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Protocol templates
Pick a study design to draft a multi-country protocol with the AsPEN library of validated phenotypes and shared defaults.
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ACNU
Active-Comparator New-User Design
When you have two drugs from the same indication and want to compare a clinical outcome between them as users start therapy.
Typical example
SGLT2 inhibitors vs DPP-4 inhibitors and risk of MACE
Strengths
Minimises confounding by indication and addresses immortal-time / prevalent-user bias.
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SCCS
Self-Controlled Case Series
When you have transient exposures and acute outcomes, and want each case to act as their own control (eliminating time-invariant confounding).
Typical example
Antipsychotic dispensing and risk of falls in older adults
Strengths
Removes between-person confounding (genetics, lifelong habits). Efficient when cases are easier to identify than the source population.
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CCO
Case-crossover
Outcome-anchored: enrol patients on the acute event itself, then look back to compare exposure prevalence in a short hazard window vs matched control windows. Best when the outcome is abrupt-onset and the exposure is transient.
Typical example
Triggers of acute MI in the 24 hours before onset
Strengths
Each case is their own control across time; matched analysis automatically removes time-invariant within-person confounding (genetics, lifelong habits, persistent comorbidities).
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DA
Descriptive analysis
When you want to characterise a population — how common a disease is, how a drug is used, who dies — rather than test a causal hypothesis. The standard output for multi-country comparisons.
Typical example
DDD/1000/day for anticonvulsants across 14 AsPEN sites, 2010–2023, with joinpoint break detection
Strengths
Provides the denominator AsPEN's causal studies depend on. Covers incidence / prevalence / mortality / drug-utilisation / switching with age-standardisation + joinpoint trend analysis built in.
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