The following data collection Administrative and Case Report Forms are listed in the appendix with instructions for completion and are in addition to the data forms required for clinical purposes.
Name of Form | Label (footer of form) | Pages | Arm | Visit | Completed By |
---|---|---|---|---|---|
Pre-Operative Questionnaire | [PREOP] | 1 | Both | Initial ENT Evaluation | Otolaryngolist |
Intra-Operative Data Sheet | [OPER] | 2 | Both | At time of Surgery EAT: Month 1 WWSC Month 9 |
Otolaryngolist |
Post-Op Phone Call | [POST1] | 1 | Both | Post Surgery (1 month f/u) EAT: Month 2 WWSC: Month 10 |
Unblinded Coordinator |
Post-Op Phone Call/Visit | [POST2] | 1 | Both | Post Surgery (3/4 month f/u) EAT: Month 5 WWSC: Month 12 (at visit, not phone call) |
Unblinded Coordinator |
Re-Evaluation for Surgical Candidacy | [REEV] | 1 | WWSC | Month 8 | Otolaryngolist |
Surgical Digital Photo Reporting Log (Administrative Form) | [SURLOG] | Page _ of _ | Both | Not applicable | Unblinded Coordinator |
Attestation: Surgical Protocol Video (Administrative) | [Video] | 1 | Both | Not applicable | Otolaryngologist |