Alter-Standardizing Clinical Trials: The Gold Standard in the Crossfire

ABSTRACT

The international landscape of medical research is in the midst of a process of diversification and change. The randomized controlled trial (RCT), long considered the global gold standard for clinical research, has become increasingly contested and is partly replaced by alternative methodologies, standards and forms of evidence. The contours of mainstream medical research are changing as a result. Regulatory paradigms and standards are, literally, being rewritten, at a global level. The evidence-based medicine (EBM) hierarchy of evidence is redefined. This special issue explores these developments through the concept of ‘alter-standardization’. The term refers to the processes, controversies and negotiations through which multiphase RCTs and the EBM system are challenged and gradually superseded by alternative methodological and regulatory forms and standards. This special issue examines the conceptual, practical and theoretical implications of these changes, and the ways in which these transformations influence the situation and possibilities of patients, knowledge producers, physicians, large pharmaceutical corporations, smaller biotech companies, as well as regulatory bodies, civil societal organizations and national health care systems. The articles in this special issue make use of comparative and historical perspectives that focus on scientific, social, economic and regulatory developments in the European Union, China, India, Japan, Argentina, the UK and the USA. They show that the alter-standardizing of clinical trials arises in a pluralistic way, that is driven by a variety of often conflicting factors, developments and expectations. These changes reflect a broad transformation in the culture and politics of biomedicine today, with implications for the ways in which new medicinal products, devices, procedures and technologies are developed, approved for clinical use, sold to consumers, and licensed by health care systems.     

Does Evidence-Based Medicine Apply to Psychiatry?

Evidence-based psychiatry (EBP) has arisen through the application of evidence-based medicine (EBM) to psychiatry. However, there may be aspects of psychiatric disorders and treatments that do not conform well to the assumptions of EBM. This paper reviews the ongoing debate about evidence-based psychiatry and investigates the applicability, to psychiatry, of two basic methodological features of EBM: prognostic homogeneity of clinical trial groups and quantification of trial outcomes. This paper argues that EBM may not be the best way to pursue psychiatric knowledge given the particular features of psychiatric disorders and their treatments. As a result, psychiatry may have to develop its own standards for rigour and validity. This paper concludes that EBM has had a powerful influence on how psychiatry investigates and understands mental disorders. Psychiatry could influence EBM in return, reshaping it in ways that are more clinically useful and congruent with patients’ needs.     

Emmanuel Levinas and the face of Terri Schiavo: bioethical and phenomenological reflections on a private tragedy and public spectacle

The controversial case of Terri Schiavo came to a close on March 31, 2005, with her death following the removal of a percutaneous endoscopic gastrostomy tube. This event followed years of controversy and social upheaval. Voices from across the entire political and cultural spectrums filled the airwaves and op-ed pages of major newspapers. Protests ensued outside of Ms. Schiavo??s care facility. Ms. Schiavo??s parents published videos of their daughter on the internet in an effort to prove that she was not in a vegetative state and could potentially recover. There is a certain mystery to the entire controversy given the fact that, legally, it was largely a matter of settled law. Precedent cases and legal statutes clearly set out the proper procedures and decisions to be followed in this case. Nonetheless, powerful challenges and virulent opposition to these standards arose. Through an investigation of this case as well as a comparative study of the case of Dax Cowart (in particular, the documentary depictions of Dax Cowart??s case) and of a photograph by Joel-Peter Witkin, I plan to investigate the source of these social upheavals and hypothesize that they were largely the result of a phenomenological reaction to the human face.     

Developing and Testing a Spiritual Care Questionnaire in the Iranian Context

As most research exploring nurses?? perceptions on the topic of spiritual care was conducted in Western countries, these findings may not be applicable in Iran because of cultural and health system differences. Therefore, a new survey instrument was developed for the Iranian context. The study was conducted in two steps: (1) development and validation of items for perception scale and (2) distribution of the questionnaire among nursing students to determine scale reliability and construct validity. The preliminary scale consisted of 50 items designed to measure the participants?? perception of spiritual care. Construct validity of the scale was examined on the remaining 33 items. On interpretation of the items, the following four components were identified: (1) meeting patient as a being in meaning and hope, (2) meeting patient as a being in relationship, (3) meeting patient as a religious being, and (4) meeting patients as a being with autonomy. The results in this paper showed that preserving dignity in the nurses?? practice meant getting involved in interpersonal caring relationships, with respect for the involved peoples?? religious beliefs and their autonomy. Proper education and professionally led supervision with reflection on past and recent experiences may develop student nurses?? and nurses?? perceptions as well as their attitudes toward spiritual care and to achieve a realistic view of the profession.     

Balancing Confidentiality and Collaboration Within Multidisciplinary Health Care Teams

As multidisciplinary perspectives are increasingly integrated into the treatment of health problems, opportunities for clinical psychologists in medical settings are expanding. Although cross-discipline collaboration is at the core of multidisciplinary treatment models, psychologists must be particularly cautious about information sharing due to their profession??s ethical standards regarding patient confidentiality. Psychologists?? ethical obligations require them to achieve a delicate balance between contributing to the treatment team and protecting patient confidentiality. In the current review, relevant ethical standards and federal guidelines are applied to everyday practices of clinical psychologists in medical settings. Additionally, recommendations for individual psychologists, health care organizations, and graduate training programs are presented.     

Medical Family Therapy: A Theoretical and Empirical Review

Medical Family Therapy (MedFT) is a relatively young sub-specialty founded initially at the intersection of Family Therapy and Family Medicine. The purpose of this article is to synthesize and review scholarly literature covering almost 30?years of history, growth, and available research on MedFT. Eighty-two articles that met specific inclusion criteria were reviewed and the literature was categorized into four distinct themes: (a) Emergence of MedFT in the literature; (b) Contemporary MedFT skills and applications; (c) Punctuating the ??family therapy?? in MedFT; and (d) MedFT effectiveness and efficacy research. What was learned was that MedFT is growing so rapidly there is now a need for a current definition, identification of core curriculum standards and competencies for training, as well as a commitment to produce rigorous research on its effectiveness and efficacy. Recommendations to advance efforts across the foci are provided.     

NICE帕金森病指南与循证医学的人文精神

循证医学是一种人性化的医学实践方法,最近发布的英国国家临床最优化研究所(NICE)帕金森病(PD)指南,即《帕金森病诊断与管理指南——第二次咨询稿》,充分体现了PD诊疗决策中的人文关怀和循证医学的人文精神。作者从NICE指南的指导思想、医患交流及姑息护理阐述了PD诊治中的人文思想和循证医学对医学人文精神的不断追求。     

What Can Feminist Epistemology Do for Surgery?

Surgery is an important part of contemporary health care, but currently much of surgery lacks a strong evidence base. Uptake of evidence‐based medicine (EBM) methods within surgical research and among practitioners has been slow compared with other areas of medicine. Although this is often viewed as arising from practical and cultural barriers, it also reflects a lack of epistemic fit between EBM research methods and surgical practice. In this paper we discuss some epistemic challenges in surgery relating to this lack of fit, and investigate how resources from feminist epistemology can help to characterize them. We point to ways in which these epistemic challenges may be addressed by gathering and disseminating evidence about what works in surgery using methods that are contextual, pluralistic, and sensitive to hierarchies.     

Gender Bias in Leader Selection? Evidence from a Hiring Simulation Study

The present research investigated factors that might affect gender discrimination in a hiring simulation context from the perspectives of social role theory and the shifting standards model. Specifically, the experimental study investigated whether gender biases are evident in the screening and hiring stage of the personnel selection process depending on the applicants?? social role and evaluators?? gender. A sample of German undergraduate business students (54 women, 53 men) was asked to make a personnel selection decision (short-listing or hiring) about a fictitious applicant (man or woman) in a specific role (leader or non-leader) for a managerial position. Consistent with social role theory??s assumption that social role information is more influential than gender information, participants selected applicants described as leaders over applicants described as non-leaders, regardless of applicant gender. In addition, in the presence of role information, female applicants portrayed as leaders were similarly short-listed and hired as male applicants with the same credentials. In the absence of role information, female applicants were similarly short-listed as male applicants; however, male applicants were hired over female applicants, albeit by male participants only. This is consistent with the shifting standards model??s assumption that group members are held to a higher standard to confirm traits on which they are perceived to be deficient: Male participants hired female applicants portrayed as non-leaders with less certainty than their male counterparts possibly due to higher confirmatory standards for leadership ability in women than men. The research and practice implications of these results are discussed.     

A Tale of Two Standards: An Examination of Young Adults�� Endorsement of Gendered and Ageist Sexual Double Standards

Current North American sexual standards allow women to be sexual within committed relationships but may still restrict women??s sexuality to a greater extent than men??s. We investigated whether these gender double standards interact with an age double standard that describes the elderly as less sexual than the young, to create particularly limiting sexual standards for older women. 305 Canadian undergraduates completed a 2 (target age) × 2 (target gender) × 2 (participant gender) within-subjects study measuring perceptions of younger (own age) and older (over 65 years old) men??s and women??s interest in traditional sex (e.g., cuddling, intercourse with main partner) and experimental sex (e.g., extra-relationship sex, viewing erotic materials). ANCOVAs controlling for ageist and sexist beliefs revealed the ageist double standard; the elderly were perceived to be less interested in sex overall than the young. There was also a sexual double standard; women were perceived to be more interested in traditional sex than men, and men more interested in experimental sex than women. For traditional sex, women perceived younger targets as more interested than the older targets, and women targets as more interested than men. For experimental sex, a three-way interaction showed the interplay between the sexual and ageist double standards. Elderly female targets were perceived as least interested, and young male targets as most interested. Results reinforce that the current sexual standards distinguish between sex for intimacy and sex for other reasons (e.g., pleasure) and that the standards are particularly restrictive for older women.     

Hegelians Axel Honneth and Robert Williams on the Development of Human Morality

An individual is in the lowest phase of moral development if he thinks only of his own personal interest and has only his own selfish agenda in his mind as he encounters other humans. This lowest phase corresponds well with sixteenth century British moral egoism which reflects the rise of the new economic order. Adam Smith (1723?C1790) wanted to defend this new economic order which is based on economic exchange between egoistic individuals. Nevertheless, he surely did not want to support the moral theory of British egoism. His book The Wealth of Nations suits well into the world view of British moral egoism, but in the book The Theory of Moral Sentiments, he presents a moral theory which is the total opposite of moral egoism. Contemporary German intellectuals saw contradiction in Adam Smith??s moral (social) philosophy which they called as Das Adam-Smith-Problem. Smith himself didn??t think that there is any contradiction in a situation where in economic sphere (civil society) individual act egoistically and in ethical sphere (encounter with the imagined Other) he feels humanity and compassion toward his fellow men. Hegel was a passionate reader of Adam Smith and he acknowledged Das Adam-Smith-Problem. He set the task of his social philosophy to overcome this paradox. He wanted to create a theory of a social totality where economic egoism and feelings of humanity are not in contradiction. In the same time Hegel wanted to create a theory on Bildung process where human spirit develops from moral un-freedom (heteronomy) to moral freedom and maturity (autonomy) taking care both aspect of love and reason. In certain Hegel??s texts notion of recognition plays crucial role. That is why modern Hegelians Ludwig Siep, Axel Honneth and Robert Williams consider the notion of recognition to be elementary in Hegel??s threefold theory of developing human spirit from family via civil society to sittliche state. For Hegel family is a sphere where people love their ??concrete other?? and where feeling surpasses reason. Civil Society is a sphere of private contracts and economic exchanges where cold egoistic and calculative reason surpasses feelings. In the sphere of State the contradiction between family and Civil Society (Das Adam-Smith-Problem) is solved by ??rational feeling??. According to Hegel State should protect citizens from alienating effect of egoistic reason of Civil Society and cultivate ??family-feelings?? to rational feelings which integrate citizen into ??sittliche community?? through reciprocal process of recognition. In this article I want to consider Hegelians Honneth??s and Williams??s relevance to the theory of moral development.     

用循证医学证据丰富经验医学内涵——谈临床医生如何面对医学实践模式改变

从具体病例分析入手谈临床医生实践循证医学既需要思维模式转变、又要求掌握实际应用方法,即要敢于分析循证医学证据的实用性、又要善于用循证医学证据丰富经验医学内涵。新医学模式的普及将是临床医生群体认识史上一次具有深度和广度的飞跃。     

Fiction, Fashion, and Function Finale: An Introduction and Conclusion to the Special Issue on Gendered Body Image, Part III

Culture specifies standards for women??s and men??s body appearance and display. In Western cultures, these standards are both concentrated and ubiquitous in the media, represented as gendered body ideals for citizens to aspire toward. Because gendered body ideals are revered, individuals try to construct and portray their body consistently with these ideals. Furthermore, because gendered body ideals are narrowly defined and restrictive, individuals constrict their behavior, relationships, and perceptions of themselves and others to fall within the parameters of these ideals. The third and final issue of this series showcases innovative studies within two streams. The first stream investigates the many ways individuals invest effort into constructing and/or portraying their body to fit the gendered body ideal. The second stream addresses the diverse ways internalization of these ideals constrict individuals?? relationships, freedoms, and perceptions of others?? bodies and lifestyles. We discuss the empirical articles alongside points raised in films by Jhally (2009) and Clark (2009) that emphasize how media portrayals of gendered body ideals foster body-related constructions and constrictions in viewers. We emphasize intersectionality when presenting the articles, recognizing that gender combines with multiple identities (e.g., sexual orientation, race, political affiliation, and age) as well as individual difference variables to mold the degree to which individuals construct and constrict themselves and others to fit gendered body ideals. We end with a discussion of how these articles can be used to generate social change by deconstructing and delegitimizing gendered body ideals.     

A Parable, A Pearl and “Popular”? How the Broadway Musical Wicked—Especially Elphaba’s Character—May Assist Adolescent Girls to Claim Their Uniqueness

In this essay I provide a brief exegesis of the parable of the ??pearl of great price?? (Matthew 13:45?C46) as an introduction to an examination of Elphaba??s character in the Broadway musical Wicked [as distinguished from her character in Gregory Maguire??s novel, Wicked (1996)] and the potential value this character has for pastoral care with adolescent girls who struggle with the need to belong as well as the need to be themselves. I argue that Wicked may be understood as a twenty-first century parable that appeals to many, adults and adolescents alike, but it is especially appealing to teenage girls because it ??taps into a certain teenage angst?? (Zinoman 2005) that relates to the quest for popularity, a first true love, and beauty makeovers. Elphaba??s seriousness has a certain kind of spiritual nature which may be related to her green skin (James 1984, p. 160) that may encourage adolescent girls to adopt their own spiritual natures and enable them to claim their own voices even as Elphaba finally ??defies gravity?? and learns to fly.     

循证医学在ICU中的应用

循证医学(Evidence-Based Medicine,EBM)是指慎重、准确而明智地应用当前所能获得的最佳的研究证据,同时结合医生个人的专业技能和临床经验,并考虑患者的价值和愿望,将三者完美地结合起来制定出对患者最有利的临床决策。然而,ICU中的各项治疗措施常缺乏大规模随机对照试验(RCT)的证据;对于已经实施的RCT同样存在着概念方面的错误,尤其是很多被认为已经RCT验证过的措施实际上并无RCT的证据。尽管如此,但近年来我们终于在临床试验结果方面有了更多积极的进步,一些干预措施已被证明可改善患者的预后。     

循证医学与临床实践

循证医学是９０ 年代诞生的新兴医学科学。其要点是将临床医学领域的研究结果进行系统、全面的综合评价,为临床医疗实践、科研、卫生决策和医学教育提供可靠的科学证据。在发达国家的运用表明它已经对临床实践产生了重大而深远的影响,并将继续在临床医学领域发挥重要的作用。     

Quality of life is a process not an outcome

Quality improvement mechanisms increasingly use outcome measures to evaluate health care providers. This move toward outcome measures is a radical departure from the traditional focus on process measures. More radical still is the proposal to shift from relatively simple and proximal measures of outcome, such as mortality, to complex outcomes, such as quality of life. While the practical, scientific, and ethical issues associated with the use of outcomes such as mortality and morbidity to compare health care providers have been well rehearsed, the specific concerns associated with the use of quality of life measures in quality of care research have received little attention. As with much research on quality of life there is a tendency to assume that the disadvantages are outweighed by the general virtue of ??listening?? to patients. In this paper we disagree with this assumption and argue that quality of life is a process, not an outcome.     

浅谈循证医学与POCT的关系

分别介绍了循证医学和Point Of Care Test(POCT)的概念及各自的特点,并从唯物辩证法的角度对两者的异同以及相互间的影响进行了阐述.     

Suicide and the Standard of Care: Optimal vs. Acceptable

ABSTRACT: The accepted standard of care in the treatment of suicidal patients is discussed from the perspectives of the law, malpractice insurance claims, the mental health professions, and the ideal. A review of decisions of professional liability in suits for wrongful death provides guidelines for what the court considers to be adequate care. Out of court settlements further connote accepted standards of reasonable care. Although attention to potential malpractice issues is necessary and appropriate, what appear to result are an acceptance of minimal standards and the practice of defensive care. It is argued that by demanding more optimal standards the consequent quality of care not only serves the patient best but provides the best legal protection as well.