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Gang Fang,1 Stacy Cooper Bailey,2 Izabela E Annis,1 Michael K Paasche-Orlow,3 Michael S Wolf,2 Laurie T Martin,4 Michael Emch,5 M Alan Brookhart,6 Karen B Farris7 1Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; 2Division of General Internal Medicine & Geriatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; 3Section of General Internal Medicine, Boston University School of Medicine, Boston, MA, USA; 4RAND Corporation, Arlington, VA, USA; 5Department of Geography and Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA; 6Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; 7College of Pharmacy, The University of Michigan, Ann Arbor, MI, USACorrespondence: Gang FangDivision of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, 2202, Kerr Hall, Chapel Hill, NC 27599-7573, USATel +1 919-966-7517Fax +1 919-966-8486Email gang_fang@unc.eduPurpose: Individual measures of health literacy are not feasible for administration on a large scale, yet estimates of community-level health literacy in the US recently became available. We sought to investigate whether community-level health literacy estimates are associated with the initiation of oral antihyperglycemic agents (OHA) and the use of standard preventive care services among older adults with newly diagnosed diabetes.Patients and methods: We conducted a retrospective cohort study of 169,758 patients, ≥65 years old with hypertension and newly diagnosed type 2 diabetes using 2007–2011 data from the Center for Medicare and Medicaid Services Chronic Conditions Warehouse. We examined the relationship between community-level health literacy estimates and initiation of OHA, receipt of flu shots, eye exams, Hemoglobin A1c tests, and lipid tests within 12 months post diabetes diagnosis.Results: Patients living in communities with above basic health literacy (vs. basic/below basic) were 15% more likely to initiate OHA (Hazard Ratio=1.15; 95% CI 1.12 to 1.18). After classifying the health literacy distribution as quintiles, the analysis revealed a dose–response relationship with OHA initiation that plateaued at the third and fourth quintiles and declined at the fifth quintile. Individuals residing in communities with higher health literacy were more likely to participate in preventive care services (relative risk ranged from 1.09 for lipid test [95% CI 1.07–1.11] to 1.43 for flu shot [95% CI 1.41–1.46]).Conclusion: Community-level health literacy estimates were associated with the initiation of OHA and uptake of standard preventive care services in older adults. Community-level health literacy may help to inform targeted diabetes education and support efforts.Keywords: health literacy, diabetes mellitus, adherence, preventive care

Investigators have the responsibility to ensure that prospective participants are fully informed about a research protocol prior to consenting to participate, yet many researchers face challenges when obtaining consent, since the majority of the general population has limited or no familiarity with research studies. These challenges are further magnified when obtaining consent from individuals with low literacy levels and who speak languages other than English. In this article we present findings from a qualitative study conducted with Spanish-speaking individuals with low-literacy designed to refine the Agency for Healthcare Research and Quality's Informed Consent and Authorization Toolkit for Minimal Risk Research. Findings from this study indicate that familiarity with providing informed consent and authorization for research or the experience of being a research participant appear to play key roles in an individual's ability to understand the consent and authorization process. While the text of the consent and authorization documents can be simplified using plain language principles, comprehension of several fundamental ideas such as risk and privacy need to be safeguarded with a consent process that confirms comprehension. Recommendations are provided to address the informational needs of individuals with low literacy levels and limited or no experience with research participation. [ABSTRACT FROM AUTHOR]

Objective: To determine whether or not limited caregiver health literacy is associated with adherence to a daily multi-vitamin with iron regimen in infants.Methods: 110 caregiver/infant dyads were enrolled in a prospective study to assess the relationship between caregiver health literacy and adherence to a daily multi-vitamin with iron regimen for infants. Households were contacted biweekly over a 3-month period. Adherence was based upon caregiver report. High adherence, our primary outcome, was defined as the administration of the multi-vitamin with iron on 5-7 days over the past week.Results: As measured by the Short Test of Functional Health Literacy in Adults (S-TOFHLA), 18% of caregivers had limited health literacy skills. Caregivers with limited health literacy skills were more likely to have higher adherence than caregivers with adequate health literacy, after adjusting for a number of possible confounding variables (AOR=2.13; 95% 1.20-3.78).Conclusion: Caregivers with limited health literacy were twice as likely to report high adherence to a daily multi-vitamin with iron regimen in infants as caregivers with adequate health literacy in adjusted analysis.Practice Implications: Health literacy may exert a differential influence on adherence depending upon the complexity of the desired health behavior. [ABSTRACT FROM AUTHOR]

Background: Emergency department visits and rehospitalization are common after hospital discharge.Objective: To test the effects of an intervention designed to minimize hospital utilization after discharge.Design: Randomized trial using block randomization of 6 and 8. Randomly arranged index cards were placed in opaque envelopes labeled consecutively with study numbers, and participants were assigned a study group by revealing the index card.Setting: General medical service at an urban, academic, safety-net hospital.Patients: 749 English-speaking hospitalized adults (mean age, 49.9 years).Intervention: A nurse discharge advocate worked with patients during their hospital stay to arrange follow-up appointments, confirm medication reconciliation, and conduct patient education with an individualized instruction booklet that was sent to their primary care provider. A clinical pharmacist called patients 2 to 4 days after discharge to reinforce the discharge plan and review medications. Participants and providers were not blinded to treatment assignment.Measurements: Primary outcomes were emergency department visits and hospitalizations within 30 days of discharge. Secondary outcomes were self-reported preparedness for discharge and frequency of primary care providers' follow-up within 30 days of discharge. Research staff doing follow-up were blinded to study group assignment.Results: Participants in the intervention group (n = 370) had a lower rate of hospital utilization than those receiving usual care (n = 368) (0.314 vs. 0.451 visit per person per month; incidence rate ratio, 0.695 [95% CI, 0.515 to 0.937]; P = 0.009). The intervention was most effective among participants with hospital utilization in the 6 months before index admission (P = 0.014). Adverse events were not assessed; these data were collected but are still being analyzed.Limitation: This was a single-center study in which not all potentially eligible patients could be enrolled, and outcome assessment sometimes relied on participant report.Conclusion: A package of discharge services reduced hospital utilization within 30 days of discharge.Funding: Agency for Healthcare Research and Quality and National Heart, Lung, and Blood Institute, National Institutes of Health. [ABSTRACT FROM AUTHOR]

Rationale: Although inadequate health literacy has been associated with lower asthma medication knowledge and worse metered-dose inhaler (MDI) technique, the relationship between health literacy and the capacity to learn asthma self-management skills is unknown.Objectives: In this prospective cohort study of adults hospitalized for severe asthma exacerbations at two inner-city hospitals, we examined the relationship between inadequate health literacy and difficulties learning and retaining instructions about discharge medications and appropriate MDI technique.Methods: At hospital discharge, participants received one-on-one, 30-min, guideline-based, written and oral instruction about their asthma discharge regimen as well as appropriate MDI technique.Measurements and Main Results: Seventy-three patients were enrolled. Inadequate health literacy was identified in 16 (22%) participants. Before instruction, inadequate health literacy was associated with lower asthma medication knowledge (5.2/10 vs. 7.2/10, p < 0.001) and worse MDI technique (3.2/6 vs. 3.9/6, p = 0.03). However, inadequate health literacy was not associated with difficulty learning (p = 0.33) or retaining (p = 0.35) instructions about the discharge regimen. Similarly, inadequate health literacy was not associated with difficulty learning (p = 0.26) or retaining (p = 0.97) appropriate MDI technique. Results were similar in multivariable models adjusted for demographic characteristics and asthma severity indicators.Conclusions: These findings suggest that inadequate health literacy is a surmountable barrier to learning and remembering key asthma self-management skills. [ABSTRACT FROM AUTHOR]

Objective: To provide an evidence-based review of plausible causal pathways that could best explain well-established associations between limited health literacy and health outcomes. Methods: Through analysis of current findings in medical and public health literature on health literacy we derived a conceptual causal model. Results: Health literacy should be viewed as both a patient and a system phenomenon. Three distinct points along a continuum of health care are suggested to be influenced by health literacy: (1) access and utilization of health care, (2) patient-provider relationship, and (3) self-care. Conclusions: The conceptual model organizes what has been learned to date and underscores promising areas of future inquiry and intervention. [ABSTRACT FROM AUTHOR]

Objectives: To determine the role of numeracy on cancer screening knowledge and practices among an ethnically diverse population. Methods: Women aged 40+ presenting for primary care at an urban academic medical center were surveyed. Numeracy was measured as a dichotomous outcome (numerate: yes/no) using 3 criteria adapted from a validated instrument. Self-report was used to determine if women were up-to-date with breast and colorectal cancer screening. Results: Adequate numeracy was associated with increasing age, white race, higher education, and knowledge of breast cancer screening guidelines. No association was found between numeracy and cancer screening practices. Conclusions: Adequate numeracy was not a key determinant of cancer screening. [ABSTRACT FROM AUTHOR]

Objective: Patients are commonly presented with complex documents that they have difficulty understanding. The objective of this study was to design and evaluate an animated computer agent to explain research consent forms to potential research participants.Methods: Subjects were invited to participate in a simulated consent process for a study involving a genetic repository. Explanation of the research consent form by the computer agent was compared to explanation by a human and a self-study condition in a randomized trial. Responses were compared according to level of health literacy.Results: Participants were most satisfied with the consent process and most likely to sign the consent form when it was explained by the computer agent, regardless of health literacy level. Participants with adequate health literacy demonstrated the highest level of comprehension with the computer agent-based explanation compared to the other two conditions. However, participants with limited health literacy showed poor comprehension levels in all three conditions. Participants with limited health literacy reported several reasons, such as lack of time constraints, ability to re-ask questions, and lack of bias, for preferring the computer agent-based explanation over a human-based one.Conclusion: Animated computer agents can perform as well as or better than humans in the administration of informed consent.Practice Implications: Animated computer agents represent a viable method for explaining health documents to patients. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To determine the prevalence of low health literacy and investigate the relationship between low health literacy and physical and psychological wellbeing in the Japanese general population. METHODS: A web-based cross-sectional survey was conducted in a national sample of Japanese adults. Health literacy was measured by self-report using the validated single-item screening question, 'How confident are you filling out forms by yourself?' Wellbeing was measured with the physical and psychological domains of the World Health Organization Quality of Life Assessment-BREF. Effect sizes were computed by dividing the mean difference in scores by the standard deviation of the scores of all participants. RESULTS: In 1040 adult enrollees (mean age, 57-year-old; women, 52%), there were 161 (15.5%; 95% confidence interval [CI], 13.3-17.7%) with low health literacy. Individuals with low health literacy reported lower physical wellbeing (60.6 vs. 71.7, p<0.001) and psychological wellbeing (59.7 vs. 68.3, p<0.001) compared with those with adequate health literacy. After adjusting for sociodemographic characteristics, health risk behaviors and chronic conditions, these differences were still significant (physical wellbeing, p<0.001; psychological wellbeing, p<0.001). The effect sizes of the difference of scores were moderate for physical wellbeing (-0.55) and also for psychological wellbeing (-0.44). CONCLUSION: The prevalence of self-reported low health literacy in Japanese adults is substantial and it is independently associated with poorer physical and mental wellbeing. PRACTICE IMPLICATIONS: Efforts to monitor health literacy and to evaluate causal pathways to poor wellbeing should be encouraged in the Japanese population. [ABSTRACT FROM AUTHOR]

Introduction: Multiple interventions have been designed to employ facilitators to address gaps in Advance Care Planning (ACP). Objective: To collect and review available evidence related to facilitated ACP interventions. Methods/Design: Narrative review using a previously described framework for scoping reviews. We searched PubMed using structured criteria and report synthesized themes detailing the design, target populations, methods, and outcome measurements for interventions in which a facilitator-who may or may not be clinical staff-engaged a patient and/or a patient's caregiver in some part of the ACP process. Results: Of 1492 articles discovered on our search, 28 met the inclusion criteria. Twelve (42.9%) studies utilized a nurse facilitator, two (7.1%) utilized trained social workers, and one (3.6%) embedded multiple facilitators. The remaining 13 (46.4%) utilized facilitators from other various professional and community backgrounds, such as lay navigators, care coordinators, and peer mentors. Twenty-five (89.2%) studies included patients with serious or chronic illness, at the end-of-life, or having a high risk of need for medical care. Four (14.3%) articles focused on marginalized populations. Intervention settings varied notably across studies. Eighteen (64.3%) integrated interventions into existing clinical workflows. Primary outcomes were measured in one of three ways: documentation in the Electronic Health Record (EHR) (25.0%); questionnaires, scales, patient reports, or non-EHR documentation (64.3%); or multiple measures (10.7%). Twenty-three (82.1%) of the studies were determined a success by study authors. Conclusion: We identified a variety of key characteristics that can be modified to target facilitated ACP interventions towards gaps in current applications of ACP., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Angelo Volandes has a financial interest in ACP Decisions, a non-profit organization developing advance care planning video decision support tools. Dr Volandes’ interests were reviewed and are managed by MGH and Mass General Brigham in accordance with their conflicts of interest policies. None of the other authors have any conflicts of interest to disclose.

Background: Patients' situations can impact their intentions to use antibiotics without medical guidance (non-prescription use) in the future. This survey determines the prevalence of intended (future) use of non-prescription antibiotics for 13 predefined situations and identifies the sociodemographic characteristics associated with intended use for these types of situations., Methods: Patient surveys (N = 564) were conducted from January 2020 to June 2021 in the waiting rooms of 6 safety-net primary care clinics and 2 emergency departments in a private healthcare system. We used principal component analysis to identify 3 situational summary factors: barriers to a doctor visit, accessibility of non-prescription antibiotics, and previous symptom relief with antibiotics. Multivariate linear regression identified the sociodemographic predictors associated with each summary factor., Results: The most common situations triggering patients to use non-prescription antibiotics were a perceived high cost of doctor visits (29.8%), having leftover prescription antibiotics (50.4%), and experiencing symptom relief with prior use of antibiotics (47.5%). Multivariate regression results revealed that younger patients ( P < 0.04) and patients attending the safety-net health system ( P < 0.001) had more intended use of non-prescription antibiotics for all 3 summary factors., Conclusions: Future stewardship interventions should consider the types of situations that drive patients' decisions to use antibiotics without a prescription. Interventions aimed at reducing barriers to health care (eg, high costs and long waits associated with doctor appointments) and educating individuals on medically appropriate, nonantibiotic treatment options may reduce antibiotic use and antimicrobial resistance., Competing Interests: B. W. T. reports grants or contracts from the VA Health Services Research and Development Service, AHRQ R01 (R01 HS029489), AHRQ R18 (R18HS028776), Craig H. Neilson Foundation, Genentech, and Peptilogics; payment from George Washington ID Board for a Review Course; travel support for meeting attendance from the VA Office of Research and Development and the Infectious Diseases Society of America; and an unpaid role on a DSMB for CSP #2004. L. G. reports grants or contracts from the VA Health Services Research and Development Service, AHRQ R01 (R01 HS029489), AHRQ R18 (R18HS028776), Craig H. Neilsen Foundation, National Institute on Alcohol Abuse and Alcoholism (R18HS028776), and a research education grant (1R25AA028203-01) from the National Institute on Alcohol Abuse and Alcoholism Award. All other authors report no potential conflicts., (© Cambridge University Press 2024.)

Patient expectations of receiving antibiotics for common symptoms can trigger unnecessary use. We conducted a survey (n = 564) between January 2020 to June 2021 in public and private primary care clinics in Texas to study the prevalence and predictors of patients' antibiotic expectations for common symptoms/illnesses. We surveyed Black patients (33%) and Hispanic/Latine patients (47%), and over 93% expected to receive an antibiotic for at least 1 of the 5 pre-defined symptoms/illnesses. Public clinic patients were nearly twice as likely to expect antibiotics for sore throat, diarrhea, and cold/flu than private clinic patients. Lack of knowledge of potential risks of antibiotic use was associated with increased antibiotic expectations for diarrhea (odds ratio [OR] = 1.6; 95% CI, 1.1-2.4) and cold/flu symptoms (OR = 2.9; 95% CI, 2.0-4.4). Lower education and inadequate health literacy were predictors of antibiotic expectations for diarrhea. Future antibiotic stewardship interventions should tailor patient education materials to include information on antibiotic risks and guidance on appropriate antibiotic indications., (© 2024 Annals of Family Medicine, Inc.)

Background: Optimal care for seriously ill and older patients often involves advance care planning (ACP), goals-of-care (GOC) conversations, and specialty palliative care consultation, three sometimes overlapping, yet distinct practices. Insufficient staffing and investment in these areas have limited their availability., Objectives: We explored the facilitators and barriers to successful implementation of the VIDEO-PCE trial. The intervention aimed to increase patient engagement in ACP, GOC, and by establishing Palliative Care Educators, a new clinical role integrated into existing hospital wards., Design: This qualitative interview study employed a semi-structured interview guide tailored to the interviewee's clinical role. The interviews elicited perceptions of the facilitators and barriers to integration of palliative care educators (PCEs) into existing workflows. We developed deductive codes a priori and inductive codes as we coded interview transcripts., Setting/subjects: Medical/surgical floor clinical colleagues, palliative care team members, and PCEs from both participating sites were interviewed., Results: Twenty-four individuals were interviewed (12 clinical staff of medical and surgical wards, seven palliative care team members, and five PCEs). Four themes were identified: (1) The work completed by the PCEs provided a foundation for future palliative care involvement; (2) Constituting the new role in practice required revision and creativity; (3) Communication was important to providing continuity of care; and (4) Establishing trust catalyzed the acceptance of the role., Conclusion: The creation and implementation of a new role within existing clinical workflows posed some challenges but were felt to relieve staff from some work burden and allow more patients to engage in ACP and GOC conversations., Trial Registration: ClinicalTrials.gov Identifier: NCT04857060., Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Angelo Volandes has a financial interest in ACP Decisions, a non-profit organization developing advance care planning video decision support tools. Dr Volandes’ interests were reviewed and are managed by MGH and Mass General Brigham in accordance with their conflicts of interest policies. Dr Aretha Delight Davis is the CEO of ACP Decisions, a nonprofit organization focused on strengthening shared decisions making through video decision aids, from which she receives a salary. None of the other authors have any conflicts of interest to disclose.

Taking leftover prescribed antibiotics without consulting a healthcare professional is problematic for the efficacy, safety, and antibiotic stewardship. We conducted a cross-sectional survey of adult patients in English and Spanish between January 2020 and June 2021 in six safety-net primary care clinics and two private emergency departments. We assessed the reasons for stopping prescribed antibiotics early and what was done with the leftover antibiotics. Additionally, we determined 1) prior leftover antibiotic use, 2) intention for future use of leftover antibiotics, and 3) sociodemographic factors. Of 564 survey respondents (median age of 51), 45% (251/564) reported a history of stopping antibiotics early, with 171/409 (42%) from safety net and 80/155 (52%) from the private clinics. The most common reason for stopping prescribed antibiotics early was "because you felt better" (194/251, 77%). Among survey participants, prior use of leftover antibiotics was reported by 149/564 (26%) and intention for future use of leftover antibiotics was reported by 284/564 (51%). In addition, higher education was associated with a higher likelihood of prior leftover use. Intention for future use of leftover antibiotics was more likely for those with transportation or language barriers to medical care and less likely for respondents with private insurance. Stopping prescribed antibiotics early was mostly ascribed to feeling better, and saving remaining antibiotics for future use was commonly reported. To curb nonprescription antibiotic use, all facets of the leftover antibiotic use continuum, from overprescribing to hoarding, need to be addressed., Competing Interests: The authors declare no conflict of interest.

Introduction: This study aimed to examine changes in emergency department (ED) visits for ambulatory care sensitive conditions (ACSCs) among uninsured or Medicaid-covered Black, Hispanic, and White adults aged 26-64 in the first 5 years of the Affordable Care Act Medicaid expansion., Methods: Using 2010-2018 inpatient and ED discharge data from nine expansion and five nonexpansion states, an event study difference-in-differences regression model was used to estimate changes in number of annual ACSC ED visits per 100 adults ("ACSC ED rate") associated with the 2014 Medicaid expansion, overall and by race/ethnicity. A secondary outcome was the proportion of ACSC ED visits out of all ED visits ("ACSC ED share"). Analyses were conducted in 2022-2023., Results: Medicaid expansion was associated with no change in ACSC ED rates among all, Black, Hispanic, or White adults. When excluding California, where most counties expanded Medicaid before 2014, expansion was associated with a decrease in ACSC ED rate among all, Black, Hispanic, and White adults. Expansion was also associated with a decrease in ACSC ED share among all, Black, and White adults. White adults experienced the largest reductions in ACSC ED rate and share., Conclusions: Medicaid expansion was associated with reductions in ACSC ED rates in some expansion states and reductions in ACSC ED share in all expansion states combined, with some heterogeneity by race/ethnicity. Expansion should be coupled with policy efforts to better link newly insured Black and Hispanic patients to non-ED outpatient care, alongside targeted outreach and expanded primary care capacity, which may reduce disparities in ACSC ED visits., (Copyright © 2024 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: Describe and compare the experiences and preferences of Deaf and hearing individuals with different levels of health literacy in accessing, interpreting, and acting upon online health information., Methods: We conducted semi-structured interviews with 17 Deaf and 10 hearing participants with high and low health literacy from three healthcare sites. We conducted thematic analysis of the transcripts to explore information navigation experiences, information sources and dissemination preferences., Results: We found thematic differences between Deaf and hearing participants with high and low health literacy in terms of information needs, information search experiences, information search perceptions, and preferred information dissemination approaches. Relative to hearing counterparts, Deaf participants were more likely to encounter challenges in accessing and understanding online information. Deaf participants with low health literacy were more likely to rely on visual graphics to support their understanding of the information than those with high health literacy. Deaf participants advocated for tailored approaches to disseminate health information to Deaf communities., Conclusion: Our findings suggest that differences in online health information navigation experiences and accessibility may inform disparities in health literacy outcomes between Deaf and hearing individuals., Practice Implications: Online health information should be presented in a manner accessible to Deaf community members., Competing Interests: Declaration of Competing Interest The authors have no conflicts of interest to disclose. The work was supported in part by the National Institute on Deafness and Other Communication Disorders (NIDCD) [R01 DC014703]; and the National Institute of General Medical Sciences [K12 GM106997]., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: The extent to which sex, racial, and ethnic groups receive advanced heart therapies equitably is unclear. We estimated the population rate of left ventricular assist device (LVAD) and heart transplant (HT) use among (non-Hispanic) White, Hispanic, and (non-Hispanic) Black men and women who have heart failure with reduced ejection fraction (HFrEF)., Methods and Results: We used a retrospective cohort design combining counts of LVAD and HT procedures from 19 state inpatient discharge databases from 2010 to 2018 with counts of adults with HFrEF. Our primary outcome measures were the number of LVAD and HT procedures per 1000 adults with HFrEF. The main exposures were sex, race, ethnicity, and age. We used Poisson regression models to estimate procedure rates adjusted for differences in age, sex, race, and ethnicity. In 2018, the estimated population of adults aged 35 to 84 years with HFrEF was 69 736, of whom 44% were women. Among men, the LVAD rate was 45.6, and the HT rate was 26.9. Relative to men, LVAD and HT rates were 72% and 62% lower among women ( P <0.001). Relative to White men, LVAD and HT rates were 25% and 46% lower ( P <0.001) among Black men. Among Hispanic men and women and Black women, LVAD and HT rates were similar ( P >0.05) or higher ( P <0.01) than among their White counterparts., Conclusions: Among adults with HFrEF, the use of LVAD and HT is lower among women and Black men. Health systems and policymakers should identify and ameliorate sources of sex and racial inequities.

We sought to analyze the relationship between health literacy, confidence in COVID-19 vaccines, and self-reported vaccination. We hypothesized that the relationship between health literacy and vaccination would be mediated by vaccine confidence. We recruited (N = 271) English- and Spanish-speaking adults in Boston and Chicago from September 2018 to September 2021. We performed a probit mediation analysis to determine if confidence in COVID-19 vaccines and health literacy predicted self-reported vaccination. We hypothesized that the relationship between health literacy and vaccination would be mediated by vaccine confidence. Participants were on average 50 years old, 65% female, 40% non-Hispanic Black, 25% Hispanic, and 30% non-Hispanic White; 231 (85%) reported at least one COVID-19 vaccination. A higher mean vaccine confidence score ( t = -7.9, p < 0.001) and higher health literacy ( t = -2.2, p = 0.03) were associated with vaccination, but only vaccine confidence predicted vaccination in a multivariate model. Vaccine confidence mediated the relationship between health literacy and COVID-19 vaccination (mediated effects: 0.04; 95% CI [0.02, 0.08]). We found that using a simple tool to measure vaccine confidence identified people who declined or delayed COVID-19 vaccination in a diverse sample of adults with varying levels of health literacy. Simple short survey tools can be useful to identify people who may benefit from vaccine promotion efforts and evidence-based communication strategies.

Advance Care Planning (ACP) is a communication process about serious illness decision making designed to inform patients of possible medical options. Native Hawaiians consistently have low rates of ACP and low use of palliative and hospice care services. Our multidisciplinary community and research group partnered to create I kua na'u "Let Me Carry Out Your Last Wishes," an ACP intervention featuring culturally tailored videos and are now testing its efficacy. Focus groups and informant interviews were conducted with Native Hawaiian community members to ensure the curriculum honored the history, opinions, and culture of Native Hawaiians. Native Hawaiian culture has traditionally been an oral culture; the spoken word transmitted the mo'olelo, stories, traditions, histories and genealogies, which merges seamlessly with video media. The I kua na'u intervention included multiple educational sessions enhanced with videos (informational and personal). The specific aims are to compare ACP knowledge (primary outcome) and readiness for ACP engagement, ACP preferences, decisional conflict, and ACP completion rates via electronic medical record review (secondary outcomes) in 220 Native Hawaiians over age 55 in: (a) a randomized controlled trial of 110 people recruited from ambulatory clinics, and (b) a pre-post study design among 110 people living on Hawaiian Homestead communities located on lands set aside for Native Hawaiians or assisted living. Our protocol aims to evaluate the efficacy of our video-based educational intervention for Native Hawaiians to support decision making in this community and decrease disparities in serious illness care. Clinical Trial Registration Number: NCT04771208., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Angelo Volandes has a financial interest in ACP Decisions, a non-profit organization developing advance care planning video decision support tools. Dr. Volandes' interests were reviewed and are managed by MGH and Mass General Brigham in accordance with their conflict-of-interest policies. No other disclosures to report. Dr. Davis (who is married to Dr. Volandes) is a Co-Founder, CEO and Board Member of ACP Decisions, a nonprofit organization that supports shared decision making through video decision aids, from which she receives a salary., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Advance Care Planning (ACP) comprises an iterative communication process aimed at understanding patients' goals, values, and preferences in the context of considering and preparing for future medical treatments and decision making in serious illness. The COVID pandemic heightened patients' and clinicians' awareness of the need for ACP., Objective: Our goal was to explore the experiences of clinicians and administrators in the context of an intervention to improve ACP during the COVID pandemic., Design: Qualitative interview study., Participants: Clinicians and administrators across five sites that participated in the ACP-COVID trial., Approach: We conducted semi-structured, qualitative interviews examining the context and approach to ACP. Interviews were analyzed using template analysis to systematically organize the data and facilitate review across the categories and participants. Templates were developed with iterative input and line-by-line review by the analytic team, to reach consensus. Findings were then organized into emergent themes., Key Results: Across 20 interviews (4 administrators, 16 clinicians) we identified three themes related to how participants thought about ACP: (1) clinicians have varying views of what constitutes ACP; (2) the health system critically shapes ACP culture and norms; and (3) the centrality of clinicians' affective experience and own needs related to ACP. Varying approaches to ACP include a forms-focused approach; a discussion-based approach; and a parental approach. System features that shape ACP norms are (1) the primacy of clinician productivity measures; (2) the role of the EHR; and (3) the culture of quality improvement., Conclusions: Despite high organizational commitment to ACP, we found that the health system channeled clinicians' ACP efforts narrowly on completion of forms, in tension with the ideal of well-grounded ACP. This resulted in a state of moral distress that risks undermining confidence in the process of ACP and may increase risk of harm for patients, family/caregivers, and providers., Trial Registration: ClinicalTrials.gov Identifier: NCT04660422., (© 2023. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Advance care planning (ACP) discussions seek to guide future serious illness care. These discussions may be recorded in the electronic health record by documentation in clinical notes, structured forms and directives, and physician orders. Yet, most studies of ACP prevalence have only examined structured electronic health record elements and ignored data existing in notes. We sought to investigate the relative comprehensiveness and accuracy of ACP documentation from structured and unstructured electronic health record data sources. We evaluated structured and unstructured ACP documentation present in the electronic health records of 435 patients with cancer drawn from three separate healthcare systems. We extracted structured ACP documentation by manually annotating written documents and forms scanned into the electronic health record. We coded unstructured ACP documentation using a rule-based natural language processing software that identified ACP keywords within clinical notes and was subsequently reviewed for accuracy. The unstructured approach identified more instances of ACP documentation (238, 54.7% of patients) than the structured ACP approach (187, 42.9% of patients). Additionally, 16.6% of all patients with structured ACP documentation only had documents that were judged as misclassified, incomplete, blank, unavailable, or a duplicate of a previously entered erroneous document. ACP documents scanned into electronic health records represent a limited view of ACP activity. Research and measures of clinical practice with ACP should incorporate information from unstructured data., (Copyright © 2023 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Objective: Using data on 5 years of postexpansion experience, we examined whether the coverage gains from Affordable Care Act Medicaid expansion among Black, Hispanic, and White individuals led to improvements in objective indicators of outpatient care adequacy and quality., Research Design: For the population of adults aged 45-64 with no insurance or Medicaid coverage, we obtained data on census population and hospitalizations for ambulatory care sensitive conditions (ACSCs) during 2010-2018 in 14 expansion and 7 nonexpansion states. Our primary outcome was the percentage share of hospitalizations due to ACSC out of all hospitalizations ("ACSC share") among uninsured and Medicaid-covered patients. Secondary outcomes were the population rate of ACSC and all hospitalizations. We used multivariate regression models with an event-study difference-in-differences specification to estimate the change in the outcome measures associated with expansion in each of the 5 postexpansion years among Hispanic, Black, and White adults., Principal Findings: At baseline, ACSC share in the expansion states was 19.0%, 14.5%, and 14.3% among Black, Hispanic, and White adults. Over the 5 years after expansion, Medicaid expansion was associated with an annual reduction in ACSC share of 5.3% (95% CI, -7.4% to -3.1%) among Hispanic and 8.0% (95% CI, -11.3% to -4.5%) among White adults. Among Black adults, estimates were mixed and indicated either no change or a reduction in ACSC share., Conclusions: After Medicaid expansion, low-income Hispanic and White adults experienced a decrease in the proportion of potentially preventable hospitalizations out of all hospitalizations., Competing Interests: A.D.H. had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The remaining authors declare no conflict of interest., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To estimate changes in the emergency department (ED) visit rate, hospitalization share of ED visits, and ED visit volumes associated with Medicaid expansion among Hispanic, Black, and White adults., Data Collection/extraction Methods: For the population of adults aged 26-64 with no insurance or Medicaid coverage, we obtained census population and ED visit counts during 2010-2018 in nine expansion and five nonexpansion states., Main Outcomes and Measures: The primary outcome was the annual number of ED visits per 100 adults ("ED rate"). The secondary outcomes were the share of ED visits leading to hospitalization, total number ("volumes") of all ED visits, ED visits leading to discharge ("treat-and-release") and ED visits leading to hospitalization ("transfer-to-inpatient"), and the share of the study population with Medicaid ("Medicaid share")., Study Design: An event-study difference in differences design that contrasts pre- versus post-expansion changes in outcomes in Medicaid expansion and nonexpansion states., Principal Findings: In 2013, the ED rate was 92.6, 34.4, and 59.2 ED visits among Black, Hispanic, and White adults, respectively. The expansion was associated with no change in ED rate in all three groups in each of the five post-expansion years. We found that expansion was associated with no change in the hospitalization share of ED visits and the volume of all ED visits, treat-and-release ED visits, and transfer-to-inpatient ED visits. The expansion was associated with an 11.7% annual increase (95% CI, 2.7%-21.2%) in the Medicaid share of Hispanic adults, but no significant change among Black adults (3.8%; 95% CI, -0.04% to 7.7%)., Conclusion: ACA Medicaid expansion was associated with no changes in the rate of ED visits among Black, Hispanic, and White adults. Expanding Medicaid eligibility may not change ED use, including among Black and Hispanic subgroups., (© 2023 Health Research and Educational Trust.)

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to a global pandemic of coronavirus disease 2019 (COVID-19). Early in the pandemic, efforts were made to test the SARS-CoV-2 antiviral efficacy of repurposed medications that were already approved and available for other indications, including hydroxychloroquine (HCQ) and azithromycin (AZI). To reduce the risk of SARS-CoV-2 exposure for clinical-trial study participants and to conform with lockdowns and social distancing guidelines, biospecimen collection for HCQ and AZI included at-home dried blood spot (DBS) collection rather than standard venipuncture by trained clinicians. In this study, we developed and validated the first sensitive and selective simultaneous LC-MS/MS method to accurately quantitate the concentration of HCQ, HCQ metabolites (Desethylchloroquine [DCQ], Bisdesethylchloroquine [BDCQ], Monodesethylhydroxychloroquine [DHCQ]) and AZI extracted from DBS. The validated method was successfully applied for the quantification of over 2000 DBS specimens to evaluate the pharmacokinetic profile of AZI, HQC, and its metabolites. This new method has a small sample volume requirement (~ 10 µL), results in high sensitivity (1 ng/mL), and would facilitate remotely conducted therapeutic drug monitoring., (© 2023. Springer Nature Limited.)

Using antibiotics without medical guidance (non-prescription antibiotic use) may contribute to antimicrobial resistance. Hispanic individuals are a growing demographic group in the United States (US) with a high prevalence of non-prescription antibiotic use. We investigated the effects of acculturation and subjective norms on Hispanic individuals' intentions to use antibiotics without a prescription from the following sources: (1) markets in the United States (not legal), (2) other countries (abroad), (3) leftovers from previous prescriptions, and (4) friends/relatives. We surveyed self-identified Hispanic outpatients in eight clinics from January 2020 to June 2021 using the previously validated Short Acculturation Scale for Hispanics (SASH). Of the 263 patients surveyed, 47% reported previous non-prescription use, and 54% expressed intention to use non-prescription antibiotics if feeling sick. Individuals with lower acculturation (Spanish-speaking preferences) expressed greater intentions to use antibiotics from abroad and from any source. Individuals with more friends/relatives who obtain antibiotics abroad were over 2.5 times more likely to intend to use non-prescription antibiotics from friends/relatives ( p = 0.034). Other predictors of intention to use non-prescription antibiotics included high costs of doctor visits and perceived language barriers in the clinic. Antibiotic stewardship interventions in Hispanic communities in the United States should consider the sociocultural and healthcare barriers influencing non-prescription use and promote language-concordant healthcare.

Importance: Despite the benefits of goals-of-care (GOC) communication, many hospitalized individuals never communicate their goals or preferences to clinicians., Objective: To assess whether a GOC video intervention delivered by palliative care educators (PCEs) increased the rate of GOC documentation., Design, Setting, and Participants: This pragmatic, stepped-wedge cluster randomized clinical trial included patients aged 65 years or older admitted to 1 of 14 units at 2 urban hospitals in New York and Boston from July 1, 2021, to October 31, 2022., Intervention: The intervention involved PCEs (social workers and nurses trained in GOC communication) facilitating GOC conversations with patients and/or their decision-makers using a library of brief, certified video decision aids available in 29 languages. Patients in the control period received usual care., Main Outcome and Measures: The primary outcome was GOC documentation, which included any documentation of a goals conversation, limitation of life-sustaining treatment, palliative care, hospice, or time-limited trials and was obtained by natural language processing., Results: A total of 10 802 patients (mean [SD] age, 78 [8] years; 51.6% male) were admitted to 1 of 14 hospital units. Goals-of-care documentation during the intervention phase occurred among 3744 of 6023 patients (62.2%) compared with 2396 of 4779 patients (50.1%) in the usual care phase (P < .001). Proportions of documented GOC discussions for Black or African American individuals (865 of 1376 [62.9%] vs 596 of 1125 [53.0%]), Hispanic or Latino individuals (311 of 548 [56.8%] vs 218 of 451 [48.3%]), non-English speakers (586 of 1059 [55.3%] vs 405 of 863 [46.9%]), and people living with Alzheimer disease and related dementias (520 of 681 [76.4%] vs 355 of 570 [62.3%]) were greater during the intervention phase compared with the usual care phase., Conclusions and Relevance: In this stepped-wedge cluster randomized clinical trial of older adults, a GOC video intervention delivered by PCEs resulted in higher rates of GOC documentation compared with usual care, including among Black or African American individuals, Hispanic or Latino individuals, non-English speakers, and people living with Alzheimer disease and related dementias. The findings suggest that this form of patient-centered care delivery may be a beneficial decision support tool., Trial Registration: ClinicalTrials.gov Identifier: NCT04857060.

Background: Using antibiotics without a prescription is potentially unsafe and may increase the risk of antimicrobial resistance. We evaluated the effect of patient, health system, and clinical encounter factors on intention to use antibiotics without a prescription that were (1) purchased in the United States, (2) obtained from friends or relatives, (3) purchased abroad, or (4) from any of these sources., Methods: The survey was performed January 2020-June 2021 in 6 publicly funded primary care clinics and 2 private emergency departments in Texas, United States. Participants included adult patients visiting 1 of the clinical settings. Nonprescription use was defined as use of antibiotics without a prescription; intended use was professed intention for future nonprescription antibiotic use., Results: Of 564 survey respondents (33% Black and 47% Hispanic or Latino), 246 (43.6%) reported prior use of antibiotics without a prescription, and 177 (31.4%) reported intent to use antibiotics without a prescription. If feeling sick, respondents endorsed that they would take antibiotics obtained from friends/relatives (22.3% of 564), purchased in the United States without a prescription (19.1%), or purchased abroad without a prescription (17.9%). Younger age, lack of health insurance, and a perceived high cost of doctor visits were predictors of intended use of nonprescription antibiotics from any of the sources. Other predictors of intended use were lack of transportation for medical appointments, language barrier to medical care, Hispanic or Latino ethnicity, and being interviewed in Spanish., Conclusions: Patients without health insurance who report a financial barrier to care are likely to pursue more dangerous nonprescription antimicrobials. This is a harm of the US fragmented, expensive healthcare system that may drive increasing antimicrobial resistance and patient harm., Competing Interests: Potential conflicts of interest. H. M. reports privately held stocks from Apple Inc. and Doximity. B. W. T. reports grants or contracts from VA Health Services Research & Development, Agency for Healthcare Research and Quality R18, Craig H. Neilson Foundation, Genentech, and Peptilogics, Inc; payment from George Washington ID Board for a Review Course; travel support for meeting attendance from VA Office of Research & Development and the Infectious Diseases Society of America; and an unpaid role on a DSMB for CSP #2004. L. G. reports grants or contracts from Agency for Healthcare Research and Quality (AHRQ) R18, Craig H. Neilsen Foundation, and a research education grant (1R25AA028203-01) from the National Institute on Alcohol Abuse and Alcoholism Award. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.)

Objective(s): Deaf American Sign Language (ASL) users are subject to health care disparities resulting from communication and language barriers. Currently, few resources on advance care planning and end-of-life care exist in ASL. This study explores Deaf ASL users' perceptions and experiences with end-of-life care and advance care planning. Methods: Semi-structured 1:1 interviews with Deaf signers were translated, and transcribed into English by a bilingual researcher. Investigators inductively coded transcripts and identified themes of barriers, facilitators, knowledge, and sources of information regarding end-of-life care. Participants' knowledge of advance care planning and completion of advance care planning documents were evaluated using a brief assessment. Results: Eleven Deaf ASL users participated in the study with two deaf interviewers. Participants reported barriers to end-of-life care including poor provider communication, inaccessible sources, and inadequate provision of accommodations, leading to patient distrust. Participants' understanding of advance care planning was facilitated by accessible forms of communication and their social networks, such as family, friends, and Deaf peers. Participants primarily gained information on end-of-life care from first-hand familial experience, peers, and media. Participants' mean advance care planning knowledge was 4.6 out of 15 (SD  =  2.6). Conclusions: Deaf ASL users face scarce accessible resources around end-of-life care, lowering their ability to understand and proceed with advance care planning. Implementation of ASL accessible advance care planning educational tools in health care settings is needed.

Objective: To adapt and validate an algorithm to ascertain transgender and gender diverse (TGD) patients within electronic health record (EHR) data., Methods: Using a previously unvalidated algorithm of identifying TGD persons within administrative claims data in a multistep, hierarchical process, we validated this algorithm in an EHR data set with self-reported gender identity., Results: Within an EHR data set of 52 746 adults with self-reported gender identity (gold standard) a previously unvalidated algorithm to identify TGD persons via TGD-related diagnosis and procedure codes, and gender-affirming hormone therapy prescription data had a sensitivity of 87.3% (95% confidence interval [CI] 86.4-88.2), specificity of 98.7% (95% CI 98.6-98.8), positive predictive value (PPV) of 88.7% (95% CI 87.9-89.4), and negative predictive value (NPV) of 98.5% (95% CI 98.4-98.6). The area under the curve (AUC) was 0.930 (95% CI 0.925-0.935). Steps to further categorize patients as presumably TGD men versus women based on prescription data performed well: sensitivity of 97.6%, specificity of 92.7%, PPV of 93.2%, and NPV of 97.4%. The AUC was 0.95 (95% CI 0.94-0.96)., Conclusions: In the absence of self-reported gender identity data, an algorithm to identify TGD patients in administrative data using TGD-related diagnosis and procedure codes, and gender-affirming hormone prescriptions performs well., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Non-prescription antibiotic use includes taking an antibiotic without medical guidance (e.g., leftovers, from friends/relatives, or purchased without a prescription). Non-prescription use contributes to antimicrobial resistance, adverse drug reactions, interactions, superinfection, and microbiome imbalance. Qualitative studies exploring perspectives regarding non-prescription use among Hispanic patients are lacking. We used the Kilbourne Framework for Advancing Health Disparities Research to identify factors influencing patients' non-prescription use and organize our findings., Methods: Our study includes Hispanic primary care clinic patients with different types of health insurance coverage in the Houston metroplex who endorsed non-prescription use in a previous survey. Semistructured interviews explored the factors promoting non-prescription use in Hispanic adults. Interviews were conducted remotely, in English or Spanish, between May 2020 and October 2021. Inductive coding and thematic analysis identified motives for non-prescription use., Results: Participants (n = 35) were primarily female (68.6%) and aged 27 to 66. Participants reported obtaining antibiotics through trusted persons, sold under-the-counter in US markets, and purchased without a prescription abroad. Factors contributing to non-prescription use included beliefs that the doctor visit was unnecessary, limited access to healthcare (due to insurance constraints, costs, and clinic wait times), and communication difficulties (e.g., language barriers with clinicians and perceived staff rudeness). Participants expressed confidence in medical recommendations from pharmacists and trusted community members., Conclusions: Patient, healthcare system, and clinical encounter factors contribute to non-prescription use in Hispanic communities. Antibiotic stewardship interventions that involve pharmacists and trusted persons, improve access to care, and address communication barriers and cultural competency in the clinic may help reduce non-prescription use in these communities., Competing Interests: Conflict of interest: None., (© Copyright by the American Board of Family Medicine.)

Background: A high rate of COVID-19 vaccination is critical to reduce morbidity and mortality related to infection and to control the COVID-19 pandemic. Understanding the factors that influence vaccine confidence can inform policies and programs aimed at vaccine promotion. We examined the impact of health literacy on COVID-19 vaccine confidence among a diverse sample of adults living in two major metropolitan areas., Methods: Questionnaire data from adults participating in an observational study conducted in Boston and Chicago from September 2018 through March 2021 were examined using path analyses to determine whether health literacy mediates the relationship between demographic variables and vaccine confidence, as measured by an adapted Vaccine Confidence Index (aVCI)., Results: Participants (N = 273) were on average 49 years old, 63 % female, 4 % non-Hispanic Asian, 25 % Hispanic, 30 % non-Hispanic white, and 40 % non-Hispanic Black. Using non-Hispanic white and other race as the reference category, Black race and Hispanic ethnicity were associated with lower aVCI (-0.76, 95 % CI -1.00 to -0.50; -0.52, 95 % CI -0.80 to -0.27, total effects from a model excluding other covariates). Lower education was also associated with lower aVCI (using college or more as the reference, -0.73 for 12th grade or less, 95 % CI -0.93 to -0.47; -0.73 for some college/associate's/technical degree, 95 % CI -1.05 to -0.39). Health literacy partially mediated these effects for Black and Hispanic participants and those with lower education (indirect effects -0.19 and -0.19 for Black race and Hispanic ethnicity; 0.27 for 12th grade or less; -0.15 for some college/associate's/technical degree)., Conclusions: Lower levels of education, Black race, and Hispanic ethnicity were associated with lower scores on health literacy, which in turn were associated with lower vaccine confidence. Our findings suggest that efforts to improve health literacy may improve vaccine confidence, which in turn may improve vaccination rates and vaccine equity., Clinical Trials Number: NCT03584490., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: JWG declares that he and his lab have received a research grant from Pfizer to create a patient decision aid for children with atopic dermatitis (unrelated to this manuscript and unrelated to vaccines, vaccine confidence, and COVID-19); Pfizer is a maker of one common COVID-19 vaccine (Pfizer-BioNTech). He and his lab also have funding for research from the National Institutes of Health and the National Eczema Association. He has no other interests to declare. MPO is a primary investigator on multiple National Institute of Health funded research projects. Otherwise, the authors whose names are listed immediately certify that they have no other affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Atrial fibrillation (AF) is a chronic cardiovascular disease that frequently causes disruptive symptoms, adverse outcomes, and poor health-related quality of life (HRQoL). We have developed a mobile health application for individuals with AF which provides a longitudinal, patient-centered program to improve self-care. The defining feature of the application is the use of a relational agent, which uses synthetic speech accompanied by animation to provide health education, empathic counseling, and monitoring. In the present manuscript we present the design, rationale, and baseline characteristics of participants enrolled in "A Mobile Relational Agent to Enhance Atrial Fibrillation Self-Care Trial," a randomized trial testing the effectiveness the application for urban-dwelling individuals with AF being treated with oral anticoagulation for prevention of thromboembolic ischemic stroke. This is a single-center, parallel-arm randomized trial that assigned patients to the novel application (relational agent) versus a control intervention (WebMD). This ongoing RCT aims to determine the effect of the mobile health application on: (1) anticoagulation adherence; (2) patient-centered outcomes (quality of life and symptoms); and (3) health care utilization. The primary outcome, anticoagulation adherence, will be measured using the proportion of days covered (PDC). The study completed enrollment on April 1, 2022 (final enrollment n = 243 participants) with expected completion date of April 2023. (http://clinicaltrials.gov registration NCT04075994)., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: Advance care planning (ACP) is underutilized among those with advanced cancer, leading to the potential of not receiving goal-concordant care. Objectives: To understand the experience of patients in creating a video declaration (ViDec) of their ACP preferences and their family member/caregivers' perceptions after viewing their ViDec. Design: Qualitative study among patients and family members/caregivers. Setting/Subjects: Patients were recruited from a large safety net hospital in the United States. Patients with any type of advanced cancer were enrolled to create a ViDec and participate in an individual interview. Patients also identified a family member/caregiver to participate. Measurements: Content and perceptions of usefulness of ViDecs among patients and family members/caregivers. Results: In total, 32 patients participated. Patients had a mean age of 61 (10) years, 15 (47%) were women, 14 (44%) were Black or African American, and 12 (37%) had a high school education or less; 25 family members/caregivers participated. Across all ViDecs, the most common theme pertained to ACP for preferred medical treatments (97%). We describe three case studies of patient and caregiver pairs to represent salient dimensions of our data: (1) high perceived usefulness of ViDec, (2) populations at risk for not receiving goal-concordant care, and (3) varied responses to ViDec among family members/caregivers. Recommendations to improve the ViDec process included providing structured prompts to patients. Conclusions: These case studies highlight the potential high-perceived usefulness of ViDecs across patients and caregivers. ViDecs have the potential to improve care among patients with advanced cancer.

Two randomized controlled trials demonstrated no clinical benefit of hydroxychloroquine (HCQ) for either postexposure prophylaxis or early treatment of SARS-CoV-2 infection. Using data from these studies, we calculated the time-weighted average change from baseline SARS-CoV-2 viral load and demonstrated that HCQ did not affect viral clearance., (© 2022 Wiley Periodicals LLC.)

Background: Atrial fibrillation (AF) is a highly morbid condition which requires long-term adherence to oral anticoagulation and may be associated with adverse quality of life and health care utilization. We developed a relational agent-an interactive smartphone-based intervention accessible regardless of digital or health literacy-to assist individuals residing in rural, Western Pennsylvania, with AF with chronic disease self-management., Methods: The "Mobile health intervention for rural atrial fibrillation" is a single center, parallel-arm randomized clinical trial for adults with AF funded by the National Institute of Health's National Heart, Lung, and Blood Institute to enroll 264 participants. All participants receive a smartphone with data plan: The intervention is a 4 month relational agent coupled with the AliveCor Kardia for heart rate and rhythm monitoring provided by smartphone, and the control a pre-installed, smartphone-based application for health-related information (WebMD). The study uses remote recruitment and engagement to enroll individuals who would otherwise be unlikely to participate in clinical research due to rurality. The primary outcome of the trial is adherence to oral anticoagulation, determined by proportion of days covered, as measured at 12 months. The secondary outcomes are quality of life, both AF-specific and general, and health care utilization. The study entails a baseline visit, a 4 month intervention phase, and 8 and 12 month follow-up visits., Conclusions: This mobile health trial tests the effectiveness of a smartphone-based relational agent to improve clinical and patient-reported outcomes in rural-dwelling individuals., Competing Interests: Conflict of interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022. Published by Elsevier Inc.)

Background: International Classification of Disease, ninth/tenth revision codes are used to identify patients with appendicitis and classify severity of disease for research and hospital reimbursement. We sought to determine accuracy of International Classification of Disease, ninth/tenth revision codes in classifying appendicitis as uncomplicated versus complicated (defined as perforated, necrotic, or abscess) compared with the clinical gold standard: surgeon characterization of the appendix in the operative report., Methods: Retrospective review of operative reports and discharge International Classification of Disease, ninth/tenth revision codes for patients ≥18 years old who underwent noninterval, nonincidental appendectomy between January 2012 and December 2019 at a tertiary referral center. Sensitivity, specificity, and positive predictive value were calculated for International Classification of Disease, ninth/tenth revision codes to classify appendicitis accurately as complicated compared with surgeon description. ICD-9/10 codes and surgeon description were categorized into complicated/uncomplicated based on the American Association for the Surgery of Trauma grading system., Results: In the study, 1,495 patients with acute appendicitis underwent appendectomy. Per surgeon description, 200 (13%) were complicated and 1,295 (87%) uncomplicated. Compared with surgeon description, discharge International Classification of Disease, ninth/tenth revision codes did not accurately identify complicated appendicitis: sensitivity = 0.68, positive predictive value = 0.77. As a sensitivity analysis, the cohort was stratified by public versus private payers, and the results did not change., Conclusion: International Classification of Disease, ninth/tenth revision codes do not accurately identify surgeon-described complicated appendicitis. Nearly one-third of the cases of complicated appendicitis were coded as uncomplicated. Such misclassification negatively impacts reimbursement for complicated appendicitis care and could lead to misleading results in research and quality improvement activities that rely on these codes., (Copyright © 2022 Elsevier Inc. All rights reserved.)

While detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by diagnostic reverse-transcription polymerase chain reaction (RT-PCR) is highly sensitive for viral RNA, the nucleic acid amplification of subgenomic RNAs (sgRNAs) that are the product of viral replication may more accurately identify replication. We characterized the diagnostic RNA and sgRNA detection by RT-PCR from nasal swab samples collected daily by participants in postexposure prophylaxis or treatment studies for SARS-CoV-2. Among 1932 RT-PCR-positive swab samples with sgRNA tests, 40% (767) had detectable sgRNA. Above a diagnostic RNA viral load (VL) threshold of 5.1 log10 copies/mL, 96% of samples had detectable sgRNA with VLs that followed a linear trend. The trajectories of diagnostic RNA and sgRNA VLs differed, with 80% peaking on the same day but duration of sgRNA detection being shorter (8 vs 14 days). With a large sample of daily swab samples we provide comparative sgRNA kinetics and a diagnostic RNA threshold that correlates with replicating virus independent of symptoms or duration of illness., Competing Interests: Potential conflicts of interest. M. E. D. is funded by the Infectious Diseases Clinical Research Consortium through the National Institute for Allergy and Infectious Diseases, National Institutes of Health (NIH; award UM1AI148684), outside the submitted work. M. L. W. H. and M. H. W. report funding from the BMGF, outside the submitted work. A. B. reports personal fees from Gates Ventures and grant funding from the NIH, the BMGF, and the New York City Department of Health and Mental Hygiene, outside the submitted work. H. Y. C. reports consulting with Ellume, Pfizer, the BMGF, GlaxoSmithKline, and Merck; she has also received research funding from Gates Ventures and Sanofi Pasteur and support and reagents from Ellume and Cepheid, outside the submitted work. H. C. S. K. is funded by the Research Supplement to Promote Diversity in Health-Related Research Program, the National Cancer Institute, NIH (grant R01 CA213130-S) and a Department of Medicine Diversity Academic Development Scholar Award from the University of Washington. C. M. J. reports consulting with AbbVie and Gilead, outside the submitted work. R. B. reports funding from BMGF and the NIH, outside the submitted work, and support for abstract and manuscript writing from Regeneron Pharmaceuticals, also outside the submitted work. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Coronavirus disease 2019 symptom definitions rarely include symptom severity. We collected daily nasal swab samples and symptom diaries from contacts of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) case patients. Requiring ≥1 moderate or severe symptom reduced sensitivity to predict SARS-CoV-2 shedding from 60.0% (95% confidence interval [CI], 52.9%-66.7%) to 31.5% (95% CI, 25.7%- 38.0%) but increased specificity from 77.5% (95% CI, 75.3%-79.5%) to 93.8% (95% CI, 92.7%-94.8%)., (© The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America.)

Background: The impact of ambulance diversion on potentially diverted patients, particularly racial/ethnic minority patients, is largely unknown. Treating Massachusetts' 2009 ambulance diversion ban as a natural experiment, we examined if the ban was associated with increased concordance in Emergency Medical Services (EMS) patients of different race/ethnicity being transported to the same emergency department (ED)., Methods: We obtained Medicare Fee for Service claims records (2007-2012) for enrollees aged 66 and older. We stratified the country into patient zip codes and identified zip codes with sizable (non-Hispanic) White, (non-Hispanic) Black and Hispanic enrollees. For a stratified random sample of enrollees from all diverse zip codes in Massachusetts and 18 selected comparison states, we identified EMS transports to an ED. In each zip code, we identified the most frequent ED destination of White EMS-transported patients ("reference ED"). Our main outcome was a dichotomous indicator of patient EMS transport to the reference ED, and secondary outcome was transport to an ED serving lower-income patients ("safety-net ED"). Using a difference-in-differences regression specification, we contrasted the pre- to post-ban changes in each outcome in Massachusetts with the corresponding change in the comparison states., Results: Our study cohort of 744,791 enrollees from 3331 zip codes experienced 361,006 EMS transports. At baseline, the proportion transported to the reference ED was higher among White patients in Massachusetts and comparison states (67.2 and 60.9%) than among Black (43.6 and 46.2%) and Hispanic (62.5 and 52.7%) patients. Massachusetts ambulance diversion ban was associated with a decreased proportion transported to the reference ED among White (- 2.7 percentage point; 95% CI, - 4.5 to - 1.0) and Black (- 4.1 percentage point; 95% CI, - 6.2 to - 1.9) patients and no change among Hispanic patients. The ban was associated with an increase in likelihood of transport to a safety-net ED among Hispanic patients (3.0 percentage points, 95% CI, 0.3 to 5.7) and a decreased likelihood among White patients (1.2 percentage points, 95% CI, - 2.3 to - 0.2)., Conclusion: Massachusetts ambulance diversion ban was associated with a reduction in the proportion of White and Black EMS patients being transported to the most frequent ED destination for White patients, highlighting the role of non-proximity factors in EMS transport destination., (© 2022. The Author(s).)

Background: Medicaid expansion has led to earlier stage diagnoses in several cancers but has not been studied in hepatocellular carcinoma (HCC), a disease with complex risk factors. We examined the effect of Medicaid expansion on the diagnosis of HCC and associations with county-level social vulnerability., Methods: Patients with HCC <65 years of age were identified from the SEER database (2010-2016). County-level social vulnerability factors were obtained from the CDC SVI and BRFSS. A Difference-in-Difference analysis evaluated change in early-stage diagnoses (stage I-II) between expansion and non-expansion states. A Difference-in-Difference-in-Difference analysis evaluated expansion impact among counties with higher proportions of social vulnerability., Results: Of 19,751 patients identified, 81.5% were in expansion states. Uninsured status decreased in expansion states (6.3%-2.4%, p < 0.0001) and remained unchanged in non-expansion states (12.7%-14.8%, p = 0.43). There was no significant difference in the incidence of early-stage diagnoses between expansion states and non-expansion states. Results were consistent when accounting for social vulnerability., Conclusion: Medicaid expansion was not associated with earlier stage diagnoses in patients with HCC, including those with higher social vulnerability. Unlike other cancers, expanded access did not translate into higher utilization of care in HCC, suggesting barriers on a multitude of levels., (Copyright © 2021. Published by Elsevier Ltd.)