The effect of intratympanic gentamicin as a prehabilitation strategy for objective and subjective vestibular function in patients undergoing microsurgery for a unilateral vestibular schwannoma.

OBJECTIVE: To review the literature on intratympanic gentamicin treatment as prehabilitation for patients undergoing surgery for a unilateral vestibular schwannoma. DATA SOURCES: A systematic literature search was conducted up to March 2023 in Pubmed, Embase, Cochrane, Web of Science, Academic Search Premier, Google Scholar and Emcare databases. REVIEW METHODS: Articles on the effect of intratympanic gentamicin followed by vestibular schwannoma surgery were reviewed. Data on objective vestibular function and subjective outcomes were compiled in tables for analysis. Relevance and methodological quality were assessed with the methodological index for non-randomized tool. RESULTS: A total of 281 articles were identified. After screening and exclusion of duplicates, 13 studies were reviewed for eligibility, of which 4 studies could be included in the review. The posturography test, the subjective visual horizontal test, and the optokinetic nystagmus test showed decreased vestibular function in the group of patients who received intratympanic gentamicin before microsurgery compared to the group of patients without gentamicin. Other objective tests did not show significant differences between patient groups. Subjective vestibular outcomes, as evaluated by questionnaires on quality of life and/or dizziness, did not seem to improve from intratympanic gentamicin pretreatment. CONCLUSION: Vestibular schwannoma patients who received intratympanic gentamicin before surgical resection of the tumor performed better in the posturography test, subjective visual horizontal test, and the optokinetic nystagmus test afterwards. However, studies that also evaluated subjective outcomes such as dizziness, anxiety, depression, and balance self-confidence did not show a positive effect of intratympanic gentamicin on the vestibular complaints and symptoms.

Glottic insufficiency caused by vocal fold atrophy with or without sulcus: systematic review of outcome measurements.

PURPOSE: Identifying outcome measurements instruments (OMIs) to evaluate treatment efficacy in patients with vocal fold atrophy and/or sulcus. METHODS: Systematic review of records published before March 2021 by searching Pubmed and EMBASE. Included studies reported on adults (> 18 year) with dysphonia caused by glottic insufficiency due to vocal fold atrophy with or without sulcus, who were enrolled into a randomized controlled trial, a non-randomized controlled trial, a case-controlled study or a cohort study. All included studies described an intervention with at least one outcome measurement. RESULTS: A total of 5456 studies were identified. After removing duplicates, screening title and abstract and full text screening of selected records, 34 publications were included in final analysis. From these 50 separate OMIs were recorded and categorized according to the ELS protocol by DeJonckere et al. (Eur Arch Otorhinolaryngol 258: 77-82, 2001). With most OMIs being used in multiple studies the total number of OMIs reported was 265. Nineteen (19) individual OMIs accounted for 80% of reports. The most frequently used OMIs according to category were: VHI and VHI-10 (subjective evaluation); G of GRBAS (perceptual evaluation); F0, Jitter and Shimmer (acoustic evaluation); MPT and MFR (aerodynamic evaluation) and glottic closure and mucosal wave (endoscopic evaluation). Of these OMIs VHI had a high percentage of significance of 90%. CONCLUSION: This systematic review identifies the most used OMIs in patients with glottic incompetency due to vocal fold atrophy and/or sulcus as a step toward defining a Core Outcome Set (COS) for this population. PROSPERO REGISTRATION: 238274.

The Diagnostic Value of Multifrequency Tympanometry in Patients with Ménière's Disease: A Prospective Analysis.

INTRODUCTION: Diagnosing Ménière's disease (MD) by its characteristics such as episodes of vertigo, fluctuating hearing loss, and tinnitus with aural fullness remains challenging. Available tests evaluating the presence of endolymphatic hydrops (EH) are often expensive or time assuming. An in-office quick and simple non-invasive diagnostic test is multifrequency tympanometry (MFT). It can measure conductance at 2 kHz probe tones, which was demonstrated to reflect variations in cochlear pressure. Previous studies investigating MFT as a diagnostic test for MD showed conflicting outcomes possibly biased by their retrospective design. METHODS: We prospectively collected MFT results (Y width) in patients with dizziness and compared MFT test results in affected (group 1) and unaffected (group 2) ears of 37 MD subjects and in control ears of 33 non-MD subjects (group 3). RESULTS: The mean value of the Y width in affected ears was 315.6 ± 70.2 daPa compared to 292.3 ± 98.6 daPa in unaffected ears in MD subjects and 259.4. ± 60.6 daPa in the non-MD group. A positive test result (i.e., a Y width of 235 daPa or more) was found in 35 ears in the MD group, 21 times involving the affected ear and 14 times involving the unaffected ear, compared to 16 in the non-MD group. No significant differences between the three groups could be demonstrated (p > 0.05). We found a sensitivity of 58.3% and specificity of 66.3% for detecting EH in an affected ear in MD subjects. CONCLUSION: There is a trend towards increased conductance tympanometry in affected ears. However, we noticed a high false positive rate of MFT and do not support standardized use of MFT as an additional diagnostic tool for detecting EH in MD patients. A negative test result on the contrary is unlikely related to EH.

The diagnostic accuracy of spirometry as screening tool for adult patients with a benign subglottic stenosis.

BACKGROUND: There is a considerable diagnostic delay in the diagnosis 'benign acquired subglottic stenosis in adults' (SGS, diagnosed by the reference standard, i.e. laryngo- or bronchoscopy). Patients are frequently misdiagnosed since symptoms of this rare disease may mimic symptoms of 'asthma.' The 'Expiratory Disproportion Index' (EDI) obtained by spirometry, may be a simple instrument to detect an SGS-patient. The aim of this study was to evaluate the diagnostic accuracy of the EDI in differentiating SGS patients from asthma patients. METHODS: We calculated the EDI from spirometry results of all SGS-patients in the Leiden University Medical Center (LUMC), who had not received treatment 2 years before their spirometry examination. We compared these EDI results with the EDI results of all true asthma patients between 2011 and 2019, who underwent a bronchoscopy (exclusion of SGS by laryngo- or bronchoscopy). RESULTS: Fifty patients with SGS and 32 true asthma patients were included. Median and IQR ranges of the EDI for SGS and asthma patients were 67.10 (54.33-79.18) and 37.94 (32.41-44.63), respectively. Area under the curve (ROC) of the accuracy of the EDI at discriminating SGS and asthma patients was 0.92 (95% CI = 0.86-0.98). The best cut-off point for the EDI was > 48 (i.e. possible upper airway obstruction), with a sensitivity of 88.0%% (95%CI = 77.2-95.0%%) and specificity of 84.4% (95%CI = 69.4-94.1%). CONCLUSIONS: The EDI has a good diagnostic accuracy discriminating subglottic stenosis patients from asthma patients, when compared to the reference standard. This measurement from spirometry may potentially shorten the diagnostic delay of SGS patients. Further studies are needed to evaluate clinical reproducibility.

Betahistine in Ménière's Disease or Syndrome: A Systematic Review.

BACKGROUND: Ménière's disease is characterized by recurrent episodes of vertigo, hearing loss, and tinnitus, often with a feeling of fullness in the ear. Although betahistine is thought to be specifically effective for Ménière's disease, no evidence for a benefit from the use of betahistine exists, despite its widespread use. Reassessment of the effect of betahistine for Ménière's disease is now warranted. SEARCH METHODS: We searched for randomized controlled trials (RCTs) in the Central Register of Controlled Trials (CENTRAL), Ovid Medline, Ovid Embase, CINAHL, Web of Science, Clinicaltrials.gov, ICTRP, and additional sources for published and unpublished trials, in which betahistine was compared to placebo. DATA COLLECTION AND ANALYSIS: Our outcomes involved vertigo, significant adverse effect (upper gastrointestinal discomfort), hearing loss, tinnitus, aural fullness, other adverse effects, and disease-specific health-related quality of life. We used GRADE to assess the quality of the evidence. MAIN RESULTS: We included 10 studies: 5 studies used a crossover design and the remaining 5 were parallel-group RCTs. One study with a low risk of bias found no significant difference between the betahistine groups and placebo with respect to vertigo after a long-term follow-up period. No significant difference in the incidence of upper gastrointestinal discomfort was found in 2 studies (low-certainty evidence). No differences in hearing loss, tinnitus, or well-being and disease-specific health-related quality of life were found (low- to very low-certainty of evidence). Data on aural fullness could not be extracted. No significant difference between the betahistine and the placebo groups (low-certainty evidence) could be demonstrated in the other adverse effect outcome with respect to dull headache. The pooled risk ratio for other adverse effect in the long term demonstrated a lower risk in favor of placebo over betahistine. CONCLUSIONS: High-quality studies evaluating the effect of betahistine on patients with Ménière's disease are lacking. However, one study with low risk of bias found no evidence of a difference in the effect of betahistine on the primary outcome, vertigo, in patients with Ménière's disease when compared to placebo. The main focus of future research should be on the use of comparable outcome measures by means of patient-reported outcome measures.

Response rate of patient reported outcomes: the delivery method matters.

BACKGROUND: Patient Reported Outcomes (PROs) are subjective outcomes of disease and/or treatment in clinical research. For effective evaluations of PROs, high response rates are crucial. This study assessed the impact of the delivery method on the patients' response rate. METHODS: A cohort of patients with a unilateral vestibular schwannoma (a condition with substantial impact on quality of life, requiring prolonged follow-up) was assigned to three delivery methods: email, regular mail, and hybrid. Patients were matched for age and time since the last visit to the outpatient clinic. The primary outcome was the response rate, determinants other than delivery mode were age, education and time since the last consultation. In addition, the effect of a second reminder by telephone was evaluated. RESULTS: In total 602 patients participated in this study. The response rates for delivery by email, hybrid, and mail were 45, 58 and 60%, respectively. The response rates increased after a reminder by telephone to 62, 67 and 64%, respectively. A lower response rate was associated with lower level of education and longer time interval since last outpatient clinic visit. CONCLUSION: The response rate for PRO varies by delivery method. PRO surveys by regular mail yield the highest response rate, followed by hybrid and email delivery methods. Hybrid delivery combines good response rates with the ease of digitally returned questionnaires.

Changes in healthcare utilisation for paediatric tonsillectomy and adenoidectomy in the Netherlands: a population-based study.

OBJECTIVES: Tonsillectomy and adenoidectomy in children are controversial subjects with large regional variation in surgical rates, partly explained by cultural differences and lack of high-quality evidence on indications for surgery. A quality of care cycle was executed on this topic in the Netherlands. The objective of this study was to estimate changes in healthcare utilisation for paediatric tonsil surgery in the Netherlands. METHODS: Population-based data on tonsillectomies and adenoidectomies in children up to age 10 were retrieved retrospectively from Dutch administrative databases between 2005 and 2018. A change point analysis was performed to detect the most pivotal change point in surgical rates. We performed univariate analyses to compare surgical patients' characteristics before and after the pivotalpoint . Impact on healthcare budget and societal costs were estimated using current prices and data from cost-effectiveness analyses. RESULTS: The annual number of adenotonsillectomies reduced by 10 952 procedures (-39%; from 129 per 10 000 children to 87 per 10 000 children) between 2005 and 2018, and the number of adenoidectomies by 14 757 procedures (-49%; from 138 per 10 000 children to 78 per 10 000 children). The most pivotal change point was observed around 2012, accompanied by small changes in patient selection for surgery before and after 2012. An estimated €5.3 million per year was saved on the healthcare budget and €10.4 million per year on societal costs. CONCLUSION: The quality of care cycle resulted in fewer operations, with a concomitant reduction of costs. We suggest that part of these savings be invested in new research to maintain the quality of care cycle.

Bilateral medialization thyroplasty in patients with vocal fold atrophy with or without sulcus.

PURPOSE: To evaluate voice outcome after bilateral medialization thyroplasty in patients with non-paralytic glottic insufficiency due to vocal fold atrophy with or without sulcus. METHODS: Retrospective cohort study on 29 patients undergoing bilateral medialization thyroplasty for vocal fold atrophy (14 procedures) or atrophy with sulcus (15 procedures) between October 2012 and November 2017. Voice data were collected and analyzed for the preoperative and the 3- and 12-month postoperative time point according to a standardized protocol, including Voice Handicap Index (VHI)-30 and perceptual, acoustic and aerodynamic parameters. Failure rate was based on number of revisions within 12 months and non-relevant improvement (< 10 points) in VHI-30 at 12 months. RESULTS: There was a clinically relevant (≥ 15 points) and statistically significant improvement (p < 0.0001) in the VHI-30 (preoperative: 55.8 points; postoperative at 12 months: 30.9 points). Fundamental frequency for male subjects decreased significantly from 175 to 159 Hz (p = 0.0001). The pre- and post-operative grade of dysphonia was significantly lower in patients with atrophy compared to atrophy and sulcus (mean difference 0.70, p = 0.017). CONCLUSION: Bilateral medialization thyroplasty is a valid treatment option for patients with atrophy with or without sulcus. Outcomes are comparable to other methods reported in literature. However, there is a great need for larger, prospective studies with long-term follow-up to gain more insight into the comparative voice outcomes for the different forms of surgery for patients with glottic incompetence due to atrophy with or without sulcus.

Bilateral trial vocal fold injection with hyaluronic acid in patients with vocal fold atrophy with or without sulcus.

PURPOSE: To evaluate the outcome of bilateral trial vocal fold injection (VFI) with hyaluronic acid in patients with vocal fold atrophy ± sulcus and to assess the predictive value of trial VFI on the outcome of durable medialization procedure. METHODS: Voice data collected according to a standardized protocol before and one month after trial VFI of 68 patients with vocal fold atrophy (30) and atrophy with sulcus (38) were analyzed. Voice Handicap Index (VHI)-30 was compared to the outcome of a durable medialization at 3 and 12 months. RESULTS: The overall VHI-30 improvement was 16.8 points (from 49.9 to 33.1), which was statistically significant and clinically relevant. 57.8% of the patients experienced enough subjective benefit after trial VFI to undergo durable medialization. Of the patients that experienced subjective benefit 62% had a clinically relevant improvement in VHI-30. There was no relevant change in other parameters and no difference between ± sulcus. After durable medialization 90-94% of the patients had VHI-30 scores similar to or better than post-trial VFI. CONCLUSION: The majority of patients experience subjective improvement after bilateral trial VFI indicating that medialization is a valid treatment option for patients with vocal fold atrophy ± sulcus. The VHI-30 only partially overlaps with patients' subjective evaluation and does not predict which patients will experience subjective improvement. It is, however, predictive for VHI-30 outcome after durable medialization. The aerodynamic and acoustic parameters showed no relevant change. Further identification of voice assessment parameters accurately reflecting the subjective experience of these patients is warranted.

Quality of life and voice outcome of patients treated with transoral CO2 laser microsurgery for early glottic carcinoma (T1-T2): a 2-year follow-up study.

PURPOSE: Longitudinal studies in laryngeal cancer can provide clinicians information about short-term and long-term functional outcomes, like quality of life (QoL) and voice outcome. This information is important when counseling patients or choosing a primary treatment modality. The present study assessed long-term (2 years) QoL and voice outcome in patients with extended T1 and limited T2 glottic carcinoma treated with transoral CO2 laser microsurgery (TLM) (unilateral type III or bilateral type II resections). METHODS: Three questionnaires were administered: the Voice Handicap Index (VHI), the European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaire (QLQ)-C30, the EORTC QLQ-HN35. A perceptual voice evaluation at six different time points was conducted: preoperatively, and postoperatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years. Fluctuations over time were investigated. RESULTS: Sixty-one patients were included in the analysis. Patients reported high-level functioning and low symptom scores 2 years postoperatively. Gender significantly affected the VHI scores at 2 years (mean VHI scores: female 8.7 vs. male, 23.9; p = 0.023). The major improvement in VHI scores was observed within the first 6 months. The tumor stage (T1a, T1b, and T2) significantly impacted the grade (mean scores at 2 years: 1.0, 1.9, and 1.7; p = 0.001). These scores stabilized at 6 months. CONCLUSIONS: Patients show good long-term QoL with low symptom scores, a low voice handicap, and mild to moderate dysphonia, 2 years postoperatively. Scores stabilize at 6 months and provide a clear indication of status at 1 and 2 years.

Bilateral vocal fold injection with autologous fat in patients with vocal fold atrophy with or without sulcus.

PURPOSE: To evaluate voice outcome after bilateral vocal fold injection with autologous fat in patients with non-paralytic glottic insufficiency due to vocal fold atrophy with or without sulcus. METHODS: This is a retrospective cohort study from September 2012 to December 2017 including 23 patients undergoing bilateral vocal fold injection with autologous fat (24 procedures) for vocal fold atrophy (15 procedures) or atrophy with sulcus (Ford type II or III) (9 procedures). Voice data were collected and analyzed for the preoperative and the 3- and 12-month postoperative time points according to a standardized protocol, including Voice Handicap Index (VHI)-30 and perceptive, acoustic and aerodynamic parameters. Failure rate was defined as non-relevant improvement (< 10 points) in VHI-30 at 12 months and number of revisions within 12 months. RESULTS: There was a clinically relevant (≥ 15 points) and statistically significant improvement in the VHI-30 (preoperative: 49.1 points; postoperative at 12 months: 29.7 points). Change in dynamic range was also statistically significant over time (p = 0.028). There were no differences in voice parameters between patients with atrophy only and atrophy with sulcus, although grade tended to be lower in patients with atrophy only over all time points. CONCLUSION: This study shows that bilateral vocal fold injection with autologous fat is a beneficial treatment not only for patients with atrophy but also for patients with sulcus. A comparison of the results with those reported from other forms of sulcus surgery confirmed this finding. However, there is a need for further prospective studies comparing the short- and long-term effects of different techniques.

Evaluation of surgical margin status in patients with early glottic cancer (Tis-T2) treated with transoral CO2 laser microsurgery, on local control.

PURPOSE: To assess the impact of surgical margins status on local control in patients with primary early glottic (Tis-T2) squamous cell carcinoma after treatment with transoral CO2 laser microsurgery (TLM) and to assess the significance of additional wound bed biopsies. METHODS: Patients with Tis-T2 tumours treated with TLM type I-III resections according to the European Laryngological Society classification between 2009 and 2013 were included in retrospective analysis. Recurrence rate was determined in patients with free versus non-free specimen margins and wound biopsies. Five-year survival rates were determined using the Kaplan-Meier method. Prognostic impact of pT-category, resection margin status, tumour differentiation, wound bed biopsy status, and number of biopsies on local control (LC) were tested with the log-rank test. RESULTS: Eighty-four patients were included in the analysis. Positive margins were seen in 68 patients (81.0%). Margin status after TLM did not significantly influence LC (p = 0.489), however, additional wound bed biopsies were significantly associated with lower LC (p = 0.009). Five-year LC, disease-specific survival, overall survival and laryngeal preservation were 78.6, 78.0, 98.6 and 100%, respectively. CONCLUSIONS: Additional wound bed biopsies can help predict local recurrence in patients treated with TLM for early glottic carcinoma. We propose that there is enough evidence to support a wait-and-see policy in patients with positive specimen margins and negative wound bed biopsies. For patients with positive wound bed biopsies, further treatment is warranted.

Rapid review: sinonasal surgery vs. medical therapy for asthma in patients with chronic rhinosinusitis with or without nasal polyps.

The objective of the study was to compare the effect of sinonasal surgery vs. medical treatment on asthma in patients with chronic rhinosinusitis with or without nasal polyps. We executed a PRISMA guidelines-based systematic search of the following databases: PubMed, CENTRAL, Embase, Scopus and CINAHL. The search ran from database inception until 26 Feb 2014. We included controlled clinical trials comparing surgical intervention with medical intervention in patients with chronic rhinosinusitis with or without nasal polyps. We included only English papers. We used a pre-defined data collection form. Two authors independently assessed study quality. We assessed directness of evidence and risk of bias using pre-defined criteria. Our search yielded 2004 original articles, six of which satisfied our inclusion criteria. One article was excluded from further review because no comparison could be made of the subgroup of operated asthmatic patients versus the non-surgical control group. Only one study used objective pulmonary function measurements in asthmatics undergoing sinonasal surgery and therefore had the highest directness of evidence. Also it had a low risk of bias. Patient characteristics, treatments and outcome measures varied across studies, as did the observed effect. Risk of bias was high in most studies. Patient characteristics, treatment and outcome measurement differed across studies, making a comparison of the effects difficult. There is a risk of publication language bias. There is insufficient evidence either for or against sinonasal surgery for asthma control as compared to medical treatment.

Positive pressure therapy for Ménière's disease or syndrome.

BACKGROUND: Ménière's disease is an incapacitating disease in which recurrent attacks of vertigo are accompanied by hearing loss, tinnitus and/or aural fullness, all of which are discontinuous and variable in intensity. A number of different therapies have been identified for patients with this disease, ranging from dietary measures (e.g. a low-salt diet) and medication (e.g. betahistine (Serc®), diuretics) to extensive surgery (e.g. endolymphatic sac surgery). The Meniett® low-pressure pulse generator (Medtronic ENT, 1999) is a device that is designed to generate a computer-controlled sequence of low-pressure (micro-pressure) pulses, which are thought to be transmitted to the vestibular system of the inner ear. The pressure pulse passes via a tympanostomy tube (grommet) to the middle ear, and hence to the inner ear via the round and/or oval window. The hypothesis is that these low-pressure pulses reduce endolymphatic hydrops. OBJECTIVES: To assess the effects of positive pressure therapy (e.g. the Meniett device) on the symptoms of Ménière's disease or syndrome. SEARCH METHODS: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 6 June 2014. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing positive pressure therapy (using the Meniett or a similar device) with placebo in patients with Ménière's disease. The primary outcome was control of vertigo; secondary outcomes were loss or gain of hearing, severity of tinnitus, perception of aural fullness, functional level, complications or adverse effects, and sick days. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies, assessed risk of bias and extracted data. We contacted authors for additional data. Where possible, we pooled study results using a fixed-effect, mean difference (MD) meta-analysis and tested for statistical heterogeneity using both the Chi² test and I² statistic. This was only possible for the secondary outcomes loss or gain of hearing and sick days. We presented results using forest plots with 95% confidence intervals (Cl). MAIN RESULTS: We included five randomised clinical trials with 265 participants. All trials were prospective, double-blind, placebo-controlled randomised controlled trials on the effects of positive pressure therapy on vertigo complaints in Ménière's disease. Overall, the risk of bias varied: three out of five studies were at low risk, one was at unclear risk and one was at high risk of bias. Control of vertigo For the primary outcome, control of vertigo, it was not possible to pool data due to heterogeneity in the measurement of the outcome measures. In most studies, no significant difference was found between the positive pressure therapy group and the placebo group in vertigo scores or vertigo days. Only one study, at low risk of bias, showed a significant difference in one measure of vertigo control in favour of positive pressure therapy. In this study, the mean visual analogue scale (VAS) score for vertigo after eight weeks of treatment was 25.5 in the positive pressure therapy group and 46.6 in the placebo group (mean difference (MD) -21.10, 95% CI -35.47 to -6.73; scale not stated - presumed to be 0 to 100). Secondary outcomes For the secondary outcomes, we carried out two pooled analyses. We found statistically significant results for loss or gain of hearing . Hearing was 7.38 decibels better in the placebo group compared to the positive pressure therapy group (MD) (95% CI 2.51 to 12.25; two studies, 123 participants). The severity of tinnitus and perception of aural fullness were either not measured or inadequate data were provided in the included studies. For the secondary outcome functional level , it was not possible to perform a pooled analysis. One included study showed less functional impairment in the positive pressure group than the placebo group (AAO-HNS criteria, one- to six-point scale: MD -1.10, 95% CI -1.81 to -0.39, 40 participants); another study did not show any significant results. In addition to the predefined secondary outcome measures, we included sick days as an additional outcome measure, as two studies used this outcome measure and it is a complementary measurement of impairment due to Ménière's disease. We did not find a statistically significant difference in sick days. No complications or adverse effects were noted by any study. AUTHORS' CONCLUSIONS: There is no evidence, from five included studies, to show that positive pressure therapy is effective for the symptoms of Ménière's disease. There is some moderate quality evidence, from two studies, that hearing levels are worse in patients who use this therapy. The positive pressure therapy device itself is minimally invasive. However, in order to use it, a tympanostomy tube (grommet) needs to be inserted, with the associated risks. These include the risks of anaesthesia, the general risks of any surgery and the specific risks of otorrhoea and tympanosclerosis associated with the insertion of a tympanostomy tube. Notwithstanding these comments, no complications or adverse effects were noted in any of the included studies.

Risk Factors for Recurrence of Benign Paroxysmal Positional Vertigo: A Prospective Study.

OBJECTIVES: Benign paroxysmal positional vertigo (BPPV) can be treated successfully in most cases. However, recurrences are common. We aimed to prospectively investigate demographic and clinical risk factors for BPPV recurrence. Our second aim was to investigate whether seasonality affects recurrences. METHODS: We recruited adult Dutch patients presenting at our dizziness clinic with a diagnosis of definite or possible BPPV for a prospective observational study with 1-year follow-up. Factors collected from patient history and questionnaires were age, sex, ethnicity, previous treatment for BPPV, duration of BPPV symptoms, number of treatment sessions for the initial BPPV episode, the affected canal, recent head trauma, and a history of vestibular neuritis, Menière's disease, (vestibular) migraine, gout, diabetes mellitus, and chronic renal failure. Factors derived from blood samples were uric acid, glycated hemoglobin, and 25-hydroxyvitamin D. RESULTS: We included 139 subjects with a mean age of 65 (SD, 13) years, of whom 70% was female. A total of 48 subjects (34.5%) suffered from at least one recurrence during the 1-year follow-up. Independent risk factors for recurrence of BPPV were "multiple treatment sessions for the initial BPPV episode" (incidence rate ratio, 1.74; 95% confidence interval 1.06-2.85; p = 0.027) and history of gout (incidence rate ratio, 1.90; 95% confidence interval, 1.01-3.57; p = 0.045). CONCLUSION: One-third of patients presenting in a tertiary dizziness clinic develop at least one recurrence of BPPV within 1 year. Multiple treatment sessions and a history of gout are independent risk factors for recurrence.

The effectiveness of intratympanic injections with methylPREDnisolon versus placebo in the treatment of vertigo attacks in MENière's disease (PREDMEN trial): a study protocol for a phase-3 multicentre, double-blinded, randomised, placebo-controlled trial.

INTRODUCTION: Intratympanic corticosteroids are commonly used in the treatment of Menière's disease (MD). However, few and small randomised controlled trials (RCT) on the effectiveness of intratympanic corticosteroids have been performed. A recent Cochrane review suggested that a well-conducted placebo-controlled RCT with a large study population is required to evaluate the effectiveness of the use of intratympanic corticosteroids in MD. The following protocol describes a phase-3 multicentre, double-blinded, randomised, placebo-controlled trial to compare the effectiveness of methylprednisolone (62.5 mg/mL) to a placebo (sodium chloride 0.9%). METHODS AND ANALYSIS: We aim to recruit 148 patients with unilateral MD from six hospitals in the Netherlands. Patients will be randomly assigned to either the methylprednisolone or the placebo group. Two injections will be given, one at baseline and one after 2 weeks. Follow-up assessments will be done at 3, 6, 9 and 12 months. The primary outcome will be the frequency of vertigo attacks. Attacks will be evaluated daily with the DizzyQuest app. Secondary outcomes include hearing loss, tinnitus, health-related quality of life, use of co-interventions and escape medication, (serious) adverse events and cost-effectiveness. These will be evaluated with audiometry and multiple commonly used, validated questionnaires. For the primary and secondary outcomes mixed model analysis, generalised estimating equation analysis and logistic regression analysis will be used. ETHICS AND DISSEMINATION: This study was submitted via the Clinical Trials Information System, reviewed and approved by the Medical Research Ethics Committee Leiden The Hague Delft and the local institutional review board of each participating centre. All data will be presented ensuring the integrity and anonymity of patients. Results will be published in scientific journals and presented on (inter)national conferences. TRIAL REGISTRATION NUMBER: This study is registered at ClinicalTrials.gov Protocol Registration and Results System, with the registration ID: NCT05851508.

Impact of evidence-based guidelines on healthcare utilisation and costs for disc related sciatica in the Netherlands: a population-based, cross-sectional study.

OBJECTIVE: The aim of this study was to assess the impact of high-quality evidence supporting surgical treatment of lumbar disc herniation (LDH) on healthcare practice in the Netherlands by examining changes in healthcare utilisation, including the timing of surgery, and the healthcare costs for patients with LDH. DESIGN: A retrospective, cross-sectional study was performed using population-based, longitudinal data obtained from the Dutch Healthcare Authority (2007-2020) and NIVEL's primary care (2012-2020) administrative databases. SETTING: The study was conducted within the healthcare system of the Netherlands. PARTICIPANTS: We included adults (≥18 years) who visited a Dutch hospital or a general practitioner (GP) for lumbar degenerative disc disease. Patients with LDH were identified based on registered diagnosis code, type of surgery (discectomy) and age (<56 years). MAIN OUTCOME MEASURES: The primary outcome measure was the difference in the annual number of LDH procedures following the publication of evidence-based guidelines in 2009 (comparing the periods 2007-2009 to 2017-2019). Secondary outcome measures focused on the timing of surgery and associated healthcare costs. To validate the outcomes, secondary outcomes also include the number of discectomies and the number of procedures in the younger age group (discectomies, laminectomies, and fusion surgery). RESULTS: The number of patients suffering from LDH increased from 55 581 to 68 997 (+24%) between 2007 and 2019. A decrease was observed in the annual number of LDH procedures (-18%), in the number of discectomies (-22%) and in the number of procedures for patients aged <56 years (-18%). This resulted in lower healthcare costs by €10.5 million annually. In 2012, 31% of all patients <56 years had surgery before 12 weeks from diagnosis at the GP, whereas 20% did in 2019. CONCLUSIONS: Healthcare utilisation for LDH changed tremendously in the Netherlands between 2007 and 2020 and seemed to be associated with the publication and implementation of evidence-based guidelines. The observed decrease in the number of procedures has been accompanied by a corresponding reduction in healthcare costs. These findings underscore the importance of adhering to evidence-based guidelines to optimise the management of patients with LDH.

Practice variation in surgical treatment for lumbar degenerative disc disease: exploring regional and hospital factors influencing surgical rates.

The presence of significant, unwarranted variation in treatment suggests that clinical decision making also depends on where patients live instead of what they need and prefer. Historically, high practice variation in surgical treatment for lumbar degenerative disc disease (LDDD) has been documented. This study aimed to investigate current regional variation in surgical treatment for sciatica resulting from LDDD. We conducted a retrospective, cross-sectional analysis of all Dutch adults (>18 years) between 2016 and 2019. Demographic data from Statistics Netherlands were merged with a nationwide claims database, covering over 99% of the population. Inclusion criteria comprised LDDD diagnosis codes and relevant surgical codes. Practice variation was assessed at the level of postal code areas and hospital service areas (HSAs). Multivariable logistic regression analysis was employed to identify variables associated with surgical treatment. Among the 119,148 hospital visitors with LDDD, 14,840 underwent surgical treatment. Practice variation for laminectomies and discectomies showed less than two-fold variation in both postal code and HSAs. However, instrumented fusion surgery demonstrated a five-fold variation in postal code areas and three-fold variation in HSAs. Predictors of receiving surgical treatment included opioid prescription and patient referral status. Gender differences were observed, with males more likely to undergo laminectomy or discectomy, and females more likely to receive instrumented fusion surgery. Our study revealed low variation rates for discectomies and laminectomies, while indicating a high variation rate for instrumented fusion surgery in LDDD patients. High-quality research is needed on the extent of guideline implementation and its influence on practice variation.

Surgery for Ménière's disease.

BACKGROUND: This is an update of a Cochrane review first published in The Cochrane Library in Issue 1, 2010.Ménière's disease is characterised by three major symptoms: vertigo, deafness, and tinnitus or aural fullness, all of which are discontinuous and variable in intensity. A number of surgical modalities, of varying levels of invasiveness, have been developed to reduce the symptoms of Ménière's disease, but it is not clear whether or not these are effective. OBJECTIVES: To assess the effectiveness of surgical options for the treatment of Ménière's disease. All surgical interventions used in the treatment of Ménière's disease, either to alter the natural history of the disease or to abolish vestibular function, were considered for this review. SEARCH METHODS: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the most recent search was 7 November 2012. SELECTION CRITERIA: Randomised or quasi-randomised controlled studies of a surgical modality versus a placebo therapy in Ménière's disease. DATA COLLECTION AND ANALYSIS: Two authors independently assessed trial quality and extracted data. We contacted study authors for further information. MAIN RESULTS: The only surgical intervention which has been evaluated in randomised controlled trials and met the inclusion criteria was endolymphatic sac surgery. We identified two randomised trials, involving a total of 59 patients; one comparing endolymphatic sac surgery with ventilation tubes and one with simple mastoidectomy. Neither study reported any beneficial effect of surgery either in comparison to placebo surgery or grommet insertion. AUTHORS' CONCLUSIONS: The two trials included in this review provide insufficient evidence of the beneficial effect of endolymphatic sac surgery in Ménière's disease.

Endolymphatic Duct Blockage as a Surgical Treatment Option for Ménière's Disease.

Endolymphatic duct blockage is a relatively new treatment option for Ménière's disease, aiming to reduce vertigo attacks while sparing hearing and equilibrium. After a regular mastoidectomy, the posterior semicircular canal is identified, and Donaldson's line is determined. This is a line through the horizontal semicircular canal, crossing the posterior semicircular canal. The endolymphatic sac is usually found at this site under the posterior semicircular canal. The bone of the endolymphatic sac and the dura are thinned until the sac is skeletonized, after which the endolymphatic duct is identified. The duct is then blocked with a titanium clip. Using a computerized tomography (CT) scan, the position is confirmed. Follow-up visits take place 1 week, 6 weeks and 1 year after surgery. To this day, only one prospective trial assessing this method has been conducted, comparing this new method to endolymphatic sac decompression. Results of the duct blockage are promising, with 96.5% of the patients free of vertigo after 2 years. However, further research is required.