Introduction: Stories From Those Who Interpret For Others in Healthcare.

This symposium includes twelve personal narratives from healthcare interpreters who have navigated challenges while interpreting for patients and healthcare providers who do not share a common language. These stories are from trained professionals who speak a variety of spoken and sign languages. They describe what it is like to be a communication tool for a Patient-Physician relationship and the many ways this service takes a toll on their own physical and emotional health.

Engaging children and adolescents in the design and conduct of paediatric research.

The importance of patient engagement in product development and clinical research is widely acknowledged. In pediatrics, parents and guardians are often vocal advocates for their children in the process, but investigators and sponsors rarely directly solicit children's or adolescents' perspectives in clinical research planning or as patient partners during the conduct of research. Here, we provide compelling reasons and recommendations for investigators and sponsors to systematically engage young people in the design, conduct, and review of research, and the premise that input will be incorporated as a routine expectation.

Perceptual Consequences of Cochlear Deafferentation in Humans.

Cochlear synaptopathy, a form of cochlear deafferentation, has been demonstrated in a number of animal species, including non-human primates. Both age and noise exposure contribute to synaptopathy in animal models, indicating that it may be a common type of auditory dysfunction in humans. Temporal bone and auditory physiological data suggest that age and occupational/military noise exposure also lead to synaptopathy in humans.

Associations Between Physiological Correlates of Cochlear Synaptopathy and Tinnitus in a Veteran Population.

Purpose: Animal models and human temporal bones indicate that noise exposure is a risk factor for cochlear synaptopathy, a possible etiology of tinnitus. Veterans are exposed to high levels of noise during military service. Therefore, synaptopathy may explain the high rates of noise-induced tinnitus among Veterans.

Decentralized clinical trials and rare diseases: a Drug Information Association Innovative Design Scientific Working Group (DIA-IDSWG) perspective.

Background: Traditional clinical trials require tests and procedures that are administered in centralized clinical research sites, which are beyond the standard of care that patients receive for their rare and chronic diseases. The limited number of rare disease patients scattered around the world makes it particularly challenging to recruit participants and conduct these traditional clinical trials.

Main Body: Participating in clinical research can be burdensome, especially for children, the elderly, physically and cognitively impaired individuals who require transportation and caregiver assistance, or patients who live in remote locations or cannot afford transportation.

Ototoxicity prognostic models in adult and pediatric cancer patients: a rapid review.

Purpose: A cornerstone of treatment for many cancers is the administration of platinum-based chemotherapies and/or ionizing radiation, which can be ototoxic. An accurate ototoxicity risk assessment would be useful for counseling, treatment planning, and survivorship follow-up in patients with cancer.

Methods: This systematic review evaluated the literature on predictive models for estimating a patient's risk for chemotherapy-related auditory injury to accelerate development of computational approaches for the clinical management of ototoxicity in cancer patients.

Oddball paradigm complexity in multi-token auditory evoked potentials.

We developed and tested a series of novel and increasingly complex multi-token electrophysiology paradigms for evoking the auditory P3 response. The primary goal was to evaluate the degree to which more complex discrimination tasks and listening environments - which are more likely to engage the types of neural processing used in real-world speech-in-noise situations - could still evoke a robust P3 response. If so, this opens the possibility of such a paradigm making up part of the toolkit for a brain-behavioral approach to improve understanding of speech processing.

Prevalence of Somatosensory Tinnitus in Veterans With Tinnitus.

Objectives: The primary objective was to estimate the prevalence of somatosensory tinnitus (ST) among Veterans with tinnitus.

Design: Three hundred four Veterans with tinnitus were phone screened for ST by performing and reporting on a series of head/neck/jaw maneuvers. A random sample of 12 individuals who screened positive and five who screened negative attended an in-person visit to confirm the presence/absence of ST.

Predicting synapse counts in living humans by combining computational models with auditory physiology.

Aging, noise exposure, and ototoxic medications lead to cochlear synapse loss in animal models. As cochlear function is highly conserved across mammalian species, synaptopathy likely occurs in humans as well. Synaptopathy is predicted to result in perceptual deficits including tinnitus, hyperacusis, and difficulty understanding speech-in-noise.

Planning for the Next Pandemic: Ethics and Innovation Today for Improved Clinical Trials Tomorrow.

The coronavirus pandemic has brought public attention to the steps required to produce valid scientific clinical research in drug development. Traditional ethical principles that guide clinical research remain the guiding compass for physicians, patients, public health officials, investigators, drug developers and the public. Accelerating the process of delivering safe and effective treatments and vaccines against COVID-19 is a moral imperative.

Randomised controlled trial of interventions for bothersome tinnitus: Desyncra versus cognitive behavioural therapy.

Objective: Compare the relative efficacy of Desyncra and Cognitive Behavioural Therapy (CBT).

Design And Study Sample: Sixty-one participants were randomly assigned to receive either Desyncra ( = 29) or CBT ( = 32). Randomisation included stratification regarding current hearing aid (HA) use.

Impacts of Diabetes, Aging, and Hearing Loss on Speech-on-Speech Masking and Spatial Release in a Large Veteran Cohort.

Purpose: Type 2 diabetes mellitus (DM2) is associated with impaired hearing. However, the evidence is less clear if DM2 can lead to difficulty understanding speech in complex acoustic environments, independently of age and hearing loss effects. The purpose of this study was to estimate the magnitude of DM2-related effects on speech understanding in the presence of competing speech after adjusting for age and hearing.

Free From Falls education and exercise program for reducing falls in people with multiple sclerosis: A randomized controlled trial.

Background: People with multiple sclerosis (PwMS) fall frequently. Community-delivered exercise and education reduce falls in older adults, but their efficacy in multiple sclerosis (MS) is unknown.

Objectives: To evaluate the impact of the Free From Falls (FFF) group education and exercise program on falls in PwMS.

A Randomized Controlled Trial Using Automated Technology for Improving Ototoxicity Monitoring in VA Oncology Patients.

Purpose Determine the efficacy of ototoxicity monitoring (OM) administered as automated protocols with the Oto-ID mobile audiometer (automated ototoxicity monitoring [A-OM]), compared with usual care (UC) OM in cancer patients receiving cisplatin. Method Participants were patients ( = 46, mean age 64.7 years; range: 30-78 years) receiving cisplatin-based chemotherapy at the Department of Veterans Affairs Portland Health Care System.

IRBs During COVID-19: Tried and True.

The COVID-19 pandemic threw health care logistics and clinical research processes into disarray. This collection of narratives describes the challenges faced by IRB administrators, staff, and committee members as they navigated the SARS-CoV-2 pandemic. The authors transitioned to remote meetings, adjusted to ever-changing information, and untangled the ethical implications of supporting open studies while making room for an influx of new protocols that addressed the pressing public health emergency.

Research on COVID-19: Stories from IRB Members, Research Administrators & Investigators.

This symposium is separated into two sections. The first includes twelve personal stories from IRB members, administrators, or staff about their experiences during the COVID-19 pandemic. The second section includes twelve personal stories from researchers.

Envelope following response measurements in young veterans are consistent with noise-induced cochlear synaptopathy.

Animal studies have demonstrated that noise exposure can lead to the loss of the synapses between the inner hair cells and their afferent auditory nerve fiber targets without impacting auditory thresholds. Although several non-invasive physiological measures appear to be sensitive to cochlear synaptopathy in animal models, including auditory brainstem response (ABR) wave I amplitude, the envelope following response (EFR), and the middle ear muscle reflex (MEMR), human studies of these measures in samples that are expected to vary in terms of the degree of noise-induced synaptopathy have resulted in mixed findings. One possible explanation for the differing results is that synaptopathy risk is lower for recreational noise exposure than for occupational or military noise exposure.

Simple model of arch support: Relevance to Charcot Neuroarthropathy.

Background: Charcot neuropathy is a common complication resulting from poorly controlled diabetes and peripheral neuropathy leading to the collapse, and ultimately the breakdown, of the midfoot. Mechanically, it is likely that a compromised arch support in this, or any other patient group that experiences foot flattening, would be associated with slippage at the distal and proximal interface regions of the plantar surface of the foot and the adjacent support surface. This slippage, although difficult to quantify with standard motion capture systems used in a gait laboratory, could potentially be assessed with systems for monitoring interface shear stresses.

Occupational Noise Exposure and Longitudinal Hearing Changes in Post-9/11 US Military Personnel During an Initial Period of Military Service.

Objectives: Auditory impairments, particularly those resulting from hazardous occupational noise exposures, are pressing concerns for the US Departments of Defense (DoD) and Veterans Affairs (VA). However, to date, no studies have estimated the rate of hearing threshold change that occurs during service or how changes may vary by military occupation. Hearing threshold changes during military service have historically been reported as the proportion of Service members demonstrating a significant threshold shift.

Subclinical Auditory Dysfunction: Relationship Between Distortion Product Otoacoustic Emissions and the Audiogram.

Purpose Distortion product otoacoustic emissions (DPOAEs) and audiometric thresholds have been used to account for the impacts of subclinical outer hair cell (OHC) dysfunction on auditory perception and measures of auditory physiology. However, the relationship between DPOAEs and the audiogram is unclear. This study investigated this relationship by determining how well DPOAE levels can predict the audiogram among individuals with clinically normal hearing.

Self-Regulatory Processes, Motivation to Conserve Resources and Activity Levels in People With Chronic Pain: A Series of Digital N-of-1 Observational Studies.

Objectives: Motivational and self-regulatory processes during goal pursuit may account for activity patterns in people with chronic pain. This article describes a series of N-of-1 observational studies designed to investigate the influence of goal-related factors on fluctuations in motivation to conserve resources and objectively measured activity levels.

Methods: Four participants with chronic pain who attended a formal pain management program (PMP; 41-59 years old; three female) were recruited and completed digital daily diaries for 11-12 weeks.

Perceptions of Light Pollution and its Impacts: Results of an Irish Citizen Science Survey.

Background: Light pollution is increasingly an area of concern for health and quality of life research. Somewhat surprisingly, there are relatively few descriptions of perceptions of light pollution in the literature. The current study examined such perceptions in a Irish sample.

Qualitative study to explore radiologist and radiologic technologist perceptions of outcomes patients experience during imaging in the USA.

Objective: We aimed to explore the patient-centred outcomes (PCOs) radiologists and radiologic technologists perceive to be important to patients undergoing imaging procedures.

Design: We conducted a qualitative study of individual semi-structured interviews.

Participants: We recruited multiple types of radiologists including general, musculoskeletal neuroradiology, body and breast imagers as well as X-ray, ultrasound, CT or MRI radiologic technologists from Washington and Idaho.

IRB Policies for Obtaining Informed Consent from Non-English-Speaking People.

United States regulations for the protection of human research subjects prescribe parameters for documentation of valid informed consent, which include the stipulation that the process be in a "language understandable to the subject." While significant energy has been devoted to improving the readability of consent documents, supplemental educational tools, and nuanced measurements of individual decisional capacity, there is little guidance about how to best meet the informational needs of adults with decisional capacity who do not speak English. This article reviews the institutional review board policies from the twenty-one research centers that received the most funding from the National Institutes of Health in 2018 and compares their guidelines for obtaining informed consent from non-English speakers.