Refining measurement of swallowing safety in the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) criteria: Validation of DIGEST version 2.

BACKGROUND: Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) is a validated method to grade the severity of pharyngeal swallowing impairment as a toxicity of cancer based on the degree and patterns of penetration/aspiration and pharyngeal residue over a standardly acquired radiographic modified barium swallow (MBS) study. Since its implementation in 2016, areas for the refinement of grading mild safety impairments have been identified by clinical and research users. The objective of this study was to assess the performance and validity of refined DIGESTsafety grading criteria (per DIGEST version 2 [DIGESTv2 ]). METHODS: Refined safety criteria were developed and vetted with clinical and research users. DIGESTv2 included 2 changes to the safety criteria. All MBSs with blinded DIGEST version 1 grading were sampled from a registry database (1331 patients underwent MBS over the period of December 2005 to July 2019). New criteria were applied to derive DIGESTsafety grading version 2. Measures of criterion validity, including the MD Anderson Dysphagia Inventory [MDADI] composite score, the Modified Barium Swallow Impairment Profile (MBSImP) pharyngeal total, the MBSImP hyolaryngeal components (items 8-11), and the Performance Status Scale for Head and Neck Cancer Patients [PSS-HN] diet, were correlated with DIGESTsafety and overall DIGEST grades from versions 1 and 2 and were compared pairwise between reassigned grades. RESULTS: With the application of version 2 safety criteria, 112 of 1331 examinations (8.4%) and 79 of 1331 examinations (5.9%) changed in their DIGESTsafety and overall grades, respectively. The safety and overall DIGEST grades (versions 1 and 2) significantly correlated with criterion measures, including the MBSImP pharyngeal total, laryngeal MBSImP parameters of interest, MDADI, and PSS-HN (P < .0001); correlations maintained a similar magnitude between versions 1 and 2. Forty-six upgraded examinations (reassigned from safety grade 1 per version 1 to grade 2 per version 2) performed similarly to other safety grade 2 examinations (version 1), and this was likewise true for 66 downgraded examinations (reassigned from safety grade 1 per version 1 to grade 0 per version 2). CONCLUSIONS: Refined criteria defining mild safety impairments with the DIGEST methodology changed grades in small numbers of examinations. DIGESTv2 criteria maintained criterion validity, demonstrated ordinality, and improved the performance of the method in these rare scenarios. LAY SUMMARY: Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) is a method developed and validated by the investigators in 2016 to grade the severity of pharyngeal swallowing dysfunction (dysphagia) with a decision tree or flowsheet to guide the clinician's review of a standard radiographic modified barium swallow study. This work reports on the validity of updated DIGEST criteria (version 2) that incorporate 2 modifications to the decision tree.

Dysphagia profiles after primary transoral robotic surgery or radiation for oropharyngeal cancer: A registry analysis.

OBJECTIVE: To describe the physiologic swallowing impairments (MBSImP™©) associated with safety/efficiency impairments (DIGESTsafety /DIGESTefficiency grades) at 3-6 months after transoral robotic surgery (TORS) or radiation therapy (RT). STUDY DESIGN: Secondary analysis of registry data. SETTING: Single, academic institution. METHODS: Two hundred and fifty-seven patients with HPV+ oropharynx cancer were stratified by primary treatment (75 TORS, 182 RT). Modified barium swallow studies were analyzed at baseline and 3-6 months using MBSImP scores and DIGESTsafety /DIGESTefficiency grades. DIGESTsafety /DIGESTefficiency grades and MBSImP were compared groupwise and associations between DIGESTsafety /DIGESTefficiency grades and MBSImP were explored by ordinal logistic regression. Exploratory analyses were stratified by multimodality treatment. RESULTS: Neither DIGESTsafety /DIGESTefficiency differed significantly between groups at baseline or 3-6 months. Laryngeal vestibule closure was impaired more frequently in the RT group (RT: 41% vs. TORS: 27%; p = 0.02) while the TORS group had significantly more pharyngeal contraction impairment (63%; p < 0.001) compared to RT at 3-6 months. CONCLUSION: The results suggest a focal injury associated with DIGESTsafety /DIGESTefficiency post-TORS in contrast to a low-level diffuse physiologic impairment associated with post-RT dysphagia.

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.

Gastrostomy tube placement in patients with oropharyngeal carcinoma treated with radiotherapy or chemoradiotherapy: factors affecting placement and dependence.

BACKGROUND: Although many patients require nutritional support during radiotherapy or chemoradiotherapy for oropharyngeal cancer, little is known regarding the risk factors that predispose to gastrostomy tube (g-tube) placement and prolonged dependence, or the therapeutic interventions that may abrogate these effects. METHODS: We performed a retrospective medical chart review of patients who were treated for primary oropharyngeal cancer at a tertiary care center from 2003 to 2008. Patients who had a complete response at the primary site at 1-year posttreatment were included. G-tube placement and dependence ≥6 months were evaluated in relationship to site and stage of primary tumor, baseline characteristics, treatment type, smoking status, and swallowing intervention. RESULTS: We evaluated 474 patients (79%) with oropharyngeal cancer; 215 patients (40%) had concurrent chemotherapy, 73 patients (15%) had induction chemotherapy, and 69 patients (15%) had induction chemotherapy followed by concurrent chemotherapy. Two hundred ninety-three patients (62%) received g-tubes, of which 238 (81%) received the g-tube during radiation. At 1-year follow-up, 41 patients (9%) remained dependent on enteral feedings. Placement of g-tubes and prolonged g-tube dependence were significantly more likely in patients with T3 to 4 tumors (p < .001), baseline self-reported dysphagia (p < .001), odynophagia (p < .001), >10% baseline weight loss (p < .001), and in those treated with concurrent chemoradiotherapy. Patients who reported adherence to exercises had significantly lower rates of g-tube placement (p < .001), and duration of dependence was significantly shorter in those who reported adherence to swallowing exercises (p < .001). CONCLUSION: Almost 40% of patients with oropharyngeal cancer treated with nonsurgical organ preservation modalities may avoid feeding tube placement. Factors that predispose to g-tube placement and prolonged dependence include T3 to T4 tumors, concurrent chemotherapy, current smoking status, and baseline swallowing dysfunction or weight loss. Adherence to an aggressive swallowing regimen may reduce long-term dependence on enteral nutrition and limit the rate of g-tube placement overall.

Outcomes of elective total laryngectomy for laryngopharyngeal dysfunction in disease-free head and neck cancer survivors.

OBJECTIVE: Total laryngectomy (TL) can be offered for management of chronic aspiration, radionecrosis, and/or airway compromise after head and neck cancer (HNC) treatment. The objective of this study was to evaluate functional outcomes after TL in disease-free HNC survivors. DESIGN: Retrospective case series with chart review. SETTING: The University of Texas MD Anderson Cancer Center. PATIENTS: Twenty-three disease-free HNC survivors who underwent TL for laryngopharyngeal dysfunction. INTERVENTION: TL ± pharyngectomy. MAIN OUTCOME MEASURES: Post-TL swallowing-related (diet, gastrostomy dependence, and pneumonia rates) and communication outcomes. RESULTS: All patients who underwent TL for dysfunction were previously treated with radiotherapy (12/23, 52%) or chemoradiotherapy (11/23, 48%). Preoperative complications included aspiration (22/23, 96%), pneumonia (16/23, 70%), tracheostomy (9/23, 39%), and stricture (7/23, 30%); 17 patients (74%) required enteral/parenteral nutrition, and 13 of 23 (57%) were nothing per oral (NPO). Rates of pneumonia, NPO status, and feeding tube dependence significantly decreased after TL (P < .001). At last follow-up after TL, all patients tolerated oral intake, but 4 (17%) required supplemental enteral nutrition. Continued smoking after radiotherapy and a preoperative history of recurrent pneumonia were significantly (P < .05) associated with final tube dependence and/or diet level. Sixteen patients (70%) underwent tracheoesophageal (TE) puncture, and 57% (13 of 23) communicated using TE voice after TL. CONCLUSION: Salvage TL may improve health status by significantly decreasing the rate of pneumonia and improve quality of life by restoring oral intake in patients with refractory laryngopharyngeal dysfunction after HNC treatment. TE voice restoration may enhance functional outcomes in select patients treated with elective TL for dysfunction.