Table 1 Changes made to initial concept map

Validity: Design

 • Trial protocol considers implementability

Relevance: Design

 • Outcomes are persuasive (prespecified outcomes would be sufficient to motivate change)

 • Evidence of persuasiveness of outcomes is available

Validity: Reporting

 • Conclusions supported by data

Validity: Design

 • Team has methodology training and includes a statistician

 • Protocol uses standardised statistical and analytical procedures

Relevance: Design

 • Pragmatic design

 • Interventions acceptable in current practices and systems

Usability: Design

 • Theory or logic model specified for how intervention is intended to work

Validity: Conduct

 • All randomised participants included in the intention-to-treat analysis

Relevance: Conduct

 • Analysis and conclusions meaningful to stakeholders

Relevance: Reporting

 • Information relevant to different stakeholders

 • Process reported for selection or exclusion of harms

Usability: Reporting

 • Clearly reported