Development and internal validation of a prediction model for the presence of tinnitus in a Dutch population-based cohort.

Objectives: In this study we aim to develop and internally validate a prediction model on tinnitus experience in a representative sample of the Dutch general population. Methods: We developed a multivariable prediction model using elastic net logistic regression with data from the Dutch Lifelines Cohort Study. This is a multigenerational cohort study on adults who are located in the northern parts of the Netherlands. The model was internally validated using 10-fold cross-validation. The outcome of the model was tinnitus presence, for which we used 24 candidate predictors on different domains (among others demographic, hearing specific, and mental health variables). We assessed the overall predictive performance, discrimination, and calibration of the model. Results: Data on 122.884 different participants were included, of which 7,965 (6.5%, 0 missing) experienced tinnitus. Nine variables were included in the final model: sex, hearing aids, hearing limitations, arterial blood pressure, quality of sleep, general health, symptom checklist of somatic complaints, cardiovascular risk factors, and age. In the final model, the Brier score was 0.056 and 0.787 in internal validation. Conclusion: We developed and internally validated a prediction model on tinnitus presence in a multigenerational cohort of the Dutch general population. From the 24 candidate predictors, the final model included nine predictors.

Prediction Models for Tinnitus Presence and the Impact of Tinnitus on Daily Life: A Systematic Review.

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.

Associations between Demographics, Tinnitus Specific-, Audiological-, General- and Mental Health Factors, and the Impact of Tinnitus on Daily Life.

Our objective was to study associations between demographics, tinnitus specific-, audiological-, general- and mental health characteristics, and impact of tinnitus in the general population. In this cross-sectional survey study in the Dutch population, data were prospectively gathered. Tinnitus impact was assessed with the Tinnitus Functional Index (TFI). We included participants who experienced tinnitus and for whom a total TFI score could be calculated (n = 212). We performed univariable and multivariable regression analyses. Due to logarithmical transformation, the B-scores were back-transformed to show the actual difference in points on the TFI. People who considered hyperacusis a small problem had a 12.5-point higher TFI score, those who considered it a mediocre problem had a 17.6-point higher TFI score and those who considered it a large problem had a 24.1-point higher TFI score compared to people who did not consider hyperacusis a problem. People who indicated having minor hearing problems had a 10.5-point higher TFI score, those with mediocre hearing problems had a 20.4-point higher TFI score and those with severe hearing problems had a 41.6-point higher TFI score compared to people who did not have subjective hearing problems. In conclusion, audiological risk factors, such as hearing problems and hyperacusis, have the largest association with the impact of tinnitus on daily life, compared to other assessed variables. The results of this study can be used in future research to find targeted interventions to diminish the impact of tinnitus.

Correlation Between Chronic Tinnitus Distress and Symptoms of Depression: A Systematic Review.

Objectives: In this systematic review, we aim to evaluate the evidence regarding the correlation between tinnitus distress and the severity of depressive symptoms in patients with chronic tinnitus. Also, the prevalence of clinically relevant depressive symptoms scores in patients with chronic tinnitus was evaluated. Methods: We performed a systematic review in PubMed, EMBASE, and the Cochrane library in June 2021 using the terms "depression" and "tinnitus," and their synonyms, following PRISMA guidelines. Studies were selected on relevance and critically appraised regarding risk of bias using the Newcastle-Ottowa Quality Assessment Scale. Results: A total of 1,912 articles were screened on title and abstract after the removal of the duplicates. Eventually, 33 (1.5%) articles were included for the final analysis. Only cross-sectional cohort studies and case-control studies with a low level of evidence and a high risk of bias due to the study design and patient selection were found. Statistically significant correlations between the experienced tinnitus distress and depressive symptoms were reported in 31 out of 33 studies. Clinically relevant depression scores had a prevalence of 4.6-41.7%. Conclusions: In this systematic review, in which mostly cross-sectional studies were included, a statistically significant correlation was found between the experienced tinnitus distress and the reported severity of symptoms of depression in patients with chronic tinnitus. A wide range of clinically relevant depression scores were reported in included studies. Due to the high risk of bias of included studies it is not possible to provide a definite answer on the existence of this relationship. Future population-based studies are necessary to provide more clarity.

Using Different Cutoffs to Define Tinnitus and Assess Its Prevalence-A Survey in the Dutch General Population.

Introduction: Tinnitus prevalence numbers in the literature range between 5 and 43%, depending on the studied population and definition. It is unclear when tinnitus becomes pathologic. Objectives: To assess the tinnitus prevalence in the Dutch general population with different cutoffs for definition. Methods: In this cross-sectional study, a questionnaire was sent to a sample (n = 2,251) of the Nivel (Netherlands Institute for Health Services Research) Dutch Health Care Consumer Panel. Three questions were asked to assess the presence of tinnitus, duration, and frequency of the complaint. We classified people as having pathologic tinnitus when participants experienced it for 5-60 min (daily or almost daily or weekly), or tinnitus for >60 min or continuously (daily or almost daily or weekly or monthly), so tinnitus impact on daily life was measured with the Tinnitus Functional Index (TFI) and a single-item question. Answers were stratified to mid-decade years of age. Prevalence numbers were weighted by gender and age to match the Dutch population. Results: Nine hundred thirty-two of 2,251 participants (41%) filled out the questionnaire. The median age was 67.0 (IQR 17) years. Three hundred thirty-eight of 932 (36%) experienced tinnitus for an undefined amount of time during the last year. Two hundred sixteen of 932 (23%) met our definition of having pathologic tinnitus (21% when weighted for age and gender). The median TFI score for all pathologic tinnitus participants was 16.6 (IQR 21.8). A percentage of 50.4% of the pathologic tinnitus participants had a TFI in the range 0-17, which can be interpreted as not a problem. Conclusion: Twenty-three percent (unweighted) or 21% (weighted) of our sample met our definition of pathologic tinnitus, which was based on a combination of duration and frequency over the last year. The TFI score of 47.7% of the pathologic tinnitus participants is ≥18. This indicates that they consider the tinnitus to be at least "a small problem" [11.1% (unweighted) or 8.9% (weighted) of the total study group]. This study illustrates the difficulties with defining pathologic tinnitus. In addition, it demonstrates that tinnitus prevalence numbers vary with different definitions and, consequently, stresses the importance of using a uniform definition of tinnitus.

Patients with tinnitus use more primary healthcare compared to people without tinnitus.

Tinnitus is a heterogeneous condition not only in terms of nature of the sound, but also in co-morbidities such as mental health issues. Prevalence number range widely between 5 and 43%. Even though the etiologic pathway between tinnitus and its comorbidities remains unclear, in this study we aim to assess whether people with tinnitus use more primary health care than people without tinnitus. To compare primary healthcare consumption between patients with tinnitus and people without tinnitus. In this cross-sectional study, data on number of consultations with the general practitioner or nurse practitioner mental health services were obtained from Nivel (Netherlands Institute for Health Service Research) Primary Care Database in 2018 (n = 963,880 people). People with an open tinnitus episode (n = 8050) were defined as a patient with tinnitus and compared to all other people. Percentages, means, ranges and mean differences were calculated for the total number of consultations and for organ specific diagnoses registered as ICPC-1 code on the day of consultation. Secondary, the total number of referrals to medical specialists and number of drug prescriptions was collected. Logistic regressions were performed to predict having one or more contacts, referrals, and prescriptions,with having tinnitus, this was corrected for age and gender. Patients with tinnitus had a mean of 9.8 (SD 10.9) primary care consultations in 2018, compared to 5.7 (SD 7.9) for people without tinnitus. More patients with tinnitus had more than one referral to medical specialists (47%) compared to people without tinnitus (25%). Patients with tinnitus have 1.2 (mean difference) more drug prescriptions than people without tinnitus. Compared to people without tinnitus, patients with tinnitus were more likely to have one or more of primary healthcare contact, independent of age group and gender. Patients with tinnitus had more consultations in primary health care than people without tinnitus. They are more often referred to medical specialists and receive more drug prescriptions. The causal relationship between tinnitus and the higher healthcare consumption remains to be researched.

What Tinnitus Therapy Outcome Measures Are Important for Patients?- A Discrete Choice Experiment.

Introduction: The therapeutic rationale varies among tinnitus therapies. A recent study identified which outcome measures should be used for different types of interventions. What patients consider the most important outcome measure in tinnitus therapy is unclear. Objectives: To study the preference of the tinnitus patient for different outcome measures in tinnitus therapy. Methods: A discrete choice experiment was conducted. Participants were provided with two alternatives per choice set (nine choice sets total). Each choice-set consisted of four attributes (tinnitus loudness, tinnitus acceptance, quality of sleep and concentration). With a difference in one of three levels (increased, similar or decreased after treatment) between the alternatives. Results were analyzed with a mixed logit model. Preference heterogeneity was explored with covariates, correlating attributes and a latent class analysis. Results: One hundred and twenty-seven participants took part. In the mixed logit models we found that the choice for a tinnitus therapy was significantly affected by all levels of the outcomes, except for a similar level in concentration and tinnitus acceptance. Tinnitus loudness was considered the most important outcome measure relative to the other attributes. Preference heterogeneity was not explained by correlating attributes. The latent class analysis identified two classes. The first class was similar to the mixed logit analysis, except for a non-significance of similar quality of sleep and tinnitus acceptance. The second class showed a statistical significant preference only for increased tinnitus acceptance and similar quality of sleep. Conclusion: Based on this study, tinnitus patients consider loudness the most important outcome measure. However, there is a variance in preference as indicated by the latent class analysis. This study underlines the importance of research into tinnitus heterogeneity. Next, this study highlights the need for research into tinnitus therapies that focus on diminishing tinnitus loudness.

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

BACKGROUND: 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". OBJECTIVE: 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. METHODS: 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. RESULTS: 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)). CONCLUSION: A slight decrease of "unclear" RoB reporting over time was found. To improve quality of reporting authors are encouraged to adhere to reporting guidelines.

MinT-trial: Mindfulness versus cognitive behavioural therapy in Tinnitus patients: protocol for a randomised controlled, non-inferiority trial.

INTRODUCTION: Chronic subjective tinnitus is a condition that affects 5.1% to 42.7% of the population, depending on the definition and studied population. Evidence-based treatment options are limited. Cognitive Behavioural Therapy (CBT) has been proven effective to improve quality of life and to diminish tinnitus distress. Positive short-term effects of mindfulness-based interventions on tinnitus distress have been reported; however, the longer term effects remain to be studied. METHODS AND ANALYSIS: We designed a monocentre randomised controlled, non-inferiority trial to compare the effectiveness of mindfulness-based cognitive therapy (MBCT) and CBT in chronic tinnitus patients. Fifty-four patients (≥32 on the Tinnitus Functional Index (TFI), suffering from tinnitus for at least 6 months) will be included in the trial and randomised into one of two intervention groups. One group will receive MBCT, the other group will receive CBT. Our primary objective is to determine whether MBCT is non-inferior to (as good as) CBT on tinnitus distress (TFI) in chronic tinnitus patients at 12 months follow-up after end of therapy. Non-inferiority will be declared if the mean decrease in TFI score for MBCT is no worse than the mean decrease in TFI score in CBT, with statistical variability, with a margin of 13 points. Most secondary objectives (tinnitus severity of problem, tinnitus intrusiveness, quality of life, anxiety, depression, symptoms of psychopathology, perceived tinnitus complaints, coping style (mostly validated questionnaires)) are expected to show non-inferiority to MBCT compared with CBT. We expect a significant difference between MBCT and CBT for mindfulness awareness. ETHICS AND DISSEMINATION: This research protocol was approved by the Institutional Review Board of the UMC Utrecht (NL67838.041.18, V.4, April 2019). The trial results will be made accessible to the public in a peer-review journal. TRIAL REGISTRATION NUMBER: NL7745.

Attitude and behaviour of Dutch Otorhinolaryngologists to Evidence Based Medicine.

OBJECTIVE: The objective of this study was to assess the attitude and behaviour of Dutch ENT surgeons and ENT residents towards Evidence Based Medicine. INTRODUCTION: Evidence Based Medicine is the cornerstone of modern clinical care. It is considered of crucial importance for optimal patient care and health care quality. Practicing it requires positive attitude and behaviour. Little is known about the attitude and behaviour towards Evidence Based Medicine in otorhinolaryngology. METHODS: We performed a web-based questionnaire among 607 Dutch Ear- Nose & Throat surgeons of whom 106 residents (cross-sectional study). The questionnaire consisted of 3 parts; (1) personal characteristics, (2) questions regarding Evidence Based Medicine attitude (McColl questionnaire, scale 0-100%) and (3) questions regarding Evidence Based Medicine behaviour (barriers and information seeking behaviour). Data were collected between March 26th 2018 and June 1st 2018. RESULTS: The median score on the overall McColl questionnaire was 50 (IQR 35). The main barriers respondents experienced were time related. Limited time in the outpatient clinic was considered a more important barrier for residents to practice EBM compared to ENT surgeons. Respondents' gut feeling and their own preference were identified as the main contributing factors in clinical decision making. CONCLUSION: In conclusion Dutch ENT surgeons have a moderate attitude on the McColl questionnaire. The main barriers to practice Evidence Based Medicine they experience are time related.

The Effect of Mindfulness-Based Interventions on Tinnitus Distress. A Systematic Review.

Objectives: With this systematic review we aim to provide an overview of the evidence of the effect of Mindfulness Based Interventions (MBIs) on (1) tinnitus distress and (2) anxiety and/or depression in tinnitus patients. Methods: We conducted a systematic search in PubMed Medline, EMBASE and PsycInfo combining the terms and synonyms of "Tinnitus" and "Mindfulness." The most recent search was performed on December 4th 2018. We wrote this systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Two independent authors identified studies, assessed the risk of bias and extracted data. Studies were considered eligible if they included adults with tinnitus, performed a protocolled MBI and measured tinnitus distress with validated questionnaires. Studies were appraised with either the Cochrane Risk of Bias tool or the MINORS criteria, depending on their design. Results: The systematic search yielded seven articles (425 patients). Three randomized controlled trials (RCTs), three cohort studies and one comparative controlled trial. Different types of MBIs, including MBCT and MBSR, were assessed with various questionnaires. Two of three RCTs showed a statistically significant decrease in tinnitus distress scores directly after treatment in the mindfulness group compared to the control group. Six of seven studies showed statistically significant decrease in tinnitus distress scores directly after mindfulness therapy. One of three RCTs showed a statistically significant improvement of depression questionnaire scores after MBI compared to the control group directly post treatment. Conclusions: A decrease of tinnitus distress scores in MBIs can be observed directly post-therapy based on moderate to high quality studies. This was found regardless of the heterogeneity of patients, study design, type of MBI and outcome assessment. Two out of three RCTs found clinically relevant decreases in tinnitus distress scores. No effect of MBIs was observed for depression and anxiety in tinnitus patients. Long term effects remain uncertain. Mindfulness may have a place in tinnitus therapy, although the long term effects need to be studied.

Growth and prevalence of feeding difficulties in children with Robin sequence: a retrospective cohort study.

OBJECTIVES: In addition to breathing problems, patients with Robin sequence (RS) often encounter feeding difficulties (FD). Data regarding the occurrence of FD and possible influencing factors are scarce. The study aim was to elucidate these factors to improve treatment strategies. MATERIAL AND METHODS: A retrospective comparative cohort study was conducted, consisting of 69 infants diagnosed with both RS and a cleft palate and 64 isolated cleft palate only (iCPO) infants. Data regarding FD, growth, and airway intervention were collected during the first 2 years of life. A systematic review of the literature was conducted to identify reported FD in RS patients. RESULTS: RS patients had more FD (91 %) than iCPO patients (72 %; p = 0.004). Also, nasogastric (NG)-tube feeding was necessary more frequently and for a longer period (both p < 0.001). Growth was lower in RS than iCPO infants (p = 0.008) and was not affected by the kind of airway management (conservative/surgical; p = 0.178), cleft palate grade (p = 0.308), or associated disorders (p = 0.785). By contrast, surgical intervention subtype did significantly affect growth. Mean reported FD for RS in the literature is 80 % (range = 47-100 %), and 55 % (range = 11-100 %) of infants need NG-tube feeding. CONCLUSIONS: FD is present in a large proportion of infants with RS, which indicates the need for early recognition and proper treatment to ensure optimal growth. Growth during the first 2 years of life is significantly lower in RS patients than iCPO patients, which indicates the need for careful attention and long-term follow-up. CLINICAL RELEVANCE: This study indicates the need for early recognition and proper treatment of FD in RS to ensure optimal growth. In addition, growth needs careful attention and long-term follow-up.