BACKGROUND: The Coronavirus Disease 2019 (COVID-19) pandemic precipitated an urgent need for clinical trials to discover safe and efficacious treatments. We examined how COVID-19 experiences, clinical trial awareness, and trust in the vaccine safety process were associated with willingness to participate in COVID-19 clinical trials. The objective was to investigate the relationship between trust in federal oversight of vaccine safety and willingness to participate in clinical trials for COVID-19 treatment across four distinct time points over an 18-month period during the COVID-19 pandemic.
METHODS: We used four waves of data collected from September 2021 to March 2023 among 582 Philadelphia residents (with a missing data rate of 0.9%). Generalized estimating equations estimated the association between willingness to participate in COVID-19 clinical trials and participants\' trust in the federal government\'s oversight of COVID-19 vaccine safety, COVID-19-related variables (COVID-19 related health challenges, history of COVID-19 infection), awareness of clinical trials and how to enroll in them, and sociodemographic characteristics (age, race/ethnicity, sexual orientation, gender, parental status, education, and insurance).
RESULTS: On average, willingness to participate in a COVID-19 clinical trial was positively associated with greater trust in the federal government\'s oversight of vaccine safety [β = 0.34, 95% confidence interval (CI): 0.15-0.53], having COVID-19 (β = 0.40, 95% CI: 0.08-0.73), awareness of clinical trials (β = 0.38, 95% CI: 0.04-0.73), and knowledge of how to enroll (β = 0.83, 95% CI: 0.44-1.23). Among sociodemographic characteristics, race/ethnicity (p = 0.001) and gender (p = 0.018) were identified as predictors for COVID-19 trial willingness.
CONCLUSIONS: Willingness to participate in clinical trials may be bolstered by strengthening the public\'s trust in the federal government\'s role within vaccine safety oversight, increasing the perceived relevance of clinical trials to individuals\' health and well-being, and offering tailored information to educate diverse communities about ongoing trials and how to enroll in them.

When disaster strikes, many players are involved in the response: local, state, and federal governments; public entities; community and faith-based organizations (FBOs). Some of these players are prepped to respond to disasters, while others emerge spontaneously to assist when need (or perceived need) arises. Consistently, FBOs are involved with disaster response efforts. \"Faith-Based Congregations\" or \"FBCs\" are a subsect of FBOs that are formally organized, stationary religious congregations such as churches, temples, mosques, etc. Unlike some FBOs, FBCs are embedded in communities and steeped in those communities\' cultures. The value of FBCs to disaster management is recognized at the federal level, as FEMA encourages local emergency managers to engage their \"Whole Community.\" Though shown to provide for many needs following disaster, FBCs\' role in disaster is largely understudied. Additionally, the mechanics of engaging with FBCs are not simple to implement. The role of FBCs, how they adapt, and the predictors of their involvement need to be better understood in order for improved cross-sector collaboration pre- and post-disaster. The purpose of this study was to explore the role of FBCs in the disaster response process and how FBCs are impacted by the early transition to recovery. This study addressed two primary research questions: What is the role of FBCs during disaster response? How do FBCs change (temporarily and permanently) during disaster response, and what factors may promote or inhibit change? To answer these questions, this qualitative study employed telephone interviews with leaders of FBCs who helped provide disaster response assistance to those impacted by Hurricane Harvey in Katy, Texas.

There is limited understanding of how older adults evaluated the federal government\'s COVID-19 response, despite their increased health risks during the pandemic and their important role in politics. We conducted qualitative thematic analysis on a nationally representative subsample of respondents aged 55+ from the COVID-19 Coping Study (N = 500) who were asked: \"How do you feel about federal government responses to and handling of the COVID-19 pandemic?\" Analyses identified largely negative opinions about the federal government and former President Trump\'s leadership, though some were neutral or positive. Participants expressed concerns that the federal government was undermining science, and that sending mixed messages about personal protective equipment and masks was dangerous. Perspectives were divergent and reflective of the country\'s polarization surrounding COVID-19 policies. Results can inform efforts to build unity between political parties and identify strategies that governments can use to better respond to future public health crises.

Political ideologies drove public actions and health behaviors in the first year of the global pandemic. Different ideas about contagion, health behaviors, and the actions of governing bodies impacted the spread of the virus and health and life. Researchers used an immediate, mixed methods design to explore sociocultural responses to the virus and identified differences and similarities in anxiety, fear, blame, and perceptions of nation across political divides.
Researchers conducted 60 in-depth, semi-structured interviews and administered over 1,000 questionnaires with people living in the United States. The team analyzed data through an exploratory and confirmatory sequential mixed methods design.
In the first months of the pandemic interviewees cited economic inequality, untrustworthy corporations and other entities, and the federal government as threats to life and pandemic control. Participants invoked ideas about others to determine blame. Findings reveal heavy associations between lack of safety during a public health crisis and blame of \"culture\" and government power across the political spectrum.
Data indicate anxiety across political differences related to ideas of contagion and the maleficence of a powerful elite. Findings on how people understand the nation, politics, and pandemic management contribute to understanding dimensions of health behaviors and underlying connections between anxiety and the uptake of conspiracy theories in public health. The article ends with recommendations drawn from project findings for future pandemic response.

BACKGROUND: Evidence-informed clinical practice guidelines (CPGs) are useful tools to inform transparent healthcare decision-making. Consideration of health economic evidence (HEE) during CPG development in a structured manner remains a challenge globally and locally. This study explored the views, current practice, training needs and challenges faced by CPG developers in the production and use of HEE for CPGs in South Africa.
METHODS: This mixed-methods study comprised an online survey and a focus group discussion. The survey was piloted and subsequently sent to CPG role players - evidence reviewers, CPG panellists, academics involved with training in relevant disciplines like health economics and public health, implementers and funders. The focus group participants hold strategic roles in CPG development and health economic activities nationally. The survey evaluated mean values, measures of variability, and percentages for Likert scales, while narrative components were thematically analysed. Focus group data were manually coded, thematically analysed and verified.
RESULTS: The survey (n = 55 respondents to 245 surveys distributed) and one focus group (n = 5 participants from 10 people invited) occurred between October 2018 and February 2019. We found the most consistent reason why HEE should inform CPG decisions was \'making more efficient use of limited financial resources\'. This was explained by numerous context and methodological barriers. Focus groups participants noted that consideration of complex HEE are not achievable without bolstering skills in applying evidence-based medicine principles. Further concerns include lack of clarity of standard methods; inequitable and opaque topic selection across private and public sectors; inadequate skills of CPG panel members to use HEE; and the ability of health economists to communicate results in accessible ways. Overall, in the absence of clarity about process and methods, politics and interests may drive CPG decisions about which interventions to implement.
CONCLUSIONS: HEE should ideally be considered in CPG decisions in South Africa. However, this will remain hampered until the CPG community agree on methods and processes for using HEE in CPGs. Focused investment by national government to address the challenges identified by the study is imperative for a better return on investment as National Health Insurance moves forward.

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Canadian federal restrictions on food marketing to children (children\'s marketing) were proposed in 2016 as Bill S-228, the Child Health Protection Act, which subsequently died on the parliamentary table. This study quantified the interactions (meetings, correspondence and lobbying) related to Bill S-228 and children\'s marketing by different stakeholders with the federal government.
Interactions between all stakeholders and government related to children\'s marketing and Bill S-228 (Sept. 1, 2016-Sept. 30, 2019) were analyzed. These included the \"Meetings and correspondence on healthy eating\" database, detailing interactions between stakeholders and Health Canada related to nutrition policies; and Canada\'s Registry of Lobbyists, reporting activities of paid lobbyists. We categorized the interactions by stakeholder type (industry, nonindustry and mixed), and analyzed the number and type of interactions with different government offices.
We analyzed 139 meetings, 65 lobbying registrants, 215 lobbying registrations and 3418 communications related to children\'s marketing and Bill S-228. Most interactions were from industry stakeholders, including 84.2% of meetings (117/139), 81.5% of lobbying registrants (53/65), 83.3% of lobbying registrations (179/215) and 83.9% of communications (2866/3418). Most interactions (> 80%) in the highest-ranking government offices were by industry.
Industry stakeholders interacted with government more often, more broadly and with higher ranking offices than nonindustry stakeholders on subjects related to children\'s marketing and Bill S-228. Although further research is needed to analyze the nature of the discourse around children\'s marketing, it is apparent that industry viewpoints were more prominent than those of nonindustry stakeholders.

During the COVID-19 pandemic in Canada, Prime Minister Justin Trudeau provided updates on the novel coronavirus and the government\'s responses to the pandemic in his daily briefings from March 13 to May 22, 2020, delivered on the official Canadian Broadcasting Corporation (CBC) YouTube channel.
The aim of this study was to examine comments on Canadian Prime Minister Trudeau\'s COVID-19 daily briefings by YouTube users and track these comments to extract the changing dynamics of the opinions and concerns of the public over time.
We used machine learning techniques to longitudinally analyze a total of 46,732 English YouTube comments that were retrieved from 57 videos of Prime Minister Trudeau\'s COVID-19 daily briefings from March 13 to May 22, 2020. A natural language processing model, latent Dirichlet allocation, was used to choose salient topics among the sampled comments for each of the 57 videos. Thematic analysis was used to classify and summarize these salient topics into different prominent themes.
We found 11 prominent themes, including strict border measures, public responses to Prime Minister Trudeau\'s policies, essential work and frontline workers, individuals\' financial challenges, rental and mortgage subsidies, quarantine, government financial aid for enterprises and individuals, personal protective equipment, Canada and China\'s relationship, vaccines, and reopening.
This study is the first to longitudinally investigate public discourse and concerns related to Prime Minister Trudeau\'s daily COVID-19 briefings in Canada. This study contributes to establishing a real-time feedback loop between the public and public health officials on social media. Hearing and reacting to real concerns from the public can enhance trust between the government and the public to prepare for future health emergencies.

Individuals with large followings can influence public opinions and behaviors, especially during a pandemic. In the early days of the pandemic, US president Donald J Trump has endorsed the use of unproven therapies. Subsequently, a death attributed to the wrongful ingestion of a chloroquine-containing compound occurred.
We investigated Donald J Trump\'s speeches and Twitter posts, as well as Google searches and Amazon purchases, and television airtime for mentions of hydroxychloroquine, chloroquine, azithromycin, and remdesivir.
Twitter sourcing was catalogued with Factba.se, and analytics data, both past and present, were analyzed with Tweet Binder to assess average analytics data on key metrics. Donald J Trump\'s time spent discussing unverified treatments on the United States\' 5 largest TV stations was catalogued with the Global Database of Events, Language, and Tone, and his speech transcripts were obtained from White House briefings. Google searches and shopping trends were analyzed with Google Trends. Amazon purchases were assessed using Helium 10 software.
From March 1 to April 30, 2020, Donald J Trump made 11 tweets about unproven therapies and mentioned these therapies 65 times in White House briefings, especially touting hydroxychloroquine and chloroquine. These tweets had an impression reach of 300% above Donald J Trump\'s average. Following these tweets, at least 2% of airtime on conservative networks for treatment modalities like azithromycin and continuous mentions of such treatments were observed on stations like Fox News. Google searches and purchases increased following his first press conference on March 19, 2020, and increased again following his tweets on March 21, 2020. The same is true for medications on Amazon, with purchases for medicine substitutes, such as hydroxychloroquine, increasing by 200%.
Individuals in positions of power can sway public purchasing, resulting in undesired effects when the individuals\' claims are unverified. Public health officials must work to dissuade the use of unproven treatments for COVID-19.

The present study aimed to examine the differences between enrolled subject populations and use of combination therapies as defined by the pivotal clinical trial protocols and the approved indications of anticancer drugs as determined by 3 major regulatory agencies.
Thirty-eight approvals were collected that received market authorization from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA) between January 2010 and September 2018 for initial approval of an anticancer drug or for an expanded therapeutic indication for a previously approved anticancer drug, based on the same pivotal clinical trial(s). The subject eligibility criteria of the pivotal clinical trials and the approved indications as established by these agencies were compared, and the differences were categorized according to patient biomarkers status, prior treatment status, and the use of combination therapies.
In 20 (53%) approvals, there was a discrepancy between biomarker status of enrolled subjects in the pivotal trial and the therapeutic indication. In 7 of these cases, the biomarkers were used to diagnose the target cancer or to stratify the study subjects in the pivotal trial. In 9 cases, the biomarker discrepancies were related to minor histologic subtypes of the target cancer. Regarding prior treatment status, the FDA and the EMA generally approved indications for the same treatment line as the pivotal trials, whereas the PMDA did not restrict approval to untreated patients when the pivotal trial included only treatment-naive subjects. In 14 approvals, the FDA and the EMA designated the same co-administered drugs as part of the approved indications in line with the pivotal trials. However, the PMDA did not specify the co-administered drugs in 2 approvals and did not require combination therapy in 1 case.
In principle, the approved therapeutic indications should be determined by the characteristics of the pivotal trial subjects and combination therapies. The use of biomarkers can be essential for identifying those patients who are most likely to benefit from a drug. Unfortunately, biomarker-defined subgroups are often insufficient in size to allow meaningful interpretation of results. Consequently, regulatory agencies may deviate from one another and from the pivotal trial protocol when interpreting study results and attempting to define the optimal treatment population. The PMDA-approved indications deviated more liberally from the pivotal trial protocols regarding specification of prior treatment status and the use of co-administered drugs.