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Table 2 Outcomes, variable type, time/period of measurement, and statistical analysis for primary and exploratory outcomes

From: The Nordic Aortic Valve Intervention (NOTION) trial comparing transcatheter versus surgical valve implantation: study protocol for a randomised controlled trial

Outcomea Type of variable Time or period of measurement Statistical type of analysisb
Myocardial infarction, stroke, or all-cause mortality (P) Binary During 12 months 1
Myocardial infarction (E) Binary During 30 days. During 12 months 1
Stroke (E) Binary During 30 days. During 12 months 1
All-cause mortality (E) Binary During 30 days. During 12 months 1
Cardiovascular mortality (E) Binary During 30 days. During 12 months 1
Prosthesis re-intervention (E) Binary During 30 days. During 12 months 1
Conduction abnormality requiring pacemaker (E) Binary During 30 days. During 12 months 1
Arrhythmia (E) Binary During 30 days. During 12 months 1
Endocarditis (E) Binary During 30 days. During 12 months 1
Mechanical ventilation in ≥24 hours (E) Binary During 30 days 1
Acute kidney injury (stage 2 or 3) (E) Binary During 30 days 1
Access-site injury (major) (E) Binary During 30 days 1
Bleeding (major–minor) (E) Ordered During 30 days 3
Number of days hospitalised (E) Discrete During 12 months 2
NYHA functional class (I to IV) (E) Orderedc At 3 months and at 12 months 3
SF-36 Quality of life (E) Continuousc At 3 months and at 12 months 4
Effective orifice area (E) Continuousc At 3 months and at 12 months 4
Prosthesis peak gradient (E) Continuousc At 3 months and at 12 months 4
Prosthesis mean gradient (E) Continuousc At 3 months and at 12 months 4
Prosthesis regurgitation (E) Orderedd At 3 months and at 12 months 3
Prosthesis–patient mismatch (severe) (E) Binary At 3 months and at 12 months 1
Left ventricular ejection fraction (E) Continuousc At 3 months and at 12 months 4
  1. P, primary outcome; E, exploratory outcome; NYHA, New York Heart Association; SF-36, Short-form health survey with 36 questions. aOutcomes defined according to Valve Academic Research Consortium criteria. bSee analytical procedures under Statistical analysis plan. c Baseline value is measured and is included in the adjusted analysis. dGraded as none, mild, moderate, or severe.