Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US

Author:

Bahk Chi Y.,Goshgarian Melanie,Donahue Krystal,Freifeld Clark C.,Menone Christopher M.,Pierce Carrie E.,Rodriguez Harold,Brownstein John S.,Furberg Robert,Dasgupta Nabarun

Funder

U.S. Food and Drug Administration

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference47 articles.

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2. Bates DW, Evans RS, Murff H, et al. Detecting adverse events using information technology. J Am Med Inform Assoc. 2003;10(2):115–28.

3. Jalbert JJ, Ritchey ME, Mi X, et al. Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective. Am J Epidemiol. 2014;180(9):949–58.

4. United States. Department of Health and Human Services. Office of Inspector General, Semiannual report. 2009. p. volumes.

5. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. 2009 [cited December 2009]; Available from: http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf .

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