Talazoparib Plus Enzalutamide in Patients With HRR-Deficient mCRPC: Practical Implementation Steps for Oncology Nurses and Advanced Practice Providers.

BACKGROUND: About one-quarter of patients with advanced prostate cancer have alterations in homologous recombination repair (HRR) genes. In a global phase 3 study, talazoparib plus enzalutamide significantly improved progression-free survival in patients with HRR-deficient metastatic castration-resistant prostate cancer (mCRPC). OBJECTIVES: This article reviews the role of oncology nurses and advanced practice providers (APPs) in administering talazoparib plus enzalutamide in patients with mCRPC. METHODS: This review and hypothetical case study illustrate the role of oncology nurses and APPs in the administration of talazoparib plus enzalutamide and the management of adverse events to ensure safe and effective use in clinical practice. FINDINGS: Oncology nurses and APPs play an important role in the dosing and administration of talazoparib plus enzalutamide and can recognize and manage adverse events in patients with HRR-deficient mCRPC.

Essential Components of an Electronic Patient-Reported Symptom Monitoring and Management System: A Randomized Clinical Trial.

Importance: Multicomponent electronic patient-reported outcome cancer symptom management systems reduce symptom burden. Whether all components contribute to symptom reduction is unknown. Objective: To deconstruct intervention components of the Symptom Care at Home (SCH) system, a digital symptom monitoring and management intervention that has demonstrated efficacy, to determine which component or combination of components results in the lowest symptom burden. Design, Setting, and Participants: This randomized clinical trial included participants who were older than 18 years, had been diagnosed with cancer, had a life expectancy of 3 months or greater, were beginning a chemotherapy course planned for at least 3 cycles, spoke English, and had daily access and ability to use a telephone. Eligible participants were identified from the Huntsman Cancer Institute, University of Utah (Salt Lake City), and from Emory University Winship Cancer Institute, including Grady Memorial Hospital (Atlanta, Georgia), from August 7, 2017, to January 17, 2020. Patients receiving concurrent radiation therapy were excluded. Dates of analysis were from February 1, 2020, to December 22, 2023. Interventions: Participants reported symptoms daily during a course of chemotherapy and received automated self-management coaching with an activity tracker without (group 1) and with (group 2) visualization, nurse practitioner (NP) follow-up for moderate-to-severe symptoms without (group 3) and with (group 4) decision support, or the complete SCH intervention (group 5). Main Outcomes and Measures: The primary outcome, symptom burden, was assessed as the summed severity of 11 chemotherapy-related symptoms rated on a scale of 1 to 10 (with higher scores indicating greater severity), if present. Results: The 757 participants (mean [SD] age, 59.2 [12.9] years) from 2 cancer centers were primarily female (61.2%). The most common cancer diagnoses were breast (132 [17.4%]), lung (107 [14.1%]), and colorectal (99 [13.1%]) cancers; 369 patients (48.7%) had metastatic disease. The complete SCH intervention including automated self-management coaching and NP follow-up with decision support (group 5) was superior in reducing symptom burden to either of the self-management coaching groups, as shown by the mean group differences in area under the curve (group 1, 1.86 [95% CI, 1.30-2.41] and group 2, 2.38 [95% CI, 1.84-2.92]; both P < .001), and to either of the NP follow-up groups (group 3, 0.57 [95% CI, 0.03-1.11]; P =.04; and group 4, 0.66 [95% CI, 0.14-1.19]; P = .014). Additionally, NP follow-up was superior to self-management coaching (group 1 vs group 3, 1.29 [95% CI, 0.72-1.86]; group 1 vs group 4, 1.20 [95% 12 CI, 0.64-1.76]; group 2 vs group 3, 1.81 [95% CI, 1.25-2.37]; and group 2 vs group 4, 1.72 [95% CI, 1.17-2.26]; all P < .001), but there was no difference between the 2 self-management coaching groups (-0.52 [95% CI, -1.09 to 0.05]; P = .07) or between the 2 NP groups (-0.10 [95% CI, -0.65 to 0.46]; P = .74). Conclusions and Relevance: In this randomized clinical trial of adult participants undergoing chemotherapy treatment for cancer, the complete intervention, rather than any individual component of the SCH system, achieved the greatest symptom burden reduction. These findings suggest that a multicomponent digital approach to cancer symptom management may offer optimal symptom burden reduction. Trial Registration: ClinicalTrials.gov Identifier: NCT02779725.

Lipid Emulsion Type and Liver Function in Parenteral Nutrition Patients: A Retrospective Study of Patients and Prescribing Practices.

Parenteral nutrition (PN) is a life-sustaining method to provide adequate nutrients to patients unable to receive oral or enteral nutrition. PN typically contains a mixture of macro- and micro-nutrients, although the lipid composition has been identified as a concern for liver disease. Therefore, the study of the intravenous lipid emulsion (ILE) prescribing practices in home-based PN (HPN) patients and whether differing lipid PN alters liver function tests (LFTs) is needed. METHODS: A retrospective study of monthly LFTs from a random sample of 105 adult HPN patients in the U.S. over a 6-month period was conducted. Patients were receiving olive oil/soy oil (n = 53, Clinolipid), mixed ILE (n = 39, SMOF Lipid), soy oil (SO; n = 4, Intralipid), or none (n = 7). LFTs monitored were alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate transaminase (AST), and total bilirubin (T Bili). RESULTS: No differences were observed in baseline LFTs across groups (all, p > 0.25, η2 < 0.04), nor were there differences in age, body mass index, days of PN, or mean PN volume (all, p > 0.36, η2 < 0.05). There were no significant interactions between ILE type and time (all p > 0.64, ηp2 < 0.03), no effect of ILE type (all p > 0.60, ηp2 < 0.03), and no effect of time (all p > 0.69, ηp2 < 0.01) in terms of LFTs. Average LFTs over six months were also not different between ILE types (all p > 0.30, η2 < 0.04). CONCLUSION: These findings suggested that patients were mostly prescribed mixed or ILE PN containing more than one lipid source and that differing ILEs in long-term HPN patients did not alter LFTs over a six-month period.

Assessing Patient Perspectives and the Health Equity of a Digital Cancer Symptom Remote Monitoring and Management System.

PURPOSE: People with cancer experience poorly controlled symptoms that persist between treatment visits. Automated digital technology can remotely monitor and facilitate symptom management at home. Essential to digital interventions is patient engagement, user satisfaction, and intervention benefits that are distributed across patient populations so as not to perpetuate inequities. We evaluated Symptom Care at Home (SCH), an automated digital platform, to determine patient engagement, satisfaction, and whether intervention subgroups gained similar symptom reduction benefits. METHODS: 358 patients with cancer receiving a course of chemotherapy were randomly assigned to SCH or usual care (UC). Both groups reported daily on 11 symptoms and completed the SF36 (Short Form Health Survey) monthly. SCH participants received immediate automated self-care coaching on reported symptoms. As needed, nurse practitioners followed up for poorly controlled symptoms. RESULTS: The average participant was White (83%), female (75%), and urban-dwelling (78.6%). Daily call adherence was 90% of expected days. Participants reported high user satisfaction. SCH participants had lower symptom burden than UC in all subgroups: age, sex, race, income, residence type, diagnosis, and stage (all P < .001 effect size 0.33-0.65), except for stages I and II cancers. Non-White and lower-income SCH participants gained a higher magnitude of symptom reduction than White participants and higher-income participants. Additionally, SCH men gained higher SF36 mental health (MH) benefit. There were no differences on other SF36 indices. CONCLUSION: Participants were highly satisfied and consistently engaged the SCH platform. SCH men gained large MH improvements, perhaps from increased comfort in sharing concerns through automated interactions. Although all intervention subgroups benefited, non-White participants and those with lower income gained higher symptom reduction benefit, suggesting that systematic care through digital tools can overcome existing disparities in symptom care outcomes.

Expert Consensus Recommendations on the Management of Treatment-emergent Adverse Events Among Men with Prostate Cancer Taking Poly-ADP Ribose Polymerase Inhibitor + Novel Hormonal Therapy Combination Therapy.

BACKGROUND AND OBJECTIVE: Recent clinical trials have shown improvement in progression-free survival in men with metastatic prostate cancer (mPC) treated with combination poly-ADP ribose polymerase (PARP) inhibitors (PARPi) and novel hormonal therapy (NHT). Regulatory bodies in the USA, Canada, Europe, and Japan have recently approved this combination therapy for mPC. Common adverse events (AEs) include fatigue, nausea and vomiting, and anemia. Nuanced AE management guidance for these combinations is lacking. The panel objective was to develop expert consensus on AE management in patients with mPC treated with the combination PARPi + NHT. METHODS: The RAND/University of California Los Angeles modified Delphi Panel method was used. AEs were defined using the Common Terminology Criteria for Adverse Events. Twelve experts (seven medical oncologists, one advanced practice registered nurse, three urologists, and one patient advocate) reviewed the relevant literature; independently rated initial AE management options for the agent suspected of causing the AE for 419 patient scenarios on a 1-9 scale; discussed areas of agreement (AoAs) and disagreement (AoDs) at a March 2023 meeting; and repeated these ratings following the meeting. Second-round ratings formed the basis of guidelines. KEY FINDINGS AND LIMITATIONS: AoDs decreased from 41% to 21% between the first and second round ratings, with agreement on at least one management strategy for every AE. AoAs included the following: (1) continue therapy with symptomatic treatment for patients with mild AEs; (2) for moderate fatigue, recommend nonpharmacologic treatment, hold treatment temporarily, and restart at a reduced dose when symptoms resolve; (3) for severe nausea or any degree of vomiting where symptomatic treatment fails, hold treatment temporarily and restart at a reduced dose when symptoms resolve; and (4) for hemoglobin 7.1-8.0 g/dl and symptoms of anemia, hold treatment temporarily and restart at a reduced dose after red blood cell transfusion. CONCLUSIONS AND CLINICAL IMPLICATIONS: This expert guidance can support management of AEs in patients with mPC receiving combination PARPi + NHT therapy. PATIENT SUMMARY: A panel of experts developed guidelines for adverse event (AE) management in patients with metastatic prostate cancer treated with a combination of poly-ADP ribose polymerase inhibitors and novel hormonal therapy. For mild AEs, continuation of cancer therapy along with symptomatic treatment is recommended. For moderate or severe AEs, cancer therapy should be stopped temporarily and restarted at the same or a reduced dose when AE resolves.

Impact of an automated, remote monitoring and coaching intervention in reducing hospice cancer family caregiving burden: A multisite randomized controlled trial.

BACKGROUND: Care for those with life-limiting cancer heavily involves family caregivers who may experience significant physical and emotional burden. The purpose of this study was to test the impact of Symptom Care at Home (SCH), an automated digital family caregiver coaching intervention, during home hospice, when compared to usual hospice care (UC) on the primary outcome of overall caregiver burden. Secondary outcomes included Caregiver Burden at weeks 1 and 8, Mood and Vitality subscales, overall moderate-to-severe caregiving symptoms, and sixth month spouse/partner bereavement outcomes. METHODS: Using a randomized, multisite, nonblinded controlled trial, 332 cancer family caregivers were enrolled and analyzed (159 SCH vs. 173 UC). Caregivers were primarily White (92%), female (69%), and spouse caregivers (53%). Caregivers provided daily reports on severity levels (0-10 scale) for their anxiety, depressed mood, fatigue, disturbed sleep, and caregiving interference with normal activities. These scores combined constituted the Caregiver Burden primary outcome. Based on reported symptoms, SCH caregivers received automated, tailored coaching about improving their well-being. Reports of moderate-to-severe caregiving symptoms also triggered hospice nurse notification. Secondary outcomes of Mood and Vitality were subcomponents of the Caregiver Burden score. A combined bereavement adjustment tool captured sixth month bereavement. RESULTS: The SCH intervention reduced overall Caregiver Burden compared to UC (p < .001), with a 38% reduction at 8 weeks and a medium-to-large effect size (d = .61). SCH caregivers experienced less (p < .001) disruption in both Mood and Vitality. There were higher levels of moderate-to-severe caregiving symptoms overtime in UC (OR, 2.722). All SCH caregivers benefited regardless of caregiver: sex, caregiver relationship, age, patient diagnosis and family income. SCH spouse/partner caregivers achieved better sixth month bereavement adjustment than UC (p < .007). CONCLUSIONS: The SCH intervention significantly decreased caregiving burden over UC and supports the maintenance of family caregiver mood and vitality throughout caregiving with extended benefit into bereavement.

Technology-Assisted mHealth Caregiver Support to Manage Cancer Patient Symptoms: A Randomized Controlled Trial.

CONTEXT: Caregivers managing symptoms of family members with cancer during home hospice care, often feel ill-prepared and need patient care coaching. OBJECTIVES: This study tested the efficacy of an automated mHealth platform that included caregiver coaching on patient symptom care and nurse notifications of poorly controlled symptoms. The primary outcome was caregiver perception of patients' overall symptom severity throughout hospice care and at weeks one, two, four, and eight. Secondary outcomes compared individual symptom severity. METHODS: Caregivers (n = 298) were randomly assigned to the Symptom Care at Home (SCH) intervention (n = 144) or usual hospice care (UC) (n = 154). All caregivers placed daily calls to the automated system that assessed the presence and severity of 11 end-of-life patient physical and psychosocial symptoms. SCH caregivers received automated coaching on symptom care based on reported patient symptoms and their severity. Moderate-to-severe symptoms were also relayed to the hospice nurse. RESULTS: The SCH intervention produced a mean overall symptom reduction benefit, over UC, of 4.89 severity points (95% CI 2.86-6.92) (P < 0.001), with a moderate effect size (d = 0.55). The SCH benefit also occurred at each timepoint (P < 0.001- 0.020). There was a 38% reduction in days reporting moderate-to-severe patient symptoms compared to UC (P < 0.001) with 10/11 symptoms significantly reduced in SCH compared to UC. CONCLUSION: Automated mHealth symptom reporting by caregivers, paired with tailored caregiver coaching on symptom management and nurse notifications, reduces cancer patients' physical and psychosocial symptoms during home hospice, providing a novel and efficient approach to improving end-of-life care.

Schizophrenia Polygenic Risk and Experiences of Childhood Adversity: A Systematic Review and Meta-analysis.

BACKGROUND AND HYPOTHESIS: Schizophrenia has been robustly associated with multiple genetic and environmental risk factors. Childhood adversity is one of the most widely replicated environmental risk factors for schizophrenia, but it is unclear if schizophrenia genetic risk alleles contribute to this association. STUDY DESIGN: In this systematic review and meta-analysis, we assessed the evidence for gene-environment correlation (genes influence likelihood of environmental exposure) between schizophrenia polygenic risk score (PRS) and reported childhood adversity. We also assessed the evidence for a gene-environment interaction (genes influence sensitivity to environmental exposure) in relation to the outcome of schizophrenia and/or psychosis. This study was registered on PROSPERO (CRD42020182812). Following PRISMA guidelines, a search for relevant literature was conducted using Cochrane, MEDLINE, PsycINFO, Web of Science, and Scopus databases until February 2022. All studies that examined the association between schizophrenia PRS and childhood adversity were included. STUDY RESULTS: Seventeen of 650 identified studies met the inclusion criteria and were assessed against the Newcastle-Ottawa Scale for quality. The meta-analysis found evidence for gene-environment correlation between schizophrenia PRS and childhood adversity (r = .02; 95% CI = 0.01, 0.03; P = .001), but the effect was small and therefore likely to explain only a small proportion of the association between childhood adversity and psychosis. The 4 studies that investigated a gene-environment interaction between schizophrenia PRS and childhood adversity in increasing risk of psychosis reported inconsistent results. CONCLUSIONS: These findings suggest that a gene-environment correlation could explain a small proportion of the relationship between reported childhood adversity and psychosis.

Use of Telemedicine in Care of Hematologic Malignancy Patients: Challenges and Opportunities.

PURPOSE OF REVIEW: For nearly 20 years, oncology specialty practices have been working to integrate telemedicine technologies into standard patient care models. However, hematology practices have been slower to adopt telemedicine due to traditional care models that rely on interdisciplinary regional care centers and their ability to provide comprehensive and centralized services. Patients have traditionally been able to access high-quality medical care, diagnostics, supportive care, and clinical trials from these regional care centers, but they are required to attend frequent in-person visits to access these services. Rural and underserved patients experience more barriers than their urban counterparts to access the same level of care. RECENT FINDINGS: The COVID-19 pandemic has elevated telemedicine into the forefront of care, highlighting both promise and limitations to incorporating telemedicine into specialty hematology care. Hematologists should consider the benefits of incorporating telemedicine technologies into standard-of-care practices to promote patient-centered care and provide equal access to all patient populations.

The unintended consequences of COVID-19 public health measures on health care for children with medical complexity.

AIM: The aim of this work is to explore the unintended consequences of pandemic public health measures on health care service usage by children with medical complexity. BACKGROUND: Medical complexity is characterized by the presence of complex, chronic conditions requiring specialized care, substantial health needs, functional dependence and/or limitations, and frequent health care usage. Children with medical complexity are among the highest users of paediatric health care services. METHODS: A web-based, cross-sectional survey was conducted in British Columbia, Canada, between August and September 2020. Inclusion criteria were (a) parent/guardian of at least one child (age 0 to 18 years, inclusive) with medical complexity and (b) residence in British Columbia. A convenience sample of 156 parents completed the survey. Data were analysed using a series of descriptive analyses (frequencies, cross-tabulations) and inferential analyses (binary logistic regressions). RESULTS: Respondents provided information for 188 children with medical complexity. Access to allied health therapies (physio, occupational, and speech and language) and medical specialists drastically declined in the initial months of the pandemic, with a shift from in-person to virtual platforms for these aspects of care. Regression modelling indicated that age and family structure influenced decisions to use in-patient hospital services. CONCLUSIONS: Public health measures implemented in the initial months of the pandemic decreased access to health care services for children with medical complexity. The long-term ramifications of these measures are unknown. Family structure was found to influence decisions to avoid accessing Emergency Department care. Given the volume of services used by these children, paediatric hospital leaders need to take their unique needs into consideration in disaster planning to ensure minimal disruptions in care.

Interlibrary loan and document delivery in North American health sciences libraries during the early months of the COVID-19 pandemic.

Objective: The study purpose was to understand how early months of the COVID-19 pandemic altered interlibrary loan (ILL) and document delivery (DD) in North American health science libraries (HSLs), specifically the decision-making and workflow adjustments associated with accessing their own collections and obtaining content not available via ILL. Methods: Researchers distributed an online 26-question survey through 24 health science library email lists from January 6-February 7, 2021. Respondents reported their library's ILL and DD activities from March-August 2020, including ILL/DD usage and policies, collection access, decision-making, and workflow adjustments. In addition to calculating frequencies, cross-tabulation and statistical tests were performed to test a priori potential associations. Two researchers independently and thematically analyzed responses to the 2 open-ended questions and reached consensus on themes. Results: Hospital libraries represented 52% (n=226/431) of respondents, along with 42% academic (n=179) and 6% (n=26) multi-type or other special. Only 1% (n=5) closed completely with no remote services, but many, 45% (n=194), ceased ILL of print materials. More than half (n=246/423; 58%) agreed that ILL requests likely to be filled from print remained unfilled more than is typical. Open-ended questions yielded 5 themes on ILL/DD staffing, setup, and systems; 6 on impacts for libraries and library users. Conclusion: Lack of communication regarding collection availability and staffing resulted in delayed or unfilled requests. Hospital and academic libraries made similar decisions about continuing services but reported different experiences in areas such as purchasing digital content. Hybrid ILL/DD workflows may continue for managing these services.

Community lives of adolescents across multiple special needs: Discrimination, community belonging, trusted people, leisure activities, and friends.

We sought to gain insights into the community lives, experiences, and activities of adolescents across multiple categories of special needs. Specifically, we: explored the particular aspects of their lives adolescents felt elicited discrimination; determined whether adolescents feel a sense of community belongingness, as well as the categories of people whom adolescents approach when help is needed; and detailed the leisure activities respondents undertake and with which frequency, in addition to the quantity of friendships they have. We performed assorted descriptive analyses of the McCreary Centre Society's 2013 British Columbia Adolescent Health Survey (BCAHS) database. We found tremendous variation in the survey responses of adolescents, both within and between special needs categories, highlighting the importance of such exploratory analyses. This paper provides inductive population-based evidence to inform theories about the community lives of adolescents with special needs, as well as to guide programs and policies targeting such youth.

Systematic review and meta-analysis of patient race/ethnicity, socioeconomics, and quality for adult type 2 diabetes.

OBJECTIVE: To review the evidence of the association between performance in eight indicators of diabetes care and a patient's race/ethnicity and socioeconomic characteristics. DATA SOURCE: Studies of adult patients with type 2 diabetes in MEDLINE published between January 1, 2000, and December 31, 2018. STUDY DESIGN: Systematic review and meta-analysis of regression-based studies including race/ethnicity and income or education as explanatory variables. Meta-analysis was used to quantify differences in performance associated with patient race/ethnicity or socioeconomic characteristics. The systematic review was used to identify potential mechanisms of disparities. DATA COLLECTION: Two coauthors separately conducted abstract screening, study exclusions, data extraction, and scoring of retained studies. Estimates in retained studies were extracted and, where applicable, were standardized and converted to odds ratios and standard errors. PRINCIPAL FINDINGS: Performance in intermediate outcomes and process measures frequently exhibited differences by race/ethnicity even after adjustment for socioeconomic, lifestyle, and health factors. Meta-analyses showed black patients had lower odds of HbA1c and blood pressure (BP) control (OR range: 0.67-0.68, P < .05) but higher odds of receiving eye or foot examination (OR range: 1.22-1.47, P < .05) relative to white patients. A high school degree or more was associated with higher odds of HbA1c control and receipt of eye examinations compared to patients without a degree. Meta-analyses of income included a handful of studies and were inconsistently associated with diabetes care performance. Differences in diabetes performance appear to be related to access-related factors such as uninsurance or lacking a usual source of care; food insecurity and trade-offs at very low incomes; and lower adherence among younger and healthier diabetes patients. CONCLUSIONS: Patient race/ethnicity and education were associated with differences in diabetes quality measures. Depending on the approach used to rate providers, not adjusting for these patient characteristics may penalize or reward providers based on the populations they serve.

Barriers and facilitators to depression screening in older adults: a qualitative study.

Objectives: The objective of this qualitative study was to better understand facilitators and barriers to depression screening for older adults.Methods: We conducted 43 focus groups with 102 providers and 247 beneficiaries or proxies: 13 focus groups with Medicare providers, 28 with older Medicare beneficiaries, and 2 with caregivers of older Medicare beneficiaries. Each focus group was recorded, transcribed, and analyzed using principles of grounded theory.Results: There was widespread consensus among beneficiary and provider focus group participants that depression screening was important. However, several barriers interfered with effective depression screening, including stigma, lack of resources for treatment referrals, and lack of time during medical encounters. Positive communication with providers and an established relationship with a trusted provider were primary facilitators for depression screening. Providers who took the time to put their beneficiaries at ease and used conversational language rather than clinical terms appeared to have the most success in eliciting beneficiary honesty about depressive symptoms. Respondents stressed the need for providers to be attentive, concerned, non-judgmental, and respectful.Conclusion: Findings indicate that using person-centered approaches to build positive communication and trust between beneficiaries and providers could be an effective strategy for improving depression screening. Better screening can lead to higher rates of diagnosis and treatment of depression that could enhance quality of life for older adults.

Hospital utilization and expenditures among a nationally representative sample of Medicare fee-for-service beneficiaries 2 years after receipt of an Annual Wellness Visit.

Medicare's Annual Wellness Visit (AWV) provides an opportunity to link beneficiaries to cancer screenings and immunizations, however, research has not examined its effectiveness. The aim of this study was to examine the effect of receiving an AWV on outcomes while accounting for the healthy user effect. This study used 2013-2017 Medicare claims data to compare hospital utilization and total expenditures among a 5% random sample of Medicare fee-for-service (FFS) beneficiaries with and without AWV use in 2014 (228,053 AWV users were propensity-score matched to 228,053 nonusers). Linear fixed effects regression models examined differences in study outcomes 12 and 24 months after AWV use, controlling for baseline differences in sociodemographics, health status, utilization, and accountable care organization attribution. The proportion of Medicare FFS beneficiaries that used the AWV increased from 13% in 2013 to 24% in 2017. Users of the AWV had a marginally significant reduction in Medicare spending 12 months (-$122, 95% CI -$256, $11, p = 0.073) and significant reductions (-$162, 95% CI, -$310, -$14, p = 0.032) 24 months after the visit, relative to non-users. However it remains unclear what is driving these savings as there was no change in hospital-related utilization and results may still be biased due to inherent differences between users and non-users. The AWV provides an opportunity for providers to focus on prevention and geriatric needs not covered in typical office visits. Practices adopting AWVs have noted increased revenue, more stable patient populations, and stronger provider-patient relationships. While utilization remains low, it is steadily increasing over time.

Multidrug-Resistant Salmonella I 4,[5],12:i:- and Salmonella Infantis Infections Linked to Whole Roasted Pigs from a Single Slaughter and Processing Facility.

We describe two outbreaks of multidrug-resistant (MDR) Salmonella I 4,[5],12:i:- infection, occurring in 2015 to 2016, linked to pork products, including whole roaster pigs sold raw from a single Washington slaughter and processing facility (establishment A). Food histories from 80 ill persons were compared with food histories reported in the FoodNet 2006 to 2007 survey of healthy persons from all 10 U.S. FoodNet sites who reported these exposures in the week before interview. Antimicrobial susceptibility testing and whole genome sequencing were conducted on selected clinical, food, and environmental isolates. During 2015, a total of 192 ill persons were identified from five states; among ill persons with available information, 30 (17%) of 180 were hospitalized, and none died. More ill persons than healthy survey respondents consumed pork (74 versus 43%, P < 0.001). Seventeen (23%) of 73 ill persons for which a response was available reported attending an event where whole roaster pig was served in the 7 days before illness onset. All 25 clinical isolates tested from the 2015 outbreak and a subsequent 2016 smaller outbreak (n = 15) linked to establishment A demonstrated MDR. Whole genome sequencing of clinical, environmental, and food isolates (n = 69) collected in both investigations revealed one clade of highly related isolates, supporting epidemiologic and traceback data that establishment A as the source of both outbreaks. These investigations highlight that whole roaster pigs, an uncommon food vehicle for MDR Salmonella I 4,[5],12:i:- outbreaks, will need further attention from food safety researchers and educators for developing science-based consumer guidelines, specifically with a focus on the preparation process.

States Encouraging Value-Based Payment: Lessons From CMS's State Innovation Models Initiative.

Policy Points Six states received $250 million under the federal State Innovation Models (SIM) Initiative Round 1 to increase the proportion of care delivered under value-based payment (VBP) models aligned across multiple payers. Multipayer alignment around a common VBP model occurred within the context of state regulatory and purchasing policies and in states with few commercial payers, not through engaging many stakeholders to act voluntarily. States that made targeted infrastructure investments in performance data and electronic hospital event notifications, and offered grants and technical assistance to providers, produced delivery system changes to enhance care coordination even where VBP models were not multipayer. CONTEXT: In 2013, six states (Arkansas, Massachusetts, Maine, Minnesota, Oregon, and Vermont) received $250 million in Round 1 State Innovation Models (SIM) awards to test how regulatory, policy, purchasing, and other levers available to state governments could transform their health care system by implementing value-based payment (VBP) models that shift away from fee-for-service toward payment based on quality and cost. METHODS: We gathered and analyzed qualitative data on states' implementation of their SIM Initiatives between 2014 and 2018, including interviews with state officials and other stakeholders; consumer and provider focus groups; and review of relevant state-produced documents. FINDINGS: State policymakers leveraged existing state law, new policy development, and federal SIM Initiative funds to implement new VBP models in Medicaid. States' investments promoted electronic health information going from hospitals to primary care providers and collaboration across care team members within practices to enhance care coordination. Multipayer alignment occurred where there were few commercial insurers in a state, or where a state law or state contracting compelled commercial insurer participation. Challenges to health system change included commercial payer reluctance to coordinate on VBP models, cost and policy barriers to establishing bidirectional data exchange among all providers, preexisting quality measurement requirements across payers that impede total alignment of measures, providers' perception of their limited ability to influence patients' behavior that puts them at financial risk, and consumer concerns with changes in care delivery. CONCLUSIONS: The SIM Initiative's test of the power of state governments to shape health care policy demonstrated that strong state regulatory and purchasing policy levers make a difference in multipayer alignment around VBP models. In contrast, targeted financial investments in health information technology, data analytics, technical assistance, and workforce development are more effective than policy alone in encouraging care delivery change beyond that which VBP model participation might manifest.

Medicaid Accountable Care Organizations in Four States: Implementation and Early Impacts.

Policy Points Maine, Massachusetts, Minnesota, and Vermont leveraged State Innovation Model awards to implement Medicaid accountable care organizations (ACOs). Flexibility in model design, ability to build on existing reforms, provision of technical assistance to providers, and access to feedback data all facilitated ACO development. Challenges included sustainability of transformation efforts and the integration of health care and social service providers. Early estimates showed promising improvements in hospital-related utilization and Vermont was able to reduce or slow the growth of Medicaid costs. These states are sustaining Medicaid ACOs owing in part to provider support and early successes in generating shared savings. The states are modifying their ACOs to include greater accountability and financial risk. CONTEXT: As state Medicaid programs consider alternative payment models (APMs), many are choosing accountable care organizations (ACOs) as a way to improve health outcomes, coordinate care, and reduce expenditures. Four states (Maine, Massachusetts, Minnesota, and Vermont) leveraged State Innovation Model awards to create or expand Medicaid ACOs. METHODS: We used a mixed-methods design to assess achievements and challenges with ACO implementation and the impact of Medicaid ACOs on health care utilization, quality, and expenditures in three states. We integrated findings from key informant interviews, focus groups, document review, and difference-in-difference analyses using data from Medicaid claims and an all-payer claims database. FINDINGS: States built their Medicaid ACOs on existing health care reforms and infrastructure. Facilitators of implementation included allowing flexibility in design and implementation, targeting technical assistance, and making clinical, cost, and use data readily available to providers. Barriers included provider concerns about their ability to influence patient behavior, sustainability of provider practice transformation efforts when shared savings are reinvested into the health system and not shared with participating clinicians, and limited integration between health care and social service providers. Medicaid ACOs were associated with some improvements in use, quality, and expenditures, including statistically significant reductions in emergency department visits. Only Vermont's ACO demonstrated slower growth in total Medicaid expenditures. CONCLUSIONS: Four states demonstrated that adoption of ACOs for Medicaid beneficiaries was both possible and, for three states, associated with some improvements in care. States revised these models over time to address stakeholder concerns, increase provider participation, and enable some providers to accept financial risk for Medicaid patients. Lessons learned from these early efforts can inform the design and implementation of APMs in other Medicaid programs.

How Much Does Medication Nonadherence Cost the Medicare Fee-for-Service Program?

BACKGROUND: Medication adherence is associated with lower health care utilization and savings in specific patient populations; however, few empirical estimates exist at the population level. OBJECTIVE: The main objective of this study was to apply a data-driven approach to obtain population-level estimates of the impact of medication nonadherence among Medicare beneficiaries with chronic conditions. RESEARCH DESIGN: Medicare fee-for-service (FFS) claims data were used to calculate the prevalence of medication nonadherence among individuals with diabetes, heart failure, hypertension, and hyperlipidemia. Per person estimates of avoidable health care utilization and spending associated with medication adherence, adjusted for healthy adherer effects, from prior literature were applied to the number of nonadherent Medicare beneficiaries. SUBJECTS: A 20% random sample of community-dwelling, continuously enrolled Medicare FFS beneficiaries aged 65 years or older with Part D (N=14,657,735) in 2013. MEASURES: Avoidable health care costs and hospital use from medication nonadherence. RESULTS: Medication nonadherence for diabetes, heart failure, hyperlipidemia, and hypertension resulted in billions of Medicare FFS expenditures, millions in hospital days, and thousands of emergency department visits that could have been avoided. If the 25% of beneficiaries with hypertension who were nonadherent became adherent, Medicare could save $13.7 billion annually, with over 100,000 emergency department visits and 7 million inpatient hospital days that could be averted. CONCLUSION: Medication nonadherence places a large resource burden on the Medicare FFS program. Study results provide actionable information for policymakers considering programs to manage chronic conditions. Caution should be used in summing estimates across disease groups, assuming all nonadherent beneficiaries could become adherent, and applying estimates beyond the Medicare FFS population.