Digna M. A. Kamalski

Measuring disease-specific health-related quality of life to evaluate treatment outcomes in tinnitus patients: a systematic review.

OBJECTIVE: To identify all disease-specific health-related quality-of-life (HR-QoL) instruments used to assess tinnitus in clinical trials and detail their psychometric properties. DATA SOURCES: A literature search was performed in the bibliographical databases of PubMed and Embase to identify all articles using specific HR-QoL instruments in tinnitus trials. REVIEW METHODS: The HR-QoL instruments used in these articles were investigated in more detail, focusing on characteristics and psychometric values by two independent reviewers. RESULTS: Seventeen studies were identified by the systematic search. The most used HR-QoL questionnaire was the Tinnitus Questionnaire, followed by the Tinnitus Handicap Inventory, the Tinnitus Reaction Questionnaire, and the Tinnitus Handicap Questionnaire. Internal consistency (Cronbachs α > 0.9) and reproducibility (> 0.8) were high for all questionnaires, and there was heterogeneity in responses between patients, endorsing the use of these questionnaires for discriminative purposes. However, the responsiveness, i.e., the usefulness of these questionnaires in evaluating treatment effects, is not known yet. CONCLUSION: The HR-QoL instruments used in tinnitus trials appear not to be validated to measure effectiveness of interventions. Using tests or instruments that are valid and reliable is a crucial component of research quality, and both should therefore be studied before final conclusions can be drawn from the questionnaires in upcoming clinical trials.

Laser versus conventional fenestration in stapedotomy for otosclerosis: A systematic review

To assess hearing results and complications following primary stapedotomy in otosclerosis patients comparing the use of laser and conventional techniques for fenestration.

The reliability and validity of cervical auscultation in the diagnosis of dysphagia: a systematic review:

Objective: To systematically review the available evidence for the reliability and validity of cervical auscultation in diagnosing the several aspects of dysphagia in adults and children suffering from dysphagia. Data sources: Medline (PubMed), Embase and the Cochrane Library databases. Review methods: The systematic review was carried out applying the steps of the PRISMA-statement. The methodological quality of the included studies were evaluated using the Dutch ‘Cochrane checklist for diagnostic accuracy studies’. Results: A total of 90 articles were identified through the search strategy, and after applying the inclusion and exclusion criteria, six articles were included in this review. In the six studies, 197 patients were assessed with cervical auscultation. Two of the six articles were considered to be of ‘good’ quality and three studies were of ‘moderate’ quality. One article was excluded because of a ‘poor’ methodological quality. Sensitivity ranges from 23%–94% and specificity ranges from 50%–74%. Inter-rater reliability was ‘poor’ or ‘fair’ in all studies. The intra-rater reliability shows a wide variance among speech language therapists. Conclusion: In this systematic review, conflicting evidence is found for the validity of cervical auscultation. The reliability of cervical auscultation is insufficient when used as a stand-alone tool in the diagnosis of dysphagia in adults. There is no available evidence for the validity and reliability of cervical auscultation in children. Cervical auscultation should not be used as a stand-alone instrument to diagnose dysphagia.

Outcomes of Different Laser Types in Laser-assisted Stapedotomy: A Systematic Review

Objective To assess hearing results and complications following primary stapedotomy in otosclerosis patients, comparing different laser types. Data Sources Pubmed, Embase, The Cochrane Library, CINAHL, and Scopus. Study Selection A systematic bibliographic search was conducted to identify all original articles, comparing hearing outcome between different lasers used for fenestration in stapedotomy. Data Extraction Directness of evidence and risk of bias of the selected articles were assessed. Studies with low or moderate directness of evidence, or high risk of bias, were not further analyzed. Data Synthesis The absolute risks, risk differences, and 95% confidence intervals were extracted only for the studies with high directness of evidence and moderate to low risk of bias. Conclusion A total of 383 unique articles were retrieved. Four studies provided direct evidence, whereas all studies carried moderate to high risk of bias. After exclusion of the studies that did not provide direct evidence and/or carried high risk of bias, 2 studies were considered eligible for data extraction. This best available evidence shows a slightly better air-bone gap closure for CO2 laser compared to potassium titanyl phosphate laser, but the clinical relevance is unclear. The risk difference of 28.1% [95% confidence interval, 22.8, 33.4] between CO2 and erbium yttrium aluminium garnet favors CO2 laser. Unfortunately, this current best available evidence is insufficient to draw any definitive conclusions on which laser to use for fenestration in stapedotomy.

A nonrandomized comparison of the thulium laser and the CO2 laser in primary stapedotomy for otosclerosis.

Objective Comparing hearing results in patients with otosclerosis treated with laser-assisted stapedotomy using the 2-&mgr;m thulium laser or the CO2 laser. Study design Prospective nonrandomized clinical study. Setting In a tertiary referral center in France (Jean Causse Ear Clinic, Béziers), 208 primary stapedotomies were performed in 204 patients between March 2008 and November 2009. Sufficient follow-up data were available for 194 procedures. Methods The fenestration in the footplate was made with the thulium laser in 98 procedures and with a flexible CO2 laser in 96 procedures. Preoperative and postoperative audiometric results were compared. Side effects, such as vertigo and tinnitus, were scored. Results Patients treated with the CO2 laser had better hearing outcome compared with those treated with the thulium laser at both 3 and 12 months of follow-up. At 3 months, the success of the surgery, defined as closure of the air-bone gap to within 10 dB, was 90.0% in the thulium group compared with 96.8% in the CO2 group. Bone conduction shift showed an overall deterioration of 1.6 dB (standard deviation, 6.9 dB) in the thulium group compared with an improvement of 1.3 dB (standard deviation, 4 dB) in the CO2 group. In the thulium group, there were four patients with sensorineural hearing loss (4.4%) and three with tinnitus (3.1%) compared with none in the CO2 group. Conclusion Stapedotomy surgery performed with a fiber-delivered thulium laser resulted in a higher chance of inner ear damage measured by bone conduction shift compared with the use of a fiber-delivered CO2 laser. We advise not to use the thulium laser for stapedotomy.

Capturing Thermal, Mechanical, and Acoustic Effects of the Diode (980 nm) Laser in Stapedotomy

Introduction The diode laser, with a wavelength of 980 nm, has promising characteristics for being used for the fenestration during stapedotomy. It is known that at this wavelength absorption in pigmented tissues is high, and absorption in water is relatively low compared with medical lasers in the infrared, making it theoretically an applicable laser for stapes surgery in patients with otosclerosis. Another important advantage is that, with respect to other lasers, this device is relatively inexpensive. Despite the potential advantages, the available literature only shows limited reports of this laser being used in stapes surgery. The present article evaluates the thermal, mechanical, and acoustic properties of the diode laser during stapes surgery. Methods For the mechanical effects, high-speed imaging with a frame rate up to 4000 f/s (=250 &mgr;s resolution) was performed in an inner ear model. For thermal effects, the high-speed Schlieren technique was used. Acoustics were recorded by a hydrophone, incorporated in the model. Pulse settings were 100 ms, 3 W, which are the same settings used during stapes surgery. Results The application of the diode laser resulted in limited mechanical and thermal effects. Impulse noise was low with an average of 52 (SD, 7.8) dB (A). Before carbonization of the tip of the delivery laser, fiber enhances ablation of the footplate. Conclusion The 980-nm diode laser is a useful tool for laser-assisted stapedotomy in patients with otosclerosis. Mechanical, thermal, and acoustic effects are limited and well within the safety limits.

Congenital Stapes Ankylosis in Children: Surgical Findings and Results in 35 Cases.

Objective: To evaluate surgical findings and hearing results in children undergoing middle ear surgery for congenital stapes ankylosis with or without other ossicular malformations (Teunissen and Cremers class I and class II malformations). Study Design: A nonrandomized, nonblinded case series of prospectively collected data. Setting: A tertiary referral center. Patients: Twenty-eight consecutive pediatric patients who underwent 35 surgical procedures for congenital stapes ankylosis with or without other ossicular malformations and had available postoperative pure-tone audiometry. Intervention: Primary stapedotomy with vein graft interposition and reconstruction with a Teflon piston, bucket handle prosthesis or total ossicular replacement prosthesis. Main Outcome Measures: Pre- and postoperative audiometric evaluation using four-frequency (0.5, 1, 2, and 4 kHz) audiometry. Air-conduction thresholds, bone-conduction thresholds, and air-bone gaps (ABGs) were measured. Postoperative audiometry was performed at 3, 6, 9, 12, 18, and 24 months after surgery and at a yearly interval thereafter. Results: Overall, a postoperative ABG closure of 10 dB or less was achieved in 73% of class I cases and in 50% of class II cases. A postoperative ABG closure of 20 dB or less was achieved in 77% of class I cases and 67% of class II cases. Postoperative sensorineural hearing loss occurred in one class I case (4%) and none of the class II cases. Conclusion: Stapedotomy is a safe and feasible treatment option in children with congenital stapes ankylosis.

Influence of Laser-Assisted Cochleostomy on Acoustically Evoked Compound Action Potentials in the Guinea Pig

Hypothesis Making a cochleostomy with a laser can affect the inner ear function. Background Different types of lasers can be used to create a fenestration in the footplate of the stapes during stapedotomy. Because of variations in absorption spectra of the laser light in various tissues or fluids, each laser has its own characteristics and possible side effects. Materials and Methods The basal turns of the cochleae of 20 guinea pigs were fenestrated using 4 types of lasers (thulium, KTP, CO2, diode; all groups n = 4). A control group (n = 4) was included to correct for the effects of the surgery alone. At 3 different time points, acoustically evoked compound action potentials (CAPs) were recorded at 5 frequencies and at different sound pressure levels. N1-P2 amplitudes were measured, and subsequently, thresholds were calculated. A repeated measures analysis of variance was used to investigate differences between groups. Results There was a decrease in CAP amplitudes and an increase in CAP thresholds after cochleostomy with each laser. The increase in thresholds was significantly larger for higher frequencies. The thulium laser evoked the largest threshold shifts, the KTP laser the smallest with the CO2, and diode lasers in intermediate positions. Overall, there was an increase in latencies after treatment. Conclusion Laser treatment on or near the cochlea can cause damage to the sensitivity of the cochlea for sound. The thulium laser seems to be the worst choice in this respect.

Effect of KTP laser cochleostomy on morphology in the guinea pig inner ear.

Background: The main advantage of using the KTP (potassium-titanyl-phosphate) laser for stapedotomy instead of the conventional micropick instrument is the smaller risk for mechanical damage. However, the KTP laser could theoretically inflict damage to inner ear structures. We hypothesize that KTP laser light [wavelength (λ) = 532 nm] is hardly absorbed in perilymph but well absorbed in solid structures. The aim of this pilot study was to assess if damage occurred after KTP laser cochleostomy in an animal model and, if so, to what extent and at which settings. Materials and Methods: In six guinea pigs, a KTP laser cochleostomy at the basal turn was created. Laser settings of 1, 3 and 5 W and 100 ms pulse time (n = 2 each) were used. Histological preparations were studied for damage to neuroendothelial cells and intrascalar blood. Results: No damage to inner ear neuroendothelial cells was observed, even at the highest power. Blood clots in the scala tympani from vessels in the cochlear wall were seen. The effects were minimal in the lowest, currently clinically used settings. Conclusion: KTP laser cochleostomy gives no damage to inner ear neuroendothelial cells but may cause intrascalar hemorrhages.

Primary stapedotomy in children with otosclerosis: A prospective study of 41 consecutive cases.

To prospectively evaluate hearing outcomes in children with otosclerosis undergoing primary stapes surgery.