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The problem
Intervention: Montelukast monotherapy versus inhaled corticosteroid monotherapy as initial controller therapy for asthma
Who it was tested with: Children aged 1 to <18 years with first incident diagnosis of asthma after birth, from two birth cohorts (AM-PREGNANT from US and Quebec Pregnancy Cohort from Canada).
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"We used Cox proportional hazards regressions, adjusting for potential confounders, to quantify the associations in each birth cohort independently. A random effects Meta-analysis was used to pool outcome-specific results if heterogeneity was acceptable." This longitudinal comparative design with confounding adjustment and pooling across cohorts meets experimental standards for observational epidemiology.
Observational study design limits causal inference; potential residual confounding by disease severity and asthma control; very small montelukast group in QPC (n=373) limits representativeness; inability to assess all potential neuropsychiatric outcomes.
Across countries and designs
1 study · 2 countries
