Translation, Cross-Cultural Adaptation, and Preliminary Validation of the Transsexual Voice Questionnaire for Male-to-Female Transsexuals (I-TVQMtF) Into Italian.

OBJECTIVE: To perform a cross-cultural adaptation into Italian and to analyse reliability and validity of the Transsexual Voice Questionnaire for male-to-female transsexuals (I-TVQMtF). STUDY DESIGN: Cross-sectional nonrandomized survey study. METHODS: For item-generation, a cross-cultural adaptation and translation process was performed following standard guidelines. Transgender women were consecutively recruited and asked to fill out the I-TVQMtF and a form on social, demographic and transition-related variables. Firstly, data collected from participants were used to perform confirmatory factor analysis, and to evaluate internal consistency and test-retest reliability Subsequently, convergent validity was evaluated comparing I-TVQMtF total scores with the two extra items addressing self-perception (SPVF) and aspiration (AVF) of voice femininity. To evaluate convergent validity, scores of the Italian version of the Voice Handicap Index were considered for comparisons. A correlation analysis was performed to verify potential association between I-TVQMtF scores and social, demographic and transition-related variables. RESULTS: Confirmatory factor analysis demonstrated that a two-factor model fits data better than the unidimensional one. Both internal consistency and test retest reliability of the I-TVQMtF were satisfactory. Negative correlations were highlighted between I-TVQMtF scores on one side and self-perception vocal functioning and aspiration vocal functioning on the other. Positive correlations between I-TVQMtF and Italian version of the Voice Handicap Index scores were also found. Finally, negative correlations were demonstrated between I-TVQMtF scores and time spent living in the female role. CONCLUSION: The I-TVQMtF appears to be a reliable and valid instrument for the assessment of voice-related quality of life in transgender women.

Closure of Tracheoesophageal Puncture after Total Laryngectomy.

Tracheoesophageal puncture with voice prosthesis placement is used to restore vocal function after total laryngectomy. However, closure of the fistula is sometimes needed. At our department, a simple and effective technique for closure was developed. It does not require interposed tissues or materials. Moreover, our procedure allows for a short rehabilitation time for swallowing and a short hospitalization. We describe advantages, pitfalls, and errors to avoid. This technique should not be performed for patients who are irradiated and those with large fistulas.

The bacterial lysate Lantigen B reduces the number of acute episodes in patients with recurrent infections of the respiratory tract: the results of a double blind, placebo controlled, multicenter clinical trial.

Studies in the 1970s and 1980s reported that bacterial lysates (BL) had a prophylactic effect on recurrent respiratory tract infections (RRTI). However, controlled clinical study procedures have evolved substantially since then. We performed a trial using updated methods to evaluate the efficacy of Lantigen B®, a chemical BL. This double blind, placebo controlled, multi-center clinical trial had the primary objective of assessing the capacity of Lantigen B to significantly reduce the total number of infectious episodes in patients with RRTI. Secondary aims were the RRTI duration, the frequency and the severity of the acute episodes, the use of drugs and the number of missed workdays. In the subgroup of allergic patients with RRTI, the number of allergic episodes (AE) and the use of anti-allergic drugs were also evaluated. One hundred and sixty patients, 79 allocated to the treated group (TG) and 81 to the placebo group (PG), were enrolled; 30 were lost during the study and 120 (79 females and 38 males) were evaluated. The PG had 1.43 episodes in the 8-months of follow-up while the TG had 0.86 episodes (p=0.036). A similar result was observed in the allergic patients (1.80 and 0.86 episodes for the PG and the TG, respectively, p=0.047). The use of antibiotics was reduced (mean 1.24 and 2.83 days of treatment for the TG and the PG). Logistic regression analysis indicated that the estimated risk of needing antibiotics and NSAIDs was reduced by 52.1 and 30.6%, respectively. With regard to the number of AE, no significant difference was observed between the two groups, but bronchodilators, antihistamines and local corticosteroids were reduced by 25.7%, 56.2% and 41.6%, respectively, in the TG. Lantigen B significantly reduced the number of infectious episodes in patients with RRTI. This finding suggests a first line use of this drug for the prophylaxis of infectious episodes in these patients.

The importance of preoperative swallowing therapy in subtotal laryngectomies.

OBJECTIVE: To examine the utility of swallowing therapy (ST) before and after surgery in patients undergoing subtotal laryngectomy. STUDY DESIGN AND SETTING: From 1990 to 2000, 43 patients underwent subtotal laryngectomy. Prior to 1997 patients received ST only after surgery, while from 1997 on, patients scheduled for subtotal laryngectomy also received some sessions of ST before surgery. RESULTS: The average time to swallowing resumption was 27.76 +/- 5.206 days for the 25 patients who received ST only after surgery, and 16.38 +/- 2.953 for those who underwent ST both before and after surgery. CONCLUSION: The difference between the two groups was significant on Student's t test (P < 0.001) and shows that preoperative rehabilitation is of significant help in the early resumption of normal deglutition. SIGNIFICANCE: The authors find that the duration of nasogastric tube feeding is reduced in subjects who underwent ST.

Supracricoid laryngectomy: age influence on long-term functional results.

OBJECTIVES/HYPOTHESIS: : Supracricoid laryngectomies (SCL) are conservative surgical techniques for the treatment of selected laryngeal carcinomas, currently adopted also in old patients. Long-term functional results have not been reported in elderly patients. The aim of this study is to compare voice and swallowing in elderly and younger patients following SCL. STUDY DESIGN: : Cross-sectional study. METHODS: : Twenty male patients who underwent SCL were recruited in the study; 10 were younger than 65 years at the time of surgery and 10 were older. Video-endoscopic ratings were taken of neoglottic vibration patterns and bolus transit. Voices were perceptually rated using the GIRBAS scale. The maximum phonation time (MPT) and the syllables diadochokinesis were measured. Spectrograms were recorded. All of the patients completed a self-assessment questionnaire for both voice and swallowing. The data obtained from the two groups were compared through the Mann-Whitney test. RESULTS: : Video-endoscopic ratings of neoglottal vibration and bolus transit showed no difference between the two groups. The perceptual assessment showed a harsh voice in both groups. No significant difference was found for mean syllable diadochokinesis and the mean MPT was 6.3 seconds and 8.8 seconds, respectively in the younger and older group. The mean value of the Yanagihara scale of voice spectrogram was 3.8 and 3.7. Voice and swallowing quality-of-life questionnaires revealed satisfied patients in both age groups. CONCLUSIONS: : Age by itself does not have a significant impact on long-term functional results following SCL. Meticulous selection of the candidate to SCL allows the application of this surgical technique with adequate long-term functional results. Laryngoscope, 2009.

Playing a brass instrument after total laryngectomy: a case report.

BACKGROUND: A brass instrument is a musical instrument in which the tone is produced by vibration of the lips as the player blows into a tubular resonator. The case of a professional brass player who continued his activity after total laryngectomy, with insertion of a voice prosthesis in a tracheoesophageal shunt, is reported. METHODS: A videoendoscopic and videofluoroscopic study of the patient during brass playing was conducted. RESULTS: A nonvibrating, open neoglottis during brass playing was found on videoendoscopy. Videofluorography revealed an enlarged hypopharynx, a thick neoglottis while playing at lower tone; at higher pitch the tongue base was retracted, the neoglottis was thin and stretched, and the subneoglottic area was extremely enlarged. CONCLUSION: The case reported shows that the insertion of a voice prosthesis in a tracheoesophageal shunt seems to create a regulating airflow system sufficiently advanced to play a brass instrument, further reducing the disability of laryngeal speakers.

Association between hypermethylated tumor and paired surgical margins in head and neck squamous cell carcinomas.

PURPOSE: Surgical margin status is reported to be a relevant prognostic factor in head and neck squamous cell carcinoma (HNSCC), associated with a high risk of local recurrence. This study examines whether gene-promoter hypermethylation could be detected in HNSCC surgical margins with no histologic evidence of malignancy, and if so, whether it reflects epigenetic events of primary tumors. EXPERIMENTAL DESIGN: Promoter methylation status of MGMT, p16, and DAP-K genes was evaluated by methylation-specific PCR in 20 primary HNSCC tumors. Histopathologically negative surgical margins of hypermethylated tumors were collected, and their methylation status compared with the primary tumor status. RESULTS: Promoter hypermethylation in at least one of the three tested genes was detected in 65% (13 of 20) of tumors. MGMT was hypermethylated in 50% (10 of 20), DAP-K in 45% (9 of 20), and p16 in 20% (4 of 20) of tumors. Methylation status was analyzed in 35 margins from 11 of 13 patients showing promoter hypermethylation in the tumor tissue. Identical methylation events were seen for at least one gene in primary tumor and surgical margins in 9 of 11 cases (82%). Association was found for gene-specific hypermethylation status in tumors and paired surgical margins, and gene-specific concordance was 63% for MGMT (kappa = 0.24), 90% for DAP-K (kappa = 0.74), and 90% for p16 (kappa = 0.79). CONCLUSIONS: Our results support the hypothesis that detection of gene promoter hypermethylation in HNSCC tumor cells-free surgical margins may be a helpful biomarker to identify molecularly altered fields in areas adjacent to the tumor.

Prognostic impact of HER-2/neu expression on squamous head and neck carcinomas.

BACKGROUND: HER-2/neu gene amplification and protein overexpression have been identified in various solid tumors, but its prognostic relevance in head and neck squamous cell carcinoma (HNSCC) is still controversial. METHODS: The study investigated the expression of HER-2/neu oncoprotein in HNSCC and sought possible correlations to various clinicopathologic parameters. Expression of HER-2/neu oncoprotein was assessed in archival tumor tissues from 87 untreated HNSCC patients by immunohistochemical technique. Data were correlated with both the clinicopathologic parameters and patient survival. RESULTS: A high membranous HER-2/neu protein expression level was found in 39% of patients. Multivariate analysis indicated that HER-2/neu protein expression and pN lymph-node status were independent prognostic factors for disease-free survival. CONCLUSIONS: HER2/neu overexpression and its relationship with survival suggest that new therapeutic approaches targeting epidermal growth factor receptor (EGFR) family receptors could provide a new way of treating HNSCC patients with HER2/neu-positive neoplastic lesions.

Long-term voice and swallowing modifications after supracricoid laryngectomy: objective, subjective, and self-assessment data.

PURPOSE: The supracricoid laryngectomies (SCLs) are conservative surgical techniques for the treatment of selected laryngeal carcinomas. The advantage of SCL is that a permanent tracheostoma is not required, thus, maintaining the principal laryngeal functions. The aim of the study is to report objective, subjective, and self-assessment long-term results of voice and swallowing in a large group of patients who underwent SCL at least 2 years before this study was undertaken. METHODS: Twenty male subjects who underwent SCL with a mean age of 71 years (range, 51-82) were involved in a retrospective study on swallowing and vocal function. Videoendoscopic ratings were taken of neoglottic vibration patterns and bolus transit. The maximum phonation time and the syllable diadochokinesis were measured. Spectrograms were recorded. Voices were perceptually rated using the Grade, Instability, Roughness, Breathiness, Asthenicity, Strain (GIRBAS) scale. All of the subjects completed a self-assessment questionnaire for both voice and swallowing. RESULTS: Videoendoscopic ratings showed moderate to severe impairment of neoglottal vibration, whereas bolus transit appeared only mildly impaired. The mean values of the GIRBAS scale were 2.4, 2.6, 2.4, 0.8, 0.5, and 0.8. The mean maximum phonation time was 7.5 seconds, whereas the mean value of the Yanagihara scale was 3.7 for voice spectrograms. Mean syllable diadochokinesis appeared as 3.3 syllables per second. Voice and swallowing quality of life questionnaires revealed satisfied patients. CONCLUSIONS: Swallowing after SCL was satisfactory; on the contrary, endoscopic, aerodynamic, perceptual, and acoustic data showed a highly dysphonic voice after SCL. However, self-assessment results revealed relatively satisfied speakers on the emotional, physical, and functional levels.

Auditory steady-state responses and clinical applications.

The auditory steady-state responses to single continuous tones modulated in amplitude have been proposed as an alternative to objective frequency-specific audiometry. The aim of this study was to compare thresholds obtained by pure-tone audiometry (PTA) and by auditory steady-state responses in normal hearing or affected by hearing loss in adults and in order to evaluate the applicability of this objective test in no collaborative hearing-impaired subjects. Eleven people, 6 normal hearing and 5 with hearing loss, underwent PTA and multiple frequency auditory steady-state responses; simultaneous carrier tones (0.5, 1, 2 and 4 KHz) modulated in amplitude at different rates (77-105 Hz) were presented monaurally (TDH 49 earphones) at variable intensities (110-20 dB SPL). The mean threshold difference between PTA and multiple frequency auditory steady-state responses was 28 dB (standard deviation=14.2) and R correlation value at 0.5-1-2-4 kHz was 0.71 (P=0.0012) at the Pearson's test. These differences were significantly smaller considering the hearing-impaired separately (11.7 dB, standard deviation=2.9). The results of this study confirm previous reports showing that the multiple auditory steady-state response method is an accurate predictor of the behavioural audiogram in patients with sensory-neural hearing impairments and can be used as a valid support for behavioural evaluations.

Voice quality after carbon dioxide laser and conventional surgery for T1A glottic carcinoma.

The different types of small vocal fold tumor therapy allow the preservation of respiration and deglutition; the quality of phonation is the most important criterion for the patient. The aim of the study is to compare vocal function after treatment of T1a tumors by conventional and laser cordectomy. Fifty-seven male patients were included in the study: 27 underwent conventional cordectomy using an external approach, and 30 underwent an endoscopic microscopic laser cordectomy. Videolaryngoscopy was performed for each subject, and the maximal phonation time was measured. Spectrograms were recorded, and a perturbation analysis was performed if a clear harmonic structure was visible. Voices were perceptually rated by two experienced phoniatricians using the GRBAS scale. Even though a slightly better voice was found after conventional surgery throughout the data, no statistically significant difference was measured in the two groups. The data on voice outcome per se do not indicate the selection of one surgical approach over another.

13-cis retinoic acid in head and neck cancer chemoprevention: results of a randomized trial from the Italian Head and Neck Chemoprevention Study Group.

Patients with squamous cell carcinoma of the head and neck (HNSCC) after being treated radically remain at high risk for both recurrent and second primary tumours. 13-cis retinoic acid (13-cRA) was demonstrated to reverse pre-malignant lesions of the oral cavity and to reduce the incidence of second primary tumours in patients treated radically for HNSCC. Synergism between retinoids and interferon in tumoural cell lines have been demonstrated. Based on these data, the Italian Head and Neck Chemoprevention Study Group started a randomized chemoprevention study in patients radically treated for stage III and IV HNSCC. From February 1992 to January 1996, 267 patients were randomized: 126 were allocated to the control group, 126 were randomized to receive 13-cRA at a dose of 0.5 mg/kg per day per os and 15 patients have been assigned to the group of 13-cRA plus interferon alpha2a (IFN-alpha2a) at a dose of 3,000,000 UI 3 times a week (randomization in this arm interrupted due to administrative financial problems). The mean follow-up was 39 months. The 5-year actuarial survival was 58.9% for patients of the 13-cRA group and 57.2% for those of the control group (P=0.94). Among evaluable patients, disease progression was observed in 45 of 123 patients (36.6%) of the 13-cRA group and in 42 of 124 (33.9%) of the control group. The 5-year actuarial relapse-free survival was 48.9% for the 13-cRA group and 55.6% for the control group (P=0.62). Adverse effects, mostly of grade I were reported in 69.4% of treated patients (haematologic disorders, mucositis, conjunctivitis, cutaneous toxicity, hypertriglyceridemia and hypercholesterolemia). Only 5 patients (4.1%) reported grade III-IV toxicity. Low-dose of 13-cRA given for 1 year is ineffective as chemoprevention in patients with radically treated HNSCC.

Delayed vertigo after stapes surgery.

OBJECTIVES: Stapes surgery restores partial or total hearing in almost 95% of cases, and in case of failure, revision surgery may often resolve the problem. Delayed vertigo is commonly related to perilymphatic fistula. The aim of this study is to report experience gained in revision stapes surgery in cases of delayed vertigo. STUDY DESIGN: This is an intervention study, before-after trial; it includes follow-up between 12 and 84 months that was based on clinical history and audiometric evaluations. METHODS: The work was carried out in the otologic surgery referral center of Piemonte in outpatient surgery. Nine patients (4 males and 5 females, between 43 and 60 years of age) who presented with delayed vertigo after stapes surgery were retrospectively reviewed. All nine underwent clinical history evaluation, pure tone audiogram, investigation of the vestibular system with a bithermal binaural caloric test, and fistula test. Vestibular tests were performed with electronystagmography recording. In all nine subjects, functional middle ear exploration was carried out by way of a transmeatal approach using local anesthesia. The demonstration of a perilymphatic leak was positive in only three (33%) cases, but the oval window region was filled with fibrin glue in all nine cases. RESULTS: At follow-up, vertigo was resolved in all cases with revision surgery, even though perilymph leak was positive only in three cases. CONCLUSION: From the results obtained, we feel that exploration of the middle ear should be always carried out in cases of delayed vertigo after stapes surgery with suspected perilymphatic fistula.

Actinomycosis of the masseter muscle: report of a case and review of the literature.

A rare case of cervicofacial actinomycosis arising primarily in the masseter muscle is described. The patient was a healthy 74-year-old woman who was not immunocompromised and had no other primary pathological finding in the oral cavity. The importance of the differential diagnosis for this unusual infection is demonstrated with tumoral pathological findings. Possible predisposing factors as well as diagnostic and therapeutic methods are discussed.

beta-carotene supplementation in patients radically treated for stage I-II head and neck cancer: results of a randomized trial.

This study was aimed at evaluating the efficacy of beta-carotene in improving survival (S) and in disease-free survival (DFS) and reducing the incidence of second primary tumors (SPT) in patients with a radically treated stage I-II squamous head and neck tumors. Eligible patients were randomly allocated to receive beta-carotene (n=104) or no treatment (n=110). beta-carotene was administered at the dose of 75 mg/day for 3-month cycles within one month intercycle intervals for a 3-year period. The 3-year compliance to the beta-carotene was 68.7%. Only eight patients reported drug-related toxicity (7.8%). The median follow-up of all patients was 59 months. The median follow-up was 61 months (range 1-116 months) in the beta-carotene and 58 months (1-123 months) in the control group. The 10-year DFS was 75.7% for the patients in the beta-carotene and 74.3% for those in the control group (P=0.56). The 10-year S was 85.9% in the beta-carotene group and 80.9% in the control group (P=0.20). beta-carotene supplementation had no significant effect on the incidence of second primary tumors (RR=0.99; 95% C.I. 0.28-3.44). A statistically non-significant 40% reduction in the risk of death among subjects assigned to the beta-carotene compared to the controls was observed (RR=0.60; 95% C.I. 0.26-1.38). No increase in the death from cardiovascular diseases was observed among patients treated with beta-carotene. Our results might support the hypothesis that an adequate beta-carotene treatment could be potentially associated with a decreased risk of death in these patients.

Leiomyosarcoma of the larynx.

Leiomyosarcoma involving the larynx is extremely rare and may be difficult to diagnose. Because of the rarity of this tumor, little information exists on its long-term follow-up and optimal management. We present a review of the literature and report on a patient with leiomyosarcoma of the larynx treated with surgery and postoperative irradiation. In addition, the diagnosis and treatment of leiomyosarcoma are discussed. At six months' follow-up the patient showed no signs of local recurrence but had developed metastases to both lungs.