替代指标在心血管疾病临床决策中的正确认识

在心血管疾病临床试验中,替代指标常用于评价干预措施的疗效.但替代指标在心血管疾病临床试验中非常复杂,因此,心血管医生在解读和评价心血管疾病临床试验的结果时,应正确认识替代指标的内涵、应用背景及其局限性,同时,还应客观地评价相关替代指标的证据强度,以寻找最好的医学证据指导其临床决策和实践.     

落实科学发展观,领跑健康中国,开创心血管疾病防控新局面

心血管疾病已成为影响国民健康的最大杀手,但半个世纪累积的大量流行病学数据与临床试验证据,与发达国家已有的的心血管疾病防控经验,证实心血管疾病可防可控.心血管疾病的预防需要整合平台,多学科参与,综合控制多种危险因素才能实现事半功倍的效果.广大临床医生应积极参与"健康中国2020"战略,领跑健康中国,为提前实现心血管疾病死亡率下降拐点的目标,开创我国心血管疾病防控新局面而奋斗.     

循证中医药针灸方法学分析与思考

循证医学方法学应用于中医药针灸临床试验研究,存在一定问题。从中医药针灸临床文献证据等级的确立和循证针灸临床试验方法学要素两个角度探讨存在的问题,认为应该建立符合中医药针灸临床特点的整体、动态、互动、综合的疗效评价体系,并采用适合评价针灸临床疗效的实用型中医药循证医学方法。     

循证中医药针灸方法学分析与思考

循证医学方法学应用于中医药针灸临床试验研究,存在一定问题.从中医药针灸临床文献证据等级的确立和循证针灸临床试验方法学要素两个角度探讨存在的问题,认为应该建立符合中医药针灸临床特点的整体、动态、互动、综合的疗效评价体系,并采用适合评价针灸临床疗效的实用型中医药循证医学方法.     

循证求证辨症

循证医学 (EBM )的兴起 ,证据成了关注热点。但何为证据 ?从一般意义讲 ,临床医学应具备 :(1)临床性 ,即不是来自实验室动物 ,“EBM强调证据必须来源于临床试验及对临床试验的系统评价”[1] 。 (2 )凭借性 ,即能够证明其患病的依据和临床医疗活动所依赖的各种理论、经验。具体到中西医学 ,证据的内涵和形成、运用迥然不同 ,有人却断言 :“有了西医作为技术支持 ,我们才能明确了解我们治的是什么病 ,才能进一步确定中医方药的准确疗效 ,才有利于总结中医学丰富的遗产。在西医辨病的基础上 ,使我们能够逐步把握某种疾病的证候变化规律 ,进…     

从雌激素替代治疗的历史看临床决策的影响因素

20世纪40年代,动物实验提供的致癌效应证据限制了雌激素替代治疗的应用。20世纪60年代,价值观因素极大地推动了雌激素替代治疗,以至于关于致癌效应的证据被忽视。20世纪70年代,人群研究提供的致癌效应证据使得雌激素替代治疗的应用不断减少。20世纪80年代,致癌效应的消除和观察性流行病学研究提供的心脏保护证据,将雌激素替代治疗的应用推向了顶峰。20世纪末,大规模随机对照试验提供的有害效应证据推动了雌激素替代治疗应用的大幅下降。雌激素替代治疗一波三折的历史体现了证据、价值观在不同时期对临床决策的不同影响,说明只有遵循循证医学的实践模式,基于现有最佳的科学证据,并结合医生的临床经验与患者的价值观,才可能做出科学、有效的临床治疗决策。     

迈向精确医疗的重要举措:真实世界证据

"真实世界证据"是当前国际上提出的一个新概念,指来自传统临床试验以外的其他类型的医疗保健信息。真实世界证据与临床试验证据的根本区别在于获取数据的场境不一样:前者源于实际医疗场地或家庭社区等真实场境,而后者则来自严格受控的科研场境。真实世界证据被定为传统临床试验证据之外的补充证据,主要用于药品和医疗器械的审批决策。由于真实世界证据来自多种临床实践和个人健康管理方面的数据之整合,能够反映真实的临床实践情况,因此它具有与精确医疗相一致的特征:整合性,个性化,真实性。     

活性蛋白C:想说爱你不容易

重组人类活性蛋白C(rhAPC)为治疗重症脓毒症的药物,目前有证据表明rhAPC的市场策略有可能已经影响到专业机构诊治指南的制定与执行;rhAPC的临床疗效亦未能被大型临床试验继续证实,因此目前rhAPC的临床应用以及疗效评价要慎重进行.同时,有必要深入反思药品生产商与专业组织的利益关系,并制订对策以加强监管.     

活性蛋白C：想说爱你不容易

重组人类活性蛋白C（rhAPC）为治疗重症脓毒症的药物,目前有证据表明rhAPC的市场策略有可能已经影响到专业机构诊治指南的制定与执行;rhAPC的临床疗效亦未能被大型临床试验继续证实,因此目前rhAPC的临床应用以及疗效评价要慎重进行。同时,有必要深入反思药品生产商与专业组织的利益关系,并制订对策以加强监管。     

循证医学及其在心血管疾病中的应用

循证医学作为一门新兴的学科,对医学的研究和实践将产生越来越大的影响。在循证医学的操作过程中,如何正确评价和应用所获得的证据极为重要。在短短的十几年间,循证医学给心血管疾病的临床实践带来了根本的变化。     

Clinical Cardiovascular Genetic Counselors Take a Leading Role in Team-based Variant Classification

We sought to delineate the genetic test review and interpretation practices of clinical cardiovascular genetic counselors. A one-time anonymous online survey was taken by 46 clinical cardiovascular genetic counselors recruited through the National Society of Genetic Counselors Cardiovascular Special Interest Group. Nearly all (95.7%) gather additional information on variants reported on clinical genetic test reports and most (81.4%) assess the classification of such variants. Clinical cardiovascular genetic counselors typically (81.0%) classify variants in collaboration with cardiologist and/or geneticist colleagues, with the genetic counselor as the team member who is primarily responsible. Variant classification is a relatively recent (mean 3.2 years) addition to practice. Most genetic counselors learned classification skills on the job from clinical and laboratory colleagues. Recent graduates were more likely to have learned this in graduate school (p?<?0.001). Genetic counselors are motivated to take responsibility for the classification of variants because of prior experiences with variant reclassification, inconsistencies between laboratories, and incomplete laboratory reports. They are also driven by a sense of professional duty and their proximity to the clinical context. This practice represents a broadening of the skill set of clinical cardiovascular genetic counselors and a unique expertise that they contribute to the interdisciplinary teams in which they work.     

对心血管病临床强化治疗的质疑

强化治疗是最近几年反复提到的话题。很多临床试验研究各种强化治疗对心血管疾病预后的影响,但结果显示强化治疗并未能带来更多的益处,甚至有害。因此我们必须理性地看待这些所谓的强化治疗。更应该倾向于个体化治疗、综合治疗,包括控制各种危险因素,改善生活的方式。把治疗的眼光放到疾病发生的早期,早治疗,以求更多获益。     

Are explanatory trials ethical? Shifting the burden of justification in clinical trial design

Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under “ideal” conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under “usual” conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs.     

Is Suicide Ideation a Surrogate Endpoint for Geriatric Suicide?

The present study explored the validity of treating suicide ideation as a surrogate endpoint that can serve as a proxy for suicide in clinical intervention research with suicidal seniors. Two criteria; that suicide ideation is modulated by the proposed intervention and that modulation of suicide ideation leads to a quantitative reduction in suicide rates, were the focus of this review. A series of literature searches of the PsychINFO and Medline databases were conducted on the terms geriatric, elderly, seniors, suicide, self-destruction, clinical, randomized, trial, treatment, intervention , and ideation . Articles were analyzed if they provided sufficient information to examine whether an intervention effectively led to a reduction in suicide ideation among seniors. Two hundred and eight articles were considered for potential inclusion in this study, with 19 articles meeting final inclusion criteria. The articles reviewed were divided into three broad categories: articles supporting suicide ideation as a surrogate endpoint for geriatric suicide ( n = 6); those not supporting this hypothesis ( n = 1); and those providing insufficient information to test the hypothesis ( n = 12). The present analysis provided modest evidence for suicide ideation as a surrogate endpoint for geriatric suicide, due, in part, to a paucity of randomized controlled trials of treatment interventions for suicidal seniors, thus demonstrating a clear need for research in this area. Implications of utilizing surrogate endpoints in suicide research are discussed.     

Assessing the remedy: the case for contracts in clinical trials

Current orthodoxy in research ethics assumes that subjects of clinical trials reserve rights to withdraw at any time and without giving any reason. This view sees the right to withdraw as a simple extension of the right to refuse to participate all together. In this paper, however, I suggest that subjects should assume some responsibilities for the internal validity of the trial at consent and that these responsibilities should be captured by contract. This would allow the researcher to impose a penalty on the subject if he were to withdraw without good reason and on a whim. This proposal still leaves open the possibility of withdrawing without penalty when it is in the subject's best interests to do so. Giving researchers recourse to legal remedy may now be necessary to protect the science, as existing methods used to increase retention are inadequate for one reason or another.     

The <Emphasis Type="Italic">Not Unreasonable</Emphasis> Standard for Assessment of Surrogates and Surrogate Decisions

Standard views on surrogate decision making present alternative ideal models of what ideal surrogates should consider in rendering a decision. They do not, however, explain the physician's responsibility to a patient who lacks decisional capacity or how a physician should regard surrogates and surrogate decisions. The authors argue that it is critical to recognize the moral difference between a patient's decisions and a surrogate's and the professional responsibilities implied by that distinction. In every case involving a patient who lacks decisional capacity, physicians and the treatment team have to make judgments about the appropriateness of both the surrogate and the surrogate's decision. They have to assess the surrogate's decisional capacity and attitude toward the patient as well as the reasons that support the surrogate's decision. This paper provides a model for acceptable surrogate decisions and a standard for blocking inappropriate surrogates. Only decisions based on widely shared reasons are allowable for surrogate refusal of highly beneficial treatment.     

Valuing risk: the ethical review of clinical trial safety

Despite its mandate on minimizing harms in clinical trials, the Common Rule provides little guidance as to how IRBs should evaluate risk. The Common Rule and derivative commentaries tend to conceptualize risk review as an expert-based endeavor aimed at an objective and universal evaluation of possible harm; they also have tended to locate risk in the research activity itself rather than in the context of research. These views of risk conflict with scholarship showing that risk evaluations are socially determined even among experts, that the context of harms can influence how persons evaluate risks, and that forums that approach risk assessment as a technical endeavor bracket from discussion the numerous values that ground risk judgments. Possible reforms are proposed for clinical trial risk review that would render it more inclusive of the different types of risk encountered and more attuned to the priorities of trial subjects.     

Turning failures into successes: a methodological shortcoming in empirical research on surrogate accuracy

Decision making for incompetent patients is a much-discussed topic in bioethics. According to one influential decision making standard, the substituted judgment standard, a surrogate decision maker ought to make the decision that the incompetent patient would have made, had he or she been competent. Empirical research has been conducted in order to find out whether surrogate decision makers are sufficiently good at doing their job, as this is defined by the substituted judgment standard. This research investigates to what extent surrogates are able to predict what the patient would have preferred in the relevant circumstances. In this paper we address a methodological shortcoming evident in a significant number of studies. The mistake consists in categorizing responses that only express uncertainty as predictions that the patient would be positive to treatment, on the grounds that the clinical default is to provide treatment unless it is refused. We argue that this practice is based on confusion and that it risks damaging the research on surrogate accuracy.

Psychological Contract in HIV Prevention Clinical Trials in Resource Poor Communities in Africa

The paper explored the application of psychological contract in HIV prevention clinical trials in resource poor communities in Africa. The psychological contract was discussed in relation to practices in New HIV Prevention Technologies in Africa. From this discussion, it would seem risk for exposure to HIV infection is less well articulated in the psychological contract between the promoters of HIV prevention clinical trials and participants in resource poor communities in Africa. The trialing of New HIV Prevention Technologies in Africa should have in-built psychological contract transparency to reduce the risk of participant exposure to HIV infection in clinical trials.