Short- and mid-term morbidity and primary-care burden due to infant respiratory syncytial virus infection: A Spanish 6-year population-based longitudinal study.

BACKGROUND: The morbidity burden of respiratory syncytial virus (RSV) in infants extends beyond hospitalization. Defining the RSV burden before implementing prophylaxis programs is essential for evaluating any potential impact on short- to mid-term morbidity and the utilization of primary healthcare (PHC) and emergency services (ES). We established this reference data using a population-based cohort approach. METHODS: Infants hospitalized for RSV from January 2016 to March 2023 were matched with non-hospitalized ones based on birthdate and sex. We defined the exposure as severe RSV hospitalization. The main study outcomes were as follows: (1) PHC and ES visits for RSV, categorized using the International Classification of Primary Care codes, (2) prescriptions for respiratory airway obstructive disease, and (3) antibacterial prescriptions. Participants were followed up from 30 days before hospitalization for severe RSV until the outcome occurrence or end of the study. Adjusted incidence rate ratios (IRRs) of the outcomes along with their 95% confidence intervals (CI) were estimated using Poisson regression models. Stratified analyses by type of PHC visit (nurse, pediatrician, or pharmacy) and follow-up period were undertaken. We defined mid-term outcomes as those taking place up to 24 months of follow-up period. RESULTS: The study included 6626 children (3313 RSV-hospitalized; 3313 non-hospitalized) with a median follow-up of 53.7 months (IQR = 27.9, 69.4). After a 3-month follow-up, severe RSV was associated with a considerable increase in PHC visits for wheezing/asthma (IRR = 4.31, 95% CI: 3.84-4.84), lower respiratory infections (IRR = 4.91, 95% CI: 4.34-5.58), and bronchiolitis (IRR = 4.68, 95% CI: 2.93-7.65). Severe RSV was also associated with more PHC visits for the pediatrician (IRR = 2.00, 95% CI: 1.96-2.05), nurse (IRR = 1.89, 95% CI: 1.75-1.92), hospital emergency (IRR = 2.39, 95% CI: 2.17-2.63), primary healthcare emergency (IRR: 1.54, 95% CI: 1.31-1.82), as well as with important increase in prescriptions for obstructive airway diseases (IRR = 5.98, 95% CI: 5.43-6.60) and antibacterials (IRR = 4.02, 95% CI: 3.38-4.81). All findings remained substantial until 2 years of post-infection. CONCLUSIONS: Severe RSV infection in infants significantly increases short- to mid-term respiratory morbidity leading to an escalation in healthcare utilization (PHC/ES attendance) and medication prescriptions for up to 2 years afterward. Our approach could be useful in assessing the impact and cost-effectiveness of RSV prevention programs.

Effectiveness and impact of universal prophylaxis with nirsevimab in infants against hospitalisation for respiratory syncytial virus in Galicia, Spain: initial results of a population-based longitudinal study.

BACKGROUND: Galicia (Spain) was one of the first regions worldwide to incorporate nirsevimab for universal respiratory syncytial virus (RSV) prophylaxis in infants into its immunisation programme. The NIRSE-GAL longitudinal population-based study aimed to assess nirsevimab effectiveness in preventing hospitalisations (ie, admittance to hospital). METHODS: The 2023-24 immunisation campaign with nirsevimab in Galicia began on Sept 25, 2023, and concluded on March 31, 2024. The campaign targeted three groups: infants born during the campaign (seasonal group), infants younger than 6 months at the start of the campaign (catch-up group), and infants aged 6-24 months with high-risk factors at the start of the campaign (high-risk group). Infants in the seasonal group were offered immunisation on the first day of life before discharge from hospital. Infants in the catch-up and high-risk groups received electronic appointments to attend a public hospital or health-care centre for nirsevimab administration. For this interim analysis, we used data collected from Sept 25 to Dec 31, 2023, from children born up to Dec 15, 2023. Data were retrieved from public health registries. Nirsevimab effectiveness in preventing RSV-associated lower respiratory tract infection (LRTI) hospitalisations; severe RSV-related LRTI requiring intensive care unit admission, mechanical ventilation, or oxygen support; all-cause LRTI hospitalisations; and all-cause hospitalisations was estimated using adjusted Poisson regression models. Data from five past RSV seasons (2016-17, 2017-18, 2018-19, 2019-20, and 2022-23), excluding the COVID-19 pandemic period, were used to estimate the number of RSV-related LRTI hospitalisations averted along with its IQR. The number needed to immunise to avoid one case in the 2023-24 season was then estimated from the averted cases. Nirsevimab safety was routinely monitored. The NIRSE-GAL study protocol was registered on ClinicalTrials.gov (NCT06180993), and follow-up of participants is ongoing. FINDINGS: 9408 (91·7%) of 10 259 eligible infants in the seasonal and catch-up groups received nirsevimab, including 6220 (89·9%) of 6919 in the seasonal group and 3188 (95·4%) of 3340 in the catch-up group. 360 in the high-risk group were offered nirsevimab, 348 (97%) of whom received it. Only infants in the seasonal and catch-up groups were included in analyses to estimate nirsevimab effectiveness and impact because there were too few events in the high-risk group. In the catch-up and seasonal groups combined, 30 (0·3%) of 9408 infants who received nirsevimab and 16 (1·9%) of 851 who did not receive nirsevimab were hospitalised for RSV-related LRTI, corresponding to an effectiveness of 82·0% (95% CI 65·6-90·2). Effectiveness was 86·9% (69·1-94·2) against severe RSV-related LRTI requiring oxygen support, 69·2% (55·9-78·0) against all-cause LRTI hospitalisations, and 66·2% (56·0-73·7) against all-cause hospitalisations. Nirsevimab effectiveness against other endpoints of severe RSV-related LRTI could not be estimated because of too few events. RSV-related LRTI hospitalisations were reduced by 89·8% (IQR 87·5-90·3), and the number needed to immunise to avoid one RSV-related LRTI hospitalisation was 25 (IQR 24-32). No severe adverse events related to nirsevimab were registered. INTERPRETATION: Nirsevimab substantially reduced infant hospitalisations for RSV-associated LRTI, severe RSV-associated LRTI requiring oxygen, and all-cause LRTI when given in real-world conditions. These findings offer policy makers and health authorities robust, real-world, population-based evidence to guide the development of strategies for RSV prevention. FUNDING: Sanofi and AstraZeneca. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.

Assessment of effectiveness and impact of universal prophylaxis with nirsevimab for prevention of hospitalizations due to respiratory syncytial virus in infants. The NIRSE-GAL study protocol.

Nirsevimab has been recently licensed for universal RSV prophylaxis in infants. NIRSE-GAL is a three-year population-based study initiated in Galicia in September 2023. It aims to evaluate nirsevimab effectiveness against RSV-related hospitalizations lower respiratory tract infections (LRTI), severe RSV, all-cause LRTI, and all-cause hospitalization. NIRSE-GAL also aims to estimate nirsevimab impact on primary healthcare use in the short and mid-term, children's wheezing and asthma, and medical prescriptions for RSV. The immunization campaigns will be scheduled based on the expected start week for the RSV season and will last the whole season. Immunization will be offered to: i) infants born during the campaign (seasonal), ii) infants < 6 months at the start of the campaign (catch-up), and iii) infants with high-risk factors, aged 6-24 months at the start of the campaign (high-risk). The follow-up period will start: i) the immunization date for all immunized infants, ii) the start of the campaign, for the non-immunized catch-up or high-risk groups, or iii) the birthdate for the non-immunized seasonal group. Infants will be followed up until outcome occurrence, death, or end of study. Nirsevimab effectiveness will be estimated using Poisson and Cox regression models. Sensitivity and stratified analyses will be undertaken. The number of averted cases and the number needed to immunize will be estimated. Immunization failure and nirsevimab safety will be monitored. NIRSE-GAL was approved by the ethics committee of Galicia (CEIC 2023-377) and registered in ClinicalTrials.gov (ID: NCT06180993). Findings will be mainly shared via peer-reviewed publications and scientific conferences.

Factors associated with a higher prevalence of work disability among asthmatic patients.

OBJECTIVE: To study asthma-related absenteeism in the asthmatic population in Spain and to identify some risk factors for absenteeism. METHODS: A cross-sectional study was performed on patients who had been diagnosed with asthma in the primary care setting at least 1 year before the start of this study. A questionnaire was designed that included socio-demographic and clinical variables. The time absent from work in the previous year was self-reported by the patients. RESULTS: More than 25% of the asthmatic population in Spain took sick leave during the previous year. Visits to a general practitioner or to the emergency department are the factors associated with the greatest risk of absenteeism. CONCLUSIONS: Absenteeism is common within the asthmatic population in Spain. The authors of this study believe that some of the determining factors could be modified by the health-care system.

Risky alcohol use and heavy episodic drinking among Spanish University students: a two-year follow-up

Objective To evaluate the incidence of risky consumption (RC) and heavy episodic drinking (HED) in the Cohort of Spanish university students at two-year follow-up and to identify predictors of these patterns of alcohol consumption and the association between these patterns and academic achievement. Method We carried out a cohort study. Alcohol consumption was measured with the AUDIT. The following variables were collected by questionnaire: place of residence, parents' education, alcohol consumption in the family, age of on set of use, alcohol expectancies, and the academic achievement. We constructed logistic regression models using three dependent variables: RC, HED, and academic achievement.Results The response rate at two-year follow-up was 64.1%. The incidence of RC and HED at two-year follow-up were 24.92% and 4.01% respectively. The prevalence of RC rose from 37.1% to 54.6%. On the contrary, HED dropped from 12.2% to 8.7%. In relation to incidence of RC, being male (OR=2.77), medium (OR=1.59) or high expectancies (OR=2.24), and early age of onset of use (OR=2.26) constituted risk factors. In contrast, living with parents constituted a protective factor (OR=0.48). For HED, being male (OR=1.92) and high expectancies (OR=2.96) were risk factors. RC and HED were risk factors for low academic achievement.Conclusions HED is a pattern of alcohol consumption mainly associated with adolescence, while RC is associated with youth. Both patterns are predictors of academic achievement. Public Health strategies should focus on modifying expectancies and limit access to alcohol at young ages (AU)

Objetivo Determinar la incidencia del consumo de riesgo de alcohol (CR) y del consumo intensivo (CI) en una cohorte de estudiantes universitarios a los 2 años de seguimiento e identificar los factores de estas pautas de consumo de alcohol y su asociación con el redimiento académico.Método Se ha realizado un estudio de cohortes. El consumo de alcohol se ha medido con el AUDIT. Las siguientes variables se han medido mediante cuestionario: lugar de residencia, educación parental, consumo de alcohol en la familia, edad de inicio de uso, expectativas sobre alcohol y rendimiento académico. Para el análisis de datos se han construido modelos de regresión logística con las tres variables dependientes consideradas: CR, CI y rendimiento académico.Resultados La tasa de respuesta en el seguimiento se situó en el 64,1%. La incidencia de CR y CI a los 2 años fue del 24,92% y el 4,01%. La prevalencia de CR aumentó del 37,1% al 54,6%. Por el contrario, el CI disminuyó del 12,2% al 8,7%. Con relación a la incidencia de CR, el ser varón (OR=2,77), las medias (OR=1.59) y altas expectativas (OR=2.24), y la edad temprana de inicio de uso (OR=2,26) son factores de riesgo. Por el contrario, el vivir con los padres muestra un factor protector (OR=0,48). Para el CI, ser varón (OR=1,92) y las altas expectativas (OR=2,96) son también factores de riesgo. Ambos patrones de consumo constituyen factores de riesgo del bajo rendimiento académico.Conclusiones El CI es un patrón de consumo principalmente asociado con la adolescencia, mientras que el CR se asocia con la juventud. Ambos patrones son predictores del rendimiento académico. Las estrategias de salud pública deberían centrarse en la modificación de expectativas y en limitar el acceso al alcohol de los más jóvenes (AU)

Risky alcohol use and heavy episodic drinking among Spanish University students: a two-year follow-up.

OBJECTIVE: To evaluate the incidence of risky consumption (RC) and heavy episodic drinking (HED) in the Cohort of Spanish university students at two-year follow-up and to identify predictors of these patterns of alcohol consumption and the association between these patterns and academic achievement. METHOD: We carried out a cohort study. Alcohol consumption was measured with the AUDIT. The following variables were collected by questionnaire: place of residence, parents' education, alcohol consumption in the family, age of onset of use, alcohol expectancies, and the academic achievement. We constructed logistic regression models using three dependent variables: RC, HED, and academic achievement. RESULTS: The response rate at two-year follow-up was 64.1%. The incidence of RC and HED at two-year follow-up were 24.92% and 4.01% respectively. The prevalence of RC rose from 37.1% to 54.6%. On the contrary, HED dropped from 12.2% to 8.7%. In relation to incidence of RC, being male (OR=2.77), medium (OR=1.59) or high expectancies (OR=2.24), and early age of onset of use (OR=2.26) constituted risk factors. In contrast, living with parents constituted a protective factor (OR=0.48). For HED, being male (OR=1.92) and high expectancies (OR=2.96) were risk factors. RC and HED were risk factors for low academic achievement. CONCLUSIONS: HED is a pattern of alcohol consumption mainly associated with adolescence, while RC is associated with youth. Both patterns are predictors of academic achievement. Public Health strategies should focus on modifying expectancies and limit access to alcohol at young ages.

Factores asociados con el control del asma en pacientes de atención primaria en España: el estudio CHAS / Factors Associated with Asthma Control in Primary Care Patients: The CHAS Study

IntroducciónEl control del asma es inadecuado en todas las poblaciones estudiadas hasta el momento actual, generando la mayor parte de los costes de la enfermedad. El obejtivo de nuestro estudio fue evaluar la prevalencia de asma mal controlada en pacientes de atención primaria, e identificar algunos factores asociados con este hecho.MétodosLlevamos a cabo un estudio transversal, incluyendo pacientes asmáticos mayores de 18 años, seguidos en consultas de atención primaria (n=2159). El control del asma se evaluó con el cuestionario «Asthma Control Questionnaire». Las variables sociodemográficas y el cumplimiento terapéutico se evaluaron mediante un cuestionario. Mediante regresión logística se calcularon los OR de asma mal controlada; utilizando como variable dependiente el control del asma, valorado de acuerdo a la puntuación ACQ.ResultadosLa prevalencia de asma no controlada fue del 63,9%. El tratamiento con corticoides orales (OR=6,55), la mayor gravedad del asma (OR=3,11), la presencia de un evento estresante reciente (OR=2,44), una menor importancia otorgada al cumplimiento terapéutico (OR=1,66) y vivir en un medio rural (OR=1,29) fueron factores de riesgo para asma mal controlada. Por el contrario, el sexo, la edad, la obesidad, el tabaquismo, el consumo de alcohol y el nivel educacional no mostraron ninguna influencia sobre el control del asma.ConclusionesEn España el asma permanece mal controlada, y algunos de los factores relacionados con esta situación podrían ser modificables desde el sistema sanitario(AU)

BackgroundAsthma control is inadequate in all populations studied to date, leading to a major part of the cost of the disease. The aim of our study was to evaluate the prevalence of uncontrolled asthma in primary care patients and identify the associated factors.MethodsWe carried out a cross-sectional study of the population of primary care asthmatic patients over 18 years old in Spain (n=2159). Asthma control was measured with the Asthma Control Questionnaire (ACQ). The sociodemographic variables and treatment compliance were measured using a questionnaire. We built logistic-regression models using Asthma control, a dichotomous variable generated from ACQ score.ResultsThe prevalence of uncontrolled asthma was 63.9%. Treatment with oral corticosteroids (OCS) (OR=6.55), greater asthma severity (OR=3.11), presence of a distressing event (OR=2.44), lower significance given to treatment compliance (OR=1.66) and living in a rural area (OR=1.29) are associated with uncontrolled asthma. On the contrary, sex, age, obesity, smoking, alcohol intake and educational level had no effect on asthma control.ConclusionsIn Spain asthma is still uncontrolled and some factors leading to this situation appear to be modifiable by the health system(AU)

[Factors associated with asthma control in primary care patients: the CHAS study]. / Factores asociados con el control del asma en pacientes de atención primaria en España: el estudio CHAS.

BACKGROUND: Asthma control is inadequate in all populations studied to date, leading to a major part of the cost of the disease. The aim of our study was to evaluate the prevalence of uncontrolled asthma in primary care patients and identify the associated factors. METHODS: We carried out a cross-sectional study of the population of primary care asthmatic patients over 18 years old in Spain (n=2159). Asthma control was measured with the Asthma Control Questionnaire (ACQ). The sociodemographic variables and treatment compliance were measured using a questionnaire. We built logistic-regression models using Asthma control, a dichotomous variable generated from ACQ score. RESULTS: The prevalence of uncontrolled asthma was 63.9%. Treatment with oral corticosteroids (OCS) (OR=6.55), greater asthma severity (OR=3.11), presence of a distressing event (OR=2.44), lower significance given to treatment compliance (OR=1.66) and living in a rural area (OR=1.29) are associated with uncontrolled asthma. On the contrary, sex, age, obesity, smoking, alcohol intake and educational level had no effect on asthma control. CONCLUSIONS: In Spain asthma is still uncontrolled and some factors leading to this situation appear to be modifiable by the health system.

[Quality prescription indicators in defined daily doses. Are we getting it right?]. / Indicadores de calidad de la prescripción en dosis diarias definidas. Lo estamos haciendo bien?

Quality prescription indicators of use potential level (UPLI) are defined as the proportion that represents consumption of specific active principles as opposed to the total consumption of the anatomical therapeutic category. The UPLIs that have gradually been defined in Spain employ the defined daily dose (DDD) as the unit of measurement. Although the DDD is not necessarily the same as the therapeutic equivalent dose (TED), some authors have argued that the DDD is a standard unit of measurement and is therefore valid. However, this view may not be correct, given that the relationships between the TED and the DDD differ, depending on the drug, even within the same anatomical therapeutic category. Therefore, the use of DDDs in UPLI s may lead to prescription of a medicine being encouraged or discouraged depending on its TED/DDD ratio.

Indicadores de calidad de la prescripción en dosis diarias definidas. ¿Lo estamos haciendo bien? / Quality prescription indicators in defined daily doses. Are we getting it right

Los indicadores de la calidad de la prescripción de gradopotencial de uso (IGPU) se definen como la proporción querepresenta el consumo de determinados principios activos frenteal consumo total de su categoría anatómica terapéutica.En los últimos años, los IGPU que se han ido definiendo ennuestro país utilizan la dosis diaria definida (DDD) como unidadde medida. Y aunque la DDD no es necesariamente iguala la dosis terapéutica equivalente (DTE), se ha argumentadoque es una unidad de medida estándar y, por tanto, válida.Esto podría no ser correcto, ya que las relaciones entreDTE y DDD son distintas en los diferentes fármacos, inclusodentro de la misma categoría anatómica terapéutica. Por ello,la utilización de las DDD en los IGPU puede llevar a incentivaro desincentivar la prescripción de un fármaco en funciónde su relación DTE/DDD(AU)

Quality prescription indicators of use potential level (UPLI)are defined as the proportion that represents consumption ofspecific active principles as opposed to the total consumptionof the anatomical therapeutic category. The UPLIs that havegradually been defined in Spain employ the defined daily dose(DDD) as the unit of measurement. Although the DDD is notnecessarily the same as the therapeutic equivalent dose (TED),some authors have argued that the DDD is a standard unit ofmeasurement and is therefore valid.However, this view may not be correct, given that the relationshipsbetween the TED and the DDD differ, depending onthe drug, even within the same anatomical therapeutic category.Therefore, the use of DDDs in UPLI s may lead to prescriptionof a medicine being encouraged or discouraged dependingon its TED/DDD ratio(AU)