CONSORT for N-of-1 Trials Checklist

Instructions

• Use the boxes to confirm each reporting item.
• Add reviewer notes under each section as needed.

Checklist Items

• Title and abstract
  • 1a. Identification as an N-of-1 trial in the title
  • 1b. Structured summary of trial design, methods, results, and conclusions
• Introduction
  • 2a. Scientific background and explanation of rationale
  • 2b. Specific objectives or hypotheses
• Methods
  • 3a. Description of trial design (including allocation ratio, if applicable)
  • 3b. Important changes to methods after trial commencement (such as eligibility criteria), with reasons
  • 4a. Eligibility criteria for participants
  • 4b. Settings and locations where the data were collected
  • 5. The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
  • 6a. Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed
  • 6b. Any changes to trial outcomes after the trial commenced, with reasons
  • 7a. How sample size was determined
  • 7b. When applicable, explanation of any interim analyses and stopping guidelines
  • 8a. Method used to generate the random allocation sequence
  • 8b. Type of randomisation; details of any restriction (e.g., blocking and block size)
  • 9. Mechanism used to implement the random allocation sequence (e.g., central telephone; web-based), describing any steps taken to conceal the sequence until interventions were assigned
  • 10. Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions
  • 11a. If done, who was blinded after assignment to interventions (e.g., participants, care providers, those assessing outcomes) and how
  • 11b. If relevant, description of the similarity of interventions
  • 12a. Statistical methods used to compare groups for primary and secondary outcomes
  • 12b. Methods for additional analyses, such as subgroup analyses and adjusted analyses
• Results
  • 13a. For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome
  • 13b. For each group, losses and exclusions after randomisation, together with reasons
  • 14a. Dates defining the periods of recruitment and follow-up
  • 14b. Why the trial ended or was stopped
  • 15. A table showing baseline demographic and clinical characteristics for each group
  • 16. For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups
  • 17a. For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (e.g., 95% confidence interval)
  • 17b. For binary outcomes, presentation of both absolute and relative effect sizes is recommended
  • 18. Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory
  • 19. All important harms or unintended effects in each group
• Discussion
  • 20. Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses
  • 21. Generalisability (external validity, applicability) of the trial findings
  • 22. Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
• Other information
  • 23. Registration number and name of trial registry
  • 24. Where the full trial protocol can be accessed, if available
  • 25. Sources of funding and other support (e.g., supply of drugs), role of funders

Notes

Reviewer notes