Table 1 Elements needed to define an outcome
From: Caveat emptor: the combined effects of multiplicity and selective reporting
Element | Description |
|---|---|
1. Domain | Title or concept that describes the outcome |
2. Specific measure | Tool or instrument that assesses the outcome domain, including the name of the tool or instrument and/or specific diagnostic criteria and ascertainment procedures |
3. Time point | When the outcome will be assessed |
4. Specific metric | Ways to characterize measurement on each individual (e.g., change in a measurement from baseline to a specific time point) |
5. Method of aggregation | Ways to summarize individual-level measurements into group-level statistics for estimating treatment effect, including if the outcome will be treated as a continuous, categorical, or time-to-event variable and, if relevant, the specific cutoff or categories |