A protocol for stakeholder engagement in head and neck cancer pragmatic trials.

Meaningful engagement with stakeholders in research demands intentional approaches. This paper describes the development of a framework to guide stakeholder engagement as research partners in a pragmatic trial proposed to evaluate behavioral interventions for dysphagia in head and neck cancer patients. We highlight the core principles of stakeholder engagement including representation of all perspectives, meaningful participation, respectful partnership with stakeholders, and accountability to stakeholders; and describe how these principles were operationalized to engage relevant stakeholders throughout the course of a large clinical trial.

Effects of Statistical Practices for Longitudinal Group Comparison of the Penetration-Aspiration Scale on Power and Effect Size Estimation: A Monte Carlo Simulation Study.

Multiple bolus trials are administered during clinical and research swallowing assessments to comprehensively capture an individual's swallowing function. Despite valuable information obtained from these boluses, it remains common practice to use a single bolus (e.g., the worst score) to describe the degree of dysfunction. Researchers also often collapse continuous or ordinal swallowing measures into categories, potentially exacerbating information loss. These practices may adversely affect statistical power to detect and estimate smaller, yet potentially meaningful, treatment effects. This study sought to examine the impact of aggregating and categorizing penetration-aspiration scale (PAS) scores on statistical power and effect size estimates. We used a Monte Carlo approach to simulate three hypothetical within-subject treatment studies in Parkinson's disease and head and neck cancer across a range of data characteristics (e.g., sample size, number of bolus trials, variability). Different statistical models (aggregated or multilevel) as well as various PAS reduction approaches (i.e., types of categorizations) were performed to examine their impact on power and the accuracy of effect size estimates. Across all scenarios, multilevel models demonstrated higher statistical power to detect group-level longitudinal change and more accurate estimates compared to aggregated (worst score) models. Categorizing PAS scores also reduced power and biased effect size estimates compared to an ordinal approach, though this depended on the type of categorization and baseline PAS distribution. Multilevel models should be considered as a more robust approach for the statistical analysis of multiple boluses administered in standardized swallowing protocols due to its high sensitivity and accuracy to compare group-level changes in swallowing function. Importantly, this finding appears to be consistent across patient populations with distinct pathophysiology (i.e., PD and HNC) and patterns of airway invasion. The decision to categorize a continuous or ordinal outcome should be grounded in the clinical or research question with recognition that scale reduction may negatively affect the quality of statistical inferences in certain scenarios.

Clinical Implementation of DIGEST as an Evidence-Based Practice Tool for Videofluoroscopy in Oncology: A Six-Year Single Institution Implementation Evaluation.

Clinical implementation of evidence-based practice (EBP) tools is a healthcare priority. The Dynamic Grade of Swallowing Toxicity (DIGEST) is an EBP tool developed in 2016 for videofluoroscopy in head and neck (H&N) oncology with clinical implementation as a goal. We sought to examine: (1) feasibility of clinical implementation of DIGEST in a national comprehensive cancer center, and (2) fidelity of DIGEST adoption in real-world practice. A retrospective implementation evaluation was conducted in accordance with the STARI framework. Electronic health record (EHR) databases were queried for all consecutive modified barium swallow (MBS) studies conducted at MD Anderson Cancer Center from 2016 to 2021. Implementation outcomes included: feasibility as measured by DIGEST reporting in EHR (as a marker of clinical use) and fidelity as measured by accuracy of DIGEST reporting relative to the decision-tree logic (penetration-aspiration scale [PAS], residue, and Safety [S] and Efficiency [E] grades). Contextual factors examined included year, setting, cancer type, MBS indication, and provider. 13,055 MBS were conducted by 29 providers in 7,842 unique patients across the lifespan in diverse oncology populations (69% M; age 1-96 years; 58% H&N cancer; 10% inpatient, 90% outpatient). DIGEST was reported in 12,137/13,088 exams over the 6-year implementation period representing 93% (95% CI: 93-94%) adoption in all exams and 99% (95% CI: 98-99%) of exams excluding the total laryngectomy population (n = 730). DIGEST reporting varied modestly by year, cancer type, and setting/provider (> 91% in all subgroups, p < 0.001). Accuracy of DIGEST reporting was high for overall DIGEST (incorrect SE profile 1.6%, 200/12,137), DIGEST-safety (incorrect PAS 0.4% 51/12,137) and DIGEST-efficiency (incorrect residue 1.2%, 148/12,137). Clinical implementation of DIGEST was feasible with high fidelity in a busy oncology practice across a large number of providers. Adoption of the tool across the lifespan in diverse cancer diagnoses may motivate validation beyond H&N oncology.

American Cancer Society Head and Neck Cancer Survivorship Care Guideline.

Answer questions and earn CME/CNE The American Cancer Society Head and Neck Cancer Survivorship Care Guideline was developed to assist primary care clinicians and other health practitioners with the care of head and neck cancer survivors, including monitoring for recurrence, screening for second primary cancers, assessment and management of long-term and late effects, health promotion, and care coordination. A systematic review of the literature was conducted using PubMed through April 2015, and a multidisciplinary expert workgroup with expertise in primary care, dentistry, surgical oncology, medical oncology, radiation oncology, clinical psychology, speech-language pathology, physical medicine and rehabilitation, the patient perspective, and nursing was assembled. While the guideline is based on a systematic review of the current literature, most evidence is not sufficient to warrant a strong recommendation. Therefore, recommendations should be viewed as consensus-based management strategies for assisting patients with physical and psychosocial effects of head and neck cancer and its treatment. CA Cancer J Clin 2016;66:203-239. © 2016 American Cancer Society.

The Acceptability of Behavioural Swallowing Interventions for Head and Neck Cancer Patients During Radiotherapy: A Qualitative Study Exploring Experiences of Clinical Trial Speech-Language Pathologists.

The PRO-ACTIVE randomized clinical trial offers 3 swallowing therapies to Head and Neck Cancer (HNC) patients during radiotherapy (RT) namely: reactive, proactive low- ("EAT-RT" only) and high-intensity ("EAT-RT + exercises"). Understanding the experiences of the trial Speech-Language Pathologists (SLPs) will be useful to inform clinical implementation. This study assessed SLP opinions of acceptability and clinical feasibility of the 3 trial therapies. 8 SLPs from 3 Canadian PRO-ACTIVE trial sites participated in individual interviews. Using a qualitative approach, data collection and thematic analysis were guided by the Theoretical Framework of Acceptability. Member checking was conducted through a follow-up focus group with willing participants. Seven themes were derived: intervention coherence, burden, barriers/facilitators, self-efficacy, attitude, ethicality, and perceived effectiveness. SLPs felt all 3 therapies had potential benefit yet perceived more advantages of proactive therapies compared to reactive. Compared to exercises, SLPs particularly endorsed the EAT-RT component. A major barrier was keeping patients motivated, which was impacted by acute toxicity and sometimes conflicting instructions from the healthcare team. Strategies utilized by to overcome barriers included: scaling exercises and/or diet up/down according to the changing patient needs and communicating therapy goals with healthcare team. A model was derived describing the perceived acceptability of the swallowing therapies according to SLPs, based on the interconnection of main themes. Proactive therapies were perceived as more acceptable to trial SLPs, for facilitating patient engagement. The perceived acceptability of the swallowing therapies was related to seven interconnected aspects of providers' experience. These findings will inform the implementation and potential uptake of the PRO-ACTIVE swallowing therapies in clinical practice.

Exploring the Acceptability of Behavioral Swallowing Interventions for Head and Neck Cancer Patients During Radiotherapy: A Qualitative Study of Patients' Experience.

The PRO-ACTIVE randomized clinical trial offers 3 swallowing therapies to Head and Neck Cancer (HNC) patients during radiotherapy namely: reactive, proactive low- ("EAT-RT" only), and high-intensity ("EAT-RT + exercises"). Understanding the perceived acceptability of these interventions is important to inform eventual implementation into clinical practice. This study explored patients' perspectives using qualitative methodology. At 2 Canadian PRO-ACTIVE trial sites, 24 trial participants were recruited for individual semi-structured interviews, representing each of the 3 trial arms. Data collection and thematic analysis were guided by the Theoretical Framework of Acceptability (TFA). Member checking was conducted through follow-up focus groups. Seven themes were derived reflecting the TFA constructs. Overall, regardless of trial arm, patients reported a positive experience with therapy. Patients identified benefits of EAT-RT therapy, reporting that it provided meaningful feedback on diet progress and supported goal setting for oral intake. Patients who received proactive therapies valued the opportunity to set expectations early, build mealtime routine iteratively over time, and have an extended engagement with the SLP. Regardless of trial arm, patients agreed proactive therapy aligned with what they think is best and that therapy intensity should accommodate individual needs. This study identified the value to HNC patients of receiving swallowing interventions during RT and setting realistic expectations around swallowing. Compared to reactive care, proactive therapies were perceived helpful in consolidating habits early, establishing realistic expectations around swallowing and building an extended rapport with the SLP. These findings will inform the implementation of proactive versus reactive swallowing therapies in clinical practice.

Tissue augmentation treatment for periprosthetic leakage in patients who have undergone a total laryngectomy: A systematic review.

OBJECTIVES: Tracheoesophageal puncture (TEP) is considered the gold standard for voice rehabilitation after total laryngectomy. One of the main causes of treatment failure, and a potentially serious complication, is the TEP enlargement and/or leakage around the voice prosthesis. The injection of biocompatible material to increase the volume of the puncture surrounding tissue has been studied as a popular option for conservative treatment of enlarged tracheoesophageal fistula. The aim of this paper was to perform a systematic review of the efficacy and safety of such treatment. DESINGN: Search conducted in PubMed/MEDLINE, the Cochrane Library, Google Scholar, Scielo and Web of Science and through the meta-searcher Trip Database based on Preferred Reporting Items for a Systematic Review and Meta-analysis (PRISMA) statement. SETTINGS: Human experiments published in peer-reviewed journals, where investigators assessed the use of peri-fistular tissue augmentation for periprosthetic leakage were evaluated. PARTICIPANTS: Laryngectomized patients with voice prosthesis, presenting periprosthetik leak due to enlarged fistula. MAIN OUTCOMES MEASURES: mean-duration without new leak. RESULTS: A total of 196 peri-fistular tissue augmentation procedures in 97 patients were found in the 15 selected articles. The 58.8% of patients had a time without periprosthetic leak after treatment of >6 months. The 88.7% of tissue augmentation treatments resulted in periprosthetic leakage cessation. The general level of evidence of the studies included in this review was low. CONCLUSIONS: Tissue augmentation treatment is a minimally invasive, biocompatible and safe solution that temporarily resolves periprosthetic leaks in many cases. There is no standard technique or material, and treatment needs to be individualised according to the experience of the practitioner and the characteristics of the patient. Future randomised studies are needed to confirm these results.

Estimating the optimal linear combination of predictors using spherically constrained optimization.

BACKGROUND: In the context of a binary classification problem, the optimal linear combination of continuous predictors can be estimated by maximizing the area under the receiver operating characteristic curve. For ordinal responses, the optimal predictor combination can similarly be obtained by maximization of the hypervolume under the manifold (HUM). Since the empirical HUM is discontinuous, non-differentiable, and possibly multi-modal, solving this maximization problem requires a global optimization technique. Estimation of the optimal coefficient vector using existing global optimization techniques is computationally expensive, becoming prohibitive as the number of predictors and the number of outcome categories increases. RESULTS: We propose an efficient derivative-free black-box optimization technique based on pattern search to solve this problem, which we refer to as Spherically Constrained Optimization Routine (SCOR). Through extensive simulation studies, we demonstrate that the proposed method achieves better performance than existing methods including the step-down algorithm. Finally, we illustrate the proposed method to predict the severity of swallowing difficulty after radiation therapy for oropharyngeal cancer based on radiation dose to various structures in the head and neck. CONCLUSIONS: Our proposed method addresses an important challenge in combining multiple biomarkers to predict an ordinal outcome. This problem is particularly relevant to medical research, where it may be of interest to diagnose a disease with various stages of progression or a toxicity with multiple grades of severity. We provide the implementation of our proposed SCOR method as an R package, available online at https://CRAN.R-project.org/package=SCOR .

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.

Conditional survival among patients with oropharyngeal cancer treated with radiation therapy and alive without recurrence 5 years after diagnosis.

BACKGROUND: Risk of recurrence among patients with oropharyngeal cancer (OPC) who survive 5 years is low. The goal of this study was to assess long-term survival of patients with OPC alive without recurrence 5 years after diagnosis. METHODS: This study included newly diagnosed patients with OPC, who had been treated with radiation and were alive without recurrence 5 years after diagnosis. Overall survival (OS) probabilities beyond 5 years were estimated using the Kaplan-Meier method. Factors associated with OS were determined using Bayesian piecewise exponential survival regression. Standardized mortality ratios for all-cause death were estimated controlling for study year, age, and sex in the US general population. RESULTS: Among 1699 patients, the additional 2-year, 5-year, and 10-year OS probabilities were 94%, 83%, and 63%, respectively, and were lower than those in the general population. Patients who were older, were current or former smokers, had other than tonsil or base of tongue tumors, or had T4 tumors had a higher risk of death. Patients who had base of tongue tumors and had received intensity-modulated radiation therapy (IMRT) or lower-radiation doses had a lower risk of death. Standardized mortality ratios were higher among current and heavy smokers and lower among recipients of IMRT and lower radiation doses. CONCLUSIONS: In this large cohort, long-term survival among patients with OPC was good but lower than predicted for the general population. Patients treated with IMRT and those with less tobacco exposure had better outcomes.

The impact of induction and/or concurrent chemoradiotherapy on acute and late patient-reported symptoms in oropharyngeal cancer: Application of a mixed-model analysis of a prospective observational cohort registry.

BACKGROUND: The goal of this study was to comprehensively investigate the association of chemotherapy with trajectories of acute symptom development and late symptom recovery in patients with oropharyngeal cancer (OPC) by comparing symptom burden between induction chemotherapy followed by concurrent chemoradiotherapy (ICRT), concurrent chemo-radiotherapy (CRT), or radiotherapy (RT) alone. METHODS: Among a registry of 717 patients with OPC, the 28-item patient-reported MD Anderson Symptom Inventory-Head and Neck Module (MDASI-HN) symptoms were collected prospectively at baseline, weekly during RT, and 1.5, 3 to 6, 12, and 18 to 24 months after RT. The effect of the treatment regimen (ICRT, CRT, and RT alone) was examined with mixed-model analyses for the acute and late period. In the CRT cohort, the chemotherapy agent relationship with symptoms was investigated. RESULTS: Chemoradiation (ICRT/CRT) compared with RT alone resulted in significantly higher acute symptom scores in the majority of MDASI-HN symptoms (ie, 21 out of 28). No late symptom differences between treatment with or without chemotherapy were observed that were not attributable to ICRT. Nausea was lower for CRT with carboplatin than for CRT with cisplatin; cetuximab was associated with particularly higher scores for acute and late skin, mucositis, and 6 other symptoms. The addition of ICRT compared with CRT or RT alone was associated with a significant increase in numbness and shortness of breath. CONCLUSION: The addition of chemotherapy to definitive RT for OPC patients was associated with significantly worse acute symptom outcomes compared with RT alone, which seems to attenuate in the late posttreatment period. Moreover, induction chemotherapy was specifically associated with worse numbness and shortness of breath during and after treatment. LAY SUMMARY: Chemotherapy is frequently used in addition to radiotherapy cancer treatment, yet the (added) effect on treatment-induced over time is not comprehensively investigated This study shows that chemotherapy adds to the symptom severity reported by patients, especially during treatment.

Determinants of patient-reported xerostomia among long-term oropharyngeal cancer survivors.

BACKGROUND: This study was conducted to identify clinicodemographic risk factors for xerostomia among long-term oropharyngeal cancer (OPC) survivors. METHODS: This cross-sectional study included 906 disease-free, adult OPC survivors with a median survival duration at the time of survey of 6 years (range, 1-16 years); self-reported xerostomia scores were available for 877 participants. Study participants had completed curative treatment between January 2000 and December 2013 and responded to a survey administered from September 2015 to July 2016. The primary outcome variable was cancer patient-reported xerostomia measured with the MD Anderson Symptom Inventory Head and Neck Cancer Module. Clinicodemographic risk factors for moderate to severe xerostomia were identified via multivariable logistic regression. RESULTS: Moderate to severe xerostomia was reported by 343 of the respondents (39.1%). Female sex (odds ratio [OR], 1.82; 95% CI, 1.22-2.71; P = .003; Bayesian false-discovery probability [BFDP] = 0.568), high school or lower education (OR, 1.73; 95% CI, 1.19-2.52; P = .004; BFDP = 0.636), and current cigarette smoking at the time of survey (OR, 2.56; 95% CI, 1.19-5.47; P = .016; BFDP = 0.800) were risk factors for moderate to severe xerostomia, and bilateral intensity-modulated radiotherapy (IMRT) combined with proton therapy and ipsilateral IMRT were protective. CONCLUSIONS: In this large xerostomia study, modern radiotherapy was a protective factor, and continued cigarette smoking at the time of survey, female sex, and high school or lower education were identified as other contributing risk factors associated with moderate to severe xerostomia. Importantly, these findings need to be confirmed in prospective studies. These results can inform future research and targeted patient-centered interventions to monitor and manage radiation therapy-associated xerostomia and preserve quality of life among patients with OPC.

Vocal-cord Only vs. Complete Laryngeal radiation (VOCAL): a randomized multicentric Bayesian phase II trial.

BACKGROUND: Radiotherapy, along with laser surgery, is considered a standard treatment option for patients with early glottic squamous cell cancer (SCC). Historically, patients have received complete larynx radiotherapy (CL-RT) due to fear of swallowing and respiratory laryngeal motion and this remains the standard approach in many academic institutions. Local control (LC) rates with CL-RT have been excellent, however this treatment can carry significant toxicities include adverse voice and swallowing outcomes, along with increased long-term risk of cerebrovascular morbidity. A recent retrospective study reported improved voice quality and similar local control outcomes with focused vocal cord radiotherapy (VC-RT) compared to CL-RT. There is currently no prospective evidence on the safety of VC-RT. The primary objective of this Bayesian Phase II trial is to compare the LC of VC-RT to that of CL-RT in patients with T1N0 glottic SCC. METHODS: One hundred and fifty-five patients with T1a-b N0 SCC of the true vocal cords that are n ot candidate or declined laser surgery, will be randomized in a 1:3 ratio the control arm (CL-RT) and the experimental arm (VC-RT). Randomisation will be stratified by tumor stage (T1a/T1b) and by site (each site will be allowed to select one preferred radiation dose regimen, to be used in both arms). CL-RT volumes will correspond to the conventional RT volumes, with the planning target volume extending from the top of thyroid cartilage lamina superiorly to the bottom of the cricoid inferiorly. VC-RT volumes will include the involved vocal cord(s) and a margin accounting for respiration and set-up uncertainty. The primary endpoint will be LC at 2-years, while secondary endpoints will include patient-reported outcomes (voice impairment, dysphagia and symptom burden), acute and late toxicity radiation-induced toxicity, overall survival, progression free survival, as well as an optional component of acoustic and objective measures of voice analysis using the Consensus Auditory-Perceptual Evaluation of Voice. DISCUSSION: This study would constitute the first prospective evidence on the efficacy and safety of VC-RT in early glottic cancer. If positive, this study would result in the adoption of VC-RT as standard approach in early glottic cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03759431 Registration date: November 30, 2018.

Self-Reported Trismus: prevalence, severity and impact on quality of life in oropharyngeal cancer survivorship: a cross-sectional survey report from a comprehensive cancer center.

OBJECTIVE: The purpose of this study was to estimate prevalence/severity of self-reported trismus, determine association with quality of life (QOL), and examine clinical risk factors in a large population of patients treated for oropharyngeal cancer. MATERIALS AND METHODS: A cross-sectional survivorship survey was conducted among patients who completed definitive treatment for oropharyngeal carcinoma, disease-free ≥ 1-year post-treatment (median survival, 7 years among 892 survivors). Associations between trismus and QOL were also analyzed using MDASI-HN, EQ-5D, and MDADI. Dietary and feeding tube status were also correlated to trismus status. RESULTS: Trismus was self-reported in 31%. Severity of trismus positively correlated (r = 0.29) with higher mean interference scores reflecting a moderate association with quality of life (p < 0.0001). There was a negative correlation for MDADI composite scores (r = - 0.33) indicating increased perceived dysphagia related to trismus severity (p < 0.0001). EQ-5D VAS scores were also negatively correlated with trismus severity (r = - 0.26, p < 0.0001). Larger T-stage (p ≤ 0.001), larger nodal stage (p = 0.03), tumor sub-site (p = 0.05), and concurrent chemoradiation (p = 0.01) associated with increased prevalence of trismus. Diet negatively correlated (r = - 0.27) with trismus severity (p = < 0.0001), and survivors with severe trismus were also more likely to be feeding tube-dependent. CONCLUSION: Severity of trismus appears to negatively impact quality of life and associate with various adverse functional outcomes in long-term oropharyngeal cancer survivorship. Trismus remains associated with advanced disease stages, tumor sub-site (tonsil), and addition of chemotherapy. Further investigation is merited for the dose-effect relationship to the muscles of mastication.

Defining the dose-volume criteria for laryngeal sparing in locally advanced oropharyngeal cancer utilizing split-field IMRT, whole-field IMRT and VMAT.

PURPOSE: To determine the optimal dose-volume constraint for laryngeal sparing using three commonly employed intensity modulated radiation therapy (IMRT) approaches in patients with oropharyngeal cancer treated to the bilateral neck. MATERIALS AND METHODS: Thirty patients with stage II-IVA oropharynx cancers received definitive radiotherapy with split-field IMRT (SF-IMRT) to the bilateral neck between 2008 and 2013. Each case was re-planned using whole-field IMRT (WF-IMRT) and volumetric modulated arc therapy (VMAT) and plan quality metrics and dose to laryngeal structures was evaluated. Two larynx volumes were defined and compared on the current study: the Radiation Therapy Oncology Group (RTOG) larynx as defined per the RTOG 1016 protocol and the MDACC larynx defined as the components of the larynx bounded by the superior and inferior extent of the thyroid cartilage. RESULTS: Target coverage, conformity, and heterogeneity indices were similar in all techniques. The RTOG larynx mean dose was lower with WF-IMRT than SF-IMRT (22.1 vs 25.8 Gy; P < 0.01). The MDACC larynx mean dose was 17.5 Gy ± 5.4 Gy with no differences between the 3 techniques. WF-IMRT and VMAT plans were associated with lower mean doses to the supraglottic larynx (42.1 vs 41.2 vs 54.8 Gy; P < 0.01) and esophagus (18.1 vs 18.2 vs 36 Gy; P < 0.01). CONCLUSIONS: Modern whole field techniques can provide effective laryngeal sparing in patients receiving radiotherapy to the bilateral neck for advanced oropharyngeal cancers. SUMMARY: We evaluated laryngeal dose in patients with locally advanced oropharyngeal cancer treated to the bilateral neck using split-field IMRT (SF-IMRT), whole-field IMRT (WF-IMRT) and volumetric arc therapy (VMAT). All three techniques provided good sparing of laryngeal structures and were able to achieve a mean larynx dose < 33 Gy. There were no significant differences in dose to target structures or non-laryngeal organs at risk among techniques.

High-Resolution Pharyngeal Manometry and Impedance: Protocols and Metrics-Recommendations of a High-Resolution Pharyngeal Manometry International Working Group.

High-resolution manometry has traditionally been utilized in gastroenterology diagnostic clinical and research applications. Recently, it is also finding new and important applications in speech pathology and laryngology practices. A High-Resolution Pharyngeal Manometry International Working Group was formed as a grass roots effort to establish a consensus on methodology, protocol, and outcome metrics for high-resolution pharyngeal manometry (HRPM) with consideration of impedance as an adjunct modality. The Working Group undertook three tasks (1) survey what experts were currently doing in their clinical and/or research practice; (2) perform a review of the literature underpinning the value of particular HRPM metrics for understanding swallowing physiology and pathophysiology; and (3) establish a core outcomes set of HRPM metrics via a Delphi consensus process. Expert survey results were used to create a recommended HRPM protocol addressing system configuration, catheter insertion, and bolus administration. Ninety two articles were included in the final literature review resulting in categorization of 22 HRPM-impedance metrics into three classes: pharyngeal lumen occlusive pressures, hypopharyngeal intrabolus pressures, and upper esophageal sphincter (UES) function. A stable Delphi consensus was achieved for 8 HRPM-Impedance metrics: pharyngeal contractile integral (CI), velopharyngeal CI, hypopharyngeal CI, hypopharyngeal pressure at nadir impedance, UES integrated relaxation pressure, relaxation time, and maximum admittance. While some important unanswered questions remain, our work represents the first step in standardization of high-resolution pharyngeal manometry acquisition, measurement, and reporting. This could potentially inform future proposals for an HRPM-based classification system specifically for pharyngeal swallowing disorders.

Single-item discrimination of quality-of-life-altering dysphagia among 714 long-term oropharyngeal cancer survivors: Comparison of patient-reported outcome measures of swallowing.

BACKGROUND: Two patient-reported outcomes (PROs) of swallowing and their correlation to quality of life (QOL) were compared in long-term survivors of oropharyngeal cancer (OPC). METHODS: Scores on the single dysphagia item from the 28-item, multisymptom MD Anderson Symptom Inventory-Head and Neck (MDASI-HN-S) were compared with scores on the dysphagia-specific composite MD Anderson Dysphagia Inventory (MDADI) and the EuroQol visual analog scale (EQ-VAS) in 714 patients who had received definitive radiotherapy ≥12 months before the survey. An MDASI-HN-S score ≥6 and an MDADI composite score <60 were considered representative of moderate/severe swallowing dysfunction. RESULTS: Moderate/severe dysphagia was reported by 17% and 16% of respondents on the MDASI-HN-S and the composite MDADI, respectively. Both swallow PROs were predictive of QOL, and the MDASI-HN-S model was slightly more parsimonious for the discrimination of EQ-VAS scores compared with MDADI scores (Bayesian information criteria, 6062 vs 6076, respectively). An MDASI-HN-S cutoff score of ≥6 correlated best with a declining EQ-VAS score (P < .0001) and was associated with increased radiotherapy dose to several normal swallowing structures. CONCLUSIONS: In this cohort, the single-item MDASI-HN-S performed favorably for the discrimination of QOL compared with the multi-item MDADI. A time-efficient model for PRO measurement of swallowing is proposed in which the MDADI may be reserved for patients who score ≥6 on the MDASI-HN-S.

Modeling symptom drivers of oral intake in long-term head and neck cancer survivors.

PURPOSE: This study examined the relationship between self-reported symptom severity and oral intake in long-term head and neck cancer (HNC) survivors. METHODS: An observational survey study with retrospective chart abstraction was conducted. HNC patients who had completed an MD Anderson Symptom Inventory-Head and Neck (MDASI-HN) questionnaire and also had clinician graded oral intake ratings (Functional Oral Intake Scale [FOIS]) were included. Correlation coefficients were computed. FOIS scores were regressed on MDASI-HN symptom items using stepwise backwards elimination for multivariate models. RESULTS: One hundred and fifty-two survey pairings were included in the analysis (median 44 months follow-up, range 7-198). Per FOIS, 28% of survivors maintained a total oral diet with no restrictions, 67% reported a restricted oral diet (without tube), 3% were partially tube-dependent with some oral intake, and 2% were NPO. Of the 22 symptom items, the most severe items in decreasing order were dry mouth, difficulty swallowing\chewing, problems with mucus, tasting food, and choking/coughing. Significant bivariate correlations, after Bonferroni correction for multiple comparisons, were present for 8 of 22 symptoms with FOIS. On multivariate analysis, symptom severity for difficulty swallowing and problems with teeth/gums remained significantly associated with FOIS. CONCLUSIONS: Oral intake in HNC survivorship is a multidimensional issue and functional outcome that is impacted not only by dysphagia but also by dental status. Symptom drivers of oral intake likely differ in acute survivorship. Nonetheless, these findings highlight the lack of specificity in this end point and also the need for multidisciplinary supportive care to optimize oral intake in survivors.

Prosthetic Rehabilitation with Palatal Lift/Augmentation in a Patient with Neurologic/Motor Deficit Due To Cancer Therapy for Chondrosarcoma.

This clinical report describes the prosthetic rehabilitation of a 25-year-old man with a history of grade II chondrosarcoma at the skull base who had undergone surgical resection and thereafter developed velopharyngeal incompetency (VPI), dysarthria, and dysphagia. Upon baseline fiberoptic endoscopic evaluation of swallowing (FEES), the patient had an atypical pattern of VPI with minimal to no velar lift during speech, blow, or suck tasks, but near complete velar lift and seal during swallowing. A palatal augmentation prosthesis combined with a resilient palatal lift extension was fabricated to enhance speech by displacing the soft palate and to decrease hypernasality, while avoiding interference with bolus transport. A resilient wrought wire extension was necessary to accommodate the velar movement upon swallowing while keeping the integrity of the velar lift during speech. In conclusion, this unique combination prosthesis was able to help the patient's atypical pattern of VPI by improving speech and preserving swallowing function, which was confirmed during a post-endoscopic evaluation.