The European Union Directive and the protection of incapacitated subjects in research: an ethical analysis

OBJECTIVE: We perform an ethical analysis of European Union Directive 2001/20/EC on the simplification and harmonization of guidelines regarding good clinical practice in the conduct of clinical trials involving drugs. BACKGROUND: The Directive provides guidance on protecting incapacitated subjects who participate in drug clinical trials. Such guidance promotes society's obligations of beneficence because the participation of incapacitated subjects in research is crucial in advancing the understanding and treatment of serious diseases. The Directive requires proxy consent for incapacitated subjects which adheres to the principle of respect for persons. The Directive also recommends additional safeguards to further protect subjects against exploitation and harm. These include respect for the assent and dissent of incapacitated subjects and the "necessity" and "subject-condition" requirements. RESULTS: While these essential protection mechanisms are commendable, the Directive fails to endorse other safeguards that have been recommended by other research ethics guidelines, especially for riskier research. The Directive's silence regarding research in the emergency setting frustrates the principle of beneficence because the lack of guidance might prove to be a barrier for the conduct of such potentially beneficial research. CONCLUSIONS: We conclude that the European Directive fails in many respects to promote several important ethical principles in research involving incapacitated subjects.     

From vision to reality: how to actualize the vision of discharging patients from a hospital, with an increased focus on prevention

Experiences in creating dialogue possibilities to stimulate interdisciplinary and intersectoral collaboration in hospital discharge and prevention are presented. Time is often a major constraint that persuades decision-makers to avoid using qualitative methodologies in research and development. Quick results are demanded of today's health-care system, not allowing ideas to be implemented or visions owned by professionals. Action-orientated research is used and recommended, despite its time-demanding methodology. A multidisciplinary management team and the authors, over a 2-year period, worked with the development and implementation of 'Preventive Discharge' in a Danish hospital clinic. The empirical starting point, developmental processes, piloting and implementation of the project are described. Earlier research from a literature review on discharge is referenced. The results show that while there are many barriers to dialogue between professions and between organizational levels, it is possible to frame such opportunities and improve interdisciplinary and intersectoral collaboration for health. External supervision may be an effective tool for stimulating dialogue. The testing phase afforded a valuable lesson when pilot-site collaborators, initially not involved in the development of the process tools, reformulated the project to suit their cultural climate while maintaining the project's original aims. Finally, a discussion is presented on actualizing the vision for 'Preventive Discharge'.     

Forgoing life support in western European intensive care units: the results of an ethical questionnaire.

OBJECTIVE: To determine current views of European intensive care physicians regarding end-of-life decisions. DESIGN: A questionnaire was sent to all physician members of the European Society of Intensive Care Medicine. All questionnaires were anonymous. RESULTS: A total of 504 completed questionnaires from 16 western European countries were analyzed. Eighty-seven percent of the respondents were male. Forty-six percent of respondents said that intensive care unit admissions were generally or commonly affected by bed shortages, particularly in the south. Nevertheless, 73% of units frequently admit patients with no hope of survival, although only 33% of respondents felt that such patients should be admitted. Eighty percent of respondents felt that written do-not-resuscitate orders should be applied, but only 58% did so, with a wide variation according to country (from 8% in Italy to 91% in The Netherlands). Ninety-three percent of physicians sometimes withhold treatment from patients with no hope of a meaningful life, but withdrawal of treatment is less common. Forty percent of respondents said that they would deliberately administer large doses of drugs to such patients until death ensued. Forty-nine percent of respondents involved staff, patients, and family in end-of-life decisions. Forty-five percent of respondents felt that an ethics consultation was useful in such situations. Physicians in the countries of southern Europe were less likely than those in the north to apply do-not-resuscitate orders, withhold treatment, and discuss such issues with the patients. However, they were more likely to value the opinion of an ethics consultant. CONCLUSIONS: Intensive care unit admissions are frequently limited by the availability of beds across Europe, particularly in the south and in the United Kingdom, yet 73% of intensivists still admit patients with no hope of survival. When treating patients with no hope of survival, 40% of intensivists will deliberately administer large doses of drugs until death ensues. There are interesting differences between what a physician actually does and what he or she believes should be done with regard to various ethical questions. Important differences in attitudes also exist between European countries.     

The NEXUS vision: an alternative to the reference value concept.

In Lundberg's brain-to-brain turnaround time loop, the postanalytical phase is undoubtedly one of the most difficult phases. Of course, error prolongation can cause serious problems when quality is not sufficiently assessed and assured in the preanalytical and analytical phases. However, in the postanalytical phase following reporting, interpretation and action are at stake; and with this the wellbeing of the patient. Here exists a grey area of responsibility between the laboratory and physician. The laboratory should correctly report the measurement as data. But to place this in the correct context requires additional information on (specific) reference values, specificity, sensitivity and possible interpretation of the data. Here is where the ultimate interaction between the laboratory and the physician (representing the patient) occurs. What happens when errors occur in this phase? Do errors occurring in the previous phases effect this phase? What types of errors occur in the postanalytical phase? Postanalytical quality is the ultimate check on the coherence of the preanalytical, analytical and postanalytical quality; it is a check on the overall quality. It ties together the quality of the question to be answered, the analytical quality that is achieved and the usefulness of the answer obtained. In addition, it also checks quality in the context of the patient and physician interaction. Can errors be avoided and can a predictable quality level be assessed and be assured? A model, called NEXUS vision is described.     

The layer concept: utilization in determining the pain generators, pathology and how structure determines treatment

The level of understanding of pain in the non-arthritic hip has made significant strides in the last couple of decades beginning with the discoveries of Reinhold Ganz, MD. However, even with the detection of subtle bony abnormalities, including femoroacetabular impingement, a clinician’s ability to differentiate pain generators in the hip has been ambiguous. Deciphering the etiology of the pathology versus the pain generator is essential in prescribing the proper treatment. The Layer Concept developed by Dr. Bryan Kelly, is a systematic means of determining which structures about the hip are the source of the pathology, which are the pain generators and how to then best implement treatment. Four layers will be discussed in this article. Layer I, the osseous layer, Layer II, the inert tissue layer, Layer III, the contractile layer and Layer IV, the neuromechanical layer.     

The concept of soul in the course of history. Thoughts on psyche,mind and awareness

This paper seeks to convey an insight into the interrelationships between body, soul and mind and to show how the concept of "soul" has evolved through the course of history. In German the word "soul" has a confusing array of meanings today. For most of us it comprises all of man's emotions, his awareness, constructive thought, drive, state of mind and spirit. The soul thus represents the essence of a person and his relationships to those closest to him. For many people the soul was and still is the principle of life, the breath of life and the force of life. The immortal soul escapes, leaves the body, is weighed and judged. At all times in history man has doggedly pursued the mysteries of self-awareness, the ultimate truth and the soul. What he found varied, depending on the age and the place. What the Hebrew Bible and the New Testament express in deep-seated metaphors, the Greek philosophers put into clear-cut words: their concept of soul was then largely integrated into Christian thought. Meister Eckhart describes the soul in mystically transfigured passion. C.G. Jung writes of the "animus and anima." Sigmund Freud uses the term "psyche." Radical materialism denies the existence and independence of the soul's processes. The questions where we come from and where we are going, why and what for, no longer find a common answer. Psychiatry, however, takes up the intellectual call of the time and replies to the challenges of the day. Thus, the search for the "soul", a search that occupies so many people, also always involves the search for the whole person.     

Resistance to aminoglycoside antibiotics in gram-negative bacilli and staphylococci isolated from blood. Report from a European collaborative study. The ESGAR Study Group (European Study Group on Antibiotic Resistance)

The incidence of resistance to gentamicin, tobramycin, amikacin and netilmicin was determined by the microdilution method in Mueller-Hinton broth among blood culture isolates consecutively collected in 37 laboratories in 14 European countries. The distribution of bacteria was similar in each laboratory, Escherichia coli and staphylococci predominating. Resistance levels varied between laboratories but they were higher to all four antibiotics in Southern Europe than in Central and Northern Europe. Aminoglycoside resistance was usually associated with production of aminoglycoside-modifying enzymes, ANT(2"), AAC (3)-V, AAC (6')-I predominating in Gram-negative bacilli and APH (2") + AAC (6') and ANT (4')-I in staphylococci.     

Part 12: from science to survival. Strengthening the chain of survival in every community. European Resuscitation Council

Cardiac arrest treatment continues to evolve. Adequate treatment of the individual patient requires that the whole ECC system function smoothly, consistently, and rapidly. To maximize community-wide survival rates, a careful evaluation of the entire Chain of Survival is necessary, using standard measurements of performance. The challenge for the next decade is to establish this infrastructure and conduct multicenter, prospective, controlled clinical trials to better define the key factors that will improve survival from cardiac arrest in every community.     

External Quality Assessment in The Netherlands: time to introduce commutable survey specimens. Lessons from the Dutch "Calibration 2000" project.

The performance of suitable secondary reference material for the use of trueness control of six routinely measured clinical enzymes in the Dutch External Quality Assessment (EQA) scheme is described. The reference material of choice was selected using the split-patient-sample between-field method (twin study) design as described in an earlier study of the Calibration 2000 project in The Netherlands. This material, which was proven to be commutable for all wet chemistry systems, was implemented as the national enzyme calibrator. It consisted of a cryo-protected lyophilised serum with additions of recombinant human enzymes. Various batches of the frozen version of this material without cryo-protection additive, called native EQA samples, were used in the general EQA scheme for performance evaluation. The results of Calibration 2000 calibrated and non-Calibration 2000 calibrated laboratories were compared for both the regular (spiked with non-human enzymes) and native EQA samples in terms of precision and bias with established reference method values for the native samples. The regular samples showed mean between-laboratory CV ranges for all six enzymes involved (low-high) of 5.5-10.3% for the non-calibrated users vs. 4.6-10.8% for the calibrated users. For the native samples these respective ranges were 5.2-9.9% vs. 2.2-4.9%. Without exception, the group of Calibration 2000 calibrated users showed the lowest bias against the reference method values. Regular EQA samples (spiked with non-human enzymes) showed poorer performance than native samples and are not suitable for accuracy assessment purposes, the main aim of EQA schemes. Native samples that are commutable should be used for trueness control in current EQA schemes.     

Gastric devascularization: an alternate approach to the surgical treatment of massive, diffuse hemorrhage from gastritis.

During a three-year period on the surgical services at the University of Texas in San Antonio, eight critically ill patients had various types of gastric devascularization to control erosive hemorrhagic gastritis. Among these patients were two women and one child. There were five chronic alcoholics, one aspirin abuser, one severely burned patient, and one patient with sepsis. Esophagogastroscopy was used in six patients but was diagnostic in only three. All of the patients were given intensive medical preoperative care, including an average of eight units of blood each. In four of the five known alcoholics, preoperative tests showed severely deranged clotting function. All of the patients received at least a four-point gastric vessel ligation. In addition, four had gastrotomies, three had vagotomies and pyloroplasties, and two had "complete" gastric vessel ligation. There was no significant rebleeding in five patients. Of the three patients with significant recurrent gastric hemorrhage, two were chronic alcoholics with poor clotting function, and neither was considered operable. One patient, the child, had massive rebleeding one week after gastric devascularization with vagotomy and pyloroplasty and required a subtotal gastrectomy. Of the four patients who ultimately died, three were chronic alcoholics and one had sepsis.     

Delya's story: from expert to novice, a critique of Benner's concept of context in the development of expert nursing practice

The concepts identified within Benner's Nineteen Eighty Four research 'From Novice to Expert' have been widely adopted within UK nursing education and development. This paper combines a narrative from a post-registration student with analysis of the literature as a case study for gaining greater understanding of Benner's work in practice. Delya's story both validates aspects of the concept of skill acquisition and challenges some of the interpretations of the model within professional education. The focus of the critique of Benner's work within the literature to date has been on a deconstruction of the concepts and semantics of her work. In presenting verbatim extracts from a case study this paper seeks to move the focus to nursing practice.     

In response to: specialization in physiotherapy: musings on current concepts and possibilities for harmonization across the European Union [Donaghy and Gosling,Phys Ther Rev 1999; 4: 51–60]

Abstract

Donaghy and Gosling have written a paper that articulates many interesting issues with respect to the specialization process in physiotherapy. I will structure this response around three topics that are particularly interesting to me: tension between generalist and specialist practitioners, differentiation of specialists from experts, and the formal specialization process.