"My Blood, You Know, My Biology Being out There ": Consent and Participant Control of Biological Samples.

The widespread and persistent underrepresentation of groups experiencing health disparities in research involving biospecimens is a barrier to scientific knowledge and advances in health equity. To ensure that all groups have the opportunity to participate in research and feel welcome and safe doing so, we must understand how research studies may be shaped to promote inclusion. In this study, we explored the decision to participate in hypothetical research scenarios among African American adults (n = 169) that varied on the basis of four attributes (form of consent, reason for research, institutional affiliation and race of the researcher). Findings indicate that participants were largely willing to contribute to biobanks but significantly preferred opportunities where they had control over the use of their biological samples through tiered or study-specific forms of consent. Broad consent procedures, although common and perhaps preferred by participants with high trust in researchers, may amount to an exclusionary practice.

Assessment of implementation methods in sepsis: study protocol for a cluster-randomized hybrid type 2 trial.

BACKGROUND: Sepsis is the leading cause of intensive care unit (ICU) admission and ICU death. In recognition of the burden of sepsis, the Surviving Sepsis Campaign (SSC) and the Institute for Healthcare Improvement developed sepsis "bundles" (goals to accomplish over a specific time period) to facilitate SSC guideline implementation in clinical practice. Using the SSC 3-h bundle as a base, the Centers for Medicare and Medicaid Services developed a 3-h sepsis bundle that has become the national standard for early management of sepsis. Emerging observational data, from an analysis conducted for the AIMS grant application, suggest there may be additional mortality benefit from even earlier implementation of the 3-h bundle, i.e., the 1-h bundle. METHOD: The primary aims of this randomized controlled trial are to: (1) examine the effect on clinical outcomes of Emergency Department initiation of the elements of the 3-h bundle within the traditional 3 h versus initiating within 1 h of sepsis recognition and (2) examine the extent to which a rigorous implementation strategy will improve implementation and compliance with both the 1-h bundle and the 3-h bundle. This study will be entirely conducted in the Emergency Department at 18 sites. A secondary aim is to identify clinical sepsis phenotypes and their impact on treatment outcomes. DISCUSSION: This cluster-randomized trial, employing implementation science methodology, is timely and important to the field. The hybrid effectiveness-implementation design is likely to have an impact on clinical practice in sepsis management by providing a rigorous evaluation of the 1- and 3-h bundles. FUNDING: NHLBI R01HL162954. TRIAL REGISTRATION: ClinicalTrials.gov NCT05491941. Registered on August 8, 2022.

Exploring the Equity Impact of Current Digital Health Design Practices: Protocol for a Scoping Review.

BACKGROUND: The field of digital health has grown rapidly in part due to digital health tools' potential to reduce health inequities. However, such potential has not always been realized. The design approaches used in digital health are one of the known aspects that have an impact on health equity. OBJECTIVE: The aim of our scoping review will be to understand how design approaches in digital health have an impact on health equity. METHODS: A scoping review of studies that describe how design practices for digital health have an impact on health equity will be carried out. The scoping review will follow the methodologies laid out by Arksey and O'Malley, the Joanna Briggs Institute, and the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) checklist. The PubMed, Embase, Web of Science, and ACM Digital Library databases will be searched for peer-reviewed papers. The ProQuest Dissertations and Theses and Global Index Medicus databases will be searched for gray literature. The results will be screened against our inclusion and exclusion criteria. Subsequently, the data extracted from the included studies will be analyzed. RESULTS: As of March 2022, a preliminary search of the peer-reviewed databases has yielded over 4900 studies, and more are anticipated when gray literature databases are searched. We expect that after duplicates are removed and screening is completed, a much smaller number of studies will meet all of our inclusion criteria. CONCLUSIONS: Although there has been much discussion about the importance of design for lowering barriers to digital health participation, the evidence base demonstrating its impacts on health equity is less obvious. We hope that our findings will contribute to a better understanding of the impact that design in digital health has on health equity and that these findings will translate into action that leads to stronger, more equitable health care systems.

The Impact of Socioeconomic Risk Factors on the Survival Outcomes of Patients With Newly Diagnosed Multiple Myeloma: A Cross-analysis of a Population-based Registry and a Tertiary Care Center.

BACKGROUND: Multiple myeloma (MM) is a heterogeneous clonal plasma cell disorder leading to differences in clinical outcomes such as overall survival (OS) among patients. We hypothesized that with expensive, novel therapeutic agents and paradigm shifts to maintain continuous therapy and improvement in OS, patients with MM are subject to the pressures of financial toxicity and the need for social support, which may be of prognostic importance. MATERIALS AND METHODS: In this study, we examined the records of 122,458 patients from the National Cancer Database (NCDB) to determine the significance of socioeconomic factors such as estimated annual household income and education level, which were based on the patient's ZIP Code and the United States Census Bureau's 5-year report from 2008 to 2012. These socioeconomic factors, in addition to marital status, were then assessed individually and as a cumulative socioeconomic score for prognostic significance in a cohort of 2543 patients treated at a tertiary care center utilizing known biologic risk factors, such as cytogenetic risk, International Staging System classification, and serum lactate dehydrogenase levels. RESULTS: Only marital status and estimated annual household income at diagnosis negatively impacted OS in a univariate analysis, but not in the context of a multivariable analysis incorporating known biologic risk factors. CONCLUSION: Future analyses in other academic and non-academic centers located in urban and rural regions are required to understand the socioeconomic drivers of OS disparity among patients with MM observed nationally.

In vivo assessment of glutamine anaplerosis into the TCA cycle in human pre-malignant and malignant clonal plasma cells.

BACKGROUND: Overexpression of c-Myc is required for the progression of pre-malignant plasma cells in monoclonal gammopathy of undetermined significance (MGUS) to malignant plasma cells in multiple myeloma (MM). c-Myc also increases glutamine anaplerosis into the tricarboxylic acid (TCA) cycle within cancer cells. Whether increased glutamine anaplerosis is associated with the progression of pre-malignant to malignant plasma cells is unknown. METHODS: Human volunteers (N = 7) and patients with MGUS (N = 11) and MM (N = 12) were prospectively recruited to undergo an intravenous infusion of 13C-labeled glutamine followed by a bone marrow aspiration to obtain bone marrow cells and plasma. RESULTS: Despite notable heterogeneity, stable isotope-resolved metabolomics (SIRM) revealed that the mean 13C-labeled glutamine anaplerosis into the TCA cycle was higher in malignant compared to pre-malignant bone marrow plasma cells relative to the remainder of their paired bone marrow mononuclear cells. RNA sequencing demonstrated a higher relative mRNA expression of c-Myc and glutamine transporters such as ASCT2 and SN2 in malignant compared to pre-malignant bone marrow plasma cells. Finally, higher quantitative levels of TCA cycle intermediates in the bone marrow plasma differentiated MM from MGUS patients. CONCLUSION: Measurement of the in vivo activity of glutamine anaplerosis into the TCA cycle provides novel insight into the metabolic changes associated with the transformation of pre-malignant plasma cells in MGUS to malignant plasma cells in MM. TRIAL REGISTRATION: NCT03384108 and NCT03119883.

Managing ICU surge during the COVID-19 crisis: rapid guidelines.

Given the rapidly changing nature of COVID-19, clinicians and policy makers require urgent review and summary of the literature, and synthesis of evidence-based guidelines to inform practice. The WHO advocates for rapid reviews in these circumstances. The purpose of this rapid guideline is to provide recommendations on the organizational management of intensive care units caring for patients with COVID-19 including: planning a crisis surge response; crisis surge response strategies; triage, supporting families, and staff.

Triage of Scarce Critical Care Resources in COVID-19 An Implementation Guide for Regional Allocation: An Expert Panel Report of the Task Force for Mass Critical Care and the American College of Chest Physicians.

Public health emergencies have the potential to place enormous strain on health systems. The current pandemic of the novel 2019 coronavirus disease has required hospitals in numerous countries to expand their surge capacity to meet the needs of patients with critical illness. When even surge capacity is exceeded, however, principles of critical care triage may be needed as a means to allocate scarce resources, such as mechanical ventilators or key medications. The goal of a triage system is to direct limited resources towards patients most likely to benefit from them. Implementing a triage system requires careful coordination between clinicians, health systems, local and regional governments, and the public, with a goal of transparency to maintain trust. We discuss the principles of tertiary triage and methods for implementing such a system, emphasizing that these systems should serve only as a last resort. Even under triage, we must uphold our obligation to care for all patients as best possible under difficult circumstances.

Relationship continuity and emotional well-being in spouses of people with dementia.

OBJECTIVES: Qualitative research has suggested that spousal experiences of discontinuity in their relationship with a person who has dementia (i.e. the relationship is experienced as radically changed) may contribute to heightened feelings of burden, entrapment, isolation, guilt and intolerance of behaviours that challenge. By contrast, continuity in the relationship may contribute to a greater sense of achievement and gratification from providing care. The present study served as a quantitative test of these suggestions. METHOD: A convenience sample of 71 spouses of people with dementia completed three questionnaires - the Zarit Burden Interview (ZBI), the Positive Aspects of Caregiving measure (PAC) and the Birmingham Relationship Continuity Measure (BRCM). RESULTS: In accordance with the hypotheses, the experience of greater relationship continuity (higher BRCM scores) was correlated with fewer negative emotional reactions to caregiving (lower ZBI scores; rho = -.795) and more positive emotional reactions (higher PAC scores; rho = .764). CONCLUSIONS: The study provided some quantitative support for suggestions arising from qualitative research about how perceptions of continuity/discontinuity in the relationship may impact on the caregiving spouse's emotional well-being. Helping couples to maintain a sense of continuity and couplehood may assist their emotional adjustment to dementia.

Development and Validation of an Assessment Tool for Competency in Critical Care Ultrasound.

BACKGROUND: Point-of-care ultrasound is an emerging technology in critical care medicine. Despite requirements for critical care medicine fellowship programs to demonstrate knowledge and competency in point-of-care ultrasound, tools to guide competency-based training are lacking. OBJECTIVE: We describe the development and validity arguments of a competency assessment tool for critical care ultrasound. METHODS: A modified Delphi method was used to develop behaviorally anchored checklists for 2 ultrasound applications: "Perform deep venous thrombosis study (DVT)" and "Qualify left ventricular function using parasternal long axis and parasternal short axis views (Echo)." One live rater and 1 video rater evaluated performance of 28 fellows. A second video rater evaluated a subset of 10 fellows. Validity evidence for content, response process, and internal consistency was assessed. RESULTS: An expert panel finalized checklists after 2 rounds of a modified Delphi method. The DVT checklist consisted of 13 items, including 1.00 global rating step (GRS). The Echo checklist consisted of 14 items, and included 1.00 GRS for each of 2 views. Interrater reliability evaluated with a Cohen kappa between the live and video rater was 1.00 for the DVT GRS, 0.44 for the PSLA GRS, and 0.58 for the PSSA GRS. Cronbach α was 0.85 for DVT and 0.92 for Echo. CONCLUSIONS: The findings offer preliminary evidence for the validity of competency assessment tools for 2 applications of critical care ultrasound and data on live versus video raters.

A study of Iranian nurses' and midwives' knowledge, attitudes, and implementation of evidence-based practice: the time for change has arrived.

BACKGROUND: Evidence-based practice (EBP) leads to enhanced quality of care, and the individual and professional development of nurses and midwives. Therefore, it is important for nurses and midwives as well as all other healthcare providers and stakeholders to inform clinical decision-making and implement EBP. AIM: This study aimed to determine the EBP knowledge, attitudes, and practice of clinical nurses and midwives in Mashhad public hospitals in Iran. METHODS: The descriptive cross-sectional study was conducted with a stratified cluster, random sample of 240 employed nurses and midwives (response rate of 96%) in Mashhad, who held a Bachelor of Science degree and had at least 1 year of clinical experience. Two valid and reliable questionnaires were used to collect demographic and EBP data. Data were analyzed using SPSS version 11.5 software and descriptive and inferential statistics calculated. RESULTS: Participants' mean age was 31.0 (SD = 5.5) years and 80% (n = 194) were female. Most participants reported low knowledge or skills and practice of EBP, but moderate attitudes toward EBP. Significant differences between the mean scores on knowledge or skills, attitudes, and practice were identified by field of study. Nurses reported higher knowledge or skills and practice of EBP than midwives (p < .001). Nurses and midwives with master-s degrees displayed greater knowledge or skills and practice of EBP, and more positive attitudes than nurses with bachelor-s degrees (p < .001). LINKING EVIDENCE TO ACTION: Although clinical nurses and midwives apply EBP in clinical settings, it is necessary to develop their knowledge or skills and practice. The results of this study can be applied by educational planners, educational managers, and authorities to enhance the quality and consistency of EBP implementation. The results provide a base for future studies in this field.

Reducing variation in the use of inhaled nitric oxide.

BACKGROUND AND OBJECTIVE: Decreasing practice variation and following clinical guidelines improve patient outcomes and reduce costs. Inhaled nitric oxide (iNO) is an effective but expensive treatment of pulmonary hypertension and right heart failure in patients with congenital or acquired heart disease. Our objective was to implement standardized initiation and weaning guidelines for iNO usage in the cardiothoracic ICU (CTICU) to reduce variation in use while maintaining quality patient care. METHODS: All CTICU patients who received iNO from January 2011 to December 2012 were retrospectively reviewed. Standardized iNO initiation and weaning guidelines were implemented in January 2012. Variables before and after guideline implementation were compared. RESULTS: From January to December 2011, there were 36 separate iNO events (6% of CTICU admissions; n = 547). Mean ± SD iNO usage per event was 159 ± 177 hours (median: 63 hours; range: 27-661 hours). From January to December 2012, there were 47 separate iNO events (8% of CTICU admissions; n = 554). Mean iNO usage per event was 125 ± 134 hours (median: 72 hours; range: 2-557 hours). Initiation guideline compliance improved from 83% to 86% (P = .9); weaning guideline compliance improved from 17% to 79% (P < .001). Although mean iNO usage per event decreased, there was no significant reduction in utilization of iNO (P = .09). CONCLUSIONS: Implementation of standardized iNO initiation and weaning guidelines in the CTICU was successful in reducing practice variation supported by increasing guideline compliance. However, decreasing practice variation did not significantly reduce iNO utilization and does not necessarily reduce cost.

Factors associated with utilization of an inpatient palliative care consultation service in an urban public hospital.

RATIONALE: To evaluate factors associated with palliative care consultation (PCC) in an urban public hospital. METHODS: A retrospective chart review of patients who died on inpatient medical services. RESULTS: Patients with a PCC were more likely to have a "do not resuscitate" (DNR) order at the time of death (p<0.001) and had a decreased likelihood of death in the ICU (p<0.001). Factors associated with PCC in a multivariate analysis included: cancer diagnosis (p=0.01), at least a high school education (p=0.04), older age (p=.003), and birth outside the US (p=0.03). CONCLUSION: The increased PCC utilization for immigrants is in contrast to previously reported literature. This increased use may be because access to services in a municipal hospital is not driven by demographic and socioeconomic factors.

Time to all-cause treatment discontinuation of olanzapine compared to other antipsychotics in the treatment of schizophrenia: a systematic review and meta-analysis.

OBJECTIVE: This comprehensive review and meta-analysis compared the effectiveness of olanzapine and other antipsychotics in schizophrenia treatment, defining effectiveness as time to all-cause medication discontinuation (primary) and as all-cause treatment discontinuation rates. This study examined randomized clinical trials (RCTs) and observational non-interventional studies. EXPERIMENTAL PROCEDURES: Schizophrenia studies that compared olanzapine with individual first- (FGAs) and/or second-generation antipsychotics (SGAs) were included in the meta-analyses. Hazard ratios (HR), risk ratios (RR), and their associated 95% confidence intervals were extracted for RCTs and observational studies. Sensitivity analyses assessed the impact of sources of funding, dose of olanzapine, and allocation concealment method on final results. RESULTS: There were 60 RCTs (N=33,360) and 27 observational studies (N=202,591) included. On time to all-cause medication discontinuation, olanzapine was significantly better than aripiprazole, quetiapine, risperidone, ziprasidone and perphenazine for RCTs and better than amisulpride, risperidone, haloperidol, and perphenazine for observational studies. There were no significant differences between olanzapine and clozapine in RCTs or observational studies. All-cause discontinuation rates in RCTs were significantly lower for olanzapine compared to all comparators except amisulpride and clozapine. In observational studies, olanzapine was less effective than clozapine. Industry-sponsored studies favored olanzapine when compared to haloperidol and perphenazine; higher dose of olanzapine favored quetiapine and perphenazine when compared to olanzapine; method of allocation concealment did not generally affect the results. CONCLUSION: Using a global measure of medication effectiveness (time to all-cause medication discontinuation), olanzapine appears to be more effective - in both RCTs and observational studies - than most SGAs and FGAs, except for clozapine.

Barriers to end-of-life care in the intensive care unit: perceptions vary by level of training, discipline, and institution.

PURPOSE: Barriers to providing quality end-of-life (EOL) care in the intensive care unit (ICU) are common, but little is known about how these barriers vary by level of training or discipline. METHODS: Medical residents and ICU fellows, attendings, and nurses at two teaching hospitals were surveyed about barriers to EOL care in the ICU. The survey consisted of questions about possible barriers in four domains: patient-family factors, clinician factors, institutional factors, and education-training factors. RESULTS: There were significant differences in reported barriers to EOL care by level of training, discipline, and institution, particularly in the education-training domain. Insufficient resident training in EOL care was reported as a large or huge barrier by a smaller proportion of residents (20%) than attendings (62%), fellows (55%) or nurses (36%) (p=0.001). Nurses' perceptions of barriers to EOL care varied between institutions. Barriers that varied significantly between nurses included difficulty communicating due to language (p=0.008), and inadequate training in recognition of pain and anxiety (p=0.001). CONCLUSIONS: We found that perceived barriers to EOL care differed significantly by level of training, discipline and institution, suggesting the interventions to improve EOL care may need to be locally targeted and specific to level of training and discipline.

Folic acid supplementation in younger and older nonpregnant women of reproductive age: findings from the Central Pennsylvania Women's Health Study (CePAWHS).

INTRODUCTION AND BACKGROUND: This study explores variables associated with daily folic acid supplementation among nonpregnant women ages 18-24, in comparison with women ages 25-45. Health-related behaviors, reproductive status, health care access, and sociodemographic variables are included. METHODS: Data are from a cross-sectional population-based survey of 2,002 women ages 18-45 in the Central Pennsylvania Women's Health Study. The analytic sample included 246 women ages 18-24 and 1,636 women ages 25-45 who were not pregnant at the time of survey. RESULTS: Seventeen percent of women ages 18-24 and 27% of women ages 24-45 used daily folic acid supplements. In multiple logistic regression analysis, folic acid use was significantly associated with only two variables among younger women: fruit consumption at least daily and regular physical activity levels meeting recommended guidelines. Among older women, folic acid use was associated with these same two health-related behaviors in addition to not smoking, seeing an obstetrician-gynecologist, receiving diet/nutrition counseling, being married or living with a partner, and no prior pregnancy. Folic acid use was not associated with pregnancy intention in either age group. CONCLUSIONS AND DISCUSSION: Women ages 18-24 have significantly lower rates of folic acid supplementation compared with older women of reproductive age, but fewer variables are associated with folic acid use among younger women. Missed opportunities to educate younger women about the benefits of folic acid supplementation are identified.