METHODS
Following prospective registration (https://osf.io/bhncy), we developed
this international consensus statement on RCT integrity, according to
recommended methods,21–25 using a multi-step
approach: a) multi-country multidisciplinary stakeholder group
composition and engagement; b) evidence synthesis of systematic reviews
of RCT integrity; c) anonymised two-round modified Delphi survey; and,
d) a final consensus development meeting.