Barriers and facilitators to the inclusion of deaf people in clinical trials.

BACKGROUND/AIMS: This article discusses the barriers that prevent deaf people from participating in clinical trials and offers recommendations to overcome these barriers and ensure equal access to study participation. METHODS: Between April and May 2022, we conducted six focus groups with 20 deaf adults who use American Sign Language, all of whom had previous experience as research study participants. Focus group prompts queried community awareness of clinical trial opportunities, barriers and facilitators to deaf people's participation in clinical trials, and recommended resources to improve clinical trial access. This qualitative focus group data is supplemented by survey data gathered from 40 principal investigators and clinical research coordinators between November 2021 and December 2021. The survey queried researchers' prior experiences with enrolling deaf participants in clinical trials and strategies they endorse for enrollment of deaf participants in future clinical trials. RESULTS: Focus group participants unanimously agreed that, compared to the general hearing population, deaf sign language users lack equivalent access to clinical trial participation. Reported barriers included lack of awareness of clinical trial opportunities, mistrust of hearing researchers, and refusal by clinical trial staff to provide accessible communication (e.g. denial of requests for sign language interpreters). Survey data from 40 principal investigators and clinical research coordinators corroborated these barriers. For example, only 2 out of 40 survey respondents had ever enrolled a deaf person in a clinical trial. Respondents indicated that the most helpful strategies for including deaf sign language users in future clinical trials would be assistance with making recruitment information accessible to deaf sign language users and assistance in identifying qualified interpreters to hire to help facilitate the informed consent process. CONCLUSION: The lack of communication accessibility is the most common factor preventing deaf sign language users from participating in clinical trials. This article provides recommendations for hearing researchers to improve deaf people's access to clinical trials moving forward, drawing from mixed-methods data.

Equitable Access to Telehealth and Other Services for Deaf People During the COVID-19 Pandemic.

Introduction: Deaf people who use American Sign Language (ASL) with low self-perceived ability to understand spoken information face inequitable access to health care due to systemic barriers. Methods: We conducted interviews with 266 deaf ASL users at baseline (May-Aug 2020) and 244 deaf ASL users at follow-up (3 months). Questions addressed (1) access to interpretation during in-person visits; (2) whether they visited clinics (3) or emergency departments (EDs); and (4) telehealth use. Analyses involved univariate and multivariable logistic regressions across levels of perceived ability to understand spoken language. Results: Less than a third were aged >65 (22.8%); Black, Indigenous, People of Color (28.6%), or LGBTQ+ (31.1%); and had no college degree (30.6%). More respondents reported outpatient visits at follow-up (63.9%) than at baseline (42.3%). Ten more respondents reported going to urgent care or an ED at follow-up than at baseline. At follow-up interviews, 57% of deaf ASL respondents with high perceived ability to understand spoken language reported receiving interpretation at clinic visits compared to 32% of ASL respondents with low perceived ability to understand spoken language (p<0.01). Telehealth and ED visits showed no between-group differences for low versus high perceived ability to understand spoken language. Discussion: Our study is the first to explore deaf ASL users' access to telehealth and outpatient encounters over time during the pandemic. The U.S. health care system is designed for people who have high perceived ability to understand spoken information. Systemic access to health care, including telehealth and clinics, must be made consistently equitable for deaf people who require accessible communication.

Development and Implementation of a Curriculum for Pediatric Trainees on Caring for Children Who Are Deaf and Hard of Hearing: A Pilot Study.

INTRODUCTION: Children who are deaf or hard of hearing (DHH) are at risk for poor developmental outcomes related to incomplete language access. Evidence based interventions are available to improve early access to language. With a better understanding of caring for DHH children, pediatricians will be more prepared to work with families in improving outcomes for this population. To date, there are no formal curricula on educating pediatric trainees on childhood hearing differences. METHODS: The authors designed a novel pilot curriculum to educate pediatric trainees on caring for DHH children, including screening, diagnosis, signed languages, and hearing technologies. The curriculum was delivered to pediatric interns in a 1-hour seminar. Pre-lecture, immediate post-lecture, and 6-month post-lecture surveys were developed and conducted to evaluate the effectiveness of the curriculum. Descriptive statistics were used to determine differences in understanding concepts before and after the curricular intervention. RESULTS: A total of 55 residents participated in the curriculum over a 14-month study period from 2018 to 2019. There were significant differences in responses between the pre- and post- surveys related to residents' understanding of childhood deafness and their confidence in their ability to care for DHH children. CONCLUSION: Pediatric trainees gained an understanding of the challenges faced by DHH children and of the interventions that aim to provide them with access to language during the critical period of development. As a result, trainees will be in a better position to care for patients and their families after a new diagnosis of a hearing difference and guide them through early language-based interventions.

Unmet Dental Needs Among Mid-to-Older Deaf and Hard of Hearing Women in the U.S.

Introduction: Despite the significant number of deaf and hard of hearing (DHH) people living in the U.S., oral health research on DHH people who use American Sign Language (ASL) is virtually nonexistent. This study aims to investigate dental needs among mid-to-older DHH women and identify social determinants of health that may place them at higher risk for unmet dental health needs as the primary outcome. Methods: This cross-sectional study uses data drawn from Communication Health domain in the PROMIS-DHH Profile and oral health data from the National Health and Nutrition Examination Survey. Both measures were administered in ASL and English between November 2019 and March 2020. Univariate and bivariate analysis included only complete data, and multivariable logistic regression analyses were conducted on multiply imputed data. Results: Out of 197 DHH women (41 to 71+ years old) who answered the dental visit question, 48 had unmet dental needs and 149 had met dental needs. Adjusting for sociodemographic variables, disparity in dental needs was observed across education [OR (95% CI): 0.45(0.15, 1.370)] and communication health [0.95 (0.90, 1.01)]. Discussion: Our study is the first to describe DHH mid-to-older women's access to oral health care. DHH women who do not have a college degree may be impacted. Further research is needed to elucidate the particular risk factors, including cultural, to which DHH individuals from marginalized racial groups are susceptible to unmet oral health needs. Conclusions: Evidence shows that DHH ASL users who have less years of education or are single experience barriers in accessing dental care.

Health disparities among Black deaf and hard of hearing Americans as compared to Black hearing Americans: A descriptive cross-sectional study.

ABSTRACT: There is a dearth of literature on health outcomes for Black people who identify as deaf or hard of hearing (DHH). Black DHH individuals generally experience at least 2 types of oppression, racism and audism, both of which contribute to health disparities within the Black and Deaf communities.To understand the prevalence of health outcomes in a Black DHH adult sample and compare this to a Black hearing sample.A descriptive cross-sectional study with primary Health Information National Trends Survey (HINTS)- American Sign Language survey data from Black DHH adults and secondary National Cancer Institute-HINTS English survey data from Black hearing adults.Black DHH adults and Black hearing adults (18 years or older).Using NCI's health information national trends survey in American Sign Language and English, self-reported data was gathered for all medical conditions as diagnosed by healthcare providers.The study showed that Black DHH adults had a higher likelihood for diabetes, hypertension, lung disease, cancer, and comorbidity compared to their hearing Black counterparts.Black DHH adults are at disparity for certain medical conditions compared to the general Black adult population. Future directions are needed to ensure that anti-racist policies include consideration of people with sensory disabilities. Inclusion of cultural and language needs of Black DHH patients in cultural humility training for healthcare providers is recommended to address health disparity in this population.

A Mixed Methods Study of Hysterectomy in a U.S. Sample of Deaf Women Who Use American Sign Language.

Background: Hysterectomy is one of the most common procedures performed in the United States. Yet, we know nothing about deaf women's experiences with hysterectomy. The study aims to establish a prevalence of hysterectomy among deaf women and provide insight into the experiences of those who have undergone hysterectomy. Materials and Methods: Quantitative data (n = 195; 27% Black, Indigenous, People of Color) were collected through a bilingual online patient-reported outcomes survey and reproductive health questions from the National Health and Nutrition Examination Survey (NHANES) between November 2019 and March 2020. Semistructured interviews were conducted between March and April 2021 with a smaller sample of deaf women who underwent hysterectomy. A multivariable logistic regression model identified the relationship between health care history and sociodemographic factors, while qualitative interview data were used to understand deaf women's experiences with hysterectomy. Results: Of the 195 deaf respondents, 34% underwent hysterectomy (n = 67). Results indicated that the odds of hysterectomy increased for higher age (per year), being African American/Black or Latinx, being married or living with a partner, being overweight or obese, and if communicating with the doctor through English writing or others. Qualitative interviews were conducted with eight women who provided consent to participate. Although all women reported improved quality of life posthysterectomy, patient-centered experience and decision making before hysterectomy were highly dependent on access to communication, information sources, and social support. Conclusions: Prioritizing the needs of deaf women leading up to, during, and after hysterectomy has the potential to improve overall experience with hysterectomy and patient-clinician communication.

Coproduction, Coeducation, and Patient Involvement: Everyone Included Framework for Medical Education Across Age Groups and Cultures.

Medical education, research, and health care practice continue to grow with minimal coproduction guidance. We suggest the Commons Principle approach to medical education as modeled by Ostrom and Williamson, where we share how adapting these models to multiple settings can enhance empathy, increase psychological safety, and provide robust just-in-time learning tools for practice. We here describe patient and public coproduction in diverse areas within health care using the commons philosophy across populations, cultures, and generations with learning examples across age groups and cultures. We further explore descriptive, mixed methods participatory action in medical and research education. We adopt an "Everyone Included" perspective and sought to identify its use in continuing medical education, citizen science, marginalized groups, publishing, and student internships. Overall, we outline coproduction at the point of need, as we report on strategies that improved engagement. This work demonstrates coproduction with the public across multiple settings and cultures, showing that even with minimal resources and experience, this partnership can improve medical education and care.

Cross-Sectional Analysis of Medical Conditions in the U.S. Deaf Transgender Community.

Purpose: This first U.S.-based, descriptive study of transgender Deaf adults looks to contribute to the gap in research regarding those who lie at the intersection of Deaf and transgender identities. The study objective is to identify characteristics that associate with medical conditions, including depression and anxiety disorders, among Deaf transgender adults. Methods: We gathered self-reported data from 74 Deaf transgender adults who used American Sign Language. Modified Poisson regression with robust standard errors was used to calculate relative risk estimates of having a medical condition among nonbinary individuals compared with gender binary individuals. Results: The sample lifetime prevalence for medical conditions in the Deaf transgender sample were as follows: 48.6% for depression/anxiety disorders, 28.8% for hypertension, 20.3% for lung conditions, 16.2% for arthritis/rheumatism, 12.3% for diabetes, 7.0% for cirrhosis/liver/kidney problems, 5.5% for heart conditions, and 2.7% for cancer. In cross-tabulation analysis across binary and nonbinary subsamples, the lifetime prevalence was significantly different only for depression and anxiety disorder with higher percentage in the nonbinary subsample. After adjusting for covariates in a regression model, identification as nonbinary increased a Deaf person's risk for being diagnosed with depression or anxiety disorder by 80% (95% confidence interval, 1.11-2.90) relative to Deaf people who self-identified as a binary gender. Conclusion: Study findings suggest that the Deaf transgender community is at risk for developing mental and physical health conditions.

Deaf adults at higher risk for severe illness: COVID-19 information preference and perceived health consequences.

OBJECTIVES: This study explores deaf and hard of hearing (DHH) individuals' preferred sources of information for COVID-19 and their perceptions of developing severe illness from COVID-19 given underlying medical conditions. METHODS: A national online bilingual American Sign Language/English survey was conducted from April 17 to May 1, 2020. Weighted sample of 474 DHH adults living in the United States. Multivariate logistic regression analyses were conducted to examine independent associations of sociodemographic variables and health indicators with perceived COVID-19 health consequences. RESULTS: About 44% of the medical condition sample used the Internet (English-based text) first for COVID-19 information, followed by TV (24%). Only 1% selected healthcare provider as the go-to source; the remainder got information from family or friends. Perceived health consequences increased with age (adjusted OR = 1.04; CI 95% = 1.02, 1.06). At-risk respondents who self-identified as persons of color were nearly three times more likely to believe that their health will be severely affected by COVID-19 compared to respondents who self-identified as white (adjusted OR = 2.94; CI 95% = 1.20, 7.18). CONCLUSIONS: Perception of COVID-19 health consequences vary among DHH adults at higher risk for severe illness. PRACTICE IMPLICATIONS: Information delivery methods must be flexible and comprehensive to meet the diverse community's needs, especially during the COVID-19 pandemic.

Perception of COVID-19 Physical Distancing Effectiveness and Contagiousness of Asymptomatic Individuals: Cross-sectional Survey of Deaf and Hard of Hearing Adults in the United States.

BACKGROUND: During the COVID-19 pandemic, there has been a rapid increase in the amount of information about the disease and SARS-CoV-2 on the internet. If the language used in video messages is not clear or understandable to deaf and hard of hearing (DHH) people with a high school degree or less, this can cause confusion and result in information gaps among DHH people during a health emergency. OBJECTIVE: The aim of this study is to investigate the relationship between DHH people's perception of the effectiveness of physical distancing and contagiousness of an asymptomatic person. METHODS: This is a cross-sectional survey study on DHH people's perceptions about COVID-19 (N=475). Items pertaining to COVID-19 knowledge were administered to US deaf adults from April 17, 2020, to May 1, 2020, via a bilingual American Sign Language/English online survey platform. RESULTS: The sample consisted of 475 DHH adults aged 18-88 years old, with 74% (n=352) identifying as White and 54% (n=256) as female. About 88% (n=418) of the sample felt they knew most things or a lot about physical distancing. This figure dropped to 72% (n=342) for the question about the effectiveness of physical distancing in reducing the spread of COVID-19 and 70% (n=333) for the question about the contagiousness of an infected person without symptoms. Education and a knowledge of the effectiveness of physical distancing significantly predicted knowledge about the contagiousness of an asymptomatic individual. Race, gender, and age did not emerge as significant predictors. CONCLUSIONS: This results of this study point to the strong connection between education and coronavirus-related knowledge. Education-related disparities can be remedied by making information fully accessible and easily understood during emergencies and pandemics.

Food Worry in the Deaf and Hard-of-Hearing Population During the COVID-19 Pandemic.

OBJECTIVE: The coronavirus disease 2019 (COVID) pandemic has highlighted preexisting health disparities, including food insecurity, in the deaf and hard-of-hearing (DHH) population. We examined factors associated with food worry during the COVID-19 pandemic. METHODS: We collected survey data on worry about food shortages, worry about contracting COVID-19, and concerns about DHH people staying home and being lonely from April 17 through May 1, 2020, via a bilingual American Sign Language/English online survey platform. The sample consisted of 537 DHH adults living in the United States. We examined the relationship between demographic characteristics and food worry. We used logistic regression and model fitting to predict the likelihood of experiencing food worry. RESULTS: The mean (SD) age of survey respondents was 47 (16), and 25% of the sample identified as people of color. Forty-two percent of survey respondents had a high level of food worry. Increased worry about contracting COVID-19 and concerns about DHH people staying home and being lonely among DHH younger adults or those without a college degree predicted food worry. Gender and race/ethnicity did not contribute to the model for food worry. CONCLUSIONS: Food worry was explained by multiple, intersecting factors, including demographic variables, worry about contracting COVID-19, and concerns about loneliness. Interventions or programs implemented by DHH-serving organizations as well as government programs, social service providers, and food banks should be fully accessible to subgroups of DHH young adults without a college degree who are at risk for food insecurity.

Ensuring full participation of people with disabilities in an era of telehealth.

The widespread use of telehealth resulting from the COVID-19 pandemic has the potential to further exacerbate inequities faced by people with disabilities. Although, for some members of the disability community, the option to engage with telehealth may result in reduced barriers to care, for others, inadequate attention to the design, implementation, and policy dimensions may be detrimental. Addressing such considerations is imperative to mitigate health inequities faced by the disability community.

Global Regulatory Review Needed for Cochlear Implants: A Call for FDA Leadership.

INTRODUCTION: Using the United States Food and Drug Administration (FDA) as example, we argue that regulatory agencies worldwide should review their guidance on cochlear implants (CIs). METHODS: This is a position paper, thus the methods are strictly argumentation. Here we give the motivation for our recommendation. The FDA's original approval of implantation in prelingually deaf children was granted without full benefit of information on language acquisition, on childcaregiver communication, and on the lived experience of being deaf. The CI clinical trials, accordingly, did not address risks of linguistic deprivation, especially when the caregiver's communication is not fully accessible to the prelingually deaf child. Wide variability in the effectiveness of CIs since initial and updated approval has been indicated but has not led to new guidance. Children need to be exposed frequently and regularly to accessible natural language while their brains are still plastic enough to become fluent in any language. For the youngest infants, who are not yet producing anything that could be called language although they might be producing salient social signals (Goldstein et al. Child Dev 80:636-644, 2009), good comprehension of communication from caregiver to infant is critical to the development of language. Sign languages are accessible natural languages that, because they are visual, allow full immersion for deaf infants, and they supply the necessary support for this comprehension. The main language contributor to health outcomes is this combination of natural visual language and comprehension in communication. Accordingly, in order to prevent possible language deprivation, all prelingually deaf children should be exposed to both sign and spoken languages when their auditory status is detected, with sign language being critical during infancy and early childhood. Additionally, all caregivers should be given support to learn a sign language if it is new to them so that they can comprehend their deaf children's language expressions fully. However, both languages should be made accessible in their own right, not combined in a simultaneous or total communication approach since speaking one language and signing the other at the same time is problematic. RESULTS: Again, because this is a position paper, our results are our recommendations. We call for the FDA (and similar agencies in other countries) to review its approval of cochlear implantation in prelingually deaf children who are within the sensitive period for language acquisition. In the meantime, the FDA should require manufacturers to add a highlighted warning to the effect that results with CI vary widely and CIs should not be relied upon to provide adequate auditory input for complete language development in all deaf children. Recent best information on users' experience with CIs (including abandonment) should be clearly provided so that informed decisions can be made. The FDA should require manufacturers' guidance and information materials to include encouragement to parents of deaf children to offer auditory input of a spoken language and visual input of a sign language and to have their child followed closely from birth by developmental specialists in language and cognition. In this way parents can align with providers to prioritize cognitive development and language access in both audio-vocal and visuo-gestural modalities. DISCUSSION: The arguments and recommendations in this paper are discussed at length as they come up.

Adverse Childhood Communication Experiences Associated With an Increased Risk of Chronic Diseases in Adults Who Are Deaf.

INTRODUCTION: This study explores adverse childhood communication experiences and its RRs for acquiring specific chronic diseases and mental health disorders in adults who are deaf and hard of hearing. METHODS: A cross-sectional design with snowball sampling was used to recruit adults who were deaf and hard of hearing and were born or became deaf in both ears before age 13 years. Patient-reported outcomes surveys in American Sign Language and English were disseminated to collect data about early life communication experiences with caregivers. Modified Poisson regression with robust SEs was used to calculate RR estimates and 95% CIs for all medical conditions with early life communication experiences as main predictors. RESULTS: Data collection occurred from May 2016 to July 2016, October 2016 to April 2018, and October 2018 to May 2019. The U.S. sample consisted of 1,524 adults who were born or became deaf early. After adjusting for parental hearing status and known correlates of medical conditions, poorer direct child-caregiver communication was significantly associated with an increased risk of being diagnosed with diabetes (RRR=1.12, 95% CI=1.01, 1.24), hypertension (RRR=1.10, 95% CI=1.03, 1.17), and heart disease (RRR=1.61, 95% CI=1.39, 1.87). Poor indirect family communication/inclusion increased risks for lung diseases (RRR=1.19, 95% CI=1.07, 1.33) and depression/anxiety disorders (RRR=1.34, 95% CI=1.24, 1.44). The absolute risk increase and number needed to harm are also reported. CONCLUSIONS: Outcomes data reported by patients who were deaf and hard of hearing demonstrated that poorer direct child-caregiver communication and ongoing exclusion from incidental family communication were associated with increased risks for multiple chronic health outcomes. Practices should consider developing and utilizing an adverse childhood communication screening measure to prevent or remediate language deprivation and communication neglect in pediatric patients who were deaf and hard of hearing.

Quality of Life and Needs of Deaf Informal Caregivers of Loved Ones with Alzheimer's and Related Dementia.

No studies have included the experiences and needs of informal caregivers who are deaf, use American Sign Language (ASL), and care for a loved one with Alzheimer's disease or related dementias (ADRD). The CDC's BRFSS Caregiver Module and PROMIS-Deaf Profile measures were administered via an online bilingual English/ASL platform between October 2019 and March 2020. Out of 194 deaf adult signers who completed an online survey, 42 respondents (mean age = 66; SD = 12; 74% White) endorsed informally caring for someone with a medical condition. In this survey subsample of informal caregivers, more years of education was significantly associated with higher generic quality of life and higher deaf-specific quality of life. A smaller subset of informal deaf informal caregivers who were currently taking care of loved ones with ADRD were then invited to participate in a semi-structured interview. Among the 22 informal caregivers who were interviewed, there was a strong agreement among the participants who felt that their quality of life as informal caregivers was worse than hearing informal caregivers who took care of loved ones with ADRD. Findings highlight the importance of a call to action to address the needs of deaf informal ADRD caregivers.

Prostate-Specimen Antigen (PSA) Screening and Shared Decision Making Among Deaf and Hearing Male Patients.

Some deaf men who use American Sign Language (ASL) experience barriers in patient-physician communication which may leave them at disparity for shared decision making compared to hearing men. Transparent communication accessibility is needed between deaf male ASL users and their physicians to maximize the benefit to risk ratio of using the prostate-specific antigen (PSA) as a screening tool for early detection. The objective is to compare shared decision-making outcomes between deaf and hearing males who are (1) age-eligible for PSA screening and (2) younger than 45 years old with a family history of cancer. An accessible health survey including questions about PSA test, PCC, modes of communication, and cancer history was administered in ASL to a nationwide sample of deaf adults from February 2017 to April 2018. Two subsamples were created: (1) 45- to 69-year-old men who were age-eligible for PSA testing and (2) 18- to 44-year-old men with a family history of cancer. Age-eligible and younger deaf men with a family history of cancer are at disparity for shared decision making compared to their hearing peers. Regardless of age and PSA testing status, deaf men felt significantly less engaged in shared decision making with their health care providers compared to hearing men. Participation in shared decision making requires not only accessible communication but also cultural competency in working with deaf patients. This is critical in the shared decision-making era in maximizing the benefit of prostate cancer screening in deaf male patient population.