1. Eligibility: To what extent are the participants in the trial similar to those who would receive this intervention if it was part of usual care? | 5 |
2. Recruitment: How much extra effort is made to recruit participants over and above what would be used in the usual care setting to engage with patients? | 5 |
3. Setting: How different are the settings of the trial from the usual setting? | 5 |
4. Organisation: How different are the resources, provider expertise, and the organisation of care delivery in the intervention arm of the trial from those available in usual care? | 4 |
5. Flexibility (delivery): How different is the flexibility in how the intervention is delivered and the flexibility anticipated in usual care? | 4 |
6. Flexibility (adherence): How different is the flexibility in how participants are monitored and encouraged to adhere to the intervention from the flexibility anticipated in usual care? | 4 |
7. Follow-up: How different is the intensity of measurement and follow-up of participants in the trial from the typical follow-up in usual care? | 3 |
8. Primary outcome: To what extent is the trial’s primary outcome directly relevant to participants? | 5 |
9. Primary analysis: To what extent are all data included in the analysis of the primary outcome? | N/A (the present study provides an analysis of secondary outcome data) |
Mean score: | 4.4 |