What Factors Contribute to Ethical Problems in Patient Care? A Scoping Review and Case Series of Clinical Ethics Consultations.

AbstractBackground: Healthcare professionals (HCPs) are frequently exposed to ethical problems in patient care that can affect the quality of care. Understanding risk factors for ethical problems may help practitioners to address these problems at an early stage. This study aims to provide an overview of ethical risk factors in patient care. Risk factors known from the literature and those found in clinical ethics consultation (CEC) cases are reviewed. METHODS: A scoping review of ethical risk factors in patient care and a CEC case series were conducted, analyzing the documentation (consultation reports, feedback forms, electronic medical records) of 204 CECs from 2012 to 2020 at a somatic and a psychiatric university hospital in Basel, Switzerland. RESULTS: Ninety-nine ethical risk factors were identified in nine articles, related to four risk areas: patient (41), family (12), healthcare team (29), and system (17). Eighty-seven of these risk factors were documented at least once in the CEC case series. The most prevalent risk factors in the consultations studied were patient vulnerability (100%), missing or unclear hospital ethics policy (97.1%), shift work (83.3%), lack of understanding between patient and HCP (73.5%), poor communication (66.2%), disagreement between patient and HCP about care (58.8%), and multiple care teams (53.4%). The prevalence differed significantly by medical specialty. CONCLUSIONS: There are highly prevalent ethical risk factors at all levels of clinical care that may be used to prevent ethical problems. Further empirical research is needed to analyze risk ratios and to develop specific risk profiles for different medical specialties.

Shall parent / patient wishes be fulfilled in any case? A series of 32 ethics consultations: from reproductive medicine to neonatology.

BACKGROUND: Questions concerning the parent/ patient's autonomy are seen as one of the most important reasons for requesting Ethics Consultations (ECs). Respecting parent/ patient's autonomy also means respecting the patient's wishes. But those wishes may be controversial and sometimes even go beyond legal requirements. The objective of this case series of 32 ECs was to illustrate ethically challenging parent / patients' wishes during the first stages of life and how the principle of patient's autonomy was handled. METHODS: The case series has a qualitative retrospective approach. A documentary sheet was designed de novo and information was gained from EC minutes and medical charts. The cases originate from the following specialties: reproductive medicine, obstetrics and neonatology as well as two interdisciplinary cases. RESULTS: Through the structured EC minutes aspects of patient / parents' wishes could be identified explicitly. Overall the patient / parents' wishes were not supported in 61% of the cases. Central reasons for rejection of patient / parent wishes were mainly the protection of the best interest of the unborn / new-born child as well as the rejection of clinical approaches that were regarded as being substandard treatment. CONCLUSION: The study shows that treatment decisions in reproductive medicine, obstetrics and neonatology raise substantial ethical questions leading to the request for ethics consultation. The systematic case series presented here gives insight into the ethical reflection carried out to support the clinicians in their decision-making and counselling. It shows that clinicians, after using ethics consultation, make deliberate decisions that do not "automatically" fulfil the treatment requests of the patients and parents (to-be).

"Getting by" in a Swiss Tertiary Hospital: the Inconspicuous Complexity of Decision-making Around Patients' Limited Language Proficiency.

BACKGROUND: While the need to address language barriers to provide quality care for all is generally accepted, little is known about the complexities of decision-making around patients' limited language proficiency in everyday clinical encounters. OBJECTIVE: To understand how linguistic complexities shape cross-cultural encounters by incorporating the perspective of both, patients and physicians. DESIGN: A qualitative hospital study with semi-structured interviews and participant-observation in a Swiss University Hospital. Thirty-two encounters were observed and 94 interviews conducted. PARTICIPANTS: Sixteen patients of Turkish and 16 of Albanian origin and all actors (administration, nurses, physicians, if required, interpreters) involved in the patients' entire process. MAIN APPROACH: Interviews were audio-recorded and transcribed verbatim. A thematic content analysis was conducted using MAXQDA. For reporting, the COREQ guidelines were used. KEY RESULTS: Three themes were relevant to patients and physicians alike: Assessment of the language situation, the use of interpreters, and dealing with conversational limits. Physicians tend to assess patients' language proficiency by their body language, individual demeanor, or adequacy of responses to questions. Physicians use professional interpreters for "high-stakes" conversations, and "get by" through "low-stakes" topics by resorting to bilingual family members, for example. Patients are driven by factors like fearing costs or the wish to manage on their own. High acceptance of conversational limits by patients and physicians alike stands in stark contrast to the availability of interpreters. CONCLUSIONS: The decision for or against interpreter use in the "real world" of clinical care is complex and shaped by small, frequently inconspicuous decisions with potential for suboptimal health care. Physicians occupy a key position in the decision-making to initiate the process of medical interpreting. The development and testing of a conceptual framework close to practice is crucial for guiding physicians' assessment of patients' language proficiency and their decision-making on the use of interpreting services.

Their view: difficulties and challenges of patients and physicians in cross-cultural encounters and a medical ethics perspective.

BACKGROUND: In todays' super-diverse societies, communication and interaction in clinical encounters are increasingly shaped by linguistic, cultural, social and ethnic complexities. It is crucial to better understand the difficulties patients with migration background and healthcare professionals experience in their shared clinical encounters and to explore ethical aspects involved. METHODS: We accompanied 32 migrant patients (16 of Albanian and Turkish origin each) during their medical encounters at two outpatient clinics using an ethnographic approach (participant observation and semi-structured interviews with patients and healthcare professionals). Overall, data of 34 interviews with patients and physicians on how they perceived their encounter and which difficulties they experienced are presented. We contrasted the perspectives on the difficult aspects and explore ethical questions surrounding the involved issues. RESULTS: Patients and physicians describe similar problem areas, but they have diverging perspectives on them. Two main themes were identified by both patients and physicians: >patients' behaviour in relation to doctors' advice< and > relationship issues<. CONCLUSIONS: A deeper understanding of the difficulties and challenges that can arise in cross-cultural settings could be provided by bringing together healthcare professionals' and patients' perspectives on how a cross- cultural clinical encounter is perceived. Ethical aspects surrounding some of the difficulties could be highlighted and should get more attention in clinical practice and research.

The second patient? Family members of cancer patients and their role in end-of-life decision making.

BACKGROUND: Family members are important companions of severely ill patients with cancer. However, studies about the desirability and difficulties of integrating relatives in the decision-making process are rare in oncology. This qualitative study explores the family role in decisions to limit treatment near the end of life from the professionals' point of view. METHODS: Qualitative in-depth interviews were conducted with oncologists (n = 12) and nurses (n = 6) working at the Department of Hematology/Oncology at the University Hospital in Munich, Germany. The data were analyzed using a descriptive qualitative methodology and discussed from a medical ethics perspective. RESULTS: Four major themes played a central role in the perception of the medical staff in regard to family members. (1) Family impact on patients' treatment preferences. (2) Strong family wish for further treatment. (3) Emotional distress of the family related to the involvement in end-of-life decision-making. (4) Importance of knowing family structures. CONCLUSIONS: The important role of the family members in patients' disease process is recognized by oncologists and oncology nurses. However, this does not seem to lead to an early involvement of the family members. Developing and establishing a systematic assessment of family members' needs and wishes in order to provide a specific-tailored support should become a priority for interdisciplinary clinical research in the near future.

How to introduce medical ethics at the bedside - Factors influencing the implementation of an ethical decision-making model.

BACKGROUND: As the implementation of new approaches and procedures of medical ethics is as complex and resource-consuming as in other fields, strategies and activities must be carefully planned to use the available means and funds responsibly. Which facilitators and barriers influence the implementation of a medical ethics decision-making model in daily routine? Up to now, there has been little examination of these factors in this field. METHODS: A medical ethics decision-making model called METAP was introduced on three intensive care units and two geriatric wards. An evaluation study was performed from 7 months after deployment of the project until two and a half years. Quantitative and qualitative methods including a questionnaire, semi-structured face-to-face and group-interviews were used. RESULTS: Sixty-three participants from different professional groups took part in 33 face-to-face and 9 group interviews, and 122 questionnaires could be analysed. The facilitating factors most frequently mentioned were: acceptance and presence of the model, support given by the medical and nursing management, an existing or developing (explicit) ethics culture, perception of a need for a medical ethics decision-making model, and engaged staff members. Lack of presence and acceptance, insufficient time resources and staff, poor inter-professional collaboration, absence of ethical competence, and not recognizing ethical problems were identified as inhibiting the implementation of the METAP model. However, the results of the questionnaire as well as of explicit inquiry showed that the respondents stated to have had enough time and staff available to use METAP if necessary. CONCLUSIONS: Facilitators and barriers of the implementation of a medical ethics decision-making model are quite similar to that of medical guidelines. The planning for implementing an ethics model or guideline can, therefore, benefit from the extensive literature and experience concerning the implementation of medical guidelines. Lack of time and staff can be overcome when people are convinced that the benefits justify the effort.

School-based suicide prevention programmes: the SEYLE cluster-randomised, controlled trial.

BACKGROUND: Suicidal behaviours in adolescents are a major public health problem and evidence-based prevention programmes are greatly needed. We aimed to investigate the efficacy of school-based preventive interventions of suicidal behaviours. METHODS: The Saving and Empowering Young Lives in Europe (SEYLE) study is a multicentre, cluster-randomised controlled trial. The SEYLE sample consisted of 11,110 adolescent pupils, median age 15 years (IQR 14-15), recruited from 168 schools in ten European Union countries. We randomly assigned the schools to one of three interventions or a control group. The interventions were: (1) Question, Persuade, and Refer (QPR), a gatekeeper training module targeting teachers and other school personnel, (2) the Youth Aware of Mental Health Programme (YAM) targeting pupils, and (3) screening by professionals (ProfScreen) with referral of at-risk pupils. Each school was randomly assigned by random number generator to participate in one intervention (or control) group only and was unaware of the interventions undertaken in the other three trial groups. The primary outcome measure was the number of suicide attempt(s) made by 3 month and 12 month follow-up. Analysis included all pupils with data available at each timepoint, excluding those who had ever attempted suicide or who had shown severe suicidal ideation during the 2 weeks before baseline. This study is registered with the German Clinical Trials Registry, number DRKS00000214. FINDINGS: Between Nov 1, 2009, and Dec 14, 2010, 168 schools (11,110 pupils) were randomly assigned to interventions (40 schools [2692 pupils] to QPR, 45 [2721] YAM, 43 [2764] ProfScreen, and 40 [2933] control). No significant differences between intervention groups and the control group were recorded at the 3 month follow-up. At the 12 month follow-up, YAM was associated with a significant reduction of incident suicide attempts (odds ratios [OR] 0·45, 95% CI 0·24-0·85; p=0·014) and severe suicidal ideation (0·50, 0·27-0·92; p=0·025), compared with the control group. 14 pupils (0·70%) reported incident suicide attempts at the 12 month follow-up in the YAM versus 34 (1·51%) in the control group, and 15 pupils (0·75%) reported incident severe suicidal ideation in the YAM group versus 31 (1·37%) in the control group. No participants completed suicide during the study period. INTERPRETATION: YAM was effective in reducing the number of suicide attempts and severe suicidal ideation in school-based adolescents. These findings underline the benefit of this universal suicide preventive intervention in schools. FUNDING: Coordination Theme 1 (Health) of the European Union Seventh Framework Programme.

What keeps oncologists from addressing palliative care early on with incurable cancer patients? An active stance seems key.

BACKGROUND: Sympathetic and frank communication about the terminal nature of advanced cancer is important to improve patients' prognostic understanding and, thereby, to allow for adjustment of treatment intensity to realistic goals; however, decisions against aggressive treatments are often made only when death is imminent. This qualitative study explores the factors that hinder such communication and reconstructs how physicians and nurses in oncology perceive their roles in preparing patients for end-of-life (EOL) decisions. METHODS: Qualitative in-depth interviews were conducted with physicians (n = 12) and nurses (n = 6) working at the Department of Hematology/Oncology at the university hospital in Munich, Germany. The data were analyzed using grounded theory methodology and discussed from a medical ethics perspective. RESULTS: Oncologists reported patients with unrealistic expectations to be a challenge for EOL communication that is especially prominent in comprehensive cancer centers. Oncologists responded to this challenge quite differently by either proactively trying to facilitate advanced care planning or passively leaving the initiative to address preferences for care at the EOL to the patient. A major impediment to the proactive approach was uncertainty about the right timing for EOL discussions and about the balancing the medical evidence against the physician's own subjective emotional involvement and the patient's wishes. CONCLUSION: These findings provide explanations of why EOL communication is often started rather late with cancer patients. For ethical reasons, a proactive stance should be promoted, and oncologists should take on the task of preparing patients for their last phase of life. To do this, more concrete guidance on when to initiate EOL communication is necessary to improve the quality of decision making for advanced cancer patients.

How much dentists are ethically concerned about overtreatment; a vignette-based survey in Switzerland.

BACKGROUND: Overtreatment (or unnecessary treatment) is when medical or dental services are provided with a higher volume or cost than is appropriate. This study aimed to investigate how a group of dentists in Switzerland, a wealthy country known to have high standards of healthcare including dentistry, evaluated the meaning of unnecessary treatments from an ethical perspective and, assessed the expected frequency of different possible behaviors among their peers. METHODS: A vignette describing a situation that is susceptible for overtreatment of a patient was presented to a group of dentists. The vignette was followed by five options. A questionnaire including the vignette was posted to 2482 dentists in the German-speaking areas of Switzerland. The respondents were asked to rate each option according to their estimation about its prevalence and their judgment about the degree to which the behavior is ethically sound. RESULTS: 732 completed questionnaires were returned. According to the responses, the most ethical and the most unethical options are considered to be the most and the least prevalent behaviors among dentists practicing in Switzerland, respectively. CONCLUSIONS: Suggesting unnecessary treatments to patients seems to be an ethically unacceptable conduct in the eyes of a sample of dentists in Switzerland. Although the respondents believed their colleagues were very likely to behave in an ethical way in response to a situation that is susceptible to overtreatment, they still seemed to be concerned about the prevalence of unethical behaviors in this regard.

A right to confidentiality or a duty to disclose? Ethical guidance for conducting prevention research with children and adolescents.

Conducting prevention research with children and adolescents raises ethical challenges especially regarding confidentiality. Research with children and adolescents often applies methodologies which aims at the disclosure of sensitive information about practices that impact on adolescent mental and physical health such as sexual activity, smoking, alcohol consumption, illegal drug use, self-damaging and suicidal behaviour (ideation and attempts). The scope of the article is to review normative documents that cover topics relevant for confidentiality when conducting research with children and adolescents. A systematic literature search in MEDLINE was performed to identify relevant international and European guidelines and codes of ethics that cover health, behavioural and social science research. Additionally, the European Research Ethics website was consulted for double check. However, none of the documents aimed at biomedical, behavioural or social research offers concrete support in resolving practical research ethics problems regarding confidentiality. The codes show a lack of clarity in any circumstances in which the researcher might have an obligation to breach confidentiality by disclosing sensitive information. Only little information is given on what kind of disclosed information, if disclosed, might justify breaching confidentiality. The findings prove a need for normative documents to address the ethical questions regarding confidentiality arising in research practice explicitly and specifically. Moreover, further forms of ethical guidance should be developed to support ethical research with children and adolescents.

The saving and empowering young lives in Europe (SEYLE) randomized controlled trial (RCT): methodological issues and participant characteristics.

BACKGROUND: Mental health problems and risk behaviours among young people are of great public health concern. Consequently, within the VII Framework Programme, the European Commission funded the Saving and Empowering Young Lives in Europe (SEYLE) project. This Randomized Controlled Trial (RCT) was conducted in eleven European countries, with Sweden as the coordinating centre, and was designed to identify an effective way to promote mental health and reduce suicidality and risk taking behaviours among adolescents. OBJECTIVE: To describe the methodological and field procedures in the SEYLE RCT among adolescents, as well as to present the main characteristics of the recruited sample. METHODS: Analyses were conducted to determine: 1) representativeness of study sites compared to respective national data; 2) response rate of schools and pupils, drop-out rates from baseline to 3 and 12 month follow-up, 3) comparability of samples among the four Intervention Arms; 4) properties of the standard scales employed: Beck Depression Inventory, Second Edition (BDI-II), Zung Self-Rating Anxiety Scale (Z-SAS), Strengths and Difficulties Questionnaire (SDQ), World Health Organization Well-Being Scale (WHO-5). RESULTS: Participants at baseline comprised 12,395 adolescents (M/F: 5,529/6,799; mean age=14.9±0.9) from Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain. At the 3 and 12 months follow up, participation rates were 87.3% and 79.4%, respectively. Demographic characteristics of participating sites were found to be reasonably representative of their respective national population. Overall response rate of schools was 67.8%. All scales utilised in the study had good to very good internal reliability, as measured by Cronbach's alpha (BDI-II: 0.864; Z-SAS: 0.805; SDQ: 0.740; WHO-5: 0.799). CONCLUSIONS: SEYLE achieved its objective of recruiting a large representative sample of adolescents within participating European countries. Analysis of SEYLE data will shed light on the effectiveness of important interventions aimed at improving adolescent mental health and well-being, reducing risk-taking and self-destructive behaviour and preventing suicidality. TRIAL REGISTRATION: US National Institute of Health (NIH) clinical trial registry (NCT00906620) and the German Clinical Trials Register (DRKS00000214).

How psychotherapists handle treatment errors -- an ethical analysis.

BACKGROUND: Dealing with errors in psychotherapy is challenging, both ethically and practically. There is almost no empirical research on this topic. We aimed (1) to explore psychotherapists' self-reported ways of dealing with an error made by themselves or by colleagues, and (2) to reconstruct their reasoning according to the two principle-based ethical approaches that are dominant in the ethics discourse of psychotherapy, Beauchamp & Childress (B&C) and Lindsay et al. (L). METHODS: We conducted 30 semi-structured interviews with 30 psychotherapists (physicians and non-physicians) and analysed the transcripts using qualitative content analysis. Answers were deductively categorized according to the two principle-based ethical approaches. RESULTS: Most psychotherapists reported that they preferred to an disclose error to the patient. They justified this by spontaneous intuitions and common values in psychotherapy, rarely using explicit ethical reasoning. The answers were attributed to the following categories with descending frequency: 1. Respect for patient autonomy (B&C; L), 2. Non-maleficence (B&C) and Responsibility (L), 3. Integrity (L), 4. Competence (L) and Beneficence (B&C). CONCLUSIONS: Psychotherapists need specific ethical and communication training to complement and articulate their moral intuitions as a support when disclosing their errors to the patients. Principle-based ethical approaches seem to be useful for clarifying the reasons for disclosure. Further research should help to identify the most effective and acceptable ways of error disclosure in psychotherapy.

Finding their voices again: a media project offers a floor for vulnerable patients, clients and the socially deprived.

'DU bist Radio' (DBR) is an award winning [DBR has been awarded with the "Catholic Media Award of the German Bishops Conference, Prädikat WERTvoll" (2011), the Suisse "Media Prize Aargau/Solothurn" (2010), the German "Alternative Media Award" (2009) and was nominated for the "Prix Europa" (2009)] monthly radio format that goes on air on three Swiss radio stations. The purpose of this program which was first broadcast in 2009 is the development of a new media format which--without applying any journalistic (or other) filter and influence--conveys authenticity of expression amongst society's most vulnerable fellow citizens such as patients, clients and the socially deprived. So-called marginal groups are encouraged to speak for themselves, as a possible paradigm case for encouraging the inclusion of patients' and relatives' "unfiltered" voices in general and in clinical ethics as well. Before handing over the microphone to the groups in focus, a team of journalists, educated in medical ethics, over a period of 4 days, teaches them on-site radio skills and craft. Once this task is completed and the actual production of the broadcast begins, the media crew does not exert any influence whatsoever on the content of the 1-h program. Thus, the final product is solely created and accounted for by the media-inexperienced participants, leading to unforeseen and often surprising results. It is discussed that the DBR approach of fostering authenticity of expression can serve as an enhancement to today's respect and autonomy oriented field of medical ethics.

Maintaining confidentiality in prospective studies: anonymous repeated measurements via email (ARME) procedure.

Respecting and protecting the confidentiality of data and the privacy of individuals regarding the information that they have given as participants in a research project is a cornerstone of complying with accepted research standards. However, in longitudinal studies, establishing and maintaining privacy is often challenging because of the necessity of repeated contact with participants. A novel internet-based solution is introduced here, which maintains privacy while at the same time ensures linkage of data to individual participants in a repeated measures design. With the use of the anonymous repeated measurements via email (ARME) procedure, two separate one-way communication systems are established through ad hoc email accounts and a secure study website. Strengths and limitations of the approach are discussed.

Evidence - competence - discourse: the theoretical framework of the multi-centre clinical ethics support project METAP.

In this paper we assume that 'theory' is important for Clinical Ethics Support Services (CESS). We will argue that the underlying implicit theory should be reflected. Moreover, we suggest that the theoretical components on which any clinical ethics support (CES) relies should be explicitly articulated in order to enhance the quality of CES. A theoretical framework appropriate for CES will be necessarily complex and should include ethical (both descriptive and normative), metaethical and organizational components. The various forms of CES that exist in North-America and in Europe show their underlying theory more or less explicitly, with most of them referring to some kind of theoretical components including 'how-to' questions (methodology), organizational issues (implementation), problem analysis (phenomenology or typology of problems), and related ethical issues such as end-of-life decisions (major ethical topics). In order to illustrate and explain the theoretical framework that we are suggesting for our own CES project METAP, we will outline this project which has been established in a multi-centre context in several healthcare institutions. We conceptualize three 'pillars' as the major components of our theoretical framework: (1) evidence, (2) competence, and (3) discourse. As a whole, the framework is aimed at developing a foundation of our CES project METAP. We conclude that this specific integration of theoretical components is a promising model for the fruitful further development of CES.

Avoiding bias in medical ethical decision-making. Lessons to be learnt from psychology research.

When ethical decisions have to be taken in critical, complex medical situations, they often involve decisions that set the course for or against life-sustaining treatments. Therefore the decisions have far-reaching consequences for the patients, their relatives, and often for the clinical staff. Although the rich psychology literature provides evidence that reasoning may be affected by undesired influences that may undermine the quality of the decision outcome, not much attention has been given to this phenomenon in health care or ethics consultation. In this paper, we aim to contribute to the sensitization of the problem of systematic reasoning biases by showing how exemplary individual and group biases can affect the quality of decision-making on an individual and group level. We are addressing clinical ethicists as well as clinicians who guide complex decision-making processes of ethical significance. Knowledge regarding exemplary group psychological biases (e.g. conformity bias), and individual biases (e.g. stereotypes), will be taken from the disciplines of social psychology and cognitive decision science and considered in the field of ethical decision-making. Finally we discuss the influence of intuitive versus analytical (systematical) reasoning on the validity of ethical decision-making.

Institutional challenges for clinical ethics committees.

Clinical ethics committees (CECs) have been developing in many countries since the 1980s, more recently in the transitional countries in Eastern Europe. With their increasing profile they are now faced with a range of questions and challenges regarding their position within the health care organizations in which they are situated: Should CECs be independent bodies with a critical role towards institutional management, or should they be an integral part of the hospital organization? In this paper, we discuss the organizational context in which CECs function in Europe focusing on five aspects. We conclude that in Europe clinical ethics committees need to maintain a critical independence while generating acceptance of the CEC and its potential benefit to both individuals and the organization. CECs, perhaps particularly in transitional countries, must counter the charge of "alibi ethics". CECs must define their contribution to in-house quality management in their respective health care organization, clarifying how ethical reflection on various levels serves the hospital and patient care in general. This last challenge is made more difficult by lack of consensus about appropriate quality outcomes for CECs internationally. These are daunting challenges, but the fact that CECs continue to develop suggests that we should make the effort to overcome them. We believe there is a need for further research that specifically addresses some of the institutional challenges facing CECs.

Weekly Internal Ethical Case Discussions in an ICU-Results Based on 9 Years of Experience With a Highly Structured Approach.

OBJECTIVES: Various ethical challenges are prevalent in ICUs. In order to handle these problems, a highly structured internal ethical case discussion within the multiprofessional team was implemented in 2011 in a Swiss ICU and has been regularly practiced almost weekly until present. To explore the results of all ethical case discussions taking place in a general ICU and to discuss the outcomes of the patients. To identify the conditions facilitating the implementation of regular ethical case discussions. DESIGN: Retrospective case series analysis. SETTING: Mixed academic ICU. PATIENTS AND INTERVENTION: All patients who had an ethical case discussion between January 2011 and December 2019 following the approach called Modular, Ethical, Treatment decisions, Allocation of resources at the micro-level, and Process. MEASUREMENTS AND MAIN RESULTS: Weekly ethical case discussions held regularly on a fixed date were found to be practical for the observed ICU. A total of 314 ethical case discussions were realized in 281 patients. Median patient age was 70 years (interquartile range, 62-77 yr); two thirds were men. The results were categorized into the following groups: established therapy continues, complications to be treated (n = 53; 16.9%); therapy continues, patient's will to be explored further (n = 77; 24.5%); therapy continues, complications to be treated only after evaluation (n = 62; 19.7%); therapy continues with limitations (e.g., do-not-resuscitate order) (n = 98; 31.2%); and change of treatment plan to end-of-life care (n = 17; 5.4%). Of the discussed patients, 115 (40.9%) died in the ICU and 29 (10.3%) after transfer to the normal ward. Seven patients (2.5%) were transferred to a hospice and 55 (19.6%) to another hospital. Sixty-nine (24.6%) were discharged to a rehabilitative facility and six returned home. CONCLUSIONS: Regular ethical case discussions can be successfully implemented, enabling careful review of the patient's will and balancing it with the prognosis of the disease. This facilitates a necessary change of the therapeutic goal whenever appropriate.

EAES recommendations on methodology of innovation management in endoscopic surgery.

BACKGROUND: Under the mandate of the European Association for Endoscopic Surgery (EAES) a guideline on methodology of innovation management in endoscopic surgery has been developed. The primary focus of this guideline is patient safety, efficacy, and effectiveness. METHODS: An international expert panel was invited to develop recommendations for the assessment and introduction of surgical innovations. A consensus development conference (CDC) took place in May 2009 using the method of a nominal group process (NGP). The recommendations were presented at the annual EAES congress in Prague, Czech Republic, on June 18th, 2009 for discussion and further input. After further Delphi processes between the experts, the final recommendations were agreed upon. RESULTS: The development and implementation of innovations in surgery are addressed in five sections: (1) definition of an innovation, (2) preclinical and (3) clinical scientific development, (4) scientific approval, and (5) implementation along with monitoring. Within the present guideline each of the sections and several steps are defined, and several recommendations based on available evidence have been agreed within each category. A comprehensive workflow of the different steps is given in an algorithm. In addition, issues of health technology assessment (HTA) serving to estimate efficiency followed by ethical directives are given. CONCLUSIONS: Innovations into clinical practice should be introduced with the highest possible grade of safety for the patient (nil nocere: do no harm). The recommendations can contribute to the attainment of this objective without preventing future promising diagnostic and therapeutic innovations in the field of surgery and allied techniques.

Saving and empowering young lives in Europe (SEYLE): a randomized controlled trial.

BACKGROUND: There have been only a few reports illustrating the moderate effectiveness of suicide-preventive interventions in reducing suicidal behavior, and, in most of those studies, the target populations were primarily adults, whereas few focused on adolescents. Essentially, there have been no randomized controlled studies comparing the efficacy, cost-effectiveness and cultural adaptability of suicide-prevention strategies in schools. There is also a lack of information on whether suicide-preventive interventions can, in addition to preventing suicide, reduce risk behaviors and promote healthier ones as well as improve young people's mental health.The aim of the SEYLE project, which is funded by the European Union under the Seventh Framework Health Program, is to address these issues by collecting baseline and follow-up data on health and well-being among European adolescents and compiling an epidemiological database; testing, in a randomized controlled trial, three different suicide-preventive interventions; evaluating the outcome of each intervention in comparison with a control group from a multidisciplinary perspective; as well as recommending culturally adjusted models for promoting mental health and preventing suicidal behaviors. METHODS AND DESIGN: The study comprises 11,000 adolescents emitted from randomized schools in 11 European countries: Austria, Estonia, France, Germany, Hungary, Ireland, Israel, Italy, Romania, Slovenia and Spain, with Sweden serving as the scientific coordinating center. Each country performs three active interventions and one minimal intervention as a control group. The active interventions include gatekeeper training (QPR), awareness training on mental health promotion for adolescents, and screening for at-risk adolescents by health professionals. Structured questionnaires are utilized at baseline, 3- and 12-month follow-ups in order to assess changes. DISCUSSION: Although it has been reported that suicide-preventive interventions can be effective in decreasing suicidal behavior, well-documented and randomized studies are lacking. The effects of such interventions in terms of combating unhealthy lifestyles in young people, which often characterize suicidal individuals, have never been reported. We know that unhealthy and risk-taking behaviors are detrimental to individuals' current and future health. It is, therefore, crucial to test well-designed, longitudinal mental health-promoting and suicide-preventive interventions by evaluating the implications of such activities for reducing unhealthy and risk behaviors while concurrently promoting healthy ones. TRIAL REGISTRATION: The German Clinical Trials Register, DRKS00000214.