The Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) have recognized social media as a new data source to strengthen their activities regarding drug ...safety.
Our objective in the ADR-PRISM project was to provide text mining and visualization tools to explore a corpus of posts extracted from social media. We evaluated this approach on a corpus of 21 million posts from five patient forums, and conducted a qualitative analysis of the data available on methylphenidate in this corpus.
We applied text mining methods based on named entity recognition and relation extraction in the corpus, followed by signal detection using proportional reporting ratio (PRR). We also used topic modeling based on the Correlated Topic Model to obtain the list of the matics in the corpus and classify the messages based on their topics.
We automatically identified 3443 posts about methylphenidate published between 2007 and 2016, among which 61 adverse drug reactions (ADR) were automatically detected. Two pharmacovigilance experts evaluated manually the quality of automatic identification, and a f-measure of 0.57 was reached. Patient's reports were mainly neuro-psychiatric effects. Applying PRR, 67% of the ADRs were signals, including most of the neuro-psychiatric symptoms but also palpitations. Topic modeling showed that the most represented topics were related to
, but also
. Cases of misuse were also identified in this corpus, including recreational use and abuse.
Named entity recognition combined with signal detection and topic modeling have demonstrated their complementarity in mining social media data. An in-depth analysis focused on methylphenidate showed that this approach was able to detect potential signals and to provide better understanding of patients' behaviors regarding drugs, including misuse.
OBJECTIVE: To examine which combination of objectively measured actigraphy parameters best characterizes the sleep-wake cycle of euthymic individuals with bipolar disorder (BD) compared with healthy ...controls (HC).METHODS: Sixty-one BD cases and 61 matched HC undertook 21 consecutive days of actigraphy. Groups were compared using discriminant function analyses (DFA) that explored dimensions derived from mean values of sleep parameters (Model 1); variability of sleep parameters (2); daytime activity (3); and combined sleep and activity parameters (4). Exploratory within-group analyses examined characteristics associated with misclassification.RESULTS: After controlling for depressive symptoms, the combined model (4) correctly classified 75% cases, while the sleep models (1 and 2) correctly classified 87% controls. The area under the curve favored the combined model (0.86). Age was significantly associated with misclassification among HC, while a diagnosis of BD-II was associated with an increased risk of misclassifications of cases.CONCLUSION: Including sleep variability and activity parameters alongside measures of sleep quantity improves the characterization of cases of euthymic BD and helps distinguish them from HC. If replicated, the findings indicate that traditional approaches to actigraphy (examining mean values for the standard set of sleep parameters) may represent a suboptimal approach to understanding sleep-wake cycles in BD.
Purpose: To incorporate quality-of-life considerations in assessing high dose therapy (HDT) for patients with Multiple Myeloma (MM). Patients and methods: A quality-adjusted survival analysis, using ...the quality-adjusted time without symptoms or toxicity (Q-TWiST) method, was applied to two randomized clinical trials conducted in patients with MM which compared randomized assignment to HDT vs. conventional chemotherapy (CCT) alone (MAG91) or followed by HDT (MAG90). Treatment benefit in terms of mean Q-TWiST was assessed through threshold utility analyses i.e., sensitivity analyses of the choice of the utility coefficients over all possible values of utility weights. Results: In both trials, results slightly favored the first-line HDT group over the first-line CCT group, with an average gain in TWiST of about 5.5 months over the 58 month-median follow-up period (27.8 vs. 22.3 months, respectively) in the MAG90 trial and 5.8 months over the 56 month-median follow-up period (19.1 vs. 13.3 months, respectively) in the MAG91 trial. The utility threshold analyses revealed that the first-line HDT group had a statistically increased mean quality-of-life adjusted time compared to the other group for a broad range of utility coefficient values. Conclusion: The development of such understandable and intuitive measures of expressing the relative benefit of complex treatment strategies is expected to be used in clinical decision making in the near future.
Social media have drawn attention for their potential use in Pharmacovigilance. Recent work showed that it is possible to extract information concerning adverse drug reactions (ADRs) from posts in ...social media. The main objective of the Vigi4MED project was to evaluate the relevance and quality of the information shared by patients on web forums about drug safety and its potential utility for pharmacovigilance.
After selecting websites of interest, we manually evaluated the relevance of the content of posts for pharmacovigilance related to six drugs (agomelatine, baclofen, duloxetine, exenatide, strontium ranelate, and tetrazepam). We compared forums to the French Pharmacovigilance Database (FPVD) to (1) evaluate whether they contained relevant information to characterize a pharmacovigilance case report (patient's age and sex; treatment indication, dose and duration; time-to-onset (TTO) and outcome of the ADR, and drug dechallenge and rechallenge) and (2) perform impact analysis (nature, seriousness, unexpectedness, and outcome of the ADR).
The cases in the FPVD were significantly more informative than posts in forums for patient description (age, sex), treatment description (dose, duration, TTO), and outcome of the ADR, but the indication for the treatment was more often found in forums. Cases were more often serious in the FPVD than in forums (46% vs. 4%), but forums more often contained an unexpected ADR than the FPVD (24% vs. 17%). Moreover, 197 unexpected ADRs identified in forums were absent from the FPVD and the distribution of the MedDRA System Organ Classes (SOCs) was different between the two data sources.
This study is the first to evaluate if patients' posts may qualify as potential and informative case reports that should be stored in a pharmacovigilance database in the same way as case reports submitted by health professionals. The posts were less informative (except for the indication) and focused on less serious ADRs than the FPVD cases, but more unexpected ADRs were presented in forums than in the FPVD and their SOCs were different. Thus, web forums should be considered as a secondary, but complementary source for pharmacovigilance.
We sought to compare the Eigenfactor Score™ journal rank with the journal Impact Factor over five years, and to identify variables that may influence the ranking differences between the two metrics. ...Datasets were retrieved from the Thomson Reuters® and Eigenfactor Score™ Web sites. Dentistry was identified as the most specific medical specialty. Variables were retrieved from the selected journals to be included in a regression linear model. Among the 46 dental journals included in the analysis, striking variations in ranks were observed according to the metric used. The Bland-Altman plot showed a poor agreement between the metrics. The multivariate analysis indicates that the number of original research articles, the number of reviews, the self-citations, and the citing time may explain the differences between ranks. The Eigenfactor Score™ seems to better capture the prestige of a journal than the Impact Factor. In medicine, the bibliometric indicators should focus not only on the overall medical field but also on specialized disciplinary fields. Distinct measures are needed to better describe the scientific impact of specialized medical publications.
BackgroundCurrent laboratory and radiological methods for diagnosis of invasive aspergillosis (IA) lack sensitivity and specificity MethodsWe prospectively evaluated the diagnostic value of ...twice-weekly screening for circulating Aspergillus fumigatus and A. flavus DNA with a polymerase chain reaction–enzyme-linked immunosorbent assay (PCR-ELISA) ResultsAmong the 201 adult patients with hematological malignancies who were included in the study, 55 IA cases were diagnosed. On the basis of the analysis of 1205 serum samples from 167 patients, the sensitivity, specificity, and positive and negative predictive values of the PCR-ELISA for proven and probable IA cases were 63.6%, 89.7%, 63.6%, and 89.7%, respectively, when samples with 2 consecutive positive results were used. The use of a combination of the PCR-ELISA and a galactomannan (GM) assay increased the sensitivity to 83.3%, increased the negative predictive value to 97.6%, and decreased the specificity to 69.8%. In most patients with IA, PCR-ELISA positivity anticipated or was simultaneous with the initiation of antifungal therapy, the abnormalities found by computed tomography, the mycological/histological diagnosis, and the GM positivity. Overall, 56.3% of the patients had at least 1 positive sample, and the false single-positive rate was 44.8% ConclusionsIn addition to serial screening for GM antigenemia and radiological surveillance, PCR-ELISA may improve the rates of early diagnosis of IA and the management of patients with hematological malignancies
Épidémiologie.
L’immunonutrition se définit par l’ajout de nutriments spécifiques en quantité supérieure à la normale pour moduler l’immunité, dans le cadre d’une assistance nutritionnelle. Les ...recommandations nationales indiquent qu’elle devrait être prescrite avant toute chirurgie digestive oncologique majeure, dans le but de réduire la morbidité postopératoire. Néanmoins, cette pratique demeure controversée. L’objectif de notre étude est d’évaluer son effet en préopératoire sur un échantillon national représentatif.
Nous avons utilisé la base de données administrative nationale « échantillon généraliste des bénéficiaires ». Les sujets ont été sélectionnés à partir des codes cancers CIM-10 croisés avec les actes de chirurgie digestive de 2012 à 2016. Deux groupes ont été identifiés, l’un avec remboursement de l’immunonutrition 45 jours avant la chirurgie et l’autre sans ce remboursement. Le critère de jugement principal était la morbidité postopératoire à 90 jours, les critères secondaires, la durée de séjours et la mortalité.
Une régression logistique et une analyse de survie ajustée sur la pondération inverse du score de propension (IPW)) ont été réalisées. Au total, 1771 patients ont été inclus, 72 % (n=1279) atteints de cancers colorectaux, 14 % (n=256) de cancers hépato-pancréato-biliaires et 12 % (n=218) de cancers oeso-gastriques et instestinaux. L’immunonutrition avait été remboursée pour 34 % des patients (n=606). Les patients du groupe immunonutrition étaient significativement plus jeunes, avec plus de syndrome d’apnée du sommeil, plus d’antécédents de chimiothérapie et utilisaient plus de compléments nutritionnels oraux. Il n’y avait pas de différence significative entre les deux groupes concernant la morbidité à 90 jours en post opératoire (OR 0,95 (IC 95 % :0,87 ; 1,04)) ni sur la survie. Cependant, le nombre de séjour long était plus faible dans le groupe immunonutrition (OR : 0,77 IC 95 % : 0,63–0,94).
À l’échelle nationale, l’utilisation préopératoire de l’immunonutrition avant chirurgie digestive oncologique majeure n’était pas associée à une réduction de la morbidité post opératoire. Cependant, elle était associée à une réduction de la durée de séjour.
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