THE CANADIAN JOURNAL OF
LE JOURNAL CANADIEN DES
Canadian Journal of Neurological Sciences
Consolidated Standards For Reporting Trials (CONSORT) Checklist
First Author's Name:
Was it reported? Yes or No If Yes, on what page number?
1. Identify the study as a randomized trial.
2. Use a structured format.
- 3. State prospectively defined hypothesis, clinical objectives, and planned subgroup or covariate analyses.
- 4. Planned study population, together with inclusion/exclusion criteria.
- 5. Planned interventions and their timing.
- 6. Primary and secondary outcome measure(s) and the minimum important difference(s), and how target sample size was projected.
- 7. Rationale and methods for statistical analyses, detailing main comparative analyses and whether they were completed on an intention-to-treat basis.
- 8. Prospectively defined stopping rules (if warranted).
- 9. Unit of randomization (eg, individual, cluster, geographic).
- 10. Method used to generate the allocation schedule.
- 11. Method of allocation concealment and timing of assignment.
- 12. Method to separate the generator from the executor of assignment.
- 13. Describe mechanism (eg. capsules tables); similarity of treatment characteristics (eg. appearance taste): allocation schedule control (location of code during trial and when broken) and evidence of successful: masking (blinding) among participants, person doing intervention, outcome accessors and data analysts.
Participant Flow and follow-up
- 14. Provide a trial profile (see flow diagram - figure) summarizing participant flow, numbers and timing of randomization assignment, interventions, and measurements for each randomized group.
- 15. State estimated effect of intervention on primary and secondary outcome measures, including a point estimate and measure of precision (confidence interval).
- 16. State results in absolute numbers when feasible (eg. 10/20, not 50%)
- 17. Present summary data and appropriate descriptive inferential statistics in sufficient detail to permit alternative analyses and replication.
- 18. Describe prognostic variables by treatment group and any attempt to adjust for them.
- 19. Describe protocol deviations from the study as planned, together with the reasons.
- 20. State specific interpretation of study findings, including sources of bias and imprecision (internal validity) and discussion of external validity, including appropriate quantitative measures when possible.
- 21. State general interpretation of the data in light of totality of the available evidence.
*This checklist of 21 items is intended to assist authors, editors, and reviewers by ensuring that information pertinent to the trial is included in the study report.
Send Submissions to:
- Canadian Journal of Neurological Sciences
Attention: Douglas Zochodne, Editor
P.O.Box 5456, Station A
Calgary, AB Canada T2H 1X8
Tel: (403) 229-9575 Fax: (403) 229-1661