CONSORT Plus Guideline: Design

University of California San Francisco

Here are the required and recommended information to be reported about a trial's design. The bolded items are part of the Minimal Data Set.

Click on Descriptor Name for an example of the item.

---

Study Design

Heading	Required Items	Recommended Items	Optional Items
Objectives	Primary objective Secondary objectives	Background to objectives
Power/Sample Size Calculation	Outcome for sample size calculation Anticipated outcome in comparison group Anticipated outcome in experimental group(s) Power Alpha and number of tails Target sample size	Target enrollment Reason for difference between enrollment and sample size targets
Statistical Analysis	Intention to treat and/or efficacy analysis done? Statistical test used for each variable type	Computer program used for each test Handling of losses to followup/censoring
A priori Subgroups	Subgroup names and definitions	Reasons for these a priori subgroups
Post hoc Subgroups	Subgroup names and definitions Reasons for these post hoc subgroups
Study Monitoring	Method of interim analysis (stopping rule) Timing of interim analysis Whether monitoring was blinded to treatment received	Description of monitoring personnel	How recommendations for study termination are communicated to investigators
Protocol Changes	Description of protocol changes	Reason for protocol changes	Dates of protocol changes
Why Study Stopped	Reason study stopped

---