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Table 2 Outcome measures, time of assessment and method of assessment

From: HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): a randomised controlled trial of hyperbaric oxygen to prevent osteoradionecrosis of the irradiated mandible: study protocol for a randomised controlled trial

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

  1. AE adverse event, CRF Case Record Form, HBO hyperbaric oxygen, MBS minor bone spicules, ORN osteoradionecrosis, SAE serious adverse event