Outcome measure | Timing | Method of assessment |
---|---|---|
Primary outcome | ||
 Presence of ORN | 6 months | Blinded review of radiograph, clinical photograph with corroboration from site investigator’s assessment in CRF (and dimensions of any exposed bone) |
Secondary outcomes | ||
 Presence of ORN | 3 and 12 months | As primary endpoint, but without radiographs unless ORN clinically evident |
 Severity of ORN | 3, 6 and 12 months | Blinded review of radiograph, clinical photograph, site investigator’s assessment (and dimensions of any exposed bone) using modified Notani Score [23, 24] |
 Quality of life | 3, 6 and 12 months | University of Washington head and neck cancer questionnaire |
 Pain following surgery | 3, 6 and 12 months | Patient-reported on a Visual Analogue Scale and use of analgesia |
 Acute symptoms | Days 1 thru 7 post surgery | Patient-reported Likert scale for pain, swelling, trismus, normalcy of diet |
 Assessment of implants (where relevant) | At closure of trial | Casenote review, by loss of any implant placed as part of trial |
 Late follow-up of MBS cases (where relevant) | At closure of trial | Casenote review, by severity of ORN using modified Notani Score [23, 24]. |
 Safety of HBO related to cancer recurrence | Within 12 months of trial treatments | SAE reporting. |
 Safety of HBO, otherwise | Within 28 days of HBO | AE/ SAE reporting of symptoms related to hyperbaric treatment |