Table 5 Recommendations for information to include in non-primary reports of randomized trials a
Item | Description |
|---|---|
Abstract | Objectives of this report, and whether analyses were pre-specified or exploratory. A statement that it is not the primary trial report |
Objectives | Specific objectives or hypothesis of this report (for example, subgroup analyses, secondary outcomes, extended follow-up) |
Methods | Set in context of main trial and its results, cite primary trial report, describe method of randomization, details of blinding (if done), completeness of follow-up, identify primary outcome, and summarize numerical results |
Outcomes | Number and type of outcomes assessed in this report, and how and when measured. Whether outcomes were pre-specified or exploratory |
Statistical methods | Statistical methods used to compare groups in this report |
Participants | Number of intervention groups and whether this report includes all groups |
Number of participants randomized to each group and whether analyzed all randomized participants | |
Results | For each outcome a summary result and sample size for each group and the estimated effect size (for example, relative risk) and its precision |
Other information | Registration number and name of trial registry |
Where the full trial protocol can be accessed, if available | |
Sources of funding and other support (such as supply of drugs), role of funder |