoint, as a reflection of the effects of the disease from a patient perspective. Our aim was to evaluate the factors determining the HRQoL in patients with asthma, according to the EQ-5D questionnaire. METHODS: Patients were included using multi-stage sampling, from Primary Care clinics from all the Autonomous Communities in Spain. The patients included were: over 18 years-old, with a confirmed diagnosis of asthma for at least one year, and had visited a Health Centre in the previous 2 years. The characteristics of the asthma disease, the adherence to treatment, the socio-demographic variables, the smoking habits, and the asthma control were collected using a questionnaire. The influence of the different variables included in the study on the EQ-5D was evaluated using multivariate logistic regression analysis. RESULTS: A total of 2,125 patients were finally included (57.7% females, mean age 48 years). The response rate was 95.4%. Some factors showed a considerable detrimental effect on the HRQoL of asthmatics. Advanced age, lower educational level and poor control of asthma are significantly associated with a worse quality of life in all the dimensions assessed by the EQ-5D scale. The baseline severity of the asthma, and having been admitted to hospital are related to a worse quality of life in 5 of the 6 dimensions analyzed. CONCLUSION: In our study, we could identify some factors related to quality of life in asthma patients. The most important were advanced age, lower education level, and poor control of the asthma.

Excess risk attributable to traditional cardiovascular risk factors in clinical practice settings across Europe - The EURIKA Study.

BACKGROUND: Physicians involved in primary prevention are key players in CVD risk control strategies, but the expected reduction in CVD risk that would be obtained if all patients attending primary care had their risk factors controlled according to current guidelines is unknown. The objective of this study was to estimate the excess risk attributable, firstly, to the presence of CVD risk factors and, secondly, to the lack of control of these risk factors in primary prevention care across Europe. METHODS: Cross-sectional study using data from the European Study on Cardiovascular Risk Prevention and Management in Daily Practice (EURIKA), which involved primary care and outpatient clinics involved in primary prevention from 12 European countries between May 2009 and January 2010. We enrolled 7,434 patients over 50 years old with at least one cardiovascular risk factor but without CVD and calculated their 10-year risk of CVD death according to the SCORE equation, modified to take diabetes risk into account. RESULTS: The average 10-year risk of CVD death in study participants (N = 7,434) was 8.2%. Hypertension, hyperlipidemia, smoking, and diabetes were responsible for 32.7 (95% confidence interval 32.0-33.4), 15.1 (14.8-15.4), 10.4 (9.9-11.0), and 16.4% (15.6-17.2) of CVD risk, respectively. The four risk factors accounted for 57.7% (57.0-58.4) of CVD risk, representing a 10-year excess risk of CVD death of 5.66% (5.47-5.85). Lack of control of hypertension, hyperlipidemia, smoking, and diabetes were responsible for 8.8 (8.3-9.3), 10.6 (10.3-10.9), 10.4 (9.9-11.0), and 3.1% (2.8-3.4) of CVD risk, respectively. Lack of control of the four risk factors accounted for 29.2% (28.5-29.8) of CVD risk, representing a 10-year excess risk of CVD death of 3.12% (2.97-3.27). CONCLUSIONS: Lack of control of CVD risk factors was responsible for almost 30% of the risk of CVD death among patients participating in the EURIKA Study.

Consumo de recursos sanitarios y pérdida de productividad en la enfermedad por reflujo gastroesofágico: resultados de un estudio transversal en el ámbito de la atención primaria en España / Use of health resources and loss of productivity in gastroesophageal reflux disease: results of a cross-sectional study in a Primary Care setting in Spain

Objetivo: Evaluar el consumo de recursos sanitarios y la productividad en pacientes con enfermedad por reflujo gastroesofágico (ERGE), y la influencia de la gravedad de la sintomatología sobre estos factores.DiseñoSubanálisis de la población española de un estudio multinacional con una fase retrospectiva de 4 meses para la identificación y selección de pacientes, y otra transversal para recoger información clínica y consumo de recursos sanitarios, realizado entre octubre de 2007 y enero de 2008.EmplazamientoCentros de atención primaria.Participantes477 pacientes que habían consultado por algún motivo relacionado con la ERGE.Mediciones principalesConsumo de recursos sanitarios, cambios en la productividad evaluada mediante el Cuestionario de Alteración de la Actividad y Productividad Laboral (WPAI-GERD).ResultadosA pesar de recibir tratamiento farmacológico en la visita índice, tras una mediana de 5,1 meses de seguimiento (rango 2,1-8,1), en la visita de recogida de datos un 15,9% (IC 95%=12,8-19,5) de los pacientes continuaba presentando sintomatología de ERGE clínicamente relevante. Los costes médicos directos anuales asociados a pruebas diagnósticas y a consultas médicas en pacientes con y sin sintomatología de ERGE clínicamente relevante fueron 666 € (DE: 2.097 €) y 370 € (DE: 2.060 €), respectivamente. El coste medio anual de la pérdida de productividad (17%) fue de 5.316 € (DE: 8.615 €). En pacientes con síntomas clínicamente relevantes de ERGE este coste fue 4 veces superior al de pacientes sin sintomatología relevante (15.188 € [DE: 11.206 €] vs 3.926 € [DE: 7.232 €]).ConclusiónLos pacientes con ERGE consumen importantes recursos sanitarios, atribuibles a los costes médicos asociados y a la notable pérdida de productividad, incluso aunque reciban tratamiento(AU)

Objective: To evaluate healthcare resource use and productivity in patients with gastro-esophageal reflux disease (GERD) and the influence of disease severity on these two factors.DesignSub-analysis of the Spanish population of a multinational study with a 4-month retrospective period for the identification and selection of patients, and a clinical visit to obtain clinical information and data on use of healthcare resources, carried out between October 2007 and January 2008.PopulationA total of 477 patients attending a Primary Care centre, with a medical consultation for GERD.Main variablesUse of healthcare resources, changes in productivity based on the Work Productivity and Activity Impairment Questionnaire for GERD patients (WPAI-GERD).ResultsDespite having received pharmacological treatment at the baseline visit, after a median of 5.1 months follow-up (range 2.1-8.1), up to 15.9% (95% CI; 12.8-19.5) patients still showed clinically relevant GERD symptoms. Direct medical costs per year associated with diagnostic tests and medical consultations in patients with or without clinically relevant GERD symptoms were 666 € (SD: 2,097 €) and 370 € (SD: 2,060 €), respectively. The mean annual cost of reduced productivity (17%) was 5,316 € (SD: 8,615 €). This cost was 4 times higher for patients with clinically relevant GERD symptoms than for patients with no relevant symptoms (15,188€ [SD: 11,206 €] vs 3,926 € [SD: 7,232 €]).ConclusionPatients with GERD use significant healthcare resources, attributable to associated medical costs and marked reduction in productivity, even though they receive pharmacological treatment(AU)

Sesgos de confusión por indicación y gravedad en estudios observacionales / Confounding bias due to indication and severity in observational studies

Los estudios observacionales están sujetos a sesgos que pueden conducir a una interpretación errónea de los resultados. El presente estudio tuvo como objetivo determinar la influencia del tratamiento con omeprazol sobre la duración de la baja laboral en pacientes con esguince de tobillo que tomaban antiinflamatorios no esteroideos. Se utilizaron los registros de la base de datos de la mutua Ibermutuamur. Encontra de lo esperado, se observó que los pacientes que recibieron omeprazol presentaron una baja más prolongada que los que no recibieron omeprazol. Es probable que estos hallazgos se deban a la influencia de un sesgo de confusión por gravedad, pues los pacientes que recibieron omeprazol presentaban un esguince más grave, aunque no se puede descartar un sesgo de confusión por indicación. Para evitar la influencia de estos errores sistemáticos se deben controlar los sesgos a lo largo de todo el estudio, desdeel diseño hasta el análisis de los datos (AU)

Observational studies are subject to biases that may lead to mis interpretation of the results. This studyaimed to determine the influence of omeprazole treatment on the duration of sick leave in patients with ankle sprains treated with non-steroidal anti-inflammatory drugs. We used the Ibermutuamur database. Contrary to our expectations, sick leave was longer in patients who received omeprazole than in those who did not. These findings were probably due to the influence of a bias due to confounding by severity,given that patients who received omeprazole had a worse kind of ankle sprain; however, a bias due to confounding by indication cannot be excluded. To avoid the influence of these systematic errors, biases should be monitored from the design stage to the data analysis stage (AU)

[Use of health resources and loss of productivity in gastroesophageal reflux disease: results of a cross-sectional study in a primary care setting in Spain]. / Consumo de recursos sanitarios y pérdida de productividad en la enfermedad por reflujo gastroesofágico: resultados de un estudio transversal en el ámbito de la atención primaria en España.

OBJECTIVE: To evaluate healthcare resource use and productivity in patients with gastro-esophageal reflux disease (GERD) and the influence of disease severity on these two factors. DESIGN: Sub-analysis of the Spanish population of a multinational study with a 4-month retrospective period for the identification and selection of patients, and a clinical visit to obtain clinical information and data on use of healthcare resources, carried out between October 2007 and January 2008. POPULATION: A total of 477 patients attending a Primary Care centre, with a medical consultation for GERD. MAIN VARIABLES: Use of healthcare resources, changes in productivity based on the Work Productivity and Activity Impairment Questionnaire for GERD patients (WPAI-GERD). RESULTS: Despite having received pharmacological treatment at the baseline visit, after a median of 5.1 months follow-up (range 2.1-8.1), up to 15.9% (95% CI; 12.8-19.5) patients still showed clinically relevant GERD symptoms. Direct medical costs per year associated with diagnostic tests and medical consultations in patients with or without clinically relevant GERD symptoms were 666 € (SD: 2,097 €) and 370 € (SD: 2,060 €), respectively. The mean annual cost of reduced productivity (17%) was 5,316 € (SD: 8,615 €). This cost was 4 times higher for patients with clinically relevant GERD symptoms than for patients with no relevant symptoms (15,188 € [SD: 11,206 €] vs 3,926 € [SD: 7,232 €]). CONCLUSION: Patients with GERD use significant healthcare resources, attributable to associated medical costs and marked reduction in productivity, even though they receive pharmacological treatment.