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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.

The objective of this study was to assess the attitude and behaviour of Dutch ENT surgeons and ENT residents towards Evidence Based Medicine. 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. 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. 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. 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 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.

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.

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.

IntroductionChronic 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 analysisWe 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 disseminationThis 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 numberNL7745.