1,721,019 research outputs found
Drug Safety and Relevant Issues in the Real-World
No full text: The global impact of the COVID-19 pandemic has underscored the pivotal role of drug safety and effective communication within the realm of pharmacovigilance, particularly in times of unprecedented public health emergencies [...]
Unresolved gustatory, olfactory and auditory adverse drug reactions to antibiotic drugs: a survey of spontaneous reporting to Eudravigilance
Full text linkObjectives: Sensory adverse drug reactions (ADRs) are generally expected to be transient in nature. However, spontaneous reports describe frequently these events as long-lasting or unresolved. In this study, the authors reviewed the Eudravigilance publicly accessible database to describe the volume and expectedness of potentially unresolved outcomes for gustatory, olfactory and auditory (GOA) suspected ADRs associated with antibiotics for systemic use. Methods: ‘Overall’ and ‘GOA’ suspected ADRs were extracted from Eudravigilance to estimate the distribution of their outcomes among different antibiotic groups. Then, the authors identified the drugs contributing to at least 15% of all suspected GOA ADRs observed for the antibiotic groups, and evaluated the expectedness. Results: The frequency of persistent/permanent outcomes was higher for GOA suspected ADRs, as compared to the overall ones. Unresolved and undetermined outcomes for antibiotic-associated GOA ADRs in Eudravigilance might hide a large number of events with underestimated clinical consequences. Several persistent/permanent antibiotic-associated GOA reactions could be classified as serious and unexpected. Conclusion: Potential long-lasting or irreversible GOA reactions are often reported for all antibiotics drugs. Further studies are warranted to clarify whether this is an actual safety issue or simply it reflects a general difficulty in outcomes assessment for such reactions
The usefulness of listening social media for pharmacovigilance purposes: a systematic review
No full textIntroduction: Social media mining could be a possible strategy to retrieve drug safety information. The mining of social media is a complex process under progressive evolution, falling into three broad categories: listening (safety data reporting), engaging (follow-up), and broadcasting (risk communication). This systematic review is aimed at evaluating the usefulness and quality of proto-signals by social media listening. Areas covered: In this systematic search, performed according to MOOSE and PRISMA statements, we selected studies, published in MEDLINE, EMBASE, and Google Scholar until 31 December 2017, that listened at least one social media to identify proto-adverse drug events and proto-signals. Expert opinion: The selected 38 studies identified serious and unexpected proto-adverse drug events characterized by poorer information quality as compared with spontaneous reporting databases. This feature allows rarely the evaluation of causal relationships. Proto-signals identified by social media listening had the potential of anticipating pre-specified known signals in only six studies. Moreover, the personal perception of patients reported in social media could be used to implement effective risk communication strategies. However, signal detection in social media cannot be currently recommended for routine pharmacovigilance, due to logistic and technical issues
Anti-tumor Necrosis Factor Drugs and Risk of Lymphoma in Patients with Inflammatory Bowel Disease
No full textBackground/Introduction: Chronic inflammation might be a risk factor for lymphoma [1]. However, at variance with rheumatoid arthritis (RA), the evidence supporting an association of inflammatory bowel diseases (IBDs) with the development of lymphoma is still scarce. Some authors suggested that pharmacological treatments for IBDs and RA, e.g. anti-tumor necrosis factor (anti-TNF) drugs, could promote the development of lymphoma [2, 3]. However, the association of the use of anti-TNF agents with the development of lymphoma is still undetermined. Aim: We analyzed studies aimed at assessing the association between the use of anti-TNF drugs and lymphoma in IBD patients.
Methods: This systematic review was performed according with MOOSE and PRISMA statements. The literature search was conducted by examining MEDLINE, EMBASE, and Google Scholar for all indexed articles published in English language from January 1st, 1999 to June 30th, 2018. We included observational studies conducted on IBD patients and focused on at least one of four anti-TNF drugs (i.e. infliximab, adalimumab, certolizumab pegol and golimumab). From each selected study, source used to collect patient clinical data, design and main methodologic characteristics (e.g. adjustments and matchings, lag period, prevalent patients, observation period, patient disease [Crohn’s disease, ulcerative colitis or IBD], and drug exposure) were extracted. An assessment of the methodologic shortcomings of the selected studies was performed.
Results: Among 41 selected full-text articles, 14 studies met the eligibility criteria and were included in the review. Only four studies found a significant association of anti-TNF drugs with lymphoma or groups of cancers including lymphoma. However, the important methodologic issues of all the included studies made their results unreliable, irrespectively of whether their findings supported an association or not. The identified shortcomings included lack of lag period, inclusion of prevalent patients, time-window bias or immortal- time bias.
Conclusions: The widespread implementation of computer-based health databases has encouraged the conduction of observational studies. However, no cautions for managing adequately the methodologic underlying such investigations are usually taken, leading to an explosion of the publication of poorly conceived studies and analytic designs that have generated incorrect or unreliable conclusions on the safety of exposure to drugs. The results of the present systematic review are fully in line with this trend. Current evidence from observational studies does not allow excluding or confirming an association of the exposure to anti-TNF treatments with lymphoma in IBD patients. Additional well-designed observational studies are warranted to provide a conclusive answer to this relevant question
Is There a Risk of Lymphoma Associated With Anti-tumor Necrosis Factor Drugs in Patients With Inflammatory Bowel Disease? A Systematic Review of Observational Studies
No full textBackground: Inflammatory bowel diseases (IBDs) are generally not considered a risk factor for the development of lymphoma. When considering IBD treatments, there is good evidence supporting thiopurines (azathioprine, 6-mercaptopurine) as a risk factor for lymphoma. Conversely, the association between the use of anti-TNF agents and the development of lymphoma remains undetermined. In this systematic review, we analyzed the evidence coming from observational studies supporting an association between the use of anti-TNF drugs and lymphoma in patients with IBDs. Methods: This systematic review was performed according with MOOSE and PRISMA statements. We searched observational studies conducted on IBD patients, using MEDLINE, EMBASE, and Google Scholar, published in English language, within the period ranging from January 1st, 1999 to June 30th, 2018. An assessment of the methodologic shortcomings of selected studies was performed as well. Results: Fourteen studies met the eligibility criteria and were included in the review. Only four studies found a significant association of anti-TNF drug with lymphoma or groups of cancers including lymphoma. However, the methodologic shortcomings of all the included studies made their results unreliable, irrespectively of whether their findings supported an association or not. Conclusions: Current evidence from observational studies does not allow excluding or confirming an association of the exposure to anti-TNF treatments with lymphoma in IBD patients
Going Beyond Counting First Authors in Author Co-citation Analysis
Full text linkThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Full text link“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Full text linkWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
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