Table 1 Standard Protocol Items of the TOTO trial: Recommendations for Interventional Trials (SPIRIT) table of the trial schedule for enrolment, interventions, and follow-up/assessments
Study period | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Clinic visit | Admission | Post-allocation | Close-out | |||||||
Timepoints | Registry | Scheduled | 0 | POD1-5 | Weekly to POM 24 | POM 6 | POM 12 | POM 18 | POM 24 | POM 24 |
Enrollment | ||||||||||
Eligibility screen | X | |||||||||
Informed consent | X | |||||||||
Baseline information | X | |||||||||
Allocation | X | |||||||||
Interventions | ||||||||||
Tonsillotomy | X | |||||||||
Tonsillectomy | X | |||||||||
Assessments | ||||||||||
Demographic data | X | X | ||||||||
Additional Adenoidectomy | X | |||||||||
TAHSI | X | X | X | X | X | |||||
TOI-14 | X | X | X | X | X | |||||
SF-12 | X | X | X | X | X | |||||
Weekly App alert | X | |||||||||
If sore throat: sore throat questionnaire | X | |||||||||
Complications, AE | X | X | X | X | ||||||
Participation sign-off | X | |||||||||