Variables to be extracted |
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1. .Protocol title, author and year, source of funding |
2. Trial characteristics (disease area, patient population, duration of the follow-up period, number of follow-up assessments, intervention, and comparator) |
3. Primary outcome (the primary outcome, whether it is a patient-reported vs non-patient-reported outcome) |
4. Planned sample size |
5. Mention of using the SPIRIT guidelines in the development of the protocol (“yes” or “no”) |
6. Description of retention strategies outlined in the protocol |
7. Does the description of the retention strategy include all the information recommended by the SPIRIT guidelines Sect. 18b (“yes” or “no”) “Plans to promote participant retention and complete follow-up including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols” (8;3) |
8. Mode of follow-up, e.g. questionnaire, clinic visit, telephone call, etc |
9. Routine data collection (yes or no) |
10. Mention of Patient and Public Involvement (PPI) in relation to retention |
11. Mention of cost associated with retention strategy |