Effect estimates may be biased when the study design or the data analysis is conditional on a collider—a variable that is caused by two other variables. Causal directed acyclic graphs are a helpful tool to identify colliders that may introduce selection bias in observational research.
Background: With more than 7500 cases reported since April 2022, Spain has experienced the highest incidence of mpox in Europe. From 12 July onward, the modified vaccinia Ankara-Bavaria Nordic (MVA-BN) smallpox vaccine was offered as pre-exposure prophylaxis for those receiving pre-exposure prophylaxis for human immunodeficiency virus (HIV-PrEP). Our aim was to assess the effectiveness of 1 dose of MVA-BN vaccine as pre-exposure prophylaxis against mpox virus (MPXV) infection in persons on HIV-PrEP. Methods: National retrospective cohort study between 12 July and 12 December 2022. Individuals aged ≥18 years receiving HIV-PrEP as of 12 July with no previous MPXV infection or vaccination were eligible. Each day, we matched individuals receiving a first dose of vaccine and unvaccinated controls of the same age and region. We used a Kaplan–Meier estimator, calculated risk ratios (RR) and vaccine effectiveness (VE = [1 − RR]x100). Results: We included 5660 matched pairs, with a median follow-up of 62 days (interquartile range, 24–97). Mpox cumulative incidence was 5.6 per 1000 (25 cases) in unvaccinated and 3.5 per 1000 (18 cases) in vaccinated. No effect was found during days 0–6 post-vaccination (VE, −38.3; 95% confidence interval [CI], −332.7 to 46.4), but VE was 65% at ≥7 days (95% CI, 22.9 to 88.0) and 79% at ≥14 days (95% CI, 33.3 to 100.0) post-vaccination. Conclusions: One dose of MVA-BN vaccine offered protection against mpox in most-at-risk population shortly after the vaccination. Further studies need to assess the VE of a second dose and the duration of protection over time.
Background: Respiratory syncytial virus (RSV) causes substantial morbidity in infants < 1 year. In October 2023, Spain recommended the monoclonal antibody nirsevimab to all children born since 1 April 2023, at birth or as catch-up if born before October 2023. Aim: We estimated nirsevimab effectiveness in preventing RSV hospitalisations during the 2023/24 season. Methods: We conducted a nationwide population-based matched case–control study. Cases were children hospitalised for lower respiratory tract infection who were RSV PCR-positive. For each case, we selected four population density controls born in the same province and date (±2 days). We defined at-birth immunisation as receiving nirsevimab during the first 2 weeks of life, and catch-up immunisation within 30 days from campaign onset. Causal intention-to-treat (ITT) and per-protocol (PP) effectiveness was estimated using inverse-probability-of-immunisation weighted conditional logistic regression. Results: We included 406 cases and 1,623 controls in catch-up and 546 cases and 2,182 controls in at-birth immunisation studies. Effectiveness in preventing RSV hospitalisations for catch-up immunisation was 71% (95% confidence interval (CI): 65–76) by ITT and 80% (95% CI: 75–84) PP. Effectiveness for at-birth immunisation was 78% (95% CI: 73–82) by ITT and 83% (95% CI: 79–87) PP. Effectiveness was similar for ICU admission, need of mechanical ventilation, and RSV viral subgroups A and B. Children born pre-term or with birthweight < 2,500 g showed lower PP effectiveness of 60–70%. Conclusions: Population-level nirsevimab immunoprophylaxis in children in their first RSV season was very effective in preventing RSV hospitalisations, ICU admission and mechanical ventilation, with reduced but still high effectiveness for pre-term and low-birthweight children.
Background: This study sought to ascertain whether there might be excess lung cancer mortality among the population residing in the vicinity of Spanish paper and board industries which report their emissions to the European Pollutant Emission Register (EPER). Methods: This was an ecological study that modelled the Standardised Mortality Ratio (SMR) for lung cancer in 8073 Spanish towns over the period 1994–2003. Population exposure to industrial pollution was estimated on the basis of distance from town of residence to pollution source. An exploratory, near-versus-far analysis was conducted, using mixed Poisson regression models and an analysis of the effect of municipal proximity within a 50-kilometre radius of each of the 18 installations. Results: Results varied for the different facilities. In two instances there was an increasing mortality gradient with proximity to the installation, though this was exclusively observed among men. Conclusion: The study of cancer mortality in areas surrounding pollutant foci is a useful tool for environmental surveillance, and serves to highlight areas of interest susceptible to being investigated by ad hoc studies. Despite present limitations, recognition is therefore due to the advance represented by publication of the EPER and the study of pollutant foci.