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

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.

Minimally invasive approach for the management of the leaking tracheoesophageal puncture.

OBJECTIVES/HYPOTHESIS: An enlarging tracheoesophageal puncture (TEP) site after total laryngectomy is associated with substantial functional, hygienic, and potentially life-threatening problems. The enlarged TEP is challenging to manage. TEP injection (TEP-I) for control of the enlarged puncture site may be beneficial in avoiding surgery. Our study reviewed the clinical outcomes of patients at a single institution with enlarged TEP treated by office-based TEP-I. STUDY DESIGN: Retrospective study. METHODS: Chart review of eight patients who had an enlarged TEP with leakage around the prosthesis treated with TEP-I after attempted customization of voice prostheses. Patient demographics and treatments were reviewed, and injection efficacy was evaluated by the duration of leakage resolution. RESULTS: Eight patients underwent 20 TEP-I procedures. The average duration of leak resolution after each injection was 174.5 days. There were no complications. Six patients required custom modifications of the voice prosthesis to control TEP leakage after TEP-I, and all patients resumed their baseline speech and swallowing function. There was a trend toward an increase in number of injections among patients with N+ disease, disease recurrence, a history of irradiation and secondary TEP. No patients required surgical closure of the TEP. CONCLUSIONS: Office-based TEP-I is a safe and effective treatment option for patients with an enlarged TEP site who have failed more conservative measures. A history of irradiation, disease recurrence, secondary TEP, and high-volume neck disease were predictive of multiple injections. Further study is warranted to accurately identify patients who may benefit from TEP-I to control leakage around the TEP.