Patient-reported Swallowing Research Articles

Radiation Dose Sensitivity of Subregions of the Larynx to Patient-Reported Swallowing Outcomes

PurposeAssess any correlation between swallowing dysfunction and radiation dose to five subregions of the larynx. Methods and MaterialsA cohort of 136 head and neck cancer patients, treated with either photon or proton radiotherapy, was assessed using an endpoint of patient-reported swallowing scores, evaluated with the EORTC QLQ-H&N35 survey, within one month following treatment. Five subregions of the larynx were contoured and dosimetric metrics were extracted for each subregion as well as the total larynx. Univariate and multivariate logistic regression statistical analyses were used to determine statistical correlation with the dose metrics and clinical variables. Univariate regression models were statistically compared using a non-nested model test. ResultsUnder univariate analysis, unilateral vs. bilateral nodal irradiation (p=0.004), concurrent chemotherapy (p=0.007), and surgery (p=0.015) were statistically significant predictors of poor swallowing score. Unilateral vs. bilateral irradiation was statistically significant under multivariate analysis (p=0.039). The epiglottis was the most predictive subregion of swallowing score with a majority (21 out of 25) of dosimetric variables being identified as statistically significant. The maximum dose to the epiglottis was the most significant dosimetric variable tested for poor swallowing score in both univariate (p=0.003) and multivariate (p=0.051) analyses. Comparison of univariate models indicated a general preference for epiglottic variables with the mean dose to the epiglottis being preferred at a statistically significant level in many cases. ConclusionsThese results show the relatively increased sensitivity of the epiglottis compared to the rest of the larynx when considering patient-reported decrements in quality-of-life swallowing score and support both the inclusion of the epiglottis in standard larynx contours and the assessment of the epiglottis dose during plan evaluation. Our data suggests that keeping the mean and max doses to the epiglottis <20–37 Gy and <53–60 Gy, respectively, will reduce swallowing difficulties.

Selective Treatment Deintensification by Reducing Radiation Dose and Omitting Concurrent Chemotherapy Based on Response to Induction Chemotherapy in Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma: A Single-Arm, Phase 2 Trial (IChoice-01)

To demonstrate the feasibility of deintensification regimen in the light of the response to induction chemotherapy (IC) in human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC). Patients with p16+ OPSCC, T1-2/N1-3M0 (excluding T1N1M0 with single and ≤3 cm lymph node) or T3-4N0-3M0 were enrolled between January 2019 and July 2021. All patients received 2 cycles of IC with docetaxel 75 mg/m2 dL and cisplatin 75 mg/m2 dL every 3 weeks. Those with major responses (≥50% decrease in both primary and lymph nodes) to IC entered the deintensification cohort (cohort D), in which intensity modulated radiation therapy alone was given to a reduced dose of 60 Gy/30 fractions. Those who failed to meet major responsesentered the concurrent chemoradiotherapy cohort (cohort C), where the dose was simultaneously integrated boosted to a standard 70 Gy/35 fractions to nonmajor response sites, concurrently with cisplatin 80 mg/m2 dL,22. Patient-reported swallow function was documented using the MD Anderson Dysphagia Inventory. The primary endpoint was 2-year progression-free survival (PFS) using Simon's 2 stage design. A total of 26 of 48 (54.2%) participants met the criteria to enter cohort D and 22 of 48 (45.8%) patients entered cohort C. With a median follow-up time of 29.7 months (6.9-48.0 months), 2-year PFS and OS rates were 85.4% and 93.6%, respectively for all enrolled patients. In cohort D, 2-year PFS and OS rates were both 100%. Grade 3 and 4 IC-related toxicities included leukopenia/neutropenia occurring in 41.7% and hyponatremia in 4.2% of patients. A higher incidence of grade 3 and 4 mucositis (61.9% vs 23.1% P=.022) was observed in cohort C. Consistent decline in longitudinal MD Anderson Dysphagia Inventory scores were observed at month 3 after radiation therapy between cohorts and both were found to recover to baseline at month 12. Selective radiation therapy dose reduction and concurrent chemotherapy removal based on IC response in HPV+OPSCC was feasible and promising. Further study of this strategy to balance efficacy and toxicity is warranted in a prospective controlled trial.

Dysphagia and shortness-of-breath as markers for treatment failure and survival in oropharyngeal cancer after radiation

BackgroundPost-treatment symptoms are a focal point of follow-up visits for head and neck cancer patients. While symptoms such as dysphagia and shortness-of-breath early after treatment may motivate additional work up, their precise association with disease control and survival outcomes is not well established. MethodsThis prospective data cohort study of 470 oropharyngeal cancer patients analyzed patient-reported swallowing, choking and shortness-of-breath symptoms at 3-to-6 months following radiotherapy to evaluate their association with overall survival and disease control. Associations between the presence of moderate-to-severe swallowing, choking and mild-to-severe shortness-of-breath and treatment outcomes were analyzed via Cox regression and Kaplan-Meier. The main outcome was overall survival (OS), and the secondary outcomes were local, regional, and distant disease control. ResultsThe majority of patients (91.3%) were HPV-positive. Median follow-up time was 31.7 months (IQR: 21.9–42.1). Univariable analysis showed significant associations between OS and all three symptoms of swallowing, choking, and shortness-of-breath. A composite variable integrating scores of all three symptoms was significantly associated with OS on multivariable Cox regression (p = 0.0018). Additionally, this composite symptom score showed the best predictive value for OS (c-index = 0.75). Multivariable analysis also revealed that the composite score was significantly associated with local (p = 0.044) and distant (p = 0.035) recurrence/progression. Notably, the same significant associations with OS were seen for HPV-positive only subset analysis (p < 0.01 for all symptoms). ConclusionsQuantitative patient-reported measures of dysphagia and shortness-of-breath 3-to-6 months post-treatment are significant predictors of OS and disease recurrence/progression in OPC patients and in HPV-positive OPC only.

239P Prospective evaluation of difference in patient-reported swallowing outcomes and quality of life of tongue vs bucco-alveolar complex cancers treated with ablative surgery

Oral cancer surgery includes radical resections of the mandible and tongue, affecting the functional swallowing outcomes. However, risk factors and swallowing outcomes are not the same for all subsites of oral cancer. The present study aimed to assess the difference in patient-reported swallowing function and quality of life after primary surgical resection in tongue vs bucco- alveolar complex (BAC) malignancies.

The impact of head and neck radiotherapy on salivary flow and quality of life: Results of the ORARAD study

ObjectivesSalivary hypofunction and xerostomia, are common side effects of radiotherapy, negatively impacting quality of life. The OraRad study presents results on the longitudinal impact of radiotherapy on salivary flow and patient-reported outcomes. Patients and MethodsProspective, multicenter cohort study of 572 patients receiving curative-intent head and neck radiotherapy (RT). Stimulated salivary flow (SSF) rate and patient-reported outcomes were measured prior to RT and at 6- and 18-months post-RT. Linear mixed effects models examined the relationship between RT dose and change in salivary flow, and change in patient-reported outcomes. Results544 patients had baseline salivary flow measurement, with median (IQR) stimulated flow rate of 0.975 (0.648, 1.417) g/min. Average RT dose to parotid glands was associated with change in salivary flow post-RT (p < 0.001). Diminished flow to 37% of pre-RT level was observed at 6 months (median: 0.358, IQR: 0.188 to 0.640 g/min, n = 481) with partial recovery to 59% of pre-RT at 18 months (median: 0.575, IQR: 0.338 to 0.884 g/min, n = 422). Significant improvement in patient-reported swallowing, senses (taste and smell), mouth opening, dry mouth, and sticky saliva (p-values < 0.03) were observed between 6 and 18 months post-RT. Changes in swallowing, mouth opening, dry mouth, and sticky saliva were significantly associated with changes in salivary flow from baseline (p-values < 0.04). ConclusionSalivary flow and patient-reported outcomes decreased as a result of RT, but demonstrated partial recovery during follow-up. Continued efforts are needed to improve post-RT salivary function to support quality of life.

Speech and swallowing function following microsurgical reconstruction of palatal defects in a series of six pediatric patients.

Reconstruction of extensive palatal defects in growing patients aims to restore speech intelligibility and swallowing function while avoiding excessive scarring formation that may cause growth disturbances in the palate and midface region. Free flaps transfer healthy, well-vascularized tissue to the defect area, and their combination with pharyngeal flaps allow for restoration of the velopharyngeal function. We examined speech and swallowing after microsurgical palate reconstruction in a series of six pediatric patients. Radial forearm free flaps were used in all cases, in combination with a superiorly based pharyngeal flap in five cases. Mean age at surgery was 10.7 years. Etiologies included recurrent oronasal fistula due to failed primary cleft palate repair (n=4), embryonal rhabdomyosarcoma of the maxilla (n=1), and inflammatory fibrous hyperplasia (n=1). Speech evaluations (with the Hirose standard and listener ratings) and swallowing assessments (based on videofluoroscopy swallowing studies and patient-reported swallowing and diet) were performed in average 44 months postoperatively. All flaps survived without major postoperative complications. Speech intelligibility was graded as "excellent" in four patients and "moderate" in two. Hypernasality and nasal obstruction were each judged as "none/minimal" in five cases and "moderate" in one case. All patients tolerated oral diet without significant nasal regurgitation. In five of six patients, the swallowing assessment showed good motion and velopharyngeal closure. Microsurgical reconstruction of extensive palatal defects using radial forearm free flap, with or without a superiorly based pharyngeal flap, is a reliable technique that can deliver substantial improvement of speech and swallowing in pediatric patients.

Swallowing Function Following Neoadjuvant Chemotherapy and Transoral Robotic Surgery for Oropharyngeal Carcinoma: A 2-Year Follow-up.

To evaluate 2-year follow-up swallowing function in patients with human papillomavirus-related oropharyngeal squamous cell carcinoma (HPV+ OPSCC) who completed neoadjuvant chemotherapy and transoral robotic surgery (NAC+S). Retrospective analysis of patients with OPSCC treated with NAC+S between 2010 and 2021. A single academic institution. This is a cross-sectional study of patient-reported swallowing function, assessed with the MD Anderson Dysphagia Inventory (MDADI) at least 2 years after completion of treatment. The inclusion criteria are patients with HPV+ OPSCC who underwent NAC+S at least 2 years ago. Those requiring adjuvant radiation or chemoradiation or experiencing relapse were excluded from the study. Completed MDADIs were received from 37 patients at a median 3.8 years posttreatment (interquartile range, 2.0-8.6 years). Of those, 94.6% (n = 35) were male and 81.1% (n = 30) were White. The median age at OPSCC diagnosis was 59.0 years (interquartile range, 41-80 years). The most frequent primary subsite of OPSCC was the base of the tongue (n = 20, 54.1%), followed by the tonsils (n = 16, 43.2%). In addition, 75.7% (n = 28) had stage IVa disease (TNM seventh edition), and 29 (78.4%) had scores ≥80, classified as optimal function. When compared with patients who received bilateral neck dissection, patients who received unilateral neck dissection were associated with an age <65 years old (P = .036) and lower clinical TNM stage (P = .04), as well as higher composite, emotional, functional, and physical MDADI scores (P = .017, .046, .013, and .05, respectively). Patients with OPSCC who were treated with NAC+S achieved satisfactory long-term swallowing outcomes. Unilateral neck dissection was significantly associated with higher MDADI scores in this patient cohort.

MYOTONIC DYSTROPHY: EP.230 Comparing patient-reported swallowing symptoms and videofluoroscopy findings in patients with Myotonic dystrophy type 1 (DM1)

MYOTONIC DYSTROPHY: EP.230 Comparing patient-reported swallowing symptoms and videofluoroscopy findings in patients with Myotonic dystrophy type 1 (DM1)

Gastrostomy tube dependence and patient-reported quality of life outcomes based on type of treatment for human papillomavirus-associated oropharyngeal cancer: Systematic review and meta-analysis.

We examined the impact of treatment modality on gastrostomy tube dependence and patient-reported outcomes in human papillomavirus-associated oropharyngeal cancer (HPV-OPSCC). We performed systematic review and meta-analysis of functional outcomes 1-3 years after treatment. Twenty-three studies were included, reporting on 3127 patients treated for HPV-OPSCC. Gastrostomy tube dependence failed to show statistically significant difference between surgery with adjuvant therapy and chemoradiotherapy with cisplatin at 12 months (8.3% [95% CI: 3.1-15.9] vs. 4.2% [1.1-9.2], p=0.37) and 24-36 months (10.5% [95% CI: 3.2-21.5] vs. 3.3% [2.0-4.9], p=0.06). Surgery with adjuvant therapy was associated with worse University of Washington Quality of Life (UW-QOL) Swallowing (84 [95% CI: 80-88] vs. 89 [87-90], p=0.03) and UW-QOL Overall scores (76 [95% CI: 72-80] vs. 84 [81-86], p=0.001) compared to chemoradiotherapy with cisplatin at 12 months. Surgery with adjuvant therapy was associated with worse performance on certain measures of patient-reported swallow and overall function compared to chemoradiotherapy with cisplatin. Further randomized controlled trials are needed to directly compare functional outcomes after treatment for HPV-OPSCC.

Trends in, and predictors of, swallowing and social eating outcomes in head and neck cancer survivors: A longitudinal analysis of head and neck 5000

ObjectiveTo investigate the recovery trajectory and predictors of outcome for swallowing difficulties following head and neck cancer treatment in a large prospective cohort. Materials and methodsData from 5404 participants of the Head and Neck 5000 study were collected from 2011 to 2014. Patient-reported swallowing was measured using the EORTC HN35, recorded at baseline (pre-treatment) and 4 and 12 months post-baseline. Mixed-effects linear multivariable regression was used to investigate time trends, compare cancer sites, and identify associations between clinical, socio-demographic and lifestyle variables. Results2458 participants with non-recurrent oral (29%) oropharyngeal (46%) and laryngeal (25%) cancer were included in the analysis. There was a clinically significant deterioration in scores between baseline and four months for swallowing (11.7 points; 95% CI 10.7–12.8) and trouble with social eating (17.9 points; 95% CI 16.7–19.2), but minimal difference between baseline and 12 months. Predictors of better swallowing and social eating were participants with larynx cancer, early-stage disease, treatment type, age, gender, co-morbidity, socio-economic status, smoking behaviour and cohabitation. ConclusionSwallowing problems persist up to a year after head and neck cancer treatment. These findings identify disease and demographic characteristics for particularly vulnerable groups, supporting the need for holistic interventions to help improve swallowing outcomes. People diagnosed with head and neck cancer at risk of severe eating and drinking problems following treatment can be identified earlier in the pathway, receive more accurate information about early and late post-treatment side-effects, which can inform shared decision-making discussions.

Patient-Reported Outcome Measures and Dosimetric Correlates for Early Detection of Acute Radiation Therapy–Related Esophagitis

BackgroundWe investigate the time to and clinical factors associated with patient-reported difficulty swallowing in lung cancer patients treated with radiation therapy (RT). MethodsBetween October 2016 and October 2019, lung cancer patients treated with conventionally fractionated RT at a tertiary cancer center were identified. Weekly, patients reported difficulty swallowing (patient-reported outcome version of the Common Terminology Criteria for Adverse Events [PRO-CTCAE] v.1: 0-none, 1-mild, 2-moderate, 3-severe, 4-very severe). Physicians graded dysphagia (CTCAE v.4: 0-none, 1-symptoms without altered intake, 2-symptomatic; altered eating/swallowing, 3-severely altered eating/swallowing, 4-life-threatening consequences, 5-death). Tumor-related difficulty swallowing was not recorded at baseline; thus, patients reporting ≥moderate symptoms ≤7 days of RT start were excluded. We evaluated the time to new patient reports of ≥moderate difficulty swallowing and CTCAE grade 2+ dysphagia and development over time using the cumulative incidence method. Multivariable logistic regression evaluated associations between clinical factors, esophageal V60, and development of esophageal symptoms. ResultsOf the 200 patients identified: median age was 69 years, 52% were male, and 89% had stage III+ disease. Patients received a median of 63 Gy with chemotherapy (91.5%). At least moderate difficulty swallowing during RT was reported by 76 of 200 patients (38%); clinicians rated dysphagia as altering oral intake or worse for 26 of 200 (13%). Median time to first report of symptoms was 21 days (interquartile ratio [IQR], 18-34.5) for the 76 patients who reported ≥moderate symptoms and 33 days (IQR, 24-42) in the 26 patients whose provider reported grade 2+ dysphagia. The 30-day incidence of patient-reported ≥moderate swallowing difficulty and provider grade 2+ dysphagia was 26% (95% CI: 20%-32%) and 6% (95% CI: 3%-9%), respectively. Esophageal V60 >7 % was the clinical factor most associated with patient-reported ≥moderate esophageal symptoms (odds ratio 6.1, 95% CI: 3.0-12.3). ConclusionsPatients report at least moderate difficulty swallowing more often and earlier than providers report grade 2+ dysphagia. Esophageal V60 ≥7% was most associated with development of moderate severity or worse patient-reported swallowing difficulty.

Long term self-reported post-operative outcomes of endoscopic and open pharyngeal pouch repairs

Background: In recent years, there has been a shift to treating pharyngeal pouches endoscopically, however few studies report the long-term functional outcomes of patients following these repairs. Our aim is to investigate and compare the self-reported long-term functional outcomes of endoscopic and open pharyngeal pouch repair. Methods: A retrospective cohort analysis was performed using patient records to identify patients who had undergone either an open or endoscopic pharyngeal pouch repair from 2002-2018. Patients were then contacted and interviewed regarding their current swallowing status according to the M.D. Anderson Dysphagia Inventory (MDADI). Results: Of 185 identified, a total of 73 (37 female, mean age 77.4±10 years) participants were interviewed. Sixteen patients had undergone an open repair, and 57 endoscopic repair. Mean time interval between surgery and completion of interview was four years and three months (range, 3 months – 14 years 6 months). Overall mean global score for MDADI was 76.2±15 across all participants, 76.1±14.4 for endoscopic repair participants, and 76.4±17.9 for open repair participants. A Mann-Whitney U test comparing global MDADI of both procedure types was non-significant U =445, P=0.883, two-tailed. Conclusions: These findings suggest that decisions as to which surgical technique to select for pharyngeal pouch repair may be made according to surgical preference or other considerations other than concern over long-term patient swallowing outcomes. Our results indicate there is no statistically significant difference between endoscopic versus open pharyngeal pouch repair with regards to long-term patient-reported swallowing function.

Impact of choice of feeding tubes on long-term swallow function following chemoradiotherapy for oropharyngeal carcinoma

Background: Prior reports have raised concerns that a prophylactic gastrostomy may be detrimental to long-term swallow function. This study evaluates patient-reported swallow function following chemoradiotherapy for oropharyngeal carcinoma in relation to the use of a prophylactic gastrostomy or nasogastric (NG) tube as required.Material and methods: The MD Anderson Dysphagia Inventory (MDADI) was posted to 204 disease-free patients at least 2 years following chemoradiotherapy for oropharyngeal carcinoma between 2010 and 2014.Results: Overall, 181/204 (89%) patients returned questionnaire at a median of 34 months post-treatment. 97/181 (54%) and 84/181 (46%) were managed with an approach of a prophylactic gastrostomy or NG tube as required, respectively. A prophylactic gastrostomy was associated with higher rates of enteral feeding (92% vs. 58%, p < .001), lower median percentage weight loss (7.0% vs. 9.4%, p < .001), increased duration of enteral feed (median 3.3 vs. 1.1 months, p < .001). There was no significant difference in patient-reported swallow function measured by MDADI summary scores and subscales for patients managed with an approach of prophylactic gastrostomy or NG as required. Duration of enteral feed correlated negatively with composite MDADI scores. A subgroup of 116/181 (64%) patients were documented as having been offered a choice of enteral feeding approach and therefore can be considered to represent clinical equipoise; there were no significant differences in MDADI scores according to route.Conclusions: Despite concern regarding the use of a prophylactic gastrostomy in prior studies, the approaches of using a prophylactic gastrostomy or an NG tube as required to support patients during/after chemoradiotherapy for oropharyngeal carcinoma were associated with similar long-term swallow outcomes.

Changes in Patient-reported Swallow Function in the Long Term After Chemoradiotherapy for Oropharyngeal Carcinoma

AimsTo assess long-term patient-reported swallow function after chemoradiotherapy for oropharyngeal carcinoma and to evaluate the frequency of deterioration/improvement over years. Materials and methodsFifty-nine patients with oropharyngeal carcinoma treated with parotid-sparing intensity-modulated radiotherapy and concurrent chemotherapy between 2010 and 2012 had previously completed the MD Anderson Dysphagia Inventory (MDADI) at a median of 34 months (range 24–59) after treatment. An MDADI was posted to 55 alive and disease-free patients after a 30 month interval; 52/55 replies were received, a median of 64 months (range 52–88) after treatment; 27/52 (52%) had been managed with a prophylactic gastrostomy. A 10 point or greater change in the MDADI scores was defined as clinically significant. ResultsOverall, in the whole cohort, patient-reported swallow function showed a small absolute improvement in MDADI composite score on the second MDADI questionnaire (>5 years after treatment) compared with the first MDADI (>2 years after treatment); mean 68.0 (standard deviation 19.3) versus 64.0 (standard deviation 16.3), P = 0.021. Using the composite score, swallow function was stable over time in 29/52 (56%) patients; a clinically significant improvement in swallow function over time was noted in 17/52 (33%) patients; conversely 6/52 (12%) patients experienced a clinically significant deterioration with time. Abnormality of pre-treatment diet and a prophylactic gastrostomy correlated with an inferior MDADI composite score on the later questionnaire (P = 0.029 and P = 0.044, respectively). ConclusionsLong-term dysphagia is prevalent >5 years after treatment. Although long-term swallow function is stable in most patients, it is not static in a minority. On MDADI composite summary scores, 33% of patients experienced an improvement, whereas 12% deteriorated with time. Further investigation is needed to determine underlying mechanisms behind these divergent outcomes.

Prospective evaluation of patient reported swallow function with the Functional Assessment of Cancer Therapy (FACT), MD Anderson Dysphagia Inventory (MDADI) and the Sydney Swallow Questionnaire (SSQ) in head and neck cancer patients

ObjectivesThe Functional Assessment of Cancer Therapy (FACT) instrument is comprised of a group of related and overlapping quality of life (QoL) questionnaires including a core general form, head and neck cancer (HNC)-specific items, and an expert-selected index (FACT-HNSI). Understanding how these relate to more HNC-specific instruments such as the MD Anderson Dysphagia Inventory (MDADI) and Sydney Swallow Questionnaire (SSQ) is vital for guiding their use in clinical trials. Materials and methodsHNC patients concurrently completed MDADI, SSQ, and FACT questionnaires at radiation oncology clinic visits (2015–2016). Spearman correlation coefficients were calculated between each FACT instrument and MDADI or SSQ. Unsupervised k-means cluster analyses were performed to identify clusters of similar QoL responses. Principal component analysis (PCA) identified the degree of variability explained by each instrument. ResultsWe identified 631 instances (363 patients) where the questionnaires were completed concurrently. Correlations between the various FACT measures and SSQ or MDADI were all significant (p < 0.001), but FACT HNC-specific subscale and FACT-HNSI showed the strongest correlation with MDADI and SSQ. Clustering identified 3 distinct groups of responses when combining instruments either pairwise or three-way. PCA revealed that MDADI and FACT HNC-specific subscale provide similar and likely redundant information. ConclusionFACT HNC-subscale and FACT-HNSI may be preferable over other FACT measures for use in clinical trials where patient-reported swallow function is evaluated. MDADI and FACT provide similar insights into HNC patient QoL while SSQ provides additional, complementary information which could serve to better stratify patients into groups with high, medium, and low QoL outcomes.

HSS Dysphagia and Dysphonia Inventory (HSS-DDI) Following Anterior Cervical Fusion

Dysphagia and dysphonia are common complications after anterior cervical spine surgery; however, reported prevalences vary greatly due to a lack of reliable clinical standards for measuring postoperative swallowing and speech dysfunction. The Hospital for Special Surgery Dysphagia and Dysphonia Inventory (HSS-DDI) was developed as a patient-derived, patient-reported instrument to measure dysphagia and dysphonia more accurately after anterior cervical spine surgery than existing indices. This multiphase survey-development study implemented a mixed-methods approach. Phase 1 involved qualitative assessment of postoperative patient-reported swallowing or speaking deficiencies to assemble a draft survey. Phase 2 established test-retest reliability and finalized the 31-item HSS-DDI. Phase 3 compared the HSS-DDI with the Swallowing-Quality of Life (SWAL-QOL) questionnaire and the M.D. Anderson Dysphagia Inventory (MDADI) for validity and responsiveness. Phase 1, performed to formulate the draft survey, included 25 patients who were asked about speech and swallowing dysfunction after anterior cervical spine surgery involving at least 3 vertebral levels. Phase 2 included 49 patients who completed the draft survey twice. The mean scores (and standard deviation) for each administration of the HSS-DDI were 67 ± 24 and 75 ± 22, the Cronbach alpha coefficients were both 0.97, and the intraclass correlation coefficient was 0.80. The 31-item HSS-DDI was finalized with all but 2 items having weighted kappa values of ≥0.40. Phase 3 included 127 patients and established external validity, with most correlation coefficients between the HSS-DDI and the SWAL-QOL and MDADI ranging from 0.5 to 0.7. Internal validity was established by identifying worsening HSS-DDI scores with increases in the number of vertebral levels involved (p = 0.02) and in the Surgical Invasiveness Index (p = 0.006). HSS-DDI responsiveness ascertained by effect size (0.73) was better than that of the SWAL-QOL and MDADI. The average administration time for the HSS-DDI was 2 minutes and 25 seconds. The HSS-DDI is efficient, valid, and more responsive to change after anterior cervical spine surgery than existing surveys. The HSS-DDI fills a gap in postoperative assessment by providing a reliable, more clinically sensitive, patient and condition-specific evaluation of dysphagia and dysphonia prospectively and longitudinally.

Impact of local steroid application on dysphagia following an anterior cervical discectomy and fusion: results of a prospective, randomized single-blind trial.

OBJECTIVE Intraoperative local steroid application has been theorized to reduce swelling and improve swallowing in the immediate period following anterior cervical discectomy and fusion (ACDF). Therefore, the purpose of this study was to quantify the impact of intraoperative local steroid application on patient-reported swallow function and swelling after ACDF. METHODS A prospective, randomized single-blind controlled trial was conducted. A priori power analysis determined that 104 subjects were needed to detect an 8-point difference in the Quality of Life in Swallowing Disorders (SWAL-QOL) questionnaire score. One hundred four patients undergoing 1- to 3-level ACDF procedures for degenerative spinal pathology were randomized to Depo-Medrol (DEPO) or no Depo-Medrol (NODEPO) cohorts. Prior to surgical closure, patients received 1 ml of either Depo-Medrol (DEPO) or saline (NODEPO) applied to a Gelfoam carrier at the surgical site. Patients were blinded to the application of steroid or saline following surgery. The SWAL-QOL questionnaire was administered both pre- and postoperatively. A ratio of the prevertebral swelling distance to the anteroposterior diameter of each vertebral body level was calculated at the involved levels ± 1 level by using pre- and postoperative lateral radiographs. The ratios of all levels were averaged and multiplied by 100 to obtain a swelling index. An air index was calculated in the same manner but using the tracheal air window diameter in place of the prevertebral swelling distance. Statistical analysis was performed using the Student t-test and chi-square analysis. Statistical significance was set at p < 0.05. RESULTS Of the 104 patients, 55 (52.9%) were randomized to the DEPO cohort and 49 (47.1%) to the NODEPO group. No differences in baseline patient demographics or preoperative characteristics were demonstrated between the two cohorts. Similarly, estimated blood loss and length of hospitalization did not differ between the cohorts. Neither was there a difference in the mean change in the scaled total SWAL-QOL score, swelling index, and air index between the groups at any time point. Furthermore, no complications were observed in either group (retropharyngeal abscess or esophageal perforation). CONCLUSIONS The results of this prospective, randomized single-blind study did not demonstrate an impact of local intraoperative steroid application on patient-reported swallowing function or swelling following ACDF. Neither did the administration of Depo-Medrol lead to an earlier hospital discharge than that in the NODEPO cohort. These results suggest that intraoperative local steroid administration may not provide an additional benefit to patients undergoing ACDF procedures. ■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: Class I. Clinical trial registration no.: NCT03311425 (clinicaltrials.gov).

Feasibility and potential value of lipofilling in post-treatment oropharyngeal dysfunction.

Head and neck cancer (HNC) patients may develop oropharyngeal dysfunction as result of volume loss or muscle atrophy of the tongue or pharyngeal musculature following treatment with surgery and/or chemoradiotherapy. If intensive swallowing therapy offers no further improvement, and the functional problems persist, transplantation of autologous adipose tissue (lipofilling) might restore functional outcomes by compensating the existing tissue defects or tissue loss. Case series. In this prospective pilot feasibility study, the application of lipofilling was studied in seven HNC patients with chronic dysphagia. The procedure was carried out under general anesthesia in several sessions using the Coleman technique. Swallowing outcomes were evaluated with standard videofluoroscopy (VFS) for obtaining objective Penetration Aspiration Scale (PAS) and residue scores. Subjective Functional Oral Intake Scale scores and Swallowing Quality of Life Questionnaire were also completed. Magnetic resonance imaging was used to evaluate the post-treatment injected fat. Five patients completed the intended three lipofilling sessions, whereas two completed two injections. One patient dropped out of the study after two injections because of progressive dysphagia requiring total laryngectomy. Four of the six remaining patients showed improved PAS scores on post-treatment VFS assessments, with two patients no longer showing aspiration for a specific consistency. Two patients were no longer feeding tube dependent. Patient-reported swallowing and oral intake improved in four out of six patients. Based on the results, the lipofilling technique seems safe and, in selected cases, of potential value for improving swallowing function in this small therapy-refractory HNC patient cohort. 4 Laryngoscope, 126:2672-2678, 2016.

Impact of Local Intraoperative Steroid Application on Patient-Reported Swallow Function Following Anterior Cervical Discectomy and Fusion Procedures

Impact of Local Intraoperative Steroid Application on Patient-Reported Swallow Function Following Anterior Cervical Discectomy and Fusion Procedures

Validity of patient-reported swallowing and speech outcomes in relation to objectively measured oral function among patients treated for oral or oropharyngeal cancer.

The objective of this study was to test the construct validity of the patient-reported outcomes Swallowing Quality of Life Questionnaire (SWAL-QOL) and Speech Handicap Index (SHI) in relation to objectively measured oral function among patients treated for oral or oropharyngeal cancer. The study sample consisted of patients treated for oral or oropharyngeal cancer. Outcome measures were the SWAL-QOL and the SHI, and the Functional Rehabilitation Outcomes Grade (FROG), a test to measure oral and shoulder function. Spearman's rank correlation coefficient was used to test associations between the SHI and SWAL-QOL scales, and the FROG scales. During a study period of 3months, 38 patients (21 males, 17 females; mean age 54years) were included who visited the outpatient clinic for follow-up care 6-155months after surgical treatment (n=14) or combined surgery and radiotherapy (n=24) for oral (n=21) or oropharyngeal cancer (n=17). Most SWAL-QOL and SHI scales (except the SWAL-QOL Fatigue scale) correlated significantly with one or more FROG oral function scales. None of the SWAL-QOL and SHI scales correlated significantly with the FROG shoulder function scale. These results support the construct validity of the SWAL-QOL and SHI questionnaires for assessing speech and swallowing problems in daily life that are moderately but significantly related to oral function. A multidimensional assessment protocol is recommended for use in clinical practice and for research purposes for measuring oral function and swallowing- and speech-related problems in daily life among head and neck cancer patients.