Differences in Evidentiary Requirements Between European Medicines Agency and European Health Technology Assessment of Oncology Drugs—Can Alignment Be Enhanced?

ObjectivesNational health technology assessments (HTAs) across Europe show differences in evidentiary requirements from assessments by the European Medicines Agency (EMA), affecting time to patient access for drugs after marketing authorization. This article analyzes the differences between EMA and HTA bodies’ evidentiary requirements for oncology drugs and provides recommendations on potential further alignment to minimize and optimally manage the remaining differences.MethodsInterviews were performed with representatives and drug assessment experts from EMA and HTA bodies to identify evidentiary requirements for several subdomains and collect recommendations for potentially more efficiently addressing differences. A comparative analysis of acceptability of the evidence by EMA and the HTA bodies and for potential further alignment between both authorities was conducted.ResultsAcceptability of available evidence was higher for EMA than HTA bodies. HTA bodies and EMA were aligned on evidentiary requirements in most cases. The subdomains showing notable differences concerned the acceptance of limitation of the target population and extrapolation of target populations, progression-free survival and (other) surrogate endpoints as outcomes, cross-over designs, short trial duration, and clinical relevance of the effect size. Recommendations for reducing or optimally managing differences included joint early dialogues, joint relative effectiveness assessments, and the use of managed entry agreements.ConclusionsDifferences between assessments of EMA and HTA bodies were identified in important areas of evidentiary requirements. Increased alignment between EMA and HTA bodies is suggested and recommendations for realization are discussed.     

Credentialed Persons, Credentialed Knowledge

The vast experimental literature on human error agrees with history of medicine, folklore, and superstition In discrediting knowledge claims based solely on anecdotal impressions. Since clinical experience consists of anecdotal impressions by practitioners, tt Is unavoidably a mixture of truths, half-truths, and falsehoods. The scientific method is the only known way to distinguish these, and it is both unscholariy and unethical for psychologists who deal with other persons' health, careers, money, freedom, and even life itself to pretend that clinical experience suffices and that quantitative research on diagnostic and therapeutic procedures is not needed. Disputes about philosophy of science (e.g., logical positivism) are irrelevant to this issue, which is simply one of distinguishing knowledge claims that bring reliable credentials and others that do not.     

浅谈电子文档的原始性和真实性及法律证据作用

该文针对电子文件或档案的原始性真实性与电子档案的法律证据作用,参考了最新的研究结果,并提出了自己的思考,逐步探讨了它们的涵义及关系.     

从医务人员的证据意识谈举证责任倒置

文章从剖宫产术后伴发腰腿痛病例分析入手，认为举证责任倒置就在我们诊疗工作中，就在我们协调医患关系的过程中。因此需要在临床实践中去感悟举证责任置的深刻含义，从而树立证据意识，做好证据的收集与保存工作，一旦发生诉讼有证为据，并由此提出了“医学证据学”的构想，而医学证据的特点有待进一步深入研究。     

绝经后骨质疏松症患者运动干预的最佳证据总结

背景 运动为防治绝经后骨质疏松症经济有效的干预措施之一,但目前其相关证据内容广泛且分散,临床尚无规范、全面的运动指导方案。目的 检索、评价并总结绝经后骨质疏松症患者运动干预的最佳证据。方法 系统检索BMJ Best Practice、Up To Date临床顾问、Dyna Med,英国国家临床医学研究所指南网、国际指南网、苏格兰学院间指南网、美国指南网,加拿大安大略注册护士协会、国际骨质疏松症基金会、英国皇家骨质疏松协会、美国骨质疏松症基金会、澳大利亚皇家全科医师学院、美国妇产科医师学会、加拿大妇产科医师协会、医脉通、澳大利亚乔安娜循证研究所网站,Cochrane Library、CINAHL、Web of Science、PubMed、Embase、中国知网、中国生物医学文献服务系统中关于绝经后骨质疏松症运动干预的临床实践指南、临床决策、证据总结、专家共识、系统评价。检索时限为建库至2022年1月。采用临床指南研究与评价系统(AGREEⅡ)对指南进行质量评价,采用证据总结评价工作表(CASE)对临床决策进行质量评价,采用澳大利亚JBI循证卫生保健中心专家共识的真实性评价工具(2016...     

Co‐occurring medical conditions in adults with Down syndrome: A systematic review toward the development of health care guidelines. Part II

Adults with Down syndrome (DS) represent a unique population who are in need of clinical guidelines to address their medical care. Many of these conditions are of public health importance with the potential to develop screening recommendations to improve clinical care for this population. Our workgroup previously identified and prioritized co‐occurring medical conditions in adults with DS. In this study, we again performed detailed literature searches on an additional six medical conditions of clinical importance. A series of key questions (KQ) were formulated a priori to guide the literature search strategy. Our KQs focused on disease prevalence, severity, risk‐factors, methodologies for screening/evaluation, impact on morbidity, and potential costs/benefits. The available evidence was extracted, evaluated and graded on quality. The number of participants and the design of clinical studies varied by condition and were often inadequate for answering most of the KQ. Based upon our review, we provide a summary of the findings on hip dysplasia, menopause, acquired cardiac valve disease, type 2 diabetes mellitus, hematologic disorders, and dysphagia. Minimal evidence demonstrates significant gaps in our clinical knowledge that compromises clinical decision‐making and management of these medically complex individuals. The creation of evidence‐based clinical guidance for this population will not be possible until these gaps are addressed.