Time point | Study | Domain | Endpoint |
---|---|---|---|
Baseline, 3, 6, 12, 18 and 24Â months | MDADI | Swallowing related QoL | Composite (total), global, emotional, functional and physical subscale scores |
Baseline, 3, 6, 12, 18 and 24Â months | WST | Swallow Performance | Swallow capacity, Swallow volume |
Baseline, 12 and 24Â months | VFa | Airway protection | Penetration Aspiration Scale [52] |
Baseline, 12 and 24Â months | VFa | Physiology | MBSImp |
Baseline, 12 and 24Â months | VFa | Pharyngeal dysphagia grade | DIGEST grade [53] |
Baseline, 3, 6, 12, 18 and 24Â months | PSS-HN | Functional Performance Status | Normalcy of diet, eating in public, understandability of speech scores |
Baseline, 3, 6, 12, 18 and 24Â months | UW-Qol v.04 | HR-QoL | Composite scores of physical and social-emotional functioning are derived from 12 domains. Patients can also highlight up to 3 priority concerns from the previous 7Â days |