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Background: In the U.S., acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure, and misuse contributes to more than 30,000 hospitalizations annually. Half to two thirds of acetaminophen overdoses are unintentional, suggesting the root cause is likely poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage. Purpose: Elicit subject feedback about active ingredient and dosing information on over-the-counter (OTC) acetaminophen and elicit feedback on proposed plain-language text and icons. Methods: Six focus groups, preceded by individual interviews, were conducted in April 2010 among 45 adults in two cities from two clinics and an adult basic education center. The individual interviews evaluated knowledge of OTC pain relievers, attention to product label information and literacy level while the group discussion elicited preference for label messages and icons. Analyses were conducted from April to June 2010. Results: Forty-four percent read at or below the 6th-grade level. Individual interviews revealed that <50% of participants routinely examine product label information. Only 31% know acetaminophen is in Tylenol®. The groups achieved consensus on a preferred icon for acetaminophen, desired explicit statement of potential liver damage in the warning against simultaneous use of acetaminophen products, and indicated preference for an icon and wording for maximum dose. Conclusions: With the high prevalence of OTC use, a consumer-centered approach to developing icons and messages to promote awareness and safe use of acetaminophen could benefit consumers. [ABSTRACT FROM AUTHOR]

Abstract:More than 14% of the American population is food insecure, or at risk of going hungry because of an inability to afford food. Food-insecure (FI) adults often reduce food intake or substitute inexpensive, energy-dense carbohydrates for healthier foods. We hypothesized these behaviors would predispose FI adults with diabetes to hypoglycemia and impaired diabetes self-management. We therefore assessed whether food insecurity was associated with multiple indicators of diabetes self-management (self-efficacy, medication- and glucose-monitoring adherence, hypoglycemia, or glycemic control) among 40 low-income adults with diabetes. Mean self-efficacy score was lower among FI than food-secure (FS) participants (34.4 vs. 41.2, p=.02). Food-insecure participants reported poorer adherence to blood glucose monitoring (RR=3.5, p=.008) and more hypoglycemia-related emergency department visits (RR=2.2, p=.007). Mean hemoglobin A1c was 9.2% among FI and 7.7% among FS participants (p=.08). Food insecurity is a barrier to diabetes self-management and a risk factor for clinically significant hypoglycemia. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the usefulness of a diabetes self-management guide and a brief counseling intervention in helping patients set and achieve their behavioral goals.Methods: We conducted a quasi-experimental study using a one group pretest posttest design to assess the effectiveness of a goal setting intervention along with a self-management guide. English- and Spanish-speaking patients with diabetes had one in-person session and two telephone follow-up calls with a non-clinical provider over a 12-16-week period. At each call and at the end of the study, we assessed success in achieving behavioral goals and problem solving toward those goals. Satisfaction with the self-management guide was assessed at the end of the study.Results: We enrolled 250 patients across three sites and 229 patients completed the study. Most patients chose to set goals in diet and exercise domains. 93% of patients achieved at least one behavioral goal during the study and 73% achieved at least two behavioral goals. Many patients exhibited problem solving behavior to achieve their goals. We found no significant differences in reported achievement of behavior goals by literacy or language. Patients were very satisfied with the guide.Conclusions: A brief goal setting intervention along with a diabetes self-management guide helped patients set and achieve healthy behavioral goals.Practice Implications: Non-clinical providers can successfully help a diverse range of patients with diabetes set and achieve behavioral goals. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To use a patient-centered approach to refine warning labels promoting the safe use of prescription drugs among patients, regardless of literacy level. METHODS: Ten discussion groups were conducted among adults recruited from a general internal medicine clinic and four adult education classes. Participants completed face-to-face cognitive interviews with literacy assessment to determine comprehension of the 10 most commonly used drug warning labels, followed by a discussion group that solicited feedback for revising text and icons. RESULTS: In all, 85 adults participated; 56% had limited literacy skills. Feedback from discussion groups indicated that the majority of icons were confusing, used difficult language, and text and icons were often discordant. Participants sought actionable language in the most simple and concise manner. In comprehension testing, five of the warning labels reached a set standard of >80% comprehension; the remaining labels were revised and three others modified on patients' request. A universal icon that conveyed 'Caution' was used for one label ('use only on your skin') as patients were unable to agree on an acceptable visual representation. CONCLUSION: A patient-centered approach to designing consumer medication information could improve the comprehensibility of existing warning labels. PRACTICE IMPLICATIONS: Pharmacies should review existing drug warnings to assess adequacy among patients, particularly those with limited literacy. Pharmacists should confirm patients understand auxiliary warnings to support safe and effective use. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To assess the efficacy of a literacy-appropriate weight loss intervention targeting providers and patients in improving physicians' weight loss counseling and patients' self-reported beliefs, and self-efficacy. METHODS: The study took place in a public hospital nephrology clinic. The intervention included two physician workshops and a small group patient education. Physician-patient communication was observed and coded. Structured interviews assessed patient recall of weight loss recommendations, weight-related beliefs, and self-efficacy. RESULTS: 64 patient visits were observed before and after the intervention. 75% of patients were African American, 96% lacked private insurance, 71% had low literacy skills; mean body mass index (BMI) of 35 kg/m(2). Physician counseling improved significantly post-intervention, particularly in assessing, supporting and advising patients about weight loss and exercise. Patients reported increases in recall of weight loss recommendations and were more likely to report greater confidence about losing weight (52% vs. 70%, p<0.01). CONCLUSIONS: This pilot study offers promising directions to address provider and patient barriers to weight loss education and counseling in a public hospital. PRACTICE IMPLICATIONS: Hospital-based weight loss interventions need to target both physicians and patients. [ABSTRACT FROM AUTHOR]

Background: A high level of reading skill and comprehension is necessary to understand and complete most consent forms that are required for participation in clinical research studies. This study was conducted to test the hypothesis that a simplified consent form would be less intimidating and more easily understood by individuals with low-to-marginal reading skills.Methods: During July 1996, 183 adults (53 patients with cancer or another medical condition and 130 apparently healthy participants) were tested for reading ability and then asked to read either the standard Southwestern Oncology Group (SWOG) consent form (16th grade level) or a simplified form (7th grade level) developed at Louisiana State University Medical Center-Shreveport (LSU). Participants were interviewed to assess their attitudes toward and comprehension of the form read. Then they were given the alternate consent form and asked which one they preferred and why.Results: Overall, participants preferred the LSU form (62%; 95% confidence interval [CI] = 54.8%-69.2%) over the SWOG form (38%; 95% CI = 30.8%-45.2%) (P = .0033). Nearly all participants thought that the LSU form was easier to read (97%; 95% CI = 93.1%-99.9%) than the SWOG form (75%; 95% CI = 65.1%-85.7%) (P<.0001). However, the degree to which the participants understood the forms was essentially the same for the LSU form (58%; 95% CI = 48.6%-67.0%) and the SWOG form (56%; 95% CI = 43.8%-66.8%).Implications: These findings raise serious questions regarding the adequacy of the design of written informed consent documents for the substantial proportion of Americans with low-to-marginal literacy skills. [ABSTRACT FROM AUTHOR]

Health care reform has mandated that hospitals and health care professionals restructure or redefine their roles in health care and the community. Patient education is shifting from a crisis-medicine focus to a prevention and health promotion strategy. One area for growth and development in the nursing profession is community health promotion and education. Adult basic education sites have the potential of providing exciting new possibilities in promotion, prevention, and nutrition education for patients. Adults with low literacy skills often lack basic information about nutrition and have poor eating behaviors. Focus groups conducted at an adult learning center revealed that these adults had misconceptions about nutrition, yet they had a strong desire to learn about good dietary practices so they could serve better meals and snacks to their children. Utilizing focus group information, health care providers designed, taught, and evaluated a nutrition education curriculum for adult basic education students. Students' knowledge of food measurements and portion sizes increased significantly (p < .05) as did their ability to read labels and recipes (p < .01). However, eating behaviors were not altered significantly. Long-term comprehensive family and community systems approaches may be required to ensure behavior change. Adult learning centers offer a unique setting for linking literacy, health care, and community efforts. [ABSTRACT FROM AUTHOR]

OBJECTIVES. To test the reading ability of parents of pediatric outpatients and to compare their reading ability with the ability necessary to read commonly used educational materials; to compare individual reading grade levels with the levels of the last grade completed in school; and to further validate a new literacy screening test designed specifically for medical settings. DESIGN. Prospective survey. SETTING. Pediatrics outpatient clinic in a large, public university, teaching hospital. PARTICIPANTS. Three hundred ninety-six parents or other caretakers accompanying pediatric outpatients. MEASUREMENTS. Demographics and educational status were assessed using a structured interview. Reading ability was tested using the Rapid Estimate of Adult Literacy in Medicine (REALM) and the Wide Range Achievement Test-Revised. Written educational materials were assessed for readability levels with a computer program (Grammatik IV). RESULTS. The mean score on the REALM for all parents placed them in the seventh to eighth grade reading range, despite the mean self-reported last grade completed in school being 11th grade 5th month. Wide Range Achievement Test-Revised scores correlated well with REALM scores (0.82). Eighty percent of 129 written materials from the American Academy of Pediatrics, the Centers for Disease Control, the March of Dimes, pharmaceutical companies, and commercially available baby books required at least a 10th grade reading level. Only 25% of 60 American Academy of Pediatrics items and 19% of all materials tested were written at less than a ninth grade level, and only 2% of all materials were written at less than a seventh grade level. CONCLUSION. This study demonstrates that parents' self-reported education level will not accurately indicate their reading ability. Testing is needed to screen at-risk parents for low reading levels. In a public health setting, a significant amount of available parent education materials and instructions require a higher reading level than most parents have achieved. In such settings, all materials probably should be written at less than a high school level if most parents are to be expected to read them. The REALM can easily be used in busy public health clinics to screen parents for reading ability. [ABSTRACT FROM AUTHOR]

More than 90 million Americans have limited literacy skills, a burden that profoundly affects the quality of their health care. You can help by recognizing the problems, simplifying your written and oral communications, and verifying that patients have received and understood the message. [ABSTRACT FROM AUTHOR]

Here's how you can identify patients with a reading problem and tailor your teaching accordingly. [ABSTRACT FROM AUTHOR]

Low literacy is a pervasive and underrecognized problem in health care Approximately 21% of American adults are functionally illiterate, and another 27% have marginal literacy skills. Such patients may have difficulty reading and understanding discharge instructions, medication labels, patient education materials, consent forms, or health surveys. Properly assessing the literacy level of individual patients or groups may avoid problems in clinical care and research. This article reviews the use of literacy assessments, discusses their application in a variety of health care settings, and cites issues providers need to consider before testing. The authors describe informal and formal methods of screening for reading and comprehension in English and Spanish including the Rapid Estimate of Adult Literacy in Medicine, the Wide Range Achievement Test-3, the Cloze procedure, the Test of Functional Health Literacy in Adults, and others. Practical implications and recommendations for specific use are made. [ABSTRACT FROM AUTHOR]

Patients who misunderstand their diagnosis and treatment plans usually exhibit poor compliance. The 90 million adult Americans with low literacy skills struggle to understand such essential health information as discharge instructions, consent forms, oral instructions and drug labels. The Joint Commission on Accreditation of Health Organizations (JCAHO) now requires that instructions be given on a level understandable to the patient. Most physicians tend to give too much information on too high a level for many patients to understand. Physicians who speak in simpler language, repeat their instructions and demonstrate key points, while avoiding too many directives, enhance their patients' understanding. Combining easy-to-read written patient education materials with oral instructions has been shown to greatly enhance patient understanding. To be effective with patients whose literacy skills are low, patient education materials should be short and simple, contain culturally sensitive graphics and encourage desired behavior. Compliance with therapy also may be improved by including family members in the patient education process. [ABSTRACT FROM AUTHOR]

Objective: To describe a process for developing low-literacy health education materials that increase knowledge and activate patients toward healthier behaviors. Methods: We developed a theoretically informed process for developing educational materials. This process included convening a multidisciplinary creative team, soliciting stakeholder input, identifying key concepts to be communicated, mapping concepts to a behavioral theory, creating a supporting behavioral intervention, designing and refining materials, and assessing efficacy. Results: We describe the use of this process to develop a diabetes self-management guide. Conclusions: Developing low-literacy health education materials that will activate patients toward healthier behaviors requires attention to factors beyond reading level. [ABSTRACT FROM AUTHOR]

Objective: To compare performance of the newest vital sign (NVS) with existing literacy measures. Methods: We administered the NVS and REALM to 129 patients, and NVS and S-TOFHLA to 119 patients all in public clinics. Results: The NVS demonstrated high sensitivity for detecting limited literacy and moderate specificity (area under the receiver operating characteristic [AUROC] curve 0.71-0.73). The NVS was less effective than the S-TOFHLA for predicting health outcomes. Conclusion: The NVS is able to identify patients with limited literacy skills, but may misclassify those with ad- equate literacy according to the REALM and S-TOFHLA. NVS scores were not associated with health outcomes. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The magnitude and consequences of low literacy in adolescent health and health care are unknown. The purpose of this study was to validate the Rapid Estimate of Adolescent Literacy in Medicine (REALM-Teen), a word-recognition test in English that can be used as a brief literacy-screening tool in health care settings. PATIENTS AND METHODS: A total of 1533 adolescents aged 10 to 19 years attending 1 of 5 middle schools, 3 high schools, 1 pediatric clinic, or 2 summer programs in Louisiana and North Carolina participated in face-to-face interviews. Demographic information was solicited, and participants were administered a battery of reading tests, including the REALM-Teen, Wide Range Achievement Test-Revised (WRAT-3), and Slosson Oral Reading Test-Revised (SORT-R). Internal consistency for the REALM-Teen was determined using Cronbach's alpha, and criterion validity was established through correlations with both the WRAT-R and SORT-R. Using reading below grade level (according to SORT-R scores) as an outcome, instrument accuracy and corresponding cutoff scores were calculated by plotting receiver operating characteristic curves and stratum-specific likelihood ratios. RESULTS: Participants were 50% black and 53% female; 34% were enrolled in middle school and 66% in high school. The average time required to administer the REALM-Teen was 3 minutes. Internal consistency was excellent, as was test-retest reliability. The REALM-Teen is strongly correlated with both the WRAT-R and SORT-R. Five reading level categories were identified: 3rd grade and below, 4th to 5th grade, 6th to 7th grade, 8th to 9th grade, and 10th grade and above. Forty-six percent of participants were reading below grade level according to the SORT-R and 28% had repeated at least 1 grade. CONCLUSION: The REALM-Teen is a brief, reliable instrument for assessing adolescent literacy skills and reading below grade level. [ABSTRACT FROM AUTHOR]

Objective: In this pilot study, we evaluated the impact of providing patients with a literacy-appropriate diabetes education guide accompanied by brief counseling designed for use in primary care.Methods: We provided the Living with Diabetes guide and brief behavior change counseling to 250 English and Spanish speaking patients with type 2 diabetes. Counseling sessions using collaborative goal setting occurred at baseline and by telephone at 2 and 4 weeks. We measured patients' activation, self-efficacy, diabetes distress, knowledge, and self-care at baseline and 3-month follow-up.Results: Statistically significant (pConclusion: A diabetes self-management support package combining literacy-appropriate patient education materials with brief counseling suitable for use in primary care resulted in important short-term health-related psychological and behavioral changes across literacy levels.Practice Implications: Coupling literacy-appropriate education materials with brief counseling in primary care settings may be an effective and efficient strategy for imparting skills necessary for diabetes self-management. [ABSTRACT FROM AUTHOR]

Objective: To create a brief assessment tool, the Medication Understanding and Use Self-Efficacy Scale (MUSE).Methods: An existing scale (Communication and Attitudinal Self-Efficacy Scale) was modified, augmented, and piloted among 267 primary care patients in Chicago, New York City, and Shreveport, LA. Participant sociodemographics, literacy, current medication use, understanding medication instructions, and medication self-efficacy were measured.Results: Using principal components analysis, two scales emerged: taking medication and learning about medication; these two factors accounted for 55% of the total variance of understanding medication instructions. Performance on the MUSE differed by literacy level; multivariate analysis detected no interaction between literacy level and MUSE score. Regression analysis, adjusted for age, education, literacy level and number of current prescription medications indicated that participants' MUSE scores predicted patient understanding of common medication instructions (beta=0.07, 95% CI 0.001-0.14, p=0.04).Conclusion: The MUSE is a valid and reliable tool measuring self-efficacy of understanding and using prescription medication. This scale differs from existing medication-specific self-efficacy scales as it addresses both learning about one's medications and adherence to the prescribed regimen.Practice Implications: The MUSE is an effective and brief research tool that can be utilized among participants with varying literacy levels. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To determine whether literacy mediates the association between education, hypertension knowledge and control. METHODS: In-person interviews with a literacy assessment and chart review were conducted with 330 hypertensive patients from six primary care safety net clinics. Mediational analysis was used to test the role of literacy skills in explaining the relationship between education and hypertension knowledge and control. RESULTS: In multivariate analyses that did not make an adjustment for the other variable, both lower educational attainment and more limited literacy were found to be significant independent predictors of poorer hypertension knowledge and control. When literacy was entered into models that included education only, the association between education and knowledge was fully attenuated and no longer significant (Grades 1-8: beta=-0.30, 95% CI=-1.44-0.83), while the relationship between education and blood pressure control was only minimally reduced (AOR 2.46, 95% CI 2.10-2.88). More limited literacy skills also was associated with hypertension control in the final model (AOR 2.68, 95% CI 1.54-4.70). CONCLUSION: Patient literacy mediated the relationship between education and hypertension knowledge. Literacy was a significant independent predictor of blood pressure control, but only minimally explained the relationship between education and blood pressure. PRACTICE IMPLICATIONS: Health literacy is critical to the design of educational tools to improve knowledge acquisition. However, in order to impact health outcome, future health literacy studies should also address other psychosocial factors that impact motivation and capability to manage disease. [ABSTRACT FROM AUTHOR]

Objective: Studies have consistently shown that African American individuals lose less weight in response to behavioral interventions, but the mechanisms leading to this result have been understudied., Methods: Data were derived from the PROmoting Successful Weight Loss in Primary CarE in Louisiana (PROPEL) study, which was a cluster-randomized, two-arm trial conducted in primary care clinics. In the PROPEL trial, African American individuals lost less weight compared with patients who belonged to other racial groups after 24 months. In the current study, counterfactual mediation analyses among 445 patients in the intervention arm of PROPEL were used to determine which variables mediated the relationship between race and weight loss. The mediators included treatment engagement, psychosocial, and lifestyle factors., Results: At 6 months, daily weighing mediated 33% (p = 0.008) of the racial differences in weight loss. At 24 months, session attendance and daily weighing mediated 35% (p = 0.027) and 66% (p = 0.005) of the racial differences in weight loss, respectively. None of the psychosocial or lifestyle variables mediated the race-weight loss association., Conclusions: Strategies specifically targeting engagement, such as improving session attendance and self-weighing behaviors, among African American individuals are needed to support more equitable weight losses over extended time periods., (© 2023 The Obesity Society.)

Background: Diverse, equitable and inclusive participation in clinical research is needed to ensure evidence-based clinical practice and lessen disparities in health outcomes. Yet, clinical trial participation remains critically low in minoritized communities, particularly among Blacks. The Louisiana Community Engagement Alliance against COVID-19 Disparities (LA-CEAL) was launched in response to the disproportionate impact of COVID-19 on Black Louisianans to understand community barriers and preferences and increase inclusive participation in research. This study aims to understand perceptions regarding COVID-19 trial participation among underrepresented Louisianans., Methods: A rapid assessment integrating cross-sectional, surveys among federally qualified health center (FQHC) patients and community residents, and focus group discussions (FGDs) from community representatives was conducted in 2020-2021. Factors and perceptions underlying trial participation were identified using logistic regression models and thematic analyses, respectively., Results: Quantitative findings (FQHC: N=908, mean age=46.6 years, 66.4% Black; community: N=504, mean age=54.2 years, 93.7% Black) indicated that 0.9% and 3.6%, respectively, ever participated in a COVID-19 trial. Doctors/Healthcare providers were most trusted (FQHC=55.1%; community=59.3%) sources of information about trials. Advancing age was associated with increased odds of being very willing to participate (OR FQHC =1.03, 95% CI 1.02-1.05; OR Community =1.02, 95% CI 1.00-1.04). Qualitative data (6 FGDs, 29 attendees) revealed limited awareness, experimentation/exploitation-based fears, and minimal racial/ethnic representation among trialists as barriers to participation., Conclusion: COVID-19 trial participation rates were low in our sample. Altruism was a key facilitator to participation; fear, mistrust, and low awareness were predominant barriers. Community-centered approaches, engaging informed providers and trusted community members, may facilitate inclusive trial participation., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to disclose., (Copyright © 2023. Published by Elsevier Inc.)

Objective: This study tested whether initial weight change (WC), self-weighing, and adherence to the expected WC trajectory predict longer-term WC in an underserved primary-care population with obesity., Methods: Data from the intervention group (n = 452; 88% women; 74% Black; BMI 37.3 kg/m 2 [SD: 4.6]) of the Promoting Successful Weight Loss in Primary Care in Louisiana trial were analyzed. Initial (2-, 4-, and 8-week) percentage WC was calculated from baseline clinic weights and daily at-home weights. Weights were considered adherent if they were on the expected WC trajectory (10% at 6 months with lower [7.5%] and upper [12.5%] bounds). Linear mixed-effects models tested whether initial WC and the number of daily and adherent weights predicted WC at 6, 12, and 24 months., Results: Percentage WC during the initial 2, 4, and 8 weeks predicted percentage WC at 6 (R 2  = 0.15, R 2  = 0.28, and R 2  = 0.50), 12 (R 2  = 0.11, R 2  = 0.19, and R 2  = 0.32), and 24 (R 2  = 0.09, R 2  = 0.11, and R 2  = 0.16) months (all p < 0.01). Initial daily and adherent weights were significantly associated with WC as individual predictors, but they only marginally improved predictions beyond initial weight loss alone in multivariable models., Conclusions: These results highlight the importance of initial WC for predicting long-term WC and show that self-weighing and adherence to the expected WC trajectory can improve WC prediction., (© 2023 The Obesity Society.)

Background: Currently there are limited data as to whether dietary intake can be improved during pragmatic weight loss interventions in primary care in underserved individuals., Methods: Patients with obesity were recruited into the PROPEL trial, which randomized 18 clinics to either an intensive lifestyle intervention (ILI) or usual care (UC). At baseline and months 6, 12, and 24, fruit and vegetable (F/V) intake and fat intake was determined. Outcomes were analyzed by repeated-measures linear mixed-effects multilevel models and regression models, which included random cluster (clinic) effects. Secondary analyses examined the effects of race, sex, age, and food security status., Results: A total of 803 patients were recruited. 84.4% were female, 67.2% African American, 26.1% received Medicaid, and 65.5% made less than $40,000. No differences in F/V intake were seen between the ILI and UC groups at months 6, 12, or 24. The ILI group reduced percent fat at months 6, 12, and 24 compared to UC. Change in F/V intake was negatively correlated with weight change at month 6 whereas change in fat intake was positively associated with weight change at months 6, 12, and 24 for the ILI group., Conclusions: The pragmatic weight loss intervention in primary care did not increase F/V intake but did reduce fat intake in an underserved population with obesity. F/V intake was negatively associated with weight loss at month 6 whereas percent fat was positively correlated with weight loss throughout the intervention. Future efforts better targeting both increasing F/V intake and reducing fat intake may promote greater weight loss in similar populations., Trial Registration: NCT Registration: NCT02561221., (© 2023. The Author(s).)

Background and Objectives: Current strategies for obesity management in primary care leave many patients inadequately treated or unable to access treatment entirely. We aimed to evaluate a comprehensive, primary care clinic-based weight management program's clinical effectiveness in a community practice setting.  Methods:  This was an 18-month pre/postintervention study. We collected demographic and anthropometric data on patients enrolled in a primary care-based weight management program. The primary outcomes were percent weight loss postintervention and the proportion of patients who achieved a clinically significant total body weight loss (TBWL) of 5% or greater.  Results:  Our program served 550 patients over 1,952 visits from March 2019 through October 2020. A total of 209 patients had adequate program exposure, defined as four or more completed visits. Among these, all received targeted lifestyle counseling and 78% received antiobesity medication. Patients who attended at least four visits had an average TBWL of 5.7% compared to an average gain of 1.5% total body weight for those with only one visit. Fifty-three percent of patients (n=111) achieved greater than 5% TBWL, and 20% (n=43) achieved greater than 10% TBWL., Conclusion: We demonstrated that a community-based weight management program delivered by obesity medicine-trained primary care providers effectively produces clinically significant weight loss. Future work will include wider implementation of this model to increase patient access to evidence-based obesity treatments in their communities.

Background: Most health literacy measures require in-person administration or rely upon self-report., Objective: We sought to develop and test the feasibility of a brief, objective health literacy measure that could be deployed via text messaging or online survey., Design: Participants were recruited from ongoing NIH studies to complete a phone interview and online survey to test candidate items. Psychometric analyses included parallel analysis for dimensionality and item response theory. After 9 months, participants were randomized to receive the final instrument via text messaging or online survey., Participants: Three hundred six English and Spanish-speaking adults with ≥ 1 chronic condition MAIN MEASURES: Thirty-three candidate items for the new measure and patient-reported physical function, anxiety, depression, and medication adherence. All participants previously completed the Newest Vital Sign (NVS) in parent NIH studies., Key Results: Participants were older (average 67 years), 69.6% were female, 44.3% were low income, and 22.0% had a high school level of education or less. Candidate items loaded onto a single factor (RMSEA: 0.04, CFI: 0.99, TLI: 0.98, all loadings >.59). Six items were chosen for the final measure, named the HL6. Items demonstrated acceptable internal consistency (α=0.73) and did not display differential item functioning by language. Higher HL6 scores were significantly associated with greater educational attainment (r=0.41), higher NVS scores (r=0.55), greater physical functioning (r=0.26), fewer depressive symptoms (r=-0.20), fewer anxiety symptoms (r=-0.15), and fewer barriers to medication adherence (r=-0.30; all p<.01). In feasibility testing, 75.2% of participants in the text messaging arm completed the HL6 versus 66.2% in the online survey arm (p=0.09). Socioeconomic disparities in completion were more common in the online survey arm., Conclusions: The HL6 demonstrates adequate reliability and validity in both English and Spanish. This performance-based assessment can be administered remotely using commonly available technologies with fewer logistical challenges than assessments requiring in-person administration., (© 2022. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Using data from the Louisiana Department of Public Health, we explored the spatial relationships between the Social Vulnerability Index (SVI) and COVID-19-related vaccination and mortality rates. Publicly available COVID-19 vaccination and mortality data accrued from December 2020 to October 2021 was downloaded from the Louisiana Department of Health website and merged with the SVI data; geospatial analysis was then performed to identify the spatial association between the SVI and vaccine uptake and mortality rate. Bivariate Moran's I analysis revealed significant clustering of high SVI ranking with low COVID-19 vaccination rates (1.00, p  < 0.001) and high smoothed mortality rates (0.61,  p  < 0.001). Regression revealed that for each 10% increase in SVI ranking, COVID-19 vaccination rates decreased by 3.02-fold (95% CI = 3.73-2.30), and mortality rates increased by a factor of 1.19 (95% CI = 0.99-1.43). SVI values are spatially linked and significantly associated with Louisiana's COVID-19-related vaccination and mortality rates. We also found that vaccination uptake was higher in whites than in blacks. These findings can help identify regions with low vaccination rates and high mortality, enabling the necessary steps to increase vaccination rates in disadvantaged neighborhoods., Competing Interests: Conflict of interestThe authors declare that the research was conducted without any commercial or financial relationships construed as a potential conflict of interest., (© The Author(s) 2022.)

Introduction: Remote patient monitoring (RPM) has demonstrated value as a tool to aid patients in management of their chronic illness in the home. Although the Mississippi Diabetes Telehealth Network Study (MSDTNS) was successful in reducing HbgA1c levels for patients participating in RPM in the Mississippi Delta, the long-term effect of RPM on patients and how to support patients to maintain the treatment effect after discharge remain unclear., Objective: This study evaluated the long-term effectiveness of an RPM program after the intervention was withdrawn., Materials and Methods: A retrospective review of medical records of patients who completed all phases of the MSDTNS from 2014 to 2016 was performed over a period of 6 months. Data collected included HbgA1c values, demographics, and changes in social determinants of health., Results: Of the 31 participants, African Americans displayed a significant difference in HbgA1c values compared with Caucasians since the end of the MSDTNS. No significant effect of other variables, such as income, marital status, insurance coverage, or age, on the change in HbgA1c values was detected since the end of the original study., Conclusions and Relevance: This limited study implies that African Americans are at higher risk for an increase in hemoglobin A1C after the program is completed. More investigation is needed to identify ways to reduce their risk and equalize the long-term effects of RPM on clinical outcomes of patients in rural or underserved communities., Competing Interests: No competing financial interests exist., (© Tearsanee Carlisle Davis et al., 2022; Published by Mary Ann Liebert, Inc.)

We examined COVID-19 concerns, vaccine acceptance, and trusted sources of information among patients in a safety-net health system in Louisiana. The participants were surveyed via structured telephone interviews over nine months in 2021. Of 204 adult participants, 65% were female, 52% were Black, 44.6% were White, and 46.5% were rural residents. The mean age was 53 years. The participants viewed COVID-19 as a serious public health threat (8.6 on 10-point scale). Black adults were more likely to perceive the virus as a threat than White adults (9.4 vs. 7.6 p < 0.0001), urban residents more than rural (9.0 vs. 8.2 p = 0.02), females more than males (8.9 vs. 8.1 p = 0.03). The majority (66.7%) had gotten the COVID-19 vaccine, with females being more likely than males (74.7 vs. 54.5% p = 0.02). There was no difference by race or rural residence. Overall, participants reported that physicians were the most trusted source of COVID-19 vaccine information (77.6%); followed by the CDC/FDA (50.5%), State Department of Health (41.4%), pharmacists (37.1%), nurses (36.7%); only 3.8% trusted social media. All sources were more trusted among black adults than White adults except family and social media. These findings could help inform efforts to design trustworthy public health messaging and clinical communication about the virus and vaccines.

Examine COVID-19 knowledge, concerns, behaviors, stress, and sources of information among patients in a safety-net health system in Louisiana. Research assistants surveyed participants via structured telephone interviews from April to October 2020. The data presented in this study were obtained in the pre-vaccine availability period. Of 623 adult participants, 73.5% were female, 54.7% Black, and 44.8% lived in rural small towns; mean age was 48.69. Half (50.5%) had spoken to a healthcare provider about the virus, 25.8% had been tested for COVID-19; 11.4% tested positive. Small town residents were less likely to be tested than those in cities (21.1% vs 29.3%, p = 0.05). Knowledge of COVID-19 symptoms and ways to prevent the disease increased from (87.9% in the spring to 98.9% in the fall, p < 0.001). Participants indicating that the virus had 'changed their daily routine a lot' decreased from 56.9% to 39.3% (p < 0.001). The main source of COVID-19 information was TV, which increased over time, 66.1-83.6% (p < 0.001). Use of websites (34.2%) did not increase. Black adults were more likely than white adults (80.7% vs 65.6%, p < 0.001) to rely on TV for COVID-19 information. Participants under 30 were more likely to get COVID-19 information from websites and social media (58.2% and 35.8% respectively). This study provides information related to the understanding of COVID-19 in rural and underserved communities that can guide clinical and public health strategies., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Individualized, precision feeding of dairy cattle may contribute to profitable and sustainable dairy production. Feeding strategies targeted at optimizing efficiency of individual cows, rather than groups of animals with similar characteristics, is a logical goal of individualized precision feeding. However, algorithms designed to make feeding recommendations for specific animals are scarce. The objective of this study was to develop and test 2 algorithms designed to improve feed efficiency of individual cows by supplementing total mixed rations (TMR) with varying types and amounts of top-dressed feedstuffs. Twenty-four Holstein dairy cows were assigned to 1 of 3 treatment groups as follows: a control group fed a common TMR ad libitum, a group fed individually according to algorithm 1, and a group fed individually according to algorithm 2. Algorithm 1 used a mixed-model approach with feed efficiency as the response variable and automated measurements of production parameters and top-dress type as dependent variables. Cow was treated as a random effect, and cow by top-dress interactions were included if significant. Algorithm 2 grouped cows based on top-dress response efficiency structure using a principal components and k-means clustering. Both algorithms were trained over a 36-d experimental period immediately before testing, and were updated weekly during the 35-d testing period. Production performance responses for dry matter intake (DMI), milk yield, milk fat percentage and yield, milk protein percentage and yield, and feed efficiency were analyzed using a mixed-effects model with fixed effects for feeding algorithm, top dress, week, and the 2- and 3-way interactions among these variables. Milk protein percentage and feed efficiency were significantly affected by the 3-way interaction of top dress, algorithm, and week, and DMI tended to be affected by this 3-way interaction. Feeding algorithm did not affect milk yield, milk fat yield, or milk protein yield. However, feeding costs were reduced, and hence milk revenue increased on the algorithm-fed cows. The efficacy of feeding algorithms differed by top dress and time, and largely relied on DMI shifts to modulate feed efficiency. The net result, for the cumulative feeding groups, was that cows in the algorithm 1 and 2 groups earned over $0.45 and $0.70 more per head per day in comparison to cows on the TMR control, respectively. This study yielded 2 candidate approaches for efficiency-focused, individualized feeding recommendations. Refinement of algorithm selection, development, and training approaches are needed to maximize production parameters through individualized feeding., (The Authors. Published by Elsevier Inc. and Fass Inc. on behalf of the American Dairy Science Association®. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).)

Plant cell size and shape are tuned to their function and specified primarily by cellulose microfibril (CMF) patterning of the cell wall. Arabidopsis thaliana leaf trichomes are unicellular structures that act as a physical defense to deter insect feeding. This highly polarized cell type employs a strongly anisotropic cellulose wall to extend and taper, generating sharply pointed branches. During elongation, the mechanisms by which shifts in fiber orientation generate cells with predictable sizes and shapes are unknown. Specifically, the axisymmetric growth of trichome branches is often thought to result from axisymmetric CMF patterning. Here, we analyzed the direction and degree of twist of branches after desiccation to reveal the presence of an asymmetric cell wall organization with a left-hand bias. CMF organization, quantified using computational modeling, suggests a limited reorientation of microfibrils during growth and a maximum branch length limited by the wall axial stiffness. The model provides a mechanism for CMF asymmetry, which occurs after the branch bending stiffness becomes low enough that ambient bending affects the principal stresses. After this stage, the CMF synthesis results in a constant bending stiffness for longer branches. The bending vibration natural frequencies of branches with respect to their length are also discussed., (Copyright © 2022 Biophysical Society. Published by Elsevier Inc. All rights reserved.)

Colorectal cancer (CRC) screening has been shown to decrease CRC mortality, yet significant disparities persist among those living in rural areas, from minority backgrounds, and those having low income. The purpose of this two-arm randomized controlled trial is to test the effectiveness and fidelity of a stepped care (increasing intensity as needed) approach to promoting 3-year adherence to CRC screening via fecal immunochemical testing (FIT) or colonoscopy in rural community clinics serving high rates of low-income and minority patients. We hypothesize that, compared to enhanced usual care (EUC), patients receiving the multifaceted CRC screening intervention will demonstrate higher rates of CRC screening completion over 3 years. Participants from six federally qualified health centers (FQHCs; N = 1200 patients) serving predominately low-income populations in rural Louisiana will be randomized to the intervention or EUC arm. All participants will receive health literacy-directed CRC counseling, simplified materials about both the FIT and colonoscopy procedures, and motivational interviewing to aid in the determination of test preference. Participants in the intervention arm will also receive motivational reminder messages from their primary care provider (via audio recording or tailored text) for either a scheduled colonoscopy or return of a completed FIT. Participants in the EUC arm will receive the standard follow-up provided by their clinic or colonoscopy facility. The primary outcome will be completion of either colonoscopy or annual FIT over 3 years. Results will provide evidence on the effectiveness of the intervention to decrease disparities in CRC screening completion related to health literacy, race, and gender. Trial registration:Clinicaltrials.gov Identifier NCT04313114., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objectives: To examine Influenza and COVID-19 vaccine concerns and uptake among adult patients in a Southern safety-net health system., Methods: Trained research assistants conducted a structured telephone interview from April to October 2021. Of 118 participants, mean age was 57.7 years, 63.6% were female, 55.1% were Black, 42.4% white, and 54.2% reported rural residence., Results: Among participants, 44.9% had received the influenza vaccine during the 2020 to 2021 season, and 66.1% had received the COVID-19 vaccine. Participants who received the influenza vaccine were more likely to report getting a COVID-19 vaccine compared to those who reported not getting a flu vaccine (81.1% vs 53.8%, P  = .002). Black adults were significantly less likely than white adults (29.2% vs 46.0%, P  = .048) and bordering on significance, males less likely than females (27.9% vs 41.3%, P  = .054) to have reported receiving both vaccines. Of note, 25.4% of participants did not get either vaccine. The most common reasons for not getting the influenza vaccine were not being concerned about getting the flu (13.8%) and belief the vaccine gave them the flu (12.3%). The primary reasons for not getting a COVID-19 vaccine were concern about vaccine safety (22.5%), concern about side effects (20.0%), and belief they were not going to get sick (20.0%)., Conclusions: These findings could help direct regional vaccine messaging and clinical communication to improve vaccine uptake among underserved populations.

Immediate and short-term changes in diet composition can support individualized, real-time interventions in precision dairy production systems, and might increase feed efficiency (FE) of dairy cattle in the short-term. The objective of this study was to determine immediate and short-term effects of changes in diet composition on production parameters of dairy cattle fed varying amounts of top dressed commodities. A 4 × 4 replicated Latin square design was used to evaluate responses of twenty-four Holstein cows fed either no top dress (Control) or increasing amounts of: corn grain (CG), soybean meal (SBM), or chopped mixed grass hay (GH) top dressed on a total mixed ration (TMR) over four, 9-day periods. Throughout each period, top dressed commodities were incrementally increased, providing 0% to 20% of calculated net energy of lactation (NE L ) intake. Measured production responses were analyzed for each 9-d period using a mixed-effects model considering two different time ranges. Samples collected from d 3 and 4 and from d 7 and 8 of each period were averaged and used to reflect "immediate" vs. "short-term" responses, respectively. In the immediate response time frame, control fed cows had lower milk yield, milk fat yield, and milk true protein yield than CG and SBM supplemented animals but similar responses to GH supplemented animals. Milk fat and protein percentages were not affected by top dress type in the immediate term. In the short-term response time-frame, GH supplemented animals had lower DMI and milk fat yield than all other groups. Control and GH supplemented cows had lower milk yield than CG and SBM fed cows. In the immediate response time frame, FE of SBM supplemented cows was superior to other groups. In the short-term time frame, FE of GH and SBM groups was improved over the control group. Results suggest that lactating dairy cows show rapid performance responses to small (<20% NE L ) changes in dietary composition, which may be leveraged within automated precision feeding systems to optimize efficiency of production. Before this potential can be realized, further research is needed to examine integration of such strategies into automatic feeding systems and downstream impacts on individual animal FE and farm profitability.

Lamellar phases of alkyldiacetylenes in which the alkyl chains lie parallel to the substrate represent a straightforward means for scalable 1-nm-resolution interfacial patterning. This capability has the potential for substantial impacts in nanoscale electronics, energy conversion, and biomaterials design. Polymerization is required to set the 1-nm functional patterns embedded in the monolayer, making it important to understand structure-function relationships for these on-surface reactions. Polymerization can be observed for certain monomers at the single-polymer scale using scanning probe microscopy. However, substantial restrictions on the systems that can be effectively characterized have limited utility. Here, using a new multi-scale approach, we identify a large, previously unreported difference in polymerization efficiency between the two most widely used commercial diynoic acids. We further identify a core design principle for maximizing polymerization efficiency in these on-surface reactions, generating a new monomer that also exhibits enhanced polymerization efficiency., (© 2021 Wiley-VCH GmbH.)

The purpose of this pilot study was to assess Chronic Myeloid Leukemia (CML) patients' adherence to, beliefs about, and barriers to oral anticancer agents (OAC) using brief self-report measures in community-based cancer clinics. Patients completed a structured interview including a health literacy assessment, a Brief Medication Questionnaire, two single-item self-report adherence questions, and the Medications Adherence Reasons Scale. Of the 86 participants, 88.4% were white; 55.8% male; mean age, 58.7 years; and 22.1% had limited health literacy. Nonadherence (missing at least one dose in the last week) was reported by 18.6% of participants and associated ( p < 0.003) with less-than-excellent perceived ability to take CML medications (16.3%). Black participants reported more difficulty taking CML medications than white participants (28.6% vs. 8.3%, p = 0.053). Among all participants, 43.0% reported their CML medicine was ineffective and 24.4% that taking CML pills was somewhat to very hard. The most common reasons for missing a dose were simply missed it (24.4%) and side effects (18.6%). Most patients perceived their ability to take CML medication was good to excellent, yet nearly one in five reported missing at least one dose in the last week. Brief, no-cost self-report assessments to screen CML patients' OAC adherence, barriers, and beliefs could facilitate counseling in busy community cancer clinics.

Background: The role pharmacies play in addressing the opioid crisis and drug-related risks such as injection drug use is evolving. Estimating the prevalence of injection drug use at the community level is challenging because of the stigma of drug use. Many community pharmacies sell nonprescription sterile syringes; thus, pharmacy-level sales of injection equipment may be an indicator of drug-related harms and unmet needs of high-risk populations., Objectives: To describe, compare, and assess the convergent validity of staff-reported nonprescription syringe (NPS) sales volume and NPS administrative sales data from community pharmacies in Massachusetts (MA) and Rhode Island (RI)., Methods: This study employed both prospective cross-sectional survey data collection and utilization of administrative pharmacy sales data. Between November 2017 and January 2018, we administered a telephone-based survey to estimate average weekly NPS type and volume for 191 chain pharmacies (CVS Health) located in communities experiencing fatal opioid overdoses above the state's 2015 annual median rate. For the same time period, we obtained NPS sales data from surveyed pharmacies and all CVS Health pharmacies in the 2 states. We calculated Spearman correlations to assess convergence of average weekly volume between pharmacy staff reports and sales data., Results: All pharmacies responded to the survey. Most (98.4%) pharmacies surveyed sold NPS, but 42.0% reported running out of stock monthly or more frequently. Pharmacy staff tended to under-report syringe sales. Staff-reported weekly NPS sales volume was 67,922 versus 70,962 syringes from administrative pharmacy sales data. Spearman correlation between reported and actual NPS sales was 0.40 (95% CI 0.27-0.51)., Conclusion: The counts of administrative pharmacy syringe sales data in MA and RI indicate high need, substantial volume, and notable access at community pharmacies. Future research should use NPS sales data rather than self-report data to track emerging trends and tailor local responses., (Copyright © 2021 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.)

Nanocrystals are often synthesized using technical grade reagents such as oleylamine (OLAm), which contains a blend of 9-cis- octadeceneamine with trans -unsaturated and saturated amines. Here, we show that gold nanowires (AuNWs) synthesized with OLAm ligands undergo thermal transitions in interfacial assembly (ribbon vs . nematic); transition temperatures vary widely with the batch of OLAm used for synthesis. Mass spectra reveal that higher-temperature AuNW assembly transitions are correlated with an increased abundance of trans and saturated chains in certain blends. DSC thermograms show that both pure (synthesized) and technical-grade OLAm have primary melting transitions near -5 °C (20-30 °C lower than the literature melting temperature range of OLAm). A second, broader melting transition (in the previous reported melting range) appears in technical grade blends; its temperature varies with the abundance of trans and saturated chains. Our findings illustrate that, similar to biological membranes, blends of alkyl chains can be used to generate mesoscopic hierarchical nanocrystal assembly, particularly at interfaces that further modulate transition temperatures.

Pimodivir exerts an antiviral effect on the early stages of influenza A virus replication by inhibiting the cap-binding function of polymerase basic protein 2 (PB2). In this study, we used a combination of sequence analysis and phenotypic methods to evaluate pimodivir susceptibility of influenza A viruses collected from humans and other hosts. Screening PB2 sequences for substitutions previously associated with reduced pimodivir susceptibility revealed a very low frequency among seasonal viruses circulating in the U.S. during 2015-2020 (<0.03%; 3/11,934) and among non-seasonal viruses collected in various countries during the same period (0.2%; 18/8971). Pimodivir potently inhibited virus replication in two assays, a single-cycle HINT and a multi-cycle FRA, with IC 50 values in a nanomolar range. Median IC 50 values determined by HINT were similar for both subtypes of seasonal viruses, A(H1N1)pdm09 and A(H3N2), across three seasons. Human seasonal viruses with PB2 substitutions S324C, S324R, or N510K displayed a 27-317-fold reduced pimodivir susceptibility by HINT. In addition, pimodivir was effective at inhibiting replication of a diverse group of animal-origin viruses that have pandemic potential, including avian viruses of A(H5N6) and A(H7N9) subtypes. A rare PB2 substitution H357N was identified in an A(H4N2) subtype poultry virus that displayed >100-fold reduced pimodivir susceptibility. Our findings demonstrate a broad inhibitory activity of pimodivir and expand the existing knowledge of amino acid substitutions that can reduce susceptibility to this investigational antiviral., (Published by Elsevier B.V.)

Background: Intensive lifestyle interventions (ILIs) are the first-line approach to effectively treat obesity and manage associated cardiometabolic risk factors. Because few people have access to ILIs in academic health centers, primary care must implement similar approaches for a meaningful effect on obesity and cardiometabolic disease prevalence. To date, however, effective lifestyle-based obesity treatment in primary care is limited. We examined the effectiveness of a pragmatic ILI for weight loss delivered in primary care among a racially diverse, low-income population with obesity for improving cardiometabolic risk factors over 24 months., Methods: The PROPEL trial (Promoting Successful Weight Loss in Primary Care in Louisiana) randomly allocated 18 clinics equally to usual care or an ILI and subsequently enrolled 803 (351 usual care, 452 ILI) adults (67% Black, 84% female) with obesity from participating clinics. The usual care group continued to receive their normal primary care. The ILI group received a 24-month high-intensity lifestyle-based obesity treatment program, embedded in the clinic setting and delivered by health coaches in weekly sessions initially and monthly sessions in months 7 through 24., Results: As recently demonstrated, participants receiving the PROPEL ILI lost significantly more weight over 24 months than those receiving usual care (mean difference, -4.51% [95% CI, -5.93 to -3.10]; P <0.01). Fasting glucose decreased more in the ILI group compared with the usual care group at 12 months (mean difference, -7.1 mg/dL [95% CI, -12.0 to -2.1]; P <0.01) but not 24 months (mean difference, -0.8 mg/dL [95% CI, -6.2 to 4.6]; P =0.76). Increases in high-density lipoprotein cholesterol were greater in the ILI than in the usual care group at both time points (mean difference at 24 months, 4.6 mg/dL [95% CI, 2.9-6.3]; P <0.01). Total:high-density lipoprotein cholesterol ratio and metabolic syndrome severity ( z score) decreased more in the ILI group than in the usual care group at both time points, with significant mean differences of the change of -0.31 (95% CI, -0.47 to -0.14; P <0.01) and -0.21 (95% CI, -0.36 to -0.06; P =0.01) at 24 months, respectively. Changes in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and blood pressure did not differ significantly between groups at any time point., Conclusions: A pragmatic ILI consistent with national guidelines and delivered by trained health coaches in primary care produced clinically relevant improvements in cardiometabolic health in an underserved population over 24 months. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02561221.

We examined knowledge of Alzheimer's disease and related dementias (ADRD), resources, and research opportunities among older African American (AA) and Caucasian caregivers. A mixed methods design integrated qualitative (focus group) and quantitative (survey) data from Northwest Louisiana. Eight focus groups (59 adults, 92% female, 78% AA, 25% rural) revealed limited knowledge. Quantitative findings from 117 ADRD caregivers (83% female, 72% AA, 30% limited heath literacy, 27% low income) indicated participants obtained information from providers (54%), friends and relatives (32%), and the internet (37%). Barriers to care were cost (24%) and lack of family agreement (17%). Few families used adult daycare (8%) or support groups (28%). Concerns about research participation were violation of privacy (30%) and fear of patient distress (27%). Distrust of doctors was minimal (3%). Findings did not vary by race. There is a need for clear, literacy-appropriate information about ADRD, caregiver resources, and clinical trials.