Minimal CONSORT Plus Data Set

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Minimal CONSORT Plus Data Set

The CONSORT Plus reporting requirements are organized into the above major groups. Listed in the tables below are the items that constitute the proposed Minimal Data Set. All RCT Bank entries must contain at least these items. The full CONSORT Plus guideline is available here.

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Click on Descriptor Name for an example of the item.

Administration

Heading	Required Items	Recommended Items
Study Names	Study name
Investigators	Principal investigator name and institution
Ethics
Contact Person	Name of contact person
Funding	Funder names
Oversight Committees
Study Sites		Brief description of study sites
Stage of Trial

Study Design

Heading	Required Items	Recommended Items
Objectives	Primary objective
Power/Sample Size Calculation
Statistical Analysis
Hypotheses	Primary hypothesis
A Priori Subgroups	Subgroup names and definitions
Post hoc Subgroups	Subgroup names and definitions
Study Monitoring
Protocol Changes
Why Study Stopped	Reason study stopped

Participants and Recruitment

Heading	Required Items	Recommended Items
Inclusion Criteria	Inclusion criteria
Exclusion Criteria	Exclusion criteria
Recruitment	Source of participants	Recruitment method
Participant Characteristics	Participant characteristics by intervention group

Treatment Assignment

Heading	Required Items	Recommended Items
Randomization	Unit of randomization	Sequence generation method

Allocation Concealment
Assignment
Randomization Efficacy	Number of participants in each intervention group
Efficacy of Assignment Blinding

Interventions

Heading	Required Items	Recommended Items
Experimental Intervention(s)	Drug Interventions Generic name and description Details of administration Procedures, Devices, or Behavorial Therapy Name of procedure, device, or behavorial therapy^[1] If a device, manufacturer, make and model^[1] Description of intervention and its administration^[1] Organizational and Other Interventions (e.g., guidelines, education) Description of intervention and its administration^[1]
Comparison Intervention	Details of comparison intervention (as above)
Intervention Blinding
Efficacy of Intervention Blinding
Compliance
Crossovers
Treatment Completion
Cointerventions

Outcomes and Analysis

Heading	Required Items	Recommended Items
Primary Outcome(s)	Name(s) and definition(s)
Secondary Outcome(s)	Name(s) and definition(s)
Baseline Characteristics
Side Effects

Outcome Assessment

Heading	Required Items	Recommended Items
Outcome Assessment, Main Study Outcomes
Outcome Assessment, Side Effects
Schedule of Assessments

Followup

Heading	Required Items	Recommended Items
Overall Followup	Number of participants having primary outcome(s) assessed at longest time point for each intervention group
Subgroup Followup	Number of participants having primary outcome(s) assessed at longest time point for each intervention group

Results

Heading	Required Items	Recommended Items
Participant Characteristics	Participant characteristics by intervention group
Main Outcome Results	Raw results (including denominators) per intervention group Estimated effect size and confidence interval
Subgroup Results
Side Effects
Conclusions

Publications

Heading	Required Items	Recommended Items
Trial Publications	Title, authors, and citation to main results paper
Publications Citing Trial

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Minimal CONSORT Plus Data Set

Administration

Study Design

Participants and Recruitment

Treatment Assignment

Interventions

Drug Interventions

Procedures, Devices, or Behavorial Therapy

Organizational and Other Interventions (e.g., guidelines, education)

Outcomes and Analysis

Outcome Assessment

Followup

Results

Publications