Childhood Adenotonsillectomy Trial

7.1.3 Screening

Potentially eligible candidates will be evaluated by an otolaryngologist prior to entry the study.

7.1.3.1 Pre-Operative ENT Evaluation (Screening)

To determine eligibility for CHAT participation, all potentially eligible subjects will be evaluated by an otolaryngologist to confirm surgical candidacy and tonsillar size (refer to section 2.3 for grading scale). Children determined to be in need of immediate surgical treatment by the ENT surgeon will not be enrolled.

Note: A previous ENT evaluation may be used to determine surgical eligibility if it was conducted within the prior 90 days.

7.1.3.2 ENT Evaluation and Preoperative Questionnaire (PREOP)

The screening evaluation will include assessment and documentation of the following:

• Tonsillar Size
• Contraindications for surgery
• Surgical candidacy

For tracking purposes all data collection forms must be initialed by the otolaryngologist performing the assessment (refer to section 4 for a list of ENT-related forms and Appendix A for PREOP form completion guidelines). If a previous ENT evaluation is being utilized, the unblinded research coordinator must extract the information required from the source document (ENT medical record); complete the PREOP form, listing the otolaryngologist’s initials, counter initial, and date. The otolaryngologist’s initials will get entered into the data management system (DMS) for tracking purposes.