Type 2 diabetes and health-related quality of life among older Medicare beneficiaries: The mediating role of sleep.

OBJECTIVE: To examine mediating effects of sleep quality and duration on the association between T2D and QoL among Medicare beneficiaries 65+. METHODS: Data from the Medicare Health Outcome Survey (2015-2020) were used. The outcome was QoL (physical and mental health component-summary scores [PCS and MCS]) measured by the Veterans-Rand-12. The main predictor was diagnosed T2D. Mediators were sleep duration and sleep quality. The effect modifier was race/ethnicity. Structural Equation Modeling was used to estimate moderated-mediating effects of sleep quality and duration across race/ethnicity. RESULTS: Of the 746,400 Medicare beneficiaries, 26.7% had T2D, and mean age was 76 years (SD ± 6.9). Mean PCS score was 40 (SD ± 12.2), and mean MCS score was 54.0 (SD ± 10.2). Associations of T2D with PCS and MCS were negative and significant. For all racial/ethnic groups, those with T2D reported lower PCS. For White, Black, Asian, and Hispanic beneficiaries only, those with T2D reported lower MCS. The negative impact of T2D on PCS and MCS was mediated through sleep quality, especially very bad sleep quality. CONCLUSION: Improving sleep may lead to improvement in QoL in elderly adults with T2D.

Strengths, weaknesses, opportunities and threats of using AI-enabled technology in sleep medicine: a commentary.

Over the past few years, artificial intelligence (AI) has emerged as a powerful tool used to efficiently automate several tasks across multiple domains. Sleep medicine is perfectly positioned to leverage this tool due to the wealth of physiological signals obtained through sleep studies or sleep tracking devices and abundance of accessible clinical data through electronic medical records. However, caution must be applied when utilizing AI, due to intrinsic challenges associated with novel technology. The Artificial Intelligence in Sleep Medicine committee of the American Academy of Sleep Medicine (AASM) reviews advancements in AI within the sleep medicine field. In this article, the Artificial Intelligence in Sleep Medicine committee members provide a commentary on the scope of AI technology in sleep medicine. The commentary identifies three pivotal areas in sleep medicine which can benefit from AI technologies: clinical care, lifestyle management and population health management. This article provides a detailed analysis of the strengths, weaknesses, opportunities, and threats associated with using AI enabled technologies in each pivotal area. Finally, the article broadly reviews barriers and challenges associated with using AI enabled technologies and offers possible solutions.

African Ancestry Individuals with Higher Educational Attainment Are Resilient to Alzheimer's Disease Measured by pTau181.

Background: Cognitive and functional abilities in individuals with Alzheimer's disease (AD) pathology (ADP) are highly variable. Factors contributing to this variability are not well understood. Previous research indicates that higher educational attainment (EA) correlates with reduced cognitive impairments among those with ADP. While cognitive and functional impairments are correlated, they are distinguishable in their manifestations. Objective: To investigate whether levels of education are associated with functional impairments among those with ADP. Methods: This research involved 410 African American (AA) individuals (Institutional Review Boards 20070307, 01/27/2023) to ascertain whether EA correlates with functional resilience and if this effect varies between APOE ɛ4 carriers and non-carriers. Utilizing EA as a cognitive reserve proxy, CDR-FUNC as a functional difficulties measure, and blood pTau181 as an ADP proxy, the non-parametric Mann-Whitney U test assessed the relationship between EA and CDR-FUNC in individuals with advanced pTau181 levels. Results: The results showed that EA correlated with functional difficulties in AA individuals with high levels of pTau181, such that individuals with high EA are more likely to have better functional ability compared to those with lower EA (W = 730.5, p = 0.0007). Additionally, we found that the effect of high EA on functional resilience was stronger in ɛ4 non-carriers compared to ɛ4 carriers (W = 555.5, p = 0.022). Conclusion: This study extends the role of cognitive reserve and EA to functional performance showing that cognitive reserve influences the association between ADP burden and functional difficulties. Interestingly, this protective effect seems less pronounced in carriers of the strong genetic risk allele ɛ4.

The associations between instructional approach, sleep characteristics and adolescent mental health: Lessons from the COVID-19 pandemic.

OBJECTIVES: To test whether adolescents' mental health during the COVID-19 pandemic is associated with the combination of their instructional approach(es) and their sleep patterns. DESIGN: Cross-sectional. SETTING: Adolescents were recruited through social media outlets in October and November 2020 to complete an online survey. PARTICIPANTS: Participants were 4442 geographically and racially diverse, community-dwelling students (grades 6-12, 51% female, 36% non-White, 87% high schoolers). MEASUREMENTS: Participants completed items from the PROMIS Pediatric Depressive Symptoms and Anxiety scales. Participants reported their instructional approach(es), bedtimes, and wake times for each day in the past week. Participants were categorized into five combined instructional approach groups. Average sleep opportunity was calculated as the average time between bedtime and waketime. Social jetlag was calculated as the difference between the average sleep midpoint preceding non-scheduled and scheduled days. RESULTS: Emotional distress was elevated in this sample, with a large proportion of adolescents reporting moderate-severe (T-score ≥ 65) levels of depressive symptoms (49%) and anxiety (28%). There were significant differences between instructional approach groups, such that adolescents attending all schooldays in-person reported the lowest depressive symptom and anxiety T-scores (P < .001, ηp2 = .012), but also the shortest sleep opportunity (P < .001, ηp2 = .077) and greatest social jetlag (P < .001, ηp2 = .037) of all groups. Adolescents attending school in person, with sufficient sleep opportunity (≥8-9 hours/night) and limited social jetlag (<2 hours) had significantly lower depressive (ηp2 = .014) and anxiety (ηp2 = .008) T-scores than other adolescents. CONCLUSIONS: Prioritizing in-person education and promoting healthy sleep patterns (more sleep opportunity, more consistent sleep schedules) may help bolster adolescent mental health.

Precision Recruitment and Engagement of Individuals at Risk for Diabetes and Hypertension in Clinical Trials (PREDHICT): A Randomized Trial for an E-Persuasive Mobile Application to Inform Decision Making about Clinical Trials.

The primary objective of this randomized trial was to test the effectiveness of the PREDHiCT digital application, which provides educational and supportive navigation to increase willingness to participate in a future clinical trial. The second objective was to test whether PREDHiCT increased clinical trial literacy or enhanced psychological facilitators of clinical trial participation, such as altruism. To test these two objectives, we conducted a 1-month remote decentralized trial with 100 participants who either have a personal or family history of cardiometabolic health conditions, such as hypertension, diabetes, and obesity. Results indicated significant changes in altruism (mean: -2.94 vs. 0.83; p-value = 0.011) and clinical trial literacy (mean: 0.55 vs. 2.59; p-value = 0.001) from baseline to 1-month follow-up between the control and intervention groups. Additionally, participants exposed to personalized clinical trial navigation had greater clinical trial literacy at the end of the study relative to the individuals in the control arm of the study. Our findings indicate that tailored education, navigation, and access to clinical trials-three unique features of our PREDHiCT app-increased altruism and clinical trial literacy but not willingness to participate in a trial.

Association of Birthplace for Sleep Duration, Sleep Quality, and Sleep Disorder Symptoms, at the US-Mexico Border.

OBJECTIVES: The present study investigated the roles birthplace and acculturation play in sleep estimates among Hispanic/Latino population at the US-Mexico border. MEASURES: Data were collected in 2016, from N = 100 adults of Mexican descent from the city of Nogales, AZ, at the US-Mexico border. Sleep was assessed with the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index categorized as none, mild, moderate, and severe, and Multivariable Apnea Prediction Index (MAP) categorized as never, infrequently, and frequently. Acculturation was measured with the Acculturation Rating Scale for Mexican-Americans II (ARSMA-II). RESULTS: The sample consisted of majority Mexican-born (66%, vs. born in the USA 38.2%). Being born in the USA was associated with 55 fewer minutes of nighttime sleep (p = .011), and 1.65 greater PSQI score (p = .031). Compared to no symptoms, being born in the USA was associated with greater likelihood of severe difficulty falling asleep (OR = 8.3, p = .030) and severe difficulty staying asleep (OR = 11.2, p = .050), as well as decreased likelihood of breathing pauses during sleep (OR = 0.18, P = .020). These relationships remained significant after Mexican acculturation was entered in these models. However, greater Anglo acculturation appears to mediate one fewer hour of sleep per night, poorer sleep quality, and reporting of severe difficulty falling asleep and staying asleep. CONCLUSIONS: Among individuals of Mexican descent, being born in the USA (vs Mexico) is associated with about 1 hour less sleep per night, worse sleep quality, more insomnia symptoms, and less mild sleep apnea symptoms. These relationships are influenced by acculturation, primarily the degree of Anglo rather than the degree of Mexican acculturation.

A Comparison of Patients' and Neurologists' Assessments of their Teleneurology Encounter: A Cross-Sectional Analysis.

Background and Objectives: To better understand patients' and neurologists' assessments of their experiences regarding effectiveness of teleneurology encounters. Methods: Following an audio-video telehealth visit, neurologists asked patients to participate in a survey-based research study about the encounter, and then, the neurologists also recorded their own evaluations. Data were analyzed using standard quantitative and qualitative techniques for dichotomous and ordered-category survey responses in this cross-sectional analysis. Results: The study included unique encounters between 187 patients and 11 general neurologists. The mean patient age was 49 ± 17.5 years. Two thirds of the patients (66.8%, 125/187) were female. One third (33.2%; 62) were patients new to the NYU Langone Health neurology practices. The most common patient chief complaints were headache (69/187, 36.9%), focal and generalized numbness or tingling (21, 11.2%), memory difficulty (15, 8%), spine-related symptoms (12, 6.4%), and vertigo (11, 5.9%). Most patients (94.7%, 177/187) reported that the teleneurology encounter satisfied their needs. Patients and their neurologists agreed that the experience was effective in 91% (162/178) of encounters, regardless of whether the visit was for a new or established patient visit. Discussion: More than 90% of new and established patients and their neurologists agreed that teleneurology encounters were effective despite some limitations of the examination, the occasional need for patient assistance, and technical difficulties. Our results provide further evidence to justify and to expand the clinical use of teleneurology.

Bringing Health Care Equity to Diverse and Underserved Populations in Sleep Medicine and Research Through a Digital Health Equity Framework.

Individuals from minoritized groups are less likely to receive sleep medicine care and be the focus of sleep research. Several barriers may explain under-representation and low participation. The coronavirus disease 2019 (COVID-19) pandemic highlighted a digital divide that exacerbated disproportionate sleep health outcomes and access to sleep medicine and research opportunities among minoritized groups. The authors' team developed a digital health equity and inclusion model and revamped its culturally-tailored community outreach program to advance sleep health equity among minoritized groups. This article describes how the authors implemented their digital sleep health equity and inclusion model during the COVID-19 pandemic.

Smart sleep: what to consider when adopting AI-enabled solutions in clinical practice of sleep medicine.

Since the publication of its 2020 position statement on artificial intelligence (AI) in sleep medicine by the American Academy of Sleep Medicine, there has been a tremendous expansion of AI-related software and hardware options for sleep clinicians. To help clinicians understand the current state of AI and sleep medicine, and to further enable these solutions to be adopted into clinical practice, a discussion panel was conducted on June 7, 2022, at the Associated Professional Sleep Societies Sleep Conference in Charlotte, North Carolina. The article is a summary of key discussion points from this session, including aspects of considerations for the clinician in evaluating AI-enabled solutions including but not limited to what steps might be taken both by the Food and Drug Administration and clinicians to protect patients, logistical issues, technical challenges, billing and compliance considerations, education and training considerations, and other unique challenges specific to AI-enabled solutions. Our summary of this session is meant to support clinicians in efforts to assist in the clinical care of patients with sleep disorders utilizing AI-enabled solutions. CITATION: Bandyopadhyay A, Bae C, Cheng H, et al. Smart sleep: what to consider when adopting AI-enabled solutions in clinical practice of sleep medicine. J Clin Sleep Med. 2023;19(10):1823-1833.

Strategies to Engage Blacks in Sleep Medicine: Lessons Learned from Three Studies Applying Community-Based Participatory Research Principles.

Introduction: Awareness, assessment and treatment of sleep apnea are disproportionately lower among Blacks, compared to other racial/ethnic groups. To address this health disparity gap, communication strategies that connect Blacks to OSA education, detection and treatment adherence interventions are needed. Strategies that engage individuals through communication technologies, community-level social network support, and medical providers in clinical settings are also needed. We present lessons learned from three studies that offer these solutions using a community-engaged research model: The Metabolic Syndrome Outcome Study (MetSO), Peer-enhanced Education to Reduce Sleep Ethnic Disparities (PEERS-ED), and Tailored Approach to Sleep Health Education (TASHE), to capture program effectiveness and lessons learned from project successes and failures. Methods: The methods of OSA community-based programs included the application of an OSA community-engaged research model. This model served as a strategic guideline for effective interventions to engage communities in research and ensure cultural appropriateness in OSA interventions. Focus groups, in-depth interviews and community steering committee meetings were conducted with various stakeholders. Delphi surveys were used to identify high priority diseases and conditions. Community barriers and needs were identified through iterative combinations of surveys and focus group meetings. Stakeholder groups participated in all aspects of our studies, including the development, dissemination and implementation phases, reflecting a bi-directional decision-making process that ensures the interests of both parties were considered. The MetSO, PEERS-ED and TASHE studies were reviewed to understand the effectiveness of the programs and to evaluate lessons learned. Results: MetSO, PEERS-ED and TASHE interventions revealed that community-engaged strategies are successful in enrolling Black populations into clinical trials. The study teams reached nearly 3,000 Blacks at risk of OSA and screened about 2,000 people in sleep apnea studies in New York City. Sleep brochures were distributed to over 10,000 people. Lessons learned from MetSO, PEERS-ED and TASHE interventions revealed that building relationships, establishing trust, identifying a study champion, learning to adjust and providing participant incentives are key strategic elements for successful recruitment and retention of Blacks participations in clinical trials. Conclusion: Strategic application of community-oriented frameworks ensures active community engagement throughout the research process, allowing for greater enrollment of Blacks in clinical studies as well as increased OSA awareness, diagnosis, and treatment.

African ancestry APOE e4 non-carriers with higher educational attainment are resilient to Alzheimer disease pathology-specific blood biomarker pTau181.

Cognitive and functional abilities in individuals with Alzheimer disease (AD) pathology (ADP) show greater than expected variability. While most individuals show substantial impairments in these abilities, a considerable number show little or no impairments. Factors contributing to this variability are not well understood. For instance, multiple studies have shown that higher levels of education are associated with reduced cognitive impairments among those with ADP. However, it remains unclear whether higher levels of education are associated with functional impairments among those with ADP. We studied 410 AA individuals with advanced levels of pTau181 (a biomarker for ADP; individuals as those having log 10 (pTau181) level greater than one standard deviation above the mean) to determine whether EA (categorized as low EA for individuals with ≤ 8 years of education and high EA for those with >8 years) promotes functional resilience and whether this effect varies between APOE ε4 carriers and non-carriers. We used the four non-memory components of the Clinical Dementia Rating (CDR) to create a composite score (CDR-FUNC) to evaluate functional difficulties (scored from 0=no impairment to 12=severe). We employed the non-parametric Mann-Whitney U test to assess the relationship between EA and CDR-FUNC in advanced levels of pTau181 individuals. The results showed that EA promotes resilience to functional problems in AA individuals with advanced levels of pTau181, such that individuals with high EA are more likely to have better functional ability compared to those with lower EA (W=730.5, p=0.0007). Additionally, we found that the effect of high EA on functional resilience was stronger in ε4 non-carriers compared to ε4 carriers (W=555.5, p=0.022). This study extends the role of cognitive reserve and EA to functional performance showing that cognitive reserve influences the association between ADP burden and functional difficulties. Interestingly, this protective effect seems less pronounced in carriers of the strong genetic risk allele ε4. The results highlight the intricate interplay of genetic and non-genetic factors in AD progression, suggesting a need for more personalized strategies to manage functional decline in AD.

Ethical and Policy Implications of Racial and Ethnic Healthcare Disparities in Sleep Health.

Despite efforts in recent years, including in policy and research, to address health disparities in the United States, many of those disparities continue to fester in marginalized racial/ethnic populations. Understanding sleep health disparities is critical in understanding the health and wellness of these groups. Using obstructive sleep apnea (OSA) in Black populations as a focus, this paper presents the role of race and ethnicity in the clinical understanding of sleep health-related issues by medical practitioners and the implications of the lack of clear policies or best practices to guide medical practitioners' attempts to meet sleep-related needs of marginalized racial/ethnic populations. Furthermore, the knowledge gap may be further complicated by the poor understanding and integration of existing evidence with the many, complex, sleep-associated co-morbidities. Policymaking in this area ought to be based on the ethical implications of disparate sleep-related health outcomes by race and ethnicity. So, we conclude by offering recommendations for developing ethically sound policies for addressing sleep problems in marginalized racial and ethnic populations.

The Gap Between AI and Bedside: Participatory Workshop on the Barriers to the Integration, Translation, and Adoption of Digital Health Care and AI Startup Technology Into Clinical Practice.

BACKGROUND: Artificial intelligence (AI) and digital health technological innovations from startup companies used in clinical practice can yield better health outcomes, reduce health care costs, and improve patients' experience. However, the integration, translation, and adoption of these technologies into clinical practice are plagued with many challenges and are lagging. Furthermore, explanations of the impediments to clinical translation are largely unknown and have not been systematically studied from the perspective of AI and digital health care startup founders and executives. OBJECTIVE: The aim of this paper is to describe the barriers to integrating early-stage technologies in clinical practice and health care systems from the perspectives of digital health and health care AI founders and executives. METHODS: A stakeholder focus group workshop was conducted with a sample of 10 early-stage digital health and health care AI founders and executives. Digital health, health care AI, digital health-focused venture capitalists, and physician executives were represented. Using an inductive thematic analysis approach, transcripts were organized, queried, and analyzed for thematic convergence. RESULTS: We identified the following four categories of barriers in the integration of early-stage digital health innovations into clinical practice and health care systems: (1) lack of knowledge of health system technology procurement protocols and best practices, (2) demanding regulatory and validation requirements, (3) challenges within the health system technology procurement process, and (4) disadvantages of early-stage digital health companies compared to large technology conglomerates. Recommendations from the study participants were also synthesized to create a road map to mitigate the barriers to integrating early-stage or novel digital health technologies in clinical practice. CONCLUSIONS: Early-stage digital health and health care AI entrepreneurs identified numerous barriers to integrating digital health solutions into clinical practice. Mitigation initiatives should create opportunities for early-stage digital health technology companies and health care providers to interact, develop relationships, and use evidence-based research and best practices during health care technology procurement and evaluation processes.

Health literacy and ophthalmology: A scoping review.

As of 2020, it is estimated that 43.3 million people are blind, and an additional 553 million have mild to severe vision impairment.50 At least 1 billion worldwide have a vision impairment that could have been prevented or has yet to be addressed.54 Poor health literacy may be a significant contributor to the prevalence of eye disease. With implications on disease burden, progression, and health outcomes, a greater understanding of the role health literacy plays in ophthalmology is needed. This is the first scoping review to assess the impact of health literacy on eye health outcomes and blindness, including ocular screening rates and/or follow-up rates, treatment adherence, and self-care practices. PubMed, Embase, and CINAHL databases were searched systematically through November 12, 2021, and we evaluated the association between health literacy and ophthalmic outcomes in 4 domains: clinical outcomes, treatment adherence rates, screening and/or follow-up rates, and self-care practices. There is evidence to suggest that health literacy is associated with ophthalmic outcomes in all these domains. To better understand how health literacy impacts eye health, further longitudinal studies examining the effect of health literacy (using standardized health literacy measures) on ophthalmic outcomes are needed. We believe a specific ophthalmic health literacy survey could help achieve this goal and help target interventions to ultimately improve outcomes among ophthalmology patients.

Development and Initial Validation of the Assessment of Sleep Environment (ASE): Describing and Quantifying the Impact of Subjective Environmental Factors on Sleep.

The purpose of this study was to develop and test the reliability and validity of a 13-item self-report Assessment of Sleep Environment (ASE). This study investigates the relationship between subjective experiences of environmental factors (light, temperature, safety, noise, comfort, humidity, and smell) and sleep-related parameters (insomnia symptoms, sleep quality, daytime sleepiness, and control over sleep). The ASE was developed using an iterative process, including literature searches for item generation, qualitative feedback, and pilot testing. It was psychometrically assessed using data from the Sleep and Healthy Activity Diet Environment and Socialization (SHADES) study (N = 1007 individuals ages 22-60). Reliability was determined with an internal consistency and factor analysis. Validity was evaluated by comparing ASE to questionnaires of insomnia severity, sleep quality, daytime sleepiness, sleep control, perceived stress, and neighborhood disorder. The ASE demonstrated high internal consistency and likely reflects a single factor. ASE score was associated with insomnia symptoms (B = 0.09, p < 0.0001), sleep quality (B = 0.07, p < 0.0001), and sleep control (B = -0.01, p < 0.0001), but not daytime sleepiness. The ASE was also associated with perceived stress (B = 0.20, p < 0.0001) and neighborhood disorder (B = -0.01, p < 0.0001). Among sleep environment factors, only smell was not associated with sleep quality; warmth and safety were negatively associated with sleepiness; and of the sleep environment factors, only light/dark, noise/quiet, and temperature (warm/cool) were not associated with insomnia symptoms. The ASE is a reliable and valid measure of sleep environment. Physical environment (light, temperature, safety, noise, comfort, humidity, and smell) was associated with insomnia symptoms and sleep quality but not sleepiness.

Associations of digital neuro-signatures with molecular and neuroimaging measures of brain resilience: The altoida large cohort study.

Background: Mixed results in the predictive ability of traditional biomarkers to determine cognitive functioning and changes in older adults have led to misdiagnosis and inappropriate treatment plans to address mild cognitive impairment and dementia among older adults. To address this critical gap, the primary goal of the current study is to investigate whether a digital neuro signature (DNS-br) biomarker predicted global cognitive functioning and change over time relative among cognitively impaired and cognitive healthy older adults. The secondary goal is to compare the effect size of the DNS-br biomarker on global cognitive functioning compared to traditional imaging and genomic biomarkers. The tertiary goal is to investigate which demographic and clinical factors predicted DNS-br in cognitively impaired and cognitively healthy older adults. Methods: We conducted two experiments (Study A and Study B) to assess DNS for brain resilience (DNS-br) against the established FDG-PET brain imaging signature for brain resilience, based on a 10 min digital cognitive assessment tool. Study A was a semi-naturalistic observational study that included 29 participants, age 65+, with mild to moderate mild cognitive impairment and AD diagnosis. Study B was also a semi-naturalistic observational multicenter study which included 496 participants (213 mild cognitive impairment (MCI) and 283 cognitively healthy controls (HC), a total of 525 participants-cognitively healthy (n = 283) or diagnosed with MCI (n = 213) or AD (n = 29). Results: DNS-br total score and majority of the 11 DNS-br neurocognitive subdomain scores were significantly associated with FDG-PET resilience signature, PIB ratio, cerebral gray matter and white matter volume after adjusting for multiple testing. DNS-br total score predicts cognitive impairment for the 80+ individuals in the Altoida large cohort study. We identified a significant interaction between the DNS-br total score and time, indicating that participants with higher DNS-br total score or FDG-PET in the resilience signature would show less cognitive decline over time. Conclusion: Our findings highlight that a digital biomarker predicted cognitive functioning and change, which established biomarkers are unable to reliably do. Our findings also offer possible etiologies of MCI and AD, where education did not protect against cognitive decline.

Out Like a Light: Feasibility and Acceptability Study of an Audio-Based Sleep Aide for Improving Parent-Child Sleep Health.

Our study examines the acceptability and feasibility of Moshi, an audio-based mobile application, among children 3-8 years old using a parent-child dyadic approach. Our 10-day within-subject pre-post study design consisted of five nights of a normal bedtime routine and a subsequent five nights exposed to one story on the Moshi application during the intervention. Each five-night period spanned three weeknights and two weekend nights. The Short-Form Children's Sleep Habits Questionnaire (SF-CSHQ) was used to measure children's sleep at baseline and post-intervention. The PROMIS, Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index were used to assess parents' sleep. Among the 25 child-parent dyads, the mean child age was 4 (SD = 1.23) and 63% were male (n = 15). Mean parent age was 35 (SD = 5.83), 84% were female (n = 21), and 48.0% were Black (n = 12). For child-only comparisons, mean post-SF-CSHQ measures were lower compared to baseline. A trend in parent sleep is reported. This study shows the potential of an audio-based mobile sleep aid to improve sleep health in a racially diverse parent and child dyad sample.

Development and Evaluation of the Clinical Trial HEalth Knowledge and Beliefs Scale (CHEKS).

Patient health literacy is vital to clinical trial engagement. Knowledge and beliefs about clinical trials may contribute to patient literacy of clinical trials, influencing engagement, enrollment and retention. We developed and assessed a survey that measures clinical trial health knowledge and beliefs, known as the Clinical trial HEalth Knowledge and belief Scale (CHEKS). The 31 survey items in CHEKS represent knowledge and beliefs about clinical trial research (n = 409) in 2017. We examined item-scale correlations for the 31 items, eliminated items with item-scale correlations less than 0.30, and then estimated internal consistency reliability for the remaining 25 items. We used the comparative fit index (CFI) and the root mean squared error of approximation (RMSEA) to evaluate model fit. The average age of the sample was 34 (SD = 15.7) and 48% female. We identified 6 of the 31 items that had item-scale correlations (corrected for overlap) lower than 0.30. Coefficient alpha for the remaining 25 items was 0.93 A one-factor categorical confirmatory factor analytic model with 16 correlated errors was not statistically significant (chi-square = 10011.994, df = 300, p < 0.001) but fit the data well (CFI = 0.95 and RMSEA = 0.07). CHEKS can assess clinical trial knowledge and beliefs.