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Table 2 Functional measures and endpoints

From: DARS: a phase III randomised multicentre study of dysphagia- optimised intensity- modulated radiotherapy (Do-IMRT) versus standard intensity- modulated radiotherapy (S-IMRT) in head and neck cancer

Time point

Study

Domain

Endpoint

Baseline, 3, 6, 12, 18 and 24 months

MDADI

Swallowing related QoL

Composite (total), global, emotional, functional and physical subscale scores

Baseline, 3, 6, 12, 18 and 24 months

WST

Swallow Performance

Swallow capacity, Swallow volume

Baseline, 12 and 24 months

VFa

Airway protection

Penetration Aspiration Scale [52]

Baseline, 12 and 24 months

VFa

Physiology

MBSImp

Baseline, 12 and 24 months

VFa

Pharyngeal dysphagia grade

DIGEST grade [53]

Baseline, 3, 6, 12, 18 and 24 months

PSS-HN

Functional Performance Status

Normalcy of diet, eating in public, understandability of speech scores

Baseline, 3, 6, 12, 18 and 24 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 7 days

  1. Abbreviations: WST Water Swallowing Test, DIGEST Dynamic Imaging Grade of Swallowing Toxicity, MBSImp Modified Barium Swallow Impairment Profile
  2. aSubset of centres only