Methodological approach for determining the Minimal Important Difference and Minimal Important Change scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module (EORTC QLQ-HN43) exemplified by the Swallowing scale.

PURPOSE: The aim of this study was to explore what methods should be used to determine the minimal important difference (MID) and minimal important change (MIC) in scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43. METHODS: In an international multi-centre study, patients with head and neck cancer completed the EORTC QLQ-HN43 before the onset of treatment (t1), three months after baseline (t2), and six months after baseline (t3). The methods explored for determining the MID were: (1) group comparisons based on performance status; (2) 0.5 and 0.3 standard deviation and standard error of the mean. The methods examined for the MIC were patients' subjective change ratings and receiver-operating characteristics (ROC) curves, predictive modelling, standard deviation, and standard error of the mean. The EORTC QLQ-HN43 Swallowing scale was used to investigate these methods. RESULTS: From 28 hospitals in 18 countries, 503 patients participated. Correlations with the performance status were |r|< 0.4 in 17 out of 19 scales; hence, performance status was regarded as an unsuitable anchor. The ROC approach yielded an implausible MIC and was also discarded. The remaining approaches worked well and delivered MID values ranging from 10 to 14; the MIC for deterioration ranged from 8 to 16 and the MIC for improvement from - 3 to - 14. CONCLUSIONS: For determining MIDs of the remaining scales of the EORTC QLQ-HN43, we will omit comparisons of groups based on the Karnofsky Performance Score. Other external anchors are needed instead. Distribution-based methods worked well and will be applied as a starting strategy for analyses. For the calculation of MICs, subjective change ratings, predictive modelling, and standard-deviation based approaches are suitable methods whereas ROC analyses seem to be inappropriate.

Respiratory-Swallow Pattern Following Total Laryngectomy.

The goal of this study was to further characterize respiratory patterns in total laryngectomees with attention to respiratory-swallow pattern as it relates to presence/absence of tracheoesophageal puncture (TEP) and bolus consistency. It was hypothesized that participants with TEP would exhibit respiratory-swallow patterns that were significantly different than those without TEP and that bolus consistency (thin or solid) would modulate respiratory-swallow pattern. Data were collected from 12 adults (8 male), aged 46-67 years (mean 57) status post total laryngectomy (1-30 years; average 6 years). Those actively receiving chemoradiation, with history of esophageal cancer, with neurologic disease, with history of lung cancer, with known or suspected recurrence of head and neck cancer (HNC), or with severe cognitive deficits were excluded. Laryngectomy participants were asked to swallow three sips of water and three bites of graham cracker. Submental surface EMG activity was used to detect swallows and a custom stoma mask in line with a pneumotachograph measured airflow during the swallows. Non-parametric Mann-Whitney test for differences was used to detect significance for our dependent variables, TEP or bolus consistency and independent variables, respiratory-swallow pattern. Laryngectomee's showed preference for swallow during inspiration which is inconsistent with the expiratory pattern preference found in healthy adults with intact larynges by McFarland et al. (Respir Physiol Neurobiol 234:89-96, 2016) but consistent with the pattern preference for inspiration (or non-dominant respiratory-swallow phase pattern) found in the HNC population at-large by Brodsky et al. (J Appl Physiol 112(10):1698-1705, 2012). No significant difference was found in swallow pattern with regards to presence/absence of TEP or bolus consistency.

Effects of Tongue Strength Training on Quality of Life in Head and Neck Cancer Patients: Results From a Pilot Interventional Clinical Trial.

BACKGROUND: Head and neck cancer (HNC) patients often have dysphagia following surgical and/or chemoradiation treatment, which can lead to reduced quality of life. Some patients suffer from decreased tongue strength and mobility that may cause discomfort and difficulty with swallowing. Our group has developed a patented genioglossus muscle strength trainer (GMST) to increase tongue protrusive force that has been used in patients with sleep apnea. We hypothesized that the GMST device would increase tongue strength in the HNC population. METHODS: We conducted an IRB approved, non-randomized, interventional clinical trial of HNC patients with dysphagia to determine the effect of GMST on tongue strength. Our secondary objective was to assess dysphagia quality of life, as determined by questionnaires. Genioglossus muscle strength measurements (measured in Newtons, N) and dysphagia quality of life scores (SWAL-QoL questionnaire) were obtained from enrolled patients at baseline and following 4 weeks of intervention. Treatment was at-home GMST exercise regimen 3 times daily, 5 days per week. Compliance was assessed via review of training logs. Two-sided paired t-tests at significance level α = .05 were performed to assess difference in mean GG muscle strength pre- and post-treatment. RESULTS: Out of 10 patients initially enrolled, 7 patients completed the trial. Eighty-six percent were male and the average age was 60. About 5 patients had surgery plus adjuvant radiation and 2 patients had primary radiation. All patients had baseline dysphagia as determined by patient complaint and/or objective measurement (prior modified barium swallow). No adverse events were reported. We observed a statistically significant increase in genioglossus muscle strength (mean change: 4.0 N, 95% CI 1.1-6.9, P = .015) after 4 weeks of treatment. Patients reported reduced swallowing burden and feeling of stigma around eating based on SWAL-QoL results. CONCLUSIONS: Our data suggest that protrusive tongue-training exercises utilizing a novel tongue trainer device is well-tolerated and increases genioglossus muscle strength in treated HNC patients complaining of dysphagia. Patient-reported outcomes based on the SWAL-QoL survey indicate improvements in quality-of-life post-treatment, although our results are limited by small sample size. Larger studies are needed to see if this device could have clinically meaningful results for this difficult-to-treat patient population.

The european organisation for research and treatment of cancer head and neck cancer module (EORTC QLQ-HN43): Estimates for minimal important difference and minimal important change.

INTRODUCTION: Minimal important change estimates (MIC) are useful for interpreting results of clinical research with quality of life (QoL) as an endpoint. For the European Organisation for Research and Treatment of Cancer head and neck cancer module, the EORTC QLQ-HN43, no such thresholds are established. METHODS: Head and neck cancer patients under active treatment (n = 503) from 15 countries completed the EORTC QLQ-HN43 three times (t1: before treatment, t2: three months after t1, t3: six months after t1). A subgroup completed a Subjective Significance Questionnaire (SSQ), indicating experienced change from the previous time point in four QoL domains. QoL was assumed to deteriorate after t1 and improve again until t3. The MIC was established using the average of mean differences in SSQ groups (MICmean) and estimates based on logistic regressions (MICpredict). Additionally, minimal detectable changes (MDC) were computed using 0.5 standard deviation and standard error of the mean. RESULTS: For swallowing, speech, dry mouth, and global QoL, the MIC for deterioration were 13, 14, 26, and 10 respectively. The MIC for improvement were 8 (swallowing), 6 (dry mouth), and 5 (global QoL); no MIC for speech improvement can be presented because of insufficient correlation between change score and anchor. The MDC estimates for deterioration were 15, 14, 15, and 11. For improvement, the MDC estimates were 13, 14, 14, and 11. CONCLUSIONS: Our results underline that no single MIC or MDC can be applied to all EORTC QLQ-HN43 scales, and that the MIC for deterioration seems larger than those for improvement.

Prospective quality initiative to maximize dysphagia screening reduces hospital-acquired pneumonia prevalence in patients with stroke.

BACKGROUND AND PURPOSE: Dysphagia can lead to pneumonia and subsequent death after acute stroke. However, no prospective study has demonstrated reduced pneumonia prevalence after implementation of a dysphagia screen. METHODS: We performed a single-center prospective interrupted time series trial of a quality initiative to improve dysphagia screening. Subjects included all patients with ischemic or hemorrhagic stroke admitted to our institution over 42 months with a 31-month (n=1686) preintervention and an 11-month (n=648) postintervention period. The intervention consisted of a dysphagia protocol with a nurse-administered bedside dysphagia screen and a reflexive rapid clinical swallow evaluation by a speech pathologist. RESULTS: The dysphagia initiative increased the percentage of patients with stroke screened from 39.3% to 74.2% (P<0.001). Furthermore, this initiative coincided with a drop in hospital-acquired pneumonia from 6.5% to 2.8% among patients with stroke (P<0.001). Patients admitted postinitiative had 57% lower odds of pneumonia, after controlling for multiple confounds (odds ratio=0.43; confidence interval, 0.255-0.711; P=0.0011). The best predictors of pneumonia were stroke type (P<0.0001), oral intake status (P<0.0001), dysphagia screening status (P=0.0037), and hospitalization before the beginning of the quality improvement initiative (P=0.0449). CONCLUSIONS: A quality improvement initiative using a nurse-administered bedside screen with rapid bedside swallow evaluation by a speech pathologist improves screening compliance and correlates with decreased prevalence of pneumonia among patients with stroke.

Reflex vs. volitional cough differences amongst head and neck cancer survivors characterized by time since treatment and aspiration status.

BACKGROUND: The aim of this study was to investigate differences in reflexive and volitional cough airflows in advanced stage head and neck cancer survivors as it relates to aspiration status and time since treatment. The hypothesis is that those who aspirate several years after treatment completion would demonstrate reduced airflows for all cough parameters compared to those recently status post treatment completion given the known progressive deterioration associated with radiotherapy. METHODS: Demographic and airflow data during both reflexive and volitional cough tasks and aspiration status as determined during fiberoptic endoscopic evaluation of swallow function were collected from 33 Head and Neck Cancer (HNC) survivors. RESULTS: Omnibus MANOVA for dependent airflow variables and independent variables aspiration status, time since treatment and cough type (reflex or volitional) was significant (F(3,1) = 184, p < 0.000) indicating that peak expiratory flow rates (PEFR) were reduced under reflex (mean PEFR 1.88 SD 0.7) versus volitional (mean PEFR 2.3, SD 0.7) cough types; reduced for aspirators versus non-aspirators (F(2,1) = 4.1, p = 0.04) and reduced for those in the subacute versus chronic phase status post Intensity Modulated Radiotherapy (IMRT) (F(2,1) = 10.05, p = 0.002). CONCLUSION: Findings of reduced reflexive compared to volitional cough airflows in head and neck cancer survivors are consistent with those from both healthy and other diseased populations. Additional findings that aspirators demonstrate reduced cough airflows compared to non-aspirators supports the hypothesis. Surprisingly, those recently status post treatment completion show worse cough airflows compared to those remotely status post treatment completion.

Impact of Tussigenic Stimuli on Perceived Upper Airway Sensation and Motor Cough Response Following Total Laryngectomy.

BACKGROUND: Total laryngectomy (TL) is standard intervention for carcinoma of the head and neck or, in cases of non-functional larynx, as a result of disease or radiation exposure. Laryngeal extirpation serves as a unique human model of both recurrent and superior laryngeal nerve section and offers insight into motor and sensory aspects of cough: both volitional and in response to tussigenic stimuli. While motor changes in cough function are expected among those status post-TL due to postoperative reconstruction of the upper airway, motor cough parameters have not been well described and sensory aspects of cough are unknown in this population, which provides insight into a vagal denervation model in humans. METHODS: Data were collected from three groups totaling 80 adults (39 male), including 25 healthy younger adults (HYA), 27 healthy older adults (HOA), and 28 adults post-TL. Cough was elicited both upon command and in response to nebulized capsaicin. Outcome measures included urge to cough and cough airflows. RESULTS: Kruskal-Wallis test showed that two of the three groups differed significantly by urge to cough χ2(2, N = 244) = 8.974, p = 0.011. Post hoc analysis showed that post-TL subjects had reduced perceived urge to cough at all concentrations of capsaicin (p < 0.05). Cough airflows were significantly reduced for post-TL subjects compared to healthy controls in all metrics except post-peak phase integral (PPPI) for which HOA and TLs were comparable under both volitional and capsaicin-induced conditions. CONCLUSIONS: These findings support the hypothesis that both cough airflow and sensations are significantly reduced in post-TL subjects when compared with HOA. Interestingly, HOA and post-TL subjects have comparably reduced UTC and cough airflows when compared to HYA. The only metric of cough airflow for which these groups differ is the PPPI, which may be a compensatory adaptation for reduced cough airflows and/or sensation.

Endoscopic Dilation of Refractory Postlaryngectomy Strictures: A Case Series and Literature Review.

BACKGROUND: Endoscopic dilation of postlaryngectomy strictures (PLS) is safe and effective; however, PLS are often refractory and require serial dilations. Long-term outcomes of dilation in patients with refractory PLS are not well reported. MATERIALS AND METHODS: Seven patients with dysphagia and refractory PLS underwent serial endoscopic dilation therapy during a 4.5-year period. Dilation characteristics, technical success, clinical success, and diet advancement (as assessed by Diet/GT scale) were measured. Results. All strictures were complex, and there were no reported complications. The median number of dilations per patient was 12 (range 7 to 48). The average interval in between dilations was six weeks. Technical success was achieved in 6/7 patients, and clinical success was achieved in 2/7 patients. 6/7 patients had advancements in Diet/GT scores. CONCLUSIONS: Dilation of refractory PLS is safe and effective and frequently requires the use of a retrograde approach, fluoroscopic guidance, and/or lumen patency strings. Serial dilations are required to maintain luminal patency, relieve dysphagia, and advance oral diet. The definition of clinical success of dilation in these patients should avoid the use of a specific time interval between dilations to characterize success.

Chronic opioid use in patients undergoing treatment for oropharyngeal cancer.

OBJECTIVES/HYPOTHESIS: Head and neck cancer pain is a prevalent problem, and the current opioid crisis has highlighted concerns raised in chronic pain management. This study assessed the characteristics of opioid use in patients undergoing treatment for oropharynx cancer and identified risk factors associated with chronic opioid use. STUDY DESIGN: Retrospective cohort study. METHODS: A study was conducted of 198 eligible patients who underwent radiotherapy as part of their treatment for oropharynx cancer at a single institution from 2012 to 2017. p16/human papillomavirus (HPV) status was determined by pathology report review. Opioid use was recorded. Statistical analysis was performed to assess risk factors for chronic opioid use and effect on overall survival. RESULTS: The average age was 62 years, and the mean follow-up was 38 months. Eighty-three percent of patients had stage III/IV disease, and 73% received chemoradiotherapy. Sixty-nine percent were HPV/p16 positive. Fifty-seven (29%) patients had preexisting chronic pain conditions. Chronic opioid use was observed in 53% of the patients. Age ≤ 62 years (P < .0001), history of depression (P = .0356), p16 negative status (P = .0097), opioid use at pretreatment visit (P = .0021), and presence of a preexisting chronic pain condition at time of diagnosis (P = .0181) were associated with chronic opioid use using univariate analysis. On multivariate analysis, T stage and anxiety/depression were associated with chronic opioid use. Overall survival was worse for patients who had chronic opioid use, but was not significant when recurrence was taken into consideration. CONCLUSIONS: More than 50% of the patients treated for oropharynx squamous cell carcinoma in this cohort were chronic opioid users after treatment. Identifying patients at greatest risk for chronic opioid use prior to treatment may help with long-term pain management in this patient population. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:2087-2093, 2019.

International validation of the revised European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43: Phase IV.

BACKGROUND: We validated the new European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43). METHODS: We enrolled 812 patients with head and neck cancer from 18 countries. Group 1 completed the questionnaire before therapy, and 3 and 6 months later. In group 2 (survivors), we determined test-retest reliability using intraclass correlation coefficients (ICC). Internal consistency was assessed using Cronbach's Alpha, the scale structure with confirmatory factor analysis, and discriminant validity with known-group comparisons. RESULTS: Cronbach's alpha was >0.70 in 10 of the 12 multi-item scales. All standardized factor loadings exceeded 0.40. The ICC was >0.70 in all but two scales. Differences in scale scores between known-groups were >10 points in 17 of the 19 scales. Sensitivity to change was found to be sufficient in 18 scales. CONCLUSIONS: Evidence supports the reliability and validity of the EORTC QLQ-HN43 as a measure of quality of life.

Consumption of fat-free fluid milk after resistance exercise promotes greater lean mass accretion than does consumption of soy or carbohydrate in young, novice, male weightlifters.

BACKGROUND: Acute consumption of fat-free fluid milk after resistance exercise promotes a greater positive protein balance than does soy protein. OBJECTIVE: We aimed to determine the long-term consequences of milk or soy protein or equivalent energy consumption on training-induced lean mass accretion. DESIGN: We recruited 56 healthy young men who trained 5 d/wk for 12 wk on a rotating split-body resistance exercise program in a parallel 3-group longitudinal design. Subjects were randomly assigned to consume drinks immediately and again 1 h after exercise: fat-free milk (Milk; n = 18); fat-free soy protein (Soy; n = 19) that was isoenergetic, isonitrogenous, and macronutrient ratio matched to Milk; or maltodextrin that was isoenergetic with Milk and Soy (control group; n = 19). RESULTS: Muscle fiber size, maximal strength, and body composition by dual-energy X-ray absorptiometry (DXA) were measured before and after training. No between-group differences were seen in strength. Type II muscle fiber area increased in all groups with training, but with greater increases in the Milk group than in both the Soy and control groups (P < 0.05). Type I muscle fiber area increased after training only in the Milk and Soy groups, with the increase in the Milk group being greater than that in the control group (P < 0.05). DXA-measured fat- and bone-free mass increased in all groups, with a greater increase in the Milk group than in both the Soy and control groups (P < 0.05). CONCLUSION: We conclude that chronic postexercise consumption of milk promotes greater hypertrophy during the early stages of resistance training in novice weightlifters when compared with isoenergetic soy or carbohydrate consumption.

Prospective Comprehensive Swallowing Evaluation of Minimally Invasive Esophagectomies with Cervical Anastomosis: Silent Versus Vocal Aspiration.

INTRODUCTION: Pneumonia and tracheal aspiration remain problematic following esophagectomy. We hypothesized that the incidence of postesophagectomy pneumonia occurs in part because of swallowing dysfunction and more importantly silent tracheobronchial aspiration. Therefore, we instituted a routine prospective formal swallowing evaluation to determine if the aspiration rate and its associated morbidity can be decreased by early identification of patients with silent or vocal aspiration. METHODS: Patients undergoing minimally invasive McKeown esophagectomy and receiving neoadjuvant chemoradiotherapy (NACR) were prospectively enrolled between December 2013 to January 2015. A standardized cineradiography observation utilizing the Rosenbek penetration-aspiration (RPA) scale was used to rule out anastomotic leak and/or aspiration. RESULTS: Of 27 patients evaluated, twelve patients were noted to have silent (n = 8) or vocal (cough n = 4) aspiration of thin liquid (n = 8) or nectar-thick consistency (n = 4) on their initial study. Three patients were noted to have an anastomotic leak and vocal aspiration on their initial study. Eight of the nine patients who aspirated but did not have an anastomotic leak on their initial study had a repeat RPA study prior to discharge showing improvement from the initial study. Six patients (22 %) had vocal cord paresis and clinical hoarseness, but only two patients who had clinical diagnosis of pneumonia were noted to have vocal cord paresis and silent aspiration. CONCLUSIONS: Swallowing dysfunction remains a common problem after minimally invasive esophagectomy (MIE) with cervical anastomosis and can be readily identified. Silent aspiration likely contributes to pneumonia after MIE.

Survey of fitness facilities for individuals post-stroke in the Greater Toronto Area.

In light of the demonstrated importance of fitness programs after stroke, the current study set out to determine the availability and characteristics of fitness programs for individuals after stroke in the Greater Toronto Area (GTA). A questionnaire was distributed to 784 fitness programs in the GTA requesting information on the facility, program characteristics, and barriers to and willingness in offering specific programs for individuals post stroke. Of the 213 respondents, 146 (69%) reported that individuals with a chronic disability participated in their activities, 39 (18%) did not allow individuals with disabilities to participate, and 28 (13%) were unaware if individuals with disabilities accessed their facilities. Sixty-two facilities (29%) offered specific fitness programs for individuals with a chronic disability including 26 (12%) that offered exercise programs for people who have had a stroke. The study identified that a small percentage of fitness programs surveyed in GTA have fitness programs for individuals post-stroke. Since the occurrence of stroke is expected to increase as the population ages, the need for community fitness programs for individuals post-stroke will continue to rise. Many facilities expressed interest in offering specific fitness programs for individuals post-stroke; therefore, barriers must be addressed to facilitate the development of these programs.