More to Offer Than Direct Clinical Benefit: FDA's Vaccine Licensure Process Ignores Population Health and Social Determinants of Disease.

The current US Food and Drug Administration (FDA) licensure process underestimates the potential benefits of vaccines at both the individual and population levels by considering only direct clinical outcomes of vaccination. While all approved vaccines do protect the person who takes them from poor clinical outcomes for a specific infectious disease, many vaccines also have the potential to offer measurable, direct nonclinical benefits. For example, coronavirus disease 2019 (COVID-19) vaccinations for school-aged children may prevent school absenteeism. Also, by preventing infection or reducing its length and severity, some vaccines also protect-to some extent-the patient's immediate contacts from contracting the same disease. These nonclinical and population-level benefits are not considered as part of the FDA's current vaccine approval process, but they could be. We argue that the FDA's structured benefit-risk assessment framework, used for vaccine approvals, can and should consider both clinical and nonclinical benefits of vaccination when sufficient evidence exists to make an informed assessment. Including them could incentivize vaccine developers to measure additional vaccination effects, inform population health, and address health inequalities-including inequalities in the social determinants of health.

What Were the Information Voids? A Qualitative Analysis of Questions Asked by Dear Pandemic Readers between August 2020-August 2021.

In the current infodemic, how individuals receive information (channel), who it is coming from (source), and how it is framed can have an important effect on COVID-19 related mitigation behaviors. In light of these challenges presented by the infodemic, Dear Pandemic (DP) was created to directly address persistent questions related to COVID-19 and other health topics in the online environment. This is a qualitative analysis of 3806 questions that were submitted by DP readers to a question box on the Dear Pandemic website between August 30, 2020 and August 29, 2021. Analyses resulted in four themes: the need for clarification of other sources; lack of trust in information; recognition of possible misinformation; and questions on personal decision-making. Each theme reflects an unmet informational need of Dear Pandemic readers, which may be reflective of the broader informational gaps in our science communication efforts.This study highlights the role of an ad hoc risk communication platform in the current environment and uses questions submitted to the Dear Pandemic question box to identify informational needs of DP readers over the course of the COVID-19 pandemic. These findings may help clarify how organizations addressing health misinformation in the digital space can contribute to timely, responsive science communication and improve future communication efforts.

Dear Pandemic: Nurses as key partners in fighting the COVID-19 infodemic.

The COVID-19 pandemic and subsequent proliferation of misinformation have created parallel public health crises. Social media offers a novel platform to amplify evidence-based communication to broader audiences. This paper describes the application of science communication engagement on social media platforms by an interdisciplinary team of female scientists in a campaign called Dear Pandemic. Nurses are trusted professionals trained in therapeutic communication and are central to this effort. The Dear Pandemic campaign now has more than 97,000 followers with international and multilingual impact. Public health strategies to combat misinformation and guide individual behavior via social media show promise, and require further investment to support this novel dissemination of science communication.

REAL-TIME SUBJECTIVE ASSESSMENT OF PSYCHOLOGICAL STRESS: ASSOCIATIONS WITH OBJECTIVELY-MEASURED PHYSICAL ACTIVITY LEVELS.

Psychosocial stress may be a factor in the link between physical activity and obesity. This study examines how the daily experience of psychosocial stress influences physical activity levels and weight status in adults. This study reports temporally ordered relationships between sedentary, light, and moderate-to-vigorous physical activity levels and real-time reports of subjective psychosocial stress levels. Adults (n=105) wore an accelerometer and participated in an ecological momentary assessment (EMA) of stress by answering prompts on a mobile phone several times per day over 4 days. Subjective stress was negatively related to sedentary activity in the minutes immediately preceding and immediately following an EMA prompt. Light activity was positively associated with a subsequent EMA report of higher stress, but there were no observed associations between stress and moderate-to-vigorous activity. Real-time stress reports and accelerometer readings for the same 4-day period showed no association. Nor were there associations between real-time stress reports and weight status.

Potential effects of California's new vaccine exemption law on the prevalence and clustering of exemptions.

Exemptions from childhood immunizations required for school entry have continued to increase among California kindergartners, and exemptions show spatial clustering within the state. A 2014 change in California's school-entry vaccine exemption law requires parents filing for an exemption to submit signed documents from a health care provider. However, the evidence presented here suggests that the policy change will probably not be sufficient to reverse the growing trend in vaccine refusals.

Explaining the U.S. rural disadvantage in COVID-19 case and death rates during the Delta-Omicron surge: The role of politics, vaccinations, population health, and social determinants.

The Delta-Omicron wave of the COVID-19 pandemic (Wave 4) in the United States occurred in Fall of 2021 through Spring of 2022. Although vaccinations were widely available, this was the deadliest period to date in the U.S., and the toll was especially high in rural areas, exacerbating an existing rural mortality penalty. This paper uses county-level multilevel regression models and publicly available data for 47 U.S. states and the District of Columbia. We describe differences in COVID-19 case and mortality rates across the rural-urban continuum during Wave 4 of the COVID-19 pandemic. Using a progressive modeling approach, we evaluate the relative contribution of a range of explanatory factors for the rural disadvantage we observe, including: pre-pandemic population health composition, vaccination rates, political partisanship, socioeconomic composition, access to broadband internet rate, and primary care physicians per capita. Results show that rural counties had higher observed burdens of cases and deaths in Wave 4 compared to more urban counties. The most remote rural counties had Wave 4 COVID-19 mortality rates 52% higher than the most urban counties. Older age composition, worse pre-pandemic population health, lower vaccination rates, higher share of votes cast for Donald Trump in the 2020 Presidential election, and lower socioeconomic composition completely explained the rural disadvantage in reported COVID-19 case rates in Wave 4, and accounting for these factors reversed the observed rural disadvantage in COVID-19 mortality. In models of mortality rate, Trump vote share had the largest effect size, followed by the percentage of the population age 50 or older, the poverty rate, the pre-pandemic mortality rate, the share of residents with a 4-year college degree, and the vaccination rate. These findings add to a growing literature describing the disproportionate toll of the COVID-19 pandemic on rural America, highlighting the combined effect of multiple sources of rural disadvantage.

Designing and testing social media campaign messages to promote COVID-19 vaccine confidence among rural adults: A community-engaged approach featuring rural community leader and clinician testimonials.

Despite the growing availability of effective COVID-19 vaccines in rural communities in the United States, widespread vaccine hesitancy delays COVID-19 vaccine coverage in rural communities and threatens to worsen pre-pandemic rural-urban disparities in other vaccination rates, including influenza and routine pediatric immunizations. Therefore, there is an urgent need to develop communication-based interventions to improve vaccine confidence in rural America. This study demonstrates the efficacy of a community-engaged approach to developing social media campaign messages in promoting COVID-19 vaccine uptake and pro-vaccine social diffusion among rural adults. Using a community-engaged approach, we developed social media campaign videos varying in (a) featured messengers (clinicians versus community leaders) and (b) the presence of personal testimonials. We conducted a national online experiment (N = 1,364 rural adults) in spring 2022. We found that videos featuring clinicians serving rural communities and their testimonials increased (a) vaccination intentions in the unvaccinated group (4-point scale, b = 0.23, p =.015) and (b) intention to discuss the messages with others (4-point scale, b = 0.14, p =.037), share the message (4-point scale, b = 0.15, p =.026), and promote the vaccines to others (9-point scale, b = 0.48, p =.013). Results suggest that vaccine promotional social media campaigns targeting rural populations can benefit from including clinician testimonials.

Dear Pandemic: A topic modeling analysis of COVID-19 information needs among readers of an online science communication campaign.

BACKGROUND: The COVID-19 pandemic was accompanied by an "infodemic"-an overwhelming excess of accurate, inaccurate, and uncertain information. The social media-based science communication campaign Dear Pandemic was established to address the COVID-19 infodemic, in part by soliciting submissions from readers to an online question box. Our study characterized the information needs of Dear Pandemic's readers by identifying themes and longitudinal trends among question box submissions. METHODS: We conducted a retrospective analysis of questions submitted from August 24, 2020, to August 24, 2021. We used Latent Dirichlet Allocation topic modeling to identify 25 topics among the submissions, then used thematic analysis to interpret the topics based on their top words and submissions. We used t-Distributed Stochastic Neighbor Embedding to visualize the relationship between topics, and we used generalized additive models to describe trends in topic prevalence over time. RESULTS: We analyzed 3839 submissions, 90% from United States-based readers. We classified the 25 topics into 6 overarching themes: 'Scientific and Medical Basis of COVID-19,' 'COVID-19 Vaccine,' 'COVID-19 Mitigation Strategies,' 'Society and Institutions,' 'Family and Personal Relationships,' and 'Navigating the COVID-19 Infodemic.' Trends in topics about viral variants, vaccination, COVID-19 mitigation strategies, and children aligned with the news cycle and reflected the anticipation of future events. Over time, vaccine-related submissions became increasingly related to those surrounding social interaction. CONCLUSIONS: Question box submissions represented distinct themes that varied in prominence over time. Dear Pandemic's readers sought information that would not only clarify novel scientific concepts, but would also be timely and practical to their personal lives. Our question box format and topic modeling approach offers science communicators a robust methodology for tracking, understanding, and responding to the information needs of online audiences.

Exposure of California kindergartners to students with personal belief exemptions from mandated school entry vaccinations.

OBJECTIVES: Personal belief exemptions (PBEs) from mandated school entry vaccinations have increased in California over the past decade. Infectious disease outbreaks in the state may be associated with the aggregation of intentionally unvaccinated children within schools. We sought to quantify the exposure of California kindergartners to children with PBEs at school. METHODS: We used cross-sectional California Department of Public Health data on 3 kindergarten cohorts to define and calculate multiple measures of exposure to children with exemptions, including interaction and aggregation indices, for the state as a whole (2008-2010) and by county (2010). RESULTS: In 2010, the PBE rate in California was 2.3 per 100 students, and the school PBE rate for the average kindergartner with a PBE was 15.6 per 100. More than 7000 kindergartners in California attend schools with PBE rates greater than 20 per 100, including 2700 kindergartners with PBEs. Exposure measures vary considerably across counties. CONCLUSIONS: Our results suggest increasing levels of exposure among kindergarten students in California to other kindergartners with PBEs. Our data provide a concrete set of metrics through which public health and education officials can identify high-risk areas as targets for policy and programmatic interventions.

Lessons Learned From Dear Pandemic, a Social Media-Based Science Communication Project Targeting the COVID-19 Infodemic.

The World Health Organization has identified excessive COVID-19 pandemic-related information as a public health crisis, calling it an "infodemic." Social media allows misinformation to spread quickly and outcompete scientifically grounded information delivered via other methods. Dear Pandemic is an innovative, multidisciplinary, social media-based science communication project whose mission is to educate and empower individuals to successfully navigate the overwhelming amount of information circulating during the pandemic. This mission has 2 primary objectives: (1) to disseminate trustworthy, comprehensive, and timely scientific content about the pandemic to lay audiences via social media and (2) to promote media literacy and information-hygiene practices, equipping readers to better manage the COVID-19 infodemic within their own networks. The volunteer team of scientists publishes 8-16 posts per week on pandemic-relevant topics. Nearly 2 years after it launched in March 2020, the project has a combined monthly reach of more than 4 million unique views across 4 social media channels, an email newsletter, and a website. We describe the project's guiding principles, lessons learned, challenges, and opportunities. Dear Pandemic has emerged as an example of a promising new paradigm for public health communication and intervention. The contributors deliver content in ways that are personal, practical, actionable, responsive, and native to social media platforms. The project's guiding principles are a model for public health communication targeting future infodemics and can bridge the chasm between the scientific community and the practical daily decision-making needs of the general public.

Eyes on the Block: Measuring Urban Physical Disorder Through In-Person Observation.

In this paper, we present results from measuring physical disorder in Los Angeles neighborhoods. Disorder measures came from structured observations conducted by trained field interviewers. We examine inter-rater reliability of disorder measures in depth. We assess the effects of observation conditions on the reliability of reporting. Finally, we examine the relationships between disorder, other indicators of neighborhood status, and selected individual outcomes.Our results indicate that there is considerable variation in the level of agreement among independent observations across items, although overall agreement is moderate to high. Durable indicators of disorder provide the most reliable measures of neighborhood conditions. Circumstances of observation have statistically significant effects on the observers' perceived level of disorder. Physical disorder is significantly related to other indicators of neighborhood status, and to children's reading and behavior development. This result suggests a need for further research into the effects of neighborhood disorder on children.

Why not just ask the resident?

This research evaluated a draft preference assessment tool (draft-PAT) designed to replace the current Customary Routine section of the Minimum Data Set (MDS) for nursing homes. The draft-PAT was tested with a sample of nursing home residents to evaluate survey-level administration time and noncompletion rates, as well as item-level nonresponse rates, response distributions, and test-retest reliability. Modifications to the draft-PAT were then retested with a subsample of residents. Completion times were brief (generally less than 10 minutes), and only a small percentage of residents were unable to complete the interview. Item-level nonresponse rates were low for the draft-PAT (0% to 8%) and even lower during retesting for items advanced to the national field trial (0% to 4%). Item response distributions indicated reasonable use of all options across both testing occasions, and item-level test-retest reliability was high. This study found that nursing home residents can reliably report their preferences. Eighteen items from the modified draft-PAT were advanced to the national field trial of the MDS 3.0. Inclusion of the PAT in the MDS revision underscores increased emphasis on including residents' voice in the assessment process.

The relationship of reported pain severity to perceived effect on function of nursing home residents.

BACKGROUND: We examined whether questions addressing the effect of pain on day-to-day function add unique information to the standardized verbal descriptor scale for pain severity in nursing homes (NHs). METHODS: Interviews were conducted with 123 residents in two Veterans Affairs NHs. All participants were asked about pain presence. Residents reporting pain were asked about severity of worst pain (mild, moderate, severe, very severe/horrible), degree of bother (not at all, a little, a moderate amount, a great deal), and the effect of pain on daily function (whether pain made it hard to "sleep," "get out of bed," or "spend time with other people" and whether activities were limited because of pain). RESULTS: Fifty-one percent of participants reported pain. The correlation between pain severity report and overall count of activity interference was significant (Spearman's rho=.449, p=.001). In general, for each activity, the proportion reporting interference increased as severity increased. Fischer's exact test showed significant association only for "hard to get out of bed" (p=.0175) and "hard to sleep" (p=.0211). As expected, residents reporting "mild" pain reported less activity interference than those reporting "very severe" pain. The association between pain and activity interference was more variable and less predictable among residents with "moderate" or "severe" pain. CONCLUSION: Questions addressing the effect of pain on day-to-day functions are an important addition to standardized pain assessments, particularly for persons who report intermediate levels of pain severity because the perceived effect on daily function may vary most among individuals at these levels.

What the resident meant to say: use of cognitive interviewing techniques to develop questionnaires for nursing home residents.

PURPOSE: Emphasis on consumer-centered care for frail and institutionalized older adults has increased the development and adaptation of surveys for this population. Conventional methods used to pretest survey items fail to investigate underlying sources of measurement error. However, the use of the cognitive interview (CI), a method for studying how respondents answer survey items, is not well established or documented in this population. This study demonstrates how CIs can be used to improve questionnaires intended for nursing home residents. DESIGN AND METHODS: CIs were conducted with 29 nursing home residents in order to identify potential problems with prospective survey items. We used scripted probes to standardize the interviews and adapted the Question Appraisal System to enumerate and classify the problems discovered. RESULTS: We fielded between one and five versions of each item in an iterative process that identified 61 item-specific problems. Additionally, residents' cognitive responses suggested that some screened their answers on the basis of perceived physical and environmental limitations, and some had difficulty answering items about preferences that fluctuate day to day. These findings led us to modify the items and response set to simplify the respondents' cognitive task. IMPLICATIONS: This study illustrates how CI techniques can be used to understand residents' comprehension of and response to survey items.

Mandatory Health Care Provider Counseling For Parents Led To A Decline In Vaccine Exemptions In California.

Receipt of childhood vaccinations in the US has been declining, and outbreaks of preventable infectious diseases have become more common. In response, in 2014 California implemented a policy change for exemptions from mandatory vaccines for school enrollment. Data on fifteen successive cohorts of kindergarteners enrolled in public and private schools between school years 2001-02 and 2015-16 were analyzed for changes in vaccination trends. The results show an increase in the prevalence and clustering of vaccine exemptions from 2001-02 through 2013-14, followed by a modest decline after implementation of a policy mandating health care provider counseling for vaccine exemption. Clustering of vaccine exemptions increased over the study period and was less responsive to the policy change than were exemption rates overall. Nor did the policy change uniformly reduce the clustering of at-risk students across counties. Trends in the use of conditional admission showed strong school-level clustering and remained relatively stable. The policy change was effective at reducing exemption rates but did not uniformly reduce clustering of exemptions. The results suggest the need to evaluate the causes of local-area clustering and to adopt a statewide policy that addresses clustering of vaccine exemptions within schools and counties.

Conditional admission, religious exemption type, and nonmedical vaccine exemptions in California before and after a state policy change.

Recent measles and pertussis outbreaks in the US have focused national attention on state laws governing exemptions from mandatory vaccines for school entry. After several years of increases in nonmedical exemptions in California, the state assembly passed Assembly Bill 2109 in 2012, making nonmedical exemptions more difficult to obtain by requiring parents to obtain a signature from a health care provider. We used data from the California Department of Public Health to describe changes in the overall prevalence of personal belief exemptions and compositional changes in immunization status for the school years 2012-2013 through 2015-2016. Following the implementation of Assembly Bill 2109, the statewide exemption rate declined from 3.1% in 2013 to 2.5% in 2014 and then to 2.3% in 2015, representing a 25% reduction from the 2013 peak. Continued surveillance of exemption rates and vaccine refusal are needed to monitor and protect herd immunity against vaccine-preventable diseases.

Exemptions From Mandatory Immunization After Legally Mandated Parental Counseling.

BACKGROUND: The success of health care provider counseling-based interventions to address vaccine hesitancy is not clear. In 2011, Washington State implemented Senate Bill 5005 (SB5005), requiring counseling and a signed form from a licensed health care provider to obtain an exemption. Evaluating the impact of a counseling intervention can provide important insight into population-level interventions that focus on interpersonal communication by a health care provider. METHODS: We used segmented regression and interaction and aggregation indices to assess the impact of SB5005 on immunization coverage and exemption rates in Washington State from school years 1997-1998 through 2013-2014. RESULTS: After SB5005 was implemented, there was a significant relative decrease of 40.2% (95% confidence interval: -43.6% to -36.6%) in exemption rates. This translates to a significant absolute reduction of 2.9 percentage points (95% confidence interval: -4.2% to -1.7%) in exemption rates. There were increases in vaccine coverage for all vaccines required for school entrance, with the exception of the hepatitis B vaccine. The probability that kindergarteners without exemptions would encounter kindergarteners with exemptions (interaction index) decreased, and the probability that kindergarteners with exemptions would encounter other such kindergarteners (aggregation index) also decreased after SB5005. Moreover, SB5005 was associated with a decline in geographic clustering of vaccine exemptors. CONCLUSIONS: States in the United States and jurisdictions in other countries should consider adding parental counseling by health care provider as a requirement for obtaining exemptions to vaccination requirements.

Toward a Better Understanding of the Link Between Parent and Child Physical Activity Levels: The Moderating Role of Parental Encouragement.

BACKGROUND: Research on adolescent physical activity is mixed regarding the role of parent activity. This study tested parent encouragement, direct modeling, and perceived influence as moderators of objectively-measured (accelerometer) parent and child moderate-to-vigorous physical activity (MVPA) associations. METHODS: Parent-child dyads (n = 423; mean child age = 11.33 yrs.) wore accelerometers for 7 days; parents completed surveys. Hierarchical linear regression models tested moderation using a product of constituent terms interaction. RESULTS: Parent-reported encouragement moderated the association between parent and child MVPA (ß = -.15, P = .01, ΔR2 = .02, P < .01). Among parents with lower MVPA, child MVPA was higher for children receiving high encouragement (mean = 3.06, SE = .17) vs. low (mean = 3.03, SE = .15, P = .02) and moderate encouragement (mean = 3.40, SE = .09) vs. low (P = .04). CONCLUSIONS: Physical activity promotion programs may use parent encouragement as a tool to boost child activity, but must consider other child and parent characteristics that could attenuate effects.