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Background: The Charlson Comorbidity Index (CCI) is a frequently used mortality predictor based on a scoring system for the number and type of patient comorbidities health researchers have used since the late 1980s. The initial purpose of the CCI was to classify comorbid conditions, which could alter the risk of patient mortality within a 1-year time frame. However, the CCI may not accurately reflect risk among American Indians because they are a small proportion of the US population and possibly lack representation in the original patient cohort. A motivating factor in calibrating a CCI for American Indians is that this population, as a whole, experiences a greater burden of comorbidities, including diabetes mellitus, obesity, cancer, cardiovascular disease, and other chronic health conditions, than the rest of the US population., Methods: This study attempted to modify the CCI to be specific to the American Indian population utilizing the data from the still ongoing The Strong Heart Study (SHS) - a multi-center population-based longitudinal study of cardiovascular disease among American Indians. A 1-year survival analysis with mortality as the outcome was performed using the SHS morbidity and mortality surveillance data and assessing the impact of comorbidities in terms of hazard ratios with the training cohort. A Kaplan-Meier plot for a subset of the testing cohort was used to compare groups with selected mCCI-AI scores., Results: A total of 3038 Phase VI participants from the SHS comprised the study population for whom mortality and morbidity surveillance data were available through December 2019. The weights generated by the SHS participants for myocardial infarction, congestive heart failure, and high blood pressure were greater than Charlson's original weights. In addition, the weights for liver illness were equivalent to Charlson's severe form of the disease. Lung cancer had the greatest overall weight derived from a hazard ratio of 8.31., Conclusions: The mCCI-AI was a statistically significant predictor of 1-year mortality, classifying patients into different risk strata χ 2 (8, N = 1,245) = 30.56 (p = 0.0002). The mCCI-AI was able to discriminate between participants who died and those who survived 73% of the time., Competing Interests: Declarations. Ethics Approval and Consent to Participate: This project was approved by the University of Oklahoma Health Sciences Center institutional review board along with the Strong Heart Study Publications and Presentations Committee (SHS700). In addition, the IRB at the National Center for Toxicological Research approved the project and publication. Consent for Publication: Not applicable. Competing Interests: The authors declare no competing interests. Author Informationinformation: Elisa Lee is one of the original principal investigators of the Strong Heart Study. Ying Zhang, Jessica Reese, and Kimberly Malloy are the current principal investigators and data stewards for the Strong Heart Study. Christine Merenda, Richardae Araojo, Christine Lee, and Milena Lolic are senior members of the FDA’s Office of Minority Health and Health Equity. The first author Paul Rogers was mentored by Dr. Julie Stoner, Chair of the Department of Biostatistics and Epidemiology and senior Strong Heart Study investigator, at the University of Oklahoma Health Sciences Center., (© 2024. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

Background: The Charlson Comorbidity Index (CCI) is a frequently used mortality predictor based on a scoring system for the number and type of patient comorbidities health researchers have used since the late 1980s. The initial purpose of the CCI was to classify comorbid conditions, which could alter the risk of patient mortality within a one-year time frame. However, the CCI may not accurately reflect risk among American Indians because they are a small proportion of the U.S. population and possibly lack representation in the original patient cohort. A motivating factor in calibrating a CCI for American Indians is that this population, as a whole, experiences a greater burden of comorbidities, including diabetes mellitus, obesity, cancer, cardiovascular disease, and other chronic health conditions, than the rest of the U.S. population., Methods: This study attempted to modify the CCI to be specific to the American Indian population utilizing the data from the still ongoing The Strong Heart Study (SHS) - a multi-center population-based longitudinal study of cardiovascular disease among American Indians.A one-year survival analysis with mortality as the outcome was performed using the SHS morbidity and mortality surveillance data and assessing the impact of comorbidities in terms of hazard ratios with the training cohort. A Kaplan-Meier plot for a subset of the testing cohort was used to compare groups with selected mCCI-AI scores., Results: A total of 3,038 Phase VI participants from the SHS comprised the study population for whom mortality and morbidity surveillance data were available through December 2019. The weights generated by the SHS participants for myocardial infarction, congestive heart failure, and high blood pressure were greater than Charlson's original weights. In addition, the weights for liver illness were equivalent to Charlson's severe form of the disease. Lung cancer had the greatest overall weight derived from a hazard ratio of 8.308., Conclusions: The mCCI-AI was a statistically significant predictor of one-year mortality, classifying patients into different risk strata X 2 (8, N = 1,245) = 30.56 (p = .0002). The mCCI-AI exhibited superior performance over the CCI, able to discriminate between participants who died and those who survived 73% of the time., Competing Interests: Declarations Competing interests The authors declare that they have no competing interests.

This study seeks to identify and characterize key barriers associated with PrEP therapy as self-reported by users on social media platforms. We used data mining and unsupervised machine learning approaches to collect and analyze COVID-19 and PrEP-related posts from three social media platforms including Twitter, Reddit, and Instagram. Predominant themes detected by unsupervised machine learning and manual annotation included users expressing uncertainty about PrEP treatment adherence due to COVID-19, challenges related to accessibility of clinics, concerns about PrEP costs and insurance coverage, perceived lower HIV risk leading to lack of adherence, and misinformation about PrEP use for COVID-19 prevention., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Patient perspectives are central to the US Food and Drug Administration's benefit-risk decision-making process in the evaluation of medical products. Traditional channels of communication may not be feasible for all patients and consumers. Social media websites have increasingly been recognized by researchers as a means to gain insights into patients' views about treatment and diagnostic options, the health care system, and their experiences living with their conditions. Consideration of multiple patient perspective data sources offers the Food and Drug Administration the opportunity to capture diverse patient voices and experiences with chronic pain., Objective: This pilot study explores posts from a web-based patient platform to gain insights into the key challenges and barriers to treatment faced by patients with chronic pain and their caregivers., Methods: This research compiles and analyzes unstructured patient data to draw out the key themes. To extract relevant posts for this study, predefined keywords were identified. Harvested posts were published between January 1, 2017, and October 22, 2019, and had to include #ChronicPain and at least one other relevant disease tag, a relevant chronic pain management tag, or a chronic pain management tag for a treatment or activity specific to chronic pain., Results: The most common topics discussed among persons living with chronic pain were related to disease burden, the need for support, advocacy, and proper diagnosis. Patients' discussions focused on the negative impact chronic pain had on their emotions, playing sports, or exercising, work and school, sleep, social life, and other activities of daily life. The 2 most frequently discussed treatments were opioids or narcotics and devices such as transcutaneous electrical nerve stimulation machines and spinal cord stimulators., Conclusions: Social listening data may provide valuable insights into patients' and caregivers' perspectives, preferences, and unmet needs, especially when conditions may be highly stigmatized., (©Claire Harter, Marina Ness, Aleah Goldin, Christine Lee, Christine Merenda, Anne Riberdy, Anindita Saha, Richardae Araojo, Michelle Tarver. Originally published in JMIR Infodemiology (https://infodemiology.jmir.org), 30.05.2023.)

Augmented reality (AR) offers new ways to visualize information on-the-go. As noted in related work, AR graphics presented via optical see-through AR displays are particularly prone to color blending, whereby intended graphic colors may be perceptually altered by real-world backgrounds, ultimately degrading usability. This work adds to this body of knowledge by presenting a methodology for assessing AR interface color robustness, as quantitatively measured via shifts in the CIE color space, and qualitatively assessed in terms of users' perceived color name. We conducted a human factors study where twelve participants examined eight AR colors atop three real-world backgrounds as viewed through an in-vehicle AR head-up display (HUD); a type of optical see-through display used to project driving-related information atop the forward-looking road scene. Participants completed visual search tasks, matched the perceived AR HUD color against the WCS color palette, and verbally named the perceived color. We present analysis that suggests blue, green, and yellow AR colors are relatively robust, while red and brown are not, and discuss the impact of chromaticity shift and dispersion on outdoor AR interface design. While this work presents a case study in transportation, the methodology is applicable to a wide range of AR displays in many application domains and settings.

Background: Among racial and ethnic minority groups, the risk of HIV infection is an ongoing public health challenge. Pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV when taken as prescribed. However, there is a need to understand the experiences, attitudes, and barriers of PrEP for racial and ethnic minority populations and sexual minority groups., Objective: This infodemiology study aimed to leverage big data and unsupervised machine learning to identify, characterize, and elucidate experiences and attitudes regarding perceived barriers associated with the uptake and adherence to PrEP therapy. This study also specifically examined shared experiences from racial or ethnic populations and sexual minority groups., Methods: The study used data mining approaches to collect posts from popular social media platforms such as Twitter, YouTube, Tumblr, Instagram, and Reddit. Posts were selected by filtering for keywords associated with PrEP, HIV, and approved PrEP therapies. We analyzed data using unsupervised machine learning, followed by manual annotation using a deductive coding approach to characterize PrEP and other HIV prevention-related themes discussed by users., Results: We collected 522,430 posts over a 60-day period, including 408,637 (78.22%) tweets, 13,768 (2.63%) YouTube comments, 8728 (1.67%) Tumblr posts, 88,177 (16.88%) Instagram posts, and 3120 (0.6%) Reddit posts. After applying unsupervised machine learning and content analysis, 785 posts were identified that specifically related to barriers to PrEP, and they were grouped into three major thematic domains: provider level (13/785, 1.7%), patient level (570/785, 72.6%), and community level (166/785, 21.1%). The main barriers identified in these categories included those associated with knowledge (lack of knowledge about PrEP), access issues (lack of insurance coverage, no prescription, and impact of COVID-19 pandemic), and adherence (subjective reasons for why users terminated PrEP or decided not to start PrEP, such as side effects, alternative HIV prevention measures, and social stigma). Among the 785 PrEP posts, we identified 320 (40.8%) posts where users self-identified as racial or ethnic minority or as a sexual minority group with their specific PrEP barriers and concerns., Conclusions: Both objective and subjective reasons were identified as barriers reported by social media users when initiating, accessing, and adhering to PrEP. Though ample evidence supports PrEP as an effective HIV prevention strategy, user-generated posts nevertheless provide insights into what barriers are preventing people from broader adoption of PrEP, including topics that are specific to 2 different groups of sexual minority groups and racial and ethnic minority populations. Results have the potential to inform future health promotion and regulatory science approaches that can reach these HIV and AIDS communities that may benefit from PrEP., Competing Interests: Conflicts of Interest: QX, MCN, TM, HG, JL, YH, MC, and TKM are employees of the startup company S-3 Research LLC. S-3 Research is a startup funded and currently supported by the National Institutes of Health–National Institute on Drug Abuse through a Small Business Innovation and Research contract for opioid-related social media research and technology commercialization., (©Qing Xu, Matthew C Nali, Tiana McMann, Hector Godinez, Jiawei Li, Yifan He, Mingxiang Cai, Christine Lee, Christine Merenda, Richardae Araojo, Tim Ken Mackey. Originally published in JMIR Infodemiology (https://infodemiology.jmir.org), 28.04.2022.)

Background: Asthma is a heterogeneous disease. Clinical blood parameters differ by race/ethnicity and are used to distinguish asthma subtypes and inform therapies. Differences in subtypes may explain population-specific trends in asthma outcomes. However, these differences in racial/ethnic minority pediatric populations are unclear., Objective: We investigated the association of blood parameters and asthma subtypes with asthma outcomes and examined population-specific eligibility for biologic therapies in minority pediatric populations., Methods: Using data from 2 asthma case-control studies of pediatric minority populations, we performed case-control (N = 3738) and case-only (N = 2743) logistic regressions to quantify the association of blood parameters and asthma subtypes with asthma outcomes. Heterogeneity of these associations was tested using an interaction term between race/ethnicity and each exposure. Differences in therapeutic eligibility were investigated using chi-square tests., Results: Race/ethnicity modified the association between total IgE and asthma exacerbations. Elevated IgE level was associated with worse asthma outcomes in Puerto Ricans. Allergic asthma was associated with worse outcomes in Mexican Americans, whereas eosinophilic asthma was associated with worse outcomes in Puerto Ricans. A lower proportion of Puerto Ricans met dosing criteria for allergic asthma-directed biologic therapy than other groups. A higher proportion of Puerto Ricans qualified for eosinophilic asthma-directed biologic therapy than African Americans., Conclusions: We found population-specific associations between blood parameters and asthma subtypes with asthma outcomes. Our findings suggest that eligibility for asthma biologic therapies differs across pediatric racial/ethnic populations. These findings call for more studies in diverse populations for equitable treatment of minority patients with asthma., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

The automotive industry is rapidly developing new in-vehicle technologies that can provide drivers with information to aid awareness and promote quicker response times. Particularly, vehicles with augmented reality (AR) graphics delivered via head-up displays (HUDs) are nearing mainstream commercial feasibility and will be widely implemented over the next decade. Though AR graphics have been shown to provide tangible benefits to drivers in scenarios like forward collision warnings and navigation, they also create many new perceptual and sensory issues for drivers. For some time now, designers have focused on increasing the realism and quality of virtual graphics delivered via HUDs, and recently have begun testing more advanced 3D HUD systems that deliver volumetric spatial information to drivers. However, the realization of volumetric graphics adds further complexity to the design and delivery of AR cues, and moreover, parameters in this new design space must be clearly and operationally defined and explored. In this work, we present two user studies that examine how driver performance and visual attention are affected when using fixed and animated AR HUD interface design approaches in driving scenarios that require top-down and bottom-up cognitive processing. Results demonstrate that animated design approaches can produce some driving gains (e.g., in goal-directed navigation tasks) but often come at the cost of response time and distance. Our discussion yields AR HUD design recommendations and challenges some of the existing assumptions of world-fixed conformal graphic approaches to design.

Race, ethnicity, sex, and age are demographic factors that can influence drug exposure and/or response, and can consequently affect treatment outcome. We evaluated demographic subgroup enrollment patterns in new therapeutic products approved by the US Food and Drug Administration (FDA) for the treatment of select cancers-breast, colorectal, lung, and prostate-that have comparative differences in morbidity and/or mortality among some demographic subgroups. In submissions of products approved between 2008 and 2013, participants (n = 22,481) were white (80%), from outside the United States (74%), between 17 and 64 years old (59%), and men (56% and 53%, including and excluding sex-specific indications, respectively). In pivotal trials of products approved between2014 and 2017, participants (n = 3,612) were white (71%), between 17 and 64 years old (61%), and men (48% and 63%, including and excluding sex-specific indications, respectively). The US-relevant minority populations were under-represented. A broader representation of patient subgroups in clinical trials may contribute to better understanding of exposure and/or response variability, and consequently help personalize drug therapy., (Published 2018. This article is a U.S. Government work and is in the public domain in the USA. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of the American Society for Clinical Pharmacology and Therapeutics.)

Background: US Food and Drug Administration (FDA) approval of new drugs depends on results from clinical trials that must be generalized to the US population. However, racial minorities are frequently under-represented in clinical studies. The enrollment of racial minorities was compared in key clinical studies submitted to the FDA in the last 10 years in support of potential marketing approval for prostate cancer (PCa) prevention or treatment., Methods: Patient demographic data were obtained from archival data sets of large registration trials submitted to the FDA to support proposed PCa indications. Six countries/regions were analyzed: the United States, Canada, Australia, Europe, the United Kingdom, and Eastern Europe. Background racial demographics were collected from national census data., Results: Seventeen key PCa clinical trials were analyzed. These trials were conducted in the past 20 years, comprising 39,574 patients with known racial information. Most patients were enrolled in the United States, but there appeared to be a trend toward increased non-US enrollment over time. In all countries, racial minorities were generally under-represented. There was no significant improvement in racial minority enrollment over time. The United States enrolled the largest nonwhite population (7.1%)., Conclusions: Over the past 20 years, racial minorities were consistently under-represented in key PCa trials. There is a need for effective measures that will improve enrollment of racial minorities. With increased global enrollment, drug developers should aim to recruit a patient population that resembles the racial demographics of the patient population to which drug use will be generalized upon approval., (© 2014 American Cancer Society.)

The US Food and Drug Administration (FDA) has an ongoing interest in identifying the race/ethnicity of clinical trial participants to ensure they are representative of the people who will use the products once they are approved, and differences in response to medical products have already been observed in racial/ethnic subgroups of the US population. As a result, we reviewed the racial/ethnic composition of study participants in clinical trials of FDA-approved oncology products. Oncology products were chosen because of the disparate incidence and impact of cancer in racial/ethnic communities. New Drug and Biologics Licensing Application databases were searched for new molecular entity (NME) approvals for oncologic treatment from January 1, 2006, through December 31, 2008. We then reviewed NME applications for the pivotal Phase II and III trials used for approval decisions. We then compared the racial/ethnic composition results from the recent trials with those conducted earlier. We also assessed FDA-approved labeling to determine the extent to which race-based findings were included. US participants averaged 20.3% (range, 11%-97%) of the total participants in the studies reviewed. A comparison of the racial/ ethnic composition showed the participation of whites and blacks or African Americans have decreased, while that of Latinos, Asians, and Native Hawaiians/Pacific Islanders has increased. The results suggest better attention to compliance with collection and reporting, as the percentage of US study participants whose race and/or ethnicity could not be determined decreased from 31% to < 1%. With respect to product labeling, the current study found 6 (60%) included race-based findings.

A human colon carcinoma cell line, Co-115, has been established in vitro from solid xenografts maintained in nude mice and subcultured for 95 passages. Co-115 cells grow in vitro as tightly packed, epithelial-like colonies, have a doubling time of about 36 hr, have a relatively low plating efficiency in agar, and release significant amounts of carcinoembryonic antigen to the culture medium. Their epithelial nature has been confirmed by ultrastructural examination. The injection of Co-115 cells into nude mice reinduced the formation of solid tumor masses that could be retransplanted and showed a morphology comparable of that of the original xenograft.