The Use of Social Media in Detecting Drug Safety–Related New Black Box Warnings, Labeling Changes, or Withdrawals: Scoping Review
Notice bibliographique
Résumé
BACKGROUND: Social media has become a new source for obtaining real-world data on adverse drug reactions. Many studies have investigated the use of social media to detect early signals of adverse drug reactions. However, the trustworthiness of signals derived from social media is questionable. To confirm this, a confirmatory study with a positive control (eg, new black box warnings, labeling changes, or withdrawals) is required. OBJECTIVE: This study aimed to evaluate the use of social media in detecting new black box warnings, labeling changes, or withdrawals in advance. METHODS: This scoping review adhered to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist. A researcher searched PubMed and EMBASE in January 2021. Original studies analyzing black box warnings, labeling changes, or withdrawals from social media were selected, and the results of the studies were summarized. RESULTS: A total of 14 studies were included in this scoping review. Most studies (8/14, 57.1%%) collected data from a single source, and 10 (71.4%) used specialized health care social networks and forums. The analytical methods used in these studies varied considerably. Three studies (21.4%) manually annotated posts, while 5 (35.7%) adopted machine learning algorithms. Nine studies (64.2%) concluded that social media could detect signals 3 months to 9 years before action from regulatory authorities. Most of these studies (8/9, 88.9%) were conducted on specialized health care social networks and forums. On the contrary, 5 (35.7%) studies yielded modest or negative results. Of these, 2 (40%) used generic social networking sites, 2 (40%) used specialized health care networks and forums, and 1 (20%) used both generic social networking sites and specialized health care social networks and forums. The most recently published study recommends not using social media for pharmacovigilance. Several challenges remain in using social media for pharmacovigilance regarding coverage, data quality, and analytic processing. CONCLUSIONS: Social media, along with conventional pharmacovigilance measures, can be used to detect signals associated with new black box warnings, labeling changes, or withdrawals. Several challenges remain; however, social media will be useful for signal detection of frequently mentioned drugs in specialized health care social networks and forums. Further studies are required to advance natural language processing and mine real-world data on social media.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,003 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».