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Background/objectives: Based on the premise that tongue and lip force is affected in individuals with orofacial myofunctional disorders (OMDs), orofacial myofunctional therapy (OMT) programs typically include the strengthening of orofacial muscles through isometric and isotonic exercises. The purpose of this study is to examine whether there is indeed a measurable difference in maximum tongue and lip strength and endurance between subjects with and without OMDs, as well as to explore Oral Health-Related Quality of Life (OHRQoL) in this population., Methods: Sixty healthy young adults (mean age 18.9 years, SD 0.69 years, range 18.0-21.4 years) participated in this study. Perceptual evaluation of orofacial functions was conducted using the Orofacial Myofunctional Evaluation with Scores (OMES) protocol. Participants were divided into three groups, namely those with physiological orofacial functions (POF; n = 20), those with inconsistent orofacial functions (IOF; n = 11), and those with consistent OMDs (OMD; n = 29). Maximum isometric pressure and endurance of tongue and lips were measured using the Iowa Oral Performance Instrument (IOPI). OHRQoL was assessed using the Oral Health Impact Profile (OHIP-14)., Results: The OMES total scores did not differ significantly between the three groups, though the subscale 'function' showed significant differences (13.637; p = 0.001). No statistically significant differences in maximum isometric pressure or endurance for tongue and lips, nor for OHIP scores, were measured between the three groups., Conclusions: Although orofacial muscle strengthening is commonly part of OMT, current findings suggest the superfluity of these types of exercises in the treatment of OMDs in healthy young adults and may indicate the need to focus on awareness and rehabilitation of pathological functions in these individuals. Re-evaluation of the efficacy of OMT programs in different populations may be an important strategy going forward., (© 2024 John Wiley & Sons Ltd.)

Greater trochanteric pain syndrome (GTPS) is a highly prevalent condition characterized by lateral hip and thigh pain. The Victorian Institute of Sport Assessment (VISA) questionnaire specifically tailored for GTPS (VISA-G) questionnaire was developed for the purpose of assessing and quantifying the severity of symptoms related to gluteal tendinopathy or GTPS. It is commonly used in research and clinical settings to evaluate the impact of GTPS on patient function and quality of life. The VISA-G questionnaire was developed for English-speaking populations. Before this questionnaire can be used in non-English-speaking populations, it has to be translated and validated for a particular population. The current study aimed to translate and validate the VISA-G questionnaire for a Dutch-speaking context (VISA-G-Dutch). In this study, we conducted a comprehensive process involving forward and back translation, along with a thorough comparison with other established hip-related questionnaires. The COSMIN checklist was used to ensure uniformity in the validation study. A sample of 100 participants, 50 symptomatic and 50 asymptomatic, completed the VISA-G-Dutch, Harris Hip Score, Hip Disability and Osteoarthritis Outcome Score, Oxford Hip Score, and Nonarthritic Hip Score questionnaires. Internal consistency and test-retest reliability were measured. Construct validity was assessed through positive correlations between the VISA-G-Dutch and gold standard questionnaires. Strong internal consistency and test-retest reliability correlations were found in both the asymptomatic and symptomatic groups. The test-retest reliability also demonstrated strong positive correlations for the symptomatic group. The standard error of measurement was ∼2.3 for the symptomatic group. These results prove that the VISA-G-Dutch is a reliable and valid tool for assessing GTPS and gluteal tendinopathy in Dutch-speaking individuals, providing clinicians with a valuable assessment tool., Competing Interests: None declared., (© The Author(s) 2024. Published by Oxford University Press.)

Introduction: Children with malocclusion, combined with orofacial myofunctional disorders (OMDs), show increased risk of developing orthodontic problems and needs later in life. Speech-language therapists typically provide orofacial myofunctional therapy (OMT) after referral by dentists, orthodontists or ENT specialists. Interdisciplinary treatment is often advisable to prevent relapse after orthodontic treatment. OMDs and OMT are often found to be controversial topics by dentistry professionals. This study aimed to investigate self-reported knowledge and attitudes of Flemish dentists and orthodontists towards OMDs and OMT., Methods: A survey containing 32 items on demographics, self-reported knowledge of OMDs and OMT, attitudes towards OMDs, OMT, and its use in clinical practice, and referral behaviour was filled out by 48 general dentists (48/79, 61%) and 31 orthodontists (31/79, 39%). The impact of specialization, degree of experience and educational programme was also evaluated., Results: Fifty-six percent of all participants (44/79) reported insufficient to non-existent knowledge of OMT. Nevertheless, the general attitude towards the use of OMT was neutral (47%, 37/79) to (very) positive (48%, 38/79). Although they found correct, evidence-based knowledge on OMDs and OMT important, the majority indicated their formal training did not provide adequate information on OMDs (52%, 41/79) and OMT (62%, 49/79). Specialization showed significant effects, as orthodontists reported themselves knowledgeable on this topic significantly more often than general dentists (p < 0.001), and generally reported a more positive stance towards OMT (p = 0.022)., Conclusion: Dentists and orthodontists indicated a general interest in the topic of OMDs and OMT, alongside an overall lack of information provided by formal education. Current findings suggest the necessity of re-evaluating current curricula on OMDs and OMT., (© 2024 S. Karger AG, Basel.)

Purpose: Individuals born with a cleft palate with or without a cleft lip (CP ± L) often experience functional, aesthetic, and psychosocial consequences well into adulthood. This study aimed to investigate outcomes of speech and health-related quality of life (HRQoL) in adults with a CP ± L who received interdisciplinary cleft care at the Ghent University Hospital using valid, reliable, and condition-specific instruments., Method: Thirteen Belgian Dutch-speaking participants with a CP ± L with a mean age of 25.4 years ( SD = 5.1, range: 20-33 years) and an age- and gender-matched control group of 13 participants without a CP ± L with a mean age of 25.2 years ( SD = 4.8, range: 20-32 years) were included in this study. Speech characteristics were evaluated perceptually and instrumentally. HRQoL was assessed through standardized patient-reported outcome measures. Outcomes were compared with those of the control group and to normative data where available., Results: Participants with a CP ± L in this sample demonstrated significantly lower speech acceptability ( p < .001) and higher rates of hypernasality ( p = .015) and nasal turbulence ( p = .005) than the control group. They showed significantly higher satisfaction with appearance of the cleft scar compared with norms of adults with a CP ± L ( p = .047). No other differences in speech characteristics, sociodemographics, or HRQoL were found between participants with and without a CP ± L., Conclusions: The reduced speech acceptability and the presence of resonance and nasal airflow disorders may indicate the need for standardized long-term outcome measurement and interdisciplinary follow-up for speech characteristics and velopharyngeal insufficiency in young and middle adulthood in future clinical practice. Additional research is necessary to further substantiate these findings and to determine predictors for these continuing complications in adults with a CP ± L., Supplemental Material: https://doi.org/10.23641/asha.24243901.

Informed consent (IC) is the process of communication between research staff and potential research participants. However, ensuring that participants clearly understand what research participation entails, raises significant challenges. The aim of this study is to provide insight into some communication barriers that research staff are confronted with and make practical recommendations to improve communication between research staff and participants. A qualitative research study using semi-structured interviews ( n  = 13) with research staff from Ghent University Hospital was conducted. Data were transcribed verbatim and coded thematically. Our results indicate that communication- and process-related factors affect the IC process. Emergent recommendations include communication training, more interactive information materials and the use of digital alternatives, increasing general knowledge about research participation and patient- and public involvement.

Objectives: Based on limited evidence from case reports and small cohort studies of metal-on-metal (MoM) hip implant patients with presumed systemic cobalt (Co) toxicity, and a few animal studies on Co-induced damage to the otovestibular system, it was hypothesised that Co exhibits an ototoxic potential alongside other systemic manifestations. Preliminary investigations from our research group in MoM patients confirmed this assumption for the auditory system, whereas no signs of Co-induced vestibular impairment were detected, and a clear dose-response relationship between the auditory function and the blood Co levels was lacking. Therefore, the current study aimed to extend and validate these findings in a larger sample of MoM patients and control subjects, to explore the potential clinical value of audiovestibular outcome measures in the risk estimation of systemic Co toxicity in this patient population., Design: Fifty patients (32 to 68 years) with a primary unilateral/bilateral MoM hip implant were matched for age, gender, and noise exposure to 50 nonimplanted control subjects. Both groups underwent the same protocol, consisting of an objective auditory [i.e., conventional and high-frequency audiometry, transient-evoked and distortion (TEOAEs and DPOAEs), auditory brainstem responses] and vestibular (i.e., cervical and ocular vestibular evoked myogenic potentials, horizontal and vertical video head impulse tests) test battery, a questionnaire inquiring auditory, balance, and general neurological symptoms, and a blood sample collection to determine the plasma Co concentration., Results: The auditory test battery presented consistently higher audiometric thresholds in the MoM patient group, with group differences ranging from 2.1 to 5.7 dB in the lower frequencies (0.25 to 6.0 kHz) and from 4.6 to 9.3 dB in the high frequencies (8.0 to 14.0 kHz). Group differences at high frequencies were statistically significant ( p ≤ 0.001). Additionally, significantly lower TEOAE ( p = 0.009) and DPOAE ( p < 0.001) amplitudes were observed in the MoM patients when the better ear was included in the analysis, and more absent TEOAE and DPOAE responses were found between 1.0 and 4.0 kHz (0.008 ≤ p ≤ 0.039). Within the vestibular test battery, the MoM patients showed longer N1 and P1 ocular vestibular evoked myogenic potentials latencies for the left ear, and lower video head impulse test gains for the left anterior and right posterior semicircular canals (0.005 ≤ p ≤0.035). The patient-reported (questionnaire) outcome delivered no significant group differences ( p > 0.01). Six patients had elevated Co levels according to our local institutional threshold (>4 or 5 µg/l for unilateral or bilateral MoM hip implants, resp.), but their audiovestibular outcome measures did not differ significantly from those of the other patients., Conclusions: Corresponding to our preliminary investigations, the results indicate possibly Co-induced (predominantly high-frequency) auditory impairment, probably triggered by toxic damage to the cochlear structures. However, the low mean difference values, the lack of group differences for the patient-reported outcome measures, and the lack of any relationship with the blood Co levels strongly reduce the clinical relevance of these findings. Therefore, the risk of Co-induced ototoxic impairment is considered to be clinically negligible for the majority of MoM hip implant patients, and the use of auditory tests in the risk estimation of systemic Co toxicity should be decided on a case-by-case basis., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Total hip arthroplasty (THA) in patients younger than 50 years poses significant challenges including postoperative limitations of activity and higher failure rates. Sub-par outcomes of hip resurfacing arthroplasty (HRA) in registries remain controversial due to multiple confounders. Favourable HRA results in some studies are often regarded as irreproducible. The aim of this study is to analyse HRA outcomes in a large international cohort., Patients and Methods: We compiled a database of 11,382 HRA patients ⩽50 years from an international group of 27 experienced HRA centres from 13 countries. 18 different metal-on-metal (MoM) HRA designs were included with a mean follow-up of 7.6 years. Outcomes were implant survivorship, revision rates, causes for revision, clinical scores and metal ion levels. Outcomes were compared between genders, sizes, implant types and pre-operative diagnoses., Results: Overall cumulative Kaplan-Meier survivorship was 88.9% at 22 years (95% CI: 88.3-89.5%). 2 HRA designs (DePuy Articular Surface Replacement (ASR), and Corin Cormet Hip Resurfacing System (CORMET)) led to inferior results while all others yielded similar survivorships. Excluding ASR and CORMET, implant survivorship in 11,063 cases was 95% at 10 years and 90% at 22 years. In men, implant survivorship was excellent: 99% at 10 years and 92.5% at 21 years. In females, implant survivorship was 90% at 10 years and 81.3% at 22 years. The overall revision rate was 3.6% with most common reasons for revision being implant loosening and adverse local tissue reactions. The best survivorship was found in patients with osteoarthritis (95% CI, 92.1-93.3% at 22 years), the poorest was among dysplastic hips (78.3%; 95% CI, 76.5-80.1% at 20 years, p <  0.001)., Conclusions: Comparable revision rates demonstrated here may mitigate some concerns for safety and longevity of MoM HRA implants. Higher demands for activity and functionality in younger patients make HRA a potential alternative to THA.

Background: Infections with SARS-CoV-2 continue to cause significant morbidity and mortality. Interleukin (IL)-1 and IL-6 blockade have been proposed as therapeutic strategies in COVID-19, but study outcomes have been conflicting. We sought to study whether blockade of the IL-6 or IL-1 pathway shortened the time to clinical improvement in patients with COVID-19, hypoxic respiratory failure, and signs of systemic cytokine release syndrome., Methods: We did a prospective, multicentre, open-label, randomised, controlled trial, in hospitalised patients with COVID-19, hypoxia, and signs of a cytokine release syndrome across 16 hospitals in Belgium. Eligible patients had a proven diagnosis of COVID-19 with symptoms between 6 and 16 days, a ratio of the partial pressure of oxygen to the fraction of inspired oxygen (PaO 2 :FiO 2 ) of less than 350 mm Hg on room air or less than 280 mm Hg on supplemental oxygen, and signs of a cytokine release syndrome in their serum (either a single ferritin measurement of more than 2000 μg/L and immediately requiring high flow oxygen or mechanical ventilation, or a ferritin concentration of more than 1000 μg/L, which had been increasing over the previous 24 h, or lymphopenia below 800/mL with two of the following criteria: an increasing ferritin concentration of more than 700 μg/L, an increasing lactate dehydrogenase concentration of more than 300 international units per L, an increasing C-reactive protein concentration of more than 70 mg/L, or an increasing D-dimers concentration of more than 1000 ng/mL). The COV-AID trial has a 2 × 2 factorial design to evaluate IL-1 blockade versus no IL-1 blockade and IL-6 blockade versus no IL-6 blockade. Patients were randomly assigned by means of permuted block randomisation with varying block size and stratification by centre. In a first randomisation, patients were assigned to receive subcutaneous anakinra once daily (100 mg) for 28 days or until discharge, or to receive no IL-1 blockade (1:2). In a second randomisation step, patients were allocated to receive a single dose of siltuximab (11 mg/kg) intravenously, or a single dose of tocilizumab (8 mg/kg) intravenously, or to receive no IL-6 blockade (1:1:1). The primary outcome was the time to clinical improvement, defined as time from randomisation to an increase of at least two points on a 6-category ordinal scale or to discharge from hospital alive. The primary and supportive efficacy endpoints were assessed in the intention-to-treat population. Safety was assessed in the safety population. This study is registered online with ClinicalTrials.gov (NCT04330638) and EudraCT (2020-001500-41) and is complete., Findings: Between April 4, and Dec 6, 2020, 342 patients were randomly assigned to IL-1 blockade (n=112) or no IL-1 blockade (n=230) and simultaneously randomly assigned to IL-6 blockade (n=227; 114 for tocilizumab and 113 for siltuximab) or no IL-6 blockade (n=115). Most patients were male (265 [77%] of 342), median age was 65 years (IQR 54-73), and median Systematic Organ Failure Assessment (SOFA) score at randomisation was 3 (2-4). All 342 patients were included in the primary intention-to-treat analysis. The estimated median time to clinical improvement was 12 days (95% CI 10-16) in the IL-1 blockade group versus 12 days (10-15) in the no IL-1 blockade group (hazard ratio [HR] 0·94 [95% CI 0·73-1·21]). For the IL-6 blockade group, the estimated median time to clinical improvement was 11 days (95% CI 10-16) versus 12 days (11-16) in the no IL-6 blockade group (HR 1·00 [0·78-1·29]). 55 patients died during the study, but no evidence for differences in mortality between treatment groups was found. The incidence of serious adverse events and serious infections was similar across study groups., Interpretation: Drugs targeting IL-1 or IL-6 did not shorten the time to clinical improvement in this sample of patients with COVID-19, hypoxic respiratory failure, low SOFA score, and low baseline mortality risk., Funding: Belgian Health Care Knowledge Center and VIB Grand Challenges program., Competing Interests: Declaration of interests JD, KFAVD, BM, CB, VB, LH, LN, and EDL have received personal PhD training fellowships from FWO Flanders. SJT and LJMS have received personal postdoctoral fellowships from FWO Flanders and from the Ghent University BOF Fund. HA has received a postdoctoral personal training grant from VLAIO Flanders. US has received a grant from the European Respiratory Society. MH has received a grant from ULB Fonds Erasme on COVID-19 research, and an EU-Horizon DisCoVeRY trial grant and EU-Solid-Act trial grant on COVID-19 therapeutics; she received support for attending meetings from Pfizer and acts as the leader of the Sciensano committee, which produces the national guidelines on COVID-19 therapeutics. ND has received honoraria from Boehringer Ingelheim and support for attending meetings from Pfizer, Johnson & Johnson (J&J), and Merck Sharp & Dohme (MSD) and has served on a data and safety monitoring board (DSMB) for Roche. SA received research grants from Bristol-Myers Squibb (BMS)–Celgene and from European Hematology Association and consultancy fees from BMS–Celgene, J&J, Astellas, and Abbvie and honoraria from Pfizer and Astellas. JvdH received consultancy fess from Novartis and SOBI and honoraria from MSD, Sanofi, and J&J, and support for attending meetings from ViiV; he serves on DSMB boards for Novartis and SOBI. HS has received consultancy fees and support for attending meetings from Roche and Boehringer Ingelheim. CL has received consultancy fees from the sponsor Belgian Health Care Knowledge Center (KCE) to serve on the clinical trial board. MB owns stock of the International Drug Development Institute and Cluepoints. DS has received honoraria and support for attending meetings from AstraZeneca, Chiesi, GSK, Roche, and Merck. FB has received support from the Ghent University Hospital Clinical Research Fund. FHa has received a VIB Grand Challenge research grant, a Ghent University Special Research Fund (BOF) research grant, and a Ghent University Hospital Innovation Research Grant as well as lecture honoraria from CSL Behring. LV has received grants from University Hospital Ghent Innovation Fund, Research Foundation—Flanders–Strategic Basic Research (FWO-SBO) and FWO to do COVID-19 related research; he received consultancy fees and honoraria from Gilead and ViiV Healthcare. EvB received a grant from Ghent University Special Research Fund (BOF) and a research grant from ExeVir to do COVID-19 related research. She received honoraria from Gilead and is a member of the Sciensano committee, which produces the national guidelines on COVID-19 therapeutics. SR has received honoraria and meeting attendance support from BMS, MSD, Pfizer, Bayer, J&J, Astellas, Roche, and Ipsen; she serves on DSMBs organised by Pfizer, J&J, BMS, and MSD. IP has received research grants from FWO and honoraria from UCB Pharma and Galapagos. She serves on advisory boards from Abbvie, Amgen, Argenx, AstraZeneca, BMS, Galapagos, and Novartis. FHu is an employee of KCE The Belgian Healthcare Knowledge center, a public federal agency. BNL received an European Research Council Advanced Grant (ERC-2017-ADG-789384) and several FWO grants, as well as a University of Ghent Methusalem Grant. All other authors declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)