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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
FDA Grand Rounds: Structuring Unstructured Data: Using new data sources to understand the needs of underserved populations
May 9, 2019
WO Bldg 2: 2047

Activity Coordinator:
Devin Thomas (Devin.Thomas@fda.hhs.gov)
Series Description

The FDA Grand Rounds is webcast monthly to highlight cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.

Lecture Description
How can unstructured FDA archival data and social media be structured to consistently and comprehensively capture the patient's voice? Findings: In this qualitative analysis of FDA archival data and social media associated with public and patient comments about opioid use disorder and pulmonary arterial hypertension, themes and topics were identified to structure data sources and help in understanding of the patients' concerns. Meaning: Collectively, these findings suggest opportunities to use new data sources to increase the comprehensive understanding of the patient's voice, including increasing confidence in the data that the FDA traditionally collects, and reaching voices of vulnerable populations.
References
  • Understanding the role of social media in online health: A global perspective on online social support by Roderick Lamar Lee and Lynette M. Kvasny. First Monday, Volume 19, Number 1 - 6 January 2014 https://firstmonday.org/ojs/index.php/fm/article/view/4048/3805 doi: 10.5210/fm.v19i1.4048.
  • Hanson, C. L., West, J., Thackeray, R., Barnes, M. D., & Downey, J. (2014). Understanding and predicting social media use among community health center patients: a cross-sectional survey. Journal of medical Internet research, 16(11), e270. doi:10.2196/jmir.3373
Series Objectives
  • Discuss the research conducted at the FDA
  • Explain how FDA science impacts public health
Learning Objectives After completion of this activity, the participant will be able to:
  • Describe how to analyze unstructured FDA archival data and social media to consistently and comprehensively capture the patient’s voice?
  • Explain how to utilize qualitative methodology to explore unstructured data with high repeatability.
  • Describe importance of triangulation of data of FDA archival data and social media.
Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.
Agenda

Lecture 1 May 9, 2019
Time Topic Speaker
12:00 - 1:00 PM EDT Structuring Unstructured Data: Using new data sources to understand the needs of underserved populations Christine Lee, PhD, PharmD
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
CME
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-19-012-L04-P for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.
Disclosure

Faculty
  • Lee, Christine, PhD, PharmD, General Health Scientist, FDA - nothing to disclose

Planning Committee
  • Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
  • KEMPF, LUCAS, MD - nothing to disclose
  • Lee, Christine, PhD, PharmD, General Health Scientist, FDA - nothing to disclose
  • Pfundt, Tiffany, PharmD, Program Coordinator, FDA/CDER/OTBB - nothing to disclose
  • Wheelock, Leslie, RN, MS, Director, OSPD, FDA, OC, OCS, OSPD - nothing to disclose

CE Consultation and Accreditation Team
  • Bryant, Traci, M.A.T., CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
  • Giroux, Virginia, MSN, FNP-BC, Associate Director for Accreditation, FDA/CDER/OEP/DLOD - nothing to disclose
  • Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration Information
Registration is complimentary; therefore refunds are not applicable.