title: Dynamic Imaging Grade of Swallowing Toxicity (DIGEST): Scale development and validation.
abstract: 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 < .0001), swallow efficiency (OPSE: r = -0.56; P < .0001), perceived dysphagia (MDADI: r = -0.41; P < .0001), and oral intake (PSS-HN diet: r = -0.49; P < .0001).
  
  
  CONCLUSIONS
  With the development of DIGEST, the MBS rating has been adapted to the CTCAE nomenclature of ordinal toxicity grading used in oncology trials. DIGEST offers a psychometrically sound measure for HNC clinical trials and investigations of toxicity profiles, dose responses, and predictive modeling. Cancer 2017;62-70. © 2016 American Cancer Society.
authors: Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors: Katherine A
authors: KA
authors: Hutcheson
authors: Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors: Martha P
authors: MP
authors: Barrow
authors: Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors: Denise A
authors: DA
authors: Barringer
authors: Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors: Jodi K
authors: JK
authors: Knott
authors: Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors: Heather Y
authors: HY
authors: Lin
authors: Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors: Randal S
authors: RS
authors: Weber
authors: Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors: Clifton D
authors: http://orcid.org/0000-0002-5264-3994
authors: CD
authors: Fuller
authors: Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors: Stephen Y
authors: SY
authors: Lai
authors: Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors: Clare P
authors: CP
authors: Alvarez
authors: University of Texas Health Science Center, School of Public Health, Houston, Texas.
authors: Janhavi
authors: J
authors: Raut
authors: Department of Otolaryngology, Icahn School of Medicine at Mount Sinai, New York, New York.
authors: Cathy L
authors: CL
authors: Lazarus
authors: Department of Oncology Speech Pathology, University of Florida Health Cancer Center-Orlando Health, Orlando, Florida.
authors: Annette
authors: A
authors: May
authors: Speech and Language Therapy Department, Sunderland City Hospitals National Health Service Foundation Trust, Sunderland, United Kingdom.|Institute of Health and Society, University of Newcastle, Newcastle Upon Tyne, United Kingdom.
authors: Joanne
authors: J
authors: Patterson
authors: Therapies Department, Royal Marsden National Health Service Foundation Trust, London, United Kingdom.|Speech and Language Therapy Department, Imperial College Healthcare National Health Service Trust, London, United Kingdom.|Department of Surgery and Cancer, Imperial College, London, United Kingdom.
authors: Justin W G
authors: JW
authors: Roe
authors: Head and Neck Surgery, Department of Otolaryngology, Stanford University, Palo Alto, California.
authors: Heather M
authors: HM
authors: Starmer
authors: Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors: Jan S
authors: JS
authors: Lewin
mesh_terms: D001464:Barium / Q000008:administration & dosage*; D003679:Deglutition / Q000502:physiology*; D003680:Deglutition Disorders / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006258:Head and Neck Neoplasms / Q000503:physiopathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D054547:National Cancer Institute (U.S.); D010614:Pharynx / Q000503:physiopathology*; D011594:Psychometrics / Q000379:methods; D011788:Quality of Life; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires; D014481:United States
chemical_list: D001464:Barium
keywords: dysphagia; head and neck cancer; radiation; surgery; toxicity