Category | Example comments |
---|---|
Consensus/awareness amongst trialists/clinicians (n = 11): ranging from needing consensus on which methods to use when, understanding when multiplicity adjustments are required, and clinician awareness | “Lack of consensus among statisticians leaves a lot of uncertainty and makes CIs uncomfortable” |
“Many trialists don’t know the different methods that can be used (or haven’t got the time to investigate their correct implementation) so a state of the art type review and a course for the most useful/suitable methods would be great” | |
“Deciding when it is required and providing justification when the decision is not to adjust” | |
Informal hypothesis testing (n = 2): including repeated presentation of primary outcome data by arm to DMCs, and data dredging | |
Confidence intervals (n = 2) | “We are supposed to be concentrating on measures of effect and confidence intervals, and downplaying p-values. How does this factor into multiplicity testing procedures?” |
Multi-arm trials (n = 2): including multiple treatment arms and adaptive trials | |
Multiple outcomes (n = 2): including classifying the purpose of secondary outcomes, and risk/benefit synthesis | |
Subgroup analyses (n = 1) | “Design for subgroup effects on basis of meta-analysis including previous results” |
Interim analyses (n = 1) | “Minimise interim analyses” |
Miscellaneous (n = 2): including the increased importance of personalised medicine and the lack of consensus of what the denominator is for significance |