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. Author manuscript; available in PMC: 2018 Apr 1.
Published in final edited form as: Laryngoscope. 2016 Jul 21;127(4):842–848. doi: 10.1002/lary.26153

Table 1.

CONSORT-PRO Objectives and Methods

Objective Characterize trajectories and predictors of longitudinal patient-reported swallowing outcomes using the MDADI among locallyadvanced OPC patients treated non-surgically
Trial Designs Three phase II non-surgical therapeutic clinical trials for locoregionally advanced HNSCC (1: induction PCC trial, 2: adaptive IMRT trial, 3: randomized induction PCC v C-TPF trial)
Participants OPC; baseline and at least one post-treatment MDADI
Intervention Primary split-field IMRT with induction and/or concurrent chemotherapy
Outcome MDADI composite score difference at 6, 12, and 24 months compared to baseline (secondary outcome measures from trials)
Statistical methods MDADI reports from all available time points (baseline, 6, 12, 24 months) were examined with linear mixed effect multivariate models without imputation of missing data.

Abbreviations: CONSORT-PRO, Consolidated Standards of Reporting Trials - Patient-Reported Outcomes; MDADI, MD Anderson Dysphagia Inventory; OPC, oropharyngeal carcinoma; HNSCC, head and neck squamous cell carcinoma; T, tumor; N, node; IMRT, intensiy modulated radiation therapy