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).