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The BONEBRIDGE is a partially implantable, transcutaneous bone conduction device that can be used to treat conductive or mixed mild-to-moderate hearing loss in patients who do not attain sufficient improvement from conventional hearing aids. The following case report describes sequential bilateral BONEBRIDGE implantation in a 25-year-old patient with achondroplasia and bilateral mixed-hearing loss with a significant sensorineural component in the setting of chronic suppurative otitis media. Although the patient did not meet the approved BONEBRIDGE criteria, implantation was successful with improvements in audiological outcomes and self-reported quality of life. There were no reported complications at 5-years post-implantation.

Cross study heterogeneity has limited the evidence based evaluation of middle meningeal artery embolization (MMAE) as a treatment for chronic subdural hematoma (CSDH). Ongoing trials and prospective studies suggest that heterogeneity in upcoming publications may detract from subsequent meta-analyses and systemic reviews. This study aims to describe this data heterogeneity to promote harmonization with common data elements (CDEs) in publications. ClinicalTrials.gov and PubMed were searched for published or ongoing prospective trials of MMAE. The Nested Knowledge AutoLit living review platform was utilized to classify endpoints from randomized control trials (RCTs) and prospective cohort studies comparing MMAE with other treatments. The qualitative synthesis feature was used to determine cross study overlap of outcome related data elements. Eighteen studies were included: 12 RCTs, two non-randomized controlled studies, two prospective single arm trials, one combined prospective and retrospective controlled study, and one prospective cohort study. The most commonly reported data element was recurrence (15/18), but seven heterogenous (non-comparable) definitions were used for ‘recurrence’. Mortality was reported in 10/18 studies, but no common timepoint was reported in more than four studies. Re-intervention and CSDH volume were reported in eight studies, CSDH width in seven, and no other outcome was common across more than five studies. There was significant heterogeneity in data element collection even among prospective registered trials of MMAE. Even among CDEs, variation in definition and timepoints prevented harmonization. A standardized approach based on CDEs may be necessary to facilitate future meta-analyses and evidence driven evaluation of MMAE treatment of CSDH.

BACKGROUND Psilocybin is a naturally occurring psychedelic that induces feelings of euphoria and spiritual awakening when administered in doses of approximately 20-30 mg/70 kg. In the last decade, there has been renewed interest in using psilocybin for major depressive disorder (MDD). OBJECTIVE This individual patient data meta-analysis will investigate the efficacy and safety of psilocybin for MDD. METHODS This study will be performed as a living systematic review housed in the Nested Knowledge online platform, allowing for data extraction, analysis, and synthesis to occur on an ongoing basis as new evidence emerges. The study is registered with PROSPERO (ID: CRD42021290905) and will be compliant with Preferred Reporting Items for Systematic Review and Meta-Analysis of Individual Participant Data (PRISMA-IPD). Major databases (PubMed, Embase, SCOPUS, PyschINFO) and international clinical trials registries will be systematically searched for relevant trials. Randomized and non-randomized trials of psilocybin for the treatment of MDD will be included; authors will be contacted if individual patient data is not readily available. The three populations of interest are patients with MDD, patients with treatment-resistant MDD, and patients with MDD and life-threatening illness. The primary outcome is depression as measured by validated clinical scales (e.g., GRID-Hamilton Depression Rating Scale [GRID-HAMD], Beck Depression Inventory [BDI], Hospital Anxiety and Depression Scale - Depression Subscale [HADS-D]). Heterogeneous scale results will be transformed to z-scores and aggregated to create a composite depression outcome. Secondary outcomes include anxiety, demoralization/hopelessness, quality of life, and death acceptance. We will analyze outcome data using hierarchical mixed-effects regression models. In order to consider clustering effects from study to study, a three-level hierarchical structure will be used: the participants within each trial are considered level one, the study is level two, and the treatment group is level three. Hierarchical regressions are also conducted to examine various effect moderators of treatment outcomes, including patient age, patient sex, baseline score for a given clinical outcome, history of psilocybin use, and psilocybin dose (including the interaction of dose volume and dose schedule). All analyses will be performed on a modified intention-to-treat basis. Repeat literature searches, screening, and subsequent updates to the review will be conducted on an ongoing basis. RESULTS The initial review and subsequent updates will be published in a peer-reviewed journal and made available online via the Nested Knowledge platform. CONCLUSIONS Despite growing interest in psilocybin as a therapy for chronic, severe, or intractable MDD, there are gaps in the literature. A rapidly expanding evidence base requires a living systematic review to adequately inform clinical practice and policymaking around psychedelics for psychological and mood disorders. This meta-analysis seeks to meet that need by providing a transparent, up-to-date, and accessible living review of psilocybin for MDD.

Adiposity significantly contributes to reproductive function. Whereas lower body weight is strongly associated with increased risk of functional hypothalamic amenorrhea (FHA), the relationship between BMI and the timing of menopause is poorly understood. Recent studies of self-reported data suggest women with BMI50 years of age and BMI18.5 kg/m 2 at the menopausal transition and history of known cause of early menopause, 239 charts were included in the analysis. Participants had a median BMI of 17.7kg/m 2 at the final menstrual period (FMP). Median age at the FMP in all low weight women with BMI Presentation: No date and time listed

IntroductionVagus nerve stimulation (VNS) is a neuromodulation therapy that can reduce the seizure burden of children with medically intractable epilepsy. Despite the widespread use of VNS to treat epilepsy, there are currently no means to preoperatively identify patients who will benefit from treatment. The objective of the present study is to determine clinical and neural network-based correlates of treatment outcome to better identify candidates for VNS therapy.Methods and analysisIn this multi-institutional North American study, children undergoing VNS and their caregivers will be prospectively recruited. All patients will have documentation of clinical history, physical and neurological examination and video electroencephalography as part of the standard clinical workup for VNS. Neuroimaging data including resting-state functional MRI, diffusion-tensor imaging and magnetoencephalography will be collected before surgery. MR-based measures will also be repeated 12 months after implantation. Outcomes of VNS, including seizure control and health-related quality of life of both patient and primary caregiver, will be prospectively measured up to 2 years postoperatively. All data will be collected electronically using Research Electronic Data Capture.Ethics and disseminationThis study was approved by the Hospital for Sick Children Research Ethics Board (REB number 1000061744). All participants, or substitute decision-makers, will provide informed consent prior to be enrolled in the study. Institutional Research Ethics Board approval will be obtained from each additional participating site prior to inclusion. This study is funded through a Canadian Institutes of Health Research grant (PJT-159561) and an investigator-initiated funding grant from LivaNova USA (Houston, TX; FF01803B IIR).

Objective To present surgical and audiometric outcomes of patients implanted with an active transcutaneous bone conduction implant following the novel middle fossa surgical approach with self-drilling screws. Study design Retrospective review. Setting Tertiary care center. Patients Thirty-seven adults with either conductive or mixed hearing loss that met indications for an active transcutaneous bone conduction implant were consecutively implanted from April, 2013 to May, 2018. Intervention Unilateral middle fossa implantation of an active transcutaneous bone conduction implant. Main outcome measures Patient charts were reviewed for surgical outcomes and complications over the 6-year period. Preoperative air conduction, preoperative bone conduction, and 3-month postoperative aided thresholds were recorded. Speech perception was assessed using CNC words and AzBio sentences. Pure-tone averages (PTAs; measured at 0.5, 1.0, 2.0 and 3.0 kHz), air-bone gap, and functional gain were calculated. Results Mean air conduction and bone conduction PTAs (±standard deviation) of the implanted ear were 66.8 dB (±14.9 dB) and 21.9 dB (±14.0 dB), respectively. Mean aided PTA was 26.5 dB (± 8.5 dB). The average functional gain was 40.3 dB (±19.0 dB). Favorable speech perception outcomes were observed. No complications or instances of revision surgery were reported, with a mean follow-up time of 32 months (range, 9-71 mo). Conclusions This is the first paper to describe outcomes of patients implanted with an active transcutaneous bone conduction implant via the middle fossa with self-drilling screws. Favorable surgical outcomes were observed with a follow-up of up to 6 years.

Background Coronavirus disease 2019 (COVID-19) continues to pose a significant threat to public health worldwide. The purpose of this study was to review current evidence obtained from randomized clinical trials on the efficacy of antivirals for COVID-19 treatment. Methods A systematic literature search was performed using PubMed to identify randomized controlled trials published up to September 4, 2021 that examined the efficacy of antivirals for COVID-19 treatment. Studies that were not randomized controlled trials or that did not include treatment of COVID-19 with approved antivirals were excluded. Risk of bias was assessed using the Scottish Intercollegiate Guidelines Network (SIGN) method. Due to study heterogeneity, inferential statistics were not performed and data were expressed as descriptive statistics. Results Of the 2,284 articles retrieved, 31 (12,440 patients) articles were included. Overall, antivirals were more effective when administered early in the disease course. No antiviral treatment demonstrated efficacy at reducing COVID-19 mortality. Sofosbuvir/daclatasvir results suggested clinical improvement, although statistical power was low. Remdesivir exhibited efficacy in reducing time to recovery, but results were inconsistent across trials. Conclusions Although select antivirals have exhibited efficacy to improve clinical outcomes in COVID-19 patients, none demonstrated efficacy in reducing mortality. Larger RCTs are needed to conclusively establish efficacy.

Purpose The purpose of this study was to obtain a self-reported account of the experience of living with oromandibular dystonia (OMD) to gain a better understanding of both the daily facilitators and barriers to communicative participation and the strategies used for adapting to life with OMD. Method Eight individuals with OMD and dysarthria participated in 1 face-to-face, semistructured interview. Interviews were audio-recorded and transcribed verbatim. Qualitative, phenomenological methods of coding, immersion, and emergence were used in the analysis of interview data. Results Three major themes and 7 subthemes emerged from the analysis of interview data. First, “speaking is different now” provided examples of how speech changes are manifested in various life situations. Second, “my roles have changed” addressed how OMD has impacted work, home, and social roles. Third, “I accept it and move on” involved finding strategies that help and adopting a different perspective. Conclusion We suggest that the management of OMD must take a more holistic approach by addressing consequences beyond the physical symptoms and be tailored to each individual based on his or her personal concerns and goals.

Deep brain stimulation (DBS) is a common tool for the treatment of movement disorders in adults; however, it remains an emerging treatment modality in children with a growing number of indications, including epilepsy and dystonia. The Child & Youth CompreHensIve Longitudinal Database of DBS (CHILD-DBS) study aims to prospectively collect relevant data on quality of life (QoL), safety, efficacy, and long-term neurodevelopmental outcomes following DBS in children. Data are collected and managed using the Research Electronic Data Capture (REDCap). This database aims to collect multicentre comprehensive and longitudinal clinical, QoL, imaging and electrophysiologic data for children under the age of 19 undergoing DBS. Both general and indication-specific measures are collected at baseline and at four time points postoperatively: 6 months, 1 year, 2 years, and 3 years. The database encompasses QoL metrics for children, including the PedsQL (Pediatric Quality of Life Inventory, generic), QOLCE (Quality of Life in Childhood Epilepsy Questionnaire, parent-rated), CHU 9D (Child Health Utility 9D), and KIDSCREEN. Caregiver clinical and QoL metrics, including QIDS (Quick Inventory of Depressive Symptomatology), GAD-7 (Generalized Anxiety Disorder 7-item scale), and CarerQoL-7D (The Care-related Quality of Life Instrument), are similarly prospectively collected. Healthcare resource utilization is also assessed before and after DBS. Lastly, stimulation parameters and radiographic and electrophysiologic data are collected within the database. The development of the current prospective paediatric DBS database with carefully selected physical and psychosocial outcomes and assessments will complement existing efforts to enhance and facilitate multisite collaboration to further understand the role of DBS in childhood.

The aim of this letter is to respond to a commentary on a published article on the middle fossa approach to BONEBRIDGE implantation with self-drilling screws published by the senior authors.

Circles, ellipses, parabolas, and hyperbolas are called conic sections because each of these curves arises as the boundary of a slice of a cone. Imagine slicing a solid cone of clay. Depending on h...

Purpose In this preliminary study, we examined self-rated communication-related quality of life (CR-QoL) of 10 control participants and 10 individuals with oromandibular dystonia (OMD) and dysarthria receiving therapeutic botulinum toxin (BoNT-A) injections. Method Participants with OMD and associated dysarthria self-rated CR-QoL pre- and post- BoNT-A injection using the American Speech-Language-Hearing Association's Quality of Communication Life Scale (ASHA QCL; Paul et al., 2004). Control participants self-rated CR-QoL during a single experimental visit. Results Significant differences were found between control participants and participants with OMD on ratings of CR-QoL across all 5 domains and subdomains of the ASHA QCL. No significant differences in CR-QoL were found over the course of the BoNT-A treatment cycle. Conclusions CR-QoL was rated lower by participants with OMD as compared with control participants across all ASHA QCL domains/subdomains with “socialization/activities” and “confidence/self-concept” having the largest effect sizes. No differences in CR-QoL were found over the course of the treatment cycle. We advocate for outcome measures that include patient report. The use of patient-reported outcome measures in conjunction with objective or impairment-based outcome measures can help inform meaningful clinical indicators of treatment success. This study adds novel information that may aid our understanding of the experience of living with OMD in this underserviced clinical population.

Oromandibular dystonia (OMD) is a rare disorder of movement characterized by tonic muscle contractions that can result in involuntary, repetitive, and patterned muscle contractions of the lingual musculature, labial musculature, and/or muscles of mastication. As a result, dysarthria can be present that can lead to reduced speech intelligibility and have an adverse impact on psychosocial functioning. In this article, we will describe the clinical and speech characteristics of OMD and the various methods of treatment. Then we will introduce and describe patient-reported outcome measures that assess two aspects of psychosocial functioning: communicative participation and quality of life. We will describe the current state of knowledge as it relates to communicative participation and quality of life in this clinical population, and, finally, we will advocate that speech-language pathologists have a unique role in the care of individuals with OMD through the inclusion of patient-reported outcome measures to provide a comprehensive and holistic management plan.

Background Bone conduction implants can be used in the treatment of conductive or mixed hearing loss. The BONEBRIDGE bone conduction implant (BB-BCI) is an active, transcutaneous device. BB-BCI implantation can be performed through either the transmastoid or retrosigmoid approach with their respective limitations. Here, we present a third, novel approach for BB-BCI implantation. Objective Describe the detailed surgical technique of BB-BCI implantation through a middle fossa approach with self-drilling screws and present preliminary audiometric outcome data following this approach. Methods A single institution, retrospective chart review was completed for patients implanted with the BB-BCI via the middle fossa approach. Preoperative planning and modelling were performed using 3D Slicer. Audiological testing was performed pre- and post-operatively following standard audiometric techniques. Results Forty patients underwent BB-BCI implantation using the middle fossa approach. Modelling techniques allowed for implantation through the use of external landmarks, obviating the need for intraoperative image guidance. The surgical technique was refined over time through experience and adaptation. Mean follow-up was 29 months (range 3–71 months) with no surgical complications, favourable cosmesis, and expected audiometric outcomes. An average functional gain of 39.6 dB (± 14.7 SD) was found. Conclusion The middle fossa technique with self-drilling screws is a safe and effective option for BONEBRIDGE implantation. As a reference for other groups considering this approach, an annotated video has been included as a supplement to the study. Electronic supplementary material The online version of this article (10.1186/s40463-019-0354-7) contains supplementary material, which is available to authorized users.

Civil rights pioneer Dorothy Foreman Cotton passed away on June 10, 2018, in Ithaca, New York, at the age of eighty-eight. On August 11, 2018, a Saturday afternoon, around seven hundred community members, friends, and local and national leaders gathered at Cornell University’s Bailey Hall to celebrate her life. Cotton was the highest-ranking woman in the Southern Christian Leadership Conference (SCLC) throughout the 1960s. She devoted her life to liberation and social justice. Remembered by many as an iconic feminist and grassroots innovator, she led an extraordinary life that undoubtedly transformed the lives of African Americans fighting for full citizenship and justice. Cotton was critical in opposing economic and social regimes of power, but she also ushered in a new sense of individual and collective subjectivity through political participation and mobilization in southern Black communities. Throughout her life, she reminded ordinary people of their vast power to effect change and transform society.

Selective dorsal rhizotomy (SDR) is a surgical treatment for spasticity, primarily in cerebral palsy (CP). There is a growing trend for patients to seek medical information from their peers on social media platforms. This study qualitatively and quantitatively assessed the use of social media as an information-sharing and support-seeking tool by patients and caregivers. A search was performed on Facebook, Twitter, and YouTube. Public information was quantitatively assessed by category, users, year of creation, and country of origin. Representative samples of comments and posts were then qualitatively assessed by thematic analysis. One hundred eighty-five Facebook groups and pages, 97 YouTube videos, and 14 Twitter accounts were identified, based in 13 countries. SDR and CP groups had a mean membership of 3063 and 2339, respectively; SDR and CP pages had a mean number of “likes” of 1650 and 10,711, respectively. Total YouTube video views were 593,135 (mean 6115). Total Twitter followers were 62,609 (mean 2160). Qualitative analysis identified seven categories of comments: emotional support and forming connections (22.34%), sharing information and advice (15.96%), appreciation and successes (31.91%), challenges and difficulties (8.51%), advertising/offering services (4.79%), inequities and access (4.79%), and social media as a second opinion (11.7%). This study outlines the use of social media platforms in the distribution of information regarding SDR. We highlight the importance placed by patients and caregivers on the advice of their peers. The current report should inform healthcare providers’ interactions with patients with respect to information seeking and provision of support.