Presse Medicale最新文献_第2页

Health technology assessment in France 法国的卫生技术评估

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-04-08 DOI: 10.1016/j.lpm.2025.104278

Lionel Collet , Pierre Cochat

引用次数: 0

Taking ethics into account: the HAS perspective 考虑伦理：HAS视角

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-04-07 DOI: 10.1016/j.lpm.2025.104283

Maxence Lyonnet , Robert Gelli , Hubert Galmiche

{"title":"Taking ethics into account: the HAS perspective","authors":"Maxence Lyonnet , Robert Gelli , Hubert Galmiche","doi":"10.1016/j.lpm.2025.104283","DOIUrl":"10.1016/j.lpm.2025.104283","url":null,"abstract":"<div><div>The HAS is unique in France due to its status as an independent public authority. Its closest equivalent is the National Institute for Health and Care Excellence (NICE) in England and Wales. It stands out from other French health agencies by its independence and wide scope, covering health and the social and medico-social sectors. Its independence, guaranteed by law, is combined with regular dialogue with public authorities and external partners. Independence does not come without accountability; it must report its actions to the state and its control bodies (Parliament ant Justice in particular) and more broadly to society and health actors. Scientific rigor, independence, and transparency are at the heart of its values. The 2011 health law, adopted following the French Mediator scandal, established a common legal framework for preventing conflicts of interest in health. The has also developed its own complementary prevention tools. It ensures that the composition of its expert committees balances different schools of thought. In terms of transparency, the HAS publishes all its opinions and decisions, as well as methodological and practical guides. In a demanding context where scientific expertise is particularly scrutinized and the risk of a health crisis, such as Covid-19, is imminent, the HAS must maintain the highest standards of conflict of interest prevention and transparency. This is essential for the quality of expertise and public trust.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104283"},"PeriodicalIF":3.2,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143924137","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Health technology assessment in Europe: A comparison of organizations and introduction to the European regulation

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-04-07 DOI: 10.1016/j.lpm.2025.104282

Judith Fernandez, Paul de Boissieu, Margaret Galbraith

{"title":"Health technology assessment in Europe: A comparison of organizations and introduction to the European regulation","authors":"Judith Fernandez, Paul de Boissieu, Margaret Galbraith","doi":"10.1016/j.lpm.2025.104282","DOIUrl":"10.1016/j.lpm.2025.104282","url":null,"abstract":"<div><div>Health Technology Assessment (HTA) is a multidisciplinary process that evaluates the medical, social, economic, legal, and ethical aspects of health technologies to determine their value throughout their lifecycle. With rising healthcare costs in Europe, robust HTA processes are crucial for making informed decisions that promote an equitable and efficient health system. HTA practices date back to 1967 in France and have expanded across Europe, with most countries adopting HTA models to guide pricing and reimbursement decisions. An analysis of European Health Technology Assessment bodies (HTAb) was conducted through an online survey to showcase the diversity of HTA systems while highlighting their shared goals. The survey, sent to 33 HTAb from July 8 to August 25, 2024, included 11 multiple-choice questions about their organization and processes, allowing for optional free text responses. Data collected were self-reported and analysed using descriptive statistics, with minimal verification of responses. Despite some differences in remit and scope, European HTAb remain steadfast in their resolve to collaborate. The European Commission and EU member states have fostered collaboration among HTA bodies through initiatives like EUnetHTA, culminating in the adoption of the HTA Regulation (EU) 2021/2282, which will be implemented starting January 12, 2025 with the production on joint clinical assessment and joint scientific consultation for some medicinal products and high-risk medical devices. The HTAR offers numerous opportunities for collaboration. Joint productions will foster a culture of mutual learning, allowing countries to benefit from shared expertise and data while ensuring the rigorous and transparent assessment of new health technologies. Moreover, a more unified approach to HTA could accelerate the adoption of new and effective technologies at the continental level, ultimately improving patient outcomes across Europe.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104282"},"PeriodicalIF":3.2,"publicationDate":"2025-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143942793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The French way of HTA: Between scientific rigor, independence and transparency 法国的HTA方式：在科学严谨、独立和透明之间。

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-04-05 DOI: 10.1016/j.lpm.2025.104281

Joachim Baba , Nathan Guerrier , Irena Guzina , Vanessa Hernando , Vassilia Ressencourt , Ivana Spasojevic , Dominic Thorrington , Charlotte Masia

{"title":"The French way of HTA: Between scientific rigor, independence and transparency","authors":"Joachim Baba , Nathan Guerrier , Irena Guzina , Vanessa Hernando , Vassilia Ressencourt , Ivana Spasojevic , Dominic Thorrington , Charlotte Masia","doi":"10.1016/j.lpm.2025.104281","DOIUrl":"10.1016/j.lpm.2025.104281","url":null,"abstract":"<div><h3>Context</h3><div>The Haute Autorité de Santé (HAS) is an independent body responsible for advising the government on the appropriateness of national funding for healthcare technologies and interventions. To fulfil this role, HAS evaluates their efficacy and safety, especially in comparison to existing alternatives.</div></div><div><h3>Methods</h3><div>We first described how the HAS is organised to carry out this mission, then outlined the different stages of the evaluation process, highlighting specific features according to the type of health technology being assessed We also reviewed the HAS's activities for 2023.</div></div><div><h3>Results</h3><div>The HAS relies on international methodological standards to assess health technologies and interventions, on the expertise of healthcare professionals and patient experiences, and input from various stakeholders where appropriate and necessary.</div></div><div><h3>Conclusion</h3><div>Through this rigorous, independent, and transparent scientific evaluation process, the HAS aims to ensure that patients have access to the best available treatments and care, and, when relevant, to the most efficient options for the French healthcare system, while guaranteeing patient safety.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104281"},"PeriodicalIF":3.2,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

French HTA and appropriateness of care: Beyond reimbursement 法国的 HTA 和护理的适当性：超越报销。

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-04-05 DOI: 10.1016/j.lpm.2025.104280

Sophie Blanchard , Valérie Lindecker-Cournil , Bertrand Mussetta , Fréderic Nahmias , Cédric Carbonneil

{"title":"French HTA and appropriateness of care: Beyond reimbursement","authors":"Sophie Blanchard , Valérie Lindecker-Cournil , Bertrand Mussetta , Fréderic Nahmias , Cédric Carbonneil","doi":"10.1016/j.lpm.2025.104280","DOIUrl":"10.1016/j.lpm.2025.104280","url":null,"abstract":"<div><div>Heath Technology Assessment (HTA) is mainly used for reimbursement/disinvestment and access to innovation purposes. In addition, HTA is a useful tool to promote appropriateness of care, as it describes the updated level of validation of assessed health technologies. Thus, several tools (proper use sheets, drug-indexed decision support systems, supervision of practices or use) based on HTA are developed to promote the appropriateness of use of drugs, medical devices or diagnostic and therapeutic procedures among healthcare professionals.</div><div>HTA can also support the development and the update of clinical practice guidelines (CPG) which are the main tool of clinical practice improvement. In addition, HTA can increase CPG implementation through reimbursement of recommended health technologies. Therefore, HTA and CPGs can be perfectly articulated to enable synergistic synchronic or asynchronic action to improve the relevance of care by enabling more dynamic and efficient actions, particularly in terms of robustness and updating.</div><div>However, HTA shares with CPGs the same difficulties of implementation in the field. To face them, whatever the implementation strategy defined, it requires a multifaceted approach involving iterative communication and the involvement of healthcare professionals, patients and stakeholders, both upstream and downstream of the HTA stages.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 2","pages":"Article 104280"},"PeriodicalIF":3.2,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143804101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Laboratory-associated infections and biosafety. 实验室相关感染和生物安全。

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-04-04 DOI: 10.1016/j.lpm.2025.104277

Patrick Berche

{"title":"Laboratory-associated infections and biosafety.","authors":"Patrick Berche","doi":"10.1016/j.lpm.2025.104277","DOIUrl":"10.1016/j.lpm.2025.104277","url":null,"abstract":"<p><p>The occurrence of laboratory-associated infections, which are caused by the handling of human or animal pathogens, represents a significant threat to the health and safety of laboratory workers and the general population. Such risks are present in clinical diagnostic and research laboratories, including those utilizing biotechnology on pathogenic organisms and industrial laboratories engaged in vaccine production. The investigation of these incidents is based on a retrospective analysis of published reports and voluntary questionnaires. The precise level of risk is challenging to ascertain, given the lack of a mandatory reporting system in the majority of countries. This indicates that many event involving exposure to contamination are not reported. The pathogens encountered in the primary published series include bacteria (e.g., Brucella spp., Mycobacterium tuberculosis, Salmonella spp., Shigella spp., Neisseria meningitidis, Coxiella burnetii), viruses (e.g., HBV, HCV, HIV, SARS-CoV-1, VEEV), and particularly dangerous viruses (e.g., hantavirus, filovirus, arenavirus), and less frequently fungi, parasites, and prions. Approximately 70% of these incidents are attributable to human errors. The primary modes of contamination are inhalation of aerosols and accidental parenteral injections. Additionally, contamination may occur during the handling of pathogens and the decontamination of waste, as well as during the inactivation processes of mass cultures utilized in vaccine production. It is therefore imperative that any incident or accident linked to contact with pathogens in laboratories be made compulsory to report. This will facilitate the systematic monitoring of these infections and data analysis for educational purposes, thereby enhancing prevention of laboratory accidents and leaks.</p>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":" ","pages":"104277"},"PeriodicalIF":3.2,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143796219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Patient-reported outcome measures: A key to patient-tailored and outcome-driven care in pulmonary embolism survivors 患者报告的结果测量：肺栓塞幸存者患者定制和结果驱动护理的关键。

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-01-22 DOI: 10.1016/j.lpm.2025.104271

Sophie N.M. ter Haar , Cindy M.M. de Jong , Francis Couturaud , Thijs E. van Mens , Frederikus A. Klok

引用次数: 0

POEMS Syndrome 诗综合症。

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-01-21 DOI: 10.1016/j.lpm.2025.104270

Arnaud Jaccard , Virginie Pascal , Laurent Magy , Murielle Roussel

{"title":"POEMS Syndrome","authors":"Arnaud Jaccard , Virginie Pascal , Laurent Magy , Murielle Roussel","doi":"10.1016/j.lpm.2025.104270","DOIUrl":"10.1016/j.lpm.2025.104270","url":null,"abstract":"<div><div>POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Protein, Skin changes) is a syndrome that involves a monoclonal B-cell proliferation, most often plasmacytic, and a variable number of manifestations listed or not in the acronym. These manifestations include sclerotic bone lesions, plasmacytic Castleman disease, papillary edema, peripheral edema, ascites, thrombocytosis and/or polycythemia, venous and/or arterial thrombosis, and renal, pulmonary, and cardiac impairments <sup>[1]</sup>. Diagnosis is often delayed due to the rarity of this entity and its clinical polymorphism, which can mimic other neurological disorders. First-line treatment for patients without bone marrow involvement and with a limited number of bone lesions is radiation. Patients with diffuse bone lesions or bone marrow involvement should receive systemic treatment, ideally intensive treatment with autologous stem cell transplantation (ASCT) when possible. Lenalidomide and bortezomib (Bortezomib) appear to be very promising, showing very rapid efficacy on neuropathy. Early initiation of treatment, before the development of severe neurological damage, along with supportive care, especially physiotherapy, is crucial for optimal neurological recovery.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 1","pages":"Article 104270"},"PeriodicalIF":3.2,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143029453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Updates on mechanisms of disease progression in precursor myeloma: Monoclonal gammopathy of undermined significance and smoldering myeloma 前体骨髓瘤疾病进展机制的最新进展：单克隆γ病和阴燃骨髓瘤。

IF 3.2 3区医学

Presse Medicale Pub Date : 2025-01-18 DOI: 10.1016/j.lpm.2025.104268

Cynthia Saade , Irene M. Ghobrial

{"title":"Updates on mechanisms of disease progression in precursor myeloma: Monoclonal gammopathy of undermined significance and smoldering myeloma","authors":"Cynthia Saade , Irene M. Ghobrial","doi":"10.1016/j.lpm.2025.104268","DOIUrl":"10.1016/j.lpm.2025.104268","url":null,"abstract":"<div><div>Monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM) are premalignant stages in the development of multiple myeloma (MM). Advances in detection, risk stratification, and therapeutic intervention have transformed our understanding of disease progression. Sensitive techniques like mass spectrometry have identified smaller monoclonal gammopathies, such as monoclonal gammopathy of indeterminate potential (MGIP), which may precede MGUS. Risk stratification models for MGUS and SMM, including the Mayo Clinic, PETHEMA, 2/20/20, IMWG, and PANGEA models, leverage tumor burden markers and cytogenetic abnormalities to predict prognosis. Genomic studies have revealed mutations, structural changes, and mutational signatures that predict progression. Immune microenvironmental alterations underscore the multifactorial nature of disease evolution, while epigenetics is emerging as a source of tumoral and microenvironmental changes. Therapies for high-risk SMM, including lenalidomide, daratumumab, and next-generation immunotherapies, demonstrate efficacy in delaying progression to MM but raise concerns regarding safety in asymptomatic patients. Future research must refine prognostic models, integrate genomic and immunophenotypic data, and establish consensus on optimal strategies for early intervention. This comprehensive review highlights the biological, clinical, and therapeutic advancements in MM and its precursors, emphasizing the importance of early risk assessment and targeted treatment to improve outcomes.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 1","pages":"Article 104268"},"PeriodicalIF":3.2,"publicationDate":"2025-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143010474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Treatment of elderly and frail myeloma patients 治疗年老体弱的骨髓瘤患者。

IF 3.2 3区医学

Presse Medicale Pub Date : 2024-12-12 DOI: 10.1016/j.lpm.2024.104266

Steven Chun-Min Shih , Alissa Visram , Hira Mian

{"title":"Treatment of elderly and frail myeloma patients","authors":"Steven Chun-Min Shih , Alissa Visram , Hira Mian","doi":"10.1016/j.lpm.2024.104266","DOIUrl":"10.1016/j.lpm.2024.104266","url":null,"abstract":"<div><div>Multiple myeloma (MM) is an incurable cancer of older adults. Given the aging population, the prevalence of older adults with MM is expected to further increase over the next decade. Challenges in treating older adults result from the heterogeneity of both aging itself and the disease. Over the past two decades, tremendous progress has been made in improving the outcome in this age group with novel therapeutics, including immunomodulatory drugs, proteasome inhibitors, and more recently anti-CD38 monoclonal antibodies, becoming an integral part of initial treatment. Further improvements are expected over the next decade with novel immunotherapy, including T-cell engagers and chimeric antigen receptor therapies. With additional novel treatments, assessment of patient frailty will become increasingly important in balancing the optimal treatment of patients. In this review, we focus on the treatment of elderly and frail older adults with MM. The first part of our review will focus on pertinent investigations, considerations for treatment initiation and initial risk stratification, including frailty assessment prior to treatment initiation. In the second part, we will focus on the overall goals of treatment and therapeutic options for newly diagnosed and those with relapsed/refractory MM, including novel immunotherapy and supportive care. Lastly, we will end this review by highlighting current knowledge gaps and providing suggestions for future directions to further improve outcomes among older adults with MM.</div></div>","PeriodicalId":20530,"journal":{"name":"Presse Medicale","volume":"54 1","pages":"Article 104266"},"PeriodicalIF":3.2,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142823846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0