Endpoints and measurements
Define exposures outcomes and assessments
Prospective observation allows planned measurements but does not randomize care. Define instruments, outcome windows and exposure updates consistently across visits and sites.
Flow diagram
Steps
Define study objectives
Specify observational exposures and outcome priorities.
Primary outcomes
Define outcome scale, assessment window and population.
Secondary outcomes
Specify roles, exploratory measures and multiplicity implications.
Measure exposure and covariates
Specify instruments, baseline timing and repeated measurements.
Schedule assessments
Define visit windows, ascertainment and validation.
Plan incomplete measurements
Prespecify handling of missed visits, missing data and conflicting measurements.
Endpoints and measurements
End flow
Tables and supporting information
Endpoint and exposure register
Add rows for multiple primary, secondary or safety outcomes.
Assessment schedule
Leave actual dates and values blank.
Instrument evidence
Attach validation and instrument references.