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  1. Article ; Online: Diagnostic accuracy of the screenings Sniffin' Sticks Test (SST-12) in COVID-19 induced olfactory disorders.

    Schepens, Emma J A / Stegeman, Inge / Kamalski, Digna M A

    PloS one

    2024  Volume 19, Issue 1, Page(s) e0295911

    Abstract: Objective olfactory function can be assessed using validated olfactory tests like the Sniffin' Sticks Test (SST). However, their extensive nature makes them less suitable for clinical practice. To address this, shorter olfactory tests like the screenings ...

    Abstract Objective olfactory function can be assessed using validated olfactory tests like the Sniffin' Sticks Test (SST). However, their extensive nature makes them less suitable for clinical practice. To address this, shorter olfactory tests like the screenings Sniffin' Sticks Test (SST-12) can be used for screening purposes and reduce testing time. The SST-12 serves as a diagnostic tool for screening olfaction in cases unrelated to COVID-19. However, these screening tests are uncertain regarding their accuracy in detecting olfactory dysfunction in patients with COVID-19 as the plausible cause. We aim to determine the diagnostic accuracy of the SST-12 in adults with post-COVID-19 olfactory dysfunction. We performed a diagnostic accuracy study with data from 113 consecutive COVID-19 diagnosed patients who experienced objectified smell loss ever since. At approximately 6 months after their diagnosis, all participants underwent the SST (reference standard), part of the SST was the SST-12 (index test). Diagnostic accuracy of the SST-12 is measured as negative predictive value (NPV), positive predictive value (PPV), sensitivity, and specificity. The SST-12 detected smell loss in 85 patients among 91 patients with smell loss and ruled out smell loss in 15 patients among the 22 patients without smell loss based on the reference standard. Making sensitivity 93.4% (CI 0.87-0.97), and specificity 68.2% (CI 0.48-0.85). Out of the 92 patients with a positive test result on SST-12, 85 patients had indeed smell loss (PPV 92.4% CI 0.86-0.97), and out of the 21 patients with a negative test result, 15 patients had no smell loss regarding the reference standard (NPV 71.4% CI 0.50-0.88). The findings suggest that the SST-12 holds promise as a useful tool for identifying individuals with smell loss, also in individuals with COVID-19 as cause, but it is important to have a good understanding of the interpretation of the results of the SST-12 when considering its implementation in clinical practice.
    MeSH term(s) Adult ; Humans ; Anosmia ; COVID-19/complications ; COVID-19/diagnosis ; Olfaction Disorders/diagnosis ; Smell ; Reference Standards ; COVID-19 Testing
    Language English
    Publishing date 2024-01-10
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2267670-3
    ISSN 1932-6203 ; 1932-6203
    ISSN (online) 1932-6203
    ISSN 1932-6203
    DOI 10.1371/journal.pone.0295911
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: The effect of smell training on COVID-19 induced smell loss.

    Schepens, E J A / de Haas, C J M / Postma, E M / van Dijk, B / Boesveldt, S / Stegeman, I / Kamalski, D M A

    Rhinology

    2024  

    Abstract: Objective: while smell training appears to be effective for post viral smell loss, its effectiveness in COVID-19 induced smell loss is currently not well known. Therefore, we aim to investigate the potential effect of smell training on patients with ... ...

    Abstract Objective: while smell training appears to be effective for post viral smell loss, its effectiveness in COVID-19 induced smell loss is currently not well known. Therefore, we aim to investigate the potential effect of smell training on patients with COVID-19 induced smell loss.
    Methods: we conducted a case-control study with two comparable cohorts. One of which (n=111) was instructed to perform smell training twice daily for 12 weeks, therapeutical adherence was monitored on a daily schedule, while the other cohort (n=50) did not perform smell training. The Sniffin' Sticks Test (SST) was used to objectify participants' sense of smell at baseline and after 12 weeks, reported as a Threshold, Discrimination, and Identification (TDI) score. We also determined the association between therapeutical adherence and the TDI scores.
    Results: we found a significant difference in psychophysical smell function between patients with COVID-19 induced smell disorders who performed 12 weeks of smell training and those who did not. Median TDI difference between groups was 2.00 However, there was no association between the therapeutical adherence and olfactory function.
    Conclusion: we discovered a significant moderate difference in psychophysical smell function between patients with COVID-19-induced smell disorders who performed smell training and those who did not, implying a possible advantage of training. However, no relationship was found between therapeutical adherence of smell training and olfactory function.
    Language English
    Publishing date 2024-03-06
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 80336-4
    ISSN 0300-0729
    ISSN 0300-0729
    DOI 10.4193/Rhin23.191
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  3. Article: Prediction Models for Tinnitus Presence and the Impact of Tinnitus on Daily Life: A Systematic Review.

    Rademaker, Maaike M / Meijers, Sebastiaan M / Smit, Adriana L / Stegeman, Inge

    Journal of clinical medicine

    2023  Volume 12, Issue 2

    Abstract: The presence of tinnitus does not necessarily imply associated suffering. Prediction models on the impact of tinnitus on daily life could aid medical professionals to direct specific medical resources to those (groups of) tinnitus patients with specific ... ...

    Abstract The presence of tinnitus does not necessarily imply associated suffering. Prediction models on the impact of tinnitus on daily life could aid medical professionals to direct specific medical resources to those (groups of) tinnitus patients with specific levels of impact. Models of tinnitus presence could possibly identify risk factors for tinnitus. We systematically searched the PubMed and EMBASE databases for articles published up to January 2021. We included all studies that reported on multivariable prediction models for tinnitus presence or the impact of tinnitus on daily life. Twenty-one development studies were included, with a total of 31 prediction models. Seventeen studies made a prediction model for the impact of tinnitus on daily life, three studies made a prediction model for tinnitus presence and one study made models for both. The risk of bias was high and reporting was poor in all studies. The most used predictors in the final impact on daily life models were depression- or anxiety-associated questionnaire scores. Demographic predictors were most common in final presence models. No models were internally or externally validated. All published prediction models were poorly reported and had a high risk of bias. This hinders the usability of the current prediction models. Methodological guidance is available for the development and validation of prediction models. Researchers should consider the importance and clinical relevance of the models they develop and should consider validation of existing models before developing new ones.
    Language English
    Publishing date 2023-01-16
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 2662592-1
    ISSN 2077-0383
    ISSN 2077-0383
    DOI 10.3390/jcm12020695
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Effect of electrical stimulation with a cochlear implant on tinnitus impact: protocol of an individual patient data meta-analysis.

    Assouly, Kelly / Smit, Adriana L / Stegeman, Inge

    BMJ open

    2022  Volume 12, Issue 6, Page(s) e063432

    Abstract: Introduction: Tinnitus is the perception of sound without an external stimulus, often experienced as a ringing, buzzing sound. While several studies have shown a reduction in tinnitus distress following cochlear implantation, others showed an increase ... ...

    Abstract Introduction: Tinnitus is the perception of sound without an external stimulus, often experienced as a ringing, buzzing sound. While several studies have shown a reduction in tinnitus distress following cochlear implantation, others showed an increase or no change after implantation. At this stage, clinicians have little certainty when counselling their patients prior to implantation regarding tinnitus post-implantation. To help clinicians to counsel cochlear implant (CI) candidates on the risk of developing or improving tinnitus after implantation, we aim to assess the effect of electrical stimulation with a CI on tinnitus impact for individual adult patients with tinnitus. We will also apply prediction models to individual patient data (IPD) of clinical trials to find predictive factors of the effect of electrical stimulation on tinnitus impact.
    Method and analysis: The IPD meta-analysis is a follow-up project of the systematic review on cochlear implantation in patients with tinnitus as a primary complaint. First, the systematic searches will be updated to date. Methodological quality of eligible studies will be assessed using the Risk of Bias In Non-randomised Studies of Intervention tool (ROBINS-I). Based on a data-sharing agreement, authors of the eligible studies will be invited to share their deidentified and complete IPD. The primary outcome is the effect of electrical stimulation with a CI on tinnitus impact 1 month or more post-implantation. IPD meta-analysis will be used to assess the primary outcome, while differentiating the tinnitus impact questionnaires. Second, linear regression analyses will be used to model the effect of electrical stimulation on tinnitus impact based on relevant predictors.
    Ethics and dissemination: The Medical Research Involving Human Subject Act does not apply, and ethical approval is not required. The study results will be made accessible to the public in a peer-review open access journal.
    Prospero registration number: CRD42022319367, review ongoing.
    MeSH term(s) Adult ; Humans ; Cochlear Implantation ; Cochlear Implants ; Electric Stimulation ; Risk Factors ; Surveys and Questionnaires ; Tinnitus/prevention & control ; Tinnitus/therapy ; Meta-Analysis as Topic ; Systematic Reviews as Topic
    Language English
    Publishing date 2022-06-17
    Publishing country England
    Document type Journal Article
    ZDB-ID 2599832-8
    ISSN 2044-6055 ; 2044-6055
    ISSN (online) 2044-6055
    ISSN 2044-6055
    DOI 10.1136/bmjopen-2022-063432
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  5. Article: Cochlear Implant Awareness: Development and Validation of a Patient Reported Outcome Measure.

    Markodimitraki, Laura M / Stegeman, Inge / Thomeer, Hans G X M

    Frontiers in neuroscience

    2022  Volume 16, Page(s) 830768

    Abstract: Background: Surgical success of cochlear implantation is usually measured through speech perception and quality of life questionnaires. Although these questionnaires cover a broad spectrum of domains, they do not evaluate the consciousness of wearing a ... ...

    Abstract Background: Surgical success of cochlear implantation is usually measured through speech perception and quality of life questionnaires. Although these questionnaires cover a broad spectrum of domains, they do not evaluate the consciousness of wearing a cochlear implant (CI) and how this impacts the daily life of patients. To evaluate this concept we aimed to develop and validate a standardized patient reported outcome measure (PROM) for use in cochlear implant users.
    Methods: Development and evaluation of the COchlear iMPlant AwareneSS (COMPASS) questionnaire was realized following the COSMIN guidelines in three phases: (1) item generation, (2) qualitative pilot study to ensure relevance, comprehensiveness, comprehensibility, and face validity, and (3) quantitative survey study for the assessment of reliability (test-retest) with 54 participants.
    Results: Nine domains of CI awareness were identified through literature research and interviews with experts and patients. These resulted in the formulation of 18 items which were tested with a pilot study, after which 3 items were deleted. The final 15-item COMPASS questionnaire proved to have good validity and satisfactory reliability. The intraclass correlation coefficient calculated for items with continuous variables ranged from 0.66 to 0.89 with seven out of eight items scoring above the acceptable level of 0.7. The Cohen's kappa calculated for items with nominal variables ranged from -0.4 to 0.78 with 11 (sub)items out of 15 scoring above fair to good agreement. Measurement error analysis for items with continuous variables showed a mean difference of -2.18 to 0.22. The calculated 95% limits of agreement for these items revealed no statistically significant difference between the two administered questionnaires. For items with nominal variables, the percentages of agreement calculated, ranged between 0 and 95%, and 83.3 and 96.6% for positive and negative agreement, respectively.
    Conclusion: The COMPASS questionnaire is a valid and reliable PROM for evaluating the cochlear implant awareness, and it can be easily used in routine clinical practice.
    Language English
    Publishing date 2022-04-29
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2411902-7
    ISSN 1662-453X ; 1662-4548
    ISSN (online) 1662-453X
    ISSN 1662-4548
    DOI 10.3389/fnins.2022.830768
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Meta-analyses of diagnostic test accuracy could not be reproduced.

    Stegeman, Inge / Leeflang, Mariska M G

    Journal of clinical epidemiology

    2020  Volume 127, Page(s) 161–166

    Abstract: Background and objectives: The aim of our study was to investigate the reproducibility of diagnostic accuracy meta-analyses, as reported in published systematic reviews.: Study design and setting: We selected all systematic reviews of diagnostic test ...

    Abstract Background and objectives: The aim of our study was to investigate the reproducibility of diagnostic accuracy meta-analyses, as reported in published systematic reviews.
    Study design and setting: We selected all systematic reviews of diagnostic test accuracy containing a meta-analysis, published in January 2018 and retrieved in Medline through Ovid. All reviews reported a summary estimate of sensitivity and specificity. We requested the protocol from their authors and used the protocol and the information in the published review to reproduce the reported meta-analysis. Successful reproduction was defined as a result differing <1% point from the reported point estimates; or reported primary study results that were in line with those of the actual primary study results; or if the data from the primary studies could be extracted without checking the data in the review first.
    Results: Of the 51 included reviews, 16 had a protocol registered in PROSPERO and five of those responded to our request for a protocol. Nineteen reviews (37%) provided the 2×2 tables that were included in the meta-analysis. In 14 of those, the outcome of the meta-analysis could be reproduced. Considering the correctness of the numbers from the primary articles and the complete reporting of the search strategy, only one meta-analysis was fully replicable.
    Conclusion: Published meta-analyses of diagnostic test accuracy were poorly replicable. This was partly because of lack of information about the methods and data used, and partly because of mistakes in the data extraction or data reporting.
    MeSH term(s) Data Accuracy ; Data Analysis ; Data Collection/methods ; Diagnostic Tests, Routine/standards ; Humans ; Information Storage and Retrieval/methods ; Meta-Analysis as Topic ; Reproducibility of Results ; Research Report/standards ; Sensitivity and Specificity ; Systematic Reviews as Topic
    Language English
    Publishing date 2020-07-15
    Publishing country United States
    Document type Journal Article
    ZDB-ID 639306-8
    ISSN 1878-5921 ; 0895-4356
    ISSN (online) 1878-5921
    ISSN 0895-4356
    DOI 10.1016/j.jclinepi.2020.06.033
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  7. Article ; Online: Tinnitus treatment by vagus nerve stimulation: A systematic review.

    Stegeman, I / Velde, H M / Robe, P A J T / Stokroos, R J / Smit, A L

    PloS one

    2021  Volume 16, Issue 3, Page(s) e0247221

    Abstract: Background: Tinnitus is a phantom sensation of sound, which can have a negative impact on quality of life of those affected. No curative treatments are currently known. Neuromodulation by vagus nerve stimulation has emerged as a new treatment option for ...

    Abstract Background: Tinnitus is a phantom sensation of sound, which can have a negative impact on quality of life of those affected. No curative treatments are currently known. Neuromodulation by vagus nerve stimulation has emerged as a new treatment option for tinnitus, though till date the effectiveness remains unclear. Therefore, we aim to review the effect of vagus nerve stimulation on tinnitus distress and tinnitus symptom severity in patients with chronic tinnitus.
    Methods: We searched Pubmed, Embase and the Cochrane Library systematically for RCTs, observational studies and case studies on the effect of VNS treatment for tinnitus on October 29, 2019. Studies including adult patients with subjective tinnitus, comparing transcutaneous or implantable VNS to placebo or no treatment or before and after application of VNS treatment on tinnitus distress and tinnitus symptom severity measured with a validated questionnaire were eligible. The risk of bias was assessed with the appropriate tool for each type of study.
    Results: Our search identified 9 primary studies of which 2 RCTs, 5 cohort studies and 2 case series or reports. 5 studies used transcutaneous VNS treatment and 4 used implanted VNS treatment. 6 studies combined VNS treatment with sound therapy. There was a serious risk of bias in all studies, especially on confounding. Most studies reported a small decrease in tinnitus distress or tinnitus symptom severity.
    Conclusion: Due to methodological limitations and low reporting quality of the included studies, the effect of VNS on tinnitus remains unclear. To draw conclusions for which patient population and to what extent (t)VNS is beneficial in the treatment of tinnitus, a randomised controlled trial should be considered.
    MeSH term(s) Acoustic Stimulation ; Female ; Humans ; Male ; Quality of Life ; Sound ; Tinnitus/physiopathology ; Tinnitus/therapy ; Treatment Outcome ; Vagus Nerve/physiology ; Vagus Nerve Stimulation/methods
    Language English
    Publishing date 2021-03-11
    Publishing country United States
    Document type Journal Article ; Systematic Review
    ISSN 1932-6203
    ISSN (online) 1932-6203
    DOI 10.1371/journal.pone.0247221
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  8. Article ; Online: Prediction models for clinical outcome after cochlear implantation: a systematic review.

    Velde, H M / Rademaker, M M / Damen, Jaa / Smit, A L / Stegeman, I

    Journal of clinical epidemiology

    2021  Volume 137, Page(s) 182–194

    Abstract: Objectives: Cochlear implants (CIs) are implantable hearing devices with a wide variation in clinical outcome between patients. We aim to provide an overview of the literature on prediction models and their performance for clinical outcome after ... ...

    Abstract Objectives: Cochlear implants (CIs) are implantable hearing devices with a wide variation in clinical outcome between patients. We aim to provide an overview of the literature on prediction models and their performance for clinical outcome after cochlear implantation in bilateral hearing loss or deafness.
    Study design and setting: In this systematic review, studies describing the development or external validation of a multivariable model for predicting clinical CI outcome were eligible for selection.
    Results: A total of 4,042 references were screened. We included nine development studies and one external validation study. The outcome measure of all development studies was speech perception performance after cochlear implantation. The most commonly used model predictors were duration of hearing loss or deafness (n = 7), different types of preoperative measurements (n = 5), and etiology (n = 3). In three studies, crucial information to enable the model to be used for individual risk prediction was missing. One study performed internal validation,two models were externally validated. One study reported specific discrimination or calibration performance measures.
    Conclusion: Although many articles describe development studies of prediction models for speech perception performance after cochlear implantation, the value of most of these models for their application in clinical practice remains unclear. Therefore, research should focus on increasing the clinical relevance of existing CI outcome prediction models.
    MeSH term(s) Cochlear Implantation ; Forecasting ; Humans ; Models, Statistical ; Treatment Outcome
    Language English
    Publishing date 2021-04-20
    Publishing country United States
    Document type Journal Article ; Systematic Review
    ZDB-ID 639306-8
    ISSN 1878-5921 ; 0895-4356
    ISSN (online) 1878-5921
    ISSN 0895-4356
    DOI 10.1016/j.jclinepi.2021.04.005
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  9. Article ; Online: A monocenter, patient-blinded, randomized, parallel-group, non-inferiority study to compare cochlear implant receiver/stimulator device fixation techniques (COMFIT) with and without drilling in adults eligible for primary cochlear implantation.

    Markodimitraki, Laura M / Harkel, Timen C Ten / Bennink, Edwin / Stegeman, Inge / Thomeer, Hans G X M

    Trials

    2023  Volume 24, Issue 1, Page(s) 605

    Abstract: Background: During the cochlear implantation procedure, the receiver/stimulator (R/S) part of the implant is fixated to prevent postoperative device migration, which could have an adverse effect on the position of the electrode array in the cochlea. We ... ...

    Abstract Background: During the cochlear implantation procedure, the receiver/stimulator (R/S) part of the implant is fixated to prevent postoperative device migration, which could have an adverse effect on the position of the electrode array in the cochlea. We aim to compare the migration rates of two fixation techniques, the bony recess versus the subperiosteal tight pocket without bony sutures.
    Methods and analysis: This single-blind randomized controlled trial will recruit a total of 112 primary cochlear implantation adult patients, eligible for implantation according to the current standard of practice. Randomization will be performed by an electronic data capture system Castor EDC, with participants block randomized to either bony recess or standard subperiosteal tight pocket in a 1:1 ratio, stratified by age. The primary outcome of this study is the R/S device migration rate; secondary outcomes include patient-experienced burden using the validated COMPASS questionnaire, electrode migration rate, electrode impedance values, speech perception scores, correlation between R/S migration, electrode array migration and patient complaints, assessment of complication rates, and validation of an implant position measurement method. Data will be collected at baseline, 1 week, 4 weeks, 8 weeks, 3 months, and 12 months after surgery. All data analyses will be conducted according to the intention-to-treat principle.
    Discussion: Cochlear implantation by means of creating a tight subperiosteal pocket without drilling a bony seat is a minimally invasive fixation technique with many advantages. However, the safety of this technique has not yet been proven with certainty. This is the first randomized controlled trial that directly compares the minimally invasive technique with the conventional method of drilling a bony seat.
    Trial registration: Netherlands Trial Register NL9698. Registered on 31 August 2021.
    MeSH term(s) Humans ; Adult ; Cochlear Implantation/adverse effects ; Cochlear Implants/adverse effects ; Single-Blind Method ; Cochlea ; Embryo Implantation
    Language English
    Publishing date 2023-09-24
    Publishing country England
    Document type Randomized Controlled Trial ; Journal Article
    ZDB-ID 2040523-6
    ISSN 1745-6215 ; 1468-6694 ; 1745-6215
    ISSN (online) 1745-6215
    ISSN 1468-6694 ; 1745-6215
    DOI 10.1186/s13063-023-07568-7
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  10. Article: A Comparative Analysis of the Incidence, Severity and Duration of Smell and Taste Loss in COVID-19 Cases Versus Non-COVID-19 Cases: A Longitudinal Cohort Study.

    Schepens, Emma J A / Kamalski, Digna M A / Stegeman, Inge / Lifelines Corona Research Initiative

    Journal of clinical medicine

    2023  Volume 12, Issue 19

    Abstract: The COVID-19 pandemic has highlighted the relevance of olfactory and gustatory disorders. However, these symptoms can also be caused by various other factors. In this study we aimed to compare the incidence, severity and duration between COVID-19 related ...

    Abstract The COVID-19 pandemic has highlighted the relevance of olfactory and gustatory disorders. However, these symptoms can also be caused by various other factors. In this study we aimed to compare the incidence, severity and duration between COVID-19 related and non-COVID-19 related smell and taste disorders. We conducted a longitudinal cohort study using data from the Dutch biobank Lifelines, which includes over 167,000 participants. The data were collected using 27 questionnaires distributed between March 2020 and May 2022. Descriptive data and the incidence of smell and taste loss in both groups were calculated. To visualize the proportion of severity rates of symptoms, a heatmap was created. A survival analysis was conducted and presented in a reversed Kaplan-Meier curve to show the probability of having persistent smell loss in both groups. The study included 235,722 participants. The incidence of smell loss was higher in the COVID-19 positive group, when compared to the COVID-19 negative group. We found varying degrees of symptom severity in COVID-19 positive cases, ranging from mild to severe, while non-COVID-19 related cases mostly reported mild symptoms. The survival outcome for smell and taste loss was 0.12 (SE 0.03, 95% CI 0.07-0.21) in COVID-19 related cases, and was 0.17 (SE 0.03, 95% CI 0.12-0.24) in cases related to other causes. This study reveals a higher incidence and severity of smell and taste loss in individuals with COVID-19 compared to non-COVID-19 related cases. However, non-COVID-19 related smell and taste loss tend to have a longer duration.
    Language English
    Publishing date 2023-09-28
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2662592-1
    ISSN 2077-0383
    ISSN 2077-0383
    DOI 10.3390/jcm12196267
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