BackgroundPreparing and submitting a voluntary adverse event (AE) report to the US Food and Drug Administration (FDA) for a medical device typically takes 40 min. User-friendly Web and mobile reporting apps may increase efficiency. Further, coupled with strategies for direct patient involvement, patient engagement in AE reporting may be improved. In 2012, the FDA Center for Devices and Radiologic Health (CDRH) launched a free, public mobile AE reporting app, MedWatcher, for patients and clinicians. During the same year, a patient community on Facebook adopted the app to submit reports involving a hysteroscopic sterilization device, brand name Essure®.MethodsPatient community outreach was conducted to administrators of the group “Essure Problems” (approximately 18,000 members as of June 2015) to gather individual case safety reports (ICSRs). After agreeing on key reporting principles, group administrators encouraged members to report via the app. Semi-structured forms in the app mirrored fields of the MedWatch 3500 form. ICSRs were transmitted to CDRH via an electronic gateway, and anonymized versions were posted in the app. Data collected from May 11, 2013 to December 7, 2014 were analyzed. Narrative texts were coded by trained and certified MedDRA coders (version 17). Descriptive statistics and metrics, including VigiGrade completeness scores, were analyzed. Various incentives and motivations to report in the Facebook group were observed.ResultsThe average Essure AE report took 11.4 min (±10) to complete. Submissions from 1349 women, average age 34 years, were analyzed. Serious events, including hospitalization, disability, and permanent damage after implantation, were reported by 1047 women (77.6 %). A total of 13,135 product–event pairs were reported, comprising 327 unique preferred terms, most frequently fatigue (n = 491), back pain (468), and pelvic pain (459). Important medical events (IMEs), most frequently mental impairment (142), device dislocation (108), and salpingectomy (62), were reported by 598 women (44.3 %). Other events of interest included loss of libido (n = 115); allergy to metals (109), primarily nickel; and alopecia (252). VigiGrade completeness scores were high, averaging 0.80 (±0.15). Reports received via the mobile app were considered “well documented” 55.9 % of the time, compared with an international average of 13 % for all medical products. On average, there were 15 times more reports submitted per month via the app with patient community support versus traditional pharmacovigilance portals.ConclusionsOutreach via an online patient community, coupled with an easy-to-use app, allowed for rapid and detailed ICSRs to be submitted, with gains in efficiency. Two-way communication and public posting of narratives led to successful engagement within a Motivation-Incentive-Activation-Behavior framework, a conceptual model for successful crowdsourcing. Reports submitted by patients were considerably more complete than those submitted by physicians in routine spontaneous reports. Further researc...

Real-time monitoring of mainstream and social media can inform public health practitioners and policy makers about vaccine sentiment and hesitancy. We describe a publicly available platform for monitoring vaccination-related content, called the Vaccine Sentimeter. With automated data collection from 100,000 mainstream media sources and Twitter, natural-language processing for automated filtering, and manual curation to ensure accuracy, the Vaccine Sentimeter offers a global real-time view of vaccination conversations online. To assess the system's utility, we followed two events: polio vaccination in Pakistan after a news story about a Central Intelligence Agency vaccination ruse and subsequent attacks on health care workers, and a controversial episode in a television program about adverse events following human papillomavirus vaccination. For both events, increased online activity was detected and characterized. For the first event, Twitter response to the attacks on health care workers decreased drastically after the first attack, in contrast to mainstream media coverage. For the second event, the mainstream and social media response was largely positive about the HPV vaccine, but antivaccine conversations persisted longer than the provaccine reaction. Using the Vaccine Sentimeter could enable public health professionals to detect increased online activity or sudden shifts in sentiment that could affect vaccination uptake.

BackgroundInfectious disease surveillance has recently seen many changes including rapid growth of informal surveillance, acting both as competitor and a facilitator to traditional surveillance, as well as the implementation of the revised International Health Regulations. The present study aims to compare outbreak reporting by formal and informal sources given such changes in the field.Methods111 outbreaks identified from June to December 2012 were studied using first formal source report and first informal source report collected by HealthMap, an automated and curated aggregator of data sources for infectious disease surveillance. The outbreak reports were compared for timeliness, reported content, and disease severity.ResultsFormal source reports lagged behind informal source reports by a median of 1.26 days (p = 0.002). In 61% of the outbreaks studied, the same information was reported in the initial formal and informal reports. Disease severity had no significant effect on timeliness of reporting.ConclusionThe findings suggest that recent changes in the field of surveillance improved formal source reporting, particularly in the dimension of timeliness. Still, informal sources were found to report slightly faster and with accurate information. This study emphasizes the importance of utilizing both formal and informal sources for timely and accurate infectious disease outbreak surveillance.

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Objective To introduce MoH+, HealthMap’s (HM) real-time feed of official government sources, and demonstrate its utility in comparing the timeliness of outbreak reporting between official and unofficial sources. Introduction Previous studies have documented significant lags in official reporting of outbreaks compared to unofficial reporting ( 1 , 2 ). MoH+ provides an additional tool to analyze this issue, with the unique advantage of actively gathering a wide range of streamlined official communication, including formal publications, online press releases, and social media updates. Methods Outbreaks reported by official sources were identified through MoH+ ( healthmap.org/mohplus ), which collects surveillance data published globally by ministries of health (MoH), other related ministries, government portals, government-affiliated organizations, and international governing bodies ( Fig. 1 ). Reporting of these outbreaks was also identified in unofficial sources using various HM feeds including Google News, ProMED, and participatory surveillance feeds. Of the 109 outbreaks identified since May 2012, 65 were excluded as they started before data collection, 7 were excluded as they were not reported by unofficial sources, and 1 was excluded as it was a non-natural outbreak. For the remaining 36 outbreaks, the median difference in first date of report between official and unofficial sources was analyzed using a Wilcoxon sign rank test. Results Outbreak reporting in official sources lagged by a statistically significant median of 2 days (p=0.003). Among unofficial sources, online news most often (75%) was the fastest to report an outbreak, followed by ProMED (22%) and participatory surveillance (3%). Among official sources, national government affiliated institutes were most often (41%) the fastest, and repeatedly providing prompt outbreak reports were the US Centers for Disease Control and Prevention (CDC), Public Health Agency of Canada, Finnish Food Safety Authority, Health Protection Scotland, UK Health Protection Agency, and French Institute of Public Health Surveillance (FIPHS). Following such institutes were the European CDC (ECDC) with 22% of first reports of outbreaks; MoH’s (17%); and WHO (10%). There were 4 instances in which official sources reported before unofficial sources—3 by the ECDC and 1 by FIPHS. Conclusions Compared to the Chan study reporting a 16 day lag between first public communication and WHO Outbreak News ( 1 ) and the Mondor study reporting a 10 day lag between non-government and government sources ( 2 ), the present study shows a much condensed lag of 2 days between unofficial and official sources. Because the two earlier studies cover a much broader historical time frame, one explanat...

The current analysis describes the scope and trends in United States content from the Vaccine Sentimeter's results, while seeking to examine any possible links between media content, vaccine coverage, and reported vaccine adverse events in the country. Vaccination coverage for 12 vaccines in the US plotted over the percentage of negative sentiment in media content

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