Purpose NCI’s Common Terminology Criteria for Adverse Events (CTCAE) is the universal framework for toxicity reporting in oncology trials. We sought 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). We hypothesized that a 5-point CTCAE-compatible MBS grade (“DIGEST”) based on the interaction of pharyngeal residue and laryngeal penetration/aspiration ratings is 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 MBS conducted before or after surgical or non-surgical organ preservation. Intra- and inter-rater reliability were tested by weighted Kappa. Criterion validity against OPSE, MBSImP™©, MDADI, and PSS-HN was assessed with one-way ANOVA and post hoc pairwise comparisons between DIGEST grades. Results Intra-rater reliability was excellent (weighted Kappa=0.82–0.84) with substantial to almost perfect agreement between raters (weighted Kappa=0.67–0.81). DIGEST significantly discriminated levels of pharyngeal pathophysiology (MBSImP™©: r=0.77, p<0.0001), swallow efficiency (OPSE: r=−0.56, p<0.0001), perceived dysphagia (MDADI: r=−0.41, p<0.0001), and oral intake (PSS-HN diet: r=−0.49, p<0.0001). Conclusions With the development of DIGEST, we have adapted MBS rating 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-response, and predictive modeling.

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.

No abstract

No abstract

Voice restoration following total a laryngectomy has evolved over the past several decades. The patient who undergoes a total laryngectomy with tracheoesophageal (TE) puncture moves through several phases of treatment during their postoperative recovery and vocal restoration. The method of TE puncture is relatively simple; however, TE voice restoration is often complicated by the challenges associated with more intensive cancer treatment regimens, the geographical distance that impedes access to rehabilitative services, and myriad available products that require specialized knowledge and experience. In this article, we will provide a contemporary view of TE voice restoration, including its challenges for patients and clinicians. In addition, we will discuss the speech-language pathologist's role in the patient's rehabilitation, from providing evaluation and instruction regarding voice restoration and care of the stoma to ensuring the patient's transition back into their normal daily routine.