Evaluating a clinical ethics committee (CEC) implementation process in an oncological research hospital: protocol for a process evaluation study using normalisation process theory (EvaCEC).

INTRODUCTION: A Clinical Ethics Committee (CEC) is a multi-professional service whose aim is to support healthcare professionals (HPs) and healthcare organisations to deal with the ethical issues of clinical practice.Although CEC are quite common worldwide, their successful implementation in a hospital setting presents many challenges.EVAluating a Clinical Ethics Committee implementation process (EvaCEC) will evaluate the implementation of a CEC in a comprehensive cancer centre in Northern Italy 16 months after its establishment. METHODS AND ANALYSIS: EvaCEC is a mixed-method study with a retrospective quantitative analysis and a prospective qualitative evaluation by a range of data collection tools to enable the triangulation of data sources and analysis. Quantitative data related to the amount of CEC activities will be collected using the CEC's internal databases. Data on the level of knowledge, use and perception of the CEC will be collected through a survey with closed-ended questions disseminated among all the HPs employed at the healthcare centre. Data will be analysed with descriptive statistics.The Normalisation Process Theory (NPT) will be used for the qualitative evaluation to determine whether and how the CEC can be successfully integrated into clinical practice. We will perform one-to-one semistructured interviews and a second online survey with different groups of stakeholders who had different roles in the implementation process of the CEC. Based on NPT concepts, the interviews and the survey will assess the acceptability of the CEC within the local context and needs and expectations to further develop the service. ETHICS AND DISSEMINATION: The protocol has been approved by the local ethics committee. The project is co-chaired by a PhD candidate and by a healthcare researcher with a doctorate in bioethics and expertise in research. Findings will be disseminated widely through peer-reviewed publications, conferences and workshops. TRIAL REGISTRATION NUMBER: NCT05466292.

Perinatal bereavement and palliative care offered throughout the healthcare system.

The aims of this article are twofold: (I) provide a general overview of perinatal bereavement services throughout the healthcare system and (II) identify future opportunities to improve bereavement services, including providing resources for the creation of standardized care guidelines, policies and educational opportunities across the healthcare system. Commentary is provided related to maternal child services, the neonatal intensive care unit (NICU), prenatal clinics, operating room (OR) and perioperative services, emergency department (ED), ethics, chaplaincy and palliative care services. An integrated system of care increases quality and safety and contributes to patient satisfaction. Physicians, nurses and administrators must encourage pregnancy loss support so that regardless of where in the facility the contact is made, when in the pregnancy the loss occurs, or whatever the conditions contributing to the pregnancy ending, trained caregivers are there to provide bereavement support for the family and palliative symptom management to the fetus born with a life limiting condition. The goal for respectful caregiving throughout an entire hospital system is achievable and critically important.

The impact of an exercise training intervention on cortisol levels and post-traumatic stress disorder in juveniles from an Ugandan refugee settlement: study protocol for a randomized control trial.

BACKGROUND: Latest research demonstrates a significant improvement in stress-related symptoms in psychological disorders as a result of exercise training (ET). Controlled clinical trials further validate the significance of ET by demonstrating lower salivary cortisol levels in patients with post-traumatic stress disorder (PTSD) after intervention. A significant change in cortisol and dehydroepiandrosterone (DHEA) levels can already be found after an 8-12-week ET program. The proposed study aims to investigate the impact of an 8-week ET on PTSD symptoms and changes in cortisol levels in a juvenile refugee sample from the Democratic Republic of the Congo (DRC) at an Ugandan refugee settlement. It is the first to implement an ET intervention in a resource-poor, post-conflict setting. METHODS/DESIGN: In a randomized controlled trial, 198 adolescent participants aged 13-16 years from the DRC who, suffer from PTSD, will be investigated. The participants are based at the Nakivale refugee settlement, an official refugee camp in Uganda, Africa, which is among the largest in the world. The participants will be randomized into an Exercise Training (ET) group with a maximum heart rate (HRmax) of > 60%, an Alternative Intervention (AI) group with low-level exercises, and a Waiting-list Control (WC) group. After the 8-week interventional phase, changes in cortisol awakening response (CAR) and DHEA in the ET group that correspond to an improvement in PTSD symptoms are expected that remain at follow-up after 3 months. DISCUSSION: To date, there is no controlled and reliable longitudinal study examining the effects of an ET program on symptom severity in individuals with PTSD that can be explained with a harmonization of cortisol secretion. The presented study design introduces an intervention that can be implemented with little expenditure. It aims to provide a promising low-threshold and cost-effective treatment approach for the application in resource-poor settings. TRIAL REGISTRATION: German Trials Register, ID: DRKS00014280 . Registered prospectively on 15 March 2018.

[Bioethics in medical institutions--new custom or help? The example of clinical ethics consultation at a University Medical Center]. / Bioethik in medizinischen Institutionen--Mode oder Hilfe? Das Beispiel der klinischen Ethikberatung eines Universitätsklinikums.

Although ethics committees are well established in the medical sciences for human clinical trials, animal research and scientific integrity, the development of clinical ethics in German hospitals started much later during the first decade of the twenty-first century. Clinical ethics consultation should be pragmatic and problem-centered and can be defined as an ethically qualified and informed conflict management within a given legal framework to deal with and resolve value-driven, normative problems in the care of patients. Clinical ethics consultations enable shared clinical decision-making of all parties (e.g. clinicians, patients, family and surrogates) involved in a particular patient's care. The clinical ethicist does not act as an ethics expert by making independent recommendations or decisions; therefore, the focus is different from other medical consultants. Ethics consultation was first established by healthcare ethics committees (HEC) or clinical ethics consultation (CEC) groups which were called in to respond to an ethically problematic situation. To avoid ethical dilemmas or crises and to act preventively with regard to ethical issues in individual patients, an ethics liaison service is an additional option to ethics case consultations which take place on a regular basis by scheduled ethics rounds during the normal ward rounds. The presence of the ethicist offers some unique advantages: it allows early recognition of even minor ethical problems and accommodates the dynamics of ethical and clinical goal-setting in the course of patient care. Most importantly, regular and non-authoritative participation of the ethicist in normal ward rounds allows continuous ethical education of the staff within the everyday clinical routine. By facilitating clinical ethical decision-making, the ethicist seeks to empower physicians and medical staff to deal appropriately with ethical problems by themselves. Because of this proactive approach, the ethics liaison service can make a significant contribution to preventative ethics in reducing the number of emerging ethical problems to the satisfaction of all parties involved.

Training in clinical ethics: launching the clinical ethics immersion course at the Center for Ethics at the Washington Hospital Center.

In May 2011, the clinical ethics group of the Center for Ethics at Washington Hospital Center launched a 40-hour, three and one-half day Clinical Ethics Immersion Course. Created to address gaps in training in the practice of clinical ethics, the course is for those who now practice clinical ethics and for those who teach bioethics but who do not, or who rarely, have the opportunity to be in a clinical setting. "Immersion" refers to a high-intensity clinical ethics experience in a busy, urban, acute care hospital. During the Immersion Course, participants join clinical ethicists on working rounds in intensive care units and trauma service. Participants engage in a videotaped role-play conversation with an actor. Each simulated session reflects a practical, realistic clinical ethics case consultation scenario. Participants also review patients' charts, and have small group discussions on selected clinical ethics topics. As ethics consultation requests come into the center, Immersion Course participants accompany clinical ethicists on consultations. Specific to this pilot, because participants' evaluations and course faculty impressions were positive, the Center for Ethics will conduct the course twice each year. We look forward to improving the pilot and establishing the Immersion Course as one step towards addressing the gap in training opportunities in clinical ethics.

Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

OBJECTIVE: To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. METHODS: A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). RESULTS: In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). CONCLUSION: Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers.

Using active simulation to enhance learning of nursing ethics.

Ethical decision making in health care is a complex issue that requires nurses to critically think about situations. Active simulation through the use of role-play was used as a teaching strategy for education on ethics. Participants served in various roles in simulations that encouraged nurses to examine their thoughts and feelings and use ethical decision-making models.

Experiential ethics education: one successful model of ethics education for undergraduate nursing students in the United States.

Lachman, Grace and Gaylord have argued that for bioethics education for undergraduate nursing students, a preferred combination of instruction involves a clinically-based nurse with ethics training and a philosophically-based ethicist with clinical training. At the University of Pennsylvania School of Nursing, undergraduate nursing ethics instruction takes this form. The course director is a philosopher with extensive clinical experience in ethics. The course utilises four distinct forms of nursing clinical inputs to educate undergraduate nursing students using a unique combination of didactic and experiential learning exercises to simulate real ethics cases. This paper describes how the course was developed and refined over the past several years and suggests several ideas for improvements in nursing ethics education at an undergraduate level.

Clinical bioethics integration, sustainability, and accountability: the Hub and Spokes Strategy.

The "lone" clinical bioethicist working in a large, multisite hospital faces considerable challenges. While attempting to build ethics capacity and sustain a demanding range of responsibilities, he or she must also achieve an acceptable level of integration, sustainability, and accountability within a complex organisational structure. In an effort to address such inherent demands and to create a platform towards better evaluation and effectiveness, the Clinical Ethics Group at the Joint Centre for Bioethics at the University of Toronto is implementing the Hub and Spokes Strategy at seven hospitals. The goal of the Hub and Spokes Strategy is to foster an ethical climate and strengthen ethics capacity broadly throughout healthcare settings as well as create models in clinical bioethics that are excellent and effective.

Psychosurgery: past, present, and future.

Psychosurgery, the neurosurgical treatment of psychiatric disease, has a history dating back to antiquity, and involves all of the clinical neurosciences. This review discusses the history of psychosurgery, its development in the 19th century, and the conditions of its use and abuse in the 20th century, with a particular focus on the frontal lobotomy. The transition to the modern era of psychosurgery is discussed, as well as the neurobiology underlying current psychosurgical procedures. The techniques of stereotactic cingulotomy, capsulotomy, subcaudate tractotomy, and limbic leukotomy are described, as well their indications and side effects. Due to the past abuse of psychosurgery, procedures are currently under strict control, and the example of the Cingulotomy Committee at the Massachusetts General Hospital is discussed. Finally, future directions of psychosurgery and somatic therapies are explored, including transcranial magnetic stimulation, vagal nerve stimulation, deep brain stimulation, gene therapy, and stem cell therapy. In summary, this review provides a concise yet comprehensive introduction to the history, current practice, and future trends of neurosurgery for psychiatric disorders.

Health professionals' views on standards for decision-making capacity regarding refusal of medical treatment in mild Alzheimer's disease.

This study was designed to determine which elements professionals consider important for evaluation of decision-making capacity. Survey with a vignette case report of an individual with mild dementia was mailed to four groups of individuals: 1. members of the Academy of Psychosomatic Medicine, 2. chairs of Veterans Affairs (VA) Ethics Advisory Committees (EACs), 3. randomly selected geriatricians who were members of the Gerontological Society of America (GSA), and 4. randomly selected psychologists who were members of the GSA. Two hundred thirty-seven psychiatrists, 95 VA EAC chairs, 103 geriatricians, and 46 psychologists responded to this survey. The majority of the respondents endorsed all five basic elements as necessary for determination of decision-making capacity in the presented vignette, but only a minority of respondents endorsed all five basic elements, and a small proportion of respondents endorsed only one or two elements. The results indicate that physicians do not use uniform standards for assessment of decision-making capacity.

End-of-life care in patients with lung cancer.

Evidence-based practice guidelines for end-of-life care for patients with lung cancer have been previously available only from the British health-care system. Currently in this setting, there has been increasing concern in attaining control of the physical, psychological, social, and spiritual distress of the patient and family. This American College of Chest Physicians'-sponsored multidisciplinary panel has generated recommendations for improving quality of life after examining the English-language literature for answers to some of the most important questions in end-of-life care. Communication between the doctor, patient, and family is central to the active total care of patients with disease that is not responsive to curative treatment. The advance care directive, which has been slowly evolving and is presently limited in application and often circumstantially ineffective, better protects patient autonomy. The problem-solving capability of the hospital ethics committee has been poorly utilized, often due to a lack of understanding of its composition and function. Cost considerations and a sense of futility have confused caregivers as to the potentially important role of the critical care specialist in this scenario. Symptomatic and supportive care provided in a timely and consistent fashion in the hospice environment, which treats the patient and family at home, has been increasingly used, and at this time is the best model for end-of-life care in the United States.

Working toward peace in the clinical setting: the role of clinical ethics in conflict resolution.

Ethics consultants or committees are often called into situations of conflict. What is their role in conflict resolution? What process should they use? What standards should they apply? The methods of alternative dispute resolution (negotiation, mediation and arbitration) provide a useful model for analysis of procedure, though they may not adequately describe all ethics consultations. Boundaries of acceptable standards may be gleaned from the precepts of medical ethics as well as from statutory and case law. In addition, the believer may obtain guidance from Scripture and prayer.