Dysphagia, trismus and speech impairment following radiation-based treatment for advanced stage oropharyngeal carcinoma: a one-year prospective evaluation.

OBJECTIVE: The objective was to assess swallowing, mouth opening and speech function during the first year after radiation-based treatment (RT(+)) after introduction of a dedicated preventive rehabilitation program for stage III-IV oropharyngeal carcinoma (OPC). METHODS: Swallowing, mouth opening and speech function were collected before and at six- and twelve-month follow-up after RT(+) for OPC as part of ongoing prospective assessments by speech-language pathologists . RESULTS: Objective and patient-perceived function deteriorated until 6 months and improved until 12 months after treatment, but did not return to baseline levels with 25%, 20% and 58% of the patients with objective dysphagia, trismus and speech problems, respectively. Feeding tube dependency and pneumonia prevalence was low. CONCLUSION: Despite successful implementation, a substantial proportion of patients still experience functional limitations after RT(+) for OPC, suggesting room for improvement of the current rehabilitation program. Pretreatment sarcopenia seems associated with worse functional outcomes and might be a relevant new target for rehabilitation strategies.

MRI Assessment of Swallow Muscle Activation with the Swallow Exercise Aid and with Conventional Exercises in Healthy Volunteers: An Explorative Biomechanical Study.

Swallowing muscle strength exercises are effective in restoring swallowing function. In order to perform the exercises with progressive load, the swallow exercise aid (SEA) was developed. Precise knowledge on which muscles are activated with swallowing exercises, especially with the SEA, is lacking. This knowledge would aid in optimizing the training program to target the relevant swallowing muscles, if necessary. Three healthy volunteers performed the three SEA exercises (chin tuck against resistance, jaw opening against resistance and effortful swallow) and three conventional exercises [conventional effortful swallow (cES), Shaker and Masako] in supine position inside an MRI scanner. Fast muscle functional MRI scans (generating quantitative T2-maps) were made immediately before and after the exercises. Median T2 values at rest and after exercise were compared to identify activated muscles. After the three SEA exercises, the suprahyoid, infrahyoid, sternocleidomastoid, and lateral pterygoid muscles showed significant T2 value increase. After the Shaker, the lateral pterygoid muscles did not show such an increase, but the three other muscle groups did. The cES and Masako caused no significant increase in any of these muscle groups. During conventional (Shaker) exercises, the suprahyoid, infrahyoid, and sternocleidomastoid muscles are activated. During the SEA exercises, the suprahyoid, infrahyoid, sternocleidomastoid, and lateral pterygoid muscles are activated. The findings of this explorative study further support the potential of the SEA to improve swallowing rehabilitation.

Objective and subjective voice outcomes after total laryngectomy: a systematic review.

BACKGROUND: Esophageal speech (ES), tracheoesophageal speech (TES) and/or electrolarynx speech (ELS) are three speech rehabilitation methods which are commonly provided after total laryngectomy (TL). METHODS: A systematic review of the literature was conducted to evaluate comparative acoustic, perceptual, and patient-reported outcomes for ES, TES, ELS and healthy speakers. RESULTS: Twenty-six articles could be included. In most studies, methodological quality was low. It is likely that an inclusion bias exists, many studies only included exceptional speakers. Significant better outcomes are reported for TES compared to ES for the acoustic parameters, fundamental frequency, maximum phonation time and intensity. Perceptually, TES is rated with a significant better voice quality and intelligibility than ES and ELS. None of the speech rehabilitation groups reported clearly better outcomes in patient-reported outcomes. CONCLUSIONS: Studies on speech outcomes after TL are flawed in design and represent weak levels of evidence. There is an urge for standardized measurement tools for evaluations of substitute voice speakers. TES is the favorable speech rehabilitation method according to acoustic and perceptual outcomes. All speaker groups after TL report a degree of voice handicap. Knowledge of caretakers and differences in health care and insurance systems play a role in the speech rehabilitation options that can be offered.

Predictive factors for pharyngocutaneous fistulization after total laryngectomy: a Dutch Head and Neck Society audit.

BACKGROUND: Incidences of pharyngocutaneous fistulization (PCF) after total laryngectomy (TL) reported in the literature vary widely, ranging from 2.6 to 65.5%. Comparison between different centers might identify risk factors, but also might enable improvements in quality of care. To enable this on a national level, an audit in the 8 principle Dutch Head and Neck Centers (DHNC) was initiated. METHODS: A retrospective chart review of all 324 patients undergoing laryngectomy in a 2-year (2012 and 2013) period was performed. Overall PCF%, PCF% per center and factors predictive for PCF were identified. Furthermore, a prognostic model predicting the PCF% per center was developed. To provide additional data, a survey among the head and neck surgeons of the participating centers was carried out. RESULTS: Overall PCF% was 25.9. The multivariable prediction model revealed that previous treatment with (chemo)radiotherapy in combination with a long interval between primary treatment and TL, previous tracheotomy, near total pharyngectomy, neck dissection, and BMI < 18 were the best predictors for PCF. Early oral intake did not influence PCF rate. PCF% varied quite widely between centers, but for a large extend this could be explained with the prediction model. PCF performance rate (difference between the PCF% and the predicted PCF%) per DHNC, though, shows that not all differences are explained by factors established in the prediction model. However, these factors explain enough of the differences that, compensating for these factors, hospital is no longer independently predictive for PCF. CONCLUSIONS: This nationwide audit has provided valid comparative PCF data confirming the known risk factors from the literature which are important for counseling on PCF risks. Data show that variations in PCF% in the DHNCs (in part) are explainable by the variations in these predictive factors. Since elective neck dissection is a major risk factor for PCF, it only should be performed on well funded indication.

Trends in treatment, incidence and survival of hypopharynx cancer: a 20-year population-based study in the Netherlands.

Hypopharynx cancer has the worst prognosis of all head and neck squamous cell cancers. Since the 1990s, a treatment shift has appeared from a total laryngectomy towards organ preservation therapies. Large randomized trials evaluating treatment strategies for hypopharynx cancer, however, remain scarce, and frequently this malignancy is evaluated together with larynx cancer. Therefore, our aim was to determine trends in incidence, treatment and survival of hypopharynx cancer. We performed a population-based cohort study including all patients diagnosed with T1-T4 hypopharynx cancer between 1991 and 2010 in the Netherlands. Patients were recorded by the national cancer registry database and verified by a national pathology database. 2999 patients were identified. The incidence increased significantly with 4.1% per year until 1997 and decreased non-significantly afterwards. For women, the incidence increased with 1.7% per year during the entire study period. Total laryngectomy as primary treatment significantly decreased, whereas radiotherapy and chemoradiation increased. The 5-year overall survival significantly increased from 28% in 1991-2000 to 34% in 2001-2010. Overall survival for T3 was equal for total laryngectomy and (chemo)radiotherapy, but for T4-patients the survival was significantly better after primary total laryngectomy (± adjuvant radiotherapy). This large population-based study demonstrates a shift in treatment preference towards organ preservation therapies. The 5-year overall survival increased significantly in the second decade. The assumed equivalence of organ preservation and laryngectomy may require reconsideration for T4 disease.

Hyoid bone displacement as parameter for swallowing impairment in patients treated for advanced head and neck cancer.

Reduced hyoid displacement is thought to contribute to aspiration and pharyngeal residues in head and neck cancer (HNC) patients with dysphagia. To further study hyoid elevation and anterior excursion in HNC patients, this study reports on temporal/kinematic measures of hyoid displacement, with the additional goal to investigate correlations with clinical swallowing impairment. A single-blind analysis of data collected as part of a larger prospective study was performed at three time points before and after chemoradiotherapy. Twenty-five patients had undergone clinical swallowing assessments at baseline, 10-weeks, and 1-year post-treatment. Analysis of videofluoroscopic studies was done on different swallowing consistencies of varying amounts. The studies were independently reviewed frame-by-frame by two clinicians to assess temporal (onset and duration) and kinematic (anterior/superior movement) measures of hyoid displacement (ImageJ), laryngeal penetration/aspiration, and presence of vallecula/pyriform sinus residues. Patient-reported oral intake and swallowing function were also evaluated. Mean maximum hyoid displacement ranged from 9.4 mm (23 % of C2-4 distance) to 12.6 mm (27 %) anteriorly, and from 18.9 mm (41 %) to 24.9 mm (54 %) superiorly, depending on bolus volume and consistency. Patients with reduced superior hyoid displacement perceived significantly more swallowing impairment. No correlation between delayed or reduced hyoid excursion and aspiration or residue scores could be demonstrated. Hyoid displacement is subject to variability from a number of sources. Based on the results, this parameter seems not very valuable for clinical use in HNC patients with dysphagia.

Radiation dose to the tongue and velopharynx predicts acoustic-articulatory changes after chemo-IMRT treatment for advanced head and neck cancer.

The aim of this study was to investigate to what extent changes in speech after C-IMRT treatment are related to mean doses to the tongue and velopharynx (VP). In 34 patients with advanced hypopharyngeal, nasopharyngeal, or oropharyngeal cancer, changes in speech from pretreatment to 10 weeks and 1 year posttreatment were correlated with mean doses to the base of tongue (BOT), oral cavity (OC) and tonsillar fossa/soft palate (VP). Differences in anteroposterior tongue position, dorsoventral degree of tongue to palate or pharynx constriction, grooving, strength, nasality, and laryngeal rise, were assessed by acoustic changes in three speech sounds that depend on a (post-) alveolar closure or narrowing (/t/, /s/, /z/), three with a tongue to palate/pharyngeal narrowing (/l/, /r/, /u/), and in vowel /a/ at comfortable and highest pitch. Acoustically assessed changes in tongue positioning, shape, velopharyngeal constriction, and laryngeal elevation were significantly related to mean doses to the tongue and velopharynx. The mean dose to BOT predicted changes in anteroposterior tongue positioning from pre- to 10-weeks posttreatment. From pretreatment to 1-year, mean doses to BOT, OC, and VP were related to changes in grooving, strength, laryngeal height, nasality, palatalization, and degree of pharyngeal constriction. Changes in speech are related to mean doses to the base of tongue and velopharynx. The outcome indicates that strength, motility, and the balance between agonist and antagonist muscle forces change significantly after radiotherapy.

A cost-effectiveness analysis of using TheraBite in a preventive exercise program for patients with advanced head and neck cancer treated with concomitant chemo-radiotherapy.

Previous studies have shown that a "Preventive Exercise Program" (PREP) is cost-effective compared to the standard exercise program provided in "Usual Care" (UC) in patients with advanced head and neck cancer. The current paper specifically estimates the cost-effectiveness of the TheraBite jaw rehabilitation device (TB) which is used as part of the PREP, compared to Speech Language Pathology (SLP) sessions as part of UC, and herewith intents to inform reimbursement discussions regarding the TheraBite device. Costs and outcomes [quality-adjusted life-years (QALYs)] of the TB compared to SLP were estimated using a Markov model of advanced head and neck cancer patients. Secondary outcome variables were trismus, feeding substitutes, facial pain, and pneumonia. The incremental cost-effectiveness ratio (ICER) was estimated from a health care perspective of the Netherlands, with a time horizon of 2 years. The total health care costs per patient were estimated to amount to €5,129 for the TB strategy and €6,915 for the SLP strategy. Based on the current data, the TB strategy yielded more quality-adjusted life-years (1.28) compared to the SLP strategy (1.24). Thus, the TB strategy seems more effective (+0.04) and less costly (-€1,786) than the SLP only strategy. At the prevailing threshold of €20,000/QALY the probability for the TB strategy being cost-effective compared to SLP was 70 %. To conclude, analysis of presently available data indicates that TB is expected to be cost-effective compared to SLP in a preventive exercise program for concomitant chemo-radiotherapy for advanced head and neck cancer patients.

Feasibility and impact of a dedicated multidisciplinary rehabilitation program on health-related quality of life in advanced head and neck cancer patients.

In an observational prospective study, feasibility and outcomes of a dedicated multidisciplinary rehabilitation program (HNR) for head and neck cancer (HNC) patients were evaluated. HRQoL was assessed before and after HNR with EORTC C30 and H&N-35 QoL questionnaires in 52 consecutive patients. Initial HRQoL scores were compared with EORTC reference scores for HNC patients and post-HNR with those available for the general healthy population. Distress was assessed before and after HNR with the distress thermometer (DT). At completion of HNR with a mean duration of 7 months, overall HRQoL was significantly improved (p < 0.001). Role, Emotional, and Social function scales and most EORTC C30 and H&N35 symptom scale items showed a statistically significant (p < 0.01) and clinically relevant improvement. Mean distress score before HNR was above the cutoff value of 5, suggesting the need for referral to rehabilitation. After completing HNR, distress decreased significantly to 3.0 (p < 0.001). HRQoL pretreatment was poorer than that of the EORTC reference HNC population, whereas at the completion of the HNR program, the HRQoL was comparable to that of the general population reference level. We conclude that a dedicated multidisciplinary HNR program is feasible and suggest that it has a positive impact on HRQoL. The multidisciplinary approach may have added value over mono-disciplinary interventions. However, our results should be judged cautiously due to the observational nature of the study.

Prospective clinical study on long-term swallowing function and voice quality in advanced head and neck cancer patients treated with concurrent chemoradiotherapy and preventive swallowing exercises.

Concurrent chemoradiotherapy (CCRT) for advanced head and neck cancer (HNC) is associated with substantial early and late side effects, most notably regarding swallowing function, but also regarding voice quality and quality of life (QoL). Despite increased awareness/knowledge on acute dysphagia in HNC survivors, long-term (i.e., beyond 5 years) prospectively collected data on objective and subjective treatment-induced functional outcomes (and their impact on QoL) still are scarce. The objective of this study was the assessment of long-term CCRT-induced results on swallowing function and voice quality in advanced HNC patients. The study was conducted as a randomized controlled trial on preventive swallowing rehabilitation (2006-2008) in a tertiary comprehensive HNC center with twenty-two disease-free and evaluable HNC patients as participants. Multidimensional assessment of functional sequels was performed with videofluoroscopy, mouth opening measurements, Functional Oral Intake Scale, acoustic voice parameters, and (study specific, SWAL-QoL, and VHI) questionnaires. Outcome measures at 6 years post-treatment were compared with results at baseline and at 2 years post-treatment. At a mean follow-up of 6.1 years most initial tumor-, and treatment-related problems remained similarly low to those observed after 2 years follow-up, except increased xerostomia (68%) and increased (mild) pain (32%). Acoustic voice analysis showed less voicedness, increased fundamental frequency, and more vocal effort for the tumors located below the hyoid bone (n = 12), without recovery to baseline values. Patients' subjective vocal function (VHI score) was good. Functional swallowing and voice problems at 6 years post-treatment are minimal in this patient cohort, originating from preventive and continued post-treatment rehabilitation programs.

Predictive factors for pharyngocutaneous fistulization after total laryngectomy.

OBJECTIVES: Postoperative complications, especially pharyngocutaneous fistulization (PCF), are more frequent after total laryngectomy (TL) performed for salvage after (chemo)radiotherapy than after primary TL. The aim of this study was to identify the incidence of PCF, predictive factors for PCF, and the relationship of PCF to survival. METHODS: We performed a retrospective chart review of 217 consecutive patients treated with TL between 2000 and 2010. Univariate and multivariable analysis with logistic regression was used to identify factors associated with PCF. We used a Kaplan-Meier survival analysis. RESULTS: The overall incidence of PCF was 26.3% (57 of 217 cases). The incidence of PCF after primary TL was 17.1% (12 of 70), that after salvage TL was 25.5% (25 of 98), that after TLE for a second primary was 37.5% (9 of 24), and that after TL for a dysfunctional larynx was 44.0% (11 of 25). The predictive factors for PCF were hypopharynx cancer (odds ratio [OR], 3.67; 95% confidence interval [CI], 1.74 to 7.71; P = .001), an albumin level of less than 40 g/L (OR, 2.20; 95% CI, 1.12 to 4.33; P = .022), previous chemoradiotherapy (OR, 3.38; 95% CI, 1.34 to 8.52; P = .010), more-extended pharyngeal resection (P = .001), and pharynx reconstruction (P = .002). The median duration of survival was 30 months (95% CI, 17.5 to 42.5); the 2-year overall survival rate was 54%. The median duration of survival of patients with PCF was 23 months (95% CI, 9.4 to 36.6), and that of those without PCF was 31 months (95% CI, 15.0 to 47.0; P = .421). The 2-year overall survival rate was 48% in patients with PCF and 57% in those without PCF (P = .290). CONCLUSIONS: Incidence of PCF after TL is significantly higher in patients with hypopharynx cancer, previous chemoradiotherapy, a low albumin level, more-extended pharyngeal resection, or pharynx reconstruction. The occurrence of PCF does not influence the rate of survival.

Ex vivo water exchange performance and short-term clinical feasibility assessment of newly developed heat and moisture exchangers for pulmonary rehabilitation after total laryngectomy.

Laryngectomized patients suffer from respiratory complaints due to insufficient warming and humidification of inspired air in the upper respiratory tract. Improvement of pulmonary humidification with significant reduction of pulmonary complaints is achieved by the application of a heat and moisture exchanger (HME) over the tracheostoma. The aim of this study was to determine whether the new Provox HMEs (XM-HME and XF-HME) have a better water exchange performance than their predecessors (R-HME and L-HME, respectively; Atos Medical, Hörby, Sweden). The other aim was to assess the short-term clinical feasibility of these HMEs. The XM-HME and XF-HME were weighed at the end of inspiration and at the end of expiration at different breathing volumes produced by a healthy volunteer. The associations between weight changes, breathing volume and absolute humidity were determined using both linear and non-linear mixed effects models. Study-specific questionnaires and tally sheets were used in the clinical feasibility study. The weight change of the XM-HME is 3.6 mg, this is significantly higher than that of the R-HME (2.0 mg). The weight change of the XF-HME (2.0 mg) was not significantly higher than that of the L-HME (1.8 mg). The absolute humidity values of both XM- and XF-HME were significantly higher than that of their predecessors. The clinical feasibility study did not reveal any practical problems over the course of 3 weeks. The XM-HME has a significantly better water exchange performance than its predecessor (R-HME). Both newly designed HMEs did succeed in the clinical feasibility study.

Early oral intake after total laryngectomy does not increase pharyngocutaneous fistulization.

Timing of oral intake after total laryngectomy (TLE) is mostly delayed until postoperative day 10-12, under the assumption that this limits the incidence of pharyngocutaneous fistulization (PCF). However, early oral intake could be advantageous and could reduce costs, providing that it does not lead to increased PCF. Comparison of PCF incidence in traditional 'late' oral intake protocol (start at postoperative day 10-12; LOI) and in early oral intake protocol (start at postoperative day 2-4; EOI). Retrospective cohort study comparing two different oral intake protocols in 247 consecutive patients laryngectomized between early 2000 until mid 2006 (LOI; N = 140), and mid 2006 until mid 2012 (EOI; N = 107). Both groups were comparable in terms of sex, age, origin of tumor, and TLE indication, except for the American Society of Anesthesiologists score (ASA), which was slightly more favorable in the LOI group (p = 0.047). Compliance with the oral intake protocols during both periods was good: the median day of starting oral intake was day 11 (range 6-103) in the LOI group vs. day 3 (range 2-84) in the EOI group (p = 0.001). The incidence of PCF was not significantly different between the two groups (25% for LOI and 32% for EOI; Fisher's exact: p = 0.255). In addition, no association was observed between the timing of oral intake and PCF (HR = 0.995; CI 0.98-1.01; p = 0.364). This study suggests that early oral intake is safe and does not increase pharyngocutaneous fistulization.

Incidence of severe tracheobronchitis and pneumonia in laryngectomized patients: a retrospective clinical study and a European-wide survey among head and neck surgeons.

Laryngectomized patients, lacking conditioning of the breathing air in the upper respiratory tract, have reported considerable pulmonary complaints. It is assumed that these patients also run a higher risk of developing severe respiratory infections. Unfortunately, there is little scientific information available about the occurrence of respiratory infections and related health costs in these patients with and without the use of an HME. Therefore, the occurrence of respiratory infections in laryngectomized patients was investigated in the Netherlands Cancer Institute and by means of a survey among head and neck oncology surgeons throughout Europe. The number of tracheobronchitis and/or pneumonia events was retrospectively scored between 1973 and 2013 in medical records of 89 laryngectomized patients treated in our institute. To assess expert experiences and opinions regarding these pulmonary problems, a study-specific survey was developed. The survey was sent by email to head and neck surgeons from ten different countries. In the medical record study, an average of 0.129 respiratory infections per patient/year was found in non-HME users and 0.092 in HME users. In the survey (response rate HN surgeons 20 %; countries 90 %) 0.285 episodes per patient/year in non-HME users was statistically higher than the 0.066 episodes per patient/year in HME users. The average mortality in the HME user group per entire career of each physician was estimated at 0.0045, and for the non-HME user group this was 0.0152. There is a tendency that the number of tracheobronchitis and pneumonia episodes in non-HME users is higher than in HME users.

Two-year results of a prospective preventive swallowing rehabilitation trial in patients treated with chemoradiation for advanced head and neck cancer.

The objective of the study was the assessment of the results of a prospective clinical trial with two preventive swallowing rehabilitation programs on the long-term side effects of chemoradiotherapy (CCRT) in advanced head and neck cancer patients. The study cohort consisted of 29 patients, randomized in two exercise groups: a standard (S) group receiving routine swallowing exercises (N = 14), and an experimental (E) group receiving swallowing exercises based on the TheraBite® Jaw Motion Rehabilitation System™ (N = 15). Assessment of functional changes was carried out with multidimensional outcome measures (e.g., videofluoroscopy, study-specific questionnaires) at four time points (pre-treatment, at 10 weeks, 1 year, and 2 years post-treatment). Overall, in the first year post-treatment many initial tumor- and treatment-related problems diminished significantly, except xerostomia (59%). The only additional improvement at 2 years was that the overall weight significantly further increased (p = 0.000), however, without regaining baseline value. In the subgroup analysis according to exercise group, this difference was significant in the E-group only (p = 0.002). The same was the case for the subgroup analysis according to site of disease, with a significant weight gain in the 'below the hyoid bone' group only. This study shows that the overall functional problems at 1 and 2 years post-CCRT are limited. Both rehabilitation programs produce similar results, with a slight but significant benefit for the E-group in weight gain at 2 years, as also seen in the 'below the hyoid bone' group. Both rehabilitation programs applied are feasible and show good compliance despite the burdensome CCRT.

Acoustic analysis of changes in articulation proficiency in patients with advanced head and neck cancer treated with chemoradiotherapy.

OBJECTIVES: Our aim was to characterize articulation proficiency and differences between tumor sites before and after chemoradiotherapy for advanced head and neck cancer with the help of acoustic measures. Our further goal was to improve objective speech measures and gain insight into muscle functioning before and after treatment. METHODS: In 34 patients with laryngeal or hypopharyngeal, nasal or nasopharyngeal, or oral or oropharyngeal cancer, we acoustically analyzed nasality, vowel space, precision, and strength of articulation in 12 speech sounds (/a/, /i/, /u/, /p/, /s/, /z/, /1/, /t/, /tj/, /k/, /x/, /r/) before treatment and 10 weeks and 1 year after treatment. Outcomes were compared between assessment points and between tumor sites. RESULTS: Nasality in nonlaryngeal sites was significantly reduced by treatment. Most affected in articulation were the oral or oropharyngeal cancer sites, followed by the nasal or nasopharyngeal sites. One year after treatment, vowel space had not recovered and consonant articulation had weakened. Laryngeal sites were less affected in articulation by tumor or treatment. CONCLUSIONS: Analyses of articulatory-acoustic features are a useful instrument for assessing articulation and speech quality objectively. Assessment of a number of sounds representing various articulation manners, places, and tongue shapes revealed patterns of speech deterioration after chemoradiotherapy. The results suggest that patients' speech could benefit from articulation exercises to address changes in muscle coordination and/or sensitivity and to counteract side effects and "underexercise" atrophy.

Development and (pre-) clinical assessment of a novel surgical tool for primary and secondary tracheoesophageal puncture with immediate voice prosthesis insertion, the Provox Vega Puncture Set.

Development and (pre-) clinical assessment were performed of a novel surgical tool for primary and secondary tracheoesophageal puncture (TEP) with immediate voice prosthesis (VP) insertion in laryngectomized patients, the Provox Vega Puncture Set (PVPS). After preclinical assessment in fresh frozen cadavers, a multicenter prospective clinical feasibility study in two stages was performed. Stage-1 included 20 patients, and stage-2 had 27. Based on observations in stage-1, the PVPS was re-designed (decrease in diameter of the dilator from 23.5 to 18 Fr.) and further used in stage-2. Primary outcome measure was immediate VP insertion without requiring additional instruments. Secondary outcome measures for comparison of the new with the traditional TEP procedure were: appreciation, ease of use, time consumption, estimated surgical risks and overall preference. A mini-max two-stage study design was used to establish the required sample size. In stage-1, dilatation forces were considered too high in patients with a fibrotic TE wall. With the final thinner version of the PVPS, VPs were successfully inserted into the TEP in 'one-go' in 24/27 (89%) of TEPs: 20 primary and 7 secondary. Participating surgeons rated appreciation, ease of use, time consumption and estimated surgical risks as better. Related adverse events were few and minor. The new PVPS appeared to be the preferred device by all participating surgeons. This study shows that the novel, disposable PVPS is a useful TEP instrument allowing quick and easy insertion of the VP in the vast majority of cases without requiring additional instruments.

A cost-effectiveness analysis of a preventive exercise program for patients with advanced head and neck cancer treated with concomitant chemo-radiotherapy.

BACKGROUND: Concomitant chemo-radiotherapy (CCRT) has become an indispensable organ, but not always function preserving treatment modality for advanced head and neck cancer. To prevent/limit the functional side effects of CCRT, special exercise programs are increasingly explored. This study presents cost-effectiveness analyses of a preventive (swallowing) exercise program (PREP) compared to usual care (UC) from a health care perspective. METHODS: A Markov decision model of PREP versus UC was developed for CCRT in advanced head and neck cancer. Main outcome variables were tube dependency at one-year and number of post-CCRT hospital admission days. Primary outcome was costs per quality adjusted life years (cost/QALY), with an incremental cost-effectiveness ratio (ICER) as outcome parameter. The Expected Value of Perfect Information (EVPI) was calculated to obtain the value of further research. RESULTS: PREP resulted in less tube dependency (3% and 25%, respectively), and in fewer hospital admission days than UC (3.2 and 4.5 days respectively). Total costs for UC amounted to €41,986 and for PREP to €42,271. Quality adjusted life years for UC amounted to 0.68 and for PREP to 0.77. Based on costs per QALY, PREP has a higher probability of being cost-effective as long as the willingness to pay threshold for 1 additional QALY is at least €3,200/QALY. At the prevailing threshold of €20,000/QALY the probability for PREP being cost-effective compared to UC was 83%. The EVPI demonstrated potential value in undertaking additional research to reduce the existing decision uncertainty. CONCLUSIONS: Based on current evidence, PREP for CCRT in advanced head and neck cancer has the higher probability of being cost-effective when compared to UC. Moreover, the majority of sensitivity analyses produced ICERs that are well below the prevailing willingness to pay threshold for an additional QALY (range from dominance till €45,906/QALY).

A new heat and moisture exchanger for laryngectomized patients: endotracheal temperature and humidity.

OBJECTIVE: To assess the endotracheal temperature and humidity and clinical effects of 2 models of a new heat and moisture exchanger (HME): Rplus, which has regular breathing resistance, and Lplus, which has lower breathing resistance. METHODS: We measured endotracheal temperature and humidity in 10 laryngectomized patients, for 10 min each, with and without the HMEs. We sequentially tested 4 HME models (all Atos Medical, Hörby, Sweden), in randomized order: Rplus, Lplus, Provox Normal (the HME we regularly use and which we considered the reference HME), and Stomvent (an older HME model). We also assessed the short-term clinical and practical effects of the Rplus and Lplus in a prospective 3-week trial with 13 laryngectomized patients. RESULTS: Rplus and Lplus had better humidification than Provox Normal (6.8 mg H(2)O/L, 4.3 mg H(2)O/L, and 3.7 mg H(2)O/L, respectively, P < .001), and no significant temperature difference. During the 3-week study period, 7 of the 13 patients reported noticeably lower mucus production with Rplus and Lplus. CONCLUSIONS: Rplus and Lplus had better heating and humidification than Provox Normal. Although Stomvent also performed well, its design is less convenient for laryngectomized patients. Further HME improvement is still warranted and should focus on improving the HME's heating capacity.

Rehabilitation program for prosthetic tracheojejunal voice production and swallowing function following circumferential pharyngolaryngectomy and neopharyngeal reconstruction with a jejunal free flap.

The case of a 68-year-old woman with postoperative speech and swallowing problems following a circumferential pharyngolaryngectomy and neopharyngeal reconstruction with a jejunal free flap is presented. The primary tumor was an extended papillary thyroid carcinoma (pT4N0M0). For vocal restoration, an indwelling Provox(®) 1 voice prosthesis was inserted secondarily. The patient received speech and swallowing therapy, including digital maneuvers at the level of the proximal (cervical) part of the jejunal graft to improve speech and swallowing function. Pre- and/ or post-treatment data on speech and swallowing function were gathered using the following assessment methods: esophageal insufflation test, Voice Handicap Index (VHI), videofluoroscopy of phonation (VFSph), digital high-speed endoscopy of jejunal vibration during voice production, fiber-optic endoscopic evaluation of swallowing (FEES), and videofluoroscopy of swallowing (VFSs). This case clearly demonstrates that even after extensive laryngopharyngectomy with jejunal free flap reconstruction, a tailored rehabilitation program can improve both voice and swallowing function, and that these results clearly can be objectified/visualized, underlining the validity of this approach.