Skip to main content

Table 2 Consensus meeting discussions and advisory decision for the abstract checklist reporting items

From: Development process of a consensus-driven CONSORT extension for randomised trials using an adaptive design

Abstract item Summary of the discussion and advisory decisions and suggestions
1b Description of trial design Query about feasibility including detailed AD features in limited word count for abstracts. Debated the use of term ‘adaptive’ in the abstract to help identify these trials; care should be taken as there is a grey area around the classification of some group sequential designs as ADs in some quotas. Some suggested making a distinction between trials where the only adaptation is to stop the whole study and other ADs that must use the term adaptive in the abstract. The E&E could address the scope by highlighting the type of ADs.
Decision: 21 (80.8%) consensus to keep the modified item but reword
1c Clearly defined outcome for this report Importance of describing adaptive outcome used to aid credibility of results and help with locating AD trials. Replace the term ‘intermediate’ outcomes consistent with earlier discussions
Decision: 19 (73.1%) consensus to keep the modified item but reword
1d Result for each group Concern expressed about the feasibility of including results for each outcome in the abstract. Discussion around the necessity of including results for primary and intermediate results, particularly where the latter are used as the basis for adaptation decisions. Concerns about confusion in terminology (‘interim’ and ‘intermediate’)
Decision: 21 (80.8%) consensus to drop the modified item and keep the original
1e Adaptive decisions made Several participants acknowledged the importance of this item but queried coverage of reporting. Helpful for literature searching to identify specific trials. Important to ensure that authors indicate where no changes or adaptations made. Suggestion to cover the checklist earlier before outcomes. Noted results inconsistencies between items 1e and 14c although it is the same item—perhaps due to the confusion highlighted under item 14c
Decision: 23 (88.5%) consensus to keep the new item
1f Conclusions For consistency with earlier items (21 and 22), the group acknowledged that this item should not be extended
Decision: 22 (84.6%) consensus to drop the modified item and keep the original