Caring for Patients with Diabetes at Safety Net Hospitals and Health Systems: What the Patients Say about Their Care

In 2002, with support from The Commonwealth Fund, the National Public Health and Hospital Institute (NPHHI) created a consortium of safety net hospital systems to work together to address common concerns regarding the care of patients with diabetes. As part of that project, NPHHI conducted a survey of patients with diabetes who received at least some of their care from four Consortium hospital systems: Cambridge Health Alliance; Community Health Network of San Francisco/San Francisco General Hospital; Cook County Bureau of Health Services; and LSU/Medical Center of Louisiana at New Orleans. Patients were surveyed on multiple domains of care, including overall satisfaction, access to important diabetes-related services, self-management, health status, and communication with their health care providers. This effort, known as the Consortium for Quality Improvement in Safety Net Hospitals and Health Systems, was the first initiative of its kind to bring a group of safety net hospital systems together to examine quality of care provided for diabetes patients. The work of the Consortium underscores the critical role that safety net hospital systems play in delivering high quality diabetes care to a patient population that is primarily low income, ethnically and racially diverse, and that has high rates of literacy problems. The study signals the need for comprehensive programs to support the care of vulnerable patients with chronic conditions and highlights areas for improved communication between providers and patients. Project outcomes can be summarized around several major findings: Although Consortium members care for large numbers of patients with diabetes who are?racially and ethnically diverse, low income or uninsured, and often with limited English?or literacy proficiency, the study found few significant differences among racial groups?regarding assessment of health status and access to care. Despite programs at safety net hospitals to increase access to care for patients, uninsured patients continue to report poorer control of their diabetes and disparities in access to care. Compared with patients with any insurance coverage, fewer uninsured patients reported having a primary care provider and more reported skipping medications due to cost Up to one-third of the patients at Consortium hospital systems reported having languages other than English as their primary language, and one-quarter reported having health literacy problems. Patients commonly reported problems understanding basic instructions involved in diabetes management. Safety net hospital systems are continually challenged to provide culturally and linguistically appropriate services for their diverse populations. Appropriate provider-patient communication becomes a particularly salient issue for patients with chronic illnesses like diabetes that require self-management and understanding of providers\u27 instructions. More research is necessary to understand the cultural and linguistic needs of various patient populations and to design targeted programs that address these needs in the context of comprehensive care management. The NPHHI study revealed the importance of providing comprehensive care that draws on relevant health professionals in the management of chronic illness. Diabetes teams should be expanded to include health care professionals and social workers able to address the variety of factors that affect diabetes care for low-income and minority patients. Much more work is necessary to develop comprehensive, tailored diabetes management programs that take into account literacy, language, and co-morbidities. The study identified several key areas for improvement in care for patients with diabetes in safety net hospitals, specifically around patient-provider communication. In general, survey respondents reported few problems with the care they received and their communication with providers, but not consistently across race and ethnicity. A sizable group of patients (one-quarter or more) reported having difficulty understanding their providers\u27 use of medical terminology, identified a need for improved communication, or noted the providers\u27 failure to take into account the patient\u27s religion or culture. Although patients generally identified few problems with the care they received, a remarkably high proportion of survey respondents indicated they were in fair or poor health and/or had pain that interfered with their ability to exercise. In part, this is a reflection of the experiences of patient populations in safety net hospital systems, who tend to suffer from co-morbidities such as heart disease and depression

Finishing the euchromatic sequence of the human genome

The sequence of the human genome encodes the genetic instructions for human physiology, as well as rich information about human evolution. In 2001, the International Human Genome Sequencing Consortium reported a draft sequence of the euchromatic portion of the human genome. Since then, the international collaboration has worked to convert this draft into a genome sequence with high accuracy and nearly complete coverage. Here, we report the result of this finishing process. The current genome sequence (Build 35) contains 2.85 billion nucleotides interrupted by only 341 gaps. It covers ∼99% of the euchromatic genome and is accurate to an error rate of ∼1 event per 100,000 bases. Many of the remaining euchromatic gaps are associated with segmental duplications and will require focused work with new methods. The near-complete sequence, the first for a vertebrate, greatly improves the precision of biological analyses of the human genome including studies of gene number, birth and death. Notably, the human enome seems to encode only 20,000-25,000 protein-coding genes. The genome sequence reported here should serve as a firm foundation for biomedical research in the decades ahead

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK.

BACKGROUND: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. METHODS: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. FINDINGS: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0-75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4-97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8-80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3-4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. INTERPRETATION: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

Background A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials

Preferences for self-management support: Findings from a survey of diabetes patients in safety-net health systems

OBJECTIVES: We sought to identify interest in different modes of self-management support among diabetes patients cared for in public hospitals, and to assess whether demographic or disease-specific factors were associated with patient preferences. We explored the possible role of a perceived communication need in influencing interest in self-management support. METHODS: Telephone survey of a random sample of 796 English and Spanish-speaking diabetes patients (esponse rate 47%) recruited from 4 urban US public hospital systems. In multivariate models, we measured the association of race/ ethnicity, primary language, self-reported health literacy, self-efficacy, and diabetes-related factors on patients’ interest in three self-management support strategies (telephone support, group medical visits, and internet -based support). We explored the extent to which patients believed that better communication with providers would improve their diabetes control, and whether this perception altered the relationship between patient factors and self-management support acceptance. RESULTS: Sixty-nine percent of respondents reported interest in telephone support, 55% in group medical visits, and 42% in internet. Compared to Non-Hispanic Whites, Spanish-speaking Hispanics were more interested in telephone support (OR 3.45, 95%CI 1.97–6.05) and group medical visits (OR 2.45, 95%CI 1.49–4.02), but less interested in internet self-management support (OR 0.56, 95%CI 0.33–0.93). African-Americans were more interested than Whites in all 3 self-management support strategies. Patients with limited self-reported health literacy were more likely to be interested in telephone support than those not reporting literacy deficits. Forty percent reported that their diabetes would be better controlled if they communicated better with their health care provider. This perceived communication benefit was independently associated with interest in self-management support (p<0.001), but its inclusion in models did not alter the strengths of the main associations between patient characteristics and self-management support preferences. CONCLUSION: Many diabetes patients in safety-net settings report an interest in receiving self-management support, but preferences for modes of delivery of self-management support vary by race/ethnicity, language proficiency, and self-reported health literacy. PRACTICE IMPLICATIONS: Public health systems should consider offering a range of self-management support services to meet the needs of their diverse patient populations. More broad dissemination and implementation of self-management support may help address the unmet need for better provider communication among diabetes patients in these settings

Glycemic and lipid control among patients with diabetes at six U.S. public hospitals

Public hospital systems share a mission to provide access to healthcare regardless of ability to pay. While public hospital systems care for large numbers of socioeconomically vulnerable and ethnically diverse populations who have diabetes, little is known about the quality of diabetes care provided in these sites

Spectroscopic identification of the haem ligands of cellobiose oxidase

AbstractA spectroscopic study of the flavocytochrome b enzyme, cellobiose oxidase, employing optical, NMR, EPR and near infra-red MCD techniques, has identified the axial ligands of the b-type haem. These are a histidine and a methionine, and this ligation set is discussed in relation to the functional role of the haem group

Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial.

BACKGROUND: The pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) might be curtailed by vaccination. We assessed the safety, reactogenicity, and immunogenicity of a viral vectored coronavirus vaccine that expresses the spike protein of SARS-CoV-2. METHODS: We did a phase 1/2, single-blind, randomised controlled trial in five trial sites in the UK of a chimpanzee adenovirus-vectored vaccine (ChAdOx1 nCoV-19) expressing the SARS-CoV-2 spike protein compared with a meningococcal conjugate vaccine (MenACWY) as control. Healthy adults aged 18-55 years with no history of laboratory confirmed SARS-CoV-2 infection or of COVID-19-like symptoms were randomly assigned (1:1) to receive ChAdOx1 nCoV-19 at a dose of 5 × 1010 viral particles or MenACWY as a single intramuscular injection. A protocol amendment in two of the five sites allowed prophylactic paracetamol to be administered before vaccination. Ten participants assigned to a non-randomised, unblinded ChAdOx1 nCoV-19 prime-boost group received a two-dose schedule, with the booster vaccine administered 28 days after the first dose. Humoral responses at baseline and following vaccination were assessed using a standardised total IgG ELISA against trimeric SARS-CoV-2 spike protein, a muliplexed immunoassay, three live SARS-CoV-2 neutralisation assays (a 50% plaque reduction neutralisation assay [PRNT50]; a microneutralisation assay [MNA50, MNA80, and MNA90]; and Marburg VN), and a pseudovirus neutralisation assay. Cellular responses were assessed using an ex-vivo interferon-γ enzyme-linked immunospot assay. The co-primary outcomes are to assess efficacy, as measured by cases of symptomatic virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events. Analyses were done by group allocation in participants who received the vaccine. Safety was assessed over 28 days after vaccination. Here, we report the preliminary findings on safety, reactogenicity, and cellular and humoral immune responses. The study is ongoing, and was registered at ISRCTN, 15281137, and ClinicalTrials.gov, NCT04324606. FINDINGS: Between April 23 and May 21, 2020, 1077 participants were enrolled and assigned to receive either ChAdOx1 nCoV-19 (n=543) or MenACWY (n=534), ten of whom were enrolled in the non-randomised ChAdOx1 nCoV-19 prime-boost group. Local and systemic reactions were more common in the ChAdOx1 nCoV-19 group and many were reduced by use of prophylactic paracetamol, including pain, feeling feverish, chills, muscle ache, headache, and malaise (all p<0·05). There were no serious adverse events related to ChAdOx1 nCoV-19. In the ChAdOx1 nCoV-19 group, spike-specific T-cell responses peaked on day 14 (median 856 spot-forming cells per million peripheral blood mononuclear cells, IQR 493-1802; n=43). Anti-spike IgG responses rose by day 28 (median 157 ELISA units [EU], 96-317; n=127), and were boosted following a second dose (639 EU, 360-792; n=10). Neutralising antibody responses against SARS-CoV-2 were detected in 32 (91%) of 35 participants after a single dose when measured in MNA80 and in 35 (100%) participants when measured in PRNT50. After a booster dose, all participants had neutralising activity (nine of nine in MNA80 at day 42 and ten of ten in Marburg VN on day 56). Neutralising antibody responses correlated strongly with antibody levels measured by ELISA (R2=0·67 by Marburg VN; p<0·001). INTERPRETATION: ChAdOx1 nCoV-19 showed an acceptable safety profile, and homologous boosting increased antibody responses. These results, together with the induction of both humoral and cellular immune responses, support large-scale evaluation of this candidate vaccine in an ongoing phase 3 programme. FUNDING: UK Research and Innovation, Coalition for Epidemic Preparedness Innovations, National Institute for Health Research (NIHR), NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and the German Center for Infection Research (DZIF), Partner site Gießen-Marburg-Langen