RESULTS
There were 30 stakeholders (Table 1) with voting rights from 14
countries in 5 continents including trialists, ethicists,
methodologists, statisticians, consumer representative, industry
representative, systematic reviewers, funding body panel members,
regulatory experts, authors, journal editors, peer-reviewers and
advisors for resolving integrity concerns. Their combined wide and
appropriate expertise, based on self-assessment, ranged broadly to
include all aspects of the RCT research lifecycle from protocol
development to knowledge transfer (Figure 1).
The initial long list of 111 statements (73 stakeholder-provided, 46
generated via evidence synthesis,20 and 8 supported by
both) was submitted to consensus via the modified Delphi survey (Figure
2). The first survey round had 26 out of 30 (86.7%) respondents and 64
statements were rated above the 76.5% APMO threshold for consensus.
Among these, the strength of the agreement among stakeholders was good
or very good in all the statements (Table 2). The remaining 47
statements along with the 7 new stakeholder-provided statements were
subjected to revisions. After merging exact and inexact duplicates, 40
statements were submitted to the second survey round, where there were
26 out of 30 (86.7%) respondents and 24 statements were rated above the
68.4% APMO threshold for consensus. Among these, the strength of the
agreement among stakeholders was good in 18 (75%) statements (Table 2).
The 64 statements agreed in the first modified Delphi survey round were
merged, removing exact and inexact duplications, to take forward 54
along with 24 agreed statements from second round to the consensus
development meeting. The remaining 16 statements that lacked consensus
after the second round were also taken forward. Sensitivity analysis for
consensus threshold deploying the predefined arbitrary 70% cut-off
showed that the APMO threshold was more conservative in the first round,
permitting more statements to be re-examined (Table 2).
There was one new stakeholder-provided statement taking to total
presented to 95 at this final stage. At the outset the stakeholder group
confirmed that statements below 50% agreement threshold were to be
excluded. Following discussion, merging, and voting in the consensus
development meeting of the final shortlist contained 81 statements (49
stakeholder-provided, 41 systematic review-generated, 9 supported by
both). Of the total, 32 (39.5%) were unique evidence-based statements.
Of the 41 statements underpinned by evidence
synthesis,20 two were based on at least one
high-moderate quality systematic review.27,31 As shown
in Table 3, the entire RCT lifecycle was covered with statements
concerning general aspects (n=6), design and approval (n=11), conduct
and monitoring (n=19), reporting of protocols and findings (n=20),
post-publication concerns (n=12), and future research and development
(n=13).