scholarly journals Community-Based Phenotypic Study of Safety, Tolerability, Reactogenicity and Immunogenicity of Emergency-Use-Authorized Vaccines Against COVID-19 and Viral Shedding Potential of Post-Vaccination Infections: Protocol for a prospective study

2021 ◽  
Author(s):  
Irene S Gabashvili
Keyword(s):  
Adverse Event Reporting System ◽  
Community Based Participatory Research ◽  
Adverse Event Reporting ◽  
Security And Privacy ◽  
World Health ◽  
Research Approach ◽  
Community Based ◽  
Post Vaccination ◽  
Viral Shedding ◽  
The Us

The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to a global pandemic that disrupted and impacted lives in unprecedented ways. Within less than a year after the beginning of the COVID-19 pandemic, vaccines developed by several research teams were emergency-use authorized and made their way to distribution sites across the US and other countries. COVID-19 vaccines were tested in clinical trials with thousands of participants before authorization, and were administered to over a billion people across the globe in the following 6 months. Post-authorization safety monitoring was performed using pre-existing systems (such as the World Health Organization's platform VigiBase or US Vaccine Adverse Event Reporting System, VAERS) and newly developed post-vaccination health checkers (such as V-safe in the US). Vaccinated individuals were also posting their experiences on multiple social media groups created on Facebook, Reddit, Telegram and other platforms, but the groups were often removed as "proliferating false claims". These forms of reporting are susceptible to biases and misclassifications and do not reach all vaccinated individuals, raising questions about risks of exacerbating health inequalities as well as security and privacy vulnerabilities. The objective of this paper is to present the protocol for a community-based participatory research approach enabling long-term monitoring of health effects, strengthening community participation via transparent messaging and support, and addressing challenges of transitioning to a new normal.

scholarly journals Cardiovascular Safety Profile of Romosozumab: A Pharmacovigilance Analysis of the US Food and Drug Administration Adverse Event Reporting System (FAERS)

2021 ◽  
Vol 10 (8) ◽  
pp. 1660
Author(s):  
Annika Vestergaard Kvist ◽  
Junaid Faruque ◽  
Enriqueta Vallejo-Yagüe ◽  
Stefan Weiler ◽  
Elizabeth M. Winter ◽  
...  
Keyword(s):  
Adverse Event ◽  
Drug Administration ◽  
Cardiovascular Events ◽  
Reporting System ◽  
Food And Drug Administration ◽  
Adverse Event Reporting System ◽  
Adverse Event Reporting ◽  
Cardiovascular Safety ◽  
Event Reporting ◽  
The Us

Background: Cardiovascular safety concerns for major cardiovascular events (MACE) were raised during the clinical trials of romosozumab. We aimed to evaluate the cardiovascular safety profile of romosozumab in a large pharmacovigilance database. Methods: All cases reported between January 2019 and December 2020 where romosozumab was reported were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS). The outcome of interest was MACE (myocardial infarction (MI), stroke, or cardiovascular death). A disproportionality analysis was conducted by estimating the reporting odds ratios (RORs) and 95% confidence intervals. Disproportionality analyses were stratified by sex and reporting region (US, Japan, other). Results: Of the 1995 eligible cases with romosozumab, the majority (N = 1188; 59.5%) originated from Japan. Overall, 206 suspected MACE reports were identified, of which the majority (n = 164; 13.8%) were from Japan, and 41 (5.2%) were from the United States (US). Among Japanese reports, patients were older and more frequently male than reports from the US. Similarly, cases with a reported MACE were older and had higher reports of cardioprotective drugs than those without cardiovascular events. Elevated reports for MACE (ROR 4.07, 95% CI: 2.39–6.93) was identified overall, which was primarily driven by the significant disproportionality measures in the Japanese reports. Conclusions: The current pharmacovigilance study identified a potential signal for elevated MACE, particularly in Japan. The results support the current safety warnings from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to avoid use in high-risk patients.

A Community-Engaged Project Discovering the Sexuality Questions of Adults With Intellectual and Developmental Disabilities

Inclusion ◽  
2021 ◽  
Vol 9 (1) ◽  
pp. 2-16
Author(s):  
Rebecca R. Kammes ◽  
Rhonda S. Black ◽  
Trisha Easley
Keyword(s):  
Developmental Disabilities ◽  
Sexuality Education ◽  
Developmentally Appropriate ◽  
Community Based Participatory Research ◽  
Research Approach ◽  
Intellectual And Developmental Disabilities ◽  
Community Based ◽  
Sexual Health Information ◽  
Education Group ◽  
Participatory Research Approach

Abstract This study used a community-based participatory research approach to examine what adults with intellectual and developmental disabilities (IDD) view as important topics in sexuality education. A thematic analysis was conducted on questions written by adults with IDD regarding sexuality after attending a sexuality education group. Results were checked for accuracy using a community focus group. Findings provide direct implications for community-based sexuality education programs for adults with IDD, demonstrating the need for mentoring regarding authentic relationship experiences as well as developmentally appropriate sexual health information. Programs need to focus on helping adults with IDD navigate these interpersonal experiences. This study also demonstrates the importance of including the voices of adults with IDD in research in order to ensure its applicability and acceptability.

scholarly journals A Community Based Participatory Approach to Training Young Adults to Design and Implement a Social Marketing Framed Lifestyle Intervention on Their College Campus

2018 ◽  
Vol 8 (3) ◽  
pp. 150 ◽  
Author(s):  
Melissa Olfert ◽  
Makenzie Barr ◽  
Kristin Riggsbee ◽  
Kendra Kattelmann ◽  
Krista Leischner ◽  
...  
Keyword(s):  
College Students ◽  
Lifestyle Intervention ◽  
Participatory Research ◽  
Social Marketing ◽  
Healthy Lifestyle ◽  
Community Based Participatory Research ◽  
College Campus ◽  
Research Approach ◽  
Environmental Intervention ◽  
Community Based

Background: Using a Community-Based Participatory Research (CBPR) approach may increase the likelihood of relevance and acceptability of the designed intervention, especially on a college campus. Furthermore, recruiting and training college students to design a social marketing framed healthy lifestyle intervention for their peers will allow the intervention to be tailored to the needs of the campus. Objectives: To describe the process of online-course training college students to develop a campus-based, social marketing health promotion intervention. Methods: Four universities recruited current college students (18+ y.o.) to develop a social marketing and environmental intervention (SMEI), which was completed during a 16-week, online/in-person hybrid semester course. Researchers and Extension professionals trained students to design 24 weeks of intervention events that would be implemented the upcoming year. Results: Seventy-eight students enrolled in the study and social marketing and environmental intervention course among the four intervention states (Florida = 30, South Dakota = 8, Tennessee = 13, West Virginia = 27); students were predominately Caucasian (65.8%), females (84.0%), and sophomore status in college (64.9%). Throughout the semester, students assessed their campus environments, set priorities, and developed weekly events and resources needed to implement the intervention on their campuses. By the end of the semester, with researcher support, students had designed 24 weeks of intervention events (marketing, recruiting, and implementation) focusing on nutrition/food/diet, physical activity, stress management, sleep, and time management. These events and resources were catalogued into a digital toolkit of instructions and activities for each week of intervention events. Conclusion: Using a Community-Based Participatory Research approach with college students interested in health allows for the development of an intervention that stems from grass roots efforts and is tailored to the acceptability and needs of their peers.

A Socially Just Leadership Approach to Community-Partnered Research for Reducing Health Disparities

2017 ◽  
Vol 45 (6) ◽  
pp. 781-809 ◽  
Author(s):  
Carolyn M. Tucker ◽  
Jaime L. Williams ◽  
Julia Roncoroni ◽  
Martin Heesacker
Keyword(s):  
Health Disparities ◽  
Community Based Participatory Research ◽  
Lessons Learned ◽  
Research Approach ◽  
Community Based ◽  
Guiding Principles ◽  
University Partnership ◽  
Partnership Approach ◽  
Leadership Approaches ◽  
Counseling Psychologists

Significant health disparities continue to plague many groups of people who have been systematically oppressed and largely unrepresented in health research. Community-based participatory research (CBPR) is a collaborative research approach that has been shown to be effective in addressing health disparities; a community–university partnership approach can be used to conduct this research. Counseling psychologists are well suited to establish and lead CBPR partnerships, yet there is a paucity of research to guide them in utilizing effective leadership approaches when conducting CBPR for reducing health disparities. Therefore, the aims of the present study were to (a) review existing leadership models applicable to conducting CBPR; (b) identify guiding principles of socially just leadership that emerged from the aforementioned review; (c) offer an example of how the guiding principles were used in a community–university partnership, highlighting challenges, solutions, and lessons learned; and (d) discuss the benefits of socially just leadership for counseling psychologists.

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