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"Smit, Adriana L."
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The effect of hearing aids on cognitive function: A systematic review
2021
Dementia currently affects 50 million people globally with this expected to triple by 2050. Even though hearing loss is associated with cognitive decline, the underlying mechanisms are not fully understood. Considering hearing loss is the largest modifiable risk factor for developing dementia, it is essential to study the effect of hearing aids on cognitive function.
To systematically review the existing literature to examine the evidence for using hearing aids intervention as a treatment for deteriorating cognitive function.
A search of PubMed, Cochrane Library, Embase and grey literature was conducted revealing 3060 unique records between 1990-2020. Two reviewers independently selected longitudinal studies observing the effects of hearing aids on cognitive function in persons without dementia at onset of the study. Due to the heterogeneity of the data, a meta-analysis could not be performed. Outcomes are described in a summary of findings table and portrayed diagrammatically.
We identified 17 unique studies, spanning 30 years of research and 3526 participants. The included studies made use of 50 different cognitive function tests. These tests were grouped into separate cognitive domains according to the DSM-V classification for further analysis. The most beneficial impact of hearing aids seems to be in the cognitive domain of executive function, with six studies showing improvement, two studies being inconclusive and three studies not demonstrating a significant effect. Three of five studies demonstrated significant improvement when screening for brief mental status. The least beneficial impact is seen in domain of complex attention, with eight studies showing no significant effects, compared with one demonstrating improvement with intervention.
Based on this systematic review, we conclude that there is controversy about the effects of hearing aids on cognition. Additional research through randomized clinical trials with standardized cognitive assessment and longer follow-up is warranted to further elucidate this relationship.
Journal Article
Development of a validated PROM set for children with tinnitus using the Patient-Reported Outcomes Measurement Information System – Protocol for the ‘Tinnitus in Children’ (TinC) study
by
Smit, Adriana L.
,
Fuchten, Denise
,
Stegeman, Inge
in
Adolescent
,
Biology and Life Sciences
,
Care and treatment
2025
Tinnitus in children remains an underexplored area of research, with limited knowledge about its prevalence and impact on daily lives. Current assessments of the impact of tinnitus in children predominantly rely on open-ended questioning during clinical interviews, inconsistent use of structured tools, and data reported by adult proxies. These methods often fail to fully capture the child's personal experience of tinnitus, underscoring the need for a standardized, child-centered measure to more accurately assess its impact and improve understanding of children's experience. To address this gap, this study proposes the development of a validated PROM set using the Patient-Reported Outcomes Measurement Information System (PROMIS).
The proposed study is a monocenter, mixed-methods, multi-phase observational study. The study will consist of six consecutive steps: (1) identifying patient-important outcomes through focus groups with children aged 8-18 years; (2) defining the underlying constructs of the outcomes and linking them to relevant PROMIS domains; (3) gathering input form an expert panel to refine the outcomes and domains; (4) discussing the PROM set with the focus groups and assess its feasibility; (5) assessing content validity in the expert panel; and (6) assessing the reliability in a sample of children with tinnitus.
By using the generic PROMIS framework to develop a condition-specific measure, the proposed study aims to create a standardized, child-centered PROM set that captures the specific impact of pediatric tinnitus, while maintaining the ability to compare outcomes across different conditions and populations. This PROM set could ultimately be used in both clinical care and research to evaluate tinnitus impact and assess the effects of treatments.
Journal Article
Longitudinal analysis of the risk factors for onset and change in tinnitus in the Busselton Healthy Ageing Study
2026
Effective prevention and intervention strategies for tinnitus rely on identifying risk factors and understanding its progression over time. However, longitudinal data on these aspects are limited. This study therefore aimed to (1) assess the incidence of tinnitus and identify risk factors associated with tinnitus development, and (2) assess the impact of tinnitus and change in impact over time and identify factors associated with this change.
Data from the Busselton Healthy Ageing Study, a population-based cohort of individuals born between 1946-1964, were used. Information on tinnitus presence and impact, general health, ear-related health and mental health was collected from 3863 participants through questionnaires and physical measurements at two time points with a six-year interval. Logistic regression analysis was used to examine risk factors for tinnitus development. Multinomial logistic regression analysis was used to examine factors associated with changes in impact.
The 6-year incidence of tinnitus was 12.1%. Statistically significant risk factors for developing tinnitus included male gender, higher BMI, larger waist circumference, fair subjective health, hearing loss, occupational noise exposure with occasional use of hearing protection, hyperacusis, migraine, and diagnosed anxiety disorder. Among participants with pre-existing tinnitus, 21.4% reported an increase in tinnitus impact over time, while 16.5% experienced a decrease. Changes in impact were influenced by general health and ear-related health factors.
The high incidence of tinnitus and its notable impact on daily life emphasize the importance of gaining a better understanding of the broad range of identified risk factors for developing tinnitus and change in impact. The multifaceted nature of these factors, comprising hearing-related issues, general health conditions and psychological aspects, underscore the complexity of tinnitus etiology and impact. By gaining more insight into these factors, we can inform future research efforts aimed at developing targeted prevention and intervention strategies tailored to specific demographic groups.
Journal Article
Short-term outcomes of cochlear implantation for single-sided deafness compared to bone conduction devices and contralateral routing of sound hearing aids—Results of a Randomised controlled trial (CINGLE-trial)
by
Wendrich, Anne W.
,
Grolman, Wilko
,
Smit, Adriana L.
in
Adult
,
Aged
,
Biology and Life Sciences
2021
Single-sided deafness (SSD) leads to difficulties with speech perception in noise, sound localisation, and sometimes tinnitus. Current treatments (Contralateral Routing of Sound hearing aids (CROS) and Bone Conduction Devices (BCD)) do not sufficiently overcome these problems. Cochlear implants (CIs) may help. Our aim was to evaluate these treatments in a Randomised Controlled Trial (RCT). Adult SSD patients were randomised using a web-based randomisation tool into one of three groups: CI; trial period of ‘first BCD, then CROS’; trial period of ‘first CROS, then BCD’. After these trial periods, patients opted for BCD, CROS, or No treatment. The primary outcome was speech perception in noise (directed from the front (S 0 N 0 )). Secondary outcomes were speech perception in noise with speech directed to the poor ear and noise to the better ear (S pe N be ) and vice versa (S be N pe ), sound localisation, tinnitus burden, and disease-specific quality of life (QoL). We described results at baseline (unaided situation) and 3 and 6 months after device activation. 120 patients were randomised. Seven patients did not receive the allocated intervention. The number of patients per group after allocation was: CI (n = 28), BCD (n = 25), CROS (n = 34), and No treatment (n = 26). In S 0 N 0 , the CI group performed significantly better when compared to baseline, and when compared to the other groups. In S pe N be , there was an advantage for all treatment groups compared to baseline. However, in S be N pe , BCD and CROS groups performed worse compared to baseline, whereas the CI group improved. Only in the CI group sound localisation improved and tinnitus burden decreased. In general, all treatment groups improved on disease-specific QoL compared to baseline. This RCT demonstrates that cochlear implantation for SSD leads to improved speech perception in noise, sound localisation, tinnitus burden, and QoL after 3 and 6 months of follow-up. For most outcome measures, CI outperformed BCD and CROS. Trial registration: Netherlands Trial Register ( www.trialregister.nl ): NTR4580 , CINGLE -trial.
Journal Article
Comparison of laryngeal mask airway vs tracheal intubation: a systematic review on airway complications
by
van Esch, Babette F.
,
Stegeman, Inge
,
Smit, Adriana. L.
in
Airway complications
,
Airway management
,
Anesthesia
2017
To determine whether the laryngeal mask airway (LMA) has advantages over the tracheal tube (TT) in terms of incidence of cough, sore throat, laryngospasm, dysphagia, dysphonia, and blood staining. This is a systematic literature review performed at the Universtity Medical Center of Utrecht. The online databases PubMed, Embase, and the Cochrane Library were searched for relevant randomized controlled trials. Two independent reviewers selected relevant articles after title, abstract, and full text screening. Articles were assessed on risk of bias in accordance with the Cochrane risk of bias tool. Study results of the LMA and the TT were related to the method of selection of the device size and the method for cuff inflation. Of the 1718 unique articles, we included 19 studies which used the LMA Classic, the LMA Proseal, the Flexible Reinforced LMA, and the LMA Supreme compared with TT. After methodological inspection, data could not be pooled due to heterogeneity among the selected studies. Overall, no clear advantage of the LMA over the TT was found but the LMA Supreme was related to the lowest incidence of airway complications. In this review, no clear difference in incidence of postoperative airway complications could be demonstrated between LMA and TT. The LMA Supreme may reduce the incidence of airway complication in comparison to the TT but high quality randomized trials are recommended to further objectify if use of the LMA decreases the risk on postoperative airway complications.
•Postoperative airway complications after laryngeal mask airway (LMA) and tracheal tube.•There is no clear difference in postoperative airway complications.•The LMA Supreme is related to the lowest incidence of airway complications.•Heterogeneity restricts pooling of data.•Future trials are needed to objectify the possible advantages of the LMA.
Journal Article
The effect of the CONSORT statement on the amount of “unclear” Risk of Bias reporting in Cochrane Systematic Reviews
2020
The 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\".
In 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.
All 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.
Data 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)).
A slight decrease of \"unclear\" RoB reporting over time was found. To improve quality of reporting authors are encouraged to adhere to reporting guidelines.
Journal Article
Analysis and comparison of clinical practice guidelines regarding treatment recommendations for chronic tinnitus in adults: a systematic review
by
Smit, Adriana L
,
Assegaf, Saloua A
,
van der Leun, Josephine A
in
Clinical medicine
,
Clinical practice guidelines
,
Cognitive behavioral therapy
2023
ObjectivesTo determine if, and to what extent, published clinical practice guidelines for the treatment of chronic tinnitus vary in their recommendations.DesignSystematic review of guidelines.Data sourcesPubMed, EMBASE and GIN electronic databases were searched in March 2022 and the search was updated in June 2023.Eligibility criteriaWe included clinical practice guidelines that gave recommendations on the treatment of tinnitus. No language restrictions were applied.Data extraction and synthesisTwo independent reviewers extracted the data and used the AGREE checklist to report on reporting.ResultsA total of 10 guidelines were identified and included, published between 2011 and 2021. Recommendations for 13 types of tinnitus treatments were compared. Large differences in guideline development and methodology were found. Seven of the 10 guidelines included a systematic search of the literature to identify the available evidence. Six of the 10 guidelines used a framework for the development of the guideline. Reporting was poor in multiple guidelines. Counselling and cognitive behavioural therapy were the only treatments that were recommended for treating tinnitus associated distress by all guidelines that reported on these topics. Tinnitus retraining therapy, sound therapy, hearing aids and cochlear implantation were not unanimously recommended either due to the lack of evidence, a high risk of bias or judgement of no beneficial effect of the specific treatment.ConclusionsThere were notable differences with respect to whether guidelines considered the available evidence sufficient enough to make a recommendation. Notably, we identified substantial differences in the rigour of guideline design and development. Reporting was poor in many guidelines. Future guidelines could benefit from the use of reporting tools to improve reporting and transparency and the inclusion of guideline experts and patients to improve the quality of clinical practice guidelines on tinnitus.
Journal Article
Quality of life, hearing results, patient satisfaction and postoperative complications of day-case versus inpatient unilateral cochlear implantation in adults: a randomized controlled, equivalence trial
by
Grolman, Wilko
,
Derks, Laura S. M.
,
Stokroos, Robert J.
in
Adult
,
Cochlear Implantation - adverse effects
,
Cochlear Implantation - methods
2024
Objective
To investigate the hypothesis that day-case cochlear implantation is associated with equal quality of life, hearing benefits and complications rates, compared to inpatient cochlear implantation.
Study design
A single-center, non-blinded, randomized controlled, equivalence trial in a tertiary referral center.
Methods
Thirty adult patients with post-lingual bilateral sensorineural hearing loss eligible for unilateral cochlear implantation surgery were randomly assigned to either the day-case or inpatient treatment group. The effect on general quality of life, patient satisfaction, (subjective) hearing improvement, postoperative complications and causes of crossover and/or readmission were assessed using questionnaires, auditory evaluations and patients’ charts over a follow-up period of 1 year.
Results
Overall quality of life measured by the HUI3 was equal between the day-case (
n
= 14) and inpatient group (
n
= 14). The overall patients’ satisfaction showed a slight favor towards an inpatient approach. There was no significant difference in the subjective and objective hearing improvement between both treatment groups. During the 1-year follow-up period no major complications occurred. Minor complications occurred intraoperatively in three day-case patients resulting in three out of nine admissions of day-case patients. Other causes of admission of day-case patients were nausea and vomiting (
n
= 1), drowsiness (
n
= 1), late scheduled surgery (
n
= 2), social reasons (
n
= 1), or due to an unclear reason (
n
= 1). No patients required readmission.
Conclusion
We found equal outcomes of QoL, patient satisfaction, objective, and subjective hearing outcomes between day-case and inpatient unilateral cochlear implantation. Nine out of 14 day-case patients were admitted for at least one night postoperatively (crossover). No major complications occurred in both groups. A day-case approach seems feasible when using specific patient selection, surgical planning and the preoperative provision of patient information into account. Besides this, the familiarity with a day-case approach of both patient and the surgical team can increase the feasibility of day-case surgery.
Level of evidence
1.
Journal Article
Dizziness and imbalance and their association with general and mental health in a community-based cross-sectional study of middle-aged individuals: the Busselton healthy ageing study
2025
Background
Dizziness and imbalance are common symptoms among patients visiting healthcare providers. Current knowledge about their prevalence, impact on daily life, and associated factors is primarily based on selected samples from individuals seeking medical help, particularly older individuals. This study aimed to estimate the prevalence, symptoms, and impact of dizziness or imbalance symptoms, and to assess the association between these symptoms and their characteristics with demographic, general health, and mental health factors in middle-aged men and women from a representative, general population sample.
Methods
Cross-sectional data were collected from participants aged 45 to 70 years in the Busselton Healthy Ageing Study (BHAS), recruited in the City of Busselton, Western Australia. The data included physical tests and health-related questionnaires covering demographics, medical history, general and mental health, including any dizziness and imbalance symptoms and their impact on daily life. Estimates were made of the prevalence, patterns, and impact of dizziness and imbalance symptoms. Logistic regression was employed to calculate the association between demographic, mental and general health (independent variables) and the presence of dizziness or imbalance symptoms (dependent variable). Adjustments were made for sex and age as confounding factors.
Results
Of the 5086 participants, 1216 (23.9%) reported imbalance or dizziness, with light-headedness the most common type (64.3%; 782 of 1216). For nearly half (565; 46.5%) the imbalance or dizziness occasionally effected daily life, while for some, the impact was frequent (
n
= 50, 4.1%) or constant (
n
= 15, 1.2%). Being female (adjusted OR 2.05, 95%CI 1.79–2.34) and older in age (in years; adjusted OR 1.02, 95%CI 1.00-1.03), having a history of general health issues, and experiencing mental health problems or mental health symptoms were significantly associated with dizziness or imbalance symptoms.
Conclusions
Dizziness or imbalance are common symptoms among individuals aged 45 to 70 years and are associated with older age, being female, and poorer general and mental health. Given that approximately half of those affected reported occasional effects on daily life, with a few reporting frequent or constant effects, the outcomes of the study could help to raise awareness among healthcare providers about the prevalence, symptoms, and associated conditions.
Journal Article
Trial registration, publication rate and characteristics in the research field of otology: A cross-sectional study
by
Smit, Adriana L.
,
van Heteren, Jan A. A.
,
van Beurden, Isabeau
in
Bias
,
Biology and Life Sciences
,
Brain research
2019
To examine 1) the publication rate of registered otology trials in ClinicalTrials.gov, 2) the public availability of the results, 3) the study characteristics associated with publication, and 4) the time to publication after trial completion.
Publication bias, the publication or non-publication of research findings, depending on the nature and direction of results, is accountable for wrong treatment decisions. The extent of publication bias in otology trials has not been evaluated.
All registered otology trials were extracted from ClinicalTrials.gov with completion date up to December 2015. A search strategy was used to identify corresponding publications up to June 2017, providing at least 18 months to publish the results after trial completion. Characteristics were obtained from ClinicalTrials.gov and corresponding publications. Regression models were used to examine study characteristics associated with publication or non-publication.
From the 419 trials identified on ClinicalTrials.gov, 225 (53.7%) corresponding publications were found in PubMed. Among these, 109 (48.4%) publications were cited on ClinicalTrials.gov and 124 (55.1%) articles reported the National Clinical Trial registry number. For 36 (8.6%) trials, results were only reported in ClinicalTrials.gov. Trials with a biological intervention were more likely to be published than studies involving drugs (odds ratio (OR) 10.41, 95% confidence interval (CI) 1.26-86.22, P = 0.030). Trials funded by industry were less likely to be published (OR 0.46, CI 0.25-0.84, P = 0.011). The median trial duration was 20 months (interquartile range (IQR) 26 months), and median time from trial completion to publication was 24 months (IQR 22 months).
In 37.7% of the registered otology trials the results remained unpublished, even several years after trial completion. With little citations on ClinicalTrials.gov and low reporting of the Clinical Trial registry number, the accessibility is limited. Our findings show that there is room for improvement in accuracy of trial registration and publication of results, in order to diminish publication bias in otology studies.
Journal Article