The First 2 Years of Biosimilar Epoetin for Cancer and Chemotherapy-Induced Anemia in the U.S.: A Review from the Southern Network on Adverse Reactions.

Biosimilars are biologic drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety, and efficacy. Biosimilar epoetin received Food and Drug Administration (FDA) approval in 2018. The manufacturer received an FDA nonapproval letter in 2017, despite receiving a favorable review by FDA's Oncologic Drugs Advisory Committee (ODAC) and an FDA nonapproval letter in 2015 for an earlier formulation. We discuss the 2018 FDA approval, the 2017 FDA ODAC Committee review, and the FDA complete response letters in 2015 and 2017; review concepts of litigation, naming, labeling, substitution, interchangeability, and pharmacovigilance; review European and U.S. oncology experiences with biosimilar epoetin; and review the safety of erythropoiesis-stimulating agents. In 2020, policy statements from AETNA, United Health Care, and Humana indicated that new epoetin oncology starts must be for biosimilar epoetin unless medical need for other epoetins is documented. Empirical studies report that as of 2012, reference epoetin use decreased from 40%-60% of all patients with cancer with chemotherapy-induced anemia to <5% of such patients because of safety concerns. Between 2018 and 2020, biosimilar epoetin use varied, increasing to 81% among one private insurer's patients covered by Medicare whose cancer care is administered with Oncology Analytics and to 41% with the same private insurer's patients with cancer covered by commercial health insurance and administered by the private insurer, to 0% in several Veterans Administration Hospitals, increasing to 100% in one large county hospital in California, and with yet-to-be-reported data from most oncology settings. We conclude that biosimilar epoetin appears to have overcome some barriers since 2015, although current uptake in the U.S. is variable. Pricing and safety considerations for all erythropoiesis-stimulating agents are primary determinants of biosimilar epoetin oncology uptake. IMPLICATIONS FOR PRACTICE: Few oncologists understand substitution and interchangeability of biosimilars with reference drugs. Epoetin biosimilar is new to the market, and physician and patient understanding is limited. The development of epoetin biosimilar is not familiar to oncologists.

COVID-19 Response Resource Engagement and User Characteristics of the Wichealth Web-Based Nutrition Education System: Comparative Cross-sectional Study.

BACKGROUND: In response to the COVID-19 pandemic, Wichealth launched 4 information resources on the site's user landing dashboard page. These resources were used consistently during the period in which they were available (April 1, 2020, through October 31, 2021); however, only 9% (n=50,888) of Wichealth users eligible for inclusion in the study accessed at least one resource. User engagement with emergency response resources within the context of a web-based health educational tool has not been well investigated due to a paucity of opportunities and a lack of the ability to evaluate relevant users at scale. OBJECTIVE: This investigation was carried out to understand if user characteristics and behaviors measured by the Wichealth web-based education system are associated with a participant's motivation, or lack thereof, to engage with the added COVID-19 resources. METHODS: Sociodemographic characteristics were gathered from Wichealth users with at least one lesson completed and a complete user profile to identify which factors increase the likelihood of user access of any of the Wichealth COVID-19 response resources during the 19-month period between April 1, 2020, and October 31, 2021. A logistic regression analysis was conducted to determine the relative importance of all factors on the likelihood of a user accessing the COVID-19 resources. RESULTS: A total of 50,888 unique Wichealth users included in the study accessed the COVID-19 response resources 66,849 times during the time period. During the same period, 510,939 unique Wichealth users completed at least one lesson about how to engage in healthy behaviors with respect to parent-child feeding but did not access any COVID-19 resources. Therefore, only 9% of Wichealth users who completed a lesson during the time when COVID-19 response resources were available accessed any of the information in those resources. Users of the Spanish language Wichealth version, older users, those less educated, and users with prior Wichealth lesson engagement demonstrated the greatest likelihood of COVID-19 resource use. CONCLUSIONS: This investigation presents findings that demonstrate significant differences between Wichealth users that opted to access COVID-19-specific resources and those who chose not to during their web-based educational session. Reaching users of a web-based educational system with supplemental information may require multiple strategies to increase coverage and ensure the widest possible distribution.

Impact of Food Preparation Video Exposure on Online Nutrition Education in Women, Infants, and Children (WIC) Program Participants: Retrospective Study.

BACKGROUND: The impact of integrating video into health education delivery has been extensively investigated; however, the effect of integrating video on a learner's subsequent performance in an online educational setting is rarely reported. Results of the relationship between the learner's online video viewing and subsequent progression toward health behavior change in a self-directed online educational session are lacking. OBJECTIVE: This study aimed to determine the relationship between viewing a Health eKitchen online video and key engagement performance indicators associated with online nutrition education for women, infants, and children (WIC). METHODS: This study involved a retrospective cohort of users grouped on the basis of whether Health eKitchen exposure occurred before or after completing a nutrition education lesson. A two-sample test for equality of proportions was performed to test the difference in the likelihood of progression between the groups overall and when stratified by lesson type, which was defined by whether the lesson focused on food preparation. Welch two-sample t tests were performed to test the difference in average link depth and duration of use between groups overall and stratified by lesson type. Logistic regression was conducted to validate the impact of video viewing prior to lesson completion while controlling for lesson type and factors known to be associated with WIC key performance indicators. RESULTS: A greater stage of change progression was observed for both food preparation (χ2=12.6, P<.001) and non-food preparation (χ2=62.8, P<.001) lessons among early stage users who had viewed a Health eKitchen video before completing a lesson. Time spent viewing educational learning resource links within the lesson was also significantly longer for both food preparation (t=7.8, P<.001) and non-food preparation (t=2.5, P=.01) lessons. Logistic regression analysis corroborated these results while controlling for known confounding factors. The odds of user progression were nearly three times greater among those who viewed a Health eKitchen video prior to lesson completion (odds ratio=2.61; 95% CI=2.08-3.29). Type of lesson (food vs non-food preparation) was the strongest predictor of progression odds (odds ratio=3.12; 95% CI=2.47-3.95). CONCLUSIONS: User access to a Health eKitchen video prior to completion of an online educational session had a significant impact on achieving lesson goals, regardless of the food preparation focus. This observation suggests the potential benefit of providing an application-oriented video at the onset of online nutrition education lessons.

wichealth.org: impact of a stages of change-based Internet nutrition education program.

OBJECTIVE: To determine the usefulness and impact of on stage of change associated with 8 WIC client nutrition issues. DESIGN: Cross-sectional design. Data were collected through an online survey and via Web pages visited by clients for each module. SETTING: intervention and data collection are Internet-based. PARTICIPANTS: 39,541 WIC participants from 7 states completed a module and online survey. Subjects were likely between the ages of 18 and 34, residing in Michigan, Illinois, or Indiana, and accessing the Internet from home. INTERVENTIONS: Intervention included 5 online modules focusing on parent-child feeding behaviors. VARIABLES MEASURED: Impact variables included stage of change movement, user belief in ability to engage in behavior, and perception of site usefulness. ANALYSIS: Data were reported using frequency, ANOVA (analysis of variance) (P < . 01), and chi-square (P < .01) analyses. RESULTS: Movement in stage was greatest for the "picky eater" (PE) module. Contemplation as the beginning stage had the greatest stage movement. Participants responded well to all measures of site usefulness. User belief in ability to engage in behavior was associated with 7 of the 8 modules. IMPLICATIONS FOR RESEARCH AND PRACTICE: is a highly popular and viable method for impacting movement in stage of change with a number of parent-child feeding issues.

A Comparison of Mobile and Fixed Device Access on User Engagement Associated With Women, Infants, and Children (WIC) Online Nutrition Education.

BACKGROUND: Online health education has expanded its reach due to cost-effective implementation and demonstrated effectiveness. However, a limitation exists with the evaluation of online health education implementations and how the impact of the system is attenuated by the extent to which a user engages with it. Moreover, the current online health education research does not consider how this engagement has been affected by the transition from fixed to mobile user access over the last decade. OBJECTIVE: This paper focuses on comparing the impact mobile versus fixed devices have on user engagement key performance indicators (KPI) associated with the wichealth website (.org), an Internet-based parent-child feeding intervention offered to clients associated with the US Department of Agriculture's Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). METHODS: Data were collected from 612,201 nutrition education lessons completed by 305,735 unique WIC participants in 21 states over a 1-year period. Data consisted of system-collected measures, profile items, and items from an exit survey administered at the conclusion of each lesson. User engagement was defined based on 3 KPIs associated with usage of the wichealth website: number of link views, link view time, and progression in stage of readiness to change. Independent samples t tests were used to compare KPIs between fixed only and mobile only device users and paired samples t tests were used to compare KPIs within users who completed at least one lesson each on both a fixed and mobile device. A logistic regression was performed to estimate the odds of KPI performance thresholds in the independent samples study group given access device type while controlling for confounding of user characteristics associated with these KPIs. RESULTS: Analysis of 8 user characteristics (lessons completed, race, ethnicity, language, state of residence, pregnancy status, beginning stage of change, and preferred nutrition education method) were significantly (P<.001) related to various KPI differences between mobile and fixed device access. Non-mobile users were significantly (P<.001) more likely to engage based on all 3 KPIs, even after logistic regression control for the potential confounding related to the strongly associated user characteristics identified. CONCLUSIONS: The findings of this study support the idea that online health education developers need to seriously consider access device when creating programs. Online health education developers need to take extra effort to truly understand access patterns of populations being served, and whether or not access device will influence user engagement performance indicators.

The eHealth Behavior Management Model: a stage-based approach to behavior change and management.

Although the Internet has become an important avenue for disseminating health information, theory-driven strategies for aiding individuals in changing or managing health behaviors are lacking. The eHealth Behavior Management Model combines the Transtheoretical Model, the behavioral intent aspect of the Theory of Planned Behavior, and persuasive communication to assist individuals in negotiating the Web toward stage-specific information. It is here - at the point of stage-specific information - that behavioral intent in moving toward more active stages of change occurs. The eHealth Behavior Management Model is applied in three demonstration projects that focus on behavior management issues: parent-child nutrition education among participants in the U.S. Department of Agriculture Special Supplemental Nutrition Program for Women, Infants and Children; asthma management among university staff and students; and human immunodeficiency virus prevention among South African women. Preliminary results have found the eHealth Behavior Management Model to be promising as a model for Internet-based behavior change programming. Further application and evaluation among other behavior and disease management issues are needed.

The risk of offending on homicide victimization: a public health concern.

OBJECTIVE: To determine whether criminal offending increases an individual's risk of becoming a homicide victim. METHODS: A case-control design was used to compare the arrest and demographic attributes of 105 homicide victims to 105 nonvictims. Bi- and multivariate logistic regression models were used to determine differences between the two groups. RESULTS: Significant differences were found between homicide victims and nonvictims using different measures of arrest. CONCLUSIONS: The field of public health needs to take a greater interest in preventing violence, and by recognizing criminal offending as a risk factor to subsequent victimization, it can attempt to reduce fatal encounters.

Impact of internet vs traditional Special Supplemental Nutrition Program for Women, Infants, and Children nutrition education on fruit and vegetable intake.

The purpose of this project was to compare the impact of Internet nutrition education to traditional nutrition education on Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) participant fruit and vegetable consumption. Interventions were delivered at 15 WIC clinics after normal WIC clinic operations or delivered online. A total of 692 and 872 participants from eight WIC agencies self-enrolled into two phases. A quasi-experimental design using an interrupted time series to determine the impact of two methods of nutrition education and follow-up nutrition counseling was used. Data were collected online and at Michigan WIC clinics during 2005-2007 at 3-month intervals during a 9-month period (per phase). Two Internet nutrition education modules were compared to WIC traditional nutrition education, which included either group classes or a self-guided nutrition education information mall. All interventions were based on the same program learning objectives. Optional motivational negotiation counseling followed 3 months post-intervention. Stage of change progression, belief in ability to change, and fruit and vegetable consumption were measured at baseline, immediately after the intervention, and 3 and 6 months post-intervention. Significance (P<0.05) was analyzed using independent samples t tests, χ(2) distribution, and sample tests for differences in binomial proportions. The Internet group experienced substantial positive differences in stage of change progression, perception that the intervention was helpful and easy to use, and fruit and vegetable consumption. Traditional nutrition education required follow-up counseling to achieve fruit and vegetable consumption levels similar to the Internet nutrition education group. Based on these findings, this study supports Internet nutrition education as a viable alternative to traditional nutrition education for increasing fruit and vegetable consumption in some WIC clients.

Key principles in internet-based weight management systems.

OBJECTIVE: To provide a review of weight management components as a means for developing suggested guidelines for online program development or selection. METHODS: Forty-two published studies associated with Internet programs were reviewed. RESULTS: Studies included online weight management components: tailored feedback, social support, self-monitoring, and interactive components. Five key principles associated with Internet-based weight management programming are presented: (1) recreate the human experience, (2) personalize to the individual, (3) create a dynamic experience, (4) provide a supportive environment, and (5) build upon sound theory. CONCLUSIONS: Key principles can guide in the development or selection of online weight management programs.