Complete CONSORT Plus Guideline

The CONSORT Plus reporting requirements are organized into the above major groups. Listed in the tables below are the required, recommended and optional items in each group. The bolded items are part of the Minimal Data Set.

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Click on Descriptor Name for an example of the item.


Administration

Heading

Required Items

Recommended Items

Optional Items

Study Names

 

 

Investigators

Investigator addresses

Specialties of investigators

Ethics

Who obtained consent

From whom consent obtained

Contact Person

 

 

Funding

Description of funder review of manuscripts

Start and end date of funding

Oversight Committees

 

Study Sites

Stage of Trial

Current stage of trial

 

 

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Study Design

Heading

Required Items

Recommended Items

Optional Items

Objectives

Background to objectives

 

Power/Sample Size Calculation

 

Statistical Analysis

 

Hypotheses

Primary hypothesis

Secondary hypothesis

 

A priori Subgroups

Subgroup names and definitions

Reasons for these a priori subgroups

 

Post hoc Subgroups

 

 

Study Monitoring

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

 

 

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Participants and Recruitment

Heading

Required Items

Recommended Items

Optional Items

Inclusion Criteria

Inclusion criteria

Justification for inclusion criteria

 

Exclusion Criteria

Exclusion criteria

 

Recruitment

Who enrolled the participants

Participant Characteristics

Participant characteristics by intervention group

Participant characteristics by subgroups

Overall participant characteristics

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Treatment Assignment

Heading

Required Items

Recommended Items

Optional Items

Randomization

 

Allocation Concealment

Methods used to implement the allocation sequence

 

 

Assignment

Who assigned participants to their groups

Delay between enrollment and assignment

Who generated the allocation sequence

Randomization Efficacy

Number of participants in each intervention group

Statistical test of differences between subgroup characteristics

Statistical test of differences between intervention group characteristics

Assignment Blinding Efficacy

 

 

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Interventions

Heading

Required Items

Recommended Items

Optional Items

Experimental Intervention(s)

Drug Interventions

 

  • NDC Drug Code[1]
  • FDA approval status[1]

 

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]
  • Proportion of cases done by each proceduralist[1]
  • Training and experience of procedure personnel[1]
  • Setting of procedure (e.g., outpatient surgicenter)[1]

FDA approval status of device[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

Method of participant blinding

Method of care provider blinding

Efficacy of Intervention Blinding

 

 

Compliance

Compliance per intervention group

 

Crossovers

Number of crossovers between all pairs of experimental and comparison groups

Reasons for crossovers

 

Treatment Completion

  • Proportion of each subgroup completing assigned intervention[1]
  • Numbers of participants in each subgroup stopping for each reason[1]

Delay between randomization and start of intervention

Cointerventions

  • Names and descriptions of cointerventions received[1]
  • Use of cointerventions per intervention group[1]
  • Names and descriptions of allowed cointerventions[1]
  • Justification for allowed cointerventions[1]
  • Use of cointerventions per subgroup[1]

 

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Outcome and Analysis

Heading

Required Items

Recommended Items

Optional Items

Primary Outcome(s)

Background/Justification

 

Secondary Outcomes

Background/Justification

 

Baseline Characteristics

 

Background/Justification

Side Effects

Background/Justification

 

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Outcome Assessment

Heading

Required Items

Recommended Items

Optional Items

Outcome Assessment, Main Study Outcomes

Description of assessors and training

Outcome Assessment, Side Effects

Assessment methods

Schedule of Assessments

Timing and schedule of assessments

 

Explanation for timing and schedule of assessments[1]

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Followup

Heading

Required Items

Recommended Items

Optional Items

Overall Followup

Subgroup Followup

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Results

Heading

Required Items

Recommended Items

Optional Items

Participant Characteristics

Participant characteristics by intervention group

Number of participants and their characteristics by subgroups[1]

Overall participant characteristics

Main Outcome Results

Raw value of test statistics (e.g., p-value)

 

Subgroup Results

  • Raw results (including denominators) per subgroup
  • Estimated effect size and confidence interval[1]

Raw value of test statistics (e.g., p-value)

 

Side Effects

  • Raw results (including denominators) per subgroup[1]
  • Raw value of comparative statistics between subgroups (e.g., p-value)[1]

 

Conclusions

Summary conclusions

 

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Publications

Heading

Required Items

Recommended Items

Optional Items

Trial Publications

Titles, authors, citations (including main results paper)

Type of content

Publications Citing Trial

 

 

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[1]Contact us, if you have an example of reporting this element.

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