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 |