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.

This is a work in progress. Send us comments you may have.

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

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

 

Subgroup Results

 

 

Side Effects

 

 

Conclusions

 

 

Publications

Heading

Required Items

Recommended Items

Trial Publications

Title, authors, and citation to main results paper

 

Publications Citing Trial

 

 

CONSORT PlusHuman Studyome Project | Contact Us |


© 2002-2010 The Regents of the University of California