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Table 6 Survey: comments

From: Approaches to multiplicity in publicly funded pragmatic randomised controlled trials: a survey of clinical trials units and a rapid review of published trials

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

 
  1. Abbreviations: CI Chief Investigator, DMC Data Monitoring Committee