Pharmacovigilance as Scientific Discovery: An Argument for Trans-Disciplinarity

AbstractPharmacovigilance currently faces several unsolved challenges. Of particular importance are issues concerning how to ascertain, collect, confirm, and communicate the best evidence to assist the clinical choice for individual patients. Here, we propose that these practical challenges partially stem from deeper fundamental issues concerning the epistemology of pharmacovigilance. After reviewing some of the persistent challenges, recent measures, and suggestions in the current pharmacovigilance literature, we support the argument that the detection of potential adverse drug reactions ought to be seen as a serendipitous scientific discovery. We further take up recent innovations from the multidisciplinary field of serendipity research about the importance of networks, diversity of expertise, and plurality of methodological perspectives for cultivating serendipitous discovery. Following this discussion, we explore how pharmacovigilance could be systematized in a way that optimizes serendipitous discoveries of untargeted drug effects, emerging from the clinical application. Specifically, we argue for the promotion of atrans-disciplinary responsive network of scientists and stakeholders. Trans-disciplinarity includes extending the involvement of stakeholders beyond the regulatory community, integrating diverse methods and sources of evidence, and enhancing the ability of diverse groups to raise signals of harms that ought to be followed up by the network. Consequently, promo...
Source: Drug Safety - Category: Drugs & Pharmacology Source Type: research

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Publication date: Available online 15 November 2019Source: Operations Research for Health CareAuthor(s): Mariana Oliveira, Valérie Bélanger, Inês Marques, Angel RuizAbstractThis paper proposes an integrated approach to merge patient prioritization and patient scheduling to improve access to services in an elective (i.e., non-urgent) context. In particular, we assume that patients are included on a waiting list for a given surgery, and that every patient on the list has received a “utility score”, which is a proxy for the relative urgency with regards to the other patients on the list. A math...
Source: Operations Research for Health Care - Category: Hospital Management Source Type: research
ConclusionsBy discussing various heterogeneity statistics, visualizations, and explanatory methods, this article provides the applied developmental researcher a foundational understanding of complexity and heterogeneity in meta-analysis.
Source: Journal of Adolescence - Category: Child Development Source Type: research
Publication date: December 2019Source: Journal of Adolescence, Volume 77Author(s): Rachel Widome, Aaron T. Berger, Kathleen M. Lenk, Darin J. Erickson, Melissa N. Laska, Conrad Iber, Gudrun Kilian, Kyla WahlstromAbstractIntroductionShort sleep duration is exceedingly common among adolescents and has implications for healthy youth development. We sought to document associations between adolescents’ sleep duration and characteristics of their schedules, behaviors, and wellbeing.MethodsWe used data from the baseline wave (9th grade year) of the START study, a cohort of 2134 students in five Minnesota high schools to ass...
Source: Journal of Adolescence - Category: Child Development Source Type: research
Publication date: 2nd Quarter 2020Source: Early Childhood Research Quarterly, Volume 51Author(s): Richard M. Clifford, Noreen Yazejian, Debby Cryer, Thelma HarmsAbstractEarly childhood classroom quality can be viewed from multiple perspectives—including parents, teachers, administrators, researchers, policymakers, and politicians. From the beginning of our work in the 1970s, we have defined and measured the quality of early learning environments with the Environment Rating Scales (ERS) from the perspective of the children in those environments. As quality definitions and measurement have changed through the decades s...
Source: Early Childhood Research Quarterly - Category: Child Development Source Type: research
Conclusion: There is a wide variety in the use and awareness of radiation during URS. To further reduce radiation and it's negative effect for patients and medical staff, awareness about radiation safety should increase among urologists. PMID: 31718463 [PubMed - as supplied by publisher]
Source: Acta Chirurgica Belgica - Category: Surgery Tags: Acta Chir Belg Source Type: research
Authors: Maertens V, Lagarde S, Wijnhoven B Abstract A 52-year-old male and 55-year-old female underwent surgical resection of a voluminous symptomatic epiphrenic diverticulum via a right thoracotomy. A formal myotomy of the distal esophagus was not performed. The first patient had an uncomplicated recovery whilst the other patient still suffers from an esophageal-cutaneous fistula and repetitive abscesses, treated by intravenous antibiotics and percutaneous drainage. The authors discuss the indication for resection, surgical techniques and complications. PMID: 31718462 [PubMed - as supplied by publisher]
Source: Acta Chirurgica Belgica - Category: Surgery Tags: Acta Chir Belg Source Type: research
CONCLUSIONS: Considering the age group in which rectal prolapse is most commonly seen, and the change in bowel habits, chronic constipation and irritation chronic seen in rectal prolapse may be responsible for the development of rectum cancer, therefore endoscopic screening should not be overlooked in rectal prolapse cases. KEY WORDS: Anorectal emergencies, Colon cancer, Rectal prolapse. PMID: 31723051 [PubMed - in process]
Source: Annali Italiani di Chirurgia - Category: Surgery Tags: Ann Ital Chir Source Type: research
CONCLUSIONS: Angiomyxoma is a rare, benign and locally aggressive tumor, which can infiltrate locally and present unusually as perineal hernia. Due to its rarity and lack of specific diagnostic requirements, it's difficult to diagnose preoperatively KEY WORDS: Angiomyxoma, Obturator hernia, Pelvic mass. PMID: 31723050 [PubMed - in process]
Source: Annali Italiani di Chirurgia - Category: Surgery Tags: Ann Ital Chir Source Type: research
CONCLUSION: The etiology of chronic groin pain post hernia repair is related in part to nerve injury. This is supported by the high frequency of sensory symptoms and numbness in these patients. However other factors including the role of tissue injury and inflammatory postoperative changes need to be considered. KEY WORDS: Chronic postoperative pain, Inguinal hernia repair, Open surgery, Laparoscopic surgery. PMID: 31719216 [PubMed - as supplied by publisher]
Source: Annali Italiani di Chirurgia - Category: Surgery Tags: Ann Ital Chir Source Type: research
Authors: Dibra A, Bushati T, Berdica L, Masati B, Maranaku S Abstract The primary hyperparathyroidism is a pathological condition that needs frequent surgical treatment. Usually it is encountered due to a parathyroid adenoma, but in rare cases it is configured as structured parathyroid tissue in a rich environment with a bulk of adipose cells. This pathology initially described as Hamartoma of the parathyroid gland and then as parathyroid adenolipoma is rarely encountered and it requires special care from medical staff because of the difficulty in its early diagnosis and also its treatment. We are presenting a case...
Source: Annali Italiani di Chirurgia - Category: Surgery Tags: Ann Ital Chir Source Type: research
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