Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting.
J Am Med Inform Assoc
; 21(4): 687-91, 2014.
Article
em En
| MEDLINE
| ID: mdl-24355131
ABSTRACT
BACKGROUND AND OBJECTIVE:
Malfunctions or poor usability of devices measuring glucose or delivering insulin are reportable to the FDA. Manufacturers submit 99.9% of these reports. We test online social networks as a complementary source to traditional FDA reporting of device-related adverse events.METHODS:
Participatory surveillance of members of a non-profit online social network, TuDiabetes.org, from October 2011 to September 2012. Subjects were volunteers from a group within TuDiabetes, actively engaged online in participatory surveillance. They used the free TuAnalyze app, a privacy-preserving method to report detailed clinical information, available through the network. Network members were polled about finger-stick blood glucose monitors, continuous glucose monitors, and insulin delivery devices, including insulin pumps and insulin pens.RESULTS:
Of 549 participants, 75 reported device-related adverse events, nearly half (48.0%) requiring intervention from another person to manage the event. Only three (4.0%) of these were reported by participants to the FDA. All TuAnalyze reports contained outcome information compared with 22% of reports to the FDA. Hypoglycemia and hyperglycemia were experienced by 48.0% and 49.3% of participants, respectively.DISCUSSION:
Members of an online community readily engaged in participatory surveillance. While polling distributed online populations does not yield generalizable, denominator-based rates, this approach can characterize risk within online communities using a bidirectional communication channel that enables reach-back and intervention.CONCLUSIONS:
Engagement of distributed communities in social networks is a viable complementary approach to traditional public health surveillance for adverse events related to medical devices.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vigilância de Produtos Comercializados
/
Sistemas de Infusão de Insulina
/
Automonitorização da Glicemia
/
Diabetes Mellitus
/
Rede Social
Tipo de estudo:
Screening_studies
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
J Am Med Inform Assoc
Ano de publicação:
2014
Tipo de documento:
Article