- 1 - Title and Abstract
- 2 - Introduction
- 3-12 - Methods
- 3a - Trial design
- 3b - Changes to trial design
- 4a - Participants
- 4b - Study settings
- 5 - Interventions
- 6a - Outcomes
- 6b - Changes to outcomes
- 7a - Sample size
- 7b - Interim analyses and stopping guidelines
- 8a - Randomisation: sequence generation
- 8b - Randomisation type
- 9 - Randomisation: allocation concealment mechanism
- 10 - Randomisation: implementation
- 11a - Blinding
- 11b - Similarity of interventions
- 12a - Statistical methods
- 12b - Additional analyses
- 13-19 - Results
- 20-22 - Discussion
- 23-25 - Other information
Examples of Interim Analyses and Stopping Guidelines
This page contains examples of CONSORT Item 7b - Interim Analyses and Stopping Guidelines.
You can submit your own Examples here.
| Two interim analyses were performed during the trial. The levels of significance maintained an overall P value of 0.05 and were calculated according to the O’Brien-Fleming stopping boundaries. This final analysis used a Z score of 1.985 with an associated P value of 0.0471. | ||
| Galgiani JN, Catanzaro A, Cloud GA, et al. | Comparison of Oral Fluconazole and Itraconazole for Progressive, Nonmeningeal Coccidioidomycosis. A Randomized, Double-Blind Trial. | Ann Intern Med. 2000;133:676-86. |
| An independent data and safety monitoring board periodically reviewed the efficacy and safety data. Stopping rules were based on modified Haybittle-Peto boundaries of 4 SD in the first half of the study and 3 SD in the second half for efficacy data, and 3 SD in the first half of the study and 2 SD in the second half for safety data. Two formal interim analyses of efficacy were performed when 50% and 75% of the expected number of primary events had accrued; no correction of the reported P value for these interim tests was performed. | ||
| Connolly SJ, Pogue J, Hart RG, Hohnloser SH, Pfeffer M, Chrolavicius S, et al. | Effect of clopidogrel added to aspirin in patients with atrial fibrillation. | N Engl J Med 2009;360:2066-78. |
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Page last edited: 18 March 2011
