• 【涉及缺乏同意能力的人群进行道德试验的进展和挑战:十年回顾。】 复制标题 收藏 收藏
    DOI:10.1016/j.cct.2020.106054 复制DOI
    作者列表:Shepherd V
    BACKGROUND & AIMS: :Informed consent is an essential requirement prior to clinical trial participation, however some 'vulnerable' groups, such as people with cognitive impairments and those in medical emergency situations, may lack decisional capacity to consent. This raises ethical and practical challenges when designing and conducting clinical trials involving these populations, who are frequently excluded as a result. Despite recent advances in improving informed consent processes, there has been far less attention paid to the enrolment of adults lacking capacity. Exclusion criteria are an important determinant of the external validity of clinical trial results. The exclusion of these populations, and consent-based recruitment biases which arise from the challenges of identifying and involving surrogate decision-makers, leads to trials which are not representative of the clinical population. This article discusses the involvement of adults who lack decisional capacity to consent in clinical trials and presents the advances over the previous decade and the remaining ethical challenges for the inclusion of this under-represented population in research.
    背景与目标: :知情同意是参加临床试验之前的一项基本要求,但是,某些“弱势”群体,例如具有认知障碍的人和处于医疗紧急情况下的人,可能缺乏决定性的同意能力。在设计和进行涉及这些人群的临床试验时,这在道德和实践方面提出了挑战,因此常常被排除在外。尽管最近在改善知情同意程序方面取得了进展,但对招募缺乏能力的成年人的关注却很少。排除标准是临床试验结果外部有效性的重要决定因素。将这些人群排除在外,以及由于识别和替代代理决策者的挑战而引起的基于同意的招聘偏见,导致无法代表临床人群的试验。本文讨论了缺乏决定性同意能力的成年人参与临床试验的情况,并介绍了过去十年的进展以及将这一代表性不足的人群纳入研究的其余伦理挑战。
  • 2 Informing Informed Consent for HIV Research. 复制标题 收藏 收藏

    【告知知情同意进行HIV研究。】 复制标题 收藏 收藏
    DOI:10.1177/1556264620933766 复制DOI
    作者列表:Campbell LM,Paolillo EW,Bryan R,Marquie-Beck J,Moore DJ,Nebeker C,Moore RC
    BACKGROUND & AIMS: :"Respect for Persons" is an ethical principle demonstrated through the informed consent process. Participants at a large HIV research center were surveyed to identify important aspects of the consent process. Persons with and without HIV (n = 103) completed a short pre/post questionnaire with both open-ended and forced choice response options. Qualitative analysis resulted in eleven themes about the most important consent elements which did not differ by HIV serostatus. Overall, participants rated the informed consent content and presentation by research staff as "extremely informative" and found the consent information to be "extremely consistent" with their study experience. Study results support the value of an interactive process and can be used to inform the design of a standardized, digital consent process.
    背景与目标: :“尊重人”是通过知情同意程序证明的道德原则。对大型HIV研究中心的参与者进行了调查,以确定同意过程的重要方面。患有和没有艾滋病毒的人(n = 103)完成了简短的前/后问卷调查,包括开放式和强迫选择反应选项。定性分析得出了关于最重要的同意元素的11个主题,这些主题在HIV血清状况方面没有差异。总体而言,参与者将知情同意书的内容和研究人员的陈述评为“极其有益”,并发现同意信息与他们的学习经历“极为一致”。研究结果支持交互过程的价值,并可用于为标准化数字同意过程的设计提供信息。
  • 【紧急腹部手术的知情同意过程。】 复制标题 收藏 收藏
    DOI:10.1136/jme.27.3.157 复制DOI
    作者列表:Kay R,Siriwardena AK
    BACKGROUND & AIMS: OBJECTIVES:To assess perceptions of the informed consent process in patients undergoing urgent abdominal surgery. DESIGN:A prospective observational study was carried out using structured questionnaire-based interviews. Patients who had undergone urgent abdominal surgery were interviewed in the postoperative period to ascertain their perceptions of the informed consent process. Replies were compared to responses obtained from a control group undergoing elective surgery, to identify factors common to the surgical process and those specific to urgent surgery. Patients' perceptions of received information were also compared to the information perceived to have been provided by the consent obtainers. SETTING:Gastrointestinal surgical service of a university teaching hospital. PATIENTS:Seventy-four consecutive patients undergoing urgent abdominal surgery and 80 control patients undergoing elective surgery. MAIN MEASUREMENTS:Principal outcome measures were patients perceptions of factors interfering with the ability to give informed consent, assessment of the quality of informed consent and the degree of discussion of the expected outcomes. RESULTS:Forty-nine of the seventy-four (66%) patients undergoing urgent surgery perceived that pain did not affect their ability to give informed consent. Twenty-seven reported an adverse effect of analgesia on the ability to give informed consent. Only 22% of patients undergoing urgent surgery perceived that there had been any discussion of potential side effects and complications of surgery. CONCLUSION:The majority of patients in this series with acute intra-abdominal surgical conditions perceive that they retain the ability to give informed consent for surgery. There is a need for improved discussion of therapeutic options and likely outcomes.
    背景与目标: 目的:评估接受紧急腹部手术的患者对知情同意过程的看法。
    设计:使用基于问卷调查的结构化访谈进行了一项前瞻性观察研究。接受紧急腹部手术的患者在术后接受采访,以确定他们对知情同意过程的看法。将答复与从进行择期手术的对照组得到的答复进行比较,以确定手术过程中常见的因素和急诊手术特有的因素。还将患者对收到信息的看法与知情同意书提供者所提供的信息进行比较。
    单位:某大学教学医院的胃肠外科。
    患者:连续接受紧急腹部手术的患者44例,接受择期手术的对照患者80例。
    主要测量指标:主要结局指标是患者对影响给予知情同意能力的因素的看法,对知情同意质量的评估以及对预期结果的讨论程度。
    结果:在接受紧急手术的七十四名患者中,有四十九名(66%)认为疼痛并没有影响他们给予知情同意的能力。 27例报告了镇痛对知情同意能力的不利影响。接受紧急手术的患者中只有22%认为有关于手术潜在副作用和并发症的讨论。
    结论:该系列中大多数患有急性腹腔内手术条件的患者都认为他们保留了知情同意手术的能力。需要对治疗选择和可能的结果进行更好的讨论。
  • 【对患者对广泛同意的观点进行大型,多站点调查:挑战和解决方案。】 复制标题 收藏 收藏
    DOI:10.1186/s12874-016-0263-7 复制DOI
    作者列表:
    BACKGROUND & AIMS: BACKGROUND:As biobanks play an increasing role in the genomic research that will lead to precision medicine, input from diverse and large populations of patients in a variety of health care settings will be important in order to successfully carry out such studies. One important topic is participants' views towards consent and data sharing, especially since the 2011 Advanced Notice of Proposed Rulemaking (ANPRM), and subsequently the 2015 Notice of Proposed Rulemaking (NPRM) were issued by the Department of Health and Human Services (HHS) and Office of Science and Technology Policy (OSTP). These notices required that participants consent to research uses of their de-identified tissue samples and most clinical data, and allowing such consent be obtained in a one-time, open-ended or "broad" fashion. Conducting a survey across multiple sites provides clear advantages to either a single site survey or using a large online database, and is a potentially powerful way of understanding the views of diverse populations on this topic. METHODS:A workgroup of the Electronic Medical Records and Genomics (eMERGE) Network, a national consortium of 9 sites (13 separate institutions, 11 clinical centers) supported by the National Human Genome Research Institute (NHGRI) that combines DNA biorepositories with electronic medical record (EMR) systems for large-scale genetic research, conducted a survey to understand patients' views on consent, sample and data sharing for future research, biobank governance, data protection, and return of research results. RESULTS:Working across 9 sites to design and conduct a national survey presented challenges in organization, meeting human subjects guidelines at each institution, and survey development and implementation. The challenges were met through a committee structure to address each aspect of the project with representatives from all sites. Each committee's output was integrated into the overall survey plan. A number of site-specific issues were successfully managed allowing the survey to be developed and implemented uniformly across 11 clinical centers. CONCLUSIONS:Conducting a survey across a number of institutions with different cultures and practices is a methodological and logistical challenge. With a clear infrastructure, collaborative attitudes, excellent lines of communication, and the right expertise, this can be accomplished successfully.
    背景与目标: 背景:随着生物库在基因组研究中将发挥越来越重要的作用,这将导致精准医学的发展,为成功开展此类研究,来自各种医疗机构的大量不同患者群体的投入将非常重要。一个重要的主题是参与者对同意和数据共享的看法,特别是自2011年卫生与公共服务部(HHS)发布了《规则制定的预先通知》(ANPRM)和随后的2015年《规则制定的预先通知》(NPRM)以来。和科学技术政策办公室(OSTP)。这些通知要求参加者同意其去识别的组织样本和大多数临床数据的研究用途,并允许以一次性,开放式或“广泛”方式获得此类同意。跨多个站点进行调查相对于单个站点调查或使用大型在线数据库都具有明显的优势,并且是了解不同人群对此主题的观点的潜在强大方式。
    方法:电子病历和基因组学(eMERGE)网络的工作组,由国家人类基因组研究所(NHGRI)支持的9个站点(13个独立机构,11个临床中心)的国家联盟,将DNA生物存储库与电子病历相结合大型基因研究(EMR)系统进行了一项调查,以了解患者对同意,样本和数据共享以进行未来研究,生物库治理,数据保护和返回研究结果的看法。
    结果:在9个站点之间进行设计和进行全国调查的工作提出了组织方面的挑战,在每个机构中满足人类受试者准则以及调查的制定和实施的挑战。通过委员会结构应对挑战,并与来自所有地点的代表讨论了项目的各个方面。每个委员会的产出均已纳入总体调查计划。成功解决了许多特定地点的问题,从而使调查可以在11个临床中心中统一制定和实施。
    结论:在具有不同文化和实践的许多机构中进行调查是方法和后勤方面的挑战。有了清晰的基础架构,协作态度,出色的沟通渠道以及适当的专业知识,就可以成功实现这一目标。
  • 【减压颅骨切除术后的并发症和知情同意:一个示例性案例研究。】 复制标题 收藏 收藏
    DOI:10.3109/02699052.2013.830194 复制DOI
    作者列表:Honeybul S,Morrison DA,Ho K,Wiggins A,Janzen C,Kruger K
    BACKGROUND & AIMS: PRIMARY OBJECTIVE:To assess clinical outcome following restoration of cranial contour in a young male who had suffered a severe traumatic brain injury. RESEARCH DESIGN:Case report. METHODS AND PROCEDURES:A young male was assessed before and after cranial reconstructive surgery with a custom-made titanium plate. The patient had previously required a bifrontal decompressive craniectomy in order to control intractable intracranial hypertension due to neurotrauma. Following an autologous cranioplasty he made very little neurological recovery and remained wheelchair-bound with severe contractures and was only able to follow single stage commands. Over the following 2 years he developed extensive resorption of his bone flap such that it required augmentation. MAIN OUTCOMES AND RESULTS:After surgery he clinically improved such that he was able to communicate more effectively and, although he remained severely disabled and fully dependent, he was able to communicate that he would have provided consent for the initial decompressive procedure even if he had known that the eventual outcome would be survival with severe disability and total dependence. CONCLUSIONS:Long-term follow-up is required for patients with severe traumatic brain injury not only to assess outcome and complications, but also to assess how acceptable that outcome is for the patient and their families.
    背景与目标: 目的:评估一名严重颅脑外伤的年轻男性颅骨轮廓恢复后的临床结局。
    研究设计:病例报告。
    方法和程序:使用定制的钛板在颅骨重建手术前后对一名年轻男性进行评估。该患者以前需要进行双额减压颅骨切除术,以控制由于神经创伤引起的难治性颅内高压。自体颅骨成形术后,他的神经功能恢复极少,并且仍然束缚在轮椅上并伴有严重的挛缩,只能遵循单阶段指令。在随后的两年中,他对骨瓣进行了广泛的吸收,因此需要对其进行增强。
    主要结果和结果:手术后,他的临床状况得到改善,使他能够更有效地进行交流,尽管他仍然严重残疾并完全依赖他,但他仍然能够传达出即使他已经接受了最初的减压手术,他也将表示同意。众所周知,最终结果将是严重残疾和完全依赖的生存。
    结论:重度颅脑外伤患者需要长期随访,不仅要评估结局和并发症,还应评估结局对患者及其家属的接受程度。
  • 【进行复苏研究并紧急放弃知情同意。】 复制标题 收藏 收藏
    DOI:10.1016/s0300-9572(00)00247-1 复制DOI
    作者列表:Kowey P,Ornato J
    BACKGROUND & AIMS: -2
    背景与目标: -2
  • 【未来以证据为依据的政策倡议的问题:国家免疫技术咨询小组的发展和愿望提供的见解。】 复制标题 收藏 收藏
    DOI:10.1186/s12961-020-00551-7 复制DOI
    作者列表:Buffardi AL,Njambi-Szlapka S
    BACKGROUND & AIMS: BACKGROUND:Attention to evidence-informed policy has grown; however, efforts to strengthen the quality and use of evidence are not starting from a blank slate. Changes in health architectures and financing pose different considerations for investments in evidence-informed policy than in the past. We identify major trends that have shifted the environment in which health policies are made, and use the evolution and future aspirations of National Immunization Technical Advisory Groups (NITAGs) in low- and middle-income countries to identify questions the sector must confront when determining how best to structure and strengthen evidence-informed health policy. DISCUSSION:Trends over the last two decades have resulted in a dense arena with many issue-specific groups, discrete initiatives to strengthen evidence-informed policy and increasing responsibility for subnational institutions. Many countries face a shifting resource base, which for some reduces the amount of resources for health. There is global momentum around universal health coverage, reflecting a broader systems approach, but few examples of how the vast array of stakeholders relate within it are available. NITAG aspirations reflect four interconnected themes related to their scope, their integration in national policy processes, health financing and relationships with ministries of finance, and NITAG positioning relative to other domestic and international entities, raising questions such as, What are the bounds of issue-specific groups and their relationship to allocation decision-making processes across health areas? How do technical advisory groups interface with what are inherently political processes? When are finances considered, by whom and how? What is the future of existing groups whose creation was intended to enhance national ownership but who need continued external support to function? When should new entities be created, in what form and with what mandate? CONCLUSIONS:Countries must determine who makes decisions about resources, when, using what criteria, and how to do so in a robust yet efficient way given the existing and future landscape. While answers to these questions are necessarily country specific, they are collective matters that cannot be addressed by specialised groups alone and have implications for new investments in evidence-informed policy.
    背景与目标: 背景:人们越来越重视以证据为依据的政策;但是,增强证据质量和使用证据的努力并非一帆风顺。与过去相比,卫生架构和资金的变化对以证据为依据的政策进行投资提出了不同的考虑因素。我们确定了改变卫生政策制定环境的主要趋势,并利用中低收入国家的国家免疫技术咨询小组(NITAG)的演变和未来愿望,确定该部门在确定如何应对时必须面对的问题最好构造和加强有据可依的健康政策。
    讨论:过去二十年来的趋势导致了一个密集的竞技场,其中有许多针对特定问题的团体,采取了一些离散的举措来加强以证据为依据的政策,并增加了对地方机构的责任。许多国家面临着不断变化的资源基础,这在某些方面减少了卫生资源。围绕全民健康覆盖的全球动力,反映了一种更广泛的系统方法,但是很少有有关广泛的利益相关者如何与之联系的例子。 NITAG的愿望反映了四个相互关联的主题,这些主题涉及其范围,它们在国家政策流程中的整合,卫生筹资以及与财政部的关系,以及NITAG在其他国内和国际实体中的定位,引发了诸如以下问题的问题:特定群体及其与跨卫生领域分配决策过程的关系?技术咨询小组如何与固有的政治流程互动?何时考虑财务,由谁以及如何考虑?现有团体的成立是为了增强国家所有权,但需要持续的外部支持才能发挥作用,它们的前景如何?什么时候应该以什么形式和什么任务创建新实体?
    结论:在给定现有和未来形势的情况下,国家必须确定谁来决定资源,何时,使用什么标准以及如何以健壮而有效的方式做出决定。尽管对这些问题的回答必然是针对特定国家的,但它们是集体问题,不能由专门小组单独解决,并且对以证据为依据的政策进行新的投资具有影响。
  • 【癌症患者遗传咨询的主流同意计划:系统评价。】 复制标题 收藏 收藏
    DOI:10.1111/ajco.13334 复制DOI
    作者列表:Scheinberg T,Young A,Woo H,Goodwin A,Mahon KL,Horvath LG
    BACKGROUND & AIMS: :As demand for germline genetic testing for cancer patients increases, novel methods of genetic counseling are required. One such method is the mainstream consent pathway, whereby a member of the oncology team (rather than a genetic specialist) is responsible for counseling, consenting, and arranging genetic testing for cancer patients. We systematically reviewed the literature for evidence evaluating mainstream pathways for patients with breast, ovarian, colorectal, and prostate cancer. Medline, EMBASE, and Cochrane Library were searched for studies that met inclusion and exclusion criteria. Article references were checked for additional studies. Trial databases were searched for ongoing studies. Of the 13 papers that met inclusion criteria, 11 individual study groups were identified (two study groups had two publications each). Ten of the 11 studies evaluated the acceptability, feasibility, and impact of BRCA testing for patients and/or clinicians in different clinical settings in breast and ovarian cancer, while the final study explored the attitudes of colorectal specialists toward genetic testing for colorectal cancer. None involved prostate cancer. Overall, mainstream pathways were acceptable and feasible. Medical oncologist- and nurse-driven pathways were particularly successful, with both patients and clinicians satisfied with this process. Although the content of pretest counseling was less consistent compared with counseling via the traditional model, patients were largely satisfied with the education they received. Further research is required to evaluate the mainstream pathway for men with prostate cancer.
    背景与目标: 随着对癌症患者种系基因测试的需求增加,需要新的遗传咨询方法。一种这样的方法是主流同意途径,即肿瘤小组的一名成员(而不是遗传专家)负责为癌症患者提供咨询,同意和安排基因检测。我们系统地回顾了文献,以评估乳腺癌,卵巢癌,结肠直肠癌和前列腺癌患者的主流途径。搜索Medline,EMBASE和Cochrane库以查找符合纳入和排除标准的研究。检查了文章参考文献以进行其他研究。在试验数据库中搜索正在进行的研究。在符合纳入标准的13篇论文中,确定了11个单独的研究组(两个研究组各有两个出版物)。 11项研究中的10项评估了BRCA检测对乳腺癌和卵巢癌不同临床环境中的患者和/或临床医生的可接受性,可行性和影响,而最终研究探讨了结直肠专家对结直肠癌基因检测的态度。没有人涉及前列腺癌。总体而言,主流途径是可以接受和可行的。医学肿瘤学家和护士驱动的途径特别成功,患者和临床医生都对此过程感到满意。尽管与通过传统模式进行咨询相比,测试前咨询的内容不太一致,但是患者对他们所接受的教育非常满意。需要进一步的研究来评估男性前列腺癌的主流途径。
  • 【支持父母和家人:一种关键的,知情的方法。】 复制标题 收藏 收藏
    DOI:10.5555/conu.2006.23.2.288 复制DOI
    作者列表:Livesley J,Long T
    BACKGROUND & AIMS: -2
    背景与目标: -2
  • 【肿瘤异质性和多肿瘤多发性告知的家庭研究设计:犹他州人口数据库的力量。】 复制标题 收藏 收藏
    DOI:10.1158/1055-9965.EPI-19-0912 复制DOI
    作者列表:Hanson HA,Leiser CL,Madsen MJ,Gardner J,Knight S,Cessna M,Sweeney C,Doherty JA,Smith KR,Bernard PS,Camp NJ
    BACKGROUND & AIMS: BACKGROUND:Previously, family-based designs and high-risk pedigrees have illustrated value for the discovery of high- and intermediate-risk germline breast cancer susceptibility genes. However, genetic heterogeneity is a major obstacle hindering progress. New strategies and analytic approaches will be necessary to make further advances. One opportunity with the potential to address heterogeneity via improved characterization of disease is the growing availability of multisource databases. Specific to advances involving family-based designs are resources that include family structure, such as the Utah Population Database (UPDB). To illustrate the broad utility and potential power of multisource databases, we describe two different novel family-based approaches to reduce heterogeneity in the UPDB. METHODS:Our first approach focuses on using pedigree-informed breast tumor phenotypes in gene mapping. Our second approach focuses on the identification of families with similar pleiotropies. We use a novel network-inspired clustering technique to explore multi-cancer signatures for high-risk breast cancer families. RESULTS:Our first approach identifies a genome-wide significant breast cancer locus at 2q13 [P = 1.6 × 10-8, logarithm of the odds (LOD) equivalent 6.64]. In the region, IL1A and IL1B are of particular interest, key cytokine genes involved in inflammation. Our second approach identifies five multi-cancer risk patterns. These clusters include expected coaggregations (such as breast cancer with prostate cancer, ovarian cancer, and melanoma), and also identify novel patterns, including coaggregation with uterine, thyroid, and bladder cancers. CONCLUSIONS:Our results suggest pedigree-informed tumor phenotypes can map genes for breast cancer, and that various different cancer pleiotropies exist for high-risk breast cancer pedigrees. IMPACT:Both methods illustrate the potential for decreasing etiologic heterogeneity that large, population-based multisource databases can provide.See all articles in this CEBP Focus section, "Modernizing Population Science."
    背景与目标: 背景:以前,基于家庭的设计和高风险谱系为发现高风险和中风险种系乳腺癌易感基因提供了价值。但是,遗传异质性是阻碍进展的主要障碍。新的策略和分析方法对于进一步发展将是必要的。通过改善疾病特征来解决异质性的潜力之一是多源数据库的可用性不断提高。涉及基于家庭的设计的进步所特有的是包括家庭结构在内的资源,例如犹他州人口数据库(UPDB)。为了说明多源数据库的广泛实用性和潜在功能,我们描述了两种不同的新颖的基于家族的方法来减少UPDB中的异构性。
    方法:我们的第一个方法侧重于在基因作图中使用谱系信息的乳腺肿瘤表型。我们的第二种方法侧重于识别具有多效性相似的家庭。我们使用一种新颖的网络启发式聚类技术来探索高危乳腺癌家庭的多癌特征。
    结果:我们的第一种方法在2q13处确定了全基因组重要的乳腺癌基因座[P = 1.6×10-8,对数的对数(LOD)等于6.64]。在该地区,IL1A和IL1B是引起炎症的关键细胞因子基因,引起了人们的特别关注。我们的第二种方法确定了五种多癌风险模式。这些簇包括预期的共聚集(例如与前列腺癌,卵巢癌和黑色素瘤的乳腺癌),并且还鉴定了新颖的模式,包括与子宫癌,甲状腺癌和膀胱癌的共聚集。
    结论:我们的研究结果表明,谱系知悉的肿瘤表型可以定位乳腺癌基因,高危乳腺癌谱系存在多种不同的癌症多效性。
    影响:这两种方法都说明了减少基于人群的大型多源数据库可以提供的病因异质性的潜力。请参阅“ CEBP焦点”部分“现代化人口科学”中的所有文章。
  • 【早期精神分裂症频谱疾病的青少年治疗:寻找一种合理的,循证医学的方法。】 复制标题 收藏 收藏
    DOI:10.1097/YCO.0b013e32835dcc2a 复制DOI
    作者列表:Schimmelmann BG,Schmidt SJ,Carbon M,Correll CU
    BACKGROUND & AIMS: PURPOSE OF REVIEW:We aimed to review literature on the efficacy and tolerability of psychosocial and psychopharmacological interventions in youth with early-onset schizophrenia spectrum disorders (EOS). A rationale for pragmatic psychopharmacology in EOS, including dosing, switching and adverse effect monitoring and management, is provided. RECENT FINDINGS:Three randomized controlled trials (RCTs) over the last 8 years demonstrated benefits of psychosocial interventions (i.e. psychoeducation, cognitive remediation, cognitive behavioural therapy) for EOS without clear advantages of one psychosocial treatment over another. Six large, placebo-controlled, short-term RCTs over the last 4 years demonstrated that aripiprazole, olanzapine, paliperidone, quetiapine and risperidone, but not ziprasidone, were superior to placebo. Except for clozapine's superiority in treatment-refractory EOS, efficacy appeared similar across studied first-generation and second-generation antipsychotics, but tolerability varied greatly across individual agents. SUMMARY:Antipsychotics are efficacious in the treatment of EOS. Given the lack of efficacy differences between antipsychotics (except for clozapine for treatment-refractory EOS), we propose that tolerability considerations need to guide choice of antipsychotics. Further and longer-term efficacy and effectiveness studies are urgently needed that should also explore pharmacologic and nonpharmacologic augmentation strategies.
    背景与目标: 审查目的:我们旨在审查有关在早期发作的精神分裂症谱系障碍(EOS)的青年中进行社会心理和心理药物干预的功效和耐受性的文献。提供了EOS中实用的心理药理学原理,包括剂量,转换和不良反应监测与管理。
    最近的发现:过去8年中的三项随机对照试验(RCT)证明了针对EOS的心理社会干预措施(即心理教育,认知矫正,认知行为疗法)的益处,而没有一种心理社会治疗方法比另一种方法具有明显优势。过去四年中有六项大型,安慰剂对照的短期RCT表明,阿立哌唑,奥氮平,帕潘立酮,喹硫平和利培酮,而非齐拉西酮优于安慰剂。除了氯氮平在难治性EOS方面的优越性外,在研究的第一代和第二代抗精神病药中疗效相似,但各药物的耐受性差异很大。
    摘要:抗精神病药可有效治疗EOS。鉴于抗精神病药之间缺乏疗效差异(氯氮平治疗难治性EOS除外),我们建议应考虑耐受性,以指导抗精神病药的选择。迫切需要进一步和长期的有效性和有效性研究,这也应该探索药理学和非药理学增强策略。
  • 【护理和助产士领导总监:通过批判性社会科学的视角提供信息。】 复制标题 收藏 收藏
    DOI:10.1111/j.1365-2834.2010.01096.x 复制DOI
    作者列表:Solman A
    BACKGROUND & AIMS: AIMS:Highlight the use of critical social science theories, practice development principles and a situational leadership framework within transformational leadership to inform Directors of Nursing and Midwifery (DoNM) practices as leaders. BACKGROUND:Healthcare is constantly changing, unpredictable, strives for quality service and cost containment, which can result in stress and crisis for healthcare workers. DoNM leadership is critical to supporting and leading staff through these complex times within healthcare. KEY ISSUES:Understanding theories, frameworks and their application to real-world practice can assist in supporting individuals and teams to navigate through the changing healthcare environment. CONCLUSION:Blending critical social science theories with practice development principles and the situational leadership framework can assist the DoNM to enact transformational leadership to support the development of individuals and teams to meet the complex healthcare needs of patients within the clinical setting. IMPLICATIONS FOR NURSE MANAGEMENT: This article contributes through the practical application of critical social science theories, practice development principles and situational leadership framework within transformational leadership as an approach for enacting DoNM leadership. To further understand and develop in the role of the contemporary DoNM in leadership, these directors are encouraged to publish their work.
    背景与目标: 目的:重点介绍在变革型领导中使用批判性社会科学理论,实践发展原则和情境领导框架,以将领导者的护理和助产士(DoNM)行为告知领导。
    背景:医疗保健不断变化,变幻莫测,力求提供优质的服务和控制成本,这可能导致医护人员承受压力和危机。在医疗保健领域的复杂时期,DoNM领导层对于支持和领导员工至关重要。
    关键问题:了解理论,框架及其在实际操作中的应用可以帮助支持个人和团队在不断变化的医疗环境中导航。
    结论:将批判社会科学理论与实践发展原则和情境领导框架相结合,可以帮助DoNM实施变革型领导,以支持个人和团队的发展,以满足临床环境中患者的复杂医疗保健需求。对护士管理的影响:本文通过在批判性领导中实践批判性社会科学理论,实践发展原则和情境领导框架(作为实践DoNM领导的一种方法)的实际应用做出了贡献。为了进一步了解和发展当代DoNM在领导中的作用,我们鼓励这些导演发表他们的作品。
  • 【少数民族高中运动员的人体艺术:普遍性,兴趣和满足感;父母的知识和同意。】 复制标题 收藏 收藏
    DOI:10.1016/j.jadohealth.2006.06.012 复制DOI
    作者列表:Benjamins LJ,Risser WL,Cromwell PF,Feldmann J,Bortot AT,Eissa MA,Nguyen AB
    BACKGROUND & AIMS: :Of 997 minority high school students, 8.6% had tattoos and 8% piercings (excluding earlobes); 21% with tattoos and 59% with piercings would not repeat the experience. Fifty-eight percent with tattoos and 43% with piercings reported parental knowledge before the procedure; 75% and 80%, respectively, were asked for proof of parental consent.
    背景与目标: :在997名少数民族高中学生中,有8.6%的人有纹身和8%的穿孔(不包括耳垂); 21%的纹身和59%的穿孔不会重复体验。在做手术之前,有58%的纹身和43%的穿孔报告了父母的知识;分别要求75%和80%的父母同意证明。
  • 14 Children and adolescents - who can give consent? 复制标题 收藏 收藏

    【儿童和青少年-谁可以给予同意?】 复制标题 收藏 收藏
    DOI: 复制DOI
    作者列表:Bird S
    BACKGROUND & AIMS: :Case histories are based on actual medical negligence claims or medicolegal referrals; however certain facts have been omitted or changed by the author to ensure the anonymity of the parties involved. Can children and adolescents consent to their own medical treatment? Do general practitioners owe teenagers a duty of confidentiality? This article examines the legal obligations of GPs when obtaining consent to medical treatment from patients who are under 18 years of age.
    背景与目标: 病史是基于实际的医疗过失声明或法医转诊而得出的;但是,作者已经省略或更改了某些事实,以确保所涉各方的匿名。儿童和青少年可以同意自己接受治疗吗?全科医生应负青少年责任吗?本文研究了18岁以下患者获得医疗同意后,GP的法律义务。
  • 【在临床实践中控制心房纤颤的心率与心律控制:从更好地掌握房颤知情治疗结果登记册(ORBIT-AF)中获得的结果。】 复制标题 收藏 收藏
    DOI:10.1016/j.ahj.2012.12.019 复制DOI
    作者列表:Steinberg BA,Holmes DN,Ezekowitz MD,Fonarow GC,Kowey PR,Mahaffey KW,Naccarelli G,Reiffel J,Chang P,Peterson ED,Piccini JP
    BACKGROUND & AIMS: BACKGROUND:All patients with atrial fibrillation (AF) require optimization of their ventricular rate. Factors leading to use of additional rhythm control in clinical practice have not been thoroughly defined. METHODS:The ORBIT-AF registry enrolled patients with AF from a broad range of practice settings and collected data on rate versus rhythm control, as indicated by the treating physician. Multivariable logistic regression analysis was performed to identify factors associated with each strategy. RESULTS:Of 10,061 patients enrolled, 6,859 (68%) were managed with rate only control versus 3,202 (32%) with rhythm control. Patients managed with rate control were significantly older and more likely to have hypertension, heart failure, prior stroke, and gastrointestinal bleeds. They also had fewer AF-related symptoms (41% with no symptoms vs 31% for rhythm control). Systemic anticoagulation was prescribed for 5,448 (79%) rate-control patients versus 2,219 (69%) rhythm-control patients (P < .0001). After multivariable adjustment, patients with higher symptom scores (severe symptoms vs. none, OR 1.62, 95% CI 1.41-1.87) and those referred to electrophysiologists (OR 1.64, 95% CI 1.45-1.85) were more likely to be managed with a rhythm control strategy. CONCLUSIONS:In this outpatient registry of US clinical practice, the majority of patients with AF were managed with rate control alone. Patients with more symptoms and who were treated by an electrophysiologist were more likely to receive rhythm-control therapies. A significant proportion of AF patients, regardless of treatment strategy, were not treated with anticoagulation for thromboembolism prophylaxis.
    背景与目标: 背景:所有房颤患者都需要优化心室率。尚未在临床实践中明确导致使用其他节律控制的因素。
    方法:按照治疗医师的指示,ORBIT-AF登记系统从广泛的实践环境中招募了AF患者,并收集了其心率与心律控制的相关数据。进行多变量逻辑回归分析以识别与每种策略相关的因素。
    结果:在10061名患者中,有6859名(68%)接受了单纯速率控制,而有3202名(32%)接受了节奏控制。进行速率控制的患者年龄较大,并且更有可能患有高血压,心力衰竭,中风和胃肠道出血。他们也有较少的房颤相关症状(41%无症状,节律控制为31%)。相对于2,219(69%)节律患者,对5448(79%)个速率控制的患者进行了全身抗凝治疗(P <.0001)。经过多变量调整后,症状评分较高(严重症状对比无症状,OR 1.62,95%CI 1.41-1.87)和转诊给电生理学家的患者(OR 1.64,95%CI 1.45-1.85)更容易接受节奏控制策略。
    结论:在这个美国临床实践的门诊登记中,大多数房颤患者仅通过速率控制进行治疗。症状更多且由电生理师治疗的患者更有可能接受节律控制疗法。不论采用何种治疗策略,相当大比例的房颤患者均未接受抗凝治疗以预防血栓栓塞。

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