a. Establishment of the international multi-stakeholder group
In August 2021, six months ahead of the proposed consensus meeting, an international stakeholder group was carefully composed selecting members based on their knowledge and experience to encompass all the critical aspects of the RCT research lifecycle. A clinical trial was defined as a study design that randomly assigns human participants to one or more interventions and follows them up for critical outcomes to determine the effect of the interventions.10 Stakeholders were representatives from: relevant professional societies; allied health professions; patient, public and consumer representatives; trialists, statisticians, and methodologists; members and reviewers of ethics, data monitoring and funding committees; peer-reviewers and biomedical journal editors. They were contacted via direct email (see the list of stakeholders and their roles in Table 1). We ensured that none of the participants had any RCT papers subjected to an active expression of concern nor retraction. All stakeholders explicitly declared their conflicts of interests using the International Committee of Medical Journal Editors (ICMJE) uniform disclosure form (Appendix 1). One non-voting member (DM) was invited to the group for advising on consensus methods and language. Two members of the group were selected as co-convenors (KSK and YK), charged with the responsibility to ensure that all participants developed ownership of the consensus scope and content, engaging them in discussions, constructive debates and resolution of disagreements. Following acceptance of the invitation, online or phone interviews were held with the stakeholders to inform them about the project objectives, and to ask them for their input to the integrity statements.