expert panel

专家小组
  • 文章类型: Journal Article
    背景:鼻出血是急诊转诊的一个经常性原因。它的管理可能很复杂;因此,为耳鼻咽喉头颈外科(OHNS)住院医师提供适当的支持以培养临床推理技能来处理此类病例至关重要.协调学习(LbC)是最近开发的教育工具,鼓励学习者通过模拟临床情景进行思考。ENT小组向居民提供有见地的反馈,反映了关于实践的不同观点。我们的研究旨在评估LbC对OHNS居民鼻出血管理培训的可行性和感知价值。
    方法:在这项定性研究中,三个OHNS外科医生,包括两名教员和一名住院医师,写了LBC场景。通过在线平台向参与者提供了LbC工具。由四名OHNS教师组成的小组就LBC问题的答案提供了反馈。耳鼻咽喉头颈外科住院医师通过在线问卷参与并就该教育工具的价值提供了意见。
    结果:总共需要10个一小时的课程来创建和上传培训工具。要提供嵌入在学习工具中的有见地的反馈,四位小组成员每人需要60分钟。在参与的37名居民中,25(68%)完成培训。总体满意度很高:88%的人赞赏这种培训方法,92%的人希望再次使用这种类型的培训。大多数居民认为,当遇到鼻出血患者(92%)和他们对鼻出血的知识(96%)时,培训使他们能够改善临床推理。
    结论:研究结果表明,OHNS居民可以从临床推理练习中受益,并使用LbC方法对需要复杂方法来管理鼻出血等疾病的临床表现进行小组成员反馈。
    BACKGROUND: Epistaxis is a recurring cause for referral to emergency departments. Its management can be complex; hence, it is critical to provide appropriate support to Otolaryngology-Head and Neck Surgery (OHNS) residents to develop clinical reasoning skills to manage such cases. Learning-by-Concordance (LbC) is a recently developed educational tool that encourages learners to think through simulated clinical scenarios. A panel of ENTs provides insightful feedback to residents, reflecting a diversity of opinions about practice. Our study aimed to assess LbC\'s feasibility and perceived value for training OHNS residents in epistaxis management.
    METHODS: In this qualitative study, three OHNS surgeons, including two faculty members and one resident, wrote the LbC scenarios. The LbC tool was made available to participants through an online platform. A panel of four OHNS faculty provided feedback on answers to LbC questions. Otolaryngology-Head and Neck Surgery residents participated and provided their opinion on the value of this educational tool through an online questionnaire.
    RESULTS: A total of 10 one-hour sessions were required to create and upload the training tool. To provide insightful feedback embedded in the learning tool, the four panelists needed 60 min each. Of the 37 participating residents, 25 (68%) completed the training. Overall satisfaction was high: 88% appreciated the training method, and 92% wanted to use this type of training again. Most residents felt the training enabled them to improve their clinical reasoning when encountering a patient with epistaxis (92%) and their knowledge about epistaxis (96%).
    CONCLUSIONS: Findings suggest that OHNS residents could benefit from clinical reasoning exercises with panelist feedback using the LbC approach for clinical presentations that require complex approaches to manage conditions such as epistaxis.
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  • 文章类型: Journal Article
    背景:多利益相关方德尔菲调查的最小样本量仍未得到充分研究。从三项大型国际多利益相关方德尔菲调查中得出,本研究旨在:1)研究增加样本量对结果可复制性的影响;2)评估结果的可复制性水平是否与参与者特征不同:例如,性别,年龄,专业。
    方法:我们使用来自Delphi调查的数据来制定改进医疗干预试验报告的指南:SPIRIT(标准方案项目:干预试验建议)和CONSORT(报告试验综合标准)扩展替代终点(n=175,22项评级);CONSORT-SPI,社会和心理干预的扩展(n=333,评级77项);烧伤护理的核心结果集(n=553,评级88项)。在三项调查中,使用带替换的重新采样从参与者数据集中抽取随机子样本。对于每个子样本,计算所有评级调查项目的中位数,并与全部参与者数据集的中位数进行比较.使用所复制的中值数目(和四分位间距)来计算可复制性百分比(和变异性)。高可复制性定义为≥80%,中等为60%和<80%结果:在样本大小为60的情况下,三个数据集的平均可复制性(变异性)占项目总数的百分比为81%(10%)。在其中一个数据集(CONSORT-SPI)中,当样本量为80时,可复制性达到≥80%.平均而言,将样本量从80增加到160,结果的可复制性又增加了3%,变异性降低了1%.对于基于参与者特征的亚组分析(如性别、年龄,专业角色),使用20至100的重采样样本显示,20至30的样本量导致64%至77%的中等复制水平。
    结论:我们发现,在多利益相关者德尔菲调查中,60至80名参与者的最小样本量在结果中提供了高水平的可复制性(≥80%)。对于仅限于个别利益相关者群体的德尔福研究(如研究人员,临床医生,病人),每组20到30个样本就足够了。
    OBJECTIVE: The minimum sample size for multistakeholder Delphi surveys remains understudied. Drawing from three large international multistakeholder Delphi surveys, this study aimed to: 1) investigate the effect of increasing sample size on replicability of results; 2) assess whether the level of replicability of results differed with participant characteristics: for example, gender, age, and profession.
    METHODS: We used data from Delphi surveys to develop guidance for improved reporting of health-care intervention trials: SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) extension for surrogate end points (n = 175, 22 items rated); CONSORT-SPI [CONSORT extension for Social and Psychological Interventions] (n = 333, 77 items rated); and core outcome set for burn care (n = 553, 88 items rated). Resampling with replacement was used to draw random subsamples from the participant data set in each of the three surveys. For each subsample, the median value of all rated survey items was calculated and compared to the medians from the full participant data set. The median number (and interquartile range) of medians replicated was used to calculate the percentage replicability (and variability). High replicability was defined as ≥80% and moderate as 60% and <80% RESULTS: The average median replicability (variability) as a percentage of total number of items rated from the three datasets was 81% (10%) at a sample size of 60. In one of the datasets (CONSORT-SPI), a ≥80% replicability was reached at a sample size of 80. On average, increasing the sample size from 80 to 160 increased the replicability of results by a further 3% and reduced variability by 1%. For subgroup analysis based on participant characteristics (eg, gender, age, professional role), using resampled samples of 20 to 100 showed that a sample size of 20 to 30 resulted to moderate replicability levels of 64% to 77%.
    CONCLUSIONS: We found that a minimum sample size of 60-80 participants in multistakeholder Delphi surveys provides a high level of replicability (≥80%) in the results. For Delphi studies limited to individual stakeholder groups (such as researchers, clinicians, patients), a sample size of 20 to 30 per group may be sufficient.
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    文章类型: Journal Article
    侵袭性念珠菌病(IC)是致命真菌感染的主要原因之一。随着免疫系统改变的患者数量的增加,IC的频率也在上升,病危,慢性疾病,和各种医疗程序。这种疾病导致高发病率和死亡率,以及延长住院时间和增加医院费用。在印度尼西亚,IC的诊断和管理仍然是一个挑战。鉴定病原真菌和抗真菌药敏试验的实验室设施仍然有限。卫生政策制定者的临床意识和财政支持也不足。早期诊断对于正确治疗以降低发病率和死亡率至关重要。由印度尼西亚肺部真菌病中心(IPMC)发起,来自印度尼西亚六个医学专业组织的几位专家代表已同意召开一系列会议,以编写关于IC诊断和管理的联合草案。专家小组旨在就印度尼西亚诊断和治疗IC的临床实践指南达成共识。
    Invasive candidiasis (IC) ranks among the primary causes of deadly fungal infections. The frequency of IC rises alongside increasing number of patients with altered immune systems, critically ill, chronic diseases, and various medical procedures. The disease causes high morbidity and mortality, as well as prolonged stay and increases hospital costs. The diagnosis and management of IC in Indonesia is still a challenge. Laboratory facilities in identifying pathogenic fungi and susceptibility tests to antifungals are still limited. Clinical awareness and financial support from health policymakers are also insufficient. Early diagnosis is essential for proper treatment to reduce morbidity and mortality rates. Initiated by the Indonesian Pulmonary Mycoses Centre (IPMC), several expert representatives from six medical professional organizations in Indonesia have agreed to set up a meeting series to prepare a joint draft on the diagnosis and management of IC. The expert panel aimed to achieve a consensus on the clinical practice guidelines for diagnosing and treating IC in Indonesia.
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  • 文章类型: English Abstract
    脚本一致性测试(SCT)是2024年法国国家医学生排名考试中的法令引入的一种考试方式。他们的目标是在不确定的情况下评估临床推理。在实践中,SCT评估新信息对基于真实临床情景的先验假设概率的影响。这种方法类似于概率(或贝叶斯)推理。由于与探索的临床情况相关的不确定性,SCT不会将学生的反应与理论知识参考中的预期反应进行比较。相反,由经验丰富的医生组成的小组的回答分布被用来建立问题的评分量表。文献数据表明,医生,即使是有经验的,像大多数人类一样,经常表现出有偏见的直觉概率推理。这些偏见引发了关于使用专家小组回答作为SCT评分量表的相关性的问题。
    The Script Concordance Tests (SCTs) are an examination modality introduced by decree in the French National Ranking Exam for medical students in 2024. Their objective is to evaluate clinical reasoning in situations of uncertainty. In practice, SCTs assess the impact of new information on the probability of a hypothesis formulated a priori based on an authentic clinical scenario. This approach resembles probabilistic (or Bayesian) reasoning. Due to the uncertainty associated with the explored clinical situation, SCTs do not compare the student\'s response to an expected one in a theoretical knowledge reference. Instead, the distribution of responses from a panel of experienced physicians is used to establish the question\'s scoring scale. Literature data suggest that physicians, even experienced ones, like most humans, often exhibit biased intuitive probabilistic reasoning. These biases raise questions about the relevance of using expert panel responses as scoring scales for SCTs.
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  • 文章类型: English Abstract
    癌症精准医学(基于基因组的癌症患者个体化治疗)已经被引入实体瘤,并涉及识别肿瘤发展和进展中的驱动基因,并建议针对这些基因的最佳治疗方法。到目前为止,许多病人都接受过这种方式的治疗。同时,基于癌症基因组测试的癌症基因组医学的准备工作也在进行中,用于造血肿瘤。在这篇文章中,我想分享有关恶性淋巴瘤的主要基因突变及其临床意义的基本信息,并讨论如何利用这些信息在未来的癌症基因组医学。
    Cancer precision medicine (genome-based individualized treatment for cancer patients) has already been introduced for solid tumors, and involves identifying driver genes in the development and progression of tumors and suggesting optimal treatments targeting those genes. So far, many patients have received this style of treatment. Meanwhile, preparations for cancer genomic medicine based on cancer gene panel testing are also underway for hematopoietic tumors. In this article, I would like to share fundamental information about the main genetic mutations in malignant lymphomas and their clinical significance, and discuss how this information should be utilized in cancer genomic medicine in the future.
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  • 文章类型: Journal Article
    拟议的专家意见旨在解决当前关于概念、临床,糖尿病周围神经病变(DPN)的治疗方面,并提供指导文件,以协助临床医生制定DPN护理的最佳实践。与会专家认为临床医生对该病的怀疑是早期识别和诊断的关键因素,强调首次入院或转诊的医生提高对疾病的认识。拟议的“筛查和诊断”算法涉及在糖尿病前期或糖尿病患者中考虑DPN,这些患者在存在DPN危险因素的情况下表现出神经病变症状和/或神经病变体征。仔细考虑实验室检查以排除远端对称性周围神经病的其他原因,并转诊进行详细的神经系统检查,以确认非典型病例中的小神经纤维或大神经纤维功能障碍。虽然,目前,DPN的一线干预措施主要表现为优化血糖控制(主要针对1型糖尿病)和多因素干预(主要针对2型糖尿病),需要针对DPN的个体化发病机制的治疗方法。α-硫辛酸(ALA)似乎是一种重要的一线致病药物,考虑到它是一种直接和间接的抗氧化剂,其作用策略是直接针对活性氧,间接地有利于内源性抗氧化能力,以改善DPN条件。该领域现有的研究还存在差距,需要精心设计,健壮,具有敏感终点和标准化方案的多中心临床试验,以通过简单有效的算法促进DPN的诊断,并跟踪疾病进展和治疗反应。识别生物标志物/预测因子,从潜在的疾病改变的角度允许个性化的方法可能为在DPN的早期阶段有效的新治疗提供机会。并可能改变疾病的自然进程。这份专家意见文件预计将提高医生对概念的认识,临床,和DPN的治疗方面,并帮助他们及时识别DPN,并将这些信息转化为他们的临床实践,以实现DPN患者管理的最佳实践。
    The proposed expert opinion aimed to address the current knowledge on conceptual, clinical, and therapeutic aspects of diabetic peripheral neuropathy (DPN) and to provide a guidance document to assist clinicians for the best practice in DPN care. The participating experts consider the suspicion of the disease by clinicians as a key factor in early recognition and diagnosis, emphasizing an improved awareness of the disease by the first-admission or referring physicians. The proposed \"screening and diagnostic\" algorithm involves the consideration of DPN in a patient with prediabetes or diabetes who presents with neuropathic symptoms and/or signs of neuropathy in the presence of DPN risk factors, with careful consideration of laboratory testing to rule out other causes of distal symmetric peripheral neuropathy and referral for a detailed neurological work-up for a confirmative test of either small or large nerve fiber dysfunction in atypical cases. Although, the first-line interventions for DPN are currently represented by optimized glycemic control (mainly for type 1 diabetes) and multifactorial intervention (mainly for type 2 diabetes), there is a need for individualized pathogenesis-directed treatment approaches for DPN. Alpha-lipoic acid (ALA) seems to be an important first-line pathogenesis-directed agent, given that it is a direct and indirect antioxidant that works with a strategy targeted directly against reactive oxygen species and indirectly in favor of endogenous antioxidant capacity for improving DPN conditions. There is still a gap in existing research in the field, necessitating well-designed, robust, multicenter clinical trials with sensitive endpoints and standardized protocols to facilitate the diagnosis of DPN via a simple and effective algorithm and to track progression of disease and treatment response. Identification of biomarkers/predictors that would allow an individualized approach from a potentially disease-modifying perspective may provide opportunities for novel treatments that would be efficacious in early stages of DPN, and may modify the natural course of the disease. This expert opinion document is expected to increase awareness among physicians about conceptual, clinical, and therapeutic aspects of DPN and to assist them in timely recognition of DPN and translating this information into their clinical practice for best practice in the management of patients with DPN.
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  • 文章类型: Journal Article
    2024年是在非小细胞肺癌(NSCLC)中发现激活表皮生长因子受体(EGFR)突变的20周年。从那以后,基于这一发现,NSCLC的治疗取得了巨大进展.其中一些研究导致肿瘤学研究概念发生了重大变化,并刺激了NSCLC以外的治疗进展。导致当前所有实体瘤的精确肿瘤学的真正时代。我们现在常规地对所有肿瘤类型,甚至NSCLC患者的血浆样本进行分子分析,以了解多种可操作的驱动突变。独立于患者的临床特征,也不限于晚期无法治愈的阶段。我们越来越多地通过使用血浆基因分型来监测治疗反应并检测对靶向治疗的抗性。此外,我们现在对早期NSCLC进行分析,寻找合适的辅助靶向治疗,从而在早期EGFR+NSCLC中最终实现潜在的"治愈",这对于在不吸烟者中实施肺癌筛查具有社会意义,因为大多数EGFR+NSCLC患者是不吸烟者.所有这些进展在2004年都是深不可测的,当时五篇论文描述了激活EGFR突变的“发现”(del19,L858R,外显子20插入,和“不常见”突变)发表。为了纪念这20周年,我们组建了一个由胸部肿瘤医学专家组成的全球小组,以2023年12月31日为纳入论文的截止日期,从这一开创性发现后的20年中选出前20篇论文(出版物或大会报告).排名21至30的论文被认为是“荣誉奖”,也有注释。我们的目标是,这30篇论文及其对其影响的注释,甚至所有排名的论文都将作为未来胸部肿瘤学学员教育的“教学大纲”。最后,我们提到了可能改变实践的临床试验。其中一个,LAURA于2024年6月2日在线发布,未被列入要投票的论文列表,但如果在发现EGFR突变的25周年纪念日再次进行这一共识评估(即自发现激活EGFR突变以来25年的前25篇论文),肯定会排名很高。
    The year 2024 is the 20th anniversary of the discovery of activating epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC). Since then, tremendous advances have been made in the treatment of NSCLC based on this discovery. Some of these studies have led to seismic changes in the concept of oncology research and spurred treatment advances beyond NSCLC, leading to a current true era of precision oncology for all solid tumors. We now routinely molecularly profile all tumor types and even plasma samples of patients with NSCLC for multiple actionable driver mutations, independent of patient clinical characteristics nor is profiling limited to the advanced incurable stage. We are increasingly monitoring treatment responses and detecting resistance to targeted therapy by using plasma genotyping. Furthermore, we are now profiling early-stage NSCLC for appropriate adjuvant targeted treatment leading to an eventual potential \"cure\" in early-stage EGFR+ NSCLC which have societal implication on implementing lung cancer screening in never-smokers as most EGFR+ NSCLC patients are never-smokers. All these advances were unfathomable in 2004 when the five papers that described \"discoveries\" of activating EGFR mutations (del19, L858R, exon 20 insertions, and \"uncommon\" mutations) were published. To commemorate this 20th anniversary, we assembled a global panel of thoracic medical oncology experts to select the top 20 papers (publications or congress presentation) from the 20 years since this seminal discovery with December 31, 2023 as the cutoff date for inclusion of papers to be voted on. Papers ranked 21 to 30 were considered \"honorable mention\" and also annotated. Our objective is that these 30 papers with their annotations about their impact and even all the ranked papers will serve as \"syllabus\" for the education of future thoracic oncology trainees. Finally, we mentioned potential practice-changing clinical trials to be reported. One of them, LAURA was published online on June 2, 2024 was not included in the list of papers to be voted on but will surely be highly ranked if this consensus survery is performed again on the 25th anniversay of the discovery EGFR mutations (i.e. top 25 papers on the 25 years since the discovery of activating EGFR mutations).
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  • 文章类型: Journal Article
    2型糖尿病(T2D)负担的增加,与患病率惊人上升有关;诊断方面的挑战,预防,和治疗;以及疾病对寿命和生活质量的重大影响,是全球医疗保健的主要问题。作为口服抗糖尿病药物(OADs),60多年来一直是T2D药物治疗的基石,而新一代SU,如格列齐特调释(MR),除心血管中性外,已知与低血糖风险低有关。本范围审查旨在专门解决格列齐特MR在T2D的当代治疗范式中的其他SU中的当前位置,并提供实用的指导文件,以帮助临床医生在现实生活中使用格列齐特MR临床实践。本文讨论的主要主题包括早期和持续血糖控制的作用以及SUs在T2D管理中的使用,格列齐特MR与其有效性和安全性相关的特性,在特殊人群中使用格列齐特治疗,以及SU作为一类和格列齐特MR的位置,特别是在当前的T2D治疗算法中。
    The increasing burden of type 2 diabetes (T2D), in relation to alarming rise in the prevalence; challenges in the diagnosis, prevention, and treatment; as well as the substantial impact of disease on longevity and quality of life, is a major concern in healthcare worldwide. Sulfonylureas (SUs) have been a cornerstone of T2D pharmacotherapy for over 60 years as oral antidiabetic drugs (OADs), while the newer generation SUs, such as gliclazide modified release (MR), are known to be associated with low risk of hypoglycemia in addition to the cardiovascular neutrality. This scoping review aimed to specifically address the current position of gliclazide MR among other SUs in the contemporary treatment paradigm for T2D and to provide a practical guidance document to assist clinicians in using gliclazide MR in real-life clinical practice. The main topics addressed in this paper include the role of early and sustained glycemic control and use of SUs in T2D management, the properties of gliclazide MR in relation to its effectiveness and safety, the use of gliclazide therapy in special populations, and the place of SUs as a class and gliclazide MR specifically in the current T2D treatment algorithm.
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  • 文章类型: Journal Article
    目的:最近的临床试验显示,联合使用聚ADP核糖聚合酶(PARP)抑制剂(PARP)和新型激素治疗(NHT)可改善转移性前列腺癌(mPC)男性患者的无进展生存期。美国的监管机构,加拿大,欧洲,日本最近批准了这种用于mPC的联合疗法。常见的不良事件(AE)包括疲劳,恶心和呕吐,和贫血。缺乏对这些组合的细微差别的AE管理指导。小组目标是就PARPi+NHT联合治疗的mPC患者的AE管理形成专家共识。
    方法:使用RAND/加州大学洛杉矶分校改良的DelphiPanel方法。使用不良事件通用术语标准定义AE。十二名专家(七名医学肿瘤学家,一名高级执业注册护士,三位泌尿科医生,和一名患者倡导者)回顾了相关文献;以1-9量表对419例患者情景中怀疑引起AE的药物的初始AE治疗方案进行了独立评估;在2023年3月的会议上讨论了协议领域(AoA)和分歧领域(AoD);并在会议后重复了这些评级。第二轮评级构成了指导方针的基础。
    在第一轮和第二轮评分之间,AoD从41%下降到21%,就每个AE至少一个管理策略达成一致。AoAs包括:(1)对轻度AE患者继续对症治疗;(2)中度疲劳,推荐非药物治疗,暂时举行治疗,并在症状缓解时以减少的剂量重新开始;(3)严重恶心或任何程度的呕吐,其中对症治疗失败,暂时停止治疗,并在症状缓解后以减少的剂量重新开始;(4)血红蛋白7.1-8.0g/dl和贫血症状,暂时保持治疗,并在红细胞输血后以减少的剂量重新开始。
    结论:本专家指南可支持接受PARPi+NHT联合治疗的mPC患者的AE管理。
    结果:一组专家制定了转移性前列腺癌患者不良事件(AE)管理指南,该指南联合使用聚ADP核糖聚合酶抑制剂和新型激素治疗。对于轻度不良事件,建议在对症治疗的同时继续癌症治疗.对于中度或重度不良事件,癌症治疗应暂时停止,并在AE消退时以相同或减少的剂量重新开始.
    OBJECTIVE: Recent clinical trials have shown improvement in progression-free survival in men with metastatic prostate cancer (mPC) treated with combination poly-ADP ribose polymerase (PARP) inhibitors (PARPi) and novel hormonal therapy (NHT). Regulatory bodies in the USA, Canada, Europe, and Japan have recently approved this combination therapy for mPC. Common adverse events (AEs) include fatigue, nausea and vomiting, and anemia. Nuanced AE management guidance for these combinations is lacking. The panel objective was to develop expert consensus on AE management in patients with mPC treated with the combination PARPi + NHT.
    METHODS: The RAND/University of California Los Angeles modified Delphi Panel method was used. AEs were defined using the Common Terminology Criteria for Adverse Events. Twelve experts (seven medical oncologists, one advanced practice registered nurse, three urologists, and one patient advocate) reviewed the relevant literature; independently rated initial AE management options for the agent suspected of causing the AE for 419 patient scenarios on a 1-9 scale; discussed areas of agreement (AoAs) and disagreement (AoDs) at a March 2023 meeting; and repeated these ratings following the meeting. Second-round ratings formed the basis of guidelines.
    UNASSIGNED: AoDs decreased from 41% to 21% between the first and second round ratings, with agreement on at least one management strategy for every AE. AoAs included the following: (1) continue therapy with symptomatic treatment for patients with mild AEs; (2) for moderate fatigue, recommend nonpharmacologic treatment, hold treatment temporarily, and restart at a reduced dose when symptoms resolve; (3) for severe nausea or any degree of vomiting where symptomatic treatment fails, hold treatment temporarily and restart at a reduced dose when symptoms resolve; and (4) for hemoglobin 7.1-8.0 g/dl and symptoms of anemia, hold treatment temporarily and restart at a reduced dose after red blood cell transfusion.
    CONCLUSIONS: This expert guidance can support management of AEs in patients with mPC receiving combination PARPi + NHT therapy.
    RESULTS: A panel of experts developed guidelines for adverse event (AE) management in patients with metastatic prostate cancer treated with a combination of poly-ADP ribose polymerase inhibitors and novel hormonal therapy. For mild AEs, continuation of cancer therapy along with symptomatic treatment is recommended. For moderate or severe AEs, cancer therapy should be stopped temporarily and restarted at the same or a reduced dose when AE resolves.
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  • 文章类型: Journal Article
    背景:新的欧盟医疗器械法规(MDR)更加重视临床证据在建立安全性和性能方面的作用。MDR第54条要求专家委员会独立审查科学,技术,和临床证据支持某些新型设备的市场授权,独立于公告机构审查的既定流程。这些专家提供审查和意见,最终在审查过程中与公告机构审查的信息一起考虑。四个专家委员会(普通和整形外科和牙科;骨科,创伤学,康复,风湿病学;循环系统和神经病学)在2021-2022年的临床评估咨询程序(CECP)下发表了至少一项科学意见(SO)。
    方法:对发表了CECP意见的四个专家委员会进行了审查,以评估每个成员在临床,技术,和每个域的0-2级生物域。对这些委员会发布的10项CECP意见进行了内容审查,以评估其与MDR设定的目标和结果预期的一致性。内容与每个临床相关的程度,技术,和生物学结构域也以0-2量表进行评估。
    结果:所有委员会主要由具有强大临床专业知识的成员组成,但只有少数人拥有强大的技术和生物学专业知识。跨委员会,与学术背景和专业知识相关的成员在临床领域的平均得分都在1.64到2.00之间,但分别只有0-0.15和0.15-0.69,在生物领域,分别为0.12-0.55和0.23-0.73,在技术领域。对10个SO的内容审查表明,所有意见都专门或主要集中在临床证据上。三个包含少量针对技术/工程问题的补充文本,五个针对生物学问题。
    结论:专家委员会主要由专家临床评审员组成,但具有重要技术或生物学专业知识的成员较少。这可能会限制委员会评估通常通过临床前测试最好理解的重大技术和生物风险的能力。扩大各委员会的专业知识可能会提高其利益/风险批评的深度。
    BACKGROUND: The new EU Medical Device Regulation (MDR) places greater importance on the role of clinical evidence to establish safety and performance. Article 54 of the MDR calls for expert committees to independently review the scientific, technical, and clinical evidence supporting the market authorization of certain novel devices independently from the established process of Notified Body reviews. These experts provide a review and opinion that ultimately is taken into consideration alongside the information reviewed by the Notified Body during the review process. Four expert committees (General and Plastic Surgery and Dentistry; Orthopaedics, Traumatology, Rehabilitation, Rheumatology; Circulatory System; and Neurology) have published at least one Scientific Opinion (SO) under the Clinical Evaluation Consultation Procedure (CECP) in 2021-2022.
    METHODS: The four expert committees with published CECP opinions were reviewed to assess the academic backgrounds and professional expertise of each member with respect to clinical, technical, and biological domains on a 0-2 scale for each domain. A content review was conducted on the 10 CECP opinions published by these committees to assess their consistency with the goals and outcome expectations set by the MDR. The extent of content related to each of the clinical, technical, and biological domains was also assessed on a 0-2 scale.
    RESULTS: All committees were composed primarily by members with strong clinical expertise, but only a few had strong technical and biological expertise. Across committees, the average scores of members related to academic background and professional expertise both ranged from 1.64 to 2.00 in the clinical domain, but only 0-0.15 and 0.15-0.69, respectively, in the biological domain, and 0.12-0.55 and 0.23-0.73, respectively, in the technical domain. A content review for the 10 SOs showed that all opinions focused exclusively or primarily on the clinical evidence. Three contained a modest amount of additional text directed at technical/engineering issues and five at biological issues.
    CONCLUSIONS: Expert committees are composed predominantly of expert clinical reviewers but have many fewer members with significant technical or biological expertise. This may limit the ability of the committees to evaluate the significant technical and biological risks that are often best understood by preclinical testing. Broadening the expertise across the committees may improve the depth of their benefit/risk critiques.
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