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  1. Advancing Regulatory Science

Improving FDA Health Communications with Older Women Regarding FDA-Regulated Products

CERSI Collaborators: University of Maryland Baltimore: Daniel Mullins, Ph.D., Susan dosReis, Ph.D., Ester Villalonga Olives, Ph.D., Moaz Abdelwadoud, MD, DrPH, MPH, Michelle Medeiros, MS, MA, CCRP, Karen Morales, BS, Rodney Elliott

FDA Collaborators: Jing (Julia) Ju, PharmD, Ph.D., Michelle Campbell, Ph.D., Heather Ovelmen, MA, Marc Kusinitz, MS, Ph.D., Kathleen Yu, MPH, Taiye Oladipo, MPH, Ayma Rouhani, MPH, Felisha Wu, MPH, Linda Verrill, Ph.D. <

CERSI Subcontractors: Westat: Jennifer Huang, PhD., Liz Jansky, M.A.

Project Start Date: March 9, 2018

Project End Date: June 30, 2022

Regulatory Science Challenge

The unmet health needs and potential caregiving responsibilities among women underscore the importance of having ready access to health information to support the health-related decisions women potentially make for themselves and for persons in their care. Accessing reliable health information, however, can be a major challenge. Despite the importance of understanding the health information needs of older women, limited research to date addresses their health information-seeking motives, perceptions, challenges, and preferences regarding FDA-regulated products. Understanding these health information-seeking elements is key to FDA’s mission to improve communication strategies and health-related materials to help the public make better-informed health decisions.

Project Description and Goals

The goal of this study was to explore health information-seeking intentions and behaviors of older women, as well as barriers they face in their attempts to access this information via a range of FDA modes of communication. The study’s objectives were to:

  1. Identify older women’s perceptions about FDA’s health communications
  2. Assess older women’s health information-seeking behaviors and intentions
  3. Examine whether older women’s perceptions, intentions, and behaviors about FDA’s health communications vary by type of FDA-regulated product (drugs and vaccines) and by age.

In Phase 1 of the project, the research team recruited older women from the Baltimore-Washington Metropolitan area and grouped them by generation to see how types of communication are preferred by older women of various ages The investigators aimed to recruit and interview participants with diverse socioeconomic and demographic characteristics. The generations included:

  1. Generation A: born 1965 to 1980
  2. Generation B: born 1946 to 1964
  3. Generation C: born 1928 to 1945

In Phase 1, Thirteen (13) exploratory, in-person, 3-15 person focus groups were conducted in Maryland at times that were convenient to participants. The research team grouped older women by age to see how health information-seeking differed. Focus group participants responded to research questions regarding perceptions, motivations, attitudes, and behavior concerning health seeking and decision making, as well as preferences for health communication materials, particularly for drugs, vaccines, medical devices, and food. Questions also addressed the role some of these older women play as caregivers to help the investigators better understand whether the health information needs vary between older women who seek health information for self-care, and those who seek health information to care for others.

In Phase 2 of the project, study recruitment was expanded to include women in urban and rural areas across four U.S. regions (West, South, Midwest, and Northeast). The research team carried out two in-person focus groups and transitioned to interviews and virtual focus groups (eight) among women aged 38 years and older, due to COVID-19. Generation age range groupings from Phase 1 were used again in Phase 2.

The moderator guides for both Phases included questions on perceptions, motivations, attitudes, and behavior concerning health-seeking and decision making, as well as preferences for health communication materials for drugs, vaccines, medical devices, and food. Questions also addressed the role some women play as caregivers to help investigators better understand whether health information needs vary between women who seek health information for self-care compared with those who seek health information to care for others. Data from both Phases were analyzed with NVivo, a qualitative data software package.

Research Outcomes/Results

Participants across all generation groups stated that their healthcare providers were their main source for health information. However, although many participants generally trusted their primary care providers, they were concerned that providers have limited time, limited knowledge, or do not communicate with specialists. Therefore, participants often sought additional health information from specialists, the internet, peers, or family members. Regarding drugs, all three generations believed their pharmacist to be a more valuable resource than their primary care physician.

Participants across generation groups actively sought information for drugs, vaccines (particularly those directed to older adults such as the flu and shingles vaccines), and food, but less so for medical devices. Participants across generation groups used similar health information seeking behaviors for drug and medical devices, including seeking advice from providers and the internet. As several Generation A participants were caregivers to young children, they spoke about seeking information pertaining to the HPV vaccine and food allergies in addition to drugs.

Generations A and B were more proficient in using the internet to search for health information than Generation C. The use of social media was mentioned across all three generations as a supporting source of information, but Generation A was more likely to use this medium. Generation C primarily preferred newsletters, both paper copy and online, as a source of health information, and participants expressed interest in receiving an FDA newsletter, if it came to them quarterly or less frequently. Generations A and B relied on speaking with friends and peers to gather health information and were interested in hearing personal testimonies. All generations mentioned that they preferred face-to-face interactions such as with healthcare providers, and the use of telephone over other sources involving computers or similar devices.

Participants suggested that the FDA consider the difference among rural and urban populations, because rural populations may have unique needs due to limited access to transportation or to the internet. It was suggested that Federal agencies partner with local organizations that are centrally located and trusted by rural communities. Face-to-face interactions with providers and community health workers were also thought to be important to people in rural communities and for those with limited or no internet access.

Participants also discussed trust and distrust of government agencies, the pharmaceutical industry and healthcare providers. Several participants mentioned that they view the FDA and their own healthcare providers as reliable and seek information from these sources, while others questioned the financial motivations of the FDA, pharmaceutical industry, and healthcare providers. Participants from rural areas described feeling that public health websites do not typically address their population’s specific health issues and that federal public health initiatives do not consider their communities as a priority. This perception has affected their trust and use of these government websites.

Most participants preferred communication sources that present health information in a concise and clear way and that can accommodate different levels of literacy and different learning styles. Participants preferred communication sources that guide readers to other sources containing more detailed information that can be accessed at any time.

Research Impacts

The research project, as measured by FDA’s CERSI Outcomes of Interest has made several important impacts. It has helped advance the field of regulatory science, shared valuable scientific knowledge, may potentially inspire various stakeholders to take action (including potential future research), and provided insights for regulatory decision-making. The project particularly focused on improving health communications and aligns with regulatory science priorities regarding health communications.

Additionally, the research explored women’s preferred health communication methods and materials related to FDA-regulated medical products. The findings may enhance external communication strategies and potentially provide valuable insights for regulatory decision-making.

The findings of this study may improve the FDA’s ability to communicate effectively to target populations on health, thus contributing to the advancement of regulatory science. The research outcomes, presented in posters, and abstracts disseminated at the APHA, CERSI, and ISOQOL conferences may also contribute to broader scientific knowledge in the field and make the results reported publicly available.

Not only does this research advance regulatory science and share scientific knowledge, but it also has the potential to deepen stakeholders' understanding and interest in developing targeted health communication materials for women in the U.S. This study's results could lead to further qualitative and quantitative research in the future, building upon these findings.

Presentations and Publications

  • Abdelwadoud, M., Huang, J., Villalonga-Olives, E., dosReis, S., Jansky, L., Mullins, C., Campbell, M., Kusinitz, M., Ovelmen, H., & Ju, J. (2022a). Older Women Health-Information Sources and Preferred Health-Communication Materials Regarding the FDA-Regulated Products. CERSI Program Showcase.
  • Abdelwadoud, M., Huang, J., Villalonga-Olives, E., DosReis, S., Jansky, L., Mullins, C., Campbell, M., Kusinitz, M., Ovelmen, H., & Ju, J. (2022b). Toward Improving FDA Health Communications: Older Women General Health-Information Seeking Intentions and Behaviors. Movers and Shapers: The Future of Drug and Device Development.
  • Huang, J., Villalonga-Olives, E Abdelwadoud, M., dosReis, S., Jansky, L., Mullins, C., Campbell, M., Buch, B., & Ju, J. (2022). Women’s Health Information-Seeking Experiences and Preferences Regarding Medications and Vaccines: A Qualitative Study. 150 Years of Creating the Healthiest Nation: Leading the Path Toward Equity. 
  • Olives, E. V., Huang, J. Abdelwadoud, M. dosReis, S., Jansky, L., Mullins, C. D., Campbell, M., Kusinitz, M., Ovelmen, H., Buch, B. D., & Ju, J. (2022). Modifying face-to-face focus group protocols for the online environment after the irruption of the COVID-19 pandemic: A comparison of methodologies with a population of aging women. Quality of Life Research, 31, S150–S150


This research project was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [Grant number: U01FD005946] totaling $432,086 with 100 percent funded by the Office of Women’s Health/FDA/HSS. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement, by the Office of Women’s Health/FDA/HHS, or the U.S. Government.

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