BackgroundThe underreporting of adverse drug reactions (ADRs) through traditional reporting channels is a limitation in the efficiency of the current pharmacovigilance system. Patients’ experiences with drugs that they report on social media represent a new source of data that may have some value in postmarketing safety surveillance.ObjectiveA scoping review was undertaken to explore the breadth of evidence about the use of social media as a new source of knowledge for pharmacovigilance.MethodsDaubt et al’s recommendations for scoping reviews were followed. The research questions were as follows: How can social media be used as a data source for postmarketing drug surveillance? What are the available methods for extracting data? What are the different ways to use these data? We queried PubMed, Embase, and Google Scholar to extract relevant articles that were published before June 2014 and with no lower date limit. Two pairs of reviewers independently screened the selected studies and proposed two themes of review: manual ADR identification (theme 1) and automated ADR extraction from social media (theme 2). Descriptive characteristics were collected from the publications to create a database for themes 1 and 2.ResultsOf the 1032 citations from PubMed and Embase, 11 were relevant to the research question. An additional 13 citations were added after further research on the Internet and in reference lists. Themes 1 and 2 explored 11 and 13 articles, respectively. Ways of approaching the use of social media as a pharmacovigilance data source were identified.ConclusionsThis scoping review noted multiple methods for identifying target data, extracting them, and evaluating the quality of medical information from social media. It also showed some remaining gaps in the field. Studies related to the identification theme usually failed to accurately assess the completeness, quality, and reliability of the data that were analyzed from social media. Regarding extraction, no study proposed a generic approach to easily adding a new site or data source. Additional studies are required to precisely determine the role of social media in the pharmacovigilance system.
The methods we describe in this article could be adapted and extended to other terminologies which do not benefit from a formal semantic representation, thus enabling better data retrieval performance. Our custom groupings of MedDRA terms were used while performing signal detection, which suggests that the graphical user interface we are currently implementing to process OntoADR could be usefully integrated into specialized pharmacovigilance software that rely on MedDRA.
With the use of dedicated tools, Twitter could become a complementary source of information for pharmacovigilance, despite a major limitation regarding causality assessment of ADRs in individual tweets, which may improve with the new limitation to 280 characters per tweet.
Background: Searching into the MedDRA terminology is usually limited to a hierarchical search, and/or a string search. Our objective was to compare user performances when using a new kind of user interface enabling semantic queries versus classical methods, and evaluating term selection improvement in MedDRA.Methods: We implemented a forms-based web interface: OntoADR Query Tools (OQT). It relies on OntoADR, a formal resource describing MedDRA terms using SNOMED CT concepts and corresponding semantic relations, enabling terminological reasoning. We then compared time spent on five examples of medical conditions using OQT or the MedDRA web-based browser (MWB), and precision and recall of the term selection.Results: OntoADR Query Tools allows the user to search in MedDRA: One may enter search criteria by selecting one semantic property from a dropdown list and one or more SNOMED CT concepts related to the range of the chosen property. The user is assisted in building his query: he can add criteria and combine them. Then, the interface displays the set of MedDRA terms matching the query. Meanwhile, on average, the time spent on OQT (about 4 min 30 s) is significantly lower (−35%; p < 0.001) than time spent on MWB (about 7 min). The results of the System Usability Scale (SUS) gave a score of 62.19 for OQT (rated as good). We also demonstrated increased precision (+27%; p = 0.01) and recall (+34%; p = 0.02). Computed “performance” (correct terms found per minute) is more than three times better with OQT than with MWB.Discussion: This pilot study establishes the feasibility of our approach based on our initial assumption: performing MedDRA queries on the five selected medical conditions, using terminological reasoning, expedites term selection, and improves search capabilities for pharmacovigilance end users. Evaluation with a larger number of users and medical conditions are required in order to establish if OQT is appropriate for the needs of different user profiles, and to check if conclusions can be extended to other kinds of medical conditions. The application is currently limited by the non-exhaustive coverage of MedDRA by OntoADR, but nevertheless shows good performance which encourages continuing in the same direction.
Our results demonstrate the feasibility of applying knowledge engineering techniques for building customized sets of MedDRA terms. Additional work is necessary to improve precision and recall, and confirm the interest of the proposed strategy.
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