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.

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.

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.

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.

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.

Genetic testing and eHealth usage among Deaf women.

In the past decade, accessible information in American Sign Language (ASL) about cancer and genetic testing is expanding on eHealth platforms, including social network sites, commercial sites, and mobile apps. Primary data on genetic testing awareness and genetic testing for BRCA 1/2 among Deaf women were gathered using HINTS-ASL survey between November 2016 and April 2018, and secondary data for hearing women were drawn from NCI's HINTS 5 Cycle 1 survey in 2017. Deaf women who had heard of DNA testing (63%) were more likely to be young adults, college graduates, and/or have a family history of cancer. Compared to hearing women, Deaf women who had heard of genetic testing were more likely to use social networking sites to read or share information about medical topics and watch health-related videos. Making eHealth platforms accessible in ASL and easy-to-understand text can help reduce knowledge gap in genetic testing, since some Deaf women may not be using genetic testing to help identify whether they are at increased risk for breast and ovarian cancer early on, before they are diagnosed with cancer.

Prevalence of Anxiety or Depression Diagnosis in Deaf Adults.

The national prevalence of depression and anxiety disorders among deaf adults who use American Sign Language (ASL) remains largely understudied. Data for self-reported depression and anxiety disorder diagnosis (n = 1,704 deaf adults; n = 3,287 hearing adults) as told by their healthcare providers were drawn from HINTS-ASL and HINTS datasets. Chi-square and Poisson regression analysis compared characteristics and predictors for depression or anxiety disorder diagnosis among deaf adults. Rate of diagnosed depression or anxiety disorder was significantly higher (25%) and occurred at earlier age (45 years; SD = 15) for deaf adults compared to hearing adults (22%; mean age = 56; SD = 14). After adjusting for covariates, deaf individuals who were White, younger, female, educated, or single were significantly more likely to self-report a diagnosis of depression/anxiety disorder as told by their healthcare providers. Deaf adults have higher reported rate of diagnosis of depression or anxiety disorder at an earlier onset compared to the general population. Communication access with healthcare providers is essential for accurate diagnosis, treatment, and follow up care.

Communication barrier in family linked to increased risks for food insecurity among deaf people who use American Sign Language.

OBJECTIVE: Food security is defined as being able to access enough food that will help maintain an active, healthy lifestyle for those living in a household. While there are no studies on food security issues among deaf people, research shows that communication barriers early in life are linked to poor physical and mental health outcomes. Childhood communication barriers may also risk later food insecurity. Design/Setting/Subjects A single food security screener question found to have 82 % sensitivity in classifying families who are at risk for food insecurity was taken from the six-item US Household Food Security Survey Module. Questions related to food insecurity screener, depression diagnosis and retrospective communication experience were translated to American Sign Language and then included in an online survey. Over 600 deaf adult signers (18-95 years old) were recruited across the USA. RESULTS: After adjusting for covariates, deaf adults who reported being able to understand little to none of what their caregiver said during their formative years were about five times more likely to often experience difficulty with making food last or finding money to buy more food, and were about three times more likely to sometimes experience this difficulty, compared with deaf adults who reported to being able to understand some to all of what their caregiver said. CONCLUSIONS: Our results have highlighted a marked risk for food insecurity and related outcomes among deaf people. This should raise serious concern among individuals who have the potential to effect change in deaf children's access to communication.

Towards Health Equity: Deaf Adults' Engagement in Social e-Health Activities and e-Communication with Health Care Providers.

Deaf people face significant barriers with accessing health information, health care services, and communication with their health care provider and as a result, show poorer health outcomes compared to the general population. Studies on the general population found that those who use social network sites (SNS) for health-related activities were more likely to communicate with their health care provider via the Internet or email. For deaf individuals who use American Sign Language (ASL), using eHealth platforms to communicate with health care providers has the potential to navigate around communication barriers and create greater opportunity to discuss screening and treatment plans. Using national data from the HINTS-ASL survey, we explored whether engagement in social eHealth activities on SNS is linked to electronic communication with health care providers after controlling for deaf patient characteristics. Our sample for this study consisted of 515 deaf participants who reported using (social media/SNS) to read and share health information. Controlling for sociodemographic variables, participants who engaged in social eHealth activity were threefold more likely to communicate with their healthcare provider electronically. Using eHealth platforms for social health engagement demonstrates potential to reduce health inequality among deaf people.

Critical health literacy in American deaf college students.

This study investigates the relationship between critical health literacy (CHL) and discussion of health information among college deaf students who use American Sign Language. CHL is crucial in making appropriate health-related decisions for oneself and aiding others in making good health-choices. Research on general youth population shows that frequent health-related discussions with both friends and family is associated with higher health literacy. However, for our sample of deaf college-aged students who might have had less access to communication at home, we hypothesize that health-related discussions with same-age peers may be more important for critical health literacy. We asked two questions to assess the frequency of health-related discussions with friends and families: "How often do you discuss health-related information with your friends" and "How often do you discuss your family medical history with your family?". Participants rated their experience on a scale from 1-5 (1=never, 5=always). To assess CHL, 38 deaf and 38 hearing participants were shown a short scenario that showed a woman confiding in her friend after finding a lump in her breast. Participants were then asked what the friend should say. Responses were scored by a team of 3 raters using a CHL rubric. As predicted, results showed a strong relationship between discussion of health-related information with friends and CHL in both deaf and hearing samples. Discussion with family was linked to CHL only for hearing participants, but not deaf participants in our study. These findings underscore the importance of socializing with health-literate, accessible peers to improve the health literacy and health outcomes of all deaf people.

Making Cancer Health Text on the Internet Easier to Read for Deaf People Who Use American Sign Language.

People with relatively limited English language proficiency find the Internet's cancer and health information difficult to access and understand. The presence of unfamiliar words and complex grammar make this particularly difficult for Deaf people. Unfortunately, current technology does not support low-cost, accurate translations of online materials into American Sign Language. However, current technology is relatively more advanced in allowing text simplification, while retaining content. This research team developed a two-step approach for simplifying cancer and other health text. They then tested the approach, using a crossover design with a sample of 36 deaf and 38 hearing college students. Results indicated that hearing college students did well on both the original and simplified text versions. Deaf college students' comprehension, in contrast, significantly benefitted from the simplified text. This two-step translation process offers a strategy that may improve the accessibility of Internet information for Deaf, as well as other low-literacy individuals.

Usability of American Sign Language Videos for Presenting Mathematics Assessment Content.

There is considerable interest in determining whether high-quality American Sign Language videos can be used as an accommodation in tests of mathematics at both K-12 and postsecondary levels; and in learning more about the usability (e.g., comprehensibility) of ASL videos with two different types of signers - avatar (animated figure) and human. The researchers describe the results of administering each of nine pre-college mathematics items in both avatar and human versions to each of 31 Deaf participants with high school and post-high school backgrounds. This study differed from earlier studies by obliging the participants to rely on the ASL videos to answer the items. While participants preferred the human version over the avatar version (apparently due largely to the better expressiveness and fluency of the human), there was no discernible relationship between mathematics performance and signed version.

Caregiver-Reported Indicators of Communication and Social Functioning for Young Children Who Are Deaf or Hard of Hearing.

We elicited caregiver-reported observations of children aged 5-10 who were deaf or hard of hearing (DHH) that resulted in two age-specific instruments: Caregiver Report of Behaviors and Events (CROBE-DHH 5-7 and 8-10). These new instruments record observations on communication and social behaviors/events. In Study 1, 36 caregivers provided qualitative data on important content on what they were able to observe for instrument development and in Study 2, 271 provided data for studying cross-sectional measurement properties. Two modules resulted in 11 items for children age 5-7 and 15 items for children 8-10 years. Items showing good 7-day reproducibility (ICC over .70) and fair 4-week reproducibility (ICC over .50) were retained. Children with milder hearing loss received higher (better) scores. Items did not distinguish between those with or without cochlear implants. Analyses suggest that the instruments are best used as individual indicator items. In both age groups, caregivers reported youths missed out on family conversations and spent little time on their own. These content-validated indicators apply to all children with DHH. Further work will evaluate the usefulness of these indicators in evaluating change in communication and social behaviors, and the implications of results for intervention.

Discourses of prejudice in the professions: the case of sign languages.

There is no evidence that learning a natural human language is cognitively harmful to children. To the contrary, multilingualism has been argued to be beneficial to all. Nevertheless, many professionals advise the parents of deaf children that their children should not learn a sign language during their early years, despite strong evidence across many research disciplines that sign languages are natural human languages. Their recommendations are based on a combination of misperceptions about (1) the difficulty of learning a sign language, (2) the effects of bilingualism, and particularly bimodalism, (3) the bona fide status of languages that lack a written form, (4) the effects of a sign language on acquiring literacy, (5) the ability of technologies to address the needs of deaf children and (6) the effects that use of a sign language will have on family cohesion. We expose these misperceptions as based in prejudice and urge institutions involved in educating professionals concerned with the healthcare, raising and educating of deaf children to include appropriate information about first language acquisition and the importance of a sign language for deaf children. We further urge such professionals to advise the parents of deaf children properly, which means to strongly advise the introduction of a sign language as soon as hearing loss is detected.

Health websites: accessibility and usability for American sign language users.

To date, there have been efforts toward creating better health information access for Deaf American Sign Language (ASL) users. However, the usability of websites with access to health information in ASL has not been evaluated. Our article focuses on the usability of four health websites that include ASL videos. We seek to obtain ASL users' perspectives on the navigation of these ASL-accessible websites, finding the health information that they needed, and perceived ease of understanding ASL video content. ASL users (n = 32) were instructed to find specific information on four ASL-accessible websites, and answered questions related to (a) navigation to find the task, (b) website usability, and (c) ease of understanding ASL video content for each of the four websites. Participants also gave feedback on what they would like to see in an ASL health library website, including the benefit of added captioning and/or signer model to medical illustration of health videos. Participants who had lower health literacy had greater difficulty in finding information on ASL-accessible health websites. This article also describes the participants' preferences for an ideal ASL-accessible health website, and concludes with a discussion on the role of accessible websites in promoting health literacy in ASL users.

Deaf Adolescents' Learning of Cardiovascular Health Information: Sources and Access Challenges.

Deaf individuals have more cardiovascular risks than the general population that are believed to be related to their cardiovascular health knowledge disparities. This phenomenological study describes where 20 deaf sign language-using adolescents from Rochester, New York, many who possess many positive characteristics to support their health literacy, learn cardiovascular health information and their lived experiences accessing health information. The goal is to ultimately use this information to improve the delivery of cardiovascular health education to this population and other deaf adolescents at a higher risk for weak health literacy. Deaf bilingual researchers interviewed deaf adolescents, transcribed and coded the data, and described the findings. Five major sources of cardiovascular health information were identified including family, health education teachers, healthcare providers, printed materials, and informal sources. Despite possessing advantageous characteristics contributing to stronger health literacy, study participants described significant challenges with accessing health information from each source. They also demonstrated inconsistencies in their cardiovascular health knowledge, especially regarding heart attack, stroke, and cholesterol. These findings suggest a great need for additional public funding to research deaf adolescents' informal health-related learning, develop accessible and culturally appropriate health surveys and health education programming, improve interpreter education, and disseminate information through social media.

Bilingualism: A Pearl to Overcome Certain Perils of Cochlear Implants.

Cochlear implants (CI) have demonstrated success in improving young deaf children's speech and low-level speech awareness across a range of auditory functions, but this success is highly variable, and how this success correlates to high-level language development is even more variable. Prevalence on the success rate of CI as an outcome for language development is difficult to obtain because studies vary widely in methodology and variables of interest, and because not all cochlear implant technology (which continues to evolve) is the same. Still, even if the notion of treatment failure is limited narrowly to those who gain no auditory benefit from CI in that they cannot discriminate among ambient noises, the reported treatment failure rate is high enough to call into question the current lack of consideration of alternative approaches to ensure young deaf children's language development. Recent research has highlighted the risks of delaying language input during critical periods of brain development with concomitant consequences for cognitive and social skills. As a result, we propose that before, during, and after implantation deaf children learn a sign language along with a spoken language to ensure their maximal language development and optimal long-term developmental outcomes.

Exploring the Interplay of Diabetes, Deaf Patient Reported Outcomes, and Cancer Screening in Deaf and Hard of Hearing Women.

Purpose: Some deaf and hard-of-hearing (DHH) individuals face health information barriers, increasing their risk of diabetes mellitus (DM) and subsequent cancer development. This study examines if health-related quality of life (HRQoL) and deaf patient-reported outcomes (DHH-QoL) mediate the relationship between DM diagnosis and cancer screening adherence among DHH individuals. Patients and Methods: In a cross-sectional study, US DHH adults assigned female at birth answered questions on cervical and breast cancer screenings from the ASL-English bilingual Health Information National Trends Survey (HINTS-ASL) and the PROMIS (Patient Reported Outcome Measurement Information System) Deaf Profile measure's Communication Health and Global Health domains. Odds ratios (OR) and 95% confidence intervals (CI) were obtained from multivariable logistic and linear regression models, examining the association between DM, DHH-QoL, and cancer screening adherence, adjusting for other covariates and HRQoL. A Baron and Kenny causal mediation analysis was used. A two-sided p < 0.05 indicated significance. Results: Most respondents were White (66.4%), heterosexual (66.2%), did not have DM (83.9%), had health insurance (95.5%), and adhered to pap smears (75.7%) and mammograms (76.9%). The average (standard deviation) DHH-QoL score was 50.9 (8.6). Those with DM had lower HRQoL scores (46.2 (9.5) vs 50.2 (8.8); p < 0.0001) than those without. Non-significant multivariable models indicate that those with DM were more adherent to pap testing (OR: 1.48; 95% CI: 0.72, 3.03; p = 0.285) and mammograms (2.18; 95% CI: 0.81, 5.88; p = 0.122), with DHH-QoL scores slightly increasing them to 1.53 (0.74, 3.16; p = 0.250) for pap testing and 2.55 (0.91, 7.13; p = 0.076) for mammograms. DHH-QoL was significantly associated with mammograms (p = 0.027), with 6% increased adherence per unit increase in the score. Overall, HRQoL and DHH-QoL were not significant mediators. Conclusion: While HRQoL/DHH-QoL in DHH individuals with DM does not mediate cancer screening adherence, higher DHH-QoL scores are associated with it. DHH-focused health literacy and communication training can improve cancer-related outcomes.