Randomized Trial of Radiotherapy Versus Transoral Robotic Surgery for Oropharyngeal Squamous Cell Carcinoma: Long-Term Results of the ORATOR Trial

PURPOSE The incidence of oropharyngeal squamous cell carcinoma (OPSCC) has risen rapidly, because of an epidemic of human papillomavirus infection. The optimal management of early-stage OPSCC with surgery or radiation continues to be a clinical controversy. Long-term randomized data comparing these paradigms are lacking. METHODS We randomly assigned patients with T1-T2, N0-2 (≤ 4 cm) OPSCC to radiotherapy (RT) (with chemotherapy if N1-2) versus transoral robotic surgery plus neck dissection (TORS + ND) (with or without adjuvant therapy). The primary end point was swallowing quality of life (QOL) at 1-year using the MD Anderson Dysphagia Inventory. Secondary end points included adverse events, other QOL outcomes, overall survival, and progression-free survival. All analyses were intention-to-treat. Herein, we present long-term outcomes from the trial. RESULTS Sixty-eight patients were randomly assigned (n = 34 per arm) between August 10, 2012, and June 9, 2017. Median follow-up was 45 months. Longitudinal MD Anderson Dysphagia Inventory analyses demonstrated statistical superiority of RT arm over time ( P = .049), although the differences beyond 1 year were of smaller magnitude than at the 1-year timepoint (year 2: 86.0 ± 13.5 in the RT arm v 84.8 ± 12.5 in the TORS + ND arm, P = .74; year 3: 88.9 ± 11.3 v 83.3 ± 13.9, P = .12). These differences did not meet the threshold to qualify as a clinically meaningful change at any timepoint. Certain differences in QOL concerns including more pain and dental concerns in the TORS + ND arm seen at 1 year resolved at 2 and 3 years; however, TORS patients started to use more nutritional supplements at 3 years ( P = .015). Dry mouth scores were higher in RT patients over time ( P = .041). CONCLUSION On longitudinal analysis, the swallowing QOL difference between primary RT and TORS + ND approaches persists but decreases over time. Patients with OPSCC should be informed about the pros and cons of both treatment options (ClinicalTrials.gov identifier: NCT01590355 ).

Free Flap microvascular pharyngeal closure results in improved dysphagia-specific quality of life following total laryngectomy

Background Total laryngectomy (TL) as either a primary or salvage treatment strategy remains an effective oncologic operation in the management of laryngeal cancer. Dysphagia is the most common complication following TL and this has a significant impact on patients’ quality of life (QOL). Following removal of the larynx, a number of pharyngeal closure techniques exist. We aimed to evaluate the effect pharyngeal closure techniques have on dysphagia-specific QOL postoperatively. Methods We retrospectively reviewed patients who had undergone TL at our institution (2014–2019). Patients alive at the time of study were invited to complete the MD Anderson Dysphagia Inventory (MDADI). Outcomes were compared among Primary Closure (PC), Pedicled Pectoralis Major Myocutaneous Flap (PMMF) and Free Flap (FF) closure groups. Results There were 27 patients identified for inclusion. Eight patients (30%) underwent PC, 10 patients (37%) had PMMF-assisted closure and 9 patients (33%) underwent FF-assisted closure. Patients within the FF group scored consistently higher MDADI scores across all subscales (emotional, functional, physical, global) as well as composite MDADI score in comparison to the PC and PMMF groups. FF closure was associated with a reduced inpatient length of stay (LOS). Additionally, no significant differences in postoperative morbidity including rates of pharyngo-cutaneous fistula (PCF) were observed between groups. Conclusions We now advocate FF closure for our patients following salvage TL due to the improved dysphagia-specific QOL, reduced inpatient LOS and lack of additional surgical morbidity. Level of evidence, Level III, therapeutic/prognostic study.

Translation and Validation of the Indonesian MD Anderson Dysphagia Inventory (MDADI) in Head and Neck Cancer Patients with Swallowing Disorders

Introduction Dysphagia is common in head and neck cancer patients; it is associated with significant morbidity, including quality of life. Several instruments can be used to assess the quality of life of dysphagia patients, including the M.D Anderson dysphagia inventory (MDADI) questionnaire, which is sufficiently valid and reliable to improve the quality of life of patients with neurological disorders and head and neck cancer. Objective The purpose of the present study is to perform adaptation, cultural translation, and validation of the MDADI questionnaire for the Indonesian language. Methods This cross-sectional study assessed the validity and reliability of the MDADI Indonesian adaptation instrument in head and neck cancer patients with swallowing disorders in the Otorhinolaryngology clinic of the Dr. Sardjito hospital, Yogyakarta, from May to August 2019. Results There were 40 study subjects, including 31 men and 9 women. The MDADI instrument adapted to Indonesian is valid and reliable as an instrument for assessing the quality of life of patients with head and neck cancer with swallowing disorders, with r-values ranging from 0.314 to 0.939. Internal consistency shows that Cronbach's α is 0.915, and test-retest reliability (intra-class correlation) ranges from 0.919 to 0.985. Conclusion The translation and validation of the Indonesian MDADI instrument were performed as an instrument for assessing the quality of life of head and neck cancer patients with swallowing disorders.

Free flap for soft palate reconstruction: long-term functional evaluation of a new technique

Purpose The soft palate (SP) has a complex anatomy and physiology. Reconstruction after tumour resection is a challenge, and procedures that only restore bulk don’t give good results. We aim to present a new technique for the in-setting and the functional outcomes. Methods We retrospectively included in a monocentric retrospective cohort study every patient with a first diagnosis of a soft palate squamous cell carcinoma (SPSCC), who underwent a tumoral resection with a free flap reconstruction, from February 2013 to July 2017. For the in-setting, a special care is given for the flap in-setting: we suture the flap more caudally than usual under the tongue base, creating a neo-posterior pilar. The primary outcome was the deglutition function, assessed by the M. D Anderson Dysphagia Inventory (MDADI). We also analyzed the patient’s quality of life with the FOSS score and the occurrence of nasal regurgitation or larynx aspiration. Results We included twenty patients, with a median follow-up of 26.5 months. The median MDADI score was 89, and the mode was 93. A Fisher test shows a significant improvement of MDADI scores for unilateral vs bilateral reconstructions (p = 0.03). The median FOSS score was 2, and the mode was 2. Seven (35%) patients complained of nasal regurgitation, three (15%) reported episodic laryngeal aspiration.

Clinical effectiveness of the sequential 4-channel NMES compared with that of the conventional 2-channel NMES for the treatment of dysphagia in a prospective double-blind randomized controlled study

Background To date, conventional swallowing therapies and 2-channel neuromuscular electrical stimulation (NMES) are standard treatments for dysphagia. The precise mechanism of 2-channel NMES treatment has not been determined, and there are controversies regarding the efficacy of this therapy. The sequential 4-channel NMES was recently developed and its action is based on the normal contractile sequence of swallowing-related muscles. Objective To evaluate and compare the rehabilitative effectiveness of the sequential 4-channel NMES with that of conventional 2-channel NMES. Methods In this prospective randomized case–control study, 26 subjects with dysphagia were enrolled. All participants received 2- or 4-channel NMES for 2–3 weeks (minimal session: 7 times, treatment duration: 300–800 min). Twelve subjects in the 4-channel NMES group and eleven subjects in the 2-channel NMES group completed the intervention. Initial and follow-up evaluations were performed using the videofluoroscopic dysphagia scale (VDS), the penetration-aspiration scale (PAS), the MD Anderson dysphagia inventory (MDADI), the functional oral intake scale (FOIS), and the Likert scale. Results The sequential 4-channel NMES group experienced significant improvement in their VDS (oral, pharyngeal, and total), PAS, FOIS, and MDADI (emotional, functional, and physical subsets) scores, based on their pretreatment data. VDS (oral, pharyngeal, and total) and MDADI (emotional and physical subsets) scores, but not PAS and FOIS scores, significantly improved in the 2-channel NMES group posttreatment. When the two groups were directly compared, the 4-channel NMES group showed significant improvement in oral and total VDS scores. Conclusions The sequential 4-channel NMES, through its activation of the suprahyoid and thyrohyoid muscles, and other infrahyoid muscles mimicking physiological activation, may be a new effective treatment for dysphagia. Trial registration: clinicaltrial.gov, registration number: NCT03670498, registered 13 September 2018, https://clinicaltrials.gov/ct2/show/NCT03670498?term=NCT03670498&draw=2&rank=1.

Adaptation and Validation of the Dynamic Imaging Grade of Swallowing Toxicity for Flexible Endoscopic Evaluation of Swallowing: DIGEST-FEES

Purpose While flexible endoscopic evaluation of swallowing (FEES) is a common clinical procedure used in the head and neck cancer (HNC) population, extant outcome measures for FEES such as bolus-level penetration–aspiration and residue scores are not well suited as global patient-level endpoint measures of dysphagia severity in cooperative group trials or clinical outcomes research. The Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) was initially developed and validated for use during videofluoroscopic evaluations as a way to grade safety, efficiency, and overall pharyngeal swallowing impairment. The purpose of this study was to adapt and validate DIGEST for use with FEES. Method A modified Delphi exercise was conducted for content validation, expert consensus, adaptation, and operationalization of DIGEST-FEES. Three blinded, expert raters then evaluated 100 de-identified post-HNC treatment FEES examinations. Intra- and interrater reliability were tested with quadratic weighted kappa. Criterion validity against the MD Anderson Dysphagia Inventory, Functional Oral Intake Scale, Secretion Severity Scale, and Yale Residue Rating Scale was assessed with Spearman correlation coefficients. Results Interrater reliability was almost perfect for overall DIGEST-FEES grade (κ w = 0.83) and safety grade (κ w = 0.86) and substantial for efficiency grade (κ w = 0.74). Intrarater reliability was excellent for all raters (0.9–0.91). Overall DIGEST-FEES grade correlated with MD Anderson Dysphagia Inventory ( r = −.43, p < .0001), Functional Oral Intake Scale ( r = −.43, p < .0001), Secretion Severity Scale ( r = .47, p < .0001), Yale Vallecular Residue ( r = .73, p < .0001), and Yale Pyriform Sinus Residue ( r = .65, p < .0001). Conclusion DIGEST-FEES is a valid and reliable scale to describe the severity of pharyngeal dysphagia in patients with HNC. Supplemental Material https://doi.org/10.23641/asha.14642787

Psychometric Properties of the MDADI—A Preliminary Study of Whether Less is Truly More?

The MD Anderson Dysphagia Inventory (MDADI) is a 20-item dysphagia-specific QOL questionnaire with four subscales: global, emotional, functional, and physical. It is widely used in clinical practice and in research; however, its psychometric properties have been under-researched. We aim to evaluate the organisation of the MDADI subscales and identify any redundant items. The MDADI is a routinely collected outcome measure at two centres in northeast England. Questionnaires completed at three months following treatment were extracted from these existing databases. Factor analysis was carried out with the aim of reducing redundancy among the set of questionnaire items. Cases with missing values were excluded. A total of 196 complete patient questionnaires were used in factor analysis. A one-factor model accounted for around 50% of the total variance in item responses. The top five endorsed items (abbreviated by the questionnaire item keywords: Excluded, Irritate, Esteem, Social, and Why) in this one factor appeared in three (emotional, functional, and physical) of the four supposed MDADI subscales, i.e. global, emotional, functional, and physical. Our results suggest an overlap of three MDADI subscales across the top five endorsed items. The content of the top five questions all appear related to the psychosocial aspects of swallowing. This implies some redundancy of the items in the original subscales of the questionnaire. Using the most endorsed items, it appears feasible to abbreviate the 20-item MDADI questionnaire to a 5-item “MiniDADI” questionnaire, which is likely to have greater utility in routine clinical practice outside of research settings.

Der deutsche Sydney Swallow Questionnaire

Zusammenfassung Hintergrund Der Sydney Swallow Questionnaire (SSQ) ist ein patientenbasierter Fragebogen zur Erhebung von subjektiven Beschwerden oropharyngealer Schluckstörungen unterschiedlicher Ursachen, mit starker inhalts-, konstrukt-, diskriminativer und prädiktiver Validität. Ziel der Arbeit/Fragestellung Ziel dieser Arbeit war die Überprüfung der Reliabilität und Validität der deutschen Fassung des Sydney Swallow Questionnaire (SSQ-G). Material und Methode In einer Kreuzvalidierungsstudie füllten 48 erwachsene deutschsprachige Patienten (12 Frauen/36 Männer) mit neurogen (n = 16), strukturell (n = 16) und funktionell (n = 16) bedingten Schluckstörungen den deutschen SSQ‑G und MD Anderson Dysphagia Inventory (MDADI) aus. Die Reliabilität des SSQ‑G wurde anhand der internen Konsistenz mittels Cronbach‑α berechnet. Die Überprüfung der Kriterien- und der Konstruktvalidität erfolgte durch eine Kreuzvalidierung mittels Spearman-Korrelationskoeffizient. Ergebnisse Die interne Konsistenz des SSQ‑G war mit Cronbach-α = 0,94 exzellent. Die SSQ-G-Fragen 1 und 17 wiesen mit MDADI-Frage 1 einen moderat signifikanten bzw. hochsignifikanten Korrelationskoeffizienten von −0,43 und −0,45 auf (p < 0,5; p < 0,001). Zwischen Fragen 8, 11 und 12 des SSQ‑G und Fragen 7, 13 und 10 des MDADI lag mit Korrelationen von −0,48 bis −0,55 ein mittlerer bis starker hochsignifikanter Zusammenhang vor (p < 0,001). Somit wurden die Reliabilität, die Kriteriums- und Konstruktvalidität statistisch bestätigt. Schlussfolgerung Mit der deutschen Version des SSQ (SSQ-G) können funktionsspezifische Schluckbeschwerden reliabel und valide erfasst werden. In Kombination mit Fragenbögen zur symptomspezifischen Lebensqualität wie dem MDADI ist somit eine differenziertere klinische Analyse von Schluckbeschwerden möglich.