Search

Abstract 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.

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 (P0.05) or higher (P

Abstract 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.

Abstract 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.

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.

Abstract Background The Hospital Readmissions Reduction Program (HRRP), established by the Centers for Medicare and Medicaid Services (CMS) in March 2010, introduced payment-reduction penalties on acute care hospitals with higher-than-expected readmission rates for acute myocardial infarction (AMI), heart failure, and pneumonia. There is concern that hospitals serving large numbers of low-income and uninsured patients (safety-net hospitals) are at greater risk of higher readmissions and penalties, often due to factors that are likely outside the hospital’s control. Using publicly reported data, we compared the readmissions performance and penalty experience among safety-net and non-safety-net hospitals. Methods We used nationwide hospital level data for 2009-2016 from the Centers for Medicare and Medicaid Services (CMS) Hospital Compare program, CMS Final Impact Rule, and the American Hospital Association Annual Survey. We identified as safety-net hospitals the top quartile of hospitals in terms of the proportion of patients receiving income-based public benefits. Using a quasi-experimental difference-in-differences approach based on the comparison of pre- vs. post-HRRP changes in (risk-adjusted) 30-day readmission rate in safety-net and non-safety-net hospitals, we estimated the change in readmissions rate associated with HRRP. We also compared the penalty frequency among safety-net and non-safety-net hospitals. Results Our study cohort included 1915 hospitals, of which 479 were safety-net hospitals. At baseline (2009), safety-net hospitals had a slightly higher readmission rate compared to non-safety net hospitals for all three conditions: AMI, 20.3% vs. 19.8% (p value

Mayfield et al. describe the implementation and feasibility of an exclusively remote randomized clinical trial of hydroxychloroquine and azithromycin for the treatment of COVID-19. The trial included monitoring of cardiovascular safety which was successfully done using digital technologies.

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.

Abstract Background Medicare’s Hospital Readmissions Reduction Program (HRRP), implemented beginning in 2013, seeks to incentivize Inpatient Prospective Payment System (IPPS) hospitals to reduce 30-day readmissions for selected inpatient cohorts including acute myocardial infarction, heart failure, and pneumonia. Performance-based penalties, which take the form of a percentage reduction in Medicare reimbursement for all inpatient care services, have a risk of unintended financial burden on hospitals that care for a larger proportion of Medicare patients. To examine the role of this unintended risk on 30-day readmissions, we estimated the association between the extent of their Medicare share of total hospital bed days and changes in 30-day readmissions. Methods We used publicly available nationwide hospital level data for 2009–2016 from the Centers for Medicare and Medicaid Services (CMS) Hospital Compare program, CMS Final Impact Rule, and the American Hospital Association Annual Survey. Using a quasi-experimental difference-in-differences approach, we compared pre- vs. post-HRRP changes in 30-day readmission rate in hospitals with high and moderate Medicare share of total hospital bed days (“Medicare bed share”) vs. low Medicare bed share hospitals. Results We grouped the 1904 study hospitals into tertiles (low, moderate and high) by Medicare bed share; the average bed share in the three tertile groups was 31.2, 47.8 and 59.9%, respectively. Compared to low Medicare bed share hospitals, high bed share hospitals were more likely to be non-profit, have smaller bed size and less likely to be a teaching hospital. High bed share hospitals were more likely to be in rural and non-large-urban areas, have fewer lower income patients and have a less complex patient case-mix profile. At baseline, the average readmissions rate in the low Medicare bed share (control) hospitals was 20.0% (AMI), 24.7% (HF) and 18.4% (pneumonia). The observed pre- to post-program change in the control hospitals was − 1.35% (AMI), − 1.02% (HF) and − 0.35% (pneumonia). Difference in differences model estimates indicated no differential change in readmissions among moderate and high Medicare bed share hospitals. Conclusions HRRP penalties were not associated with any change in readmissions rate. The CMS should consider alternative options – including working collaboratively with hospitals – to reduce readmissions.

Introduction Despite the known benefit to patients and families, discussions about goals, values and preferences for medical care in advancing serious illness often do not occur. Many system and clinician factors, such as patient and clinician reticence and shortage of specialty palliative care teams, contribute to this lack of communication. To address this gap, we designed an intervention to promote goals-of-care conversations and palliative care referrals in the hospital setting by using trained palliative care educators and video decision aids. This paper presents the rationale, design and methods for a trial aimed at addressing barriers to goals-of-care conversations for hospitalised adults aged 65 and older and those with Alzheimer’s disease and related Dementias, regardless of age.Methods and analysis The Video Image about Decisions to Improve Ethical Outcomes with Palliative Care Educators is a pragmatic stepped wedge, cluster randomised controlled trial, which aims to improve and extend goals-of-care conversations in the hospital setting with palliative care educators trained in serious illness communication and video decision aids. The primary outcome is the proportion of patients with goals-of-care documentation in the electronic health record. We estimate that over 9000 patients will be included.Ethics and dissemination The Institutional Review Board (IRB) at Boston Medical Center will serve as the single IRB of record for all regulatory and ethical aspects of this trial. BMC Protocol Number: H-41482. Findings will be presented at national meetings and in publications. This trial is registered at ClinicalTrials.gov.Trial registration number NCT04857060; ClinicalTrials.gov

Introduction Older patients with advanced chronic kidney disease (CKD) often are inadequately prepared to make informed decisions about treatments including dialysis and cardiopulmonary resuscitation. Further, evidence shows that patients with advanced CKD do not commonly engage in advance care planning (ACP), may suffer from poor quality of life, and may be exposed to end-of-life care that is not concordant with their goals. We aim to study the effectiveness of a video intervention on ACP, treatment preferences and other patient-reported outcomes.Methods and analysis The Video Images about Decisions for Ethical Outcomes in Kidney Disease trial is a multi-centre randomised controlled trial that will test the effectiveness of an intervention that includes a CKD-related video decision aid followed by recording personal video declarations about goals of care and treatment preferences in older adults with advancing CKD. We aim to enrol 600 patients over 5 years at 10 sites.Ethics and dissemination Regulatory and ethical aspects of this trial include a single Institutional Review Board mechanism for approval, data use agreements among sites, and a Data Safety and Monitoring Board. We intend to disseminate findings at national meetings and publish our results.Trial registration number NCT04347629.

Abstract Background The Hospital Value Based Purchasing Program (HVBP) in the United States, announced in 2010 and implemented since 2013 by the Centers for Medicare and Medicaid Services (CMS), introduced payment penalties and bonuses based on hospital performance on patient 30-day mortality and other indicators. Evidence on the impact of this program is limited and reliant on the choice of program-exempt hospitals as controls. As program-exempt hospitals may have systematic differences with program-participating hospitals, in this study we used an alternative approach wherein program-participating hospitals are stratified by their financial exposure to penalty, and examined changes in hospital performance on 30-day mortality between hospitals with high vs. low financial exposure to penalty. Methods Our study examined all hospitals reimbursed through the Medicare Inpatient Prospective Payment System (IPPS) – which include most community and tertiary acute care hospitals – from 2009 to 2016. A hospital’s financial exposure to HVBP penalties was measured by the share of its annual aggregate inpatient days provided to Medicare patients (“Medicare bed share”). The main outcome measures were annual hospital-level 30-day risk-adjusted mortality rates for acute myocardial infarction (AMI), heart failure (HF) and pneumonia patients. Using difference-in-differences models we estimated the change in the outcomes in high vs. low Medicare bed share hospitals following HVBP. Results In the study cohort of 1902 US hospitals, average Medicare bed share was 61 and 41% in high (n = 540) and low (n = 1362) Medicare bed share hospitals, respectively. High Medicare bed share hospitals were more likely to have smaller bed size and less likely to be teaching hospitals, but ownership type was similar among both Medicare bed share groups.. Among low Medicare bed share (control) hospitals, baseline (pre-HVBP) 30-day mortality was 16.0% (AMI), 10.9% (HF) and 11.4% (pneumonia). In both high and low Medicare bed share hospitals 30-day mortality experienced a secular decrease for AMI, increase for HF and pneumonia; differences in the pre-post change between the two hospital groups were small (

Background. When stakeholders offer divergent input, it can be unclear how to prioritize information for decision aids (DAs) on mammography screening. Objectives. This analysis triangulates perspectives (breast cancer screening experts, primary care providers [PCPs], and patients with limited health literacy [LHL]) to understand areas of divergent and convergent input across stakeholder groups in developing a breast cancer screening DA for younger women with LHL. Design. A modified online Delphi panel of 8 experts rated 57 statements for inclusion in a breast cancer screening DA over three rounds. Individual interviews with 25 patients with LHL and 20 PCPs from a large safety net hospital explored informational needs about mammography decision making. Codes from the qualitative interviews and open-ended responses from the Delphi process were mapped across stakeholders to ascertain areas where stakeholder preferences converged or diverged. Results. Four themes regarding informational needs were identified regarding 1) the benefits and harms of screening, 2) different screening modalities, 3) the experience of mammography, and 4) communication about breast cancer risk. Patients viewed pain as the primary harm, while PCPs and experts emphasized the harm of false positives. Patients, but not PCPs or experts, felt that information about the process of getting a mammogram was important. PCPs believed that mammography was the only evidence-based screening modality, while patients believed breast self-exam was also important for screening. All stakeholders described incorporating personal risk information as important. Limitations. As participants came from one hospital, perceptions may reflect local practices. The Delphi sample size was small. Conclusions. Patients, experts, and PCPs had divergent views on the most important information needed for screening decisions. More evidence is needed to guide integration of multiple stakeholder perspectives into the content of DAs. Article Highlights This study combines data from patients with limited health literacy, primary care providers (PCPs), and experts to examine priorities for information inclusion in a breast cancer screening decision aid. All stakeholders described including personal risk information as important. While experts and PCPs prioritized providing evidence-based screening options only, emphasized false positives as the primary mammography harm, and downplayed the relevance of delivering mammography process information, patients had a broader scope of harms (e.g., pain), wanted more information on breast self- exam, and viewed process information as fundamental to their decision making. This study demonstrates that there are differences in what doctors and experts prioritize communicating about breast cancer screening and what patients want to learn about.

Background: Users of American Sign Language (ASL) who are deaf often face barriers receiving health information, contributing to significant gaps in health knowledge and health literacy. To reduce the spread of coronavirus disease 2019 (COVID-19) and its risk to the public, the government and health care providers have encouraged social distancing, use of face masks, hand hygiene, and quarantines. Unfortunately, COVID-19 information has rarely been available in ASL, which puts the deaf community at a disadvantage for accessing reliable COVID-19 information. Objective: This study's primary objective was to compare COVID-19–related information access between participants who are deaf and participants who are hearing. Methods: The study included 104 adults who are deaf and 74 adults who are hearing who had participated in a prior health literacy study. Surveys were conducted between April and July 2020 via video conference, smartphone apps, or phone calls. COVID-19 data were linked with preexisting data on demographic and health literacy data as measured by the Newest Vital Sign (NVS) and the ASL-NVS. Key Results: Neither group of participants differed in their ability to identify COVID-19 symptoms. Adults who are deaf were 4.7 times more likely to report difficulty accessing COVID-19 information (p = .011), yet reported using more preventive strategies overall. Simultaneously, adults who are deaf had 60% lower odds of staying home and calling their doctor versus seeking health care immediately or doing something else compared with participants who are hearing if they suspected that they had COVID-19 (p = .020). Conclusions: Additional education on recommended COVID-19 management and guidance on accessible health care navigation strategies are needed for the deaf community and health care providers. Public health officials should ensure that public service announcements are accessible to all audiences and should connect with trusted agents within the deaf community to help disseminate health information online in ASL through their social media channels. [HLRP: Health Literacy Research and Practice. 2021;5(2):e162–e170.] Plain Language Summary: Compared to participants who are hearing, a higher portion of participants who are deaf reported challenges with accessing, understanding, and trusting COVID-19 information. Although respondents who are deaf had similar knowledge of symptoms compared to participants who are hearing, they used more prevention strategies and were more likely to plan immediate care for suspected symptoms. Improved guidance on COVID-19 management and health care navigation accessible to the deaf community is needed.

Background: Treatment options for outpatients with COVID-19 could reduce morbidity and prevent SARS-CoV-2 transmission. Methods: In this randomized, double-blind, three-arm (1:1:1) placebo-equivalent controlled trial conducted remotely throughout the United States, adult outpatients with laboratory-confirmed SARS-CoV-2 infection were recruited. Participants were randomly assigned to receive hydroxychloroquine (HCQ) (400 mg BID x1day, followed by 200 mg BID x9days) with or without azithromycin (AZ) (500 mg, then 250 mg daily x4days) or placebo-equivalent (ascorbic acid (HCQ) and folic acid (AZ)), stratified by risk for progression to severe COVID-19 (high-risk vs. low-risk). Self-collected nasal swabs for SARS-CoV-2 PCR, FLUPro symptom surveys, EKGs and vital signs were collected daily. Primary endpoints were: (a) 14-day progression to lower respiratory tract infection (LRTI), 28-day COVID-19 related hospitalization, or death; (b) 14-day time to viral clearance; secondary endpoints included time to symptom resolution (ClinicalTrials.gov: NCT04354428). Due to the low rate of clinical outcomes, the study was terminated for operational futility. Findings: Between 15th April and 27th July 2020, 231 participants were enrolled and 219 initiated medication a median of 5.9 days after symptom onset. Among 129 high-risk participants, incident LRTI occurred in six (4.7%) participants (two control, four HCQ/AZ) and COVID-19 related hospitalization in seven (5.4%) (four control, one HCQ, two HCQ/AZ); no LRTI and two (2%) hospitalizations occurred in the 102 low-risk participants (one HCQ, one HCQ/AZ). There were no deaths. Among 152 participants with viral shedding at enrollment, median time to clearance was 5 days (95% CI=4–6) in HCQ, 6 days (95% CI=4–8) in HCQ/AZ, and 8 days (95% CI=6–10) in control. Viral clearance was faster in HCQ (HR=1.62, 95% CI=1.01–2.60, p = 0.047) but not HCQ/AZ (HR=1.25, p = 0.39) compared to control. Among 197 participants who met the COVID-19 definition at enrollment, time to symptom resolution did not differ by group (HCQ: HR=1.02, 95% CI-0.63–1.64, p = 0.95, HCQ/AZ: HR=0.91, 95% CI=0.57–1.45, p = 0.70). Interpretation: Neither HCQ nor HCQ/AZ shortened the clinical course of outpatients with COVID-19, and HCQ, but not HCQ/AZ, had only a modest effect on SARS-CoV-2 viral shedding. HCQ and HCQ/AZ are not effective therapies for outpatient treatment of SARV-CoV-2 infection. Funding: The COVID-19 Early Treatment Study was funded by the Bill & Melinda Gates Foundation (INV-017062) through the COVID-19 Therapeutics Accelerator. University of Washington Institute of Translational Health Science (ITHS) grant support (UL1 TR002319), KL2 TR002317, and TL1 TR002318 from NCATS/NIH funded REDCap. The content is solely the responsibility of the authors and does not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. PAN and MJA were supported by the Mayo Clinic Windland Smith Rice Comprehensive Sudden Cardiac Death Program.Trial registration ClinicalTrials.gov number NCT04354428

Introduction Predialysis education for patients with advanced chronic kidney disease (CKD) typically focuses narrowly on haemodialysis and peritoneal dialysis as future treatment options. However, patients who are older or seriously ill may not want to pursue dialysis and/or may not benefit from this treatment. Conservative kidney management, a reasonable alternative treatment, and advance care planning (ACP) are often left out of patient education and shared decision-making. In this study, we will pilot an educational intervention (Conservative Kidney Management Options and Advance Care Planning Education—COPE) to improve knowledge of conservative kidney management and ACP among patients with advanced CKD who are older and/or have poor functional status.Methods and analysis This is a single-centre pilot randomised controlled trial at an academic centre in Philadelphia, PA. Eligible patients will have: age ≥70 years and/or poor functional status (as defined by Karnofsky Performance Index Score

Introduction Advance care planning (ACP) is associated with improved health outcomes for patients with cancer, and its absence is associated with unfavourable outcomes for patients and their caregivers. However, older adults do not complete ACP at expected rates due to patient and clinician barriers. We present the original design, methods and rationale for a trial aimed at improving ACP for older patients with advanced cancer and the modified protocol in response to changes brought by the COVID-19 pandemic.Methods and analysis The Advance Care Planning: Promoting Effective and Aligned Communication in the Elderly study is a pragmatic, stepped-wedge cluster randomised trial examining a Comprehensive ACP Program. The programme combines two complementary evidence-based interventions: clinician communication skills training (VitalTalk) and patient video decision aids (ACP Decisions). We will implement the programme at 36 oncology clinics across three unique US health systems. Our primary outcome is the proportion of eligible patients with ACP documentation completed in the electronic health record. Our secondary outcomes include resuscitation preferences, palliative care consultations, death, hospice use and final cancer-directed therapy. From a subset of our patient population, we will collect surveys and video-based declarations of goals and preferences. We estimate 11 000 patients from the three sites will be enrolled in the study.Ethics and dissemination Regulatory and ethical aspects of this trial include Institutional Review Board (IRB) approval via single IRB of record mechanism at Dana-Farber Cancer Institute, Data Use Agreements among partners and a Data Safety and Monitoring Board. We plan to present findings at national meetings and publish the results.Trial registration number NCT03609177; Pre-results.

Abstract Background Acute myocardial infarction (AMI) is a common high-risk disease with inpatient mortality of 5% nationally. But little is known about this outcome among Asian Americans (Asians), a fast growing racial/ethnic minority in the country. The objectives of the study are to obtain near-national estimates of differences in AMI inpatient mortality between minorities (including Asians) and non-Hispanic Whites and identify comorbidities and sociodemographic characteristics associated with these differences. Method This is a retrospective analysis of 2010–2011 state inpatient discharge data from 10 states with the largest share of Asian population. We identified hospitalization with a primary diagnosis of AMI using the ICD-9 code and used self-reported race/ethnicity to identify White, Black, Hispanic, and Asian. We performed descriptive analysis of sociodemographic characteristics, medical comorbidities, type of AMI, and receipt of cardiac procedures. Next, we examined overall inpatient AMI mortality rate based on patients’ race/ethnicity. We also examined the types of AMI and a receipt of invasive cardiac procedures by race/ethnicity. Lastly, we used sequential multivariate logistic regression models to study inpatient mortality for each minority group compared to Whites, adjusting for covariates. Results Over 70% of the national Asian population resides in the 10 states. There were 496,472 hospitalizations with a primary diagnosis of AMI; 75% of all cases were Whites, 10% were Blacks, 12% were Hispanics, and 3% were Asians. Asians had a higher prevalence of cardiac comorbidities, including hypertension, diabetes, and kidney failure compared to Whites (p-value

This supplement of HLRP: Health Literacy Research and Practice seeks to affirm the relevance of adult basic education (ABE) to advancements in the health literacy field. The worlds of health literacy and ABE have much in common, as both are preoccupied with promoting self-efficacy. Yet, they have largely remained unconnected in their research, policy, and practice. This supplement aims to highlight ways in which the health literacy and ABE fields have intersected and influenced each other to the benefit of adult populations with inadequate literacy skills, including those with limited print literacy and numeracy skills, and those with limited English proficiency.

Little research has been done about patient educational materials (PEMs) written in Arabic. Readability of Arabic PEMs has not previously been assessed because, until recently, there was no validated Arabic readability assessment tool. A total of 207 PEMs in both Arabic and English were collected from the Medline Plus portal. Readability was assessed using Flesch-Kincaid in English and the Open Source Metric for Measuring Arabic Narratives, a new Arabic readability test. We also examined Arabic documents for other linguistic features that could lead to confusion. Mean readability grades were 6.1 and 7.1 for Arabic and English, respectively (p < .01). In 31.6% of PEMs, the English text was higher by two or more grades than the Arabic text, and the Arabic text was higher by two or more grades than the English text in 3.8% of PEMs. No diacritical marks in Arabic were used. An array of esoteric Arabic medical terms, transliterated English terms, Arabicized English terms, and written versions of spoken Arabic dialects were used.

The U.S. Food and Drug Administration (FDA) recently issued an order (U.S. Department of Health and Human Services, 2018a) that limits the sale of Bayer's (Whippany, NJ) Essure system for permanent birth control to those health facilities that provide structured information to patients on the benefits and risks of the hysteroscopically implanted metal coils, as higher rates of unintended pregnancy have been identified in real-world conditions compared to initial trial outcomes (Hurskainen et al., 2010). In early 2016, a black box warning (U.S. Department of Health and Human Services, 2016) was issued for the device and Bayer was ordered to conduct a postmarket surveillance study to gather additional data about the benefits and risks of Essure. This most recent order takes the black box warning a step further: issuing a document entitled “Patient-Doctor Discussion Checklist. Acceptance of Risk and Informed Decision Acknowledgement” (Bayer Healthcare, 2018). Physicians are required to provide and review this document with patients considering Essure and obtain a patient signature indicating consent. The checklist is accompanied by a 16-page patient brochure, one-half of which is devoted to safety information for the product.