Definition of the problemQuality of care also includes a professional approach to ethical challenges. This involves the moral interpretation of an issue and the management of intra- and interpersonal reflection processes. Combining both is the central task of clinical ethics consultation (CEC). Despite its importance only a few studies have dealt with the appropriate methods for steering reflection processes.ArgumentsCEC requires a theory-based and methodological approach. The argumentation shows the effects that systems theory and systemic methods have on the effectiveness of (...) CEC. The main methods such as clarification of mandates and handling complexity are presented, and their impact on dealing with ethical challenges is shown through the discussion of two cases.ConclusionThe paper provides insight into systems thinking. It discusses the influence that systemic tools have on dealing with typical challenges within clinical ethics counselling. It also shows how specific counselling methods impact a normative level. (shrink)

BackgroundHow should clinical ethics support services such as clinical ethics committees (CECs) be implemented and evaluated? We argue that both the CEC itself and theimplementationof the CEC should be considered as ‘complex interventions’.Main textWe present a research project involving the implementation of CECs in community care in four Norwegian municipalities. We show that when both the CEC and its implementation are considered as complex interventions, important consequences follow – both for implementation and the study thereof. Emphasizing four such sets of (...) consequences, we argue, first, that the complexity of the intervention necessitates small-scale testing before larger-scale implementation and testing is attempted; second, that it is necessary to theorize the intervention in sufficient depth; third, that the identification of casual connections charted in so-called logic models allows the identification of factors that are vital for the intervention to succeed and which must therefore be studied; fourth, that an important part of a feasibility study must be to identify and chart as many as possible of the causally important contextual factors.ConclusionThe conceptualization of the implementation of a CEC as a complex intervention shapes the intervention and the way evaluation research should be performed, in several significant ways. We recommend that researchers consider whether a complex intervention approach is called for when studying CESS implementation and impact. (shrink)

BackgroundAmidst expanding roles in education and policy making, questions have been raised about the ability of Clinical Ethics Committees s to carry out effective ethics consultations. However recent reviews of CECs suggest that there is no uniformity to CECons and no effective means of assessing the quality of CECons. To address this gap a systematic scoping review of prevailing tools used to assess CECons was performed to foreground and guide the design of a tool to evaluate the quality of CECons.MethodsGuided (...) by Levac et al’s methodological framework for conducting scoping reviews, the research team performed independent literature reviews of accounts of assessments of CECons published in six databases. The included articles were independently analyzed using content and thematic analysis to enhance the validity of the findings.ResultsNine thousand sixty-six abstracts were identified, 617 full-text articles were reviewed, 104 articles were analyzed and four themes were identified – the purpose of the CECons evaluation, the various domains assessed, the methods of assessment used and the long-term impact of these evaluations.ConclusionThis review found prevailing assessments of CECons to be piecemeal due to variable goals, contextual factors and practical limitations. The diversity in domains assessed and tools used foregrounds the lack of minimum standards upheld to ensure baseline efficacy.To advance a contextually appropriate, culturally sensitive, program specific assessment tool to assess CECons, clear structural and competency guidelines must be established in the curation of CECons programs, to evaluate their true efficacy and maintain clinical, legal and ethical standards. (shrink)

Evaluating the feasibility and first perceived outcomes of a newly developed clinical ethics support instrument called CURA. This instrument is tailored to the needs of nurses that provide palliative care and is intended to foster both moral competences and moral resilience. This study is a descriptive cross-sectional evaluation study. Respondents consisted of nurses and nurse assistants (n = 97) following a continuing education program (course participants) and colleagues of these course participants (n = 124). Two questionnaires with five-point Likert scales (...) were used. The feasibility questionnaire was given to all respondents, the perceived outcomes questionnaire only to the course participants. Data collection took place over a period of six months. Respondents were predominantly positive on most items of the feasibility questionnaire. The steps of CURA are clearly described (84% of course participants agreed or strongly agreed, 94% of colleagues) and easy to apply (78–87%). The perceived outcomes showed that CURA helped respondents to reflect on moral challenges (71% (strongly) agreed), in perspective taking (67%), with being aware of moral challenges (63%) and in dealing with moral distress (54%). Respondents did experience organizational barriers: only half of the respondents (strongly) agreed that they could easily find time for using CURA. CURA is a feasible instrument for nurses and nurse assistants providing palliative care. However, reported difficulties in organizing and making time for reflections with CURA indicate organizational preconditions ought to be met in order to implement CURA in daily practice. Furthermore, these results indicate that CURA helps to build moral competences and fosters moral resilience. (shrink)

Evaluating the impact of clinical ethics support services remains a challenging task. 1 Against this background, we applaud the authors for developing a theoretical framework that aims to explain how repeated moral case deliberations may promote ‘practical wisdom’ in healthcare professionals and improve the quality of care in health facilities. 2 In our view, it is of particular value to draw attention to the learning processes that may be induced by ethics support services. Understanding such learning processes on the individual (...) and organisational level is a prerequisite for longitudinal research designs that may be suitable to study the impact of specific ethics support services on criteria deemed relevant in patient care. 3 In our comment, we would like to focus on one aspect, which we deem necessary to be able to explain the possible impact of ethics support on the quality of healthcare. This is the... (shrink)

BackgroundClinical ethics case consultations (CECCs) provide a structured approach in situations of ethical uncertainty or conflicts. There have been increasing calls in recent years to assess the quality of CECCs by means of empirical research. This study provides detailed data of a descriptive quantitative and qualitative evaluation of a CECC service in a department of cardiology and intensive care at a German university hospital.MethodsSemi-structured document analysis of CECCs was conducted in the period of November 1, 2018, to May 31, 2020. (...) All documents were analysed by two researchers independently.ResultsTwenty-four CECCs were requested within the study period, of which most (n = 22; 92%) had been initiated by physicians of the department. The patients were an average of 79 years old (R: 43–96), and 14 (58%) patients were female. The median length of stay prior to request was 12.5 days (R: 1–65 days). The most frequent diagnoses (several diagnoses possible) were cardiology-related (n = 29), followed by sepsis (n = 11) and cancer (n = 6). Twenty patients lacked decisional capacity. The main reason for a CECC request was uncertainty about the balancing of potential benefit and harm related to the medically indicated treatment (n = 18). Further reasons included differing views regarding the best individual treatment option between health professionals and patients (n = 3) or between different team members (n = 3). Consensus between participants could be reached in 18 (75%) consultations. The implementation of a disease specific treatment intervention was recommended in five cases. Palliative care and limitation of further disease specific interventions was recommended in 12 cases.ConclusionsTo the best of our knowledge, this is the first in-depth evaluation of a CECC service set up for an academic department of cardiology and intensive medical care. Patient characteristics and the issues deliberated during CECC provide a starting point for the development and testing of more tailored clinical ethics support services and research on CECC outcomes. (shrink)

BackgroundAs moral case deliberations (MCDs) have increasingly been implemented in health care institutions as a form of ethics support, it is relevant to know whether and how MCDs actually contribute to positive changes in care. Insight is needed on what actually happens in daily care practice following MCD sessions. This study aimed at investigating the impact of MCD and exploring how ‘impact of MCD’ should be conceptualized for future research.MethodsA multiple-case study was conducted in a care organization for people with (...) intellectual disabilities and/or acquired brain injury, by observing MCD sessions as ‘cases’, followed by interviews with health care professionals concerning the follow-up to these cases, and a focus group with involved MCD facilitators. A conceptual scheme concerning the possible impact formed the basis for analysis: (1) individual moral awareness; (2) the actions of health care professionals; (3) collaboration among health care professionals; (4) the concrete situation of the client; (5) the client’s quality of care and life; (6) the organizational and policy level.ResultsAccording to interviewees, their moral awareness and their collaboration, both among colleagues and with clients’ relatives, improved after MCD. Perceived impact on client situation, quality of care/life and the organizational level varied among interviewees or was difficult to define or link to MCD. Three aspects were added to the conceptual scheme concerning the impact of MCD: (a) preparations and expectations prior to the MCD session; (b) a translational step between the conclusions of the MCD session and practical events in the following period, and (c) collaboration with clients’ relatives. A negative impact of MCD was also found on misunderstandings among participants and disappointment about lack of follow-up.ConclusionsConcretizing and conceptualizing the ‘impact’ of MCD is complicated as many factors play a role either before or during the transition from MCD to practice. It is important to consider ‘impact’ in a broad sense and to relate it to the goals and context of the MCD in question. Future studies in this field should pay additional attention to the preparations, content and process involved in ethics support, including clients’ and relatives’ experiences. (shrink)

This article presents an ethics support instrument for healthcare professionals called CURA. It is designed with a focus on and together with nurses and nurse assistants in palliative care. First, we shortly go into the background and the development study of the instrument. Next, we describe the four steps CURA prescribes for ethical reflection: (1) Concentrate, (2) Unrush, (3) Reflect, and (4) Act. In order to demonstrate how CURA can structure a moral reflection among caregivers, we discuss how a case (...) was discussed with CURA at a psychogeriatric ward of an elderly care home. Furthermore, we go into some considerations regarding the use of the instrument in clinical practice. Finally, we focus on the need for further research on the effectiveness and implementation of CURA. (shrink)

There is a claim that clinical ethics support services (CESS) improve healthcare quality within healthcare organisations. However, there is lack of strong evidence supporting this claim. Rather, the current focus is on the quality of CESS themselves or on individual learning outcomes. In response, this article proposes a theoretical framework leading to empirical hypotheses that describe the relationship between a specific type of CESS, moral case deliberation and the quality of care at the organisational level. We combine insights from the (...) literature on CESS, organisational learning and quality improvement and argue that moral case deliberation causes healthcare professionals to acquire practical wisdom. At the organisational level, where improving quality is a continuous and collective endeavour, this practical wisdom can be aggregated into morisprudence, which is an ongoing formulation of moral judgements across cases encountered within the organisation. Focusing on the development of morisprudence enables refined scrutinisation of CESS-related quality claims. (shrink)

Since the 1980s, there has been an increasing acknowledgement of the importance of recognising the ethical dimension of clinical decision-making. Medical professional regulatory authorities in some countries now include ethical knowledge and practice in their required competencies for undergraduate and post graduate medical training. Educational interventions and clinical ethics support services have been developed to support and improve ethical decision making in clinical practice, but research evaluating the effectiveness of these interventions has been limited. We undertook a systematic review of (...) the published literature on measures or models of evaluation used to assess the impact of interventions to improve ethical decision making in clinical care. We identified a range of measures to evaluate educational interventions, and one tool used to evaluate a clinical ethics support intervention. Most measures did not evaluate the key impact of interest, that is the quality of ethical decision making in real-world clinical practice. We describe the results of our review and reflect on the challenges of assessing ethical decision making in clinical practice that face both developers of educational and support interventions and the regulatory organisations that set and assess competency standards. (shrink)

This study explores the impact of participation in a series of moral case deliberations (MCD) on the moral craftsmanship (MCS) of Dutch prison staff. Between 2017–2020, ten MCDs per team were implemented in three prisons (i.e., intervention group). In three other prisons (i.e., control group) no MCDs were implemented. We compared the intervention and control group using a self-developed questionnaire, administered before (pre-measurement) and after the series of MCDs (post-measurement). Results After the MCDs, participants scored significantly higher on 7 of (...) the 70 items related to MCS. On some items there were significant impact differences between the various professional disciplines. Discussion Possible explanations for a relatively low impact are discussed. A shorter and validated questionnaire is needed in order to further study the MCS of professionals and the impact of Ethics Support Services (ESS). Conclusions There was a positive development on some elements of MCS after participation in a series of MCDs. (shrink)

BackgroundClinical ethics consultations can be complex interventions, involving multiple methods, stakeholders, and competing ethical values. Despite longstanding calls for rigorous evaluation in the field, progress has been limited. The Medical Research Council proposed guidelines for evaluating the effectiveness of complex interventions. The evaluation of CEC may benefit from application of the MRC framework to advance the transparency and methodological rigor of this field. A first step is to understand the outcomes measured in evaluations of CEC in healthcare settings. ObjectiveThe primary (...) objective of this review was to identify and map the outcomes reported in primary studies of CEC. The secondary objective was to provide a comprehensive overview of CEC structures, processes, and roles to enhance understanding and to inform standardization.MethodsWe searched electronic databases to identify primary studies of CEC involving patients, substitute decision-makers and/or family members, clinicians, healthcare staff and leaders. Outcomes were mapped across five conceptual domains as identified a priori based on our clinical ethics experience and preliminary literature searches and revised based on our emerging interpretation of the data. These domains included personal factors, process factors, clinical factors, quality, and resource factors. ResultsForty-eight studies were included in the review. Studies were highly heterogeneous and varied considerably regarding format and process of ethical intervention, credentials of interventionist, population of study, outcomes reported, and measures employed. In addition, few studies used validated measurement tools. The top three outcome domains that studies reported on were quality, process factors, and clinical factors. The majority of studies examined multiple outcome domains. All five outcome domains were multidimensional and included a variety of subthemes.ConclusionsThis scoping review represents the initial phase of mapping the outcomes reported in primary studies of CEC and identifying gaps in the evidence. The confirmed lack of standardization represents a hindrance to the provision of high quality intervention and CEC scientific progress. Insights gained can inform the development of a core outcome set to standardize outcome measures in CEC evaluation research and enable scientifically rigorous efficacy trials of CEC. (shrink)

Background: Clinical ethics support services have been advocated in recent decades. In clinical practice, clinical ethics support services are often requested for difficult decisions near the end of life. However, their contribution to improving healthcare has been questioned and demands for evaluation have been put forward. Research indicates that there are considerable challenges associated with defining adequate outcomes for clinical ethics support services. In this systematic review, we report findings of qualitative studies and surveys, which have been conducted to evaluate (...) clinical ethics support services near the end of life. Methods: Electronic databases and other sources were queried from 1970 to May 2018. Two authors screened studies independently. Methodological quality of studies was assessed. For each arm of the review, an individual synthesis was performed. Prospero ID: CRD42016036241. Ethical Considerations: Ethical approval is not needed as it is a systematic review of published literature. Results: In all, 2088 hits on surveys and 2786 on qualitative studies were found. After screening, nine surveys and four qualitative studies were included. Survey studies report overall positive findings using a very wide and heterogeneous range of outcomes. Negative results were reported only occasionally. However, methodological quality and conceptual justification of used outcomes was often weak and limits generalizability of results. Conclusion: Evidence points to positive outcomes of clinical ethics support services. However, methodological quality needs to be improved. Further qualitative or mixed-method research on evaluating clinical ethics support services may contribute to the development of evaluating outcomes of clinical ethics support services by means of broaden the range of appropriate (process-oriented) outcomes of (different types of) clinical ethics support services. (shrink)

Evaluation of clinical ethical case consultations has been discussed as an important research task in recent decades. A rigid framework of evaluation is essential to improve quality of consultations and, thus, quality of patient care. Different approaches to evaluate those services appropriately and to determine adequate empirical endpoints have been proposed. A key challenge is to provide an answer to the question as to which empirical endpoints—and for what reasons—should be considered when evaluating the quality of a service. In this (...) paper, we argue for an approach that adopts the role of ethics consultants as its point of departure. In a first step, we describe empirical and ethical characteristics of evaluating clinical ethical case. We show that the mode of action and the explicit normative character of the interventions constitute two characteristics which pose challenges to the selection of appropriate quality criteria and require special attention. In a second step, we outline the way in which an analysis of the role of ethics consultants in the context of a clinical ethical case consultation services can account for the existing challenges by linking empirically measurable endpoints with normative theory. Finally, we discuss practical implications of our model for evaluation research. (shrink)

In their national follow-up study on ethics consultation in the U.S., Fox et al. report the worrying finding of a decline in efforts to evaluate ECs. Compared to the findings of Fox et...

Background Non-adherence to medication is associated with increased risk of relapse in patients with bipolar disorder. Objectives To validate patient-evaluated adherence to medication measured via smartphones against validated adherence questionnaire; and investigate characteristics for adherence to medication measured via smartphones. Methods Patients with BD evaluated adherence to medication daily for 6–9 months via smartphones. The Medication Adherence Rating Scale and the Rogers’ Empowerment questionnaires were filled out. The 17-item Hamilton Depression Rating Scale, the Young Mania Rating Scale and the Functional (...) Assessment Short Test were clinically rated. Data were collected multiple times per patient. The present study represents exploratory pooled reanalyses of data collected as part of two randomised controlled trials. Findings During the study 90.50% of the days were evaluated as ‘medication taken’, 6.91% as ‘medication taken with changes’ and 2.59% as ‘medication not taken’. Adherence to medication measured via smartphones was valid compared with the MARS. Younger age and longer illness duration were significant predictors for non-adherence to medication. Decreased affective symptoms measured with smartphone-based patient-reported mood and clinical ratings as well as decreased empowerment were associated with non-adherence. Conclusions Smartphone-based monitoring of adherence to medication was valid compared with validated adherence questionnaire. Younger age and longer illness duration were predictors for non-adherence. Increased empowerment was associated with adherence. Clinical implications Using smartphones for empowerment of adherence using patient-reported measures may be helpful in everyday clinical settings. Trial registration number NCT01446406 and NCT02221336. (shrink)

BackgroundClinical Ethics Support services are offered to support healthcare professionals in dealing with ethically difficult situations. Evaluation of CES is important to understand if it is indeed a supportive service in order to inform and improve future implementation of CES. Yet, methods to measure outcomes of CES are scarce. In 2014, the European Moral Case Deliberation Outcomes Instrument was developed to measure outcomes of Moral Case Deliberation. To further validate the instrument, we tested it in field studies and revised it. (...) This paper presents the Euro-MCD 2.0 and describes the revision process.MethodsThe revision process comprised an iterative dialogue among the authors as Euro-MCD-project team, including empirical findings from six Euro-MCD field-studies and input from European experts in CES and theory. Empirical findings contained perceptions and experiences of MCD outcomes among healthcare professionals who participated in MCDs in various settings in Norway, Sweden and the Netherlands. Theoretical viewpoints on CES, literature on goals of CES and MCD and ethics theory guided the interpretation of the empirical findings and final selection of MCD outcomes.ResultsThe Euro-MCD 2.0 Instrument includes three domains: Moral Competence, Moral Teamwork and Moral Action. Moral Competence consists of items about moral sensitivity, analytical skills and virtuous attitude. Moral Teamwork includes open dialogue and supportive relationships and Moral Action refers to moral decision-making and responsible care. During the revision process, we made decisions about adding and reformulating items as well as decreasing the number from 26 to 15 items. We also altered the sentence structure of items to assess the current status of outcomes instead of an assumed improvement over time and we omitted the question about perceived importance.ConclusionsThe Euro-MCD 2.0 is shorter, less complex and more strongly substantiated by an integration of empirical findings, theoretical reflections and dialogues with participants and experts. Use of the Euro-MCD 2.0 will facilitate evaluation of MCD and can thereby monitor and foster implementation and quality of MCD. The Euro-MCD 2.0 will strengthen future research on evaluation of outcomes of MCD. (shrink)

Ethics support services like Moral Case Deliberation intend to support healthcare professionals in ethically difficult situations. To assess outcomes of MCD, the Euro-MCD Instrument has been developed. Field studies to test this instrument are needed and have been conducted, examining important outcomes before MCD participation and experienced outcomes. The current study aimed to describe how participants’ perceive the importance of MCD outcomes after MCD; compare these perceptions with those before MCD participation; and test the factor structure of these outcomes. Swedish, (...) Norwegian and Dutch healthcare professionals rated the importance of outcomes in the Euro-MCD Instrument after four and eight MCDs. Ratings were compared with those before MCD participation using paired and independent samples t-tests. The factor structure was tested using exploratory factor analyses. After 4 and 8 MCDs, 443 respectively 247 respondents completed the instrument. More than 69% rated all MCD outcomes as ‘quite’ or ‘very’ important, especially outcomes from Enhanced Collaboration, Improved Moral Reflexivity and Improved Moral Attitude. Significant differences for 16 outcomes regarding ratings before and after MCD participation were not considered meaningful. Factor analyses suggested three categories, which seemingly resemble the domains Improved Moral Reflexivity, Enhanced Collaboration and a combination of Improved Moral Attitude and Enhanced Emotional Support. After participation in MCDs, respondents confirmed the importance of outcomes in the Euro-MCD Instrument. The question on perceived importance and the categorization of outcomes need reconsideration. The revised instrument will be presented elsewhere, based on all field studies and theoretical reflections. (shrink)