How donanemab data address the coverage with evidence development questions.

The Centers for Medicare & Medicaid Services (CMS) established a class-based National Coverage Determination (NCD) for monoclonal antibodies directed against amyloid for Alzheimer's disease (AD) with patient access through Coverage with Evidence Development (CED) based on three questions. This review, focused on donanemab, answers each of these CED questions with quality evidence. TRAILBLAZER-ALZ registration trials are presented with supporting literature and real-world data to answer CED questions for donanemab. TRAILBLAZER-ALZ registration trials demonstrated that donanemab significantly slowed cognitive and functional decline in amyloid-positive early symptomatic AD participants, and lowered their risk of disease progression while key safety risks occurred primarily within the first 6 months and then declined. Donanemab meaningfully improved health outcomes with a manageable safety profile in an early symptomatic AD population, representative of Medicare populations across diverse practice settings. The donanemab data provide the necessary level of evidence for CMS to open a reconsideration of their NCD. HIGHLIGHTS: Donanemab meaningfully improved outcomes in trial participants with early symptomatic Alzheimer's disease. Comorbidities in trial participants were consistent with the Medicare population. Co-medications in trial participants were consistent with the Medicare population. Risks associated with treatment tended to occur in the first 6 months. Risks of amyloid-related imaging abnormalities were managed with careful observation and magnetic resonance imaging monitoring.

The Association of School Nurse Workload With Student Health and Academic Outcomes: A Cross-Sectional Study.

This study assessed associations between school nurse workload and student health and academic outcomes. We hypothesized that lower school nurse workload would be associated with better student outcomes, with associations being greater for members of groups who experience health disparities. Our methods entailed secondary analysis of data for New York City school students in kindergarten through 12th grade during 2015-2016 (N = 1,080,923), using multilevel multivariate regression as the analytic approach. Results demonstrated lower school nurse workload was associated with better outcomes for student participation in asthma education but not chronic absenteeism, early dismissals, health office visits, immunization compliance, academic achievement, or overweight/obesity. Our findings suggest school nurses may influence proximal outcomes, such as participation in disease-related education, more easily than downstream outcomes, such as absenteeism or obesity. While contrary to our hypotheses, results align with the fact that school nurses deliver community-based, population health-focused care that is inherently complex, multilevel, and directly impacted by social determinants of health. Future research should explore school nurses' perspectives on what factors influence their workload and how they can best impact student outcomes.

Does "wearing off" of efficacy occur in galcanezumab-treated patients at the end of the monthly treatment cycle? Post hoc analyses of four phase III randomized trials.

OBJECTIVE: The purpose of this study was to propose a definition of "wearing off" at the individual patient-level and determine the percentage of patients with migraine who experience "wearing off" of efficacy of galcanezumab at the end of a treatment cycle using this predefined threshold. BACKGROUND: Anecdotal reports suggest that some patients may experience "wearing off" of efficacy during the last week of their calcitonin gene-related peptide monoclonal antibody treatment cycle. A previous post hoc analysis of galcanezumab demonstrated consistent efficacy at each week throughout all monthly dosing intervals at the population-level, but "wearing off" has not been assessed at the individual patient-level. METHODS: Post hoc analyses of clinical trial data from four galcanezumab phase III, randomized, placebo-controlled studies in a total of 2680 patients with high-frequency episodic migraine (EVOLVE-1, EVOLVE-2, and CONQUER studies) or chronic migraine (CM; REGAIN and CONQUER studies) were conducted. "Wearing off" was defined as an increase of greater than or equal to 2 weekly migraine headache days in the last week of the treatment cycle compared to the second week for at least 2 months. The analyses were conducted (1) in all patients and (2) in patients with a clinically meaningful response to treatment. RESULTS: The percentage of patients meeting the threshold of "wearing off" was not statistically significantly different among the placebo, galcanezumab 120 mg, and galcanezumab 240 mg treatment groups, both in the total population and in patients with a clinically meaningful response (all ≤9.0%). Although the frequency of "wearing off" in patients with CM and prior preventive failures was numerically greater in the galcanezumab groups (8/89 or 9.0%) compared to placebo (3/95 or 3.2%), these differences were not statistically significant. CONCLUSIONS: Consistent with previous analyses at the population-level that showed no evidence of decreased efficacy at the end of a treatment cycle, rates of individual patients meeting the threshold of "wearing off" in this analysis were low and similar among placebo, galcanezumab 120 mg, and galcanezumab 240 mg treatment groups.

Situating nursing science and public health within a shared context.

The purpose of this editorial is to discuss the opportunities associated with situating nursing science and public health within a shared context as an avenue for nursing to capitalize on its strong foundation for promoting health equity and mitigating the many social and structural determinants of poor health. We highlight one example of how this might be done, by housing departments of nursing in larger colleges of public health. Conducting nursing science within a college of public health presents both opportunities and challenges which are discussed here. Considering the benefits and challenges of collectively situating nursing and public health with a shared context creates numerous natural starting points for productive conversation, collaboration, and discovery that can benefit both public health and nursing's ability to interrogate past harms and transform our approach to move towards a more healthy and equitable future for all.

The early effects of cumulative and individual adverse childhood experiences on child diet: Examining the role of socioeconomic status.

Adverse Childhood Experiences (ACEs) have been associated with detrimental long-term health outcomes, including obesity risk. Existing research has yet to examine whether early life ACEs are associated with diet in early childhood within socioeconomic subgroups. Data were drawn from the Early Childhood Longitudinal Study-Birth Cohort (2001-2002). Mother-child dyads (n = 7000) were recruited when children were 9-months old, and followed longitudinally at 2 years, and 4 years. Mothers reported children's exposure to five ACEs at 9-months and 2 years and children's daily intake of fruits, vegetables, sweet snacks, and sugar-sweetened beverages (SSBs) at 4 years. Weighted multiple linear regression models tested the effect of cumulative and individual ACEs on child diet in full, low-, and high-SES samples. Cumulative ACE score was inversely associated with frequency of fruit intake in full (b = -0.08, p = 0.005) and low-SES samples (b = -0.10, p < 0.001). Domestic violence was associated with less frequent fruit intake in full (b = -0.21, p = 0.01) and low-SES samples (b = -0.29 p = 0.008). In the full sample, incarceration was associated with less frequent fruit intake (b = -0.24, p = 0.02), and domestic violence was associated with higher sweet snack (b = 0.22, p = 0.01) and SSB intake (b = 0.27, p = 0.009). Results provide preliminary evidence on the association between cumulative and specific ACEs and child diet, and how this relationship varies by SES context. Future research is needed to understand the complex multi-level mechanisms operating along this pathway in order to inform interventions supporting behavior change and to build evidence for policies that may reduce diet-related disparities in ACE exposure.

The impact of change in neighborhood poverty on BMI trajectory of 37,544 New York City youth: a longitudinal study.

BACKGROUND: Neighborhood poverty may increase childhood obesity risk. However, evidence for the neighborhood poverty-obesity relationship is limited. The purpose of this study was to examine how moving to a higher or lower poverty neighborhood impacts body mass index (BMI) z-score trajectories among youth, with the goal of informing policy change, interventions, and clinical practices to reduce childhood obesity. METHODS: Methods entailed secondary analysis of existing longitudinal data. The sample included youth attending New York City public schools in grades kindergarten through twelfth from school years 2006/2007 through 2016/2017. Eligibility criteria included moving to a higher or lower poverty neighborhood during the data midpoint [school years 2010/2011 through 2013/2014] of the 12-year data-period; New York City-specific metrics were used to define both neighborhood (Neighborhood Tabulation Area) and relevant neighborhood poverty levels (< 5, 5 to < 10%, 10 to < 20%, 20 to < 30%, 30 to < 40% and ≥ 40% of individuals below Federal Poverty Level). Two-piece latent growth curve models were used to describe BMI z-score trajectories of youth who moved to higher versus lower poverty neighborhoods, with propensity score weighting to account for preexisting differences between the two groups. Primary analyses were stratified by sex and exploratory subgroup analyses were stratified by sex and developmental stage (early childhood, middle childhood, and adolescence) to explore sensitive periods for neighborhood poverty exposure. RESULTS: Of 532,513 youth with home address data, 18,370 youth moved to a higher poverty neighborhood and 19,174 moved to a lower poverty neighborhood (n = 37,544). Females and males who moved to a higher poverty neighborhood experienced less favorable BMI z-score trajectories for obesity risk, though effects were small. Exploratory subgroup analyses demonstrated that negative effects of neighborhood poverty were most pronounced among young and adolescent females and young males, whereas effects were mixed for other subgroups. CONCLUSIONS: Youth who moved to higher poverty neighborhoods experienced less favorable BMI z-score trajectories for obesity risk, though effects were small and most consistent for females and younger youth. Additional research is needed to illuminate neighborhood poverty's impact on obesity, in order to inform policy, intervention, clinical, and research efforts to reduce obesity and improve child well-being.

The Association between Parents and Children Meeting Physical Activity Guidelines.

PURPOSE: To examine the association between parents and children meeting physical activity (PA) guidelines, by gender, among 8-12 year old children with BMI ≥75th percentile DESIGN AND METHODS: This was a secondary analysis of baseline data from a school-based healthy weight management intervention in Minnesota for 8-12 year old children. Survey data about PA participation were collected from 2014 through 2018. Analyses entailed descriptive statistics and multivariate logistic regression controlling for child age, race/ethnicity, BMIz, child's perception of parent support for activity, and number of sports played. RESULTS: Children's (n = 132) mean age was 9.32 ± 0.89 years, 49% were female, 63% were members of racial/ethnic minority groups, and 33% met PA Guidelines (≥60 minutes daily). Parents' (n = 132) mean age was 39.11 ± 7.05 years, mean BMI of 30.90 ± 8.44, 94% were female, 42% were members of racial/ethnic minority groups, and 57% met PA Guidelines for Americans (≥150 minutes moderate or >75 minutes vigorous PA weekly). There was no association between parents and children meeting PA guidelines for the total sample (OR = 1.43, 95% CI = 0.63-3.24, p = 0.39) or girls (OR = 0.65, 95% CI = 0.18-2.33, p = 0.51). Boys whose parents met PA guidelines had 3.84 times greater odds of meeting PA guidelines (95% CI = 1.28-13.4, p = 0.04). CONCLUSIONS: PA interventions for boys may benefit from focus on parents' PA. Further research should investigate correlates of girls' PA. PRACTICE IMPLICATIONS: Pediatric nurses working with children to increase PA should encourage parents' PA. For parents of boys, this may increase the child's PA. Considered broadly, nurses should be aware of gender influences on children's engagement in PA.

The influence of empowered work environments on the psychological experiences of nursing assistants during COVID-19: a qualitative study.

BACKGROUND: Nursing Assistants (NA) who feel empowered tend to perform their duties better, have higher morale and job satisfaction, and are less likely to leave their jobs. Organizational empowerment practices in hospitals likely shape the psychological experiences of empowerment among these personnel; however, little is known about this relationship. OBJECTIVE: We used qualitative inquiry to explore the relationship between organizational empowerment structural components and feelings of psychological empowerment among hospital frontline workers during a public health emergency. METHODS: Kanter's Theory of Structural Empowerment and Spreitzer's Psychological Empowerment in the Workplace Framework were applied to identify the conceptual influences of organizational practices on psychological experiences of empowerment. In-depth interviews were conducted with a convenience sample of NAs, caring for hospitalized COVID-19 patients. Directed content analysis was performed to generate a data matrix consisting of the psychological experiences of meaning, competence, self-determination, and impact embedded under the organizational structural components of information, resources, support, and opportunity. RESULTS: Thirteen NAs (mean age = 42 years, 92% female) completed interviews. Information, or lack thereof, provided to the NAs influenced feelings of fear, preparation, and autonomy. Resources (e.g., protocols, equipment, and person-power) made it easier to cope with overwhelming emotions, affected the NAs' abilities to do their jobs, and when limited, drove NAs to take on new roles. NAs noted that support was mostly provided by nurses and made the NAs feel appreciated, desiring to contribute more. While NAs felt they could consult leadership when needed, several felt leadership showed little appreciation for their roles and contributions. Similar to support, the opportunity to take care of COVID-19 patients yielded a diverse array of emotions, exposed advances and gaps in NA preparation, and challenged NAs to autonomously develop new care practices and processes. CONCLUSION: Management and empowerment of healthcare workers are critical to hospital performance and success. We found many ways in which the NAs' psychological experiences of empowerment were shaped by the healthcare system's empowerment-related structural conditions during a public health emergency. To further develop an empowered and committed critical workforce, hospitals must acknowledge the organizational practice influence on the psychological experiences of empowerment among NAs.

Using a Community Workgroup Approach to Increase Access to Physical Activity in an Underresourced Urban Community.

Background. Regular physical activity is associated with improved physical and psychosocial well-being. Increasing access to physical activity in underresourced communities requires collaborative, community-engaged methods. One such method is community workgroups. Purpose. The purpose of this article is to describe implementation, strengths, challenges, and results of the workgroup approach as applied to increasing access to physical activity, using our recent study as an illustrative example. Method. A 1-day conference was held in April 2017 for community leaders. The first half of the conference focused on disseminating results of a multifaceted community assessment. The second half entailed community workgroups. Workgroups focused on applying community assessment results to develop strategies for increasing access to physical activity, with plans for ongoing workgroup involvement for strategy refinement and implementation. A professional artist documented the workgroup process and recommendations via graphic recording. Results. Sixty-three community leaders attended the conference and participated in the workgroups. Workgroup participants reported that greater macrosystem collaboration was critical for sustainability of physical activity programming and that, particularly in underresourced urban communities, re-imagining existing spaces (rather than building new spaces) may be a promising strategy for increasing access to physical activity. Discussion. Considered collectively, the community workgroup approach provided unique insight and rich data around increasing access to physical activity. It also facilitated stakeholder engagement with and ownership of community health goals. With careful implementation that includes attention to strengths, challenges, and planning for long-term follow-up, the community workgroup approach can be used to develop health promotion strategies in underresourced communities.

Reconciling opposing perceptions of access to physical activity in a gentrifying urban neighborhood.

OBJECTIVE: We sought to understand perspectives on access to physical activity in a gentrifying neighborhood. DESIGN: This qualitative descriptive study used street intercept interviews and photo documentation. SAMPLE: Participants included members (n = 19) of a gentrifying neighborhood in a northeastern city. RESULTS: Participants held markedly different perceptions of opportunities for physical activity. Some participants, particularly area university students or those who are identified as White, perceived the neighborhood as favorable to physical activity, with high walkability and abundant resources. Other participants, particularly those who identified as Black or African-American, felt it was difficult to be physically active because neighborhood recreation facilities are scarce or unaffordable and parks are poorly maintained or unsafe. Multiple participants noted strategies to overcome neighborhood barriers to physical activity. Regardless of neighborhood perceptions, family and friends played an important role in influencing physical activity. CONCLUSIONS: Nurses must consider how disparities in actual and perceived access to neighborhood resources influence participation in physical activity, particularly in gentrifying neighborhood. Public health nurses are embedded in the neighborhoods that they serve, providing a unique opportunity to understand and address the impact of neighborhood on health.

Addressing the Social Determinants of Health: A Call to Action for School Nurses.

Social determinants of health (SDOH), the conditions in which children are born, grow, live, work or attend school, and age, impact child health and contribute to health disparities. School nurses must consider these factors as part of their clinical practice because they significantly and directly influence child well-being. We provide clinical guidance for addressing the SDOH when caring for children with three common health problems (obesity, insufficient sleep, and asthma). Given their unique role as school-based clinical experts, care coordinators, and student advocates, school nurses are well suited to serve as leaders in addressing SDOH.

Prevalence of rheumatoid arthritis in the United States adult population in healthcare claims databases, 2004-2014.

This study aimed to determine the prevalence of rheumatoid arthritis in the United States (US) adult insured population from 2004 to 2014. This was an observational, retrospective, cross-sectional study based on US administrative health insurance claims databases (Truven Health MarketScan® Research database and IMS PharMetrics Plus database). Trends in RA prevalence focusing on the 10-year period covering January 1, 2004-December 31, 2014 were analyzed using a validated algorithm for the identification of RA. Prevalence rates in the databases were determined and age- and gender-adjusted rates were projected to the US population in 2014. Analysis of data from the two databases indicated that the RA prevalence rate in commercially insured adult US population ranged from 0.41 to 0.54% from 2004 to 2014. The prevalence varied substantially by gender and age in each year and increased gradually across the years for most subgroups. In 2014, out of 31,316,902 adult patients with continuous enrollment in the Truven Health MarketScan® Research database, 157,634 (0.50%) patients met our criteria for RA. Similarly, out of 35,083,356 adult patients in the IMS PharMetrics Plus database, 139,300 (0.50%) patients met our criteria for RA. In 2014, the overall age-adjusted prevalence of RA ranged from 0.53 to 0.55% (0.29-0.31% for males and 0.73-0.78% for females). The prevalence of RA in the US appeared to increase during the period from 2004 to 2014, affecting a conservative estimate of 1.28-1.36 million adults in 2014.

Implementation of a School Nurse-led Intervention for Children With Severe Obesity in New York City Schools.

PURPOSE: The Healthy Options and Physical Activity Program (HOP) is a school nurse-led intervention for children with severe obesity. HOP was developed by experts at the New York City Department of Health and Mental Hygiene and implemented in New York City schools beginning in 2012. The purpose of this study was to evaluate HOP implementation with the goal of informing HOP refinement and potential future HOP dissemination. DESIGN AND METHODS: This study entailed a retrospective analysis of secondary data. Analytic methods included descriptive statistics, Wilcoxon rank sum and Chi square tests, and multivariate logistic regression. RESULTS: During the 2012-2013 school year, 20,518 children were eligible for HOP. Of these, 1054 (5.1%) were enrolled in the program. On average, enrolled children attended one HOP session during the school year. Parent participation was low (3.2% of HOP sessions). Low nurse workload, low school poverty, higher grade level, higher BMI percentile, and chronic illness diagnosis were associated with student enrollment in HOP. CONCLUSIONS: As currently delivered, HOP is not likely to be efficacious. Lessons learned from this evaluation are applicable to future nurse-led obesity interventions. PRACTICE IMPLICATIONS: Prior to implementing a school nurse-led obesity intervention, nursing workload and available support must be carefully considered. Interventions should be designed to facilitate (and possibly require) parent involvement. Nurses who deliver obesity interventions may require additional training in obesity treatment. With attention to these lessons learned, evidence-based school nurse-led obesity interventions can be developed.

Dance for Health: An Intergenerational Program to Increase Access to Physical Activity.

PURPOSE: The purpose of this study was to evaluate Dance for Health, an intergenerational program to increase access to physical activity in an underserved, high risk urban community. DESIGN AND METHODS: Dance for Health was developed using community-based participatory research methods and evaluated using an observational study design. The program entailed two hour line dancing sessions delivered by trained dance instructors in the neighborhood recreation center. The weekly sessions were delivered for one month in the spring and one month in the fall from 2012-2016. Nurse practitioner students mentored local high school students to assess outcomes: achievement of target heart rate, Borg Rating of Perceived Exertion, number of pedometer steps during dance session, Physical Activity Enjoyment Scale, and adiposity. Analytic methods included descriptive statistics and mixed effects models. RESULTS: From 2012-2016, 521 participants ranging from 2-79 years attended Dance for Health. Approximately 50% of children and 80% of adults achieved target heart rate. Achievement of target heart rate was not related to perceived exertion, though it was related to pedometer steps in adults. All participants rated the program highly for enjoyment. There was no change in adiposity. CONCLUSIONS: Dance for Health demonstrated high levels of community engagement and enjoyment. It led to adequate levels of exertion, particularly for adults. Our evaluation can inform program refinement and future intergenerational physical activity programs. PRACTICE IMPLICATIONS: Dance is an enjoyable, culturally appropriate, low cost method for increasing access to physical activity for children and families.

What Barriers and Facilitators Do School Nurses Experience When Implementing an Obesity Intervention?

A recent evaluation of a school nurse-led obesity intervention demonstrated a 5% implementation rate. The purpose of this study was to explore school nurses' perceived barriers to and facilitators of the intervention in order to understand reasons for the low implementation rate. Methods included semi-structured individual interviews with school nurses. Data were analyzed using content analysis and heat mapping. Nineteen nurses participated and eight themes were identified. Parental and administrative gatekeeping, heavy nurse workload, obesogenic environments, and concerns about obesity stigma were barriers to implementation. Teamwork with parents and school staff was a key facilitator of implementation. Nurses also noted the importance of cultural considerations and highlighted the need to tailor the intervention to the unique needs of their school environment and student population. These findings suggest that for school nurses to play a key role in school-based obesity interventions, barriers must be identified and addressed prior to program implementation.

Which Propensity Score Method Best Reduces Confounder Imbalance? An Example From a Retrospective Evaluation of a Childhood Obesity Intervention.

BACKGROUND: Propensity score (PS) methods are increasingly being employed by researchers to reduce bias arising from confounder imbalance when using observational data to examine intervention effects. OBJECTIVE: The purpose of this study was to examine PS theory and methodology and compare application of three PS methods (matching, stratification, weighting) to determine which best improves confounder balance. METHODS: Baseline characteristics of a sample of 20,518 school-aged children with severe obesity (of whom 1,054 received an obesity intervention) were assessed prior to PS application. Three PS methods were then applied to the data to determine which showed the greatest improvement in confounder balance between the intervention and control group. The effect of each PS method on the outcome variable-body mass index percentile change at one year-was also examined. SAS 9.4 and Comprehensive Meta-analysis statistical software were used for analyses. RESULTS: Prior to PS adjustment, the intervention and control groups differed significantly on seven of 11 potential confounders. PS matching removed all differences. PS stratification and weighting both removed one difference but created two new differences. Sensitivity analyses did not change these results. Body mass index percentile at 1 year decreased in both groups. The size of the decrease was smaller in the intervention group, and the estimate of the decrease varied by PS method. DISCUSSION: Selection of a PS method should be guided by insight from statistical theory and simulation experiments, in addition to observed improvement in confounder balance. For this data set, PS matching worked best to correct confounder imbalance. Because each method varied in correcting confounder imbalance, we recommend that multiple PS methods be compared for ability to improve confounder balance before implementation in evaluating treatment effects in observational data.

Proteolytic cleavage of antigen extends the durability of an anti-PCSK9 monoclonal antibody.

Lilly PCSK9 antibody LY3015014 (LY) is a monoclonal antibody (mAb) that neutralizes proprotein convertase subtilisin-kexin type 9 (PCSK9). LY decreases LDL cholesterol in monkeys and, unlike other PCSK9 mAbs, does not cause an accumulation of intact PCSK9 in serum. Comparing the epitope of LY with other clinically tested PCSK9 mAbs, it was noted that the LY epitope excludes the furin cleavage site in PCSK9, whereas other mAbs span this site. In vitro exposure of PCSK9 to furin resulted in degradation of PCSK9 bound to LY, whereas cleavage was blocked by other mAbs. These other mAbs caused a significant accumulation of serum PCSK9 and displayed a shorter duration of LDL-cholesterol lowering than LY when administered to mice expressing the WT human PCSK9. In mice expressing a noncleavable variant of human PCSK9, LY behaved like a cleavage-blocking mAb, in that it caused significant PCSK9 accumulation, its duration of LDL lowering was reduced, and its clearance (CL) from serum was accelerated. Thus, LY neutralizes PCSK9 and allows its proteolytic degradation to proceed, which limits PCSK9 accumulation, reduces the CL rate of LY, and extends its duration of action. PCSK9 mAbs with this property are likely to achieve longer durability and require lower doses than mAbs that cause antigen to accumulate.