journal
https://read.qxmd.com/read/38307754/evaluation-of-digital-medical-devices-how-to-take-into-account-the-specificities-of-these-solutions
#21
JOURNAL ARTICLE
Anouk Trancart, Valery-Pierre Riche, Antoine Disset, Dorothée Camus, Anne Josseran, Pascal Bécache, Cécile Charle-Maachi, Laure De Place, Arthur Denninger, Jérôme Fabiano, Charlotte Gourio, Vincent Vercamer
The beginning of the 21st century has seen an increasing number of digital medical devices (DMDs) arrive on the European market, bringing major benefits and changes for society. DMDs are unique in that they bring intelligence to the organisation of care, and generate and collect a wealth of real-life data with ultra-fast life cycles. They have specific requirements, particularly in terms of data security and interoperability. In France and Europe, the construction of evidence, the assessment process and evaluation methodologies with a view to purchase or reimbursement must adjust to these changes, given the specific features of these technologies...
January 11, 2024: Thérapie
https://read.qxmd.com/read/38158271/-overview-of-the-implementation-of-pharmaceutical-interviews-in-pharmacies-in-france-analysis-of-responses-to-a-questionnaire
#22
JOURNAL ARTICLE
Eric Barat, Camille Pouant, Annaelle Soubieux, Marianne Arrii, Jean-Didier Bardet, Catherine Chenailler, Rémi Varin
OBJECTIVE: To evaluate the development of pharmaceutical interviews in pharmacies in France, in order to understand the organization implemented, any limitations and the expansion of eligible pathologies. METHOD: A dematerialized questionnaire was designed and distributed between November 2022 and February 2023 to pharmacists and pharmacy students in France (mainland and overseas) via a link to a Google Form. RESULTS: Ninety-four pharmacists from 8 different regions of France responded to the survey...
December 16, 2023: Thérapie
https://read.qxmd.com/read/38142193/acute-generalized-exanthematous-pustulosis-analysis-of-cases-managed-in-a-tunisian-tertiary-hospital
#23
JOURNAL ARTICLE
Neila Fathallah, Zied Kenani, Sana Mokni, Ryma Gammoudi, Raoudha Slim, Nadia Fetoui Ghariani, Najet Ghariani, Chaker Ben Salem, Bouraoui Ouni, Mohamed Denguezli
Acute generalized exanthematous pustulosis (AGEP) is a severe and life-threatening cutaneous adverse reaction. Drug-induced AGEP is mainly related to antibiotics. More recently, AGEP following spider bites has been increasingly described. Treatment includes withdrawal of the offending drug and supportive care. In Tunisia, data concerning severe cutaneous adverse reactions (SCARs) in general and especially AGEP is lacking. Herein, we conducted a retrospective study to investigate the epidemiological, clinical characteristics and etiologies of AGEP referred to the Dermatology department...
December 14, 2023: Thérapie
https://read.qxmd.com/read/38103949/data-monitoring-committees-and-clinical-trials-from-scientific-justification-to-organisation
#24
JOURNAL ARTICLE
Clara Locher, Silvy Laporte, Peggy Derambure, Olivier Chassany, Cécile Girault, Alix Avakiantz, Claire Bahans, Dominique Deplanque, Pierre Fustier, Anne-Françoise Germe, Behrouz Kassaï, Louis Lacoste, Nadine Petitpain, Matthieu Roustit, Tabassome Simon, Cécile Train, Michel Cucherat
Clinical trials often last several months or even several years. As the trial progresses, it can be tempting to find out whether the data obtained already answers the question posed at the start of the trial in order to stop inclusions or monitoring earlier. However, knowing and taking into account interim results can sometimes compromise the integrity of the results, which is counterproductive. To minimise this risk and ensure that the treatments are assessed reliably, safety and/or efficacy criteria are monitored during the study by a Data Monitoring Committee...
December 5, 2023: Thérapie
https://read.qxmd.com/read/38102030/how-can-the-environmental-sustainability-of-healthcare-products-be-taken-into-account-throughout-their-life-cycle
#25
JOURNAL ARTICLE
Bruno Laviolle, Pierre-Frédéric Degon, Cécile Gillet-Giraud, Dominique Thiveaud, Philippe Lechat, Vera Boïko-Alaux, Claire Fougerou, Clara Jolly, Abir Petit, Isabelle Rémy-Jouet, Raphaël Yven, Laurence Bouret, Laurie Marrauld, Marie-Pierre Vaslet, Virginie Delay, Anne-Laure Gavory, Florence Olle, Julie Langevin, Louise Forteau
Healthcare product procurement accounts for around 50% of the French healthcare system's greenhouse gas emissions. This lesson learned from the publication of the Shift Project's work in November 2021 has been a catalyst within the healthcare system, accelerating the consideration and implementation of actions aimed at reducing the environmental impact of the healthcare system, before, during and after care. In addition to their carbon footprint, healthcare products have a wide range of environmental impacts, including on water, air and soil, throughout their entire life cycle...
December 5, 2023: Thérapie
https://read.qxmd.com/read/38105121/-not-available
#26
JOURNAL ARTICLE
Anne-Laure Morin, Emmanuelle Blanc, Armelle Phalipon, Pierre-Henri Bertoye, Philippe Amiel, Cécile Artaud, Philippe Barthélemy, Elisabeth Botelho-Nevers, Soizic Courcier, Jean-Luc Cracowski, François Eisinger, Remi Forrat, Alina Gruber, Euzebiusz Jamrozik, Odile Launay, Claire Le Jeunne, David Simhon
No abstract text is available yet for this article.
December 1, 2023: Thérapie
https://read.qxmd.com/read/38105120/controlled-human-infection-trials-legitimacy-and-conditions-of-implementation-in-france
#27
JOURNAL ARTICLE
Anne-Laure Morin, Emmanuelle Blanc, Armelle Phalipon, Pierre-Henri Bertoye, Philippe Amiel, Cécile Artaud, Philippe Barthélemy, Elisabeth Botelho-Nevers, Soizic Courcier, Jean-Luc Cracowski, François Eisinger, Remi Forrat, Alina Gruber, Euzebiusz Jamrozik, Odile Launay, Claire Le Jeunne, David Simhon
This round table is the result of an observation. The observation being that controlled human infection clinical trials (also called "infectious challenge" trials or "Controlled Human Infection Models", "CHIM") recommended or even encouraged in the context of vaccine developments in particular, are not carried out in France. However, there are no formal prohibitions within regulations or ethical principles, which point to the prior assessment of risks and benefits for individuals and for society. The participants in this Round Table thus wished to examine, through the prism of their respective disciplines, the scientific and medical relevance of conducting such trials in France and, if possible, to imagine the conditions under which they would be carried out, thus resulting in recommendations on (1) the advisability of their conduct in France (2), the conditions under which they would be implemented in terms of logistics and regulations, and (3) their social acceptability...
December 1, 2023: Thérapie
https://read.qxmd.com/read/38065821/can-precision-medicine-be-integrated-into-routine-therapeutic-decisions-at-the-bedside-of-patients
#28
JOURNAL ARTICLE
Florian Lemaitre, Virginie Florentin, Olivier Blin, Arnaud Bayle, Sylvain Benito, Jean-Vannak Chauny, Ariane Galaup, Daria Korchagina, Marie Lang, Christophe Le Tourneau, Hervé Pelloux, Nicolas Picard, Romain Guilhaumou
Therapeutic strategies are shifting from a "one-size-fits-all" population-based approach to a stratified approach targeting groups with similar characteristics, or even individuals, tailoring treatments to the unique characteristics of each patient. Since such strategies rely on increasingly complex knowledge and healthcare technologies, along with an understanding of the tools of precision medicine, the appropriate dissemination and use of these strategies involves a number of challenges for the medical community...
December 1, 2023: Thérapie
https://read.qxmd.com/read/38246801/-misuse-of-paracetamol-in-primary-care-cross-sectional-study-in-a-french-rural-context
#29
JOURNAL ARTICLE
Shérazade Kinouani, Claire Vielle, Céline Lambert, Julie Dupouy, Catherine Laporte
OBJECTIVE: To estimate the prevalence of the paracetamol use for a reason other than pain (qualitative misuse) during the last 12 months in patients consulting their general practitioner, as well as the reasons for this misuse. METHODS: Descriptive cross-sectional analysis, with gender weighting to estimate the prevalence of paracetamol misuse. RESULTS: In total, data from 209 patients were included in the analysis. Among them, 11 patients declared having taken paracetamol for a reason other than pain, i...
November 29, 2023: Thérapie
https://read.qxmd.com/read/38158272/certolizumab-induced-optic-neuritis-in-a-patient-with-spondyloarthritis-a-case-report-and-review-of-the-literature
#30
LETTER
Hiba Boussaa, Saffet Nouicer, Saoussen Miladi, Yasmine Makhlouf, Kawther Ben Abdelghani, Alia Fazaa, Ahmed Laatar
No abstract text is available yet for this article.
November 29, 2023: Thérapie
https://read.qxmd.com/read/38057212/the-christmas-adverse-event-syndrome-an-analysis-of-the-who-pharmacovigilance-database
#31
JOURNAL ARTICLE
Alex Hlavaty, Matthieu Roustit, Marc Manceau, Jean-Luc Cracowski, Charles Khouri
OBJECTIVES: We hypothesized that during the Christmas season the safety profile and the toxicity of some drugs may be exacerbated. We therefore assessed and characterized changes in drug safety profiles over the Christmas period. DESIGN: We performed a retrospective longitudinal analysis of adverse events reported in the World Health Organization (WHO) pharmacovigilance database between April 1st 2017 to March 31th 2023. SETTING: We extracted cases reported by the 5 main contributors' countries of the WHO pharmacovigilance database with a Christmas tradition: USA, France, Germany, Italy and UK...
November 25, 2023: Thérapie
https://read.qxmd.com/read/38036330/psychoactive-substance-intoxication-leading-to-general-hospital-admission-in-young-and-middle-aged-people-during-and-after-the-first-lockdown
#32
JOURNAL ARTICLE
Justine Perino, Hanta Ramaroson, Nathalie Ong, Victoire Lancelot, Julien Bezin, Véronique Gilleron, Amélie Daveluy, Marie Tournier
INTRODUCTION: Incidence of hospitalisations related to psychoactive substance (H-PS) intoxication has been strongly decreased during the coronavirus disease 2019 (COVID-19) pandemic especially in young adult and French region of Nouvelle-Aquitaine was mostly concerned. This study aimed to describe (i) the incidence of H-PS in Bordeaux teaching hospital during and after the first 2020 lockdown in adults aged 18-29 years or 30+ then (ii) their characteristics specifically associated with the pandemic period by comparing 2020 with 2017-2019 baseline period...
November 22, 2023: Thérapie
https://read.qxmd.com/read/38042752/drug-induced-tumoral-disease-a-global-pharmacovigilance-database-analysis
#33
JOURNAL ARTICLE
Yoann Zelmat, Fabien Despas
INTRODUCTION: Cancer remains a worldwide threat, having caused almost 10 million deaths in 2020. The American Cancer Society has identified both known and probable carcinogens, including commonly used drugs. The aim of this study is to describe the drugs most frequently reported in the occurrence of cancer. METHODS: Among all individual case safety reports (ICSRs) in the global pharmacovigilance database VigiBase, we searched for the 50 most reported drugs with an adverse drug reaction term belonging to the query "Malignant or unspecified tumors" until June 30, 2023...
November 18, 2023: Thérapie
https://read.qxmd.com/read/38008601/a-revisited-version-of-the-disputatio-for-pharmacological-training-an-educational-study
#34
JOURNAL ARTICLE
Louise Carton, Romain Bordy, Perle Totoson, Edouard-Jules Laforgue, Jean-Marc Pelerin, Thomas Portier-Feunteun, Sabine Mainbourg, Dominique Deplanque, Luc Zimmer, Silvy Laporte, Régis Bordet, Guillaume Grenet, Samuel Legeay
OBJECTIVE: The disputatio is a pedagogical method existing since the Middle-Ages where students had to debate about a question asked by a "master", exercising their thinking and oratory skills. To move away from traditional vertical teaching methods, the disputatio has been revived by pharmacologists. Thus, for almost three successive years, several groups of young French pharmacologists and therapists confronted their ideas concerning a medical question at a therapeutic impasse. The aim here is to describe the initial feedback received from participants...
November 18, 2023: Thérapie
https://read.qxmd.com/read/38008600/-validation-of-the-french-version-of-the-assessment-tool-for-hospital-admissions-related-to-medications-at-harm10-to-detect-drug-related-hospitalizations
#35
JOURNAL ARTICLE
Héloïse Capelle, Coralie Baldin, Pierre Caunes, Isabelle Pons, Céline Meguerditchian, Jean-Noël Argenson, Aurélie Daumas, Guillaume Hache
Admissions of the elderly related to medication errors are frequent in hospital, more than half would be avoidable, but there is currently no validated method in French to identify them. The objective of this work was to validate the French version of the AT-HARM10 tool in order to use it for patients admitted in our healthcare facilities. The tool has 10 questions. A positive response to any of the first 3 questions identify admissions that are unlikely to be drug-related. A positive response to one of the following 7 questions identify possible medication-related admissions...
November 17, 2023: Thérapie
https://read.qxmd.com/read/38008599/drug-induced-fetal-and-offspring-disorders-beyond-birth-defects
#36
JOURNAL ARTICLE
Margaux Louchet, Mylène Tisseyre, Florentia Kaguelidou, Jean-Marc Treluyer, Laure-Hélène Préta, Laurent Chouchana
Studies on drug utilization in western countries disclosed that about nine over ten women use at least one or more drugs during pregnancy. Determining whether a drug is safe or not in pregnant women is a challenge of all times. As a developing organism, the fetus is particularly vulnerable to effects of drugs used by the mother. Historically, research has predominantly focused on birth defects, which represent the most studied adverse pregnancy outcomes. However, drugs can also alter the ongoing process of pregnancy and impede the general growth of the fetus...
November 14, 2023: Thérapie
https://read.qxmd.com/read/38129247/-not-available
#37
JOURNAL ARTICLE
Florian Lemaitre, Virginie Florentin, Olivier Blin, Arnaud Bayle, Sylvain Benito, Jean-Vannak Chauny, Ariane Galaup, Daria Korchagina, Marie Lang, Christophe Le Tourneau, Hervé Pelloux, Nicolas Picard, Romain Guilhaumou
No abstract text is available yet for this article.
November 10, 2023: Thérapie
https://read.qxmd.com/read/38114387/what-should-be-done-to-combat-misinformation-about-health-products
#38
JOURNAL ARTICLE
Joëlle Micallef, Hervé Maisonneuve, Sophie Muller, Mathieu Molimard, Bernard Bégaud, Sandrine Cabut, Mina Daban, Milou-Daniel Drici, Chantal Gatignol, Anne Grumblat, Catherine Guaspare-Cartron, Bruno Lasserre, Adel Mebarki, Catherine Pons, Frédérique Prabonnaud, Catherine Raynaud, Olivier Saint-Lary
The increasing role of digital technology, social media, the wide range of channels and the volume of information, the role of medicine as a societal subject, public information that is insufficient and poorly suited to situations of uncertainty are all observations which led to the theme of this round table. After discussing the definition of disinformation, which is not limited to fake news, and talking about contributors who misinform, whether intentionally or not, the participants of this round table made nine recommendations (R) to combat disinformation about health products: create a collaborative platform, information/training on health products, a platform with five major characteristics, namely accessibility, flexibility, objectivity, transparency and independence, as well as media suited to the different targets (R1); promote basic knowledge on health products: education/training to restore the particularly poor image of medication, and teach the public how to use basic concepts appropriately (R2); improve communication to the public based on the observation that information is the main weapon against misinformation and entails, in particular, coordinating communication from the different institutions to make public information more audible, making institutional messages clearer, ensuring they are more factual and prioritising them (R3); know how to communicate using the correct codes and tools (R4), because, to be understood, the substance and the form are inseparable; develop research on communication in the field of health products (R5); acquire tools to identify and regulate as soon as possible (R6); keep check of content by developing critical thinking (R7); define quality criteria for information sources (R8); identify, assess and reference initiatives for the public that could be placed on the platform (R9)...
November 10, 2023: Thérapie
https://read.qxmd.com/read/37993369/-not-available
#39
JOURNAL ARTICLE
Bruno Laviolle, Pierre-Frédéric Degon, Cécile Gillet-Giraud, Dominique Thiveaud, Philippe Lechat, Vera Boïko-Alaux, Claire Fougerou, Clara Jolly, Abir Petit, Isabelle Rémy-Jouet, Raphaël Yven, Laurence Bouret, Laurie Marrauld, Marie-Pierre Vaslet, Virginie Delay, Anne-Laure Gavory, Florence Olle, Julie Langevin, Louise Forteau
No abstract text is available yet for this article.
November 3, 2023: Thérapie
https://read.qxmd.com/read/37985309/-not-available
#40
JOURNAL ARTICLE
Clara Locher, Silvy Laporte, Peggy Derambure, Olivier Chassany, Cécile Girault, Alix Avakiantz, Claire Bahans, Dominique Deplanque, Pierre Fustier, Anne-Françoise Germe, Behrouz Kassaï, Louis Lacoste, Nadine Petitpain, Matthieu Roustit, Tabassome Simon, Cécile Train, Michel Cucherat
No abstract text is available yet for this article.
November 3, 2023: Thérapie
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