Childhood Adenotonsillectomy Trial

Table of Contents - Surgical Quality Control Core

• 7.1.0 Quality Monitoring of Surgical Intervention
  • 7.1.1 Overview
  • 7.1.2 Lists of Visits related to AT
  • 7.1.3 Screening
  • 7.1.3.1 Pre-Operative ENT Evaluation (Screening)
  • 7.1.3.2 ENT Evaluation and Preoperative Questionnaire (PREOP)
• 7.2.0 Scheduling of AT Surgery
  • 7.2.1 Early Adenotonsillectomy (EAT) Group - Blinded Phase
  • 7.2.2 Watchful Waiting Supportive Care (WWSC) - Unblinded "Open Label" Phase
  • 7.2.3 AT Guidelines
  • 7.2.4 Intra-Operatives Tonsillar Photographs
  • 7.2.4.1 Special Instructions for Telescope Equipment
  • 7.2.4.2 Electronic Transfer of Photos and Corresponding CRF
  • 7.2.4.3 Training Video for Surgical Procedures
• 7.3.0 Role of Unblinded Research Coordinator
  • 7.3.1 Administrative and Case Report Forms Related to ENT
  • 7.3.1.1 Table of ENT Forms
  • 7.3.1.2 Intra-Operative Form
  • 7.3.1.3 Post-Operative Follow Up Forms
  • 7.3.1.4 Unblinded Phase of Study - WWSC Group
  • 7.3.1.5 WWSC Arm Re-Evaluation
• 7.4.0 Adverse Events Related to AT
  • 7.4.1 Serious Adverse Events Related to AT
  • 7.4.2 Tracking Adverse Events and Serious Adverse Events for AT
  • 7.4.3 Quality Control of AE Data Related to AT
• 7.5.0 Surgical Quality Assurance for AT
  • 7.5.1 Quality Control Center (QCC)
  • 7.5.2 Central Training
  • 7.5.3 Informed Consent
  • 7.5.4 Site Visit
  • 7.5.5 Standardization of Operative Intervention
  • 7.5.6 Quality Control by Operative Photos
  • 7.5.7 Surgical Monitoring