FraMaDySc: dysphagia screening for patients after surgery for head and neck cancer.

PURPOSE: Oropharyngeal dysphagia is one of the most common postoperative consequences in head and neck cancer patients. Above all, these patients often suffer from aspiration and limitations of oral intake. However, no reliable dysphagia screening is available for this target group. This study aimed to develop and validate a screening, FraMaDySc, based on a water swallow test (WST) for the identification of postsurgical patients with a risk of aspiration, limitations of oral intake, and, as their derivate, a relevant oropharyngeal dysphagia in general (OD) that constituted the main reference standard. METHODS: A total of 184 postsurgical head and neck cancer patients were tested with a WST. The patients were, on average, 62 years old and predominantly male (71%). After WST, they underwent Fiberoptic Endoscopic Evaluation of Swallowing (FEES®). FEES® results were dichotomized by Penetration aspiration scale and Functional oral intake scale. Patients with a "fail" result on one of these two scales were classified as having OD. Quality criteria of WST were quantified by means of cross-tabulation with FEES® results. RESULTS: OD was found in 65% of patients, aspiration in 44%, limitations of oral intake in 56%. WST delivered a "fail" result in 65% of patients. WST showed sensitivity 91% and specificity 88% for OD. Quality criteria for aspiration (sensitivity 64%, specificity 93%) and limitations of oral intake (sensitivity 80%, specificity 87%) were lower. CONCLUSION: FraMaDySc is a standardized, quick, and valid WST and therefore an excellent screening tool for the identification of OD in postoperative head and neck cancer patients.

[Nutritional Risk Screening in head-and-neck cancer patients prior to oncological therapy]. / Screening auf Mangelernährung bei Kopf-Hals-Tumor-Patienten vor onkologischer Therapie.

OBJECTIVE: Head-and-neck cancer patients run a high risk of peri- or post-treatment malnutrition that can severely affect the therapy outcome. However, little is known about malnutrition under the pre-treatment condition. Therefore, this study aimed to provide a systematic description of the pre-treatment nutritional status and risk of malnutrition in this population. MATERIAL AND METHODS: Before the onset of the oncological therapy, nutritional status of 102 head-and-neck cancer patients was assessed by body mass index (BMI), their risk of malnutrition by "Nutritional Risk Screening" (NRS). Tumour stage and site, patients' age and sex as well as oropharyngeal dysphagia were analysed as possible influence factors. The latter was quantified by the Flexible Endoscopic Evaluation of Swallowing (FEES). RESULTS: According to BMI, malnutrition (undernutrition) was found in 6% of patients, a risk of malnutrition (NRS) in 27% of patients, and oropharyngeal dysphagia in 15%. In a linear regression, only oropharyngeal dysphagia was identified as a significant influence factor for the risk of malnutrition (ß = 0.380/3.776; p < .001). CONCLUSIONS: Pre-treatment risk of malnutrition was found in a quarter of head-and-neck cancer patients. For the early identification of this risk and for the introduction of measures that would help to avoid it, a pre-treatment examination of swallowing functions and a systematic malnutrition screening by means of NRS are recommended.

[Pre-treatment dysphagia in head-and-neck cancer patients]. / Prätherapeutische Dysphagie bei Kopf-Hals-Tumor-Patienten.

BACKGROUND: The swallowing and nutritional status of head-and-neck cancer patients after oncological therapy have been extensively researched. However, the same topics are seldom scrutinized before the onset of oncological therapy, although they can influence treatment success in the long term. OBJECTIVE: This study focusses on a systematic assessment of swallowing function and nutritional status in head-and-neck cancer patients prior to oncological therapy. MATERIALS AND METHODS: In 102 patients, penetration/aspiration (PA scale), limitations of oral intake (Functional Oral Intake Scale, FOIS), and the need for further intervention (NFI) were endoscopically assessed to objectively quantify swallowing function. The subjective evaluation of swallowing function was carried out with the gEAT-10 (German EAT-10) questionnaire, nutritional status was assessed by body mass index (BMI). Possible impact factors for swallowing function and BMI were analyzed by univariate and multivariate methods. RESULTS: PAS, FOIS, and NFI values were abnormal in ≤ 15% of patients. BMI was more often too high than too low. Objectively assessed swallowing functions depended predominantly on tumor stage and showed moderate correlations with gEAT-10. The latter mostly yielded a "fail" result. The nutritional status depended on the patients' biological sex and NFI. CONCLUSION: In the pre-treatment setting, neither dysphagia nor malnutrition were found in most patients. Impaired swallowing was associated with higher tumor stages, malnutrition with female sex and NFI. A systematic pre-treatment assessment of swallowing and nutritional status in head-and-neck cancer patients appears necessary for modern oncological therapy and optimal patient outcome.

[Follow-up II of newborn hearing screening : Evaluation of a follow-up II facility after implementation of newborn hearing screening in Germany]. / Follow-up-II des Neugeborenen-Hörscreenings : Evaluation der Ergebnisqualität einer Follow-up-II-Einrichtung nach Einführung des Neugeborenen-Hörscreenings in Deutschland.

BACKGROUND: With the implementation of newborn hearing screening, evaluation in terms of quality and goal achievement was required. The present study evaluates a follow-up II facility from 2009 to 2016. METHODS: Data of 2705 newborns were retrospectively evaluated. The annual number of patients was analyzed, as well as the median age at first presentation, at diagnosis, and at treatment, each according to the reason for presentation and the diagnosis. RESULTS: From 2009 to 2016, the number of presented newborns increased by 91.4%. Newborns with abnormal initial screening or risk factors were presented significantly later than those for initial screening (median 5.3 and 8.0 vs. 4.6 weeks, respectively; p < 0.001). Permanently or transiently hearing-impaired patients were presented and diagnosed significantly later than those with normal hearing (age at initial presentation 6.1 and 7.6 vs. 5.4 weeks, p < 0.01 and p < 0.001, respectively; age at diagnosis 11.4 and 23.1 vs. 5.9 weeks, respectively; p < 0.001). Permanent hearing loss was treated at the age of 14.1 weeks. From 2009 to 2014, the age at first presentation and at diagnosis increased and subsequently mostly decreased until 2016. CONCLUSION: The age at first presentation and at diagnosis depends on the reason for presentation and on the diagnosis. Despite increasing patient numbers, the Joint Federal Committee (Gemeinsame Bundesausschuss, G­BA) targets were met due to effective and efficient organizational structuring of the follow-up II facility. However, early admission to a follow-up II facility is a prerequisite for the success of newborn hearing screening.

[Post-operative prevalence of dysphagia in head-and-neck cancer patients in the acute care units]. / Postoperative Dysphagieprävalenz bei Kopf-Hals-Tumorpatienten im akutstationären Setting.

OBJECTIVE: Dysphagia constitutes a frequent post-operative functional impairment in head-and-neck cancer patients. This impairment can result in aspiration/penetration and limitations of oral intake. Therefore, often it requires a therapeutic intervention. In this study, prevalence of post-operative dysphagia and its associations with the tumour stage, localisation, patients' age, and biological sex were analysed for the inpatient treatment setting. MATERIAL AND METHODS: A total of 201 adult head-and-neck cancer patients (mean age 63 years) were analysed prospectively by FEES in two university hospitals in regard to their penetration/aspiration, limitations of oral intake, and need for therapeutic interventions directly after the operative tumour treatment. Additionally, the influence of the same patients' characteristics on these three parameters were analysed by means of univariate and multivariate statistical methods. RESULTS: Out of 201 patients, 66.7 % needed a therapeutic intervention because of their dysphagia, 57.2 % needed a nasogastral or PEG tube due to limitations of oral intake, 45.3 % had an aspiration. In the latter subgroup, 38.5 % had a silent aspiration. Higher tumour stage, patients' higher age and male sex were shown to be significant influence factors for dysphagia, tumour localisation showed only a marginally significant result. CONCLUSIONS: The study demonstrated a clinical importance and relevance of the consequent and systematic treatment of post-operative dysphagia in head-and-neck cancer patients in the acute care units as a constituent of a modern oncological therapy.

[Language competence of four-year-old children with immigration background in Hesse: quo vadis?] / Sprachstand 4-jähriger Kinder mit Migrationshintergrund in Hessen: quo vadis?

A sustainable integration of persons with immigration background is more topical than ever before. The importance of language as one of the key aspects of integration is beyond discussion. In 2018, ca. 1 091 000 persons with the non-German citizenship were registered in the German state of Hesse. One third of all Hessian inhabitants and a half of those of preschool age had an immigration background. The tendency is increasing due to, first, ongoing immigration and, second, higher birth rates in non-German families. Consequently, the numbers of preschoolers with minimal German language skills and with language-related disorders such as hearing disorders are also rising. This study aimed to analyze the German language competence of Hessian four-year-old children with immigration background. The assessment was carried out by the validated, standardized test "Kindersprachscreening". For children who were classified as needing additional medical assistance in acquiring German, following variables were analyzed: participation in therapies, known diagnoses of impairments and illnesses, parents' and kindergarten teachers' awareness of the child's need for additional medical assistance in acquiring German.

[Validation of the German version of Eating Assessment Tool for head and neck cancer patients]. / Validierung der deutschen Version des Eating Assessment Tool bei Kopf-Hals-Tumor-Patienten.

OBJECTIVE: The assessment of subjective swallowing complaints constitutes an important element in a multidimensional, modern management of head and neck cancer patients suffering from dysphagia. For this purpose, an internationally recognized and validated 10-item questionnaire EAT-10 is used that was developed and validated by Belafski et al. in 2008. The purpose of the present study is the translation of EAT-10 into the German language and its validation for head and neck cancer patients. MATERIAL AND METHODS: After the translation of EAT-10 into German according to the guidelines for the translation of foreign measuring instruments, a validation of gEAT-10 was carried out on the basis of the sample of 210 head and neck cancer patients. The reliability was determined by means of the internal consistency (Cronbach's Alpha) and item-total correlations (Spearman). The construct validity was verified by the uni- and multivariate analyses of the distribution of gEAT-10 total scores depending on gender, age, BMI, tumor stage and localization as well as type of the oncological therapy. RESULTS: The internal consistency amounted to α = .94, the item-total correlations varied between ρ = .59 and ρ = .85. No significant associations between gEAT-10 total scores and gender as well as age were identified in univariate calculations. Such associations were found for BMI, tumor stage and localization as well as type of the oncological therapy. However, only the tumor stage yielded a significant result in a regression. CONCLUSIONS: The gEAT-10 was shown to be a reliable and construct valid questionnaire for the assessment of subjective swallowing complaints in patients with head and neck cancer.

Identification of the most significant electrode positions in electromyographic evaluation of swallowing-related movements in humans.

Surface electromyography (sEMG) is a well-established procedure for recording swallowing-related muscle activities. Because the use of a large number of sEMG channels is time consuming and technically sophisticated, the aim of this study was to identify the most significant electrode positions associated with oropharyngeal swallowing activities. Healthy subjects (N = 16) were tested with a total of 42 channels placed in M. masseter, M. orbicularis oris, submental and paralaryngeal regions. Each test subject swallowed 10 ml of water five times. After having identified 16 optimal electrode positions, that is, positions with the strongest signals quantified by the highest integral values, differences to 26 other ones were determined by a Mann-Whitney U test. Kruskal-Wallis H test was utilized for the analysis of differences between single subjects, subject subgroups, and single electrode positions. Factors associated with sEMG signals were examined in a linear regression. Sixteen electrode positions were chosen by a simple ranking of integral values. These positions delivered significantly higher signals than the other 26 positions. Differences between single electrode positions and between test subjects were also significant. Sixteen most significant positions were identified which represent swallowing-related muscle potentials in healthy subjects.

Validation of the secretion severity rating scale.

Accumulation of secretions within the hypopharynx, aditus laryngis, and trachea is one characteristic of severe dysphagia and is of high clinical and therapeutic relevance. For the graduation of the secretion severity level, a secretion scale was provided by Murray et al. in 1996. The purpose of the study presented here is the validation of this scale by analyzing the intra-rater and inter-rater reliability as well as concurrent validity. For examination of reliability and validity, a reference standard was defined by two expert clinicians who reviewed 40 video recordings of fiberendoscopic swallowing evaluations, with 10 videos for each severity grade. These videos were rated and rerated independently and blinded by 4 ENT-residents with an interval of 4 weeks. Both the intra-rater (Kendall's τ > 0.847***) and inter-rater reliability (Kendall's W > 0.951***) were highly significant and can be considered good or very good. Correlation of the median of all ratings with the reference standard was close to the highest possible value 1 (τ = 0.984***). The scale was proved to be a reliable and valid instrument for graduation of one of the principal symptoms of oropharyngeal dysphagia and is recommended as an evidence-based instrument for standardized fiberoptic endoscopic evaluation of swallowing.

Penetration-Aspiration: Is Their Detection in FEES ® Reliable Without Video Recording?

Penetration-aspiration is known as the main finding in deglutition-disordered patients with implications for diagnostics and therapeutic management. Reliable detection of penetration-aspiration is given with fiberoptic endoscopic evaluation of swallowing (FEES(®)) as one of the gold standards in instrumental swallowing evaluation. The advice to implement video recording in FEES(®) to assure quality in identifying penetration-aspiration is often ignored, especially in bed-side settings. Thus, the aim of this study was to compare reliability and validity in detecting penetration-aspiration events with and without video recording. Eighty FEES(®) sequences, ten per severity grade of the Penetration-Aspiration Scale by Rosenbek et al., were rated by four blinded ENTs with two different methods. The first method simulated the evaluation without video recording (Method A), and the second one with video recording (Method B). Rating was performed twice per setting with 2 weeks in between and every time newly randomized. Intra- and inter-rater reliability as well as validity were analyzed for both evaluation methods. R-to-Z transformation was used to reveal the more reliable method and ordinal regression to determine potential rating influences. Method B demonstrated higher intra- and inter-rater reliability values than Method A and was revealed as more reliable in identifying penetration-aspiration according to r-to-Z transformation (Z = -2.92, p = .004). Ordinal regression detected a significant influence of the evaluation method choice on the rating results (p = .016). As Method B turned out to be more reliable than Method A in detecting penetration-aspiration, the presented study recommends the implementation of video recording in swallowing diagnostics.

Water swallow screening test for patients after surgery for head and neck cancer: early identification of dysphagia, aspiration and limitations of oral intake.

Patients with head and neck cancer (HNC) are at high risk for oropharyngeal dysphagia (OD) following surgical therapy. Early identification of OD can improve outcomes and reduce economic burden. This study aimed to evaluate the validity of a water screening test using increasing volumes postsurgically for patients with HNC (N=80) regarding the early identification of OD in general, and whether there is a need for further instrumental diagnostics to investigate the presence of aspiration as well as to determine the limitations of oral intake as defined by fiberoptic endoscopic evaluation of swallowing. OD in general was identified in 65%, with aspiration in 49%, silent aspiration in 21% and limitations of oral intake in 56%. Despite a good sensitivity, for aspiration of 100% and for limitations of oral intake of 97.8%, the presented water screening test did not satisfactorily predict either of these reference criteria due to its low positive likelihood ratio (aspiration=2.6; limitations of oral intake=3.1). However, it is an accurate tool for the early identification of OD in general, with a sensitivity of 96.2% and a positive likelihood ratio of 5.4 in patients after surgery for HNC.

Predictability of oral and laryngopharyngeal function for aspiration and limitation of oral intake in patients after surgery for head and neck cancer.

Swallowing disorders are common in patients after surgery for head and neck cancer. The clinical assessment of oral and laryngopharyngeal abilities is widely used as a dysphagia assessment tool in this patient group, despite a lack of research. The goal of this study was to assess the predictability of clinical parameters for aspiration and limitation of oral intake. A swallowing disorder with the need for further intervention was identified by fiberoptic endoscopic evaluation of swallowing (FEES) in 65%, with aspiration in 49%, silently in 21%, and limited oral intake with tube dependency in 56% of studied patients. Four clinical parameters (dysglossia, wet voice, tongue motility, and tongue strength) correlated significantly with aspiration and limitation of oral intake. However, none of these clinical parameters was able to predict one of our two reference criteria, due to low positive likelihood ratios, mostly less than two. Clinical assessment is therefore inappropriate for early detection of swallowing disorders in such patients.

HPV status and overall survival of patients with oropharyngeal squamous cell carcinoma--a retrospective study of a German head and neck cancer center.

BACKGROUND/AIM: A change in epidemiology of head and neck squamous cell carcinoma (HNSCC) has been noticed: while overall incidence has decreased, the incidence of oropharyngeal SCC (OSCC) has been increasing over the past decades. A growing body of evidence suggests a causative role of the human papillomavirus (HPV) as an independent risk factor in development of OSCC. The aim of this study was to determine the HPV status in all OSCC specimens collected in our biological database since 1988, correlating the results with overall survival, and to compare them with the current literature data. PATIENTS AND METHODS: A total of 104 tumor samples were obtained and included in this study. Patient records were reviewed. HPV status was determined by a two-step polymerase chain reaction (PCR) combined with p16 immunohistochemistry. Statistical analysis was performed with BiAS™. RESULTS: Overall 12 (12%) of the 104 tumor samples were HPV-positive. Most of the patients had advanced disease [(UICC) stage III or IV)]: 91.7 % in the HPV-positive group versus 78.2% in the HPV-negative group. Multivariate analysis showed that HPV status (p=0.04), UICC stage (p=0.01) and age at initial diagnosis (p=0.0006) were all independent determinants of overall survival. A positive HPV status (hazard ratio=0.52; 95%) was associated with a 48% increase of overall survival compared to patients with HPV-negative tumors. CONCLUSION: Our findings confirm a prevalence of HPV-positive tumors within OSCC. Due to its epidemiologic and prognostic relevance, HPV status should be considered an important part of tumor staging. For this purpose, HPV detection via two-step PCR combined with p16 immunohistochemistry seems reliable.

A documentation system to save time and ensure proper application of the fiberoptic endoscopic evaluation of swallowing (FEES®).

A properly performed fiberoptic endoscopic evaluation of swallowing (FEES(®)) is comprehensive and time-consuming. Editing times of FEES protocols and attempts for efficiency maximization are unknown. Here, the protocol editing times of completed FEES examinations were determined. The present study reports the time savings and quality gains of a newly developed documentation system tailored to the FEES standard of Langmore. Four independent examiners analyzed twelve videos of FEES procedures, six without and six with the documentation system. Effectiveness of the documentation system was evaluated according to the times for total evaluation, interpretation, documentation, report writing, and for report completeness. The documentation system reduced editing times and increased report completeness with large effect sizes. Averaged total evaluation time decreased from 42 to 27 min, report completeness increased from 55 to 80%. The use of the documentation system facilitates and improves the assessment of the swallowing process.

Evaluation of auditory development in infants and toddlers who received cochlear implants under the age of 24 months with the LittlEARS) Auditory Questionnaire.

BACKGROUND AND AIMS: Newborn hearing screening and early intervention for congenital hearing loss have created a need for tools assessing the hearing development of very young children. A multidisciplinary evaluation of children's development is now becoming standard in clinical practice, though not many reliable diagnostic instruments exist. For this reason, the LittlEARS Auditory Questionnaire (LEAQ) was created to assess the auditory skills of a growing population of infants and toddlers who receive hearing instruments. The LEAQ relies on parent report, which has been shown to be a reliable way of assessing child development. Results with this tool in a group of children who received very early cochlear implantation are presented. METHODS: The LEAQ is the first module of the LittlEARS comprehensive test battery for children under the age of two who have normal hearing (NH), cochlear implants (CIs) or hearing aids (HAs). The LEAQ is a parent questionnaire comprised of 35 "yes/no" questions which can be completed by parents in less than 10 min. Sixty-three children who received unilateral CIs at a young age were assessed longitudinally and their performance was compared to that of a NH group. RESULTS: All CI children reached the maximum possible score on the LEAQ on average by 22 months of hearing age, i.e. 38 months of chronological age. In comparison, the NH group reached the maximum score by 24 months of age demonstrating that auditory skills of CI children often develop quicker than those of NH children. In the two comparison groups of children aged (a) younger and older than 12 months, and (b) between 6-9 and 21-24 months at first fitting, the early implanted children reached the highest scores faster than the later implanted children. Furthermore, three children with additional needs were tested. They showed slower growth over time but also received benefits from early implantation. CONCLUSIONS: The LEAQ is a quick and effective tool for assessing auditory skills of very young children with or without hearing loss. In our study, the auditory skills of children with CI progressed very quickly after implantation and were comparable with those of NH peers.

Computer-assisted documentation of the fiberoptic endoscopic evaluation of swallowing.

BACKGROUND: Because documentation and report writing in fiberoptic endoscopic evaluation of swallowing (FEES) is time consuming and susceptible to omissions, a software solution to ameliorate these problems by maintaining document quality is desirable. MATERIAL/METHODS: Based on the FEES procedure of Langmore, a documentation software (DS) which presents a digitized FEES recording and masks with precast text fields was designed to facilitate and unify data input. The oropharyngeal secretion scale of Murray and the penetration-aspiration scale of Rosenbek were integrated to increase comparability of dysphagia information. Four independent examiners analyzed 12 digitized FEES-recordings, 6 without and 6 with the DS, to determine its effect on the times needed for total evaluation, interpretation, documentation, report writing, and report completeness. RESULTS: The documentation software (DS) reduced the total evaluation time from 42 min to 18 min and increased the evaluation completeness from 55% to 95%, both with very large effect sizes. The time saving was mainly due to an automated report generation at the end of the analysis. CONCLUSIONS: The DS can be offered as a valuable and effective tool in daily clinical routine and for research purposes.

Does the 23-valent pneumococcal vaccine protect cochlear implant recipients?

OBJECTIVES/HYPOTHESIS: The incidence of meningitis is increased in cochlear implant (CI) recipients. Besides malformations, immunological deficiencies are predisposing factors. Therefore, the immunological background of CI recipients and the immunogenicity of the recommended 23-valent pneumococcal polysaccharide vaccine (PPV-23) were investigated. STUDY DESIGN: Prospective study in a tertiary care referral center. METHODS: One hundred twenty CI recipients who were at least 5 years of age were vaccinated with PPV-23. Levels of immunoglobulins G, A, and M (IgG, IgA, and IgM, respectively) and IgG subclasses IgG1-IgG4 before vaccination and serum concentrations of antibodies against seven pneumococcal serotypes before and 4 weeks after vaccination were determined. The cohort was subdivided by patient age into groups A1 (5-8 y), A2 (8-12 y), and A3 (>12 y). RESULTS: Geometric mean concentrations of pneumococcal antibodies before vaccination were remarkably low in all three groups, emphasizing the importance of vaccination in this risk group. All groups showed a statistically significant increase in geometric mean concentrations after immunization. For group A1 compared with groups A2 and A3, response was limited, especially for serotypes 6B (geometric mean concentration, 1.71 microg/mL; P = .0007), 23F (geometric mean concentration, 2.28 microg/mL; P = .04), and 14 (geometric mean concentration, 3.98 microg/mL; P = .0004). The percentages of patients reaching the presumed protective threshold of at least 1 microg/mL pneumococcal antibody concentration were at least 71.1% in group A1, 93.8% in group A2, and 90.5% in group A3. This raises the question of whether PPV-23 evokes satisfying seroprotection in CI recipients younger than 8 years of age. CONCLUSION: With regard to the increased risk for bacterial meningitis, the authors recommend priming CI recipients younger than 8 years of age with pneumococcal conjugate vaccine followed by a PPV-23 booster.