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Table 1 CONSORT 2010 checklist of information to include when reporting a randomized trial

From: Single high-dose buprenorphine for opioid craving during withdrawal

Section/topic

Item no.

Checklist item

Reported on page no.

Title and abstract

 

1a

Identification as a randomized trial in the title

1

1b

Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)

1

Introduction

Background and objectives

1a

Scientific background and explanation of rationale

2

2b

Specific objectives or hypotheses

2

Methods

Trial design

2a

Description of trial design (such as parallel, factorial) including allocation ratio

2

2b

Important changes to methods after trial commencement (such as eligibility criteria), with reasons

2

Participants

2a

Eligibility criteria for participants

2

2b

Settings and locations where the data were collected

2

Interventions

2

The interventions for each group with sufficient details to allow replication, including how and when they were actually administered

2

Outcomes

2a

Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed

2

2b

Any changes to trial outcomes after the trial commenced, with reasons

2

Sample size

2a

How sample size was determined

2

2b

When applicable, explanation of any interim analyses and stopping guidelines

NA

Randomization:

   

Sequence generation

2a

Method used to generate the random allocation sequence

2

2b

Type of randomization; details of any restriction (such as blocking and block size)

2

Allocation concealment mechanism

2

Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned

2

Implementation

2

Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions

2

Blinding

2a

If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how

2

2b

If relevant, description of the similarity of interventions

NA

Statistical methods

2a

Statistical methods used to compare groups for primary and secondary outcomes

2

2b

Methods for additional analyses, such as subgroup analyses and adjusted analyses

2

Results

Participant flow (a diagram is strongly recommended)

3a

For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome

2

3b

For each group, losses and exclusions afterrandomization, together with reasons

3

Recruitment

3a

Dates defining the periods of recruitment and follow-up

3

3b

Why the trial ended or was stopped

3

Baseline data

3

A table showing baseline demographic and clinical characteristics for each group

3

Numbers analyzed

3

For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups

3

Outcomes and estimation

3a

For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)

3

3b

For binary outcomes, presentation of both absolute and relative effect sizes is recommended

3

Ancillary analyses

3

Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory

3

Harms

3

All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)

3

Discussion

Limitations

6

Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses

3

Generalizability

6

Generalizability (external validity, applicability) of the trial findings

6

Interpretation

6

Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence

6

Other information

 

Registration

6

Registration number and name of trial registry

6

Protocol

6

Where the full trial protocol can be accessed, if available

6

Funding

6

Sources of funding and other support (such as supply of drugs), role of funders

6