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Serum cotinine has become the most widely used biomarker of secondhand smoke exposure (SHS) over time in all ages. The aim of this study was to review the serum cotinine cut-points used to classify children under 5 years as exposed to SHS. A systematic review performed in the Pubmed (MEDLINE) and EMBASE databases up to April 2021 was conducted using as key words \"serum cotinine\", \"tobacco smoke pollution\" (MeSH), \"secondhand smoke\", \"environmental tobacco smoke\" and \"tobacco smoke exposure\". Papers which assessed SHS exposure among children younger than 5 years old were included. The PRISMA 2020 guidelines were followed. Analysis was pre-registered in PROSPERO (registration number: CRD42021251263). 247 articles were identified and 51 fulfilled inclusion criteria. The selected studies were published between 1985-2020. Most of them included adolescents and adults. Only three assessed postnatal exposure exclusively among children under 5 years. None of the selected studies proposed age-specific cut-points for children < 5 years old. Cut-point values to assess SHS exposure ranged from 0.015 to 100 ng/ml. The most commonly used cut-point was 0.05 ng/ml, derived from the assay limit of detection used by the National Health and Nutrition Examination Survey (NHANES). No studies have calculated serum cotinine age-specific cut-points to ascertained SHS exposure among children under 5 years old. Children's age-specific cut-points are warranted for health research and public health purposes aimed at accurately estimating the prevalence of SHS exposure and attributable burden of disease to such exposure, and at reinforcing 100% smoke-free policies worldwide, both in homes, private vehicles and public places.

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). 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. 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 catch-up group and 3188 (95·4%) of 3340 in the seasonal 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. 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. Sanofi and AstraZeneca. For the Spanish translation of the abstract see Supplementary Materials section.

Abstract Background This study sought to analyse the trend in smoking-attributable mortality (SAM) in Spain among the population aged ≥35 years across the period 1990–2018. Methods SAM was estimated by applying a prevalence-independent method, which uses lung cancer (LC) mortality as a proxy of tobacco consumption. We sourced observed mortality from the National Institute of Statistics (Spain), LC mortality rates in smokers and never smokers from the Cancer Prevention Study I–II, and relative risks from 5 US cohorts. Estimates of annual SAM by cause of death, sex and age are shown, along with crude and annual standardised SAM rates. The trend in standardised all-cause and LC rates was analysed using a joinpoint regression model. Results Tobacco caused 1 717 150 deaths in Spain in the period 1990–2018. Among men, cancers replaced cardiovascular diseases–diabetes mellitus (CVD–DM) as the leading group of tobacco-related cause of death in 1994. Among women, CVD–DM remained the leading cause of death throughout the period. Trend analysis of standardised SAM rates due to all causes and LC showed a decrease in men and an increase in women. Conclusions The tobacco epidemic in Spain across the period 1990–2018 has had an important impact on mortality and has evolved differently in both genders. SAM is expected to increase dramatically in women in the coming years. SAM data highlight the importance of including a gender perspective in SAM analyses, in designing more effective and comprehensive public health interventions and in developing gender-specific tobacco control policies to curb tobacco consumption.

Bivalent human papillomavirus (HPV) vaccine was incorporated into the childhood vaccination calendar in Galicia, Spain in 2008. The objectives of this study were to estimate direct, indirect and total effectiveness of HPV vaccine and to identify sexual habits changes in the post-vaccination period in Galicia, Spain.Endocervical scrapings of 745 women attending 7 Health Areas of the Galician Public Health Service were collected in the post-vaccination period, from 2014-2017. Two groups were studied: women born between 1989 and 1993 (n = 397) and women born in 1994 or later (n = 348). Twelve high-risk human papillomavirus (HR-HPV) genotypes were detected by Cobas® 4800 HPV test (Roche Diagnostics, Mannheim, Germany). The Linear Array® HPV Genotyping Test (Roche Diagnostics) was used for HR-HPV genotype detection other than HPV 16/18. Information about sexual habits was collected by a self-filled questionnaire. Post-vaccination data were compared to previously published pre-vaccination data obtained between 2008 and 2010 in Galicia from women of the same age (18-26 years old, n = 523). The Stata 14.2 software was employed for statistical analyses.Data from 392 unvaccinated and 353 vaccinated women were compared. For unvaccinated and vaccinated women, HPV 16/18 prevalence was 9.2% and 0.8%, respectively, and HPV 31/33/45 prevalence was 8.4% and 1.1%, respectively. Direct, indirect and total effectiveness of the HPV vaccine were (%, 95% CI): 94 (72-99), 30 (-11-56) and 95 (79-99), respectively, for HPV 16/18 and 83 (46-94), -10 (-88-33) and 84 (54-94), respectively, for HPV 31/33/45. The number of women with first intercourse before 17 years old and 3 or more sexual partners along life was higher in the post-vaccination period (p < 0.05). A positive impact of bivalent HPV vaccine was observed, both on direct and cross protection. Sexual habits could have changed in the post-vaccination period.

ObjectivesCotinine is the gold standard to estimate prevalence of secondhand tobacco smoke (SHS) exposure, and assay limit of detection (LOD) cut-points are typically used regardless of age. Our aim was to compare the concordance between mother-reported SHS exposure and serum cotinine categorising children as exposed with the assay LOD or age-specific cut-points.DesignData from the Health Outcomes and Measures of the Environment (HOME) Study, a prospective pregnancy and birth cohort.SettingHospital or participants’ homes.Participants389 pregnant women aged 18 years and older, between 13 and 19 weeks of gestation, living in a five-county region of the Cincinnati, Ohio metropolitan area, and with follow-up on their children at birth and ages 12, 24, 36 and 48 months.Primary and secondary outcome measuresChildren’s serum cotinine, mother-reported active smoking and SHS exposure were available at birth and during follow-up visits. We used Cohen’s kappa index to assess concordance between maternal self-report and child’s serum cotinine concentrations. We estimated optimal age-specific cut-points, their sensitivity–specificity and positive–negative predictive values with receiver operating characteristic curves.ResultsSelf-reported exposure and cotinine data were available for 280 women who gave birth to singleton child. When applying the assay LOD (0.015 ng/mL), concordance between maternal report and serum cotinine, without accounting for age, was below 0.23 at all times. When using age-specific cut-points (12 months: 0.11 ng/mL; 24 months: 0.08 ng/mL; 36 months: 0.05 ng/mL and 48 months: 0.04 ng/mL), concordance improved, being low at 12 months (0.39), moderate at 24 and 36 months (0.47 and 0.43) and high at 48 months (0.62).ConclusionsConcordance between mother-reported SHS exposure among children under 5 years and serum cotinine improved considerably after applying the cohort-specific and age-specific cut-points. Future studies are necessary to verify these results.

Background: Organised colorectal cancer (CRC) screening programmes have been widely implemented across Europe; however, robust population-level evaluations of their real-world effectiveness, particularly for programmes based exclusively on faecal immunochemical testing (FIT), remain limited. The Galician CRC screening programme was progressively implemented between 2013 and 2019. Methods: We conducted a population-based ecological time-series study using data from the Galician Tumour Registry (ICD-10 C18–C21) for 2015–2023. Age-standardised mortality (ASMR) and incidence (ASIR) rates were analysed. They were calculated using the direct standardisation method, applying age-specific rates to the 2013 European Standard Population (ESP2013). Structural changes associated with programme implementation were evaluated using interrupted time-series (ITS) models, estimating annual percent change (APC) before and after implementation and the net change in slope (ΔAPC). Absolute and relative changes in ASMR and ASIR were calculated by comparing 2015–2017 and 2019–2023. Analyses were performed for the overall population and for individuals aged 50–69 years. Results: Between 2015 and 2023, overall CRC mortality declined significantly (APC −3.00%; 95% CI −3.37 to −2.63). ITS analysis demonstrated a marked modification of mortality trajectories following programme implementation. Mortality shifted from an increasing pre-implementation slope (APC +13.70%; 95% CI 10.12, 17.39) to a significant annual decline post-implementation (APC −3.62%; 95% CI −4.47, −2.76), yielding a ΔAPC of −17.32. In individuals aged 50–69 years, the structural change was more pronounced (ΔAPC −19.88), with post-implementation mortality decreasing by −8.08% annually (95% CI −10.43, −5.66). Incidence showed a comparable structural modification. Overall APC changed from +15.26% (95% CI 5.48, 25.95) before implementation to −2.48% (95% CI −5.29, 0.41) afterwards (ΔAPC −17.74). In the screening-eligible population, APC shifted from +21.32% (95% CI 4.60, 40.71) to −3.74% (95% CI −7.62, 0.30), corresponding to a ΔAPC of −25.06. Descriptively, ASMR declined from 41.92 to 35.91 per 100,000 (−14.33%), and ASIR from 98.37 to 85.16 per 100,000 (−13.42%) between 2015 and 2017 and between 2019 and 2023. Relative reductions were larger in individuals aged 50–69 years and were more pronounced for colon cancer than for rectal cancer. Conclusions: Implementation of an organised FIT-based screening programme was associated with a structural change in CRC mortality and incidence trends, particularly among individuals aged 50–69 years.

Purpose: To assess the possible influence of the presence of varicocele on the quantification of testicular stiffness. Methods: Ultrasound with shear wave elastography (SWE) was performed on 48 consecutive patients (96 testicles) referred following urology consultation for different reasons. A total of 94 testes were studied and distributed in three groups: testes with varicocele (group A, n = 19), contralateral normal testes (group B; n = 13) and control group (group C, n = 62). Age, testicular volume and testicular parenchymal tissue stiffness values of the three groups were compared using the Kruskal–Wallis test. Results: The mean age of the patients was 42.1 ± 11.1 years. The main reason for consultation was infertility (64.6%). The mean SWE value was 4 ± 0.4 kPa (kilopascal) in group A, 4 ± 0.5 kPa in group B and 4.2 ± 0.7 kPa in group C or control. The testicular volume was 15.8 ± 3.8 mL in group A, 16 ± 4.3 mL in group B and 16.4 ± 5.9 mL in group C. No statistically significant differences were found between the three groups in terms of age, testicular volume and tissue stiffness values. Conclusion: Tissue stiffness values were higher in our control group (healthy testicles) than in patients with varicocele.

There is little information on chronic obstructive pulmonary disease (COPD) mortality trends, age of death, or male:female ratio. This study therefore sought to analyze time trends in mortality with COPD recorded as the underlying cause of death from 1980 through 2017, and with COPD recorded other than as the underlying cause of death. We conducted an analysis of COPD deaths in Galicia (Spain) from 1980 through 2017, including those in which COPD was recorded other than as the underlying cause of death from 2015 through 2017. We calculated the crude and standardized rates, and analyzed mortality trends using joinpoint regression models. There were 43,234 COPD deaths, with a male:female ratio of 2.4. Median age of death was 82 years. A change point in the mortality trend was detected in 1996 with a significant decrease across the sexes, reflected by an annual percentage change of −3.8%. Taking deaths into account in which COPD participated or contributed without being the underlying cause led to an overall 42% increase in the mortality burden. The most frequent causes of death when COPD was not considered to be the underlying cause were bronchopulmonary neoplasms and cardiovascular diseases. COPD mortality has decreased steadily across the sexes in Galicia since 1996, and age of death has also gradually increased. Multiple-cause death analysis may help prevent the underestimation of COPD mortality.

As part of the NIRSEGAL study ( https://www.nirsegal.es/en ), we present the clinical characteristics and course of respiratory syncytial virus (RSV)-related low respiratory tract infection (LRTI) hospitalizations in infants eligible for nirsevimab administration during the 2023–2024 season. Infants eligible for nirsevimab immunization (born between 1 April, 2023, and 30 March, 2024) who were hospitalized due to RSV-related LRTI between September 25, 2023, and April 15, 2024, in a hospital from the Galician Public Health system were included. Clinical and demographic characteristics of RSV-related LRTI hospitalizations were analyzed, with comparisons made between breakthrough cases (those immunized with nirsevimab) and non-breakthrough cases. During the study period, 69 RSV-related LRTI hospitalizations were recorded, with a median hospital stay of 4 (interquartile range (IQR) 3–6) days; 65.2% ( N  = 45) were breakthrough cases. The median age was 2.7 (IQR 1.5–5.2) months, and more than half of them ( N  = 39, 56.5%) were male. The incidence of cases was parallel to the RSV epidemic curve, suggesting no waning of nirsevimab efficacy. Of the total hospitalizations, 16 infants (23.2%) had a high-risk condition, 44 (63.8%) needed oxygen support, 15 (21.7%) were admitted to the intensive care unit (ICU), and 11 (15.9%) received non-invasive mechanical ventilation (NIMV). No statistically significant differences were observed in these characteristics when comparing breakthrough and non-breakthrough cases. Conclusion : In the nirsevimab era, a substantial proportion of children who were hospitalized for RSV-related LRTI needed oxygen support, NIMV, and ICU admission. Clinical characteristics, timing, and outcomes were comparable between breakthrough and non-breakthrough cases. Trial registration : The NIRSE-GAL study protocol was registered on ClinicalTrials.gov (NCT06180993). What is Known : • Nirsevimab, a long-acting monoclonal antibody, has shown high effectiveness in preventing RSV-related hospitalizations and has been included in some European countries’ immunization programs . What is New: • During the first RSV season after the universal implementation of nirsevimab in Galicia (Spain), a large proportion of hospitalized infants had high-risk conditions, yet disease severity markers (oxygen need, ICU admission, NIVM) were comparable between breakthrough and non-breakthrough cases . • No signal of waning protection over time was observed among breakthrough cases, reinforcing the potential value of early, season-wide immunization .

The main goals of this study are to estimate the percentage of mothers who declared feeding their children with baby-led weaning (BLW) and to characterize them. A cross-sectional survey was carried out in 2016 targeting women who had given birth in 2016 (sample size 6777) in Galicia (Spain). The questionnaire included questions regarding the mother’s characteristics and behaviors, attitudes, and practices related to BLW. Prevalence of exclusive and non-exclusive BLW was estimated. Different maternal characteristics were evaluated for their possible association with BLW using a logistic regression model. The percentages and ORs were presented with a 95% confidence interval. The study included 6355 women, of which 38.6% (37.4–39.9) had heard of BLW and the overall prevalence of BLW was estimated at 14.0% (13.1–14.9). Prevalence of exclusive BLW was estimated at 2.1% (2.4–3.3). No differences were observed when age was taken into consideration. Children fed with BLW were more likely among mothers who continue with exclusive breastfeeding (OR, 4.1 (95% CI, 3.3–5.0)); live in an urban setting (OR, 1.6 (1.2-2.2)); or have a higher level of education (OR, 1.3 (1.1-1.5)).Conclusion: Full adherence to BLW seems low among mothers who claimed to have fed their children following this method.What is Known:• Baby-led weaning (BLW) has been present in our society for almost two decades, but it remains unclear how many mothers choose BLW for their children.What is New:• BLW is not a common choice for weaning in Spain, and more than half of the mothers had not heard about it.• Full adherence to BLW seems low among mothers who claimed to have fed their children following this method.