Table 1 The 17 data collection categories
Category | Example |
|---|---|
Outcomes | |
 1. Primary Outcome | As identified in the trial protocol |
 2. Primary outcome but not primary analysis | Primary outcome is weight loss at 12 months but weight loss is also measured at 3 months |
 3. Secondary Outcomes | As designated in the trial protocol |
 4. Outcome data not listed as primary, secondary or health economics outcome |  |
 5. Items from a core outcome set |  |
 6. Health Economics |  |
Non-outcomes | |
 7. Participant identification items | Participant ID, postal contact details, general practitioner name and contact details |
 8. Items needed for randomisation | Age, sex, site |
 9. Eligibility |  |
 10. Demographics | Age, sex, family history of condition of interest |
 11. Medical History |  |
 12. Data Management Item | Visit number |
 13. Safety Data | Concomittant medications |
 14. Regulatory Data | Deviation logging, reason for withdrawal |
 15. Compliance Data | Dose administered, tablets taken or returned, confirmation of completed processes, randomisation allocation |
 16. Process Outcomes | How much blood was collected, who delivered the educational information |
 17. Miscellaneous |  |