What risks should be permissible in controlled human infection model studies?

Controlled human infection model (CHIM) studies involve the intentional exposure of healthy research volunteers to infectious agents. These studies contribute to knowledge about the cause or development of disease and to the advancement of vaccine research. But they also raise ethical questions about the kinds of risks that should be permissible and whether limits should be imposed on research risks in CHIM studies. Two possible risk thresholds have been considered for CHIM studies. The first suggests constraining ethically permissible risks according to a minimal risk threshold and the second endorses a higher risk threshold that excludes irreversible or fatal infections. I argue that neither of these thresholds is persuasive and situate questions about risk thresholds in CHIM studies within a broader debate about permissible risks in research. I argue that risks in CHIM studies should be constrained according to limits on research risks that do not offer corresponding benefits in all studies rather than developing a unique risk threshold for CHIM studies. I then propose five recommendations for the ethical assessment of risk in CHIM studies.     

国内静脉注射伏立康唑和氟康唑预防真菌感染临床疗效和安全性比较的Meta分析

目的 通过Meta分析探讨静脉注射伏立康唑和静脉注射氟康唑预防真菌感染的临床疗效和安全性。方法 以伏立康唑为实验组,氟康唑为对照组。通过计算机检索中国期刊全文数据库(CNKI)、万方数据库、维普数据库,并进一步对纳入文献的参考文献进行扩大检索。对符合纳入标准的随机对照研究(RCT)按Cochrane系统评价的方法,独立进行资料提取、质量评价并交叉核对后,采用Stata14.0软件进行Meta分析。结果 共纳入19篇研究,共计1492例患者。伏立康唑有着更高的有效率和有更低的不良反应,两者差异有统计学意义(RR=1.20,95%CI=1.14~1.26,P<0.001)和RR=0.76,95%CI=0.65~0.90,P=0.001)。同时在控制感染发热和真菌清除方面,伏立康唑有着更好的效果,两者差异有统计学意义,分别为(RR=1.63,95%CI=1.40~1.90,P<0.001和RR=1.27,95%CI=1.13~1.44,P<0.001)。结论 Meta分析结果表明伏立康唑比氟康唑预防真菌感染有更好的疗效和预后及更低的不良反应。     

法医学司法鉴定中吸毒与艾滋病群体隐私权与知情权的伦理学问题探讨

在法医学司法鉴定过程中,当事人所具有的隐私权与司法鉴定工作所需要的知情权之间必然存在着一定的矛盾与冲突。如何在尊重当事人隐私权的基础上充分获取司法鉴定工作所需的知情权,是司法鉴定机构在司法鉴定工作中所面临的重要任务。本文对法医学司法鉴定中吸毒与艾滋病群体隐私权与知情权的医学伦理学相关问题进行分析探讨。     

冰冻粪菌移植治疗艰难梭菌相关腹泻效果的Meta分析

目的 应用Meta分析评价冰冻粪菌移植(FMT)治疗艰难梭菌感染(CDI)相关腹泻的效果。 方法 计算机检索CNKI、CBM、WanFang Data、PubMed、EMbase、Web of Science、The Cochrane Library数据库关于冰冻FMT治疗CDI相关腹泻的随机对照试验,检索时限均为建库至2019年8月。 结果 共纳入8个研究,包括665例患者。Meta分析结果显示:冰冻FMT相比万古霉素/非达霉素治疗CDI相关腹泻差异有统计学意义[OR=23.94,95% CI=(6.80,84.34),P0.05)。多次FMT相比单次FMT能显著治愈CDI相关腹泻,差异有统计学意义[OR=9.79,95% CI=(4.27,22.46),P0.05)。 结论 冰冻FMT相比万古霉素/非达霉素治疗CDI相关腹泻有更好的疗效,且通过灌肠或结肠镜移植冰冻/冻干粪菌可以是一种替代新鲜粪菌的治疗方法,同时多次FMT治疗CDI相关腹泻的治愈率高于单次FMT,CDI患者不良反应和病亡率的发生与FMT无直接关系。以上结论需要更多高质量的研究加以证实。     

What do patients want? Surgical informed-consent and patient-centered care – An augmented model of information disclosure

The ideal moral standard for surgical informed-consent calls upon surgeons to carry out a disclosure dialogue with patients so they have as full as possible an understanding of the procedure before they sign the informed-consent form. This study is the first to empirically explore patient preferences regarding disclosure dialogue. Twelve Israelis who underwent life-saving surgeries participated in a narrative study. Three themes emerged from the analysis: objectification of patients, anxiety provoking processes and information, and lack of information that was essential for patients. Findings contribute to existing debates among surgeons regarding the scope and importance of some disclosure components. Analysis led to our formulation of an augmented subjective model of information disclosure that participants prefer, which extends beyond the immediate present of the surgery to the period after discharge, and until return to routine. Surgeons should be aware of patient preferences in disclosure, and gaps between perceptions of surgeons, and preferences and needs of patients.     

The Enhancement of Children versus Circumcision: A Case of Double Moral Standards?

The application of enhancement technologies to children and non‐medical infant male circumcision are both topics that enjoy the continuous attention of bioethical research but are usually discussed in isolation from each other. Yet one can show that three major arguments used by opponents of the enhancement of children are also applicable to circumcision. These arguments are based on the insecurity of these procedures, the child's right to an open future, and human nature as a foundation of human dignity. People who reject the enhancement of children because of these arguments but accept circumcision hold mutually inconsistent moral convictions or apply double moral standards to these cases. This is particularly important when legislative systems treat the enhancement of children and circumcision in a considerably different manner, which is true for many contemporary legislative systems. At least three strategies can be adopted in order to avoid such inconsistencies, two of which, however, fail for various reasons. According to a third, more promising strategy, circumcision should be subsumed under human enhancement and treated like other enhancement technologies. This strategy justifies restrictions on, but not the prohibition of circumcision. Furthermore, proponents of circumcision should be prepared for future technologies that provide similar benefits as circumcision but are not as contentious as this intervention, so that, in the future, circumcision could become more and more unacceptable.     

HEALTH AS FREEDOM: ADDRESSING SOCIAL DETERMINANTS OF GLOBAL HEALTH INEQUITIES THROUGH THE HUMAN RIGHT TO DEVELOPMENT

In spite of vast global improvements in living standards, health, and well-being, the persistence of absolute poverty and its attendant maladies remains an unsettling fact of life for billions around the world and constitutes the primary cause for the failure of developing states to improve the health of their peoples. While economic development in developing countries is necessary to provide for underlying determinants of health – most prominently, poverty reduction and the building of comprehensive primary health systems – inequalities in power within the international economic order and the spread of neoliberal development policy limit the ability of developing states to develop economically and realize public goods for health. With neoliberal development policies impacting entire societies, the collective right to development, as compared with an individual rights-based approach to development, offers a framework by which to restructure this system to realize social determinants of health. The right to development, working through a vector of rights, can address social determinants of health, obligating states and the international community to support public health systems while reducing inequities in health through poverty-reducing economic growth. At an international level, where the ability of states to develop economically and to realize public goods through public health systems is constrained by international financial institutions, the implementation of the right to development enables a restructuring of international institutions and foreign-aid programs, allowing states to enter development debates with a right to cooperation from other states, not simply a cry for charity.     

EMBalance - validation of a decision support system in the early diagnostic evaluation and management plan formulation of balance disorders in primary care: study protocol of a feasibility randomised controlled trial

BackgroundBalance problems are caused by multiple factors and often lead to falls and related fractures, bringing large socio-economic costs. The complexity of balance control mechanisms, the lack of medical expertise, and the absence of specialised equipment contribute to the delayed or incorrect diagnosis and management ofthese patients. Advances in computer science have allowed the development of computer systems that support clinical diagnosis and treatment decisions based on individualised patient data. The aim of the EMBalance decision support system (DSS) is to support doctors facing this clinical challenge, to make a definitive diagnosis and implement an effective management plan. The EMBalance study will determine the accuracy of this supportive tool when used by non-specialist doctors. This study is funded by the European Union’s Seventh Framework Programme.Methods/designEMBalance is a proof-of-concept study designed as a non-commercial, international, multi-centre, single-blind, parallel-group randomised controlled trial to be carried out at four clinical sites in the United Kingdom, Germany, Greece and Belgium. The study is comprised of three stages: internal pilot, phase I (diagnosis) and stage II (management). For this purpose, 200 patients presenting with persistent dizziness (>3 months’ duration) to primary care services will be randomised to either the intervention group (diagnostic assessment with the DSS) or a control group (diagnostic assessment without the DSS). Patients allocated to the intervention group will be assessed by a doctor with the support of the EMBalance DSS, while patients allocated to the control group will receive a visit as per standard practice. Ultimately, all patients’ diagnoses and management plans will be certified by a consultant in neuro-otology.DiscussionEMBalance is the first trial to test the accuracy of a DSS in both the diagnosis of and the management plan for vestibular disorders across the healthcare systems of four different countries. The EMBalance study is the result of a combined effort of engineers and physicians to develop an accurate tool to support non-specialist doctors, with no risk for the patient. This trial will provide reliable information about the benefits of implementing DSSs in primary care while supporting the feasibility of testing the EMBalance algorithms in further research.

Trial registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT02704819","term_id":"NCT02704819"}}NCT02704819. Registered 29 February 2016.

Electronic supplementary material

The online version of this article (doi:10.1186/s13063-016-1568-x) contains supplementary material, which is available to authorized users.