Dynamic Imaging Grade of Swallowing Toxicity (DIGEST): Scale development and validation

• Published in: Cancer 2017-01, Vol.123 (1), p.62-70
• Main Authors: Hutcheson, Katherine A., Barrow, Martha P., Barringer, Denise A., Knott, Jodi K., Lin, Heather Y., Weber, Randal S., Fuller, Clifton D., Lai, Stephen Y., Alvarez, Clare P., Raut, Janhavi, Lazarus, Cathy L., May, Annette, Patterson, Joanne, Roe, Justin W. G., Starmer, Heather M., Lewin, Jan S.
• Format: Article
• Language: English
• Subjects: Barium; Barium - administration & dosage; Biocompatibility; Cancer; Clinical trials; Criteria; Deglutition - physiology; Deglutition Disorders - physiopathology; Double-Blind Method; Dysphagia; Evaluation; Female; Grading; Head & neck cancer; head and neck cancer; Head and Neck Neoplasms - physiopathology; Humans; Imaging; Male; Mathematical models; Medical research; Middle Aged; Modelling; National Cancer Institute (U.S.); Nomenclature; Oncology; Patients; Pharynx; Pharynx - physiopathology; Preservation; Psychometrics - methods; Quality; Quality of Life; radiation; Reliability; Reproducibility of Results; Sound; Surgery; Surveys and Questionnaires; Swallowing; Terminology; Toxicity; United States; Variance analysis
• ISSN: 0008-543X; 1097-0142
• DOI: 10.1002/cncr.30283

BACKGROUND The National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) is the universal framework for toxicity reporting in oncology trials. The objective of this study was to develop a CTCAE‐compatible modified barium swallow (MBS) grade for the purpose of grading pharyngeal dysphagia as a toxicity endpoint in cooperative‐group organ‐preservation trials for head and neck cancer (HNC). It was hypothesized that a 5‐point, CTCAE‐compatible MBS grade (Dynamic Imaging Grade of Swallowing Toxicity [DIGEST]) based on the interaction of pharyngeal residue and laryngeal penetration/aspiration ratings would be feasible and psychometrically sound. METHODS A modified Delphi exercise was conducted for content validation, expert consensus, and operationalization of DIGEST criteria. Two blinded raters scored 100 MBSs conducted before or after surgical or nonsurgical organ preservation. Intrarater and interrater reliability was tested with weighted κ values. Criterion validity against oropharyngeal swallow efficiency (OPSE), the Modified Barium Swallow Impairment Profile (MBSImP™©), the MD Anderson Dysphagia Inventory (MDADI), and the Performance Status Scale for Head and Neck Cancer Patients (PSS‐HN) was assessed with a 1‐way analysis of variance and post hoc pairwise comparisons between DIGEST grades. RESULTS Intrarater reliability was excellent (weighted κ = 0.82‐0.84) with substantial to almost perfect agreement between raters (weighted κ = 0.67‐0.81). DIGEST significantly discriminated levels of pharyngeal pathophysiology (MBSImP™©: r = 0.77; P