Postoperative infections following cochlear implant surgery.

INTRODUCTION: The aim of this study was to report the frequency and management of postoperative wound infections and to investigate bacteriology and biofilm formation following 653 consecutive cochlear implantations in adults. METHODS: A retrospective file review of 653 consecutive adult cochlear implantations between 1994 and 2015 at the Department of Otorhinolaryngology at Odense University Hospital. A reporting consensus was used to classify infections. RESULTS: The major and minor infection rates were 2% and 8%, respectively. The explantation rate due to infection was 1%. The most common pathogen found was Staphylococcus aureus and biofilm formation was found in 73% of the explantations. CONCLUSION: Postoperative infection occurred in 10% of the implantations. However, few of these were severe. Staphylococcus aureus was the most common pathogen and the presence of biofilm seemed to be associated with a higher risk of explantation.

Refixation Saccades with Normal Gain Values: A Diagnostic Problem in the Video Head Impulse Test: A Case Report.

Refixation saccades with normal gain value occur more frequently with increasing age. The phenomenon has also been observed in different vestibular disorders. In this case, we present a young male with normal gain value and refixation saccades tested with the video head impulse test (vHIT) the day after his cochlear implantation. One month after surgery, refixation saccades were no longer present. This suggests that refixation saccades can occur as a result of temporary pathology such as surgery. Refixation saccades with normal gain values might reflect a partial deficit in the vestibulo-ocular reflex. However, this partial deficit is in conflict with the current way of interpreting vHIT results in which the vestibular function is classified as either normal or pathological based only on the gain value. Refixation saccades, which are evident signs of vestibulopathy, are not considered in the evaluation. A new way of interpreting the vHIT based on the saccades must be considered.

Bone-anchored hearing aids are effective and associated with a high degree of satisfaction.

INTRODUCTION: The objective of this study was to evaluate patients' satisfaction with bone-anchored hearing aids (BAHA). METHODS: This study was retrospective and based on a postal questionnaire. The study sample consisted of patients undergoing surgery at Odense University Hospital in the 1992-2013-period. The questionnaire was a combination of Satisfaction with Amplification in Daily Life questions from the Hearing Aid Research Lab at the University of Memphis and questions used in a previous Danish study. We also used data from each patient's medical records. All information was collected in a database. RESULTS: The response rate was 80% and the user percentage 88. The majority of the patients used their BAHA seven days a week and most of the day. 88% reported that it was in their best interest that they had received a BAHA. 80% of the respondents were able to communicate better using their BAHA in one-on-one conversations. CONCLUSION: BAHA is helpful in one-on-one conversations in quiet surroundings. Sound quality in group situations seems to be the main problem associated with BAHA. However, this study showed that BAHA is an effective hearing aid that is associated with a high degree of satisfaction. FUNDING: not relevant. TRIAL REGISTRATION: not relevant.

The impact of ventilation tubes in otitis media on the risk of cholesteatoma on a national level.

OBJECTIVE: To estimate the impact of treatment with middle ear ventilation tube insertion (VTI) in children with otitis media (OM) on the risk of cholesteatoma on a national level. METHODS: Data were obtained from the Danish National Patient Register, the National Health Service Register and Statistics Denmark. Cumulative incidence proportions were estimated by the Kaplan-Meier method and hazard ratios with Cox regression analysis. The first surgically treated middle ear cholesteatoma in a child (STMEC1) was considered an event. RESULTS: A total of 217,206 children, born after December 31, 1996, who had VTI from January 1, 1997 to August 31, 2011 were identified. Of these, 374 subsequently had a STMEC1. A corresponding 36,981 children without any VTI were identified for comparison using a random 5% sample of the Danish population. Of these, 5 had a STMEC1. The cumulative incidence proportion with STMEC1 at 12 years of age for children with 0, 1, 2, 3, and ≥4 VTI's was 0.04% (95% confidence interval 0.02-0.12%), 0.21% (0.18-0.26%), 0.35% (0.28-0.43%), 0.40% (0.30-0.54%), and 0.55% (0.44-0.70%), respectively. In the regression model each additional year of age before the first VTI increased the risk of STMEC1 by 54% (47-63%), while each additional year between two successive tube insertions increased the risk by 28% (15-43%). CONCLUSION: We found that prolonged OM requiring multiple VTIs was associated with an increased risk of STMEC1. Early age at first VTI and short time between two VTIs was associated with a lower risk of STMEC1. This may be the result of reduced time with negative middle ear pressure and OM. However, these findings may be susceptible to selection bias, as age at first VTI and time between VTIs, as well as the outcome variable, STMEC1, may all depend on the underlying indication for VTI. In short the present study suggests that treatment with VTI in children with OM reduces the risk of STMEC1 on a population level. However, for the individual child the absolute risk reduction is very small, and the decision of treatment with VTI must always rely on the symptoms and clinical findings in the individual child.

Changes in salivary secretion and sense of taste following cochlear implantation: a prospective study.

CONCLUSION: A set of methods for evaluating changes in salivary secretion and sense of taste following cochlear implantation (CI) was applied and tested. No association between implantation and objectively assessed sense of taste was found. However, a statistically significant decrease in non-stimulated salivary flow on the day after surgery was found. OBJECTIVES: To develop and test a research method describing the course of changes in salivary secretion and sense of taste following CI. METHODS: This was a longitudinal study examining 13 patients undergoing CI at Odense University Hospital in 2012. Questionnaires, sialometry and gustatory testing were applied. RESULTS: A general postoperative decrease in salivary secretion could not be found. However, a 29.9% mean reduction in non-stimulated salivary flow was observed when looking specifically at the visit the day after surgery (p = 0.001). When adjusting for perioperative administration of glycopyrrolate (p < 0.001) and atropine (p = 0.178), the former was highly associated with a 69.7% mean decrease in non-stimulated salivary flow at the visit the day after surgery. The third examination was still, independent of glycopyrrolate administration, borderline significantly associated with a 14.5% mean decrease (p = 0.054). We did not find any significant decrease in sense of taste following implantation.

Quality-of-Life Differences among Diagnostic Subgroups of Children Receiving Ventilating Tubes for Otitis Media.

OBJECTIVE: The pathological picture may differ considerably between diagnostic subgroups of children with otitis media receiving ventilating tubes. The aims of this study are to investigate differences in quality of life among diagnostic subgroups of children treated with ventilating tubes and to investigate possible predictors for clinical success. STUDY DESIGN: Longitudinal observational study. SETTING: Secondary care units. METHODS: Four hundred ninety-one families were enrolled in the study. The Otitis Media-6 questionnaire was applied in the assessment of child quality of life. Caregivers completed questionnaires at 7 time points from before treatment to 18-month follow-up. Logistic regression analysis was used to investigate possible predictors for clinical success. RESULTS: Response rates ranged from 96% to 81%; diagnostic distribution: 15% recurrent acute otitis media (rAOM), 47% otitis media with effusion (OME), and 38% mixed diagnosis of rAOM and OME (rAOM/OME). There were no significant differences between children diagnosed with rAOM and children diagnosed with rAOM/OME. However, these children had a significantly poorer quality of life at baseline compared with children diagnosed with only OME. Factors associated with clinical success included a diagnosis of rAOM, number of interrupted nights, physician visits, and canceled social activities due to OM. CONCLUSIONS: Results highlight the importance of distinguishing between diagnostic subgroups of children having ventilating tube treatment. A diagnosis of rAOM was found to predict baseline quality of life. Children with rAOM with or without OME were found to suffer significantly more than children with only OME before treatment. Factors associated with disease severity were found to predict clinical success.

Cholesteatoma in Danish children - a national study of changes in the incidence rate over 34 years.

OBJECTIVE: To describe temporal trends in the incidence rate of surgically treated middle ear cholesteatoma in Danish children from 1977 to 2010. METHODS: Data on surgically treated middle ear cholesteatoma was drawn from the Danish National Patient Register. A change in incidence rate over time was examined using Poisson regression analysis, while the cumulative incidence proportion was estimated using life-tables. RESULTS: A total of 5850 cases of surgically treated middle ear cholesteatoma distributed among 3874 children aged 0-15 years were identified. From 1977 to 2002 the age-standardized incidence rates for first-time surgically treated middle ear cholesteatoma increased from 8 to 15 per 100,000 person-years with an estimated annual increase of 1.8% (95% confidence interval (CI) 1.3-2.2%). From 2002 to 2010 the rates decreased from 15 to 10 per 100,000 person-years with an annual decrease of 5.4% (95% CI 3.2-7.5%). Age-specific incidence rates were at maximum around the age of 9 years during the whole period. The estimated cumulative incidence proportion at age 16 years based on the 2010 age-specific incidence rates was 0.16% (95% CI 0.09-0.32%) compared with 0.20% (95% CI 0.11-0.37%) based on the 2000 age-specific incidence rates. CONCLUSION: From 2002 to 2010 there was a decrease in the incidence rate of first-time surgically treated middle ear cholesteatoma. The decrease was preceded by a significant increase in the incidence rate of middle ear ventilation tube insertion. However, further studies are needed to find possible explanations for the decrease.

Increasing rate of middle ear ventilation tube insertion in children in Denmark.

OBJECTIVE: To study the incidence rates of middle ear ventilation tube insertion in children aged 0 to 15 years in Denmark from 1997 to 2010. METHODS: Using two national registers, the Danish National Health Service Register and the Danish National Patient Register, practically all cases of middle ear ventilation tube insertion performed in Denmark in the period were identified. A possible change in incidence rate over time was examined using Poisson regression analysis, while the cumulative incidence proportion was estimated using life-tables. RESULTS: A total of 502,569 uni- or bilateral ventilation tube insertions distributed among 269,459 different children were identified. From 1997 to 2010 the age standardized incidence rate in 0-15-year-olds increased from 26 to 40 per 1000 person years with an estimated annual increase of 2.0% (95% confidence interval 1.9-2.1%). The largest increase in incidence rate was found in 1-year-olds with an annual increase of 4.5% (95% confidence interval 4.4-4.6%). Age-specific incidence rates remained at maximum around the age of 14 months throughout the period. The cumulative incidence proportion for the 2010 birth cohort by the time they reach the age of 5 years was estimated to 29% (95% confidence interval 28-29%). CONCLUSION: The rate for middle ear ventilation tube insertion in Denmark was high compared to other developed countries, and an estimated 3 in 10 children born in 2010 will undergo at least one ventilation tube insertion before their fifth birthday.

Caregiver Quality of Life and Daily Functioning in Relation to Ventilating Tube Treatment.

OBJECTIVE: Caregiver quality of life and daily functioning may improve after ventilating tube treatment in children with otitis media. The aims of this study are to assess possible changes in caregiver quality of life and daily functioning in relation to ventilating tube treatment and to investigate possible predictors for clinical success. STUDY DESIGN: Longitudinal observational study. SETTING: Secondary care units. METHODS: Four hundred ninety-one families were enrolled in the study. The Caregiver Impact Questionnaire was applied in the assessment of caregiver quality of life. Caregivers completed questionnaires at baseline and at 1, 3, 6, 12, and 18 months' follow-up. Variables on caregiver daily functioning comprised 4 weeks' history of number of interrupted nights, absenteeism, cancelled social activities, and doctor visits as a result of otitis media in the child. RESULTS: Response rates ranged from 96% to 79%. Significant improvements in disease-specific quality of life were seen after treatment. The poorest baseline quality of life was found in caregivers of children with recurrent acute otitis media. Significant improvements were found on all variables on daily functioning. Predictors for caregiver-perceived clinical success included child sex, number of interrupted nights, doctor visits, absenteeism, and cancelled social activities. CONCLUSION: Results of this study support the notion that caregivers of children with otitis media with defined surgical indications improve their quality of life and daily functioning after ventilating tube treatment. Factors related to caregiver functioning and disease severity were found to be associated with caregivers experiencing important improvements after treatment.

Otitis Media and Caregiver Quality of Life: Psychometric Properties of the Modified Danish Version of the Caregiver Impact Questionnaire.

OBJECTIVE: Otitis media in children may have a considerable impact on caregiver quality of life. The disease-specific Caregiver Impact Questionnaire is designed to assess caregiver quality of life in relation to child otitis media. Assessment of the psychometric properties of this instrument is limited. This study assesses the psychometric properties of this instrument including validity, reproducibility, responsiveness, and interpretability. STUDY DESIGN: Longitudinal validation study. SETTING: Secondary care units. METHODS: Analyses were based on data from 435 families. Validity was assessed using confirmatory factor analysis, internal consistency, and hypothesis testing. Test-retest reliability and measures of smallest detectable change were investigated in the assessment of reproducibility. Responsiveness was investigated by means of hypothesis testing and receiver operating characteristic analysis. An anchor-based distribution method was applied for determining minimal important change as perceived by the respondent. RESULTS: Factor analysis confirmed the hypothesized 1-factor structure with an acceptable fit. Cronbach's alpha was .90. In the analysis of construct validity, 88.9% of the hypothesized correlations were correctly predicted. Intraclass correlation coefficient was 0.87 and smallest detectable change corresponded to approximately one-fourth of the scale. Responsiveness was found to be good and a change score of 13.8 represented minimal important change. CONCLUSION: The modified Danish version of the Caregiver Impact Questionnaire is a valid and reproducible measurement tool that is also sensitive to measuring change in the current setting. A change score representing minimal important change as perceived by the respondent is proposed. Results of this study support the use of this instrument.

The Otitis Media-6 questionnaire: psychometric properties with emphasis on factor structure and interpretability.

BACKGROUND: The Otitis Media-6 questionnaire (OM-6) is the most frequently used instrument to measure health related quality of life in children with otitis media. The main objectives of this study are 1) to translate and cross-culturally adapt the OM-6 into Danish, and 2) to assess important psychometric properties including structural validity and interpretability of the OM-6 in a Danish population of children suffering from otitis media. METHODS: The OM-6 was translated and cross-culturally adapted according to international guidelines. A longitudinal validation study enrolled 491 children and their families, and the measurement properties of the OM-6 were evaluated using the Cosmin taxonomy. The properties assessed were construct and structural validity (confirmatory factor analysis) including internal consistency, reproducibility (test-retest reliability and smallest detectable change), responsiveness and interpretability. RESULTS: A total of 435 children were eligible to participate in the study. Analyses of structural validity and internal consistency indicated that parent appraisal of hearing and speech problems may be problematic. Both scales showed similarly good test-retest reliability and construct validity, were able to discriminate between diagnostic subgroups and responsive to change. Cut-off values of 16.7 and 30.0 were found to represent minimal important change for the patients. CONCLUSIONS: The Danish version of the OM-6 is a reliable, valid, responsive and interpretable questionnaire to measure quality of life in children with otitis media. This study sheds light on possible weaknesses of the instrument that needs to be acknowledged in the utilization of the instrument. However, despite these issues our results support the continuing use of OM-6 as a 1-factor functional health scale with a separate global health rating. Furthermore, indications of values representing minimal important change as perceived by the respondent are presented.

Bronchoschopy should always be performed in children on suspicion of foreign body aspiration.

INTRODUCTION: Foreign body aspiration (FBA) can have a fatal outcome, and the diagnosis is challenging since symptoms and signs may vary. We therefore investigated whether it was possible to identify predictors indicating the presence of a foreign body. MATERIAL AND METHODS: The medical records of children undergoing bronchoscopy at Odense University Hospital for suspected FBA in the period from 1977 to 2010 were reviewed and analyzed. RESULTS: A total of 143 children underwent bronchoscopy due to suspected FBA. The medical records of 137 of these children were accessible. Their median age was 1.84 years, 62.8% were male and foreign bodies were found in 76 cases (55.5%). The only variable that statistically significantly predicted the presence of a foreign body was a radiologic finding (any abnormal chest X-ray or fluoroscopy) (p = 0.023). A foreign body was found in 22 out of 47 (46.8%) patients with no radiologic findings and in three of 11 (27%) patients with neither symptoms at admission nor radiologic or physical findings. CONCLUSION: Parental suspicion of an FBA indicates acute bronchoscopy in children regardless of signs, symptoms and findings.

Surgical complications following cochlear implantation in adults based on a proposed reporting consensus.

CONCLUSION: The rate of severe complications was low and cochlear implantation is a relatively safe procedure. Standardization is crucial when reporting on cochlear implant complications to ensure comparability between studies. A consensus on the reporting of complications proposed by a Danish team of researchers was applied, evaluated and found beneficial. OBJECTIVES: To report the surgical complications following cochlear implantation at our centre, applying and evaluating a proposed reporting consensus. METHODS: A retrospective file review of 308 consecutive adult implantations in 269 patients between 1994 and 2010 at Odense University Hospital was performed. RESULTS: The three most common major complications were wound infection (1.6%), permanent chorda tympani syndrome (1.6%) and electrode migration/misplacement/accidental removal (1.3%). Permanent facial nerve paresis occurred following one implantation (0.3%). Transient chorda tympani syndrome (30.8%), vertigo/dizziness (29.5%) and tinnitus (4.9%) were the most frequent minor complications.

Validation of the cholesteatoma diagnosis in the Danish National Hospital Register.

INTRODUCTION: The aim was to evaluate the validity and the degree of completeness of the cholesteatoma diagnosis in the Danish National Hospital Register (DNHR). VALIDITY: A random sample of 286 patients with a cholesteatoma diagnosis who had been admitted to an ear-nose-throat department on Funen between 1977 and 2007 were selected from the DNHR for validation. The diagnosis was verified on the basis of surgical chart review. Completeness: The DNHR was compared with the local Ear-database at Odense University Hospital (EDOUH) covering the 1996-2007 period. VALIDITY: A total of 273 patients had 422 registrations of a cholesteatoma diagnosis combined with relevant surgery (CWRS). The remaining 13 of the initially 286 selected patients had a cholesteatoma diagnosis, but without relevant surgery. Surgical charts could be retrieved for 262 patients with 401 registrations. The positive predictive value (PPV) of the CWRS in the DNHR was 85.8%. When only the first-time patients with CWRS were recorded, the PPV was 89.3%. Completeness: A total of 329 cases of surgery were recorded in the DNHR, the EDOUH or both. Surgical charts could be retrieved for 322. The diagnosis was confirmed for 277. Based on the confirmed cases, the degree of completeness of the CWRS in the DNHR was estimated to 91.0%. When only the first-time patients were included, the degree of completeness was estimated to 89.3%. CONCLUSION: Misclassification of the first CWRS in the NHR was close to 10%, and the DNHR may be considered a useful tool for epidemiological research on cholesteatoma.

Decreasing incidence rate for surgically treated middle ear cholesteatoma in Denmark 1977-2007.

INTRODUCTION: The objective was to estimate the annual incidence rate of surgically treated middle ear cholesteatoma (STMEC) in Denmark from 1977 to 2007, taking age, gender and secular trends into consideration. MATERIAL AND METHODS: We used the Danish National Hospital Register to identify all registered cases of STMEC in Denmark between 1977 and 2007. Only the first registration of STEMC (STEMC1) was used for estimation of the annual incidence rate. RESULTS: A total of 13,606 cases of STMEC1 were identified. The highest incidence rates were seen in the beginning of the eighties with a maximum male incidence rate of 14.3 per 100,000 person-years in 1982 and a maximum female incidence rate of 9.1 per 100,000 person-years in 1981. In 2007 the incidence rate per 100,000 person-years was 8.5 for males and 5.4 for females. The age-specific incidence rate peaked at approx. nine years for both males and females with incidence rates of 21.4 and 13.6 per 100,000 person-years, respectively. The male:female incidence rate ratio was 1.51. CONCLUSION: The incidence rate of STMEC1 in Denmark showed a statistically significant decrease from 1977 to 2007. A male predominance was found. The age-specific incidence rate peaked at the age of approx. nine years. Further studies are required to perform a detailed analysis of factors that may influence the incidence rate of STMEC1, e.g. the incidence of grommet insertion and adenoidectomy, antibiotic treatment of middle ear infections and an expanding use of otomicroscopy in the early 1980s.

[Vocal fold palsy--etiology and outcome]. / Stemmebåndsparese--aetiologi og forløb.

INTRODUCTION: The etiology of vocal fold palsy (VFP) is varied, and both Danish and foreign studies report variable frequencies of causes. We have evaluated etiologies of both unilateral (UVFP) and bilateral palsy (BVFP) and also analyzed the outcome of the palsies. As far as we know, our material is the largest published in Danish. MATERIAL AND METHODS: From 01.01.2000 to 30.06.2004 229 patients with VFP were evaluated in the ENT department of Odense University Hospital. We reviewed medical records and registered and analyzed data regarding etiology and outcome. RESULTS: Trauma caused 39% of all cases and was thereby the most common etiology of VFP. 27% of the cases were idiopathic. Cancer caused 22% of all cases, most frequent for left-sided UVFP, but also a substantial number of right-sided and bilateral cases were due to malignancy. Neurological disease caused 18% of BVFP but only 1% of UVFP. The outcome of the palsy depended on the etiology. VFP caused by malignancy only rarely recovered. Chances of recovery were greatest for idiopathic VFP or palsy caused by neurological disease, but also a large proportion of traumatic VFP recovered. CONCLUSION: In a large patient population from Funen we found that trauma was the most common cause of VFP. Malignancy also frequently caused VFP. The outcome depended on the etiology. This is important when informing patients.

[Vocal fold palsy--investigation and follow-up]. / Stemmebåndsparese--udredning og opfølgning.

INTRODUCTION: A new protocol for investigation of vocal fold palsy (VFP) was introduced in the ENT-department, Odense University Hospital on 1 January 2002. The protocol included ultrasonography (US) of the neck, x-ray of the chest and clinical examination at 3-month intervals for 1 year as well as MRI scanning of the brainstem, neck and mediastinum initially and after 6 months (or CT scanning under special circumstances). We have evaluated our protocol for investigation and in particular with regard to efficiency of diagnostic methods and the effect of long-term follow-up. MATERIAL AND METHODS: From 1 January 2002 to 30 June 2002 we investigated 48 patients with VFP of occult origin in our department. We reviewed medical records and registered and analyzed data regarding efficiency of diagnostic methods and the effect of follow-up. RESULTS: Ten out of 48 VFP (21%) proved to be caused by malignancy. Eight VFP had other causes and 30 were idiopathic. Nine out of ten malignant diseases were found during initial investigation. One patient was diagnosed with breast cancer and widespread metastases 10 months after initial investigation. CONCLUSION: An extensive protocol for investigation of VFP is indicated. In our opinion, a protocol should include US, CT or MRI scanning of brainstem, neck and mediastinum. Our material is too limited to draw any final conclusions concerning long-term follow-up.

[Assessment of thyroplasty for vocal fold paralysis]. / Monitorering af operativ behandling af stemmebåndsparese ved tyroplastik.

INTRODUCTION: Thyroplasty with silicone rubber implantation is a surgical procedure for treatment of patients with vocal fold paralysis. The aim of the present study was to evaluate the outcome of the operation and to monitor which of the analyses were the more beneficial. MATERIAL AND METHODS: Twenty consecutive patients were enrolled in the study. To assess the treatment, videostroboscopic evaluation was performed and maximal phonation time was measured. A phonetogram was recorded to evaluate voice capacity and intensity, and a voice quality analysis was performed using the Multi-Dimensional Voice Program. Furthermore, patients answered the Voice Handicap Index (VHI) questionnaire. RESULTS: The capacity and intensity of the voice were significantly increased with an improvement of the highest intensity of 13 dB. The capacity of the voice was increased more than 2.5 times. The voice quality was improved significantly as measured by the jitter percentage, shimmer percentage and voice turbulence index. The VHI was decreased by 40, from a mean preoperative value of 82. A total of 90% of patients were satisfied. CONCLUSION: Besides videostroboscopy, a phonetogram is the most important analysis because it offers a quantitative measure of the voice capacity and intensity, which are the major problems experienced by patients with vocal fold paralysis. Used together, these tools are highly instrumental in guiding the patient's choice of surgery or no surgery.