Theoretical models for patient-physician communication in clinical practice are frequently described in the literature. Respecting patient autonomy is an ethical problem the physician faces in a medical emergency situation. No theoretical physician-patient model seems to be ideal for solving the communication problem in clinical practice. Theoretical models can at best give guidance to behavior and judgement in emergency situations. In this article the premises of autonomous treatment decisions are discussed. Based on a case-report we discuss different genuine efforts the physician (...) can do to uncover treatment refusal and respect patient autonomy in an emergency situation. Autonomy requires competence and in emergency medicine time does not allow intimate exploration of patient competence and reasons for treatment refusal. We find that the physician must base her decision on a firm theoretical base combined with a practical and realistic view of the patient's situation on a case to case basis. (shrink)

The first clinical ethics committees in Norway were established in 1996. This started as an initiative from hospital clinicians, the Norwegian Medical Association, and health authorities and politicians. Norwegian hospitals are, by and large, publicly funded through taxation, and all inpatient treatment is free of charge. Today, all the 23 hospital trusts have established at least one committee. Center for Medical Ethics , University of Oslo, receives an annual amount of US$335,000 from the Ministry of Health and Care Services to (...) coordinate the committees and to facilitate competency building for committee members. (shrink)

Clinical ethics committees have existed in Norway since 1996. By now all hospital trusts have one. An evaluation of these committees’ work was started in 2004. This paper presents results from an interview study of eight clinicians who evaluated six committees’ deliberations on 10 clinical cases. The study indicates that the clinicians found the clinical ethics consultations useful and worth while doing. However, a systematic approach to case consultations is vital. Procedures and mandate of the committees should be known to (...) clinicians in advance to ensure that they know what to expect. Equally important is bringing all relevant facts, medical as well as psychosocial, into the discussion. A written report from the deliberation is also important for the committees to be taken seriously by the clinicians. This study indicates that the clinicians want to be included in the deliberation, and not only in the preparation or follow-up. Obstacles for referring a case to the committee are the medical culture’s conflict aversion and its anxiety of being judged by outsiders. The committees were described as a court by some of the clinicians. This is a challenge for the committees in their attempt to balance support and critique in their consultation services. (shrink)

Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade moral disagreement, (...) conflict, and 'outsiders' are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well-known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper. (shrink)

Clinical ethics support services are developing in Europe. They will be most useful if they are designed to match the ethical concerns of clinicians. We conducted a cross-sectional mailed survey on random samples of general physicians in Norway, Switzerland, Italy, and the UK, to assess their access to different types of ethics support services, and to describe what makes them more likely to have used available ethics support. Respondents reported access to formal ethics support services such as clinical ethics committees (...) (23%), consultation in individual cases (17.6%), and individual ethicists (8.8%), but also to other kinds of less formal ethics support (23.6%). Access to formal ethics support services was associated with work in urban hospitals. Informal ethics resources were more evenly distributed. Although most respondents (81%) reported that they would find help useful in facing ethical difficulties, they reported having used the available services infrequently (14%). Physicians with greater confidence in their knowledge of ethics (P = 0.001), or who had had ethics courses in medical school (P = 0.006), were more likely to have used available services. Access to help in facing ethical difficulties among general physicians in the surveyed countries is provided by a mix of official ethics support services and other resources. Developing ethics support services may benefit from integration of informal services. Development of ethics education in medical school curricula could lead to improved physicians sensititity to ethical difficulties and greater use of ethics support services. Such support services may also need to be more proactive in making their help available. (shrink)

The structure of ethics work in a hospital is complex. Professional ethics, research ethics and clinical ethics committees (CECs) are important parts of this structure, in addition to laws and national and institutional codes of ethics. In Norway all hospital trusts have a CEC, most of these discuss cases by means of a method which seeks to include relevant guidelines and laws into the discussion. In recent years many committees have received more cases which have concerned questions of principle. According (...) to Ellen Fox and co-authors the traditional CEC model suffers from a number of weaknesses. Therefore, in their organization a separate body deals with organizational matters. In this paper, we discuss what is gained and what is lost by creating two separate bodies doing ethics consultation. We do this through an analysis of detailed minutes of CEC discussions in one CEC during a 6-year period. 30 % of all referrals concerned matters of principle. Some of these discussions originated in a dilemma related to a particular patient. Most of the discussions had some consequences within the hospital organization, for clinical practice, for adjustment of guidelines, or may have influenced national policy. We conclude that a multiprofessional CEC with law and ethics competency and patient representation may be well suited also for discussion of general ethical principles. A CEC is a forum which can help bridge the gap between clinicians and management by increasing understanding for each others’ perspectives. (shrink)

Next SectionThe principle of respect for autonomy has shaped much of the bioethics' discourse over the last 50 years, and is now most commonly used in the meaning of respecting autonomous choice. This is probably related to the influential concept of informed consent, which originated in research ethics and was soon also applied to the field of clinical medicine. But while available choices in medical research are well defined, this is rarely the case in healthcare. Consideration of ordinary medical practice (...) reveals that the focus on patient choice does not properly grasp the moral aspects involved in healthcare. Medical decisions are often portrayed as if doctors and patients in confidence confront specific decisions about examinations or treatment, yet the reality often involves many different participants, with decisions being made over time and space. Indeed, most of the decisions are never even presented to patients, as it would be unethical to suggest something that is not medically justifiable. The options patients do confront are somewhat arbitrarily constructed within the narrow framework of both what is deemed to be medically appropriate and how the healthcare system is organised practically. While the autonomy discourse has proven valuable, a failure to distinguish between the fields of medical research and clinical medicine has generated a focus on patient choice that does not reflect what is really at stake in healthcare settings. This is alarming, because the current discourse misrepresents medical practice in a way that actually contributes to bioethical self-delusion. (shrink)

The purpose of this study was to investigate nurses’ decisions about priorities in home-based nursing care. Qualitative research interviews were conducted with 17 nurses in home-based care. The interviews were analyzed and interpreted according to a hermeneutic methodology. Nurses describe clinical priorities in home-based care as rationing care to mind the gap between an extensive workload and staff shortages. By organizing home-based care according to tight time schedules, the nurses’ are able to provide care for as many patients as possible. (...) Furthermore, legal norms set boundaries for clinical priority decisions, resulting in marginalized care. Hence, rationing care jeopardizes important values in the nurse-patient relationship, in particular the value of individualized and inclusive nursing care. The findings are highly relevant for clinical practice, since they have major implications for provision of nursing care. They revive debates about the protection of values and standards of care, and nurses’ role and responsibility when resources are limited. (shrink)

Coercion in mental health care gives rise to many ethical challenges. Many countries have recently implemented state policy programs or development projects aiming to reduce coercive practices and improve their quality. Few studies have explored the possible role of ethics in such initiatives. This study adds to this subject by exploring health professionals’ descriptions of their ethical challenges and strategies in everyday life to ensure morally justified coercion and best practices. Seven semi-structured telephone interviews were carried out in 2012 with (...) key informants in charge of central development projects and quality-assurance work in mental health services in Norway. No facilities used formal clinical ethics support. However, the informants described five areas in which ethics was of importance: moral concerns as implicit parts of local quality improvement initiatives; moral uneasiness and idealism as a motivational source of change; creating a normative basis for development work; value-based leadership; and increased staff reflexivity on coercive practices. The study shows that coercion entails both individual and institutional ethical aspects. Thus, various kinds of moral deliberation and ethics support could contribute to addressing coercion challenges by offering more systematic ways of dealing with moral concerns. However, more strategic use of implicit and institutional ethics is also needed. (shrink)

As the pressure on available health care resources grows, an increasing moral challenge in intensive care is to secure a fair distribution of nursing care and medical treatment. The aim of this article is to explore how limited resources influence nursing care and medical treatment in intensive care, and to explore whether intensive care unit clinicians use national prioritization criteria in clinical deliberations. The study used a qualitative approach including participant observation and in-depth interviews with intensive care unit physicians and (...) nurses working at the bedside. Scarcity of resources regularly led to suboptimal professional standards of medical treatment and nursing care. The clinicians experienced a rising dilemma in that very ill patients with a low likelihood of survival were given advanced and expensive treatment. The clinicians rarely referred to national priority criteria as a rationale for bedside priorities. Because prioritization was carried out implicitly, and most likely partly without the clinician's conscious awareness, central patient rights such as justice and equality could be at risk. (shrink)

When clinical ethics committee members discuss a complex ethical dilemma, what use do they have for normative ethical theories? Members without training in ethical theory may still contribute to a pointed and nuanced analysis. Nonetheless, the knowledge and use of ethical theories can play four important roles: aiding in the initial awareness and identification of the moral challenges, assisting in the analysis and argumentation, contributing to a sound process and dialogue, and inspiring an attitude of reflexivity. These four roles of (...) ethical theory in clinical ethics consultation are described and their significance highlighted, while an example case is used as an illustration throughout. (shrink)

BackgroundEthically challenging critical events and decisions are common in nursing homes. This paper presents nursing home doctors’ descriptions of how they include the patient and next of kin in end-of-life decisions.MethodsWe performed ten focus groups with 30 nursing home doctors. Advance care planning; aspects of decisions on life-prolonging treatment, and conflict with next of kin were subject to in-depth analysis and condensation.ResultsThe doctors described large variations in attitudes and practices in all aspects of end-of-life decisions. In conflict situations, many doctors (...) were more concerned about the opinion of next of kin than ensuring the patient’s best interest.ConclusionsMany end-of-life decisions appear arbitrary or influenced by factors independent of the individual patient’s values and interests and are not based on systematic ethical reflections. To protect patient autonomy in nursing homes, stronger emphasis on legal and ethical knowledge among nursing home doctors is needed. (shrink)

With disagreement, doubts, or ambiguous grounds in end–of-life decisions, doctors are advised to involve a clinical ethics committee. However, little has been published on doctors’ experiences with discussing an end-of-life decision in a CEC. As part of the quality assurance of this work, we wanted to find out if clinicians have benefited from discussing end-of-life decisions in CECs and why. We will disseminate some Norwegian doctors’ experiences when discussing end-of-life decisions in CECs, based on semi-structured interviews with fifteen Norwegian physicians (...) who had brought an end-of-life decision case to a CEC. Almost half of the cases involved conflicts with the patients’ relatives. In a majority of the cases, there was uncertainty about what would be the ethically preferable solution. Reasons for referring the case to the CEC were to get broader illumination of the case, to get perspective from people outside the team, to get advice, or to get moral backing on a decision already made. A great majority of the clinicians reported an overall positive experience with the CECs’ discussions. In cases where there was conflict, the clinicians reported less satisfaction with the CECs’ discussions. The study shows that most doctors who have used a CEC in an end-of-life decision find it useful to have ethical and/or legal aspects illuminated, and to have the dilemma scrutinized from a new perspective. A systematic discussion seems to be significant to the clinicians. (shrink)

The aim of this article is to generate knowledge about parents’ participation in life-and-death decisions concerning their very premature and/or critically ill infants in hospital neonatal units. The question is: what are parents’ attitudes towards their involvement in such decision making? A descriptive study design using in-depth interviews was chosen. During the period 1997-2000, 20 qualitative interviews with 35 parents of 26 children were carried out. Ten of the infants died; 16 were alive at the time of the interview. The (...) comparative method (grounded theory) was used to analyse the data. The analysis was carried out continuously and in parallel with data collection. Six categories were revealed by the analysis: indecision and uncertainty (ambivalence); information and communication; participate, but do not decide; seeming to be included; the parents’ child; and individual consideration. The findings appear to indicate that parents agree that they should not have the final word in decisions concerning their infants’ future life or death. Such a responsibility would put too heavy a burden on parents who lack the medical knowledge and the professional experience needed to make such a decision, and would be likely to lead to them experiencing strong feelings of guilt. The findings show that parents should be well informed and listened to during the whole decision-making process. Their primary concern was how nurses and physicians communicate with parents who are experiencing a crisis, and how this serious information is presented. (shrink)

How may clinical ethics committees inspire ethical reflection among healthcare professionals? How may they deal with organizational ethics issues? In recent years, Norwegian CECs have attempted different activites that stretch or go beyond the standard trio of education, consultation, and policy work. We studied the novel activities of Norwegian CECs by examining annual reports and interviewing CEC members. Through qualitative analysis we identified nine categories of novel CEC activities, which we describe by way of examples. In light of the findings, (...) we argue that some novel working methods may be well suited to promote ethical reflection among clinicians, and that the CEC may be a suitable venue for discussing issues of organizational ethics. (shrink)

In many Western countries, studies have demonstrated extensive use of coercion in nursing homes, especially towards patients suffering from dementia. This article examines what kinds of strategies or alternative interventions nursing staff in Norway used when patients resist care and treatment and what conditions the staff considered as necessary to succeed in avoiding the use of coercion. The data are based on interdisciplinary focus group interviews with nursing home staff. The study revealed that the nursing home staff usually spent a (...) lot of time trying a wide range of approaches to avoid the use of coercion. The most common strategies were deflecting and persuasive strategies, limiting choices by conscious use of language, different kinds of flexibility and one-to-one care. According to the staff, their opportunities to use alternative strategies effectively are greatly affected by the nursing home’s resources, by the organization of care and by the staff’s competence. (shrink)

Diagnostic errors are more frequently a result of the clinician's failure to combine medical knowledge adequately than of data inaccuracy. Diagnostic reasoning studies are valuable to understand and improve diagnostic reasoning. However, most diagnostic reasoning studies are characterized by some limitations which make these studies seem more simple than diagnostic reasoning in real life situations actually is. These limitations are connected both to the failure to acknowledge components of knowledge used in clinical practice as well as to acknowledge the physician-patient (...) relationship's influence on clinical knowledge and on the reasoning process itself. In addition the modes of reasoning described in these studies frequently is oversimplified. In this paper three simplistic and competing models of diagnostic reasoning are analyzed and criticized, followed by an evaluation of two alternative models proposing a combined view. (shrink)

This article examines the involvement of residents and their relatives in end-of-life decisions and care in Norwegian nursing homes. It also explores challenges in these staff—family relationships. The article is based on a nationwide survey examining Norwegian nursing homes’ end-of-life care at ward level. Only a minority of the participant Norwegian nursing home wards ‘usually’ explore residents’ preferences for care and treatment at the end of their life, and few have written procedures on the involvement of family caregivers when their (...) relative is in the terminal phase. According to the respondents, most staff seem to comfort relatives well. However, several challenges were described. The study revealed a need for better procedures in the involvement of residents and relatives in nursing home end-of-life care. The findings emphasize a need to strengthen both the involvement of nursing home physicians and staff communication skills. (shrink)

Background We present and discuss the results of a Norwegian survey of medical doctors' views on potential ethical dilemmas in professional practice. Methods The study was conducted in 2015 as a postal questionnaire to a representative sample of 1612 doctors, among which 1261 responded. We provided a list of 41 potential ethical dilemmas and asked whether each was considered a dilemma, and whether the doctor would perform the task, if in a position to do so. Conceptually, dilemmas arise because of (...) tensions between two or more of four doctor roles: the patient’s advocate, a steward of societal interests, a member of a profession and a private individual. Results 27 of the potential dilemmas were considered dilemmas by at least 50% of the respondents. For more than half of the dilemmas, the anticipated course of action varied substantially within the professional group, with at least 20% choosing a different course than their colleagues, indicating low consensus in the profession. Conclusions Doctors experience a large range of ethical dilemmas, of which many have been given little attention by academic medical ethics. The less-discussed dilemmas are characterised by a low degree of consensus in the profession about how to handle them. There is a need for medical ethicists, medical education, postgraduate courses and clinical ethics support to address common dilemmas in clinical practice. Viewing dilemmas as role conflicts can be a fruitful approach to these discussions. (shrink)

While certain substantial moral dilemmas in health care have been given much attention, like abortion, euthanasia or gene testing, doctors rarely reflect on the moral implications of their daily clinical work. Yet, with its aim to help patients and relieve suffering, medicine is replete with moral decisions. In this qualitative study we analyse how doctors handle the moral aspects of everyday clinical practice. About one hundred consultations were observed, and interviews conducted with fifteen clinical doctors from different practices. It turned (...) out that the doctors’ approach to clinical cases followed a rather strict pattern across specialities, which implied transforming patients’ diverse concerns into specific medical questions through a process of ‘essentialising’: Doctors broke the patient’s story down, concretised the patient’s complaints and categorised the symptoms into a medical sense. Patients’ existential meanings were removed, and the focus placed on the patients’ functioning. By essentialising, doctors were able to handle a complex and ambiguous reality, and establish a medically relevant problem. However, the process involved a moral as well as a practical simplification. Overlooking existential meanings and focusing on purely functional aspects of patients was an integral part of clinical practice and not an individual flaw. The study thus questions the value of addressing doctors’ conscious moral evaluations. Yet doctors should be aware that their daily clinical work systematically emphasises beneficence at the expense of others—that might be more important to the patient. (shrink)

It is generally accepted today that the biomedical model's exclusive focus on the patient's somatic condition is too narrow. The biomedical model, however, has additional shortcomings. In the first place, resources are left out of the diagnostic perspective. Secondly, the automatic interpretation of symptoms and deviations from normal as present or potential threats to the individual's health. In this paper it is claimed that these characteristics of the biomedical model can lead to medicalization. To elucidate these claims, an alternative approach (...) to antenatal care, is presented in which the psychosocial conditions of pregnant women are integrated. Some practical problems that follow from this approach are discussed. (shrink)

BackgroundInternationally, clinical ethics support has yet to be implemented systematically in community health and care services. A large-scale Norwegian project attempted to increase ethical competence in community services through facilitating the implementation of ethics support activities in 241 Norwegian municipalities. The article describes the ethics project and the ethics activities that ensued.MethodsThe article first gives an account of the Norwegian ethics project. Then the results of two online questionnaires are reported, characterizing the scope, activities and organization of the ethics activities (...) in the Norwegian municipalities and the ethical topics addressed.ResultsOne hundred and thirty-seven municipal contact persons answered the first survey, whereas 217 ethics facilitators from 48 municipalities responded to the second. The Norwegian ethics project is vast in scope, yet has focused on some institutions and professions whilst seldom reaching others. Patients and next of kin were very seldom involved. Through the ethics project employees discussed many important ethical challenges, in particular related to patient autonomy, competence to consent, and cooperation with next of kin. The “ethics reflection group” was the most common venue for ethics deliberation.ConclusionsThe Norwegian project is the first of its kind and scope, and other countries may learn from the Norwegian experiences. Professionals have discussed central ethical dilemmas, the handling of which arguably makes a difference for patients/users and service quality. The study indicates that large scale implementation of CES structures for the municipal health and care services is complex, yet feasible. (shrink)

BackgroundAll hospital trusts in Norway have clinical ethics committees. Some of them invite next of kin/patients to be present during the discussion of their case. This study looks closer at how parents of seriously ill children have experienced being involved in CEC discussions.MethodsTen next of kin of six seriously ill children were interviewed. Their cases were discussed in two CECs between April of 2011 and March of 2014. The main ethical dilemma was limitation of life-prolonging treatment. Health care personnel who (...) could elucidate the case were also present in the discussion. The interviewer observed each discussion and then interviewed the next of kin shortly after the meeting, following a structured interview guide.ResultsAll next of kin emphasized that it had been important for them to be present. They stressed the important role of the CEC chair and appreciated that their case was discussed in a systematic way. Some next of kin appreciated that the child’s impending death was discussed openly, and believed that this would facilitate their future grieving. Having had an opportunity to hear all the arguments behind the decision to be made would probably help them to accept the road ahead.All of them felt that they were taken seriously and listened to. They felt that they had added vital information to the discussion. All but one couple did not want any decision-making responsibility, some of them even worried that they might have influenced the discussion too much.ConclusionsNone of the next of kin felt that being present during the CEC discussion had been too heavy a burden. On the contrary, they claimed that their presence in a CEC discussion may add vital information to the discussion and may improve the quality of the decision. It is important that the CEC’s role is explained to them so they are well prepared for what to expect. They need to be followed up after the discussion. (shrink)

Fair prioritization of healthcare resources has been on the agenda for decades, but resource allocation dilemmas in clinical practice remain challenging. Can clinical ethics committees be of help? The aim of the study was to explore whether and how CECs handle priority setting dilemmas and contribute to raising awareness of fairness concerns. Descriptions of activities involving priority setting in annual reports from Norwegian CECs were studied and categorized through qualitative content analysis. Three hundred thirty-nine reports from 38 CECs were studied. (...) We found 78 activities where resource use or priority setting were explicitly highlighted as main topics. Of these, 29 were seminars or other educational activities, 21 were deliberations on individual patient cases, whereas 28 were discussions of principled or general cases. Individual patient cases concerned various distributional dilemmas where values were at stake. Six main topics and seven roles for the CEC were identified. CECs handle issues concerning the introduction of new costly drugs, extraordinarily costly established treatment, the application of priority setting criteria, resource use for vulnerable groups, resource constraints compromising practice, and futility of care. The CEC can act as an analyst, advisor, moderator, disseminator, facilitator, watch dog, and guardian of values and laws. In order to fulfil their responsibilities in handling priority setting cases, CECs need knowledge of both the ethics and the institutionalized systems of priority setting. There is potential for developing this aspect of the CECs’ work further. The Norwegian CECs are involved in priority setting decisions where they can play multiple constructive roles. In particular, they advise and raise awareness of ethical aspects in resource allocations; bridge clinical practice with higher-level decisions; and promote fair resource allocation and stakeholder rights and interests. (shrink)

BackgroundNorway has extensive and detailed legal requirements and guidelines concerning involvement of next of kin during involuntary hospital treatment of seriously mentally ill patients. However, we have little knowledge about what happens in practice. This study explores NOK’s views and experiences of involvement during involuntary hospitalisation in Norway.MethodsWe performed qualitative interviews-focus groups and individual-with 36 adult NOK to adults and adolescents who had been involuntarily admitted once or several times. The semi-structured interview guide included questions on experiences with and views (...) on involvement during serious mental illness and coercion.ResultsMost of the NOK were heavily involved in the patient’s life and illness. Their conceptions of involvement during mental illness and coercion, included many important aspects adding to the traditional focus on substitute decision-making. The overall impression was, with a few exceptions, that the NOK had experienced lack of involvement or had negative experiences as NOK in their encounters with the health services. Not being seen and acknowledged as important caregivers and co sufferers were experienced as offensive and could add to their feelings of guilt. Lack of involvement had as a consequence that vital patient information which the NOK possessed was not shared with the patient’s therapists.ConclusionsDespite public initiatives to improve the involvement of NOK, the NOK in our study felt neglected, unappreciated and dismissed. The paper discusses possible reasons for the gap between public policies and practice which deserve more attention: 1. A strong and not always correct focus on legal matters. 2. Little emphasis on the role of NOK in professional ethics. 3. The organisation of health services and resource constraints. 4. A conservative culture regarding the role of next of kin in mental health care. Acknowledging these reasons may be helpful to understand deficient involvement of the NOK in voluntary mental health services. (shrink)

Many of the elderly in nursing homes are very ill and have a reduced quality of life. Life expectancy is often hard to predict. Decisions about life-prolonging treatment should be based on a professional assessment of the patient’s best interest, assessment of capacity to consent, and on the patient’s own wishes. The purpose of this study was to investigate and compare how these types of decisions were made in nursing homes and in hospital wards. Using a questionnaire, we studied the (...) decision-making process for 299 nursing home patients who were treated for dehydration using intravenous fluids, or for bacterial infections using intravenous antibiotics. We compared the 215 patients treated in nursing homes to the 84 nursing home patients treated in the hospital. The patients’ capacity to consent was considered prior to treatment in 197 of the patients treated in nursing homes and 56 of the patients treated in hospitals. The answers indicate that capacity to consent can be difficult to assess. Patients that were considered capable to consent, were more often involved in the decision-making in nursing homes than in hospital. Next of kin and other health personnel were also more rarely involved when the nursing home patient was treated in hospital. Whether advance care planning had been carried out, was more often unknown in the hospital. Hospital doctors expressed more doubt about the decision to admit the patient to the hospital than about the treatment itself. This study indicates a potential for improvement in decision-making processes in general, and in particular when nursing home patients are treated in a hospital ward. The findings corroborate that nursing home patients should be treated locally if adequate health care and treatment is available. The communication between the different levels of health care when hospitalization is necessary, must be better. ClinicalTrials. gov NCT01023763 [The registration was delayed one month after study onset due to practical reasons]. (shrink)