Publications on Clinical Research in Otolaryngology–A Systematic Analysis of Leading Journals in 2010

Background: We wanted to asses and characterize the volume of Otolaryngology publications on clinical research, published in major journals.Methods and Material: To assess volume and study type of clinical research in Otolaryngology we performed a literature search in high impact factor journals. We included 10 high impact factor Otolaryngology journals and 20 high impact factor medical journals outside this field (2011). We extracted original publications and systematic reviews from 2010. Publications were classified according to their research question, that is therapy, diagnosis, prognosis or etiology.Results: From Otolaryngology journals (impact factor 1.8 to 2.8) we identified 694 (46%) publications on original observations and 27 (2%) systematic reviews. From selected medical journals (impact factor 6.0 to 101.8) 122 (2%) publications related to Otolaryngology, 102 (83%) were on original observations and 2 (0.04%) systematic reviews. The most common category was therapy (40%).Conclusion: Half of publications in Otolaryngology concerns clinical research, which is higher than other specialties. In medical journals outside the field of Otolaryngology, a small proportion (2%) of publications is related to Otolaryngology. Striking is that systematic reviews, which are considered high level evidence, make up for only 2% of publications. We must ensure an increase of clinical research for optimizing medical practice

No Difference in Behavioral and Self-Reported Outcomes for Simultaneous and Sequential Bilateral Cochlear Implantation: Evidence From a Multicenter Randomized Controlled Trial

Objective: The primary aim of this study was to longitudinally compare the behavioral and self-reported outcomes of simultaneous bilateral cochlear implantation (simBiCI) and sequential BiCI (seqBiCI) in adults with severe-to-profound postlingual sensorineural hearing loss.Design: This study is a multicenter randomized controlled trial with a 4-year follow-up period after the first moment of implantation. Participants were allocated by randomization to receive bilateral cochlear implants (CIs) either, simultaneously (simBiCI group) or sequentially with an inter-implant interval of 2 years (UCI/seqBiCI group). All sequential patients where encouraged to use their hearing aid on the non-implanted ear over of the first 2 years. Patients were followed-up on an annual basis. The primary outcome was speech perception in noise coming from a source directly in front of the patient. Other behavioral outcome measures were speech intelligibility-in-noise from spatially separated sources, localization and speech perception in quiet. Self-reported outcome measures encompassed questionnaires on quality of life, quality of hearing and tinnitus. All outcome measures were analyzed longitudinally using a linear or logistic regression analysis with an autoregressive residual covariance matrix (generalized estimating equations type).Results: Nineteen participants were randomly allocated to the simBiCI group and 19 participants to the UCI/seqBiCI group. Three participants in the UCI/seqBiCI group did not proceed with their second implantation and were therefore unavailable for follow-up. Both study groups performed equally well on speech perception in noise from a source directly in front of the patient longitudinally. During all 4 years of follow-up the UCI/seqBiCI group performed significantly worse compared to the simBiCI group on spatial speech perception in noise in the best performance situation (8.70 dB [3.96 – 13.44], p < 0.001) and localization abilities (largest difference 60 degrees configuration: -44.45% [-52.15 – -36.74], p < 0.0001). Furthermore, during all years of follow-up, the UCI/seqBiCI group performed significantly worse on quality of hearing and quality of life questionnaires. The years of unilateral CI use were the reason for the inferior results in the UCI/SeqBiCI group. One year after receiving CI2, the UCI/seqBiCI group performance did not statistically differ from the performance of the simBiCI group on all these outcomes. Furthermore, no longitudinal differences were seen in tinnitus burden prevalence between groups. Finally, the complications that occurred during this trial were infection, dysfunction of CI, facial nerve palsy, tinnitus and vertigo.Conclusion: This randomized controlled trial on bilaterally severely hearing impaired participants found a significantly worse longitudinal performance of UCI/seqBiCI compared to simBiCI on multiple behavioral and self-reported outcomes regarding speech perception in noise and localization abilities. This difference is associated with the inferior performance of the UCI/seqBiCI participants during the years of unilateral CI use. After receiving the second CI however, the performance of the UCI/seqBiCI group did not significantly differ from the simBiCI group.Trial Registration: Dutch Trial Register NTR1722

No Difference in Behavioral and Self-Reported Outcomes for Simultaneous and Sequential Bilateral Cochlear Implantation:Evidence From a Multicenter Randomized Controlled Trial

Objective: The primary aim of this study was to longitudinally compare the behavioral and self-reported outcomes of simultaneous bilateral cochlear implantation (simBiCI) and sequential BiCI (seqBiCI) in adults with severe-to-profound postlingual sensorineural hearing loss. Design: This study is a multicenter randomized controlled trial with a 4-year followup period after the first moment of implantation. Participants were allocated by randomization to receive bilateral cochlear implants (Cis) either, simultaneously (simBiCKI group) or sequentially with an inter-implant interval of 2 years (UCI/seqBiCI group). All sequential patients where encouraged to use their hearing aid on the non-implanted ear over of the first 2 years. Patients were followed-up on an annual basis. The primary outcome was speech perception in noise coming from a source directly in front of the patient. Other behavioral outcome measures were speech intelligibility-innoise from spatially separated sources, localization and speech perception in quiet. Self-reported outcome measures encompassed questionnaires on quality of life, quality of hearing and tinnitus. All outcome measures were analyzed longitudinally using a linear or logistic regression analysis with an autoregressive residual covariance matrix (generalized estimating equations type). Results: Nineteen participants were randomly allocated to the simBiCl group and 19 participants to the UCI/seqBiCI group. Three participants in the UCI/seqBiCI group did not proceed with their second implantation and were therefore unavailable for followup. Both study groups performed equally well on speech perception in noise from a source directly in front of the patient longitudinally. During all 4 years of follow-up the UCI/seqBiCI group performed significantly worse compared to the simBiCl group on spatial speech perception in noise in the best performance situation (8.70 dB [3.96 13.44], p <0.001) and localization abilities (largest difference 60 degrees configuration: -44.45% [-52.15 - -36.74], p <0.0001). Furthermore, during all years of follow-up, the UCI/seqBiCI group performed significantly worse on quality of hearing and quality of life questionnaires. The years of unilateral CI use were the reason for the inferior results in the UCI/SeqBiCI group. One year after receiving CI2, the UCI/seqBiCI group performance did not statistically differ from the performance of the simBiCl group on all these outcomes. Furthermore, no longitudinal differences were seen in tinnitus burden prevalence between groups. Finally, the complications that occurred during this trial were infection, dysfunction of CI, facial nerve palsy, tinnitus and vertigo. Conclusion: This randomized controlled trial on bilaterally severely hearing impaired participants found a significantly worse longitudinal performance of UCI/seqBiCI compared to simBiCI on multiple behavioral and self-reported outcomes regarding speech perception in noise and localization abilities. This difference is associated with the inferior performance of the UCI/seqBiCI participants during the years of unilateral CI use. After receiving the second CI however, the performance of the UCI/seqBiCI group did not significantly differ from the simBiCI group

The Effect of Earplugs in Preventing Hearing Loss From Recreational Noise Exposure : A Systematic Review

Importance: The prevalence of hearing loss among children and adolescents is rising dramatically, caused mainly by increased exposure to recreational noise. Objective: To present a systematic overview of the effectiveness of wearing earplugs to music venues, such as nightclubs and concert halls, to prevent hearing loss and tinnitus directly after exposure. Evidence Acquisition: PubMed, EMBASE, and the Cochrane Library databases were searched for articles from database inception to June 22, 2015, using the keywords music and earplugs and all synonyms. Titles, abstracts, and full text of retrieved articles were screened for eligible articles. The directness of evidence (relevance of the assessed articles) and risk of bias of eligible articles were assessed. For the included articles, the study characteristics and data on our outcomes of interest (hearing loss and tinnitus) were extracted. Data analysis occurred from June 22 to July 3, 2015. Findings: Of 228 articles screened, 4 were eligible for critical appraisal. After critical appraisal, 2 studies with a high directness of evidence and low or moderate risk of bias remained for data extraction. Only 1 of these articles was a randomized clinical trial, which found significantly lower postconcert differences in thresholds and a lower proportion of threshold shifts in the group using earplugs compared with the unprotected group. In the other study, only 3 individuals wore earplugs, and no significant differences were found between the 2 groups. Conclusions and Relevance: The available evidence on the effectiveness of earplugs in preventing hearing damage directly after recreational music exposure is scarce. Only 1 well-conducted randomized clinical trial was found, which showed that wearing earplugs to concerts is effective in reducing postconcert threshold shifts. There is a need for further research on this topic to strengthen the level of evidence. Physicians should promote awareness on the risks of recreational noise and recommend the use of earplugs among their patients who visit music venues

Cochlear implantation in children with unilateral hearing loss : A systematic review

OBJECTIVES: To systematically review the literature on cochlear implantation (CI) for children with unilateral hearing loss (UHL). DATA SOURCES: PubMed, Cochrane, CINAHL, and Embase databases were searched for articles up to June 29, 2015 for UHL, children and CI, and all of their synonyms. METHODS: After screening of titles, abstracts, and full texts for eligible articles, directness of evidence (DoE) and risk of bias (RoB) were assessed for the included articles. Study characteristics and data on our outcomes of interest (speech perception in noise, sound localization, quality of life, and speech and language development) were extracted. RESULTS: In total, 296 unique articles were retrieved, of which five articles satisfied the eligibility criteria. All of these articles were case series or case reports and had a low to moderate DoE and a high RoB. In these studies, heterogeneous findings were reported in small patient samples. Speech perception in noise and localization ability improved in most patients. Although only measured in one study each, quality of life and speech and language development improved. Most of these results were not statistically significant. CONCLUSIONS: No firm conclusions can be drawn on the effectiveness of CI in children with UHL, due to heterogeneous findings, small sample sizes, and the lack of high Level of Evidence studies. Based on the findings of this systematic review, cochlear implantation may be an effective treatment option in children with UHL. Laryngoscope, 126:713-721, 2016

Cochlear implantation in children with unilateral hearing loss : A systematic review

OBJECTIVES: To systematically review the literature on cochlear implantation (CI) for children with unilateral hearing loss (UHL). DATA SOURCES: PubMed, Cochrane, CINAHL, and Embase databases were searched for articles up to June 29, 2015 for UHL, children and CI, and all of their synonyms. METHODS: After screening of titles, abstracts, and full texts for eligible articles, directness of evidence (DoE) and risk of bias (RoB) were assessed for the included articles. Study characteristics and data on our outcomes of interest (speech perception in noise, sound localization, quality of life, and speech and language development) were extracted. RESULTS: In total, 296 unique articles were retrieved, of which five articles satisfied the eligibility criteria. All of these articles were case series or case reports and had a low to moderate DoE and a high RoB. In these studies, heterogeneous findings were reported in small patient samples. Speech perception in noise and localization ability improved in most patients. Although only measured in one study each, quality of life and speech and language development improved. Most of these results were not statistically significant. CONCLUSIONS: No firm conclusions can be drawn on the effectiveness of CI in children with UHL, due to heterogeneous findings, small sample sizes, and the lack of high Level of Evidence studies. Based on the findings of this systematic review, cochlear implantation may be an effective treatment option in children with UHL. Laryngoscope, 126:713-721, 2016

The effect of the CONSORT statement on the amount of "unclear" Risk of Bias reporting in Cochrane Systematic Reviews.

BackgroundThe Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve clarity and consistency of transparency of reporting in Randomized Controlled Trials (RCTs). The Cochrane Risk of Bias (RoB) tool for RCTs helps authors to judge the RoB. as ''low", "high" or "unclear".ObjectiveIn this study we aimed to assess whether the implementation and updates of the CONSORT statement influenced the trend of "unclear" RoB scores of RCTs included in Cochrane systematic reviews.MethodsAll Cochrane reviews published in December to October 2016 were retrieved. The publication year of RCTS included in the reviews were sorted into time frames (≤1995, 1996-2000, 2001-2009 and ≥2010) based on the release- and updates of the CONSORT statement (1996, 2001 and 2010). The association between "unclear" RoB versus "low or high" RoB and the year of publication in different time frames were calculated using a binary logistic regression.ResultsData was extracted from 64 Cochrane reviews, with 989 RCTS (6471 items). The logistic regression showed that the odds of RCTs published ≥2010, compared to ≤1995 were more likely not to report an "unclear" RoB for the total data (Odds Ratio (OR) 0.69 (95% Confidence interval: 0.59-0.80)), random sequence generation (OR 0.32 (0.22-0.47), allocation concealment (0.64 (0.43-0.95)) and incomplete outcome data (OR 0.60 (0.39-0.91)).ConclusionA slight decrease of "unclear" RoB reporting over time was found. To improve quality of reporting authors are encouraged to adhere to reporting guidelines

Effectiveness of Earplugs in Preventing Recreational Noise-Induced Hearing Loss : A Randomized Clinical Trial

IMPORTANCE: The incidence of hearing loss has risen in past years. Attendance at music festivals and concerts may contribute to this increasing problem. OBJECTIVE: To assess the effectiveness of earplugs in preventing temporary hearing loss immediately following music exposure. DESIGN, SETTING, AND PARTICIPANTS: A randomized, single-blind clinical trial was conducted on September 5, 2015, at an outdoor music festival in Amsterdam, the Netherlands. Normal-hearing adult volunteers were recruited via social media. An exclusion criterion was the participants' intention to wear earplugs. Of the 86 volunteers assessed, 51 were included in the study. All analyses were performed on an intention-to-treat basis. INTERVENTIONS: Participants were randomly assigned to a group using earplugs or an unprotected group during a 4½-hour festival visit. MAIN OUTCOMES AND MEASURES: The primary study outcome was a temporary threshold shift (TTS) on the audiogram, primarily for frequencies at 3 and 4 kHz. Secondary study outcomes included distortion product otoacoustic emission (DPOAE) measurements and claims of tinnitus using a questionnaire and tinnitus matching experiments. RESULTS: Of 51 participants included, 25 were randomized to the earplug group and 26 to the unprotected group. Nine in each group (36% and 35%, respectively) were men, and the mean (SD) ages were 27.3 (5.6) years in the earplug group and 27.0 (6.2) years in the unprotected group. Baseline demographics were similar in both groups. The time-averaged, equivalent A-weighted sound pressure level experienced was 100 dBA during the festival. A TTS over frequencies at 3 and 4 kHz after exposure was seen in 4 of 50 ears (8%) in the earplug group compared with 22 of 52 ears (42%) in the unprotected group (P < .001). The relative risk for a TTS after exposure was 5.3 (95% CI, 2.0-14.3) for the unprotected group vs the earplug group. The number needed to treat with earplugs for preventing 1 TTS was 2.9. The DPOAE amplitudes decreased significantly more over the frequencies 2 to 8 kHz in the unprotected group: the mean (SD) decrease in magnitude was 0.6 (2.8) dB in the earplug group vs 2.2 (1.9) dB in the unprotected group (P = .04). Newly induced tinnitus following sound exposure occurred in 3 of the 25 participants (12%) in the earplug group vs 10 of 25 (40%) in the unprotected group (difference, 28%; 95% CI, 3.6%-49.0%; P = .02). CONCLUSIONS AND RELEVANCE: Earplug use is effective in preventing temporary hearing loss after loud music exposure. The present randomized clinical trial adds proof to the scarce evidence and knowledge on this topic, which is a growing global problem. TRIAL REGISTRATION: trialregister.nl Identifier: NTR5401

No Squelch Effect After Sequential Bilateral Cochlear Implantation in Postlingually Deafened Adults : Is There a First Ear Advantage?

OBJECTIVES: To investigate whether a squelch effect develops in postlingually deafened adults after sequential bilateral cochlear implantation. STUDY DESIGN: Prospective study as part of a randomized controlled trial on the difference between simultaneous versus sequential bilateral cochlear implantation. SETTING: Tertiary referral center. PARTICIPANTS: Sixteen postlingually deafened adults. INTERVENTION: Sequential bilateral cochlear implantation with a 2-year interimplant interval. MAIN OUTCOME MEASURE: A squelch effect was defined as a better bilateral score than unilateral score on a speech-intelligibility-in-noise test with spatially separated sources. The squelch effect was evaluated for the participants' best performing cochlear implant (CI) ear, the left CI in the condition with speech from -60 degrees azimuth and noise from +60 degrees azimuth (S-60 N+60), the right CI (N-60 S+60), CI1 and CI2. Evaluations took place 1, 2 and median 4 years after sequential implantation. RESULTS: No significant squelch effect was found, except for the right CI (N-60 S+60) after 2 years. No differences in speech perception-in-noise from straight ahead were seen between CI1 and CI2. Comparing performance of participants whose better or worse ear was implanted first did not reveal differences either. For the best performing situation, 7/16, 6/16, and 3/12 participants exhibited a squelch effect after 1, 2, and 4 years of follow-up. CONCLUSIONS: Participants who underwent sequential bilateral cochlear implantation with a 2-year interimplant interval did not develop an evident squelch effect on group level after a median follow-up of 4 years. Individual participants were able to make use of the squelch effect. The less evident squelch effect is at odds with our group of simultaneously implanted bilateral cochlear implant users. Neither a difference between CI1 and CI2, nor implanting the better or worse ear first could explain the less evident squelch effect in these patients. TRIAL REGISTRATION: Dutch Trial Register NTR1722