Childhood Adenotonsillectomy Trial

6.6.7 Medical Monitoring and Reporting

Severity of OSA will be determined by PSG review at the central PSG RC. Any PSG study meeting Urgent Medical Referral criteria (i.e. , upper limits for study inclusion based on OAI, AHI, desaturation, and evidence of clinically significant cardiac arrhythmia) will be identified with 48 hours of its receipt at the PRC, will be reviewed by the PRC Director, with an Urgent Referral Alert Notification electronically transmitted to the study coordinator and/or alternate site designee, who will facilitate appropriate clinical management. Children so identified on baseline studies will not be eligible for randomization, so providing such data to the site will not contaminate outcomes. Data from follow- up PSGs will be available at a time when all follow up data have been collected to minimize influencing study outcomes, an approach that is standard for research data. An exception is for any information identified that may pose acute health risks or would influence immediate treatment, in which case such data will be shared earlier. Surgeons will be informed by the site coordinator of the baseline research PSG for children randomized to EAT if the AHI > 20, OAI > 15, or marked desaturation is seen (percentage oxygen desaturation of =< 92% for > 2% of sleep time), since these levels may influence perioperative care. A copy of the abbreviated Sleep Report will be sent to the un-blinded coordinator by the PRC Administrator with instructions to notify the surgeon if the child has been randomized to EAT.

All Urgent Referral Alerts will be logged into a PSG Alert Log indicating the date reviewed and date site coordinator was notified. A copy of the acknowledged receipt of the Urgent Referral by the site will be kept with the PSG Quality documents. All remaining studies are scored based on date received. Bi-monthly review of scored studies by site by scorer is done to maintain equal distribution of studies from all sites among the scorers.