Variations in reporting of nurse involvement in end-of-life practices in intensive care units worldwide (ETHICUS-2): A prospective observational study.

BACKGROUND: ICU nurses are most frequently at the patient's bedside, providing care for both patients and family members. They perform an essential role and are involved in decision-making. Despite this, research suggests that nurses have a limited role in the end-of-life decision-making process and are occasionally not involved. OBJECTIVE: Explore global ICU nurse involvement in end of life decisions based on the physician's perceptions and sub-analyses from the ETHICUS-2 study. DESIGN: This is a secondary analysis of a prospective multinational, observational study of the ETHICUS-2 study. SETTING: End of life decision-making processes in ICU patients were studied during a 6-month period between Sept 1, 2015, and Sept 30, 2016, in 199 ICUs in 36 countries. INTERVENTION: None. METHODS: The ETHICUS II study instrument contained 20 questions. This sub-analysis addressed the four questions related to nurse involvement in end-of-life decision-making: Who initiated the end-of-life discussion? Was withholding or withdrawing treatment discussed with nurses? Was a nurse involved in making the end-of-life decision? Was there agreement between physicians and nurses? These 4 questions are the basis for our analysis. Global regions were compared. RESULTS: Physicians completed 91.8 % of the data entry. A statistically significant difference was found between regions (p < 0.001) with Northern Europe and Australia/New Zealand having the most discussion with nurses and Latin America, Africa, Asia and North America the least. The percentages of end-of-life decisions in which nurses were involved ranged between 3 and 44 %. These differences were statistically significant. Agreement between physicians and nurses related to decisions resulted in a wide range of responses (27-86 %) (p < 0.001). There was a wide range of those who replied "not applicable" to the question of agreement between physicians and nurses on EOL decisions (0-41 %). CONCLUSION: There is large variability in nurse involvement in end-of-life decision-making in the ICU. The most concerning findings were that in some regions, according to physicians, nurses were not involved in EOL decisions and did not initiate the decision-making process. There is a need to develop the collaboration between nurses and physicians. Nurses have valuable contributions for best possible patient-centered decisions and should be respected as important parts of the interdisciplinary team. TWEETABLE ABSTRACT: Wide global differences were found in nurse end of life decision involvement, with low involvement in North and South America and Africa and higher involvement in Europe and Australia/New Zealand.

Global Comparison of Communication of End-of-Life Decisions in the ICU.

BACKGROUND: Prolonging life in the ICU increasingly is possible, so decisions to limit life-sustaining therapies frequently are made and communicated to patients and families or surrogates. Little is known about worldwide communication practices and influencing factors. RESEARCH QUESTION: Are there regional differences in end-of-life communication practices in ICUs worldwide? STUDY DESIGN AND METHODS: This analysis of data from a prospective, international study specifically addressed end-of-life communications in consecutive patients who died or had limitation of life-sustaining therapy over 6 months in 199 ICUs in 36 countries, grouped regionally. End-of-life decisions were recorded for each patient and ethical practice was assessed retrospectively for each ICU using a 12-point questionnaire developed previously. RESULTS: Of 87,951 patients admitted, 12,850 died or experienced a limitation of therapy (14.6%). Of these, 1,199 patients (9.3%) were known to have an advance directive, and wishes were elicited from 6,456 patients (50.2%). Limitations of life-sustaining therapy were implemented for 10,401 patients (80.9%), 1,970 (19.1%) of whom had mental capacity at the time, and were discussed with 1,507 patients (14.5%) and 8,461 families (81.3%). Where no discussions with patients occurred (n = 8,710), this primarily was because of a lack of mental capacity in 8,114 patients (93.2%), and where none occurred with families (n = 1,622), this primarily was because of unavailability (n = 720 [44.4%]). Regional variation was noted for all end points. In generalized estimating equation (GEE) analyses, the odds for discussions with the patient or family increased by 30% (OR, 1.30; 95% CI, 1.18-1.44; P < .001) for every one-point increase in the Ethical Practice Score and by 92% (OR, 1.92; 95% CI, 1.28-2.89; P = .002) in the presence of an advance directive. INTERPRETATION: End-of-life communication with patients and families or surrogates varies markedly in different global regions. GEE analysis supports the hypothesis that communication may increase with ethical practice and an advance directive. Greater effort is needed to align treatment with patients' wishes.

Changes in intensive care unit nurse involvement in end of life decision making between 1999 and 2016: Descriptive comparative study.

OBJECTIVE: Comparison of nurse involvement in end of life decision making in European countries participating in ETHICUS I- 1999 and ETHICUS II- 2015. METHODOLOGY: This was a prospective observational study of 22 European ICUs included in the ETHICUS-II and I. Data were collected as per the ETHICUS-I and ETHICUS-II protocols. Four questions within the ETHICUS protocols related to nurse involvement in end of life decision making were analyzed. This is a comparison of changes in nurse involvement in end of life decisions from 1999 to 2015. SETTING: International e-based questionnaire completed by an intensive care clinician when an end of life decision was performed on any patient. SUBJECTS: Intensive care physicians and nurses, no interventions were performed. MEASUREMENTS: A 20 question survey was used to describe the decision making process, on what basis was the decision made, who was involved in the decision making process, and what precise decisions were made. RESULTS: A total of 4592 cases from 22 centres are included. While there was more agreement between nurses and physicians in ETHICUS-I compared to ETHICUS-I, fewer discussions with nurses occurred in ETHICUS-II. The frequency of end of life decisions that were discussed with nurses decreased in all three regions between ETHICUS-I and ETHICUS-II. CONCLUSION: Based on the results of the current study, nurses should be further encouraged to increase their involvement in end of life decision-making, especially those in southern Europe.

Variations in end-of-life practices in intensive care units worldwide (Ethicus-2): a prospective observational study.

BACKGROUND: End-of-life practices vary among intensive care units (ICUs) worldwide. Differences can result in variable use of disproportionate or non-beneficial life-sustaining interventions across diverse world regions. This study investigated global disparities in end-of-life practices. METHODS: In this prospective, multinational, observational study, consecutive adult ICU patients who died or had a limitation of life-sustaining treatment (withholding or withdrawing life-sustaining therapy and active shortening of the dying process) during a 6-month period between Sept 1, 2015, and Sept 30, 2016, were recruited from 199 ICUs in 36 countries. The primary outcome was the end-of-life practice as defined by the end-of-life categories: withholding or withdrawing life-sustaining therapy, active shortening of the dying process, or failed cardiopulmonary resuscitation (CPR). Patients with brain death were included in a separate predefined end-of-life category. Data collection included patient characteristics, diagnoses, end-of-life decisions and their timing related to admission and discharge, or death, with comparisons across different regions. Patients were studied until death or 2 months from the first limitation decision. FINDINGS: Of 87 951 patients admitted to ICU, 12 850 (14·6%) were included in the study population. The number of patients categorised into each of the different end-of-life categories were significantly different for each region (p<0·001). Limitation of life-sustaining treatment occurred in 10 401 patients (11·8% of 87 951 ICU admissions and 80·9% of 12 850 in the study population). The most common limitation was withholding life-sustaining treatment (5661 [44·1%]), followed by withdrawing life-sustaining treatment (4680 [36·4%]). More treatment withdrawing was observed in Northern Europe (1217 [52·8%] of 2305) and Australia/New Zealand (247 [45·7%] of 541) than in Latin America (33 [5·8%] of 571) and Africa (21 [13·0%] of 162). Shortening of the dying process was uncommon across all regions (60 [0·5%]). One in five patients with treatment limitations survived hospitalisation. Death due to failed CPR occurred in 1799 (14%) of the study population, and brain death occurred in 650 (5·1%). Failure of CPR occurred less frequently in Northern Europe (85 [3·7%] of 2305), Australia/New Zealand (23 [4·3%] of 541), and North America (78 [8·5%] of 918) than in Africa (106 [65·4%] of 162), Latin America (160 [28·0%] of 571), and Southern Europe (590 [22·5%] of 2622). Factors associated with treatment limitations were region, age, and diagnoses (acute and chronic), and country end-of-life legislation. INTERPRETATION: Limitation of life-sustaining therapies is common worldwide with regional variability. Withholding treatment is more common than withdrawing treatment. Variations in type, frequency, and timing of end-of-life decisions were observed. Recognising regional differences and the reasons behind these differences might help improve end-of-life care worldwide. FUNDING: None.

Inter-physician variability in strategies linked to treatment limitations after severe traumatic brain injury; proactivity or wait-and-see.

BACKGROUND: Prognostic uncertainty is a challenge for physicians in the neuro intensive care field. Questions about whether continued life-sustaining treatment is in a patient's best interests arise in different phases after a severe traumatic brain injury. In-depth information about how physicians deal with ethical issues in different contexts is lacking. The purpose of this study was to seek insight into clinicians' strategies concerning unresolved prognostic uncertainty and their ethical reasoning on the issue of limitation of life-sustaining treatment in patients with minimal or no signs of neurological improvement after severe traumatic brain injury in the later trauma hospital phase. METHODS: Interviews with 18 physicians working in a neurointensive care unit in a large Norwegian trauma hospital, followed by a qualitative thematic analysis focused on physicians' strategies related to treatment-limiting decision-making. RESULTS: A divide between proactive and wait-and-see strategies emerged. Notwithstanding the hospital's strong team culture, inter-physician variability with regard to ethical reasoning and preferred strategies was exposed. All the physicians emphasized the importance of team-family interactions. Nevertheless, their strategies differed: (1) The proactive physicians were open to consider limitations of life-sustaining treatment when the prognosis was grim. They initiated ethical discussions, took leadership in clarification and deliberation processes regarding goals and options, saw themselves as guides for the families and believed in the necessity to prepare families for both best-case and worst-case scenarios. (2) The "wait-and-see" physicians preferred open-ended treatment (no limitations). Neurologically injured patients need time to uncover their true recovery potential, they argued. They often avoided talking to the family about dying or other worst-case scenarios during this phase. CONCLUSIONS: Depending on the individual physician in charge, ethical issues may rest unresolved or not addressed in the later trauma hospital phase. Nevertheless, team collaboration serves to mitigate inter-physician variability. There are problems and pitfalls to be aware of related to both proactive and wait-and-see approaches. The timing of best-interest discussions and treatment-limiting decisions remain challenging after severe traumatic brain injury. Routines for timely and open discussions with families about the range of ethically reasonable options need to be strengthened.

Back to WHAT? The role of research ethics in pandemic times.

The Covid-19 pandemic creates an unprecedented threatening situation worldwide with an urgent need for critical reflection and new knowledge production, but also a need for imminent action despite prevailing knowledge gaps and multilevel uncertainty. With regard to the role of research ethics in these pandemic times some argue in favor of exceptionalism, others, including the authors of this paper, emphasize the urgent need to remain committed to core ethical principles and fundamental human rights obligations all reflected in research regulations and guidelines carefully crafted over time. In this paper we disentangle some of the arguments put forward in the ongoing debate about Covid-19 human challenge studies (CHIs) and the concomitant role of health-related research ethics in pandemic times. We suggest it might be helpful to think through a lens differentiating between risk, strict uncertainty and ignorance. We provide some examples of lessons learned by harm done in the name of research in the past and discuss the relevance of this legacy in the current situation.

Barriers and challenges in the process of including critically ill patients in clinical studies.

BACKGROUND: Clinical research in severely ill or injured patients is required to improve healthcare but may be challenging to perform in practice. The aim of this study was to analyse barriers and challenges in the process of including critically ill patients in clinical studies. METHODS: Data from critically ill patients considered for inclusion in an observational study of venous thromboembolism in Norway were analysed. This included quantitative and qualitative information from the screening log, consent forms and research notes. RESULTS: Among 279 eligible critically ill patients, 204 (73%) were omitted from the study due to challenges and barriers in the inclusion process. Reasons for omission were categorised as practical in 133 (65%), medical in 31 (15%), and legal or ethical in 40 (20%) of the patients. Among 70 included patients, 29 (41%) consents were from patients and 41 (59%) from their next of kin. Several challenges were described herein; these included whether patients were competent to give consent, and which next of kin that should represent the patient. Furthermore, some included patients were unable to recall what they have consented, and some appeared unable to separate research from treatment. CONCLUSIONS: Barriers and challenges in the inclusion process led to the omission of near three out of four eligible patients. This analysis provided information about where the problem resides and may be solved. The majority of challenges among included patients were related to issues of autonomy and validity of consent. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03405766).

Framework to Support the Process of Decision-Making on Life-Sustaining Treatments in the ICU: Results of a Delphi Study.

OBJECTIVES: To develop a consensus framework that can guide the process of decision-making on continuing or limiting life-sustaining treatments in ICU patients, using evidence-based items, supported by caregivers, patients, and surrogate decision makers from multiple countries. DESIGN: A three-round web-based international Delphi consensus study with a priori consensus definition was conducted with experts from 13 countries. Participants reviewed items of the decision-making process on a seven-point Likert scale or with open-ended questions. Questions concerned terminology, content, and timing of decision-making steps. The summarized results (including mean scores) and expert suggestions were presented in the subsequent round for review. SETTING: Web-based surveys of international participants representing ICU physicians, nurses, former ICU patients, and surrogate decision makers. PATIENTS: Not applicable. INTERVENTIONS: Not applicable. MEASUREMENTS AND MAIN RESULTS: In three rounds, respectively, 28, 28, and 27 (of 33 invited) physicians together with 12, 10, and seven (of 19 invited) nurses participated. Patients and surrogates were involved in round one and 12 of 27 responded. Caregivers were mostly working in university affiliated hospitals in Northern Europe. During the Delphi process, most items were modified in order to reach consensus. Seven items lacked consensus after three rounds. The final consensus framework comprises the content and timing of four elements; three elements focused on caregiver-surrogate communication (admission meeting, follow-up meeting, goals-of-care meeting); and one element (weekly time-out meeting) focused on assessing preferences, prognosis, and proportionality of ICU treatment among professionals. CONCLUSIONS: Physicians, nurses, patients, and surrogates generated a consensus-based framework to guide the process of decision-making on continuing or limiting life-sustaining treatments in the ICU. Early, frequent, and scheduled family meetings combined with a repeated multidisciplinary time-out meeting may support decisions in relation to patient preferences, prognosis, and proportionality.

Neurocritical care physicians' doubt about whether to withdraw life-sustaining treatment the first days after devastating brain injury: an interview study.

BACKGROUND: Multilevel uncertainty exists in the treatment of devastating brain injury and variation in end-of-life decision-making is a concern. Cognitive and emotional doubt linked to making challenging decisions have not received much attention. The aim of this study was to explore physicians´ doubt related to decisions to withhold or withdraw life-sustaining treatment within the first 72 h after devastating brain injury and to identify the strategies used to address doubt. METHOD: Semi-structured interviews were conducted with 18 neurocritical care physicians in a Norwegian trauma centre (neurosurgeons, intensivists and rehabilitation specialists) followed by a qualitative thematic analysis. RESULT: All physicians described feelings of doubt. The degree of doubt and how they dealt with it varied. Institutional culture, ethics climate and individual physicians´ values, experiences and emotions seemed to impact judgements and decisions. Common strategies applied by physicians across specialities when dealing with uncertainty and doubt were: 1. Provision of treatment trials 2. Using time as a coping strategy 3. Collegial counselling and interdisciplinary consensus seeking 4. Framing decisions as purely medical. CONCLUSION: Decisions regarding life-sustaining treatment after devastating brain injury are crafted in a stepwise manner. Feelings of doubt are frequent and seem to be linked to the recognition of fallibility. Doubt can be seen as positive and can foster open-mindedness towards the view of others, which is one of the prerequisites for a good ethical climate. Doubt in this context tends to be mitigated by open interdisciplinary discussions acknowledging doubt as rational and a normal feature of complex decision-making.

Treatment-limiting decisions in patients with severe traumatic brain injury in a Norwegian regional trauma center.

BACKGROUND: Treatment-limiting decisions (TLD) for severe traumatic brain injury (sTBI) have been sparsely studied. This study determine prevalence, main reason for, categories and timing of TLDs in a Norwegian regional trauma setting. METHODS: A retrospective study of a 2-year cohort of 579 sTBI patients admitted to Oslo University Hospital (OUH). Prospectively collected data in the OUH Trauma Registry were combined with retrospective data from a chart review regarding TLDs. RESULTS: TLDs were documented for 101/579 sTBI patients (17%). The situation was evaluated as futile in 59 cases and as potentially inappropriate in 42 cases. The three most frequent types of TLDs were withholding of neurosurgery, do not resuscitate orders and withdrawing of organ support. In 70% of cases, the first TLD was made within 2 days after injury, while in 14%, the first TLD was made later than day 7. Twenty percent (20/101) of the first TLDs were later adjusted, revoked in 4 patients and broadening of TLDs in 16 patients. The median time from the decision to death was 2 days (range 1-652). TLDs were documented in 93% of in-hospital death cases (n = 79). In-hospital deaths occurred in 73% of TLD group cases and 1% of non-TLD group cases. Family interaction and multi-team discussions were documented in >88% of cases, but no advanced directives were found, and notifications of patients' preferences were found in only 7% of cases. DISCUSSION: Clinicians should consider limiting treatment if continued treatment is not in the patients best interest. A range of different types of TLDs were applied for patients after sTBI in the trauma hospital setting. CONCLUSION: TLDs were found in 17% of sTBI patients. Value considerations behind TLDs in this care context need to be further explored.