Calibrating variant curation by clinical context based on factors that influence patients' tolerance of uncertainty.

PURPOSE: Shared decision making manages genomic uncertainty by integrating molecular and clinical uncertainties with patient values to craft a person-centered management plan. Laboratories seek genomic report consistency, agnostic to clinical context. Molecular reports often mask laboratory-managed uncertainties from clinical decision making. Better integration of these uncertainty management strategies requires a nuanced understanding of patients' perceptions and reactions to test uncertainties. We explored patients' tolerance to variant uncertainty in 3 parameters: (1) relative causal significance, (2) risk accuracy, and (3) classification validity. METHOD: Deliberative forums were undertaken with 18 patients with predictive testing experience. Uncertainty deliberations were elicited for each parameter. A thematic framework was first developed, and then mapped to whether they justified tolerance to more or less parameter-specific uncertainty. RESULTS: Six identified themes mapped to clinical and personal domains. These domains generated opposing forces when calibrating uncertainty. Personal themes justified tolerance of higher uncertainty and clinical themes lower uncertainty. Decision making in uncertainty focused on reducing management regret. Open communication increased tolerance of classification validity and risk accuracy uncertainty. Using these data, we have developed a nascent clinical algorithm integrating molecular uncertainty with clinical context through a targeted communication framework. CONCLUSION: Maximizing test utility necessitates context-specific recalibration of uncertainty management and communication.

Development of a person-centred digital platform for the long-term support of people living with an adult-onset genetic disease predisposition: a mixed-methods study protocol.

INTRODUCTION: Individuals at an inherited high-risk of developing adult-onset disease, such as breast cancer, are rare in the population. These individuals require lifelong clinical, psychological and reproductive assistance. After a positive germline test result, clinical genetic services provide support and care coordination. However, ongoing systematic clinical follow-up programmes are uncommon. Digital health solutions offer efficient and sustainable ways to deliver affordable and equitable care. This paper outlines the codesign and development of a digital health platform to facilitate long-term clinical and psychological care, and foster self-efficacy in individuals with a genetic disease predisposition. METHODS AND ANALYSIS: We adopt a mixed-methods approach for data gathering and analysis. Data collection is in two phases. In phase 1, 300 individuals with a high-risk genetic predisposition to adult disease will undertake an online survey to assess their use of digital health applications (apps). In phase 2, we will conduct focus groups with 40 individuals with a genetic predisposition to cardiac or cancer syndromes, and 30 clinicians from diverse specialities involved in their care. These focus groups will inform the platform's content, functionality and user interface design, as well as identify the barriers and enablers to the adoption and retention of the platform by all endusers. The focus groups will be audiorecorded and transcribed, and thematic and content data analysis will be undertaken by adopting the Unified Theory of Acceptance and Use of Technology. Descriptive statistics will be calculated from the survey data. Phase 3 will identify the core skillsets for a novel digital health coordinator role. Outcomes from phases 1 and 2 will inform development of the digital platform, which will be user-tested and optimised in phase 4. ETHICS AND DISSEMINATION: This study was approved by the Peter MacCallum Human Research Ethics Committee (HREC/88892/PMCC). Results will be disseminated in academic forums, peer-reviewed publications and used to optimise clinical care.

Heterogeneity in how women value risk-stratified breast screening.

PURPOSE: Risk-stratified screening has potential to improve the cost effectiveness of national breast cancer screening programs. This study aimed to inform a socially acceptable and equitable implementation framework by determining what influences a woman's decision to accept a personalized breast cancer risk assessment and what the relative impact of these key determinants is. METHODS: Multicriteria decision analysis was used to elicit the relative weights for 8 criteria that women reported influenced their decision. Preference heterogeneity was explored through cluster analysis. RESULTS: The 2 criteria valued most by the 347 participants related to program access, "Mode of invitation" and "Testing process". Both criteria significantly influenced participation (P < .001). A total of 73% preferred communication by letter/online. Almost all women preferred a multidisease risk assessment with potential for a familial high-risk result. Four preference-based subgroups were identified. Membership to the largest subgroup was predicted by lower educational attainment, and women in this subgroup were concerned with program access. Higher relative perceived breast cancer risk predicted membership to the smallest subgroup that was focused on test parameters, namely "Scope of test" and "Test specificity". CONCLUSION: Overall, Australian women would accept a personalized multidisease risk assessment, but when aligning with their preferences, it will necessitate a focus on program access and the development of online communication frameworks.

Exploring Implementation of Personal Breast Cancer Risk Assessments.

Personal Breast Cancer (BC) Risk Assessments (PBCRA) have potential to stratify women into clinically-actionable BC risk categories. As this could involve population-wide genomic testing, women's attitudes to PBCRA and views on acceptable implementation platforms must be considered to ensure optimal population participation. We explored these issues with 31 women with different BC risk profiles through semi-structured focus group discussions or interviews. Inductive thematic coding of transcripts was performed. Subsequently, women listed factors that would impact on their decision to participate. Participants' attitudes to PBCRA were positive. Identified themes included that PBCRA acceptance hinges on result actionability. Women value the ability to inform decision-making. Participants reported anxiety, stress, and genetic discrimination as potential barriers. The age at which PBCRA was offered, ease of access, and how results are returned held importance. Most women value the opportunity for PBCRA to inform increased surveillance, while highlighting hesitance to accept reduced surveillance as they find reassurance in regular screening. Women with BRCA pathogenic variants value the potential for PBCRA to identify a lower cancer risk and potentially inform delayed prophylactic surgery. This study highlights complexities in adopting advances in BC early detection, especially for current users who value existing processes as a social good.

Vertical Integration Into Skilled Nursing Facilities and Hospital Readmission Rates.

Following the Affordable Care Act (ACA), more hospitals vertically integrated into skilled nursing facilities (SNFs). Hospitals are now being penalized for avoidable readmissions, creating a greater demand for better coordination of care between hospitals and SNF. We created a longitudinal panel data set by merging data from the American Hospital Association's Annual Survey, CMS' Hospital Compare, and the Rural Urban Commuting Area data. Hospital and year fixed-effects models were used to examine the relationship between hospital vertical integration into SNF and 30-day pneumonia and heart failure (HF) readmission rates between 2008 and 2011. Our primary analyses modeled the impact of hospital vertical integration into SNF on 30-day readmissions for both pneumonia and HF using hospital and year fixed effects. Our secondary analyses examined whether hospital vertical integration into SNF was associated with a change in readmissions rates among different types of hospitals. Our results indicate that hospitals that vertically integrated into SNF were associated with a reduction in hospital 30-day pneumonia readmission rates (ß = -0.233, p = .039). Vertical integration into SNF was not significantly associated with 30-day HF readmissions. Our secondary analyses found variation in the impact of vertical integration on readmission rates among different hospital organizational types.

Market and organizational factors associated with hospital vertical integration into sub-acute care.

BACKGROUND: Changes in payment models incentivize hospitals to vertically integrate into sub-acute care (SAC) services. Through vertical integration into SAC, hospitals have the potential to reduce the transaction costs associated with moving patients throughout the care continuum and reduce the likelihood that patients will be readmitted. PURPOSE: The purpose of this study is to examine the correlates of hospital vertical integration into SAC. METHODOLOGY/APPROACH: Using panel data of U.S. acute care hospitals (2008-2012), we conducted logit regression models to examine environmental and organizational factors associated with hospital vertical integration. Results are reported as average marginal effects. FINDINGS: Among 3,775 unique hospitals (16,269 hospital-year observations), 25.7% vertically integrated into skilled nursing facilities during at least 1 year of the study period. One measure of complexity, the availability of skilled nursing facilities in a county (ME = -1.780, p < .001), was negatively associated with hospital vertical integration into SAC. Measures of munificence, percentage of the county population eligible for Medicare (ME = 0.018, p < .001) and rural geographic location (ME = 0.069, p < .001), were positively associated with hospital vertical integration into SAC. Dynamism, when measured as the change county population between 2008 and 2011 (ME = 1.19e-06, p < .001), was positively associated with hospital vertical integration into SAC. Organizational resources, when measured as swing beds (ME = 0.069, p < .001), were positively associated with hospital vertical integration into SAC. Organizational resources, when measured as investor owned (ME = -0.052, p < .1) and system affiliation (ME = -0.041, p < .1), were negatively associated with hospital vertical integration into SAC. PRACTICE IMPLICATIONS: Hospital adaption to the changing health care landscape through vertical integration varies across market and organizational conditions. Current Centers for Medicare and Medicaid reimbursement programs do not take these factors into consideration. Vertical integration strategy into SAC may be more appropriate under certain market conditions. Hospital leaders may consider how to best align their organization's SAC strategy with their operating environment.

Evaluating the impact of a healthy corner store initiative on food access domains.

Healthy Corner Store Initiatives (HCSIs) are one food access strategy that aims to improve food environments by supporting local food stores in expanding their healthy offerings. This study presents the evaluation results from one such HCSI. Fresh Foods Here evaluated its network of eight stores in Columbus, Ohio between November 2013 and August 2014. Data from invoices, inventories, rapid market assessments, and customers surveys were analyzed for evidence of impact on the service delivery and personal domains of food access. For some indicators, initial gains were concentrated between pre- and interim evaluation periods, followed by either a leveling off or decline between interim and post. However, overall results were promising, with increases noted in the number of healthy items ordered by store owners, in daily foot traffic and transactions, and in consumer confidence for certain healthy behaviors. Lessons learned concerning the operation and evaluation of HCSIs are shared.

Hospital Vertical Integration Into Subacute Care as a Strategic Response to Value-Based Payment Incentives, Market Factors, and Organizational Factors: A Multiple-Case Study.

This study explores the extent to which payment reform and other factors have motivated hospitals to adopt a vertical integration strategy. Using a multiple-case study research design, we completed case studies of 3 US health systems to provide an in-depth perspective into hospital adoption of subacute care vertical integration strategies across multiple types of hospitals and in different health care markets. Three major themes associated with hospital adoption of vertical integration strategies were identified: value-based payment incentives, market factors, and organizational factors. We found evidence that variation in hospital adoption of vertical integration into subacute care strategies occurs in the United States and gained a perspective on the intricacies of how and why hospitals adopt a vertical integration into subacute care strategy.

"I Don't Know What Fun Is": Examining the Intersection of Social Capital, Social Networks, and Social Recovery.

PURPOSE: The purpose of this paper is to understand how people with problematic drug use access positive social capital. Social capital is defined as relations that provide valuable resources to individuals through participation in social networks. People with low socioeconomic status remain at a disadvantage for acquiring positive social capital, a component of recovery capital. The concept of social recovery emphasises the relational processes of recovery. DESIGN/METHODOLOGY/APPROACH: In-depth life history data were collected from 29 individuals who used heroin, cocaine, crack, or methamphetamine for at least five years, have less than a high school education, and unstable employment and housing. Qualitative data were coded for social networks accessed throughout the life course, distinguished by bonding, bridging and linking social capital. FINDINGS: Social networks included drug treatment programs; non-drug-using family and friends; religious/spiritual groups; workplace networks, and social clubs/activities. Bonding and/or bridging social capital were acquired through treatment, family and friends, religious/spiritual groups, workplaces, and social clubs. Linking social capital was not acquired through any social networks available, and many barriers to accessing mainstream social networks were found. LIMITATIONS: This is a small study conducted in the US. SOCIAL IMPLICATIONS: A greater focus on social recovery is needed to achieve sustained recovery for individuals lacking access to and engagement in mainstream social networks. PRACTICAL IMPLICATIONS: Social recovery is proposed as an analytical tool as well as for developing prevention, intervention, and treatment strategies.

Cost Analysis of an Advanced Practice Registered Nurse Transitional Care Model for Cardiac Patients.

Interest in care transitions has intensified in light of emphasis placed on hospital readmissions. This study provides a comparative analysis of the costs of providing transitional care through a program for cardiac patients against hospital readmission costs. The advanced practice registered nurse-managed BRIDGE model reduced health care costs associated with readmissions that were in excess of program costs. On average, there was a per-patient savings of $4,944 in avoided readmissions within 30 days of hospital discharge. Over the duration of the program, this equates to a $306,537 savings in patients with acute coronary syndrome. Nurse practitioners have a unique, holistic, and supportive approach to providing care that may make them ideal for the transitional care setting.

Safety studies conducted on a sanitizing agent containing benzalkonium chloride.

UNLABELLED: Free N Clear is a sanitizing agent composed of United States Pharmacopeial Convention grade benzalkonium chloride (BAC), acetic acid, and methylparaben. Free N Clear is proposed for use as a sanitizing agent at a 1: 50 dilution (2% solution), which contains approximately 100 ppm BAC. As part of a program to assess its safety, a 2% solution of Free N Clear (diluted Free N Clear) was administered by gavage to Sprague-Dawley rats for 91d and tested for genetic toxicity in vitro and in vivo. In the 91d study, the no observable adverse-effect level of diluted Free N Clear in male and female Sprague-Dawley rats is 5000 mg/kg bw/day, the highest dose administered. Diluted Free N Clear was not mutagenic in a bacterial reverse mutation assay that tested concentrations extending into the toxic range, and did not increase the frequency of micronucleated polychromatic erythrocytes in bone marrow cells of male or female Sprague-Dawley rats when tested at the maximum permissible dose volume of 20 mL/kg bw. The results support safety of Free N Clear, when used at the concentration proposed for use. PRACTICAL APPLICATION: The significance of these findings will allow for the development of Free N Clear as a potential sanitizing agent for food.